Environmental Health Division
Health Risk Assessment Unit
651-201-4899
[email protected]
2010-2011 HRL RULE AMENDMENT
COMMENTS RECEIVED AND MDH RESPONSES
Exhibit J
J1. Overview:
Minnesota Rules 1400.2310, subpart J requires that MDH submit to the Office of Administrative
Hearings “all written comments and submissions on the proposed rule received during the
comment period, requests for hearing, and withdrawals of requests for hearing received by the
agency, except those that only requested copies of documents.” This Exhibit J contains the
following:
Summary of Comments Received and MDH’s Responses to Comments:
During the official 30-day comment period MDH received comments that fell into three categories:
objections from the 3M Company to the perfluorochemical Health Risk Limits (HRLs); objections
from the Minnesota Center for Environmental Advocacy (MCEA) to the HRL for acetochlor
degradates; and objections from five organizations and 37 individuals to the proposed repeal of the
existing Health Risk Limit (HRL) value for manganese (Part 4717.7500, subpart 61). Exhibit J2
summarizes the comments received and MDH’s responses.
MDH Response to Requests for a Public Hearing:
MDH received 35 requests for hearing. All but three of the requests objected to the repeal of the
manganese HRL from the current rules. MDH considered all comments and information received
during the official comment period, and determined one change was warranted. Exhibit J3
describes MDH’s decision about this one, albeit insubstantial, change that MDH made to the
proposed rules.
Withdrawals of Requests for a Public Hearing:
Exhibit J4 includes the fourteen hearing withdrawals that MDH received in response to its decision
to retain the HRL value for manganese. MDH canceled the hearing with the appropriate subsequent
notification.
All Public Correspondence Received:
After receiving rule-related comments and requests for a public hearing, MDH posted the
correspondence received on MDH’s rules webpage. 1 Exhibit J5 compiles all official
correspondence MDH received, grouped by those who submitted it.
1
http://www.health.state.mn.us/divs/eh/risk/rules/water/publicinput.html#commentdual
Page 1 of 17
J2. Summary of Comments Received and MDH’s Responses to Comments:
MDH received the following sets of comments in response to the proposed HRL rules (Minnesota
Rules, Chapter 4717. Parts 7860 and 7500) and the Dual Notice of Intent to Adopt Rules that was
published in the State Register on October 22, 2010. The comments are summarized below
followed by MDH responses.
Part 1: Responses to comments from 3M on the proposed HRLs for two
perfluorochemicals, PFBA and PFBS
1.1. Intake rate
Comment:
Commenter states that MDH inappropriately used an intake rate based on infants in deriving
the proposed short-term HRL.
Response:
This comment is outside the scope of the current rules revision because it objects to the
underlying methodology that MDH adopted in the last rules revision. MDH followed its
adopted methodology and used an infant’s intake rate to derive the proposed HRL for shortterm exposure. This is consistent with the default intake rate for short-term durations and
protection of subpopulations at elevated risk due to increased exposure (See Minnesota Rules
4717.7820 subparts 9A(2) and 14. Also see 2008 SONAR, pages 48-50). Therefore, this
comment is not relevant and MDH makes no change.
1.2. Other intake rates used for PFBA
Comment:
MDH used intake rates that are inappropriate to derive the draft HRL for PFBA because such
rates are not used by other agencies.
Response:
This comment, too, objects to the methodology that MDH adopted in 2009, which is outside the
scope of the current rules revision. The rationale for intake rate selection is discussed in
exposure durations (See Minnesota Rules 4717.7830. Also see 2008 SONAR, page 45-46).
MDH notes that the California Environmental Protection Agency also uses 95th percentile
intake rates, including infant intake rates, to derive Public Health Goals for drinking water.
Using either an intake rate of 0.285 L/kg-day or 0.289 L/kg-day results in the same proposed
PFBA short-term HRL value (7 μg/L). Therefore, this comment is not relevant and MDH
makes no change.
Page 2 of 17
1.3. PFBA reference dose
a) Endpoints
Comment:
The PFBA reference dose that MDH calculated uses overly conservative assumptions about the
health effects that PFBA has on the human body. The specifics follow.
Liver:
Comment:
MDH assumes that increased liver weight is a critical effect of PFBA. However, liver enlargement
was not associated with clinical chemistry or histological evidence of liver toxicity.
Response:
This comment overlooks important factors. First, MDH identified structural (morphological
changes) and liver weight changes that are critical effects for the calculated subchronic and chronic
duration Reference Doses (RfDs) (See 2010 SONAR, Appendix E - chemical summary sheet for
PFBA, pages 129-137).
Second, MDH used the methodology that it adopted in the last revision (See 2008 SONAR, pages 8
and 82). Thus, when the calculated short-term HRL is lower than a calculated the longer-term
subchronic or chronic duration HRL, the subchronic or chronic duration value is set equal to the
lower, short-term value. To be protective of short-term exposures, MDH set both the subchronic and
chronic proposed PFBA HRLs equal to the short-term proposed HRL. The critical effect for the
short-term duration is changes in cholesterol levels, not liver weight changes. MDH stands behind
these calculations and makes no change.
Thyroid:
Comment:
MDH states that PFBA produced thyroid hormone and thyroid gland changes. Hypothyroxinemia
(changes in serum total thyroid hormone levels) observed in rats, however, was not accompanied by
evidence of hypothyroidism.
Response:
This comment fails to acknowledge that decreases in circulating levels of thyroxine (T4) are of
concern. Thyroxine functions in controlling metabolism (e.g. increases basal metabolic rate) as well
as influencing neurological development. Epidemiological and experimental evidence identifies
hypothyroxinemia (low circulating free T4, whether or not thyroid stimulating hormone [TSH] is
altered) as a serious risk factor for poor neuropsychological development. Without sufficient data to
the contrary, MDH will consider the hypothyroxinemia (decreased T4) observed in rats to be
relevant to humans.
The commenter also states that “MDH mistakenly states in its subchronic calculations that thyroid
weights were increased in the 90-day study, and MDH refers to such effects in the 90-day study as
secondary effects.”
Page 3 of 17
The 90-day study does form the basis of the subchronic calculations. However, results from other
toxicity studies are also considered when identifying potential health effects. Effects observed at
doses up to or similar in magnitude to the dose level associated with the critical effect are identified
as co-critical effects (See 2008 SONAR Section IV.C.2, page 29). These effects can be observed in
the critical study or in other studies. MDH identified increased relative thyroid weight to be a co­
critical effect based on observations made in the 28-day, not the 90-day study. MDH stands by its
calculation and makes no change.
Cholesterol Reduction:
Comment:
Although PFBA reduced serum total cholesterol in the 28-day study, this effect was not seen in the
90-day study. While the effect was not replicated in the longer study the relevance to humans must
be examined.
Response:
MDH’s public health-protective approach is consistent with current risk assessment methodology.
The commenter cites a study (Bjork and Wallace 2009) as direct evidence that the hepatic (liver)
effects observed in rats are not relevant to humans. This study evaluated gene transcription in
human and rat liver cells in culture. MDH, however, also considered studies conducted in whole
animals using genetically modified mice (mice that have been engineered to express human hepatic
characteristics) to make them relevant to human physiology. These studies suggest that some
hepatic effects (e.g., increased liver weight and hypertrophy [enlargement due to increased size of
cells]) are similar between “wild type” (unmodified) mice and “humanized” mice, while others (e.g.,
hyperplasia [enlargement due to increased number of cells] and focal necrosis [occurrence of
numerous, well circumscribed foci of necrosis or cell death]) are not. More work is needed to
understand the mechanisms of action, multiple effects, and relevance to humans. Without sufficient
data, MDH will continue to consider these hepatic effects relevant to humans. MDH stands by its
assessment and makes no change.
b) Application of the Human Equivalent Dose (HED) methodology
Comment:
The PFBA reference dose that MDH calculated is overly conservative because it uses an unusual “dose
metric” adjustment for animal-to-human extrapolation. It is unclear why MDH applies this adjustment
for PFBA and not for other chemicals.
Response:
This comment is outside of the current rules revision because it objects to MDH’s 2009 methodology
that it adopted in the last rules revision. The process that MDH used to derive RfDs, including the
calculation of a Human Equivalent Dose (HED) is described in the 2008 SONAR (See Section IV.C.2,
page 30). Additional details are also provided in the U.S. Environmental Protection Agency (EPA)
documents cited within Section IV of the 2008 SONAR. MDH prefers to use chemical-specific
information in place of applying default approaches. MDH identified PFBA and PFBS as chemicals for
which sufficient chemical-specific information is available. MDH also used chemical-specific
information in the previous rules revision for calculating HEDs for PFOA and PFOS. Sufficient
chemical-specific information is not available for all chemicals.
Page 4 of 17
The proposed methodology, including the calculation of HEDs, is based on the best available science
and most current risk assessment methodology. MDH stands by its HED calculations for PFBA and
PFBS as the best value that it can justify based on the current science available.
c) Uncertainty Factors
Comment:
MDH calculated its PFBA reference dose using uncertainty factors that are overly conservative. The
specifics follow:
Short-term Exposure:
Comment: The rationale offered for the “database insufficiencies” is that the 28-day study did not
identify a No Observable Adverse Effect Level (NOAEL) or acceptable benchmark dose for thyroid
effects. This is not correct. Dr. Gaylor’s benchmark dose calculations for the 28-day study
submitted to MDH provided BMDL10 values for both TT4 and FT4. The BMDL10 values are 54 and
69 mg/kg-d, respectively. Thus the justification for an added database uncertainty factor is not
apparent.
Response:
MDH evaluated the benchmark dose modeling (BMD) that 3M submitted. Benchmark dose
modeling uses mathematical models to determine the dose associated with a certain effect in
exposed animals compared to control or unexposed animals (See 2008 SONAR page 29). Including
data from control animals is essential in determining the significance of changes observed in
exposed animals. The modeling results that 3M referred to here were generated by deleting the
control data from the modeling run. Modeling results that do not include control data are not
appropriate to use as a point of departure (See 2008 SONAR, page 116). MDH staff confirmed with
an EPA expert that modeling results generated without control data should not be used.
Significant decreases in thyroxine (T4) were observed at all dose levels tested. Therefore MDH
could not identify a threshold dose (a dose at which the significant changes are no longer observed).
Without having appropriate BMD modeling or a threshold dose for alterations in T4 levels, MDH
applied an uncertainty factor to compensate for database insufficiency. Under the methodology
adopted in the last revision (See 2008 SONAR, page 32), MDH may apply a database uncertainty
factor to address deficiencies that potentially yield a lower point of departure. MDH applied this
database uncertainty out of concern that additional data regarding a threshold for T4 effects might
result in a lower point of departure. This method is consistent with current risk assessment practice.
MDH stands by its application of a database uncertainty factor of 3.
Subchronic Exposure:
Comment:
MDH indicates that the assessment of thyroid hormones “was compromised by missing serum
hormone data.” MDH takes this position while also contending that thyroid hormone effects are co­
critical effects.
Page 5 of 17
Response:
Under the methodology adopted in the last revision (See 2008 SONAR, pages 8 and 82), when the
calculated short-term proposed HRL is lower than a calculated longer-term subchronic or chronic
duration proposed HRL, the subchronic or chronic duration value is set equal to the lower, shortterm value. Therefore, regardless of whether MDH incorporates a database uncertainty factor into
the calculations of the subchronic value, the resulting subchronic value would be set to the lower
short-term proposed HRL of 7 μg/L.
1.4. Intake Rates Used for PFBS
Comment:
MDH inappropriately uses an infant intake rate when developmental effects are not at issue.
Response:
See response 1.1.
1.5 Critical effects and point of departure of PFBS reference dose
a) Critical Effects
Comment:
The critical point of departure used in deriving the PFBS reference dose is inappropriate. – 200
mg/kg-d rather than 60 mg/kg-d is the appropriate NOAEL (No Observable Adverse Effect Level).
Response:
MDH selected 60 mg/kg-day as the NOAEL based on decreased hemoglobin (oxygen-carrying protein
in red blood cells) and hematocrit (the proportion of blood that consists of red blood cells) observed in
laboratory animals exposed at the next highest dose level (200 mg/kg-d). The authors of the published
90-day study (Lieder et al 2009) also identified 60 mg/kg-day as an NOAEL. MDH stands by its
NOAEL determination.
Comment:
It is inappropriate for MDH to rely on increased liver weight and hepatocellular hypertrophy as co­
critical effects, particularly when considering human relevance.
Response:
See Response 1.3.a. Cholesterol Reduction. MDH stands by its decision to list liver weight and cell
enlargement (hypertrophy) as co-critical effects.
b) Uncertainty Factors
Comment:
MDH’s application of a database uncertainty factor of 3 based on the need for further studies of
neurological and thyroid effects is not warranted.
Response:
Page 6 of 17
MDH disagrees. In applying a database uncertainty factor, MDH considers chemical-specific evidence
of thyroid effects but also considers whether researchers have observed related chemicals to have
thyroid effects. Observers have seen thyroid effects for several perfluorinated compounds. MDH
determined the need for additional neurological research based on the results of the peripheral
neuropathy evaluation conducted in the 28-day study (Primedica Redfield report 2001). The comment
refers to the neurological assessment in the 90-day study conducted by different investigators (York
2002, Argus Research), which did not include an equivalent peripheral neuropathy evaluation.
`
As stated in Response 1.3.c. above, MDH may apply a database uncertainty factor to address data
deficiencies that potentially yield a lower point of departure. Applying a database uncertainty factor to
address concerns that additional data regarding thyroid and neurological effects might result in a lower
point of departure is consistent with current risk assessment practice. MDH stands by its application of
a database uncertainty factor of 3.
Comment:
MDH’s application of an uncertainty factor of 3 based on the absence of a chronic study is not
necessary since the database includes a full two-generation reproductive study (Lieder et al 2009)
Response:
MDH disagrees. As described in the 2010 SONAR (page 63), MDH considers several factors when
extrapolating from a subchronic to a chronic duration. Included among these factors is whether data
indicating other, additional sensitive health effects appear as the duration of exposure increases. As
explained in the chemical summary sheet for PFBA (See 2010 SONAR, Appendix E, pages 138-144)
researchers observed additional effects in blood (decreased hemoglobin and hematocrit) in the longer
90-day study, but did not observe these effects following shorter exposure durations.
The comment suggests that the full two-generation reproductive study should suffice as a chronic
study. The two-generation reproductive study, however, falls short because it focused on reproductive
outcomes. While the two-generation study included an evaluation of body weight, clinical chemistry,
organ weights and tissue changes that developed over the reproductive period, the study did not
include a blood-related assessment (e.g. hemoglobin, hematocrit, etc.) necessary to determine whether
these endpoints, which only begin to show up after 90 days, would become more severe within a
chronic duration of exposure. MDH stands behind its determination.
Part 2: Responses to comments from the Minnesota Center for Environmental Advocacy
(MCEA) on the proposed 2010 HRL rules
2.1. The number of chemicals
Comment:
MDH proposed HRLs for too few chemicals (14 compared to the 230 previously “identified”)
Page 7 of 17
Response:
MDH notes that this comment is outside the scope of this work but points out that these proposed rules
represent the second round in a multi-phase process to add more chemicals to the HRL rules using the
methodology adopted in 2009. Using the 2009 revised methodology, which is superior to the 1993
methodology, requires more labor for each chemical reviewed, resulting in a longer chemical review
process. MDH has recognized for some time that bringing the HRLs up to date requires a multi-phase
approach. For this and future rule making, MDH selects chemicals with advice from representatives of
other state agency environmental programs and conducts these assessments in an order based on
priorities suggested by the agencies. MDH intends to begin the next rule amendment within one year of
completing the current rule revision.
2.2. Acetochlor ESA and OXA
Comment:
Commenter states that acetochlor ESA and OXA should not have their own chemical-specific guidance
values. MDH should instead recommend the default approach of using the parent (acetochlor) guidance
values.
Response:
MDH proposes Health Risk Limits for contaminants that meet two criteria: 1) contaminants are found in
Minnesota groundwater and 2) there are adequate mammalian toxicological studies available.
Acetochlor ESA and OXA, which result from acetochlor degrading in the environment, met these
criteria and MDH evaluated them using the established methodology.
MDH has assessed some pesticide degradates that lack toxicological data and were assigned the parent
compound’s guidance values, however these chemicals that are not part of this revision
2.3. Lower HRL values
Comment:
MDH should use lower HRL values for select chemicals (noted below):
o Alachlor
o Atrazine
o Benzene
o Chloroform
o cis-1,2-DCE
o Nitrates (based on outdated federal standard)
o PCP (pentachlorophenol)
o 1,1,1-TCA
o 2-(2,4,5-trichlorophenoxy) propionic acid
o Vinyl chloride
Response:
HRLs for all of the chemicals listed above were adopted into rule in 2009. Therefore, these comments
are outside the scope of the 2010 HRL rules revision.
Page 8 of 17
2.4. Additional lifetime cancer risk
Comment:
MDH should use 10-6 additional lifetime cancer risk.
Response:
Since the 1970s MDH has used 10-5 (one in 100,000) as the additional lifetime cancer risk for nonthreshold (linear) carcinogens and since 1993 MDH has adopted rules that use the value in the methods
sections, including the 2009 rules revision. None of the 14 proposed HRL chemicals were determined to
be a non-threshold (linear) carcinogen and therefore none considered an additional lifetime risk for
cancer. Additional lifetime cancer risk is therefore not within the scope this current rules revision.
Part 3: Responses to comments from citizens and organizations on MDH’s proposed repeal of
HRL value for manganese
3.1 Proposed repeal of adopted 1993 HRL value for manganese of 100 μg/L leaves in place a higher
unpromulgated value of 300 μg/L, a higher guidance value.
Comment:
The proposed repeal of the 1993 HRL value of 100 μg/L for manganese (Minnesota Rules, Chapter
4717, Part 7500, Subpart 61), would leave in place Risk Assessment Advice (RAA) of 300 μg/ L, an
unpromulgated guidance value. This would result in a higher value and therefore pose greater
vulnerability and risk to public health.
Response:
The citizens who made this comment persuaded MDH not to repeal the 1993 HRL value of 100 µg/L for
manganese as originally proposed in the 2010 rule revision. Some commenters brought a new study to
MDH risk assessors’ attention during the official 30-day comment period. The study by Bouchard and
coauthors 2, which was published in September 2010, showed an association between exposure to
manganese in drinking water and children’s IQ levels. The study showed that these adverse effects were
associated with a lower concentration of manganese in drinking water than previous studies observed —
as low as 100 µg/L. These reported levels are lower than the MDH risk assessment advice that MDH
based on the US EPA Health Advisory value of 300 µg/L. Consequently, MDH has withdrawn its
intended repeal of the 1993 HRL of 100 µg/L until it has reviewed manganese further.
3.2 MDH authority to repeal HRL values for contaminants with systemic human toxicity
Comment:
MDH does not have the authority to repeal HRL values for contaminants with systemic human toxicity
(See Exhibit J, page 171)
2
Bouchard MF, Sauvé S, Barbeau B, Legrand M, Brodeur M-È, et al. 2010 Intellectual Impairment in School-Age
Children Exposed to Manganese from Drinking Water. Environ Health Perspect doi:10.1289/ehp.1002321
Page 9 of 17
Response:
The Groundwater Protection Act of 1989 (Minnesota Statutes, section 103H.201, subd. (1)(a))
authorizes MDH to adopt HRLs. Further, Minnesota Statutes, section 103H.201, subd. (3)(a) and (b),
authorize MDH to review and revise HRLs (See 2010 SONAR, pages 2-3).
3.3 Previous MDH guidance for manganese –
Comment:
Commenters note confusion about previous MDH guidance for manganese – health based values (i.e.
1993 HRL of 100 µg/L, 1997 Risk Assessment Advice of 1,000 µg/L, 2008 Risk Assessment Advice of
300 µg/L)
Response:
This comment is no longer relevant since MDH has decided not to repeal the 1993 HRL for manganese.
3.4 Proposed mining activities in Northern Minnesota
Comment:
The proposed mining activities in Northern Minnesota could result in increased manganese pollution
and put the public at risk.
Response:
Concern about the potential impact of proposed mining activities in Northern Minnesota mentioned by
commenters falls outside the scope of MDH’s 2010 proposed rules.
3.5 No public meeting
Comment:
The proposed rules revision is taking place without a public meeting.
Response:
MDH hosted a public meeting on the proposed rules on May 19, 2010, and notified those who subscribe
to MDH’s electronic subscription list on groundwater rules, guidance and chemical review updates.
MDH also notified stakeholders who had expressed an interest in the HRL rule activities in the past. A
summary of the information presented and discussed at this stakeholder meeting is posted on the MDH
HRL rules related webpage (See
http://www.health.state.mn.us/divs/eh/risk/rules/water/publicinput.html#stakeholder )
Part 4: Responses to other comments from citizens on MDH’s proposed HRL rules
MDH received additional comments from citizens and determined that they are beyond the scope
of the 2010 proposed rules.
4.1 MDH guidance, Risk Assessment Advice (RAA)
Page 10 of 17
Comment:
MDH guidance, RAA, has not been promulgated and is not enforceable.
Response:
This comment is outside of the scope of the proposed rules revision.
4.2 The cumulative effects of toxins
Comment:
The rules do not address the cumulative effects of the other toxins that are listed in the rules changes
when there are simultaneous exposures to multiple toxicants, including manganese. The Minnesota
Department of Health should be advocating for the reduction of all such toxins.
Response:
The methodology adopted in 2009 addresses exposure to multiple chemicals with similar health effects
(See the Health Risk Limits Rules for Groundwater, Minnesota Rules, Chapter 4717. 7880 and 7890).
The 2009 rules concerning exposures to multiple chemicals are applied by risk managers to evaluate
specific mixtures of chemicals that are found in groundwater. MDH does not have evidence that there is
a specific mixture of manganese plus other chemicals that should be assessed in a manner that is not
already addressed in the HRL rules.
4.3 Commenter is concerned about body exposures to chemicals and the use of animal testing to
determine the chemical toxicity. (See Exhibit J5, page 136)
Response:
This issue is outside of the scope of the rules revision.
4.4 Loosened standards
Comment:
Eight of the proposed HRLs loosen or repeal standards. For example, the HRL value for acetone will
change from 700 ug/L to 4,000 ug/L (See Exhibit J5, page 121)
Response:
The HRL values proposed in the 2010 rules are based on up-to-date science and risk assessment
methods. Previous values were based on knowledge that existed at the time they were adopted.
Subsequent values may go up or down, based on new studies that provide new information. For
example, chemicals may be less toxic when ingested from drinking water than when inhaled from the
air, or vice versa. A new study might clarify which route is more toxic, and guidance might shift up or
down based on that information. Sometimes our understanding of how a chemical reacts in the body
might also warrant a change in a value. New methodologies used to assess the hazard of chemicals
might also change and that can determine whether a value goes up or down compared to a previous
value. MDH proposes values based on what current science supports.
Page 11 of 17
J3. MDH Response to Requests for a Public Hearing:
MDH received 35 requests for hearing related to the 2010 HRL rules revision. The majority of the
hearing requests (chart of requestors noted below) expressed concern about the regulatory and
health impacts of repealing the 1993 HRL of 100 µg/L for manganese (Part 4717.7500, subpart 61).
Commenters were concerned that the only other recommendation was a higher value of 300 µg/L
(advice offered by the US Environmental Protection Agency (EPA) and MDH since 2004).
The citizens who requested the hearing brought new information about the health effects of
manganese to MDH risk assessors’ attention during the official comment period. The new
information, a study by Bouchard released in September of 2010, showed an association between
exposure to manganese in drinking water and a decrease in children’s IQ levels. The effects in this
study were associated with a lower concentration (100 ug/L) of manganese in drinking water than
previously observed in similar studies and lower than the US EPA Health Advisory value of 300
µg/L. MDH found that this new information introduced uncertainty about what level of manganese
in drinking water could result in neurological effects in children. This new information persuaded
MDH staff to step back from its intended repeal of the 1993 manganese value until it has reviewed
the chemical and research further. MDH amended its proposed rules to remove the repealer for
manganese.
The following individuals and organizations requested a hearing:
Requests for Hearing Related to Manganese (See Exhibit J5)
Name
Page
Name
no.
Andresen
34
Muller
Arneson
44
Norrgard
Aspelund
46
Palcich
Audubon Minnesota
48
Palkovich
Austerheim
51
Save Lake Superior
Environment Minnesota
55
Association
Fride
62
Szymialis
Graves
66
Tammen
Heck, E
73
Vastveit, C
Heck, P
76
Vastveit, H
Johnson, C
81
Vastveit, K
Johnson, D
86
Vegemast
Koschak, J
90
Water Legacy
Koschak, S
95
Wegscheid
Kram
97
Winters, K
Larsen
99
Winters, M
Mosman
115
Page no.
121
131
135
140
146
151
155
158
160
162
165
168
178
180
182
In addition, MDH also received additional requests for hearing on the proposed rules from three
other individuals which are outside the scope of the proposed rules.
Page 12 of 17
Other Requests for Hearing (See Exhibit J5)
Name
Page
no.
Akembuom
31
Dezurik
60
Moua
19
Page 13 of 17
J4. Withdrawals of Requests for a Public Hearing:
MDH received scientific data and a substantial number of comments about retaining the HRL for
manganese. MDH found that the request from the public had scientific merit and decided to retain
the HRL of 100 µg/L in rule pending a subsequent review. MDH sent e-mails describing this
decision (attached, see following pages) to those who asked for a hearing on the issue of
manganese. This decision satisfied these citizens’ concerns. By December 3, 2010, fourteen of the
requests for a hearing were withdrawn, reducing the total number of official hearing requests below
25. The withdrawals are attached (See exhibit J5). MDH canceled the hearing and electronically
notified the hearing requestors and subscribers of MDH’s electronic subscription list on
Groundwater Rules and Guidance (approximately 1,200 subscribers). MDH also posted the Notice
of Hearing Withdrawal on the MDH website. 3
Withdrawals of Hearing Requests Related to Manganese (See Exhibit J5)
Name
Page no. Name
Page no.
Andresen
Fride
Johnson, C
Johnson, D
Larsen
Mosman
Muller
3
41
63
82
87
101
116
124
Norrgard
Palcich
Save Lake Superior Association
Szymialis
Tammen
Water Legacy
Winters, M
133
137
148
153
156
174
185
http://www.health.state.mn.us/divs/eh/risk/rules/water/publicinput.html
Page 14 of 17
Email from MDH to Hearing Requestors
Sent: Tuesday, November 23, 2010 12:23 PM
You are receiving this communication because you either submitted comments or requested a hearing on the
Minnesota Department of Health’s (MDH) proposed rules on Health Risk Limits for Groundwater (Minn.
Rules, Chapter 4717, Parts 7860 and 7500), specifically for manganese.
MDH will keep the manganese value of 100 μg/L currently in rule
Thank you for your comments objecting to the proposed repeal of the 100 μg/L value for manganese
(Minnesota Rules, Chapter 4717, Part 7500, subpart 61). We had proposed repealing the value because we
also had a more recent recommendation to use a value of 300 μg/L. Commenters urged us to review a very
recent study about manganese’s potential neurological effects.[1] In our initial review of that study we have
come to
the conclusion that we should not repeal the existing value for manganese at this time. Consequently, MDH
is withdrawing its proposed repeal of subpart 61. MDH plans to review manganese and will issue updated
guidance pending further review.
Please consider whether you need a hearing
We believe that there is no longer a reason to request a hearing before a judge because we have made the
rules change that you requested. We respectfully ask that you consider withdrawing your request for a
hearing in order to avoid the unnecessary expense of holding a formal hearing on this issue.
In order to withdraw your request we require a response from you in writing. You may respond directly to
this e‐mai l. Suggested text for your use appears below but any written response is sufficient. Please
respond by 4:30 p.m. on November 30, 2010, so that MDH can cancel the scheduled hearing and send out
appropriate notices. If there is a hearing, I will send you information about the hearing process. You are
encouraged to subscribe to MDH’s electronic subscription list to receive updates on guidance,
groundwater rules, contaminants of emerging concern and other programs.
Thank you for your consideration.
Nitika Moibi
Withdrawal of Hearing Request
Full name:
Address:
Date:
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit for manganese in
Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a
public hearing on the proposed rules on Health Risk Limits (HRLs) for Groundwater (Minnesota Rules,
Chapter 4717, Parts 7860 and 7500).
Page 15 of 17
Email from MDH to Hearing Requestors
Sent: Tuesday, November 23, 2010 12:23 PM
Sent: Tuesday, November 23, 2010 4:09 PM
We are sending this follow up e-mail to clarify our previous communication to you regarding MDH’s
decision to not repeal the existing guidance of 100 μg/L for manganese from the current Health Risk Limit
(HRL) rules. We will update the Groundwater Values Table entry for manganese on the MDH website to
reflect the 1993/94 HRL value of 100 μg/L. Unfortunately, we cannot make this change until after
December 3, 2010, as the entire MDH website is currently being redesigned (see attached announcement).
Some commenters were concerned that the MDH website still showed the value of 300 μg/L. If this is a
concern to you, please consider withdrawing your hearing request with the stipulation that MDH will update
the website to reflect this decision (see suggested text below). MDH plans to review manganese in the
future, but until the review is complete, MDH will recommend a HRL of 100 μg/L. The HRL value of 100
μg/L will not be repealed from the current rules without a future rulemaking process. We hope this clarifies
your questions as you consider whether to withdraw your hearing request. Please respond by 4:30 p.m. on
November 30, 2010, so that MDH can cancel the scheduled hearing and send out appropriate notices.
If you have additional questions, please let me know.
Thanks.
Nitika Moibi
Withdrawal of Hearing Request
Full name:
Address:
Date:
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit (HRL) for
manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my
request for a public hearing on the proposed rules on Health Risk Limits for Groundwater (Minnesota Rules,
Chapter 4717, Parts 7860 and 7500), provided MDH removes the guidance value of 300 μg/L from the
MDH website at its earliest opportunity.
______________________________________________________________________________________
Page 16 of 17
J5. All Public Correspondence Received:
All correspondence received begins on the next page.
Page 17 of 17
3M General Office 3M Center
St. Paul, MN 55144-1000
651 733 1110
3IVI November 17, 201 0
Nitika Moibi, Agency Contact Person
Mr. John Line Stine, Assistant Commissioner
Ms. Linda Bruemmer, Director, Environmental Health Division
Minnesota Department of Health
P.O. Box 64975
Saint Paul, MN 55164-0975
Via U.S. Mail and via e-mail to [email protected].
Re: Draft HRLs for PFBA and PFBS
Dear Mr. Stine and Ms. Bruemmer:
3M appreciates the opportunity to comment on the draft Health Risk Limit ("HRL")
values for PFBA and PFBS. We offer for your consideration comments on the derivation of
each of the draft standards.
As you know, HRLs must comply with Minn. Stat. Sec. 144.0751, which requires that
drinking water standards developed by the Minnesota Department of Health ("MDH") must:
(1) be based on scientifically acceptable, peer-reviewed information; and
(2) include a reasonable margin of safety to adequately protect the health of
infants, children and adults ....
(Emphasis added). We address below issues related to both the science on PFBA and PFBS and
the reasonableness of the draft calculations for the HRLs. In particular, 3M would like to urge
greater transparency with regard to the extent to which the proposed HRLs are based on policy
judgments as opposed to science. Multiple elements of the calculations embody highly
conservative assumptions, and when these assumptions are multiplied together in the derivation
of the proposed HRLs, it produces an arbitrary result that is neither "reasonable" nor consistent
with "scientifically acceptable, peer-reviewed information."
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 1 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 2 of29
PFBA
Three principal elements are used in deriving an HRL: the assumed daily Intake Rate
for drinking water, the Relative Source Contribution from drinking water as opposed to other
sources, and the Reference Dose likely to be without appreciable adverse effects. We address
the Intake Rate and Reference Dose used in arriving at the draft HRL for PFBA.
1.
Intake Rate
MDH intake rates are based on consumption of water from only the community water
supply, and exclude bottled water and all other beverages. (See Statement of Need and
Reasonableness ("SONAR") for Health Risk Limits dated July 11, 2008, pages 42-43, 45.)
MDH has calculated its proposed HRL for PFBA based on short-term exposure, defined
in MDH's regulations as a period of more than 24 hours, up to 30 days. (Minn. Admin. Rules
Section 4717.7820, subpart 9A.) MDH's Short-Term calculation for PFBA uses an intake rate of
0.289 liters of drinking water per kilogram of a person's body weight per day ("Likg/day").
According to the July 11, 2008 SONAR document, MDH has derived this assumed short-term
intake rate by using draft EPA data for the assumed 95th percentile of intake rates for infants
from one to three months of age.
At the time, MDH relied on draft EPA data. The final EPA Child-Specific Exposure
Factors Handbook provides a figure of0.285 rather than MDH's 0.289 Llkg/day for the 95th
percentile intake of infants to 3 months. 1 MDH has not updated its calculations.
Although MDH has based the intake rate on infants' 95th percentile exposure,
developmental effects on infants are neither a critical nor co-critical effect in the laboratory
toxicology study MDH uses to develop its short-term exposure HRL for PFBA. Indeed, 3M,
along with EPA researchers, conducted a developmental effects study for PFBA, and there is no
compelling indication that infants are more sensitive to the effects of PFBA than adults.
MDH states that "[i]t is important ...to match the exposure assumptions to the life stage
that is most sensitive to the toxic effects of the chemical." (July 11, 2008 SONAR, page 44.) See
also MDH's statement in the July 11, 2008 SONAR, page 48: "MDH has determined that an
intake rate appropriate for infants should be used in deriving HRLs for developmental effects.")
Conversely, it is inappropriate to use the infant intake rate (which produces the highest possible
intake rate for short-term exposure), when there is no compelling evidence of effects from PFBA
at this life stage in the developmental study.
1
See EPA Child-Specific Exposure Factors Handbook, Sept. 2008, page 3-3, available at
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l99243. See also EPA's July 2009 External
Review Draft of the Exposure Factors Handbook, at page 3-3, available at
http:/I cfpub.epa. gov/ncea/cfm/record is play .cfm ?deid=209866.
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 2 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17,2010
Page 3 of29
Moreover, even if infant intake rates (which are not used by other agencies) were
appropriate, the assumed intake rates are not grounded in reality. In fact, MDH's assumed infant
intake rates range between 33% to 80% higher than the age-weight and sex specific intakes
advised by the American Academy of Pediatrics for infants (newborns to 3 months), even at the
95th percentiles of body weight.
According to the American Academy of Pediatrics, after the first few days a formula-fed
newborn will take from 2 to 3 ounces of formula per feeding and will eat every three to four
hours on average during the first few weeks. See http://www.healthychildren.org/English/agesstages/baby/feeding-nutrition/pages/Amount-and-Schedule-of-Formula-Feedings.aspx.
Assuming the maximum (3 ounces of formula every 3 hours), a newborn would have a total
intake of24 ounces. However, the MDH assumption for intake for an average weight (50th
percentile) newborn boy is 35 ounces a 45% increase above recommendation (see table below).
For a newborn boy at the 95th percentile, the MDH assumption for intake is 43 ounces- almost
an 80% increase above the highest recommendation for a newborn. For a newborn girl at the
50th and 95th percentiles of weight, the MDH assumptions on intake are 42% and 70% above the
highest maximum recommendation by the American Academy of Pediatrics.
By one month, the American Academy of Pediatrics advises a baby will consume at least
four ounces of formula per feeding with a fairly predictable feeding schedule of every four hours.
For a one month infant, this would amount to a range likely between 24 ounces per day (4
ounces per feeding/6 feedings per day) to 30 ounces (increase intake rate 25% to 5 ounces per
feeding/6 feedings per day). Assuming the maximum intake (30 ounces), MDH's assumed
intake rate of 0.289L/kg/d at one month would lead to a total of 45 ounces for baby boy at the
501h percentile of body weight and 49 ounces for a baby boy at the 95th percentile body weight
(see table below). For girl babies, the total intake would be 40 and 47 ounces, respectively.
These intake rates that are assumed by MDH result in overestimations of between 33% and 67%
above the daily recommended total amount for infants at 1 month.
According to the American Academy of Pediatrics, a 3 month old baby should take in
about 2.5 ounces of formula for each pound of body weight. Therefore, according to the table
below, a 6.1 kg (13.4lb) boy who is at the 501h percentile body weight at 3 months should take
in daily about 34 ounces of formula per the American Academy of Pediatrics recommendation.
Yet the MDH assumption of 0.289 L/kg/day for infants 1 - 3 months would result in a total daily
intake of 60 ounces per day- a 75% overestimation of daily intake for a baby boy who is at the
501h percentile of body weight at 3 months. This large degree of overestimation of intake by the
MDH assumption would also exist at the 95 1h percentile of body weight for a 3 month old baby
boy as well as for baby girls at 3 months at their 50th and 95 1h body weight percentiles.
These calculations are presented in the following table, which uses birth weight values
from the Centers for Disease Control for boys and girls
(http://www.kidsgrowth.com/stages/viewgrowthcharts.cfm??id+BW036 and
http://www.kidsgrowth.com/stages/viewgrowthcharts.cfm ?id=G W036).
3
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 3 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 4 of29
CONSUMPTION BY INFANTS USING MDH'S ASSUMED INTAKE RATES
Percentile of Infant Weight Reported by CDC
MDH Assumed Rate of Intake of 0.289L/kgld
Percentile at Birth
Weight
Consum)!tion Using MDH Assum[!tion
Number of
Liters/Day
Ounces/Day
3 oz. Feedings/Day"
Bo(
95 1
50th
4.4 kg (9.7 lbs)
3.6 kg (7.7 lbs)
1.3
1.0
43
35
14
12
Girls
95th
50th
4.1 (9.0 lbs)
3.5 (7.7 lbs)
1.2
1.0
41
34
13
Weight
Liters/Day
Ounces/Day
Number of
4 oz. Feedings/Dayb
Botts
95
50th
5.0 kg (11.0 lbs)
4.6 kg(l0.1lbs)
1.4
1.3
49
45
12
ll
Girls
95th
50th
4.8 (1 0.6 lbs)
4.1 (9.0 Jbs)
1.4
1.2
47
40
12
10
Weight
Liters/Day
Ounces/Day
Number of
6 oz. Feedings/Dal
Botts
95
50th
7.3 kg (16.1 lbs)
6.1 kg (13.4 lbs)
2.1
1.8
71
60
12
10
Girls
95th
6.7 (14.7 lbs)
1.9
65
11
11
Percentile at 1 Month
Percentile at 3 Months
American Academy of Pediatrics formula feeding recommendations:
a. At birth through first few weeks of life recommendation is 2 to 3 ounces formula every 3 to 4 hours.
b. At 1 month recommendation is at least 4 ounces formula about every four hours.
c. At 3 months recommendation is about 2.5 ounces formula for every I pound body weight (5.5 ounces/kg) per
day divided into multiple feedings (assume 6).
Based upon the above calculations, the MDH intake rate of0.289 L/kg/d is beyond any
"reasonable margin of safety" for infants' daily intake. Indeed, such a rate assumes a number of
ounces per feedings per day that could cause both vomiting (assuming a 1 month infant can
consume no more than 4 ounces per feeding and a 3 month infant consumes no more than 6
ounces per feeding) and infant obesity. Therefore, it is not appropriate to base an HRL on this
assumed 95th percentile level of infant intake, which lacks scientific and medical basis.
4
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 4 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17,2010
Page 5 of29
Just as the intake rate used by MDH in its short-term HRL calculations is unrealistic, so
are the intake rates assumed for adults in MDH's subchronic and chronic duration calculations.
For example, to derive a chronic or lifetime HRL value, MDH uses an intake rate of0.043 liters
of water per kilogram of body weight per day. We examine in the table below what this means
for adults aged 45-50 using body weight data from the Centers for Disease Control NHANES III
study.
Water Consumption Among Men and Women Aged 45- 50 at MDH's Assumed Chronic Rate of Intake of 0.043L/kgld Percentile"
Kilograms
Liters/Day
Men
95th
116 (255 lbs)
5.0
169
21
75th
50th
25th
5th
94 (2071bs)
82 (180 lbs)
76 (167lbs)
62 (1361bs)
4.0
3.5
3.3
2.7
137
119
111
90
17
15
14
11
Ounces/Day
8-oz. Glasses/Day
Women
95th
106 (233 lbs)
4.6
156
20
75th
80 (176lbs)
3.4
115
14
50th
68 (150 lbs)
2.9
98
12
25th
60 (132 lbs)
2.6
88
II
5th
50 (11 0 lbs)
2.2
74
9
a. Data from NHANES III (see http://www.halls.md/chart/men-weight-w.htm and
http:www.halls.md/chart/women-weight-w.htm)
Thus, MDH is assuming that people, based on their weight, consume 9 to 21 glasses of a single
community's tap water per day (i.e., about a half a gallon to 1.3 gallons) every day, for an entire
lifetime, in addition to all other beverages such as bottled water, fruit juices, soda, beer, wine, or
other beverages. Not only are extreme amounts of water intake unrealistic, but actual
consumption of excessive amounts of water can lead to serious and immediate health
consequences. 2
2
See Ballantyne, "Strange But True: Drinking Too Much Water Can Kill, Scientific American (June 21,
2007), available at http://www.scientificamerican.com/article.cfm?id=strange-but-true-drinking-toomuch-water-can-kilL The Scientific American article notes:
5
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 5 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17,2010
Page 6 of29
EPA derives drinking water standards (under its Safe Drinking Water Act mandate to
achieve a "reasonable margin of safety") using an assumption of 0.029 L/kg/day, or 2 liters per
day (more than eight 8-ounce glasses) intake for a 70 kilogram adult. According to MDH, this
70 kilogram adult would consume 3 liters per day, or 13 8-ounce glasses of water from this
single source, consumed daily for a lifetime. EPA's approach covers the consumption of
approximately 90% ofthe adult population. See July 11,2008 SONAR, page 43. Yet MDH
assumes people consume 50% more. Once again, the intake rate assumption by MDH does not
seem to be grounded in reality.
If MDH is to make such extreme assumptions on intake, then the nature of these
assumptions must be taken into account when setting other elements of the HRL calculation that
are based on professional judgment. And the degree of conservatism in MDH' s assumptions
must be transparent to the public. Conservative assumptions are of course appropriate to protect
public health. However, given how the assumptions are multiplied together in the calculation,
once the extremely conservative assumptions are compounded with other conservative
assumptions, the HRL reaches a level well beyond that needed to protect people at the 95th or
even 1ooth percentile of exposure.
2.
Reference Dose
A 2005 study in the New England Journal ofMedicine found that close
to one sixth of marathon runners develop some degree of hyponatremia,
or dilution of the blood caused by drinking too much water ...."Rapid
and severe hyponatremia causes entry of water into brain cells leading to
brain swelling, which manifests as seizures, coma, respiratory arrest,
brain stem herniation and death," explains M. Amin Amaout, chief of
nephrology at Massachusetts General Hospital and Harvard Medical
School.
Where did people get the idea that guzzling enormous quantities of water
is healthful? A few years ago Heinz Valtin, a kidney specialist from
Dartmouth Medical School, decided to determine if the common advice
to drink eight, eight-ounce glasses of water per day could hold up to
scientific scrutiny. After scouring the peer-reviewed literature, Valtin
concluded that no scientific studies support the "eight x eight" dictum
(for healthy adults living in temperate climates and doing mild exercise).
In fact, drinking this much or more "could be harmful, both in
precipitating potentially dangerous hyponatremia and exposure to
pollutants, and also in making many people feel guilty for not drinking
enough," he wrote in his 2002 review for the American Journal of
Physiology-Regulatory, Integrative and Comparative Physiology. And
since he published his findings, Valtin says, "not a single scientific report
published in a peer-reviewed publication has proven the contrary."
6
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 6 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 201 0
Page 7 of29
There are no known human health effects from exposure to PFBA, and production
workers at 3M's Cottage Grove facility and other plants have not shown adverse health effects
caused by exposure to perfluorochemicals. Moreover, PFBA is eliminated from the body
relatively rapidly. Nevertheless, 3M recognizes that MDH needs to derive a protective
Reference Dose based upon the toxicological studies.
The Reference Dose calculation by MDH is overly conservative in three respects: 1) the
implied seriousness of the endpoints at issue, 2) the application of the Human Equivalent Dose
methodology, and 3) the selection of uncertainty factors.
a.
Endpoints
The effects of repeat oral dosing of laboratory rodents with PFBA are mild, primarily
consisting of adaptive, non-pathologic hepatocellular hypertrophy, reduction in serum total
cholesterol, and serum hypothyroxinemia. We address each of these endpoints below.
i.
Interpreting Liver Weight Effects
Although MDH has proposed increased liver weight as a critical effect of PFBA, the liver
enlargement seen with PFBA was not associated with clinical chemistry or histological evidence
of liver toxicity. The liver enlargement seen in rats at higher doses was a mild, reversible effect
that reflects the normal adaptation to dosing during the experimental study, as opposed to a true
adverse effect. There was no progression of incidence or severity of responses between the 28day and 90-day studies.
EPA generally does not rely on liver enlargement as the critical endpoint for risk
assessment. We have found only one instance in the entire EPA IRIS database of values for 359
substances in which hypertrophy alone was used for the point of departure for setting an
acceptable dose of a substance. As noted in the EPA Office of Pesticide Programs HED
Guidance Document# G202.01 on Hepatocellular Hypertrophy (Oct. 21, 2002), liver
hypertrophy does not necessarily represent liver toxicity, nor is it necessarily a precursor to a
particular manifestation of toxicity. Guidance Document# G202.01 suggests a weight-ofevidence approach that includes evaluation of other findings, including: 1) type and severity of
observed effects; 2) onset, duration, and progression of effects; 3) study method and design; and,
4) other relevant effects and data.
MDH has stated that if liver enzymes and histopathology are evaluated and only a liver
weight increase is seen, the effect is not regarded as adverse. In a document entitled "Health
Risk Limit (HRL) Rule Amendment Public Meeting Questions and Answers, May 2010,"
available at http://www.health.state.mn.us/divs/ehlrisk/rules/water/hrlmeetingqa.pdf, MDH
provided the following statement regarding the meaning of liver hypertrophy unaccompanied by
other evidence of liver injury:
7
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 7 of 189
Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 8 of29
Q: (follow-up) How do you determine what is adverse? For
example, if liver hypertrophy is observed but no changes in liver
enzymes or histology are observed at that dose or higher doses
would you consider that adverse?
A: Liver hypertrophy (i.e., increased liver weight) changes can
represent an adaptive response. If the toxicity study included a
variety of liver assessment parameters (i.e., liver enzymes were
evaluated, complete histopathological assessment was conducted)
and only hypertrophy was observed, even at higher doses, this
observation alone would not be considered adverse. Hypertrophy
can be an early indicator of insult. If increased liver weight was
observed but histopathological changes were evident at the higher
dose levels, if increased liver weight occurred at the highest dose
level tested, or if additional parameters were not evaluated (e.g., no
histopathology evaluation, no liver enzyme assessment) the effect
could be considered to [be] a "minimal" adverse effect.
(Id., page 1, emphasis added.) Despite this statement, MDH does not appear to have followed
this approach regarding evaluation of PFBA-induced liver weight increases. It is inexplicable
why increased liver weight in the 90-day study with PFBA is regarded as an adverse effect,
particularly in light of the fact that the mode of action of the PFBA-induced hepatocellular
enlargement has been established and published scientific papers demonstrate that human liver
cells would be expected to be less susceptible to PFBA-induced effects than rodent liver cells.
Adaptive hepatocellular hypertrophy in response to exposure of rodents to xenobiotics is
often the consequence of reversible induction of xenobiotic-metabolizing systems in the liver
cell. Three primary xenosensor nuclear receptors play a central role in this process (Waxman
1999; Lake 2009): the peroxisome proliferator activated receptor a (PPARa), which controls the
expression of cytochrome P450 (Cyp) 4A family enzymatic proteins; the constitutive androstane
receptor (CAR), which controls the expression of Cyp2B family proteins; and the pregnane X
receptor (PXR), which controls expression of Cyp3A family proteins. PFBA-induced
hepatocellular hypertrophy has been demonstrated to be a result of activation ofthe nuclear
receptor PP ARa at lower doses, with the additional potential contribution of activation of CAR
at higher doses. When rat and human primary hepatocytes were exposed in cell culture to PFBA,
only the rat hepatocytes demonstrated an increase in PP ARa activation, suggesting that the
human hepatocytes were either unresponsive or much less responsive than rat hepatocytes (Bjork
and Wallace 2009).
In the 28-day and 90-day studies ofPFBA used by MDH in the derivation of the HRL,
quantitative reverse transcriptase polymerase chain reaction (quantitative RT-PCR) technology
was used to evaluate the hepatic concentrations of messenger RNA, transcribed from DNA as a
result of activation of the above-mentioned nuclear receptors. In both of these PFBA studies,
PPARa was shown to be induced in a dose-dependent manner that correlated with liver weight
8
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 201 0
Page 9 of29
===::c·
Activation of PPARa leads to increases in peroxisomal bodies and expansion of the
smooth endoplasmic reticulum in the liver cell, and this added intracellular mass is reflected in
the overall liver weight. Another consequence of PPARa and CAR!PXR activation in rodents is
the potential stimulation of cell division (hyperplasia) and a decrease in the normal process of
removal of worn out cells (apoptosis). These processes also increase liver mass and can
potentially lead to tumor formation in rodents.
However, as has been demonstrated in the case of strong PPARa and CAR/PXR agonists
with mice genetically modified to remove the mouse receptors and replace these with the human
forms ofthe receptors (Gonzalez and Shah; Ross et al. 2010), the human forms ofthe receptors
do not support a hyperplastic response. The lack of a hyperplastic response in human
hepatocytes exposed to PP ARa and CAR activators has also been demonstrated (Elcombe 1996;
Goll 1999; Perrone 1998; Parzefall 1991; Hirose 2009).
Furthermore, this lack of support of a hyperplastic response has been demonstrated
specifically with PFBA (Foreman et al. 2009) and its higher homologue, PFOA (Nakamura et al.
2009) in mice humanized for PPARa. In addition, Foreman et al. also demonstrated that
activation of the human form of PPARa with PFBA does not produce frank liver toxicity.
Moreover, Bjork and Wallace (2009), working with primary rat and human hepatocytes as well
as a human liver cell line (HepG2 cells) in culture, demonstrated that human hepatocytes did not
respond to PFBA-induced PPARa activation at concentrations up to 200 ~-tM (42,600 ppb); rat
hepatocytes responded at PFBA concentration of25 ~-tM (5,325 ppb) and above.
Thus,
•
The mechanism governing PFBA-induced hepatocellular hypertrophy in rodents
has been demonstrated as largely dependent on PPARa activation,
•
Human liver cells have been shown to be refractory to the PFBA-induced
activation of PPARa, and
•
PFBA-induced activation of the human form of PPARa is expected to be limited,
at most, to adaptive and reversible hepatocellular hypertrophy.
The human pharmaceutical experience with strong PPARa agonists used to treat
hyperlipidemia (fibrate class of drugs) and CAR!PXR agonists (e.g., Phenobarbital use as an
anticonvulsant) further supports a general lack of frank liver toxicity in humans with agents that
activate these nuclear receptors (Whysner; Lake 2009; Ross 201 0).
Thus, the liver effects seen in rodents are adaptive, and PFBA is likely to have very little
effect on the human liver. MDH should not include liver effects as a co-critical effect of PFBA.
9
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 10 of29
ii. Thyroid Effects
MDH states that treatment of rats with PFBA produced thyroid hormone and thyroid
gland changes. However, the hypothyroxinemia (changes in serum total thyroid hormone levels)
observed in rats with PFBA was not accompanied by any evidence of hypothyroidism. Thyroid
stimulating hormone (TSH or thyrotropin) was unaffected by treatment, and the typical response
of increased cellularity and hypertrophy of the thyroid follicular epithelium was not observed on
histomorphometric analyses of tissues from both 28-day and 90-day studies in the rat.
•
Both the 28-day study and the 90-day study analyzed the rats' serum for total thyroxine
(TT4), free thyroxine (FT4), and thyrotropin (TSH) hormones. 3
•
TSH is the hormone most indicative of thyroidal homeostatic stress. At the end of 28-day
oral treatment and at the end of the 3-week recovery period, PFBA at levels up to 150
mg/kg/day did not affect serum TSH levels in either male or female rats compared to the
respective controls. At the end of the 90-day dosing period and 3-week recovery period,
repeated oral administration ofPFBA to rats, up to 30 mg/kg/day, did not affect serum
TSH.
•
In the 28-day study, there were statistically significant dose-dependent reductions in
serum TT4 and FT4levels observed in male rats. However, such alteration was absent at
the end of recovery period, with the exception of male rats from 150 mg/kg/day dose
group for which serum TT4 was still reduced compared to the respective control. During
the 90-day dosing period and 3-week recovery period, PFBA at levels up to 30
mg/kg/day did not affect serum TT4 or FT4 levels in either male or female rats, except in
male rats receiving the highest dose ofPFBA (30 mg/kg/day). Male rats from this dose
group had reduced serum TT4 at the end of treatment but increased serum TT4 at the end
of recovery when compared to controls.
•
In evaluating the effects on TT4 and FT4, it is important to consider that there was no
change in TSH, which would increase based on compensatory release from the pituitary
if thyroid hormone availability to tissues was physiologically inadequate. 3M has
provided MDH with a poster presented by 3M scientists at the 2008 EUROTOX meeting
which contains data demonstrating that PFBA exposure in rats does not interfere with the
release of TSH from the pituitary when rats were made hypothyroid with
propylthiouracil. This latter information is also available as a published abstract (Chang
et al. 2008). In addition, in the rat, relatively small elevations of serum TSH can result in
large increases in hyperplasia of the thyroid follicular epithelium (Klaassen and Hood
3
Manuscripts on the PFBA 28-day and 90-day studies are in preparation. Additional thyroid
data have been summarized in the poster by Chang, et al., at EPA's PFAA Days II Conference,
June 2010, attended by MDH. 3M has provided MDH with a copy of the poster.
10
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17,2010
Page 11 of29
2001 ), which was not observed on histomorphometric analysis of thyroids from the 28day and 90-day studies by an experienced veterinary pathologist. In other words, any
observed hypothyroxinemia was not accompanied by hypothyroidism.
The decreases in thyroid hormone that MDH lists as a critical effect in both the 28-day and 90day studies were related to several factors, but ultimately are not relevant for human risk
assessment:
•
The activation of PPARa and CAR nuclear receptors receptor in rodent livers results in
an increase in enzymes that metabolize thyroid hormone, ultimately reducing levels of
thyroid hormone in the blood serum (Wieneke et al. 2009). With PFBA, this is a very
mild effect, even in rodents.
•
Thyroid hormone can also be decreased in serum via displacement resulting from
competition for binding. This is a known effect with small amphiphilic organic acids and
free fatty acids. Thyroid hormone is mostly bound to protein in the serum (>99% ).
Large doses of PFBA, such as those given in toxicology studies, were shown to displace
some thyroid hormone from protein, transiently increasing free T4 (FT4). This increased
FT4 is metabolized and excreted by the liver. As the displacement and metabolism
continue, total T4 (TT4) eventually is reduced. However, physiological thyroid hormone
homeostasis is maintained (Chang et al. 2008; Chang et al. 2009).
•
The presence ofPFBA produces a negative bias in FT4 measurement by analogue
method, analogous to that caused by PFOS (Chang et al. 2007). Unfortunately, the
dialysis method, which can remove the bias in the presence of PFOS, cannot remove it in
the presence of PFBA, because PFBA itself crosses the dialysate membrane (Tikanoja at
al. 1990; Faber et al. 1993). The result is an FT4 measurement after dialysis that is
artificially lower than the real level ofFT4. 3M has reviewed this measurement issue
with leading thyroid endocrinologists at Harvard Medical School and the Mayo Clinic.
These endocrinologists agree with our interpretation of the measurement issue and the
difficulty, in this case, in obtaining a reliable measure of true FT4 concentration. They
also agree that TSH serves as the principal diagnostic ofthyroid status.
•
In sum, the changes in FT4 measurements are produced by binding site displacement and
certain biases in the analytical method used in the studies. They do not affect thyroid
function; based on the serum TSH levels, repeated oral administration of PFBA to rats
did not appear to suppress the physiological thyroid hormone status in rats. They remain
euthyroid.
•
Indeed, the lack of hypothyroidism is confirmed by several additional measures.
Morphometric analyses were performed on male rats from both studies, including
examination of a total of 134 thyroids. Transcript levels for messenger RNA were also
quantified. Hepatic mRNA signals for thyroid receptor activation (thsrp, fasn, por, ME)
were not decreased by treatment with PFBA.
11
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Ms. Linda Bruemmer
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•
Thyroid-related effects seen in rats must be interpreted with caution when considering
their relevance to humans (Capen 1997; Cohen et al. 2004; Curran, et al. 1991 ). In the
rat, activation of PP ARa, CAR, and PXR may result in increased uptake, metabolism,
and elimination ofthyroid hormones leading to a compensatory release ofTSH to the
circulation and a proliferative response in the thyroid follicular epithelium. Due to
pharmacokinetic and pharmacodynamic differences between rats and humans, this mode
of action leading to stimulation of thyroid follicular hyperplasia is considered to be of
questionable relevance to humans (Cohen et al., 2004; McClain 1995.) The rat-specific
nature of this response is also highlighted by the observation that many agents that reduce
circulating thyroid hormones in rats via extra-hepatic mechanisms have little or no effect
in mice (Craft et al. 2002; Viollon-Abadie et al. 1999) or humans (Ohnhaus, et al. 1981 ).
•
Perhaps most important, however, is the fact that thyroid hormone is bound primarily and
very strongly to human thyroid binding globulin. Rats do not have a specific thyroid
binding globulin, and bind the hormone to albumin and transthyretin. The binding in the
rat is 100 to 10,000 times weaker than it is to human thyroid binding globulin. Thyroid
hormone displacement from protein is primarily a chemical, not a biological
phenomenon. Equivalent doses of any compound given to both rats and humans would
result in far less (if any) displacement of hormone in the human compared to the rat. It
follows that humans are far less sensitive than rats to findings that result from hormone
displacement. The difference in rat and human thyroid hormone binding is wellestablished in endocrinology literature (Schussler 2000).
•
Thus, any thyroid observations in the rats exposed to PFBA do not generalize to humans,
and are therefore not appropriate as co-critical effects for human risk assessment.
Thyroid and thyroid hormone findings in rats, particularly those that are mediated by
competition for binding and upregulation of metabolic systems, must be interpreted with
caution when translating to human risk. MDH has not taken into account the wellestablished literature on the differences between rats and humans in the way in which
thyroid hormone is carried in serum and the degree of response to upregulation of thyroid
hormone metabolizing systems.
Finally, we point out that MDH mistakenly states in its subchronic calculation that
thyroid weights were increased in the 90-day study, and MDH refers to such effects in the 90day study as secondary effects. This is not correct, as thyroid weights were not measured in the
subchronic 90-day study. As the protocol 3M provided to MDH for review in advance of the
study made clear, this was due to the challenge of accurately weighing rat thyroid glands.
(Thyroid weight determination is problematic due to the need to trim tissue from the thyroids
prior to weighing and the small size of the thyroids in rats. Histological analysis ofthe thyroid
gland is much more revealing, and 3M had histomorphometric analyses conducted. In addition,
proliferation of the thyroid follicular tissues was also evaluated by S-phase incorporation of
bromodeoxyuridine. These are procedures that go beyond the standard for conducting guideline
28-day and 90-day studies.)
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iii.
Interpreting Cholesterol Reduction
Although oral doses of PFBA given to male rats in the 28-day study reduced serum total
cholesterol in a dose-dependent manner, this effect was not seen in the 90-day study.
While the effect was not replicated in the longer study, assuming PFBA at least temporarily can
lower serum cholesterol at experimental doses given to laboratory rats, the relevance to humans
must be examined
Mode of action data collected in conjunction with the repeat-dose toxicology studies with
PFBA has demonstrated that the PPARa activation mode of action is responsible for the
observed reduction in serum cholesterol. This is based on the observation of increased mRNA
concentrations resulting from activation of PPARa regulated genes associated with fat
metabolism and cholesterol reduction. It is not surprising that PPARa activation results in
lowering of cholesterol in the rats. Reduction in serum total cholesterol is a known consequence
of PPARa activation. Indeed, this mode of action has been exploited in the development of
drugs to treat hyperlipidemia in humans.
However, from a pharmacodynamic perspective, humans are less responsive to PPARaactivating xenobiotics (Klaunig et al. 2003; Lake 2009). In fact, for PFBA, when human and rat
hepatocytes were exposed directly in culture to concentrations ofPFBA up to 200 j.tM (42,600
j.tg/L), mRNA markers of PPARa activation from human hepatocytes were not increased;
whereas, those from rat hepatocytes were increased at PFBA concentrations in media of 25 j.tM
(5,325 j.tg/L) and above (Bjork and Wallace 2009). Thus, there is direct evidence from exposure
of primary human and rat hepatocytes to PFBA that the human hepatocytes are 10 times or more
less responsive to the PPARa induction effects of PFBA.
Accordingly, ifMDH is to rely on reduction in cholesterol as a critical effect for PFBA,
the agency must take into account the relative responsiveness of rodents versus humans to this
effect. To apply standard default uncertainty factors in a formulaic manner to the BMDLw value
for this effect is an arbitrary policy choice contrary to scientific evidence.
Human Equivalent Dose Calculation
PFBA, unlike PFOA, is eliminated relatively rapidly from the human body (Chang et al.
2008). As a result, PFBA will have very limited accumulation on repeated exposure. This is
supported by elimination studies in mice, rats, monkeys, and humans (Chang et al. 2008).
Chang et al. 2008 examined data from 177 non-occupationally exposed residents in the
East Metro area (3M employees). 95% of serum PFBA concentrations were less than 2 ng/mL
and 74% were less than the method quantitation limit of0.5 ng/mL. The highest concentration
was 6.2 ng/mL (parts per billion).
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Ms. Linda Bruemmer
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In MDH's East Metro Biomonitoring Study, PFBA was detected in the blood serum of
only 28% of the study participants, who were believed to be exposed to PFBA via drinking
water. (See http://www.health.state.mn. us/divs/eh/tracking/finalpfcrpt.pdf, at page 7.) The
highest serum level of PFBA found in any participant in the East Metro biomonitoring study was
8.5 ppb. That person was a current or former 3M employee, consuming Oakdale municipal
water, with over 30 years residence and presumed exposure, who described herself as being in
good health. ld. at pages 11-12. To put this human serum level in perspective, the threshold for
reduction of cholesterol in rats from the 28-day study was 20,000 ppb (based on the benchmark
dose lower confidence limit used by MDH) --2,353 times higher than the serum concentration of
the most-exposed Minnesota drinking water consumer. This is a very large margin of safety.
In deriving the draft HRL, MDH has chose to employ a Human Equivalent Dose
calculation using serum elimination half-lives. (The serum elimination half-life of a substance is
the time required to reduce the serum concentration by half.) The serum elimination half-life of
PFBA in humans is estimated (based on measurements of PFBA in serum after exposure to
compounds that metabolize to PFBA) to be in the range of 1 to 4 days versus, while the serum
half-life in male rats is estimated as 6 to 9 (Chang et al. 2008). Using the ratio of72 hours for
the human and 9 hours for the male rat (as representative half-lives), MDH adds an unusual
correction factor of 8 to represent a Human Equivalent Dose in the derivation of the Reference
Dose. The addition of an unusual "dose metric" adjustment to address animal to human
extrapolation is comparable to the use of an additional "safety factor" for cross-species
extrapolation.
However, it is unclear why MDH applies this dose metric adjustment for PFBA and not
for other chemicals. In an analysis of rat versus human elimination half-lives for 179
compounds, Ward et al. (2005) state that only 7% of the compounds have a longer halflife in
rats than in humans. In other words, 93% of the 179 compounds studied had a longer half-life in
humans than in rats, just as is the case with PFBA. Yet, MDH applies the dose metric only to
perfluoroalkyls (PFOS, PFOS, PFBS and PFBA) and to vinyl chloride, and not to any other
compounds. With the exception of vinyl chloride and perfluoroalkyls, MDH indicates in its
summary sheets that there are "insufficient data" to apply a Human Equivalent Dose and relies
instead on standard default uncertainty factors. However, human elimination data is available
for ethylene glycol (Upadhyay et al. 2008) and the literature contains papers such as that by
Ward et al. (2005) that model the relatively strong correlation between human elimination
kinetics and laboratory animal elimination kinetics. MDH has an obligation to articulate the
basis for applying the adjustment specifically in the case ofPFBA while ignoring it in other
cases. MDH must comply with the statutory requirement to establish HRLs providing a
"reasonable" margin of safety. Application of the dose metric adjustment to PFBA, which clears
rapidly from humans, appears arbitrary without specific justification.
Indeed, ifMDH had no data regarding the half-life ofPFBA, MDH likely would apply a
factor of 10 for uncertainty in cross-species extrapolation (typically divided in to subfactors of
10°.5 (3 .16) each for pharmacodynamic and pharmacokinetic uncertainty). Here, with a
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Mr. John Line Stine
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compound that has an estimated half life of only three days in humans (not years as with PFOS
or PFOA), MDH has applied a factor of 8 for rat to human half-life differences. MDH also
applies a factor of 3 for interspecies toxicodynamic differences, for a total factor of 24 rather
than the standard factor of 10 to account for species differences. Under a conventional approach,
the proposed Reference Dose and hence the HRL would be 2.4 times higher, or 16 ppb rather
than 7 ppb if no other changes were made. Moreover, it has been shown above that, based on
mode of action data and direct observation, the weight of evidence strongly suggests that human
liver cells are umesponsive or at least 10 times less responsive than those of rats to the effects of
exposure to PFBA This latter fact would argue for a reduction in the toxicodynamic subfactor
of3.)
In their paper estimating the human elimination half-life ofPFBA, Chang et al. (2008)
point out that the exposures were to a material that metabolizes to PFBA and that the elimination
half-life estimate likely may be an overestimate. Ward et al. (2005), based on modeling the
strong correlation between rat and human elimination half-lives among 179 compounds, suggest
that the human elimination half life (hHL) is best modeled as 4.3 times the rat elimination halflife (rHL) to the 0.8697 power (or, hHL 4.3*(rHL)0·8697 ). Using that factor, the human
elimination half-life would become 29 h rather than the 72 h used by MD H. This would give a
ratio of 3 .2, identical to the commonly employed interspecies pharrnacokinetic uncertainty
subfactor of 10° 5 (3 .16).
b.
Uncertainty Factors
In addition to the dose metric adjustment factor of 8, MDH has employed an uncertainty
factor of 100. These numbers are multiplied together, for a total adjustment of 800.
Short-Term Exposure
In arriving at the uncertainty factor of 100, MDH uses traditional factors for interspecies
toxicodynamic differences (3), and intraspecies variability ( 10), but also adds a factor of 3
multiplied with these other factors for "database insufficiencies."
The rationale offered for this factor is that the 28-day study did not identify an NOAEL
or acceptable benchmark dose for thyroid effects. That is not correct. Dr. Gaylor's benchmark
dose calculations for 28-day study submitted to MDH in December 2007 provide BMDL10 values
for both TT4 and FT4, which are cited as co-critical thyroid effects by MDH. The BMDL10
values are 54 and 69 mg/kg-d, respectively-- far above the Point of Departure used by MDH.
Thus, the justification for an added database uncertainty factor is not apparent.
Furthermore, as discussed above, 3M has carried out additional investigations into the
mode of action governing the hypothyroxinemia observed in the toxicology studies, and has
provided MDH with data showing
•
competition with thyroxine for binding in rat serum;
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Mr. John Line Stine
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•
•
•
•
increased thyroid hormone turnover and elimination (radiotracer studies),
with associated increase in mRNA transcripts for genes coding for
UGT1A1 (T4-specific UGT);
lack of sustained TSH elevation;
lack of hyperplastic response ofthyroid follicles; and
lack of any decrease in T3-regulated gene expression .
These data demonstrate that actions leading to hypothyroxinemia in the rat do not result in
altered thyroid hormone physiological homeostasis. Moreover, it is known that humans are less
sensitive due to pharmacodynamic and pharmacokinetic differences in the regulation of thyroid
hormone. 3M does not believe that MDH can justify a database insufficiency factor given the
wealth of available information.
In addition, MDH's February 2008 calculation of an HBV for PFBAjustified a database
uncertainty of 3 for PFBA in its short-term exposure calculation based on both the lack of an
NOAEL or benchmark dose for thyroid effects AND the lack of a reproductive study. 3M and
EPA have now conducted a developmental study, with dosing during gestation (Das et al. 2008).
MDH has recently clarified that the database uncertainty factor is not based on the need for a
multigenerational developmental study, given the results of this published study. See "Health
Risk Limit (HRL) Rule Amendment Public Meeting Questions and Answers, May 201 0,"
available at http://www.health.state.mn.us/divs/ehlrisk/rules/waterlhrlmeetingqa.pdf ("An
example is the case of PFBA where we did not apply a DB UF for the lack of a multi-generation
study because the developmental study that was conducted was an extended one generation study
that supplied the relevant information.") And yet, MDH has not revised the database uncertainty
factor used in the short-term exposure calculation.
Sub-Chronic Exposure
With respect to the subchronic exposure calculation, MDH goes even further and applies
a database insufficiency factor of 10 (which then multiplies all the other uncertainty factors).
MDH indicates that the assessment of thyroid hormones "was compromised by missing
serum hormone data." MDH takes this position while also contending that thyroid hormone
effects are co-critical effects.
This characterization of the study data is inappropriate. Both the 28-day study and the
90-day study analyzed the rats' serum for total thyroxine (TT4), free thyroxine (FT4), and
thyrotropin (TSH) hormones. Serum TT4 was analyzed using a chemiluminometric analog
method. FT4 was measured using equilibrium dialysis, and TSH was measured by
radioimmunoassay. Measurements ofTSH, TT4 and FT4 were completed in all dose groups, in
both males and females, as well as in the recovery animals in both studies. The only exception is
that FT4 measurements were not available for the male control animals at the end of exposure in
the 90-day study, although measurements are available for the male control group in the study at
the end of the 3-week recovery period. While FT4 measurements are not available for this one
16
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Mr. John Line Stine
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November 17, 2010
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dose group for one hormone at one time point, measurements ofTT4, FT4 and TSH hormones
across 18 dose groups in the two studies, or 53 total end-of-treatment groups, are available, along
with 42 recovery dose groups in which the three hormones were measured. Thus, the "missing
data" are for one hormone measurement in one out of 95 dose groups.
The inability to analyze this one remaining control group in just the male animals in the
90-day study was due to a shortage of serum remaining after all other measurements called for in
the protocol had been completed. (The equilibrium dialysis method for FT4 requires 1.2 mL of
serum per sample, a significant volume. Due to problems with the anesthesia at terminal
sacrifice in this group, sufficient serum was not available. Accordingly, priority was
appropriately given to the dosed groups and to TSH (the principal clinical diagnostic measure of
thyroid hormone homeostasis) and other measurements such as serum PFBA levels and clinical
chemistry values.)
The lack of FT4 data in end-of-study control group males does not "compromise" the
value of the studies, which provide serum TT4 and TSH and thyroid follicular morphometric
analysis data for control group and complete data for all other groups. The vast majority of
toxicology studies do not include any thyroid hormone measurements, and extensive data are
available here. In particular, it should be noted that the measurement of TSH in rat serum
requires a rat-specific TSH assay system that is highly specialized and is only available from
limited sources. The assay system for the data generated in conjunction with the 3M studies was
provided by the National Hormone and Pituitary Program (NHPP) of the National Institute of
Diabetes and Digestive and Kidney Diseases, National Institutes of Health. The other thyroid
hormones were measured by either the Mayo Medical Laboratories reference laboratories or
NHPP. The characterization ofthe lack ofFT4 data from the one male control group as
compromising the study because of "missing data" is not only inappropriate but misses the point
that 3M went far beyond the norm for toxicological investigation when conducting these studies.
In addition, evaluation of proliferation of the thyroid follicular tissues by S-phase
incorporation ofbromodeoxyuridine, morphometric analyses of the thyroids and mRNA
measurements provide confirmation as to the lack of physiological effect in the rats. The typical
response of increased cellularity and hypertrophy of the thyroid follicular epithelium was not
observed on histomorphometric analyses of tissues from both 28-day and 90-day studies in the
rat. 3M took the additional step of measuring mRNA signals as markers for various biological
responses in order to provide mode of action data. It is quite uncommon in standard toxicology
study protocols to perform such detailed and sophisticated histomorphometric and mechanistic
analyses, reflecting the degree to which 3M went to provide sound scientific data for MDH to
use in risk assessment. This information demonstrated that thyroid hormone physiological
homeostasis was maintained.
In sum, far more data on potential thyroid effects of PFBA are available than in most
toxicology studies or for most compounds, there is a wealth of information available, and the
proposed database uncertainty factor is not appropriate as a matter of either science or policy.
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Mr. John Line Stine
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Finally, MDH's statement that there are "no available neurotoxicity studies" is
perplexing. A functional observation battery addressing neurotoxicity endpoints was included in
both the 28-day and 90-day studies of PFBA.
PFBS
We review below the assumed daily Intake Rate for drinking water used for PFBS, and
calculation of the Reference Dose for PFBS from the toxicology studies.
1.
Intake rate
MDH uses an intake rate of 0.245 L/kg/day for the PFBS subchronic calculation. This
intake rate is based on the 95th percentile intake over the first four months of life because, MDH
explains, four months is the estimated time to steady state serum concentrations for PFBS. 4
Once again, however, as described above with respect to PFBA, MDH uses an infant's
exposure rate, when developmental effects are not at issue. The justification for this is not clear.
And again, as a factual matter, the values used by MDH remain unrealistic, but somewhat
less so than PFBA because of the lower intake rate (0.245 L/kg/d) used for PFBS. For example,
using the MDH assumed intake rate of 0.245 L/kg/d for PFBS, a I month old baby boy infant at
the 95th percentile body weight is assumed by MDH to intake 41 ounces of formula compared to
the recommendation by the American Academy of Pediatrics of approximately 30 ounces (33%
overestimation by MDH even at the 95th percentile weight).
The table below shows the levels of water consumption MDH is assuming (0.245 L/kg/d)
for infants:
4
MDH's time to steady-state calculation relies on a value for the mean human half-life ofPFBS of27.7
days. However, Olsen et al. 2009 report a geometric mean human half-life value of 25.8 days.
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Mr. John Line Stine
Ms. Linda Bruemmer
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CONSUMPTION BY INFANTS USING MDH'S ASSUMED INTAKE RATES
Percentile of Infant Weight Reported by CDC
MDH Assumed Rate of Intake of 0.245L/kgld
Percentile at Birth
Weight
Consum_ution Using MDH Assum_ution
Number of
Liters/Day
Ounces/Da:y
3 oz. Feedings/Da):"
Botts
95
50th
4.4 kg (9.7 lbs)
3.6 kg (7.7 lbs)
1.1
0.9
36
30
12
10
Girls
95th
50th
4.1 (9.0 lbs)
3.5 (7.7 lbs)
1.0
0.9
34
29
11
10
Weight
Liters/Day
Ounces/Day
Number of
4 oz. Feedings!Da!l
Botts
95
50th
5.0 kg (11.0 lbs)
4.6 kg (I 0.1 lbs)
1.2
1.1
41
38
10
Girls
95th
50th
4.8 (10.6 lbs)
4.1 (9.0 lbs)
1.1
1.0
40
34
10
8
Weight
Liters/Day
Ounces/Day
Number of
6 oz. Feedings!Dai
Bots
95 1
50th
7.3 kg (16.1 lbs)
6.1 kg (13.4 lbs)
1.8
1.5
60
51
10
8
Girls
95th
6.7 (14.7lbs)
1.6
55
9
Percentile at 1 Month
Percentile at 3 Months
10
American Academy of Pediatrics formula feeding recommendations:
a. At birth through first few weeks of life recommendation is 2 to 3 ounces formula every 3 to 4 hours.
b. At 1 month recommendation is at least 4 ounces formula about every four hours.
c. At 3 months recommendation is about 2.5 ounces formula for every 1 pound body weight (5.5
ounces/kg) per day divided into multiple feedings (assume 6).
For chronic duration, MDH continues to assume intake of 0.043 Llkg/day water for the
PFBS HRL, as was done for the PFBA HRL. Therefore, as discussed with the HRL for PFBA,
the MDH intake rate is not grounded in reality. For example, this continues to equate to 3 liters
oftap water per day lifetime for a 70-kilogram adult. This is equivalent to 13 8-ounce glasses of
tap water for every day of a 70 kg adult person's life without even considering any other sources
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Mr. John Line Stine
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of fluid intake. This water intake estimate by MDH for the PFBS HRL remains a gross (50%)
overestimate of reasonable lifetime daily water consumption and thus lacks scientific credibility.
2.
Reference Dose
a.
Critical Effects
In calculating the chronic value on which the draft HRL is based, MDH refers to the
NOAEL of 60 mg/kg/day from the 90-day repeat-dose study with PFBS. That level is based on
the occurrence of hematological changes in male rats at the next higher dose. While reduced red
blood cell, hemoglobin and hematocrit values were seen in the PFBS-treated rats, they were mild
and not clinically significant. There were no histopathological findings in bone marrow. As
described by the study authors:
PFBS treatment resulted in mild but statistically significant
decreases in RBC count in male rats in the 600 mg/kg-day
dose group and in hematocrit and hemoglobin in the 200 and
600 mg/kg-day dose groups. Histologic examination of bone
marrow in the 600 mg/kg-day dose-group males did not reveal
any abnormalities as compared to controls. Taking the hematology
data from the study as a whole, this pattern would suggest slight
to mild plasma volume expansion; although other potential etiologies
cannot be ruled out with the available data.
[O]n gavage dosing with K+PFBS for 90 days at daily
doses up to 600 mg/kg, no alterations in liver cell morphology were
noted and observed effects were relatively minor.
(Lieder et al. 2009, at 50, 51.) Interestingly, Australia's Department of Health, National
Industrial Chemicals Notification and Assessment Scheme assessment of the 90-day PFBS study
determined the NOAEL to be 200 mg/kg/day. (Australia NICNAS 2005.) Accordingly, 3M's
scientists believe that 200 mg/kg/day is the appropriate NOAEL for the PFBS 90-day study.
MDH cites as a co-critical effect for PFBS the incidence of increased liver weight and
hypertrophy. However, no increase in liver weight is reported in the peer-reviewed published
report of the 90-day study (Lieder et al. 2009 at Table 2), or the Australian review. MDH
apparently relies on the developmental study, in which liver weights (absolute and/or relative) in
males were increased in the P and Fl generation males at the two highest dose levels (300 and
1000 mg/kg/day). These were correlated to microscopic evidence of adaptive hypertrophy. As
discussed above with respect to PFBA, it is not appropriate to rely on rodent liver weight alone
as a critical effect. MDH has stated that liver hypertrophy alone is not considered an adverse
effect. Furthermore, PFBS has been shown to activate PPARa (Wolf et al. 2008). However,
Bjork and Wallace (2009) did not show activation in cultured human hepatocytes exposed to 25
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11M PFBS in culture media. Therefore, the arguments supporting greatly lessened sensitivity of
human liver to PPARa would apply in the case ofPFBS. Thus, it is inappropriate for MDH to
rely on increased liver weight and hepatocellular hypertrophy as co-critical effects for PFBS,
particularly when considering potential human relevance.
b.
Uncertainty Factors
MDH applies a database uncertainty factor of 3 on the basis that further studies of
neurological and thyroid effects are warranted.
Thyroid hormone measurements are not commonly employed in rat toxicology studies,
and rats are known to be poor models for humans with respect to thyroid effects. MDH does not
routinely apply additional uncertainty factors for absence of thyroid hormone measurements in
toxicological studies.
There is no suggestion ofthyroid disease (histologically or clinically) in the PFBS studies
to date. Perhaps MDH is extrapolating whatever concerns it may have regarding PFBA to PFBS.
That would be inappropriate since the two compounds are distinct, and as shown above, PFBA
does not induce hypothyroidism. Or perhaps MDH is focused on PFOS, for which thyroid
hormone homeostasis was originally investigated as a potential explanation for developmental
effects noted in a two-generation study (Luebker et al. 2005). The two-generation study with
PFBS did not produce findings similar to those observed with PFOS (Lieder et al. 2009). The
justification for a database uncertainty factor based on thyroid effects for PFBS is not clear.
MDH expresses a desire for more neurological research, but acknowledges the 90-day
study of PFBS revealed no neurotoxicity in the rats. As the study authors reported:
There were no statistically significant or biologically important
differences between K +PFBS-treated male and female rats and
their respective control rats in any of the measured parameters.
Parameters evaluated included: home cage behavior; autonomic
functions (lacrymation, salivation, palpebral closure, prominence
of the eye, papillary reaction to light, piloerection, respiration,
defecation, and urination); sensorimotor functions; excitability;
gait and sensorimotor coordination; forelimb and hindlimb grip
strength; and abnormal clinical observations (including but not
limited to: convulsions; tremors; unusual behavior; hypotonia;
hypertonia; emaciation; dehydration; unkempt appearance; and
deposits around the eyes nose or mouth). (Lieder et al. 2009, page
47.)
The neurobehavioral battery (peripheral neuropathy, motor activity and audio-visual) in the 28day study was negative, except for tail-flick responses in males at 900 mg/kg/day that suggested
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hyperexcitability. MDH says further research is needed, but the rationale for that suggestion,
and for a database uncertainty factor to address neurotoxicity, is unclear.
MDH applies an additional uncertainty factor of 3 for the absence of a chronic study.
The database does include a full two-generation reproductive study. (Lieder, Toxicology 259:3345 (2009).) A two-year chronic bioassay on PFBS is unnecessary based upon the results of
studies to date:
• PFBS is water soluble and does not bioaccumulate. It is not metabolized and cannot
covalently bond to modify biological compounds. PFBS has a half-life of elimination in
rats of only a few hours.
• PFBS is not genotoxic in either the Ames test or chromosomal aberration tests and does
not possess structural characteristics of a genotoxic agent.
• In the 90-day sub-chronic oral dosing study, clinical chemistry and microscopic
pathology assessments have not revealed adverse systemic findings that would warrant
further study in a chronic bioassay. No changes in serum clinical chemistry values that
would indicate systemic effects have been noted, even at doses as high as 900 mg/kg/day.
An increased incidence of minimal-to-mild microscopic effects in the kidney that were
observed at doses greater than 100 mg/kg/day is explainable when considering the
relatively high doses of PFBS, which is a strong surfactant and is excreted rapidly in
urine. High concentrations would be found in the urine at such a dose given the rapid
excretion ofPFBS.
• Considering PFBS' halflife of elimination, a two year study would not be expected to
result in internal doses any higher than those seen in the 90-day study, which did not
indicate adverse systemic toxicity. Chronic dosing at levels below those causing
irritating concentrations of PFBS in the urine should not result in any other significant
effects.
• PFBS is a PPARa activator, but has been shown to be weaker in producing hepatic
PPARa responses than PFOS (Bjork and Wallace 2009). A chronic dietary study of
PFOS producing quite high serum and liver concentrations in rats resulted only in what
the UK Committee on Carcinogenicity characterized as an "equivocal evidence of
carcinogenicity in the animal studies limited to hepatocellular adenoma." Reports from
mechanistic studies conducted at CXR Biosciences under the direction of Dr. Cliff
Elcombe (provided to MDH and presently prepared for submission to the peer-reviewed
literature) have demonstrated that the hepatocellular adenoma observed on chronic
dietary dosing of rats with PFOS is consistent with activation of PPARa with possible
involvement of activation of CAR/PXR. This mode of action is not considered relevant
to humans based on known lack of a proliferative hepatocellular proliferative response in
human liver cells (Ross et al. 2010; Lake 2009; Gonzalez and Shah 2008).
22
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17,2010
Page 23 of29
Considering all the data available for PFBS, it appears that a two year bioassay is not a necessary
test, and that the resources could be put to better use. It is inappropriate to recommend a chronic
study be conducted to "check the box" in order to remove the database uncertainty factor.
Scientific judgment should be applied, and neither PFBS' chemical characteristics nor the
extensive toxicology data raise suspicion that it might cause cancer to a high enough level to
warrant the expense or the animal use required for a two-year study.
Thus, the two database uncertainties, which together multiply MDH's other uncertainty
factors by I 0, do not appear justified.
Adoption of Standards
Finally, we would like to register our concern regarding an MDH statement with regard
to the application ofHRLs. In MDH's May 19,2010 public meeting presentation discussing the
draft amendments to the HRLs, MDH stated: "A newer HBV or RAA takes precedence over an
older HRL, even though the HRL is promulgated and the HBV or RAA is not. ... It is always
the more recent value that takes precedence." (Id., available at
http://www.health.state.mn.us/divs/eh/risk/rules/water/mtngpresentation.pdf, at Slide 68,
emphasis in original.) We find this assertion surprising, and legally unsupportable.
Minnesota Statutes Section 103H.20 1, subd.(2)(a) provides that "Health risk limits shall
be adopted by rule." The Minnesota Administrative Procedures Act ("MAPA") defines a "Rule"
as "every agency statement of general applicability and future effect, including amendments,
suspensions, and repeals of rules, adopted to implement or make specific the law enforced or
administered by that agency or to govern its organization or procedure." Minn. Stat. § 14.02
Subd. 4 (2009). MAP A sets out the required procedures for rulemaking. The Minnesota
Supreme Court has made clear that all types of rules are subject to the rulemaking requirements
ofMAPA. Cable Communications Boardv. Nor-West Cable Communications Partnership, 356
N. W.2d 658, 667 (Minn. 1984). An agency must promulgate as rules all formal and informal
procedures "to the extent that those procedures directly affect the rights of or procedures
available to the public." Weber v. Hvass, 626 N.W.2d 426, 433-34 (Minn. Ct. App. 2001)
(quoting Minn. Stat. § 14.06).
Minn. Stat.§ 14.00l.describes the over-arching purposes of the Administrative
Procedures Act (APA), which include:
(I) to
(2) to
(3) to
(4) to
(5) to
provide oversight of powers and duties delegated to administrative agencies;
increase public accountability of administrative agencies;
ensure a uniform minimum procedure;
increase public access to governmental information;
increase public participation in the formulation of administrative rules;
23
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 20 lO
Page 24 of29
7) to simplify the process ofjudicial review of agency action as well as increase its ease
and availability.
The MAP A grants procedural rights "with the expectation that better substantive results will be
achieved in the everyday conduct of state government by improving the process by which those
results are attained." Minn. Stat. § 14.00 l. None of these objectives are obtained if MDH
supplants adopted regulations with informal guidance.
Indeed, we do not understand how MDH can supersede or amend a validly promulgated
binding regulation by a subsequently-issued agency statement that has not been adopted as a
regulation. As the Minnesota Supreme Court has made clear in Cable Communications Board,
supra, if an agency's new policy is not consistent with its current rules, the court will invalidate
the agency action unless MAPA procedures for rulemaking were followed. Id. at 667-668. 5
Thus, MDH is required under MAPA to amend its HRLs by rulemaking, not by
announcing a new policy setting a different standard.
Minnesota courts have not been reluctant to invalidate agency policies that are inconsistent with the
agency's rules. See, e.g., In re Rate Appeal ofBenedictine Health Center, 728 N.W.2d 497, 506-07
(Minn. 2007) (invalidating a Department of Human Services policy as an unpromulgated rule which was
inconsistent with the agency's related rules); Swenson v. Dep 't ofPublic Welfare, 329 N.W. 2d 320, 324
(Minn. 1983) (invalidating agency's decision to limit certain social services to three days a week, finding
that the agency's rule required the services be available five days a week); White Bear Lake Care Center,
Inc. v. Minnesota Dep 't ofPublic Welfare, 319 N.W.2d 7, 8-9 (Minn. 1982)(invalidating agency's
computation of nursing home per diem rates which inconsistent with computation required by the agency
rules); Wingo v. Commissioner ofPublic Safety, 2001 WL 290504, No. C6-00-1674, *2-3 (Minn. Ct.
App. March 27, 2001) (finding that the approval by the Commissioner of Public Safety of a certain model
of breathalyzer test equipment that was not listed in the regulations was subject to formal rulemaking
procedures under MAPA; however, because the record was silent as to the materiality of the change, the
court deferred to the Commissioner's interpretation).
5
24
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 25 of29
***
3M appreciates the opportunity to comment on the draft HRLs, and particularly
appreciates the amount of effort MDH staff has devoted to developing these drafts. We believe
the drafts could be improved, and offer these comments in the spirit of fostering rigor,
transparency and consistency in the HRLs.
Respectfully submitted,
;r~;;KJ rO
;;lfJC:Wiirector
Larry R. Zobel, M.D., M.P.H.
JLt!:A.Nash
Assistant General Counsel
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Mr. John Line Stine
Ms. Linda Bruemmer
November 17, 2010
Page 26 of29
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Das, K. P., Grey, B. E., Zehr, R. D., Wood, C. R., Butenhoff, J. L., Chang, S.C., Ehresman, D.
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Appl Pharmacol160, 21-32, 10.1006/taap.l999.8737S0041-008X(99)98737-9 [pii].
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J., Korosi, S. A. and North, C. J. (1989). Comparative studies
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Lieder, P. H., Chang, S.C., York, R. G. and Butenhoff, J. L. (2009). Toxicological Evaluation of
Potassium Perfluorobutanesulfonate in a 90-Day Oral Gavage Study with Sprague
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Butenhoff, J. L. (2009). A comparison of the pharmacokinetics of
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Parzefall, W., Erber, E., Sedivy, R. and Schulte-Hermann, R. (1991). Testing for induction of
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peroxisome proliferators on fatty acyl-CoA oxidase, DNA synthesis, and apoptosis in
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C. R. and Elcombe, C. R. (2010). Human constitutive Androstane Receptor (CAR) and
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Toxicol Sci 116, 452466.
Schussler, G. C. (2000). The thyroxine-binding proteins. Thyroid 10, 141-9.
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compared with equilibrium dialysis in patients with thyroid dysfunction and nonthyroidal
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Ms. Linda Bruemmer
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Upadhyay, S., Carstens, J., Klein, D., Faller, T. H., Halbach, S., Kirchinger, W., Kessler, W.,
Csanady, G. A. and Filser, J. G. (2008). Inhalation and epidermal exposure of volunteers
to ethylene glycol: kinetics of absorption, urinary excretion, and metabolism to glycolate
and oxalate. Toxicol Lett 178, 131-41.
USEPA (2002). Hepatocellular Hypertrophy. HED ToxSAC 2002 HED Guidance Doc G2002. OJ.
Viollon-Abadie, C., Lassere, D., Debruyne, E., Nicod, L., Carmichael, N. and Richert, L. (1999).
Phenobarbital, beta-naphthoflavone, clofibrate, and pregneno1one-16alpha-carbonitrile do
not affect hepatic thyroid hormone UDP-glucuronosyl transferase activity, and thyroid
gland function in mice. Toxicol Appl Pharmaco/155, 1-12.
Ward, K. W., Erhardt, P. and Bachmann, K. (2005). Application of simple mathematical
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Pharmacol Toxicol Methods 51, 57-64.
Waxman, D. J. (1999). P450 gene induction by structurally diverse xenochemicals: central role
of nuclear receptors CAR, PXR, and PPAR. Arch Biochem Biophys 369, 11-23.
Whysner, J., Ross, P.M. and Williams, G. M. (1996). Phenobarbital mechanistic data and risk
assessment: enzyme induction, enhanced cell proliferation, and tumor promotion.
Pharmacol Ther 71, 153-91.
Wieneke, N., Neuschafer-Rube, F., Bode, L. M., Kuna, M., Andres, J., Carnevali, L. C., Jr.,
Hirsch-Ernst, K. I. and Puschel, G. P. (2009). Synergistic acceleration of thyroid
hormone degradation by phenobarbital and the PP AR alpha agonist WY 1464 3 in rat
hepatocytes. Toxicol Appl Pharmaco/240, 99-107.
Wolf, C. J., Takacs, M. L., Schmid, J. E., Lau, C. and Abbott, B. D. (2008). Activation of mouse
and human peroxisome proliferator-activated receptor alpha by perfluoroalkyl acids of
different functional groups and chain lengths. Toxicol Sci I 06, 162-71.
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Attachments:
roger akembuom <[email protected]>
Wednesday, November 10, 2010 8:59 PM
Moibi, Nitika (MDH)
Request for a Public Hearing on Rules Amendment fo Groundwater Health Risk Limits
Public Hearing.docx
Dear Sir/Madam: Please find attached a request for a public hearing on the proposed rule amendment to ground water health risk limits. Thanks, Rogers akembuom 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Dear Sir/Madam, I wish to request a public hearing on the amendment to the ground water Health Risk Limit. I have read through the SONAR and will like to have some clarification those chemicals that do not have sufficient data to determine their health risks to citizens. I will like to request this public hearing because chemicals like dichlorodifluoromethane have been referred to as “highly volatile”. Despite referring to this chemical and others as “highly volatile”, the intended amendments say there is insufficient data on these chemicals. The public will benefit from a public hearing that seeks to explain what it means when these chemicals are referred as “highly volatile”. Does this high volatility have no effect on the health of citizens? A public hearing will help to inform citizens, and highlight what they can look for in their underground water. Sincerely, Rogers Akembuom 2569 Copper Cliff Trail Woodbury, MN, 55125 651‐702‐1425 MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 32 of 189
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Lori Andresen <[email protected]>
Tuesday, November 16, 2010 11:35 PM
Moibi, Nitika (MDH)
Moyer, Paul (MDH)
Public Hearing Request for Manganese Rule Change
Re: Public Hearing Request for Manganese Rule Change
Dear Ms. Moibi,
I am requesting that the Minnesota Department of Health hold a public meeting on the proposed rule change for
Manganese, specifically the repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). Manganese is a known neurotoxin and it would be prudent to
keep the current standard of 100 µg/L HRL value rather than lower the standard to a 300 µg/L health-protective
guidance. In order to best shield Minnesotans from any possible ill effects of manganese exposure, the current
standard should be defended against the proposal to weaken it through a rule change.
Excerpted from‐ Manganese in drinking water: Study suggests adverse effects on children's
intellectual abilities
at http://esciencenews.com/articles/2010/09/20/manganese.drinking.water.study.suggests.adverse.effect
s.childrens.intellectual.abilities Lead author Maryse Bouchard explains, "We found significant deficits in the intelligence quotient (IQ)
of children exposed to higher concentration of manganese in drinking water. Yet, manganese
concentrations were well below current guidelines." The average IQ of children whose tap water was in
the upper 20% of manganese concentration was 6 points below children whose water contained little or
no manganese. The analyses of the association between manganese in tap water and children's IQ took
into account various factors such as family income, maternal intelligence, maternal education, and the
presence of other metals in the water. For co-author Donna Mergler, "This is a very marked effect; few
environmental contaminants have shown such a strong correlation with intellectual ability." The authors
state that the amount of manganese present in food showed no relationship to the children's IQ. "Because of the common occurrence of this metal (Manganese) in drinking water and the observed
effects at low concentrations, we believe that national and international guidelines for safe manganese in
water should be revisited." the authors conclude.
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One wonders if the current attempt to weaken the Manganese standard is related to mining schemes in NE
Minnesota- for Manganese and Copper-Nickel Sulfides. Manganese is often dispersed through the
environment by mining operations. The recent proposals across NE Minnesota should demand higher scrutiny
and standards- not weaker. Our agencies are tasked with protecting us, please do so.
Sincerely,
Lori Andresen
Duluth, Minnesota
3025 E Superior ST
Duluth, Minnesota
55812
http://www.startribune.com/local/106828988.html?elr=KArksUUUoDEy3LGDiO7aiU Fast-tracked projects, and pollution?
Critics say a team with the MPCA has become too cozy with industry it regulates, claiming mining and ethanol
permits are being awarded with "a wink and a nod."
By TOM MEERSMAN, Star Tribune
Last update: November 6, 2010 - 11:36 PM
A special team was set up to streamline mining and ethanol projects at the Minnesota Pollution Control Agency
recently. But the team is approving permits so quickly that it's damaging Minnesota's air and water, say current
and former scientists at the agency.
The team, called the Strategic Projects Sector, gives industry proposals immediate priority and attention.
"The marching orders are to make mining and ethanol happen, and make them happen no matter what, and
make them happen easy and fast," said Janette Brimmer, former legal affairs director for the Minnesota Center
for Environmental Advocacy.
Ann Foss, SPS division director, said that the team does not provide special treatment. The MPCA created
separate teams for biofuels and mining a couple of years ago, and then combined them into a single unit last
spring. The team was formed not to grant favors, said Foss, but to handle regulations more efficiently,
especially for complex projects that need several different kinds of permits.
2
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"It helps ensure that decisions are made in a timely manner and that things are well coordinated," she said.
However, several current and former agency workers have said that the team has become too much of an
advocate for the big-ticket projects.
Gary Kimball, an MPCA research scientist who retired last April, said some deadlines were pushed so hard that
air and water quality analysts didn't have enough time to determine whether projects would be able to meet
pollution control standards.
"A good number of us had reservations about getting the information we needed in order to make decent
judgments," Kimball said.
Permits get 'wink and a nod'
Other MPCA scientists still working at the agency, who spoke on condition of anonymity, agreed. They see
recent violations by ethanol plants as evidence of the rush to help industry get up and running quickly. Five of
the state's 21 ethanol plants paid more than $2.8 million in fines and other penalties during the past year.
Recent ethanol violations "are no surprise to those who've worked on these projects," said one MPCA scientist,
because the permits were approved with a "wink and a nod."
Some of the more experienced scientists have been removed from projects, said another, because they pointed
out mistakes or refused to go along with industry requests.
In late September, five environmental and parks groups appealed to the U.S. Environmental Protection Agency
to reject an air permit the MPCA gave to United Taconite in August.
The permit unlawfully "double-credited" the emissions reductions for some plant modifications, the groups
said, so the company will continue contributing to regional haze near the Boundary Waters Canoe Area
wilderness and Voyageurs National Park. Those areas are supposed to receive the highest air quality protection
under federal law.
Michael Robertson, environmental policy consultant for the Minnesota Chamber, said ethanol and mining firms
would strongly disagree that they receive special treatment from the agency's new team, and some find the
permit process time-consuming and cumbersome.
"I don't think our guys would say that permits that come out of that group are going to have everything that they
want in them, or that they're totally happy with them," he said.
Ethanol owners with dozens of problems have been cooperating, said agency officials, and have reached
settlements and paid fines instead of challenging the alleged violations in court.
Some of the problems are resolved over breakfast at Keys Cafe in downtown St. Paul. Foss schedules two or
three 7 a.m. meetings there each month to accommodate requests from consultants and lobbyists, including
those from mining firms. She said the meetings are part of her daily work schedule and help consultants work
through confusing regulations.
However, an MPCA scientist with knowledge of some of the meetings said that their purpose is more to
"manipulate the process" to avoid regulations and receive variances from normal pollution limits.
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Easy industry access raises a red flag for Nancy Schuldt, water projects coordinator for the Fond du Lac
environmental program. The tribe is very concerned about the PolyMet copper-nickel mine proposed for
northeastern Minnesota and others that may follow, she said.
"There seems to be a lot of communication between MPCA and industry, but we have to ask for any of that
information," Schuldt said. "It's not forthright."
MPCA officials meet quarterly with tribes about various mining projects, but some say tribal concerns are
largely ignored when it comes to approving permits with minimal requirements or loopholes.
"What we want is for the companies to follow the law," said one tribal staffer who agreed to speak on condition
of anonymity. "It does seem like somewhere behind the scenes they're getting around it."
Jeff Smith, director of MPCA's industrial division, said that larger construction projects always receive priority,
but that doesn't mean they are hurried.
Ethanol and mining operations must comply with state and federal environmental standards, he said.
MPCA: 'No special shortcut'
"There's no special shortcut around those regulations," Smith said. "The permits we issue protect public health
and the environment."
Smith said he can understand how lots of meetings with industry officials might be perceived as "overly
supportive or working outside the boundaries." However, others may request their own meetings, he said, and
companies exert no undue influence on agency decisions. "We would not be meeting with them if it didn't
advance the conversation and help get these permits out faster and in compliance with state and federal
regulations," Smith said.
Scott Strand, executive director of the Minnesota Center for Environmental Advocacy, said it's normal for an
agency to meet with developers to solve problems. The danger is that MPCA may rely too much on industries
for information used to make decisions.
Strand said part of the problem is that too many in the agency view industry as the customer, rather than the
party to be regulated.
"That's not right," he said. "The customer is the public and the environment."
Tom Meersman • 612-673-7388
http://www.startribune.com/local/56781297.html 4
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Brad Moore
Former head of PCA is now consultant to mining
firm
Brad Moore is working with Barr Engineering and Crow Wing Power Co. in a project to mine manganese in
Emily, Minn.
By MIKE KASZUBA and TOM MEERSMAN, Star Tribune staff writers
Last update: September 2, 2009 - 10:43 PM
Nine months after leaving as head of the state Pollution Control Agency and promising not to take a job that
presented a conflict of interest, Brad Moore is playing an important role in a proposed mining project that will
need his former agency's approval.
Moore now works for Barr Engineering of Minneapolis and is a point person for a Crow Wing Power Co.
proposal in northern Minnesota to mine one of the largest high-grade deposits of manganese in North America.
Though Moore is barred by state law from personally appearing before the PCA board or participating in
proceedings of the agency for one year, his involvement as a government relations and public affairs expert
comes as the project enters an intricate series of tests to show state officials that manganese can be mined from
the site without polluting nearby lakes.
Moore said he has been careful to follow state law regarding conflicts of interest and was abiding by "the letter
of the law and also the spirit."
His role with the mining project illustrates the often-delicate line that PCA commissioners and other state
agency heads face as they step between regulatory jobs and the industries they regulate.
When he was appointed to head the PCA by Gov. Tim Pawlenty in 2006, Moore succeeded Sheryl Corrigan,
whom critics accused of being too accommodating to industry and at one point of allowing business interests to
weaken a plan to restrict mercury emissions from power plants.
5
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During his time at the PCA, Moore was praised for changing the perception that the agency was too cozy with
business. When he left last November, Moore promised that his new job at Barr Engineering would not lead to
any conflicts. "Much of the work is going to be outside of Minnesota in other jurisdictions, and you're not going
to see me before the Pollution Control Board anytime soon," he said.
"We were surprised to see that Brad was working on stuff in the state after his comments," said Paul Aasen,
interim executive director of the Minnesota Center for Environmental Advocacy, which is monitoring the
project but has not taken a position on it.
Reed Larson, the PCA's north central region manager, acknowledged that Moore's new role had the potential to
be awkward. "It's kind of funny to see the former commissioner sitting across the table," he said. "[We] analyze
the project on its own merits."
Currently manganese must be imported. It is used in steel production, and also is seen as valuable for reducing
power plant emissions, as well as for use in water purification and in rechargeable batteries. The small 5-acre
site in Emily, Minn., in north central Minnesota, has long been eyed for mining.
The Crow Wing Power proposal is being touted as more environmentally friendly than past proposals. The
process, known as bore hole extraction, would involve drilling holes into the site and then using pressurized
water to recover the manganese.
A first-phase demonstration project is being monitored by the PCA, but an initial permit request for the project
is not expected to come before the agency's board until early next year. The mining proposal also must be
approved by the Department of Natural Resources, where Moore also served as an assistant commissioner.
At public meetings in June and July, Moore provided an overview of the regulatory approvals the project would
need, including environmental permits from his former agency.
"He keeps me informed on everything that's going on," said George Pepek, the mayor of Emily.
Doug Connell, Barr Engineering's president, said he contacted Moore while he was the PCA commissioner
about working for Barr because he sensed Moore's job "was not going the way he wanted." Moore said that he
never granted Barr Engineering any favors while heading the agency. Since late 2005, the company has had
contracts with the PCA totaling just over $1 million to work on water quality projects.
Moore said he began working on the Emily project about a month after leaving the PCA. He said most of his
work involved "citizen engagement" and helping to steer the project through the state, local and federal
regulatory process, which will include getting around a city ordinance that prohibits the mining project. "I help
ensure that the documents that are submitted to agencies pass muster," he said.
As he works on the project, Moore said, he has not touted his former role as PCA commissioner to citizen
groups in an attempt to influence their opinions. "I never, when I'm in public meetings, talk about where I've
been," he said, although he said that he is occasionally introduced as a former agency commissioner.
In his new job, Moore has also met with environmental groups about the mining project -- a role that has not
gone unnoticed.
Aasen, from the Minnesota Center for Environmental Advocacy, said Moore met with the group earlier this
year to explain the project -- a move that Aasen said was an attempt to get the group to endorse it. "Anytime
you move public to private or private to public ... as a regulator, it raises questions," he said.
6
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Mike Zipko, a spokesman for Cooperative Mineral Resources, the Crow Wing Power subsidiary that is
overseeing the project, downplayed Moore's role and possible influence with his former agency. "Brad was not
the reason that Barr got hired," he said.
Moore is not the only former PCA commissioner who has remained actively engaged with the agency.
Chuck Williams, whose term as commissioner from 1991 to 1996 was the longest of any PCA head, is an
independent environmental consultant for several mining companies and attends PCA board meetings monthly.
Peder Larson, who succeeded Williams as commissioner from 1996 through 1998, is a Minneapolis
environmental attorney whose work includes ethanol projects. Larson said he steered clear of the agency's board
for at least a couple years after leaving his job but has since appeared before it.
Larson said many consultants and lawyers who come before the PCA representing business have previously
worked for the agency as engineers or division managers. Knowing people at the agency, he said, can be a slight
advantage. "It's not based on whether they'll do you a favor," he said. "It's more like a client says, 'I've got to
talk with this person at the agency; can you tell me about him?'"
Chris Nelson, the PCA's mining sector manager, said he has met with Moore about the mining project and that
it was not surprising that Moore and other former agency officials work for firms with projects before the
agency.
"If you have an environmental, technical background and you decide to leave state government ... you're not
going to go work and do music videos or something," he explained.
Mike Kaszuba • 651-222-1673
7
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Lori Andresen <[email protected]>
Thursday, December 02, 2010 2:57 PM
Moibi, Nitika (MDH)
Withdrawal of Hearing Request
To: Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201‐4907 Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/ Withdrawal of Hearing Request Date: December 2, 2010
I withdraw my request for a hearing regarding the Health Risk Limit (HRL) for manganese in Minnesota Rules,
Chapter 4717, Part 7500, subpart 61 based upon MDH guarantee that the current HRL will not be repealed, that
a guidance value of 300 ug/L be removed from the MDH website, and THAT CITIZENS BE INFORMED OF
ANY ONGOING DECISIONS REGARDING THE HRL FOR MANGANESE.
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Thank you,
Lori Andresen
3025 E Superior ST
Duluth, MN
55812
2
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Carla Arneson <[email protected]>
Wednesday, November 17, 2010 1:49 AM
Moibi, Nitika (MDH)
Comments on proposed amendments on HRL for Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed
changes in groundwater protections will result in even greater vulnerability and risk to public health. In particular, I
oppose the repeal of an HRL value for manganese and replacing it with the proposed health-
protective guidance (Risk Assessment Advice).
Such a change would fly in the face of the latest research indicating that manganese seriously impairs the
intelligence quotient of children. Researchers in Quebec, Canada, alarmed by the results of their recent
(September) study are asking for stricter manganese limits and further study. "The findings from the present study
support the hypothesis that low-level, chronic exposure to manganese from drinking water is associated with
significant intellectual impairments in children." The study was funded by Canadian Institutes for Health Research.
Surely the Minnesota Department of Health cares as much about our children, whose health and welfare depends
on its decisions.
Sincerely,
Carla Arneson
Ely, Mn. 55731
218.365.3042
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Leiv Aspelund <[email protected]>
Wednesday, November 17, 2010 4:21 PM
Moibi, Nitika (MDH)
Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am
concerned about repeal of an HRL value for manganese and replacing it with the proposed health-protective
guidance (Risk Assessment Advice).
Sincerely,
Leiv Aspelund
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Attachments:
ARNOSTI, Donald <[email protected]>
Wednesday, November 17, 2010 3:16 PM
Moibi, Nitika (MDH)
Moyer, Paul (MDH); PETERSON, Mark
Relaxation of Manganese standards in Groundwater
Manganese standard.doc
Dear Ms. Moibi, Please take Audubon Minnesota's comments into consideration regarding the Minnesota Department of Healths's proposed changes to groundwater standards, particularly those concerning manganese. We are requesting that you hold a public meeting on this matter, as provided for in your notice. Please do not hesitate to contact me with any questions. Sincerely, Don Arnosti Policy Director Audubon Minnesota 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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It has recently come to our attention that the Minnesota Department of Health is
proposing to eliminate existing Health Risk Limit for Manganese and replace it
with a less-protective Guidance. We are concerned that this proposal seems to
be taking place without a public meeting.
We are requesting that the Minnesota Department of Health hold a public
meeting on the proposed rule change for Manganese, particularly the proposal to
repeal the existing Health Risk Limit and to replace it with a proposed, lessprotective "health-protective guidance." Over-exposure to manganese is known
to affect the nervous system, causing Parkinson's-like symptoms and impairing
learning in children.
Since the proposed rule change was published this peer-reviewed article was
published in Environmental Health Perspectives: " Intellectual Impairment in
School-Age Children Exposed to Manganese from Drinking Water." This information
indicates a need to strengthen, not weaken our water quality standards for magnesium.
In light of this new information, we request that the Minnesota Department of Health
withdraw their proposal to change the existing Health Risk Limit for Manganese to a
less-protective Guidance.
On behalf of all 12,000 members of the National Audubon Society in Minnesota,
Don Arnosti
Policy Director
Audubon Minnesota
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Erlend Bøgwald Austerheim <[email protected]>
Wednesday, November 17, 2010 5:22 AM
Moibi, Nitika (MDH)
Re: Request for a Public Hearing on the Proposed Rule Changes to
Limits of Groundwater
Health Risk
Dear Ms Moibi, I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota, Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am concerned about repeal of an HRL value for manganese and replacing it with the proposed health‐protective guidance (Risk Assessment Advice). Sincerely, Erlend B. Austerheim Udbyes gt. 7 7030 Trondheim Norway 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Carolyn Carr <[email protected]>
Wednesday, November 17, 2010 3:33 PM
Moyer, Paul (MDH); Moibi, Nitika (MDH)
Comments on Manganese Standard Revisions
To: Paul Moyer, MN Dept of Health
Nitika Moibi, MN Dept of Health
I understand the MN Dept of Health is proposing to repeal the Health Risk Limit for manganese by converting the Health
Risk Limit of 100 micrograms/liter to a Guidance Limit of 300 micrograms/liter. I oppose this decrease in protection of
human health, and urge the agency NOT to proceed with this repeal, and to instead maintain the current Health Risk
Limit.
Protecting human health is the essential obligation of the Dept of Health. Manganese is well-known danger to human
health from impacts to the nervous system. A recent peer-reviewed journal article (Bouchard MF, Sauvé S, Barbeau B,
Legrand M, Brodeur M-È, Bouffard T, et al. 2010. Intellectual Impairment in School-Age Children Exposed to Manganese
from Drinking Water. Environ Health Perspect :-. doi:10.1289/ehp.1002321), presents results from a cross-sectional study
which suggest that exposure to manganese at levels common in groundwater is associated with impairment in children
(based on IQ scores, adjusted for confounding factors). Increased levels of manganese concentration found in children's
drinking water and their hair were found to present increased risks.
Eliminating the existing Rule exposes Minnesota citizens to increased risks from environmental pollution. In areas near
sulfide mining and processing in Minnesota, drinking water is being currently threatened by manganese toxicity. Tripling
the allowable limit of manganese concentration in groundwater from 100 to 300 micrograms/liter increases the threat of
manganese exposure to the public. This decrease in protection from this industrial pollutant is unacceptable, and violates
the trust citizens place in this agency. The Health Department should maintain the existing manganese Health Risk Limit
and should not substitute it with a lower Guidance Limit.
Sincerely,
Carolyn Carr
4050 39th Ave. S.
Minneapolis MN 55406
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Attachments:
Samantha Chadwick <[email protected]>
Wednesday, November 17, 2010 4:33 PM
Moibi, Nitika (MDH)
Moyer, Paul (MDH)
Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota
Rules, Chapter 4717, Part 7860 and Part 7500. Manganese.
16 November 2010.doc; ATT00001..htm; image001.jpg; ATT00002..htm
16 November 2010
Dear Ms. Moibi,
We are very concerned to learn that the Minnesota Department of Health is considering repealing the health risk
limit for the pollutant manganese, which is dangerous to public health and is one of the pollutants expected to
be a problem with new sulfide mines being proposed in our state.
A such a move is considered, we believe it is important that the Minnesota Department of Health hold a public
meeting on the proposed rule change for Manganese, specifically the repeal of an HRL value for manganese and
replacing it with the proposed health-protective guidance (Risk Assessment Advice). The Health Department
should be protecting Minnesotans from industrial pollution, not eliminating standards that would require
pollution to be controlled.
Sincerely,
Samantha Chadwick
Preservation Advocate
Environment Minnesota
1313 5th St SE Suite 316
Minneapolis MN 55414
Environment Minnesota is a state-wide citizen based environmental group working for clean air, clean water,
and open space. www.EnvironmentMinnesota.org
1
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16 November 2010
Dear Ms. Moibi,
We are very concerned to learn that the Minnesota Department of Health is considering
repealing the health risk limit for the pollutant manganese, which is dangerous to public
health and is one of the pollutants expected to be a problem with new sulfide mines being
proposed in our state.
A such a move is considered, we believe it is important that the Minnesota Department of
Health hold a public meeting on the proposed rule change for Manganese, specifically the
repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). The Health Department should be
protecting Minnesotans from industrial pollution, not eliminating standards that would
require pollution to be controlled.
Sincerely,
Samantha Chadwick
Preservation Advocate
Environment Minnesota
1313 5th St SE Suite 316
Minneapolis MN 55414
Environment Minnesota is a state-wide citizen based environmental group working for
clean air, clean water, and open space. www.EnvironmentMinnesota.org
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
To:
Subject:
Moyer, Paul (MDH)
RE: DO NOT REPEAL OF THE MANGANESE STANDARD
From: Jean Chovan [mailto:[email protected]]
Sent: Wednesday, November 17, 2010 10:10 AM
To: Moyer, Paul (MDH)
Subject: DO NOT REPEAL OF THE MANGANESE STANDARD
1.
2.
3.
4.
Manganese is dangerous to human health, causing impacts to the nervous system;
Repealing the Health Risk Limit will eliminate an important Rule protecting Minnesota citizens from environmental pollution;
There is a real and present danger of manganese toxicity in drinking water resulting from sulfide mining and processing;
The Health Department should be protecting Minnesotans from industrial pollution, not eliminating standards that would require pollution to be
controlled.
Thank you,
Jean Chovan
16 7th Ave SE
Rochester, MN 55904
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
frank dezurik <[email protected]>
Wednesday, November 17, 2010 3:52 PM
Moibi, Nitika (MDH)
[email protected]
Request for a Public Hearing on the Proposed Rule changes to health risk limits of
groundwater.
Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently being considered by the state of Minnesota , Department of Health (MDH) , And I am requesting that the MDH conduct a public hearing regarding these proposed changes in groundwater protections because they will Result in even greater vulnerability and risk to the Public’s health. Sincerely, Frank J. DeZurik ( resident of Emily,Mn.) 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Mark Fride <[email protected]>
Tuesday, November 16, 2010 7:33 PM
Moibi, Nitika (MDH)
Re: Public Hearing Request for Manganese Rule Change
Re: Public Hearing Request for Manganese Rule Change
Hello Ms. Moibi,
I am requesting that the Minnesota Department of Health hold a public meeting on the proposed rule change for
Manganese, specifically the repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). Manganese is a known neurotoxin and it is in the best interest
of the citizens of Minnesota to keep the current standard of 100 µg/L HRL value rather than lower the standard
to a 300 µg/L health-protective guidance. Sincerely,
Mark Fride
Duluth, Minnesota
225 Mitchell Circle
55811
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Mark Fride <[email protected]>
Thursday, December 02, 2010 2:56 PM
Moibi, Nitika (MDH)
Withdrawal of Hearing Request
To: Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201‐4907 Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/ Withdrawal of Hearing Request Date: December 2, 2010
I withdraw my request for a hearing regarding the Health Risk Limit (HRL) for manganese in Minnesota Rules,
Chapter 4717, Part 7500, subpart 61 based upon MDH guarantee that the current HRL will not be repealed, that
a guidance value of 300 ug/L be removed from the MDH website, and THAT CITIZENS BE INFORMED OF
ANY ONGOING DECISIONS REGARDING THE HRL FOR MANGANESE.
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Thank you,
Mark Fride
225 Mitchell Circle
Duluth, MN
55811-5904
2
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 4:21 PM
Moibi, Nitika (MDH)
Public Hearing Request for Manganese Rule Change
Dear Ms. Moibi,
I am requesting that the Minnesota Department of Health hold a public meeting on the proposed rule change for
Manganese, specifically the repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). Manganese is a known neurotoxin and should be kept at the
current standard of 100 µg/L HRL value rather than lowering the standard to 300 µg/L health-protective
guidance to protect the health of Minnesotans.
Therefore, I am asking that the current HRL value be maintained and not modified. Thank you.
Sincerely,
Bob Graves
1420 Wild Ridge Trl.
Newport, MN 55055
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Ricardo Grijalva <[email protected]>
Wednesday, November 17, 2010 3:32 PM
Moibi, Nitika (MDH)
i oppose!!
i do not think this is right !!!!
it AFFECTS US GREATLY!!!
The Health Department should not repeal the manganese Health Risk Limit
Manganese is dangerous to human health, causing impacts to the nervous
system~!!!!!!
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Frank Hawthorne <[email protected]>
Wednesday, November 17, 2010 11:37 AM
Moibi, Nitika (MDH); Moyer, Paul (MDH)
COMMENT OPPOSING THE REPEAL OF THE MANGANESE STANDARD:
Dear Sirs:
Regarding proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules,
Chapter 4717, Part 7860 and Part 7500.
As consumers with personal interest in our own health--plus sharing a greater, abiding interest in the
environment we all share--my wife & I write to you today to urge that the Health Department not repeal the
Manganese Health Risk Limit.
As you know, Manganese is dangerous to human health, causing impacts to the nervous system. Sulfide mining causes
acid mine drainage that affects aquatic systems and increases mercury in fish. It also leaches metals into water
that are dangerous to human consumers as well as to the ecosystem.
Over-exposure to this mining by-product is known to affect the nervous system, causing Parkinson's like
symptoms and impairing learning in children.
Please keep these points in mind as you deliberate this proposal. Thank you for considering our views.
Frank & Dottie Hawthorne
427 Sixth St. S.W.
Rochester, MN 55902
1
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Date: November 17, 2010
From: Elizabeth and Paul Heck, JD
8713 Walton Oaks Drive
Bloomington, MN 55438
To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Public Comment on Proposed Rule Changes to Health Risk Limits of
Groundwater
We oppose the proposed rule changes to health risk limits currently under consideration
by the State of Minnesota, Department of Health. In particular, we are concerned
about repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). This proposed change has the potential
to place the public at greater health risk than the current statute.
As a home owner in the vicinity of an experimental manganese mining operation with the
potential for large-scale mining, we have deep concerns about possible groundwater
contamination. The project is for the Cooperative Mineral Resources (CMR) Bulk
Sample Collection located just north of Emily, Minnesota. Discharge containing
manganese and other potential unwanted minerals is to be dispersed directly into the
ground, not removing contaminants, rather simply diluting them. The EAW for the project
states that proposed actions will cause unknown impacts and further states that the
quality of water after passing through the unlined sedimentation basin and unlined rapid
infiltration basin is “expected” to meet groundwater quality standards and that it is
“anticipated” that there will be no impact on the water quality of the aquifer. The EAW
does not sufficiently demonstrate that the experimental operation would not cause harm
to humans or the environment.
For this project and other similar operations, there is a need to establish up-front some
clearly defined triggers which, if met, would force mining operations to treat
discharges/effluent. Groundwater quality standards and limits on contaminants allowed
into groundwater need to be strengthened, not weakened. Mining companies and other
entities need to be held accountable for their actions with specific numeric standards for
maximum contaminant discharges levels. This means retaining a specific HRL value for
manganese rather than a “guidance”.
Please reconsider the proposed legislative changes for manganese. Thank you for the
opportunity to comment on this Rule.
Sincerely,
Elizabeth and Paul Heck, JD
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Elizabeth Heck <[email protected]>
Tuesday, November 16, 2010 1:20 PM
Moibi, Nitika (MDH)
Rule Changes to Health Risk Limits of Groundwater
Date: November 16, 2010 From: Elizabeth Heck 8713 Walton Oaks Drive Bloomington, MN 55438 To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975 Saint Paul, MN 55164-0975 [email protected] Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am
concerned about repeal of an HRL value for manganese and replacing it with the proposed
health-protective guidance (Risk Assessment Advice). Sincerely, Elizabeth Heck 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Date: November 17, 2010
From: Elizabeth and Paul Heck, JD
8713 Walton Oaks Drive
Bloomington, MN 55438
To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Public Comment on Proposed Rule Changes to Health Risk Limits of
Groundwater
We oppose the proposed rule changes to health risk limits currently under consideration
by the State of Minnesota, Department of Health. In particular, we are concerned
about repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). This proposed change has the potential
to place the public at greater health risk than the current statute.
As a home owner in the vicinity of an experimental manganese mining operation with the
potential for large-scale mining, we have deep concerns about possible groundwater
contamination. The project is for the Cooperative Mineral Resources (CMR) Bulk
Sample Collection located just north of Emily, Minnesota. Discharge containing
manganese and other potential unwanted minerals is to be dispersed directly into the
ground, not removing contaminants, rather simply diluting them. The EAW for the project
states that proposed actions will cause unknown impacts and further states that the
quality of water after passing through the unlined sedimentation basin and unlined rapid
infiltration basin is “expected” to meet groundwater quality standards and that it is
“anticipated” that there will be no impact on the water quality of the aquifer. The EAW
does not sufficiently demonstrate that the experimental operation would not cause harm
to humans or the environment.
For this project and other similar operations, there is a need to establish up-front some
clearly defined triggers which, if met, would force mining operations to treat
discharges/effluent. Groundwater quality standards and limits on contaminants allowed
into groundwater need to be strengthened, not weakened. Mining companies and other
entities need to be held accountable for their actions with specific numeric standards for
maximum contaminant discharges levels. This means retaining a specific HRL value for
manganese rather than a “guidance”.
Please reconsider the proposed legislative changes for manganese. Thank you for the
opportunity to comment on this Rule.
Sincerely,
Elizabeth and Paul Heck, JD
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 75 of 189
Nov 16 10 02:00p
LANDMARK GROUPS
9529960890 p.1
Date: November 16, 2010
From: Paul Heck 8713 Walton Oaks Drive Bloomington, MN 55438
To: Nitika Moibi Minnesota Department of Health 625 Robert Street North P.O. Box 64975 Saint Paul, MN 55164-0975 Re:
Request for a Public Hearing on the Proposed Rule Changes to Health
Risk Limits Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under
consideration by the State of Minnesota, Department of Health (MDH)
and request that the MDH conduct a Public Hearing as these proposed changes
in groundwater protections will result in even greater vulnerability and risk to
public health. In particular, I am concerned about repeal of an HRL value for
manganese and replacing it with the proposed health-protective guidance (Risk
Assessment Advice).
Sincerely, Paul Heck MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 76 of 189
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
david <[email protected]>
Wednesday, November 17, 2010 2:50 PM
Moyer, Paul (MDH); Moibi, Nitika (MDH)
Rep.David Bly; Kevin Dahle
Proposed amendments to Rules/ Manganese
Nov. 17, 2010 Re: Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules, Chapter 4717, Part 7860 and Part 7500. Manganese. Dear Mr. Moyer: The Health Department should not be amending the manganese Health Risk Limit. Manganese is dangerous to human health, causing impacts to the nervous system. Raising the Health Risk Limit from 100 micrograms/liter to 300 micrograms/liter would put Minnesota citizens at risk. Manganese toxicity in drinking water resulting from sulfide mining and processing is a particular concern. Please keep me on a mailing list for followup. Thank you for taking my comment. Stephanie Henriksen PO Box 267 Dundas, MN 55019 507‐645‐7086 [email protected] 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 1:52 PM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits in Groundwater
Dear Ms. Moibi: I oppose the proposed rule changes to Health Risk Limits currently being considered by MDH. My feeling is that the proposed changes whould not be beneficial to the public and could in effect, put the general public at greater risk. I have particular concern regarding the increase in allowable manganese in groundwater in light of the proposed mining about to commence within the City of Emily. I feel we need to keep the current, or even more stringent protections in place if protecting the public is to be the top priority in these matters. Sincerely, Carol A. Johnson 44733 Old Hwy 6 Emily, MN 56447 (320) 221‐3677 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 80 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 2:01 PM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits of Groundwater
Nitika Moibi MN Dept. of Health 625 Robert St. N. P. O. Box 64975 Saint Paul, MN 55164‐0975 Dear Ms. Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by MDH. I request that the MN Dept. of Health conduct a Public Hearing on this matter as I feel these rule changes will result in a greater risk to public health. Of particular concern to me is the relaxation of the limit of acceptable manganese levels, in light of the manganese mining about to commence within the City of Emily. Sincerely, Carol A. Johnson 44733 Old Hwy 6 Emily, MN 56447 (320) 221‐3677 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 81 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Dave and Corey Johnson <[email protected]>
Wednesday, November 24, 2010 12:27 AM
Moibi, Nitika (MDH)
Re: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related
Hearing Requests
From: Moibi, Nitika (MDH)
Sent: Tuesday, November 23, 2010 4:09 PM
To: Moibi, Nitika (MDH)
Subject: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related Hearing Requests
We are sending this follow up e‐mail to clarify our previous communication to you regarding MDH’s decision to not repeal the existing guidance of 100 μg/L for manganese from the current Health Risk Limit (HRL) rules. We will update the Groundwater Values Table entry for manganese on the MDH website to reflect the 1993/94 HRL value of 100 μg/L. Unfortunately, we cannot make this change until after December 3, 2010, as the entire MDH website is currently being redesigned (see attached announcement). Some commenters were concerned that the MDH website still showed the value of 300 μg/L. If this is a concern to you, please consider withdrawing your hearing request with the stipulation that MDH will update the website to reflect this decision (see suggested text below). MDH plans to review manganese in the future, but until the review is complete, MDH will recommend a HRL of 100 μg/L. The HRL value of 100 μg/L will not be repealed from the current rules without a future rulemaking process. We hope this clarifies your questions as you consider whether to withdraw your hearing request. Please respond by 4:30 p.m. on November 30, 2010, so that MDH can cancel the scheduled hearing and send out appropriate notices. If you have additional questions, please let me know. Thanks. Nitika Moibi Withdrawal of Hearing Request Full name: Carol A. Johnson Address: 915 N. Miller Ave., Litchfield, MN 55355 Date: 11/24/2010 Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit (HRL) for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing on the proposed rules on Health Risk Limits for Groundwater (Minnesota Rules, Chapter 4717, 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 82 of 189
Parts 7860 and 7500), provided MDH removes the guidance value of 300 μg/L from the MDH website at its earliest opportunity. ____________________________________________________________________________________________________________
________________________________________ Nitika Moibi, MPP Planner Principal State Health Risk Assessment Unit Division of Environmental Health Minnesota Department of Health 625 Robert Street North St. Paul, MN 55164 Phone: (651) 201‐4907 Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/  Please consider whether it is necessary to print this email 2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 83 of 189
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 1:56 PM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits in Groundwater
Dear Ms. Moibi: Nitika Moibi MN Dept. of Health 625 Robert St. N. P. O. Box 64975 Saint Paul, MN 55164‐0975 Dear Ms. Moibi: I oppose the proposed rule changes to Health Risk Limits currently being considered by MDH. My feeling is that the proposed changes whould not be beneficial to the public and could in effect, put the general public at greater risk. I have particular concern regarding the increase in allowable manganese in groundwater in light of the proposed mining about to commence within the City of Emily. I feel we need to keep the current, or even more stringent protections in place if protecting the public is to be the top priority in these matters. Sincerely, David P. Johnson 44733 Old Hwy 6 Emily, MN 56447 (320) 894‐5903 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 85 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 2:02 PM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits of Groundwater
Nitika Moibi MN Dept. of Health 625 Robert St. N. P. O. Box 64975 Saint Paul, MN 55164‐0975 Dear Ms. Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by MDH. I request that the MN Dept. of Health conduct a Public Hearing on this matter as I feel these rule changes will result in a greater risk to public health. Of particular concern to me is the relaxation of the limit of acceptable manganese levels, in light of the manganese mining about to commence within the City of Emily. Sincerely, David P. Johnson 44733 Old Hwy 6 Emily, MN 56447 (320) 894‐5903 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 86 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Dave and Corey Johnson <[email protected]>
Wednesday, November 24, 2010 12:30 AM
Moibi, Nitika (MDH)
Re: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related
Hearing Requests
From: Moibi, Nitika (MDH)
Sent: Tuesday, November 23, 2010 4:09 PM
To: Moibi, Nitika (MDH)
Subject: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related Hearing Requests
We are sending this follow up e‐mail to clarify our previous communication to you regarding MDH’s decision to not repeal the existing guidance of 100 μg/L for manganese from the current Health Risk Limit (HRL) rules. We will update the Groundwater Values Table entry for manganese on the MDH website to reflect the 1993/94 HRL value of 100 μg/L. Unfortunately, we cannot make this change until after December 3, 2010, as the entire MDH website is currently being redesigned (see attached announcement). Some commenters were concerned that the MDH website still showed the value of 300 μg/L. If this is a concern to you, please consider withdrawing your hearing request with the stipulation that MDH will update the website to reflect this decision (see suggested text below). MDH plans to review manganese in the future, but until the review is complete, MDH will recommend a HRL of 100 μg/L. The HRL value of 100 μg/L will not be repealed from the current rules without a future rulemaking process. We hope this clarifies your questions as you consider whether to withdraw your hearing request. Please respond by 4:30 p.m. on November 30, 2010, so that MDH can cancel the scheduled hearing and send out appropriate notices. If you have additional questions, please let me know. Thanks. Nitika Moibi Withdrawal of Hearing Request Full name: David P. Johnson Address: 44733 Old Hwy 6, Emily , MN 56447 Date: 11/24/2010 Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit (HRL) for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing on the proposed rules on Health Risk Limits for Groundwater (Minnesota Rules, Chapter 4717, 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 87 of 189
Parts 7860 and 7500), provided MDH removes the guidance value of 300 μg/L from the MDH website at its earliest opportunity. ____________________________________________________________________________________________________________
________________________________________ Nitika Moibi, MPP Planner Principal State Health Risk Assessment Unit Division of Environmental Health Minnesota Department of Health 625 Robert Street North St. Paul, MN 55164 Phone: (651) 201‐4907 Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/  Please consider whether it is necessary to print this email 2
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jane @ River Point Resort & Outfitting Co. <[email protected]>
Wednesday, November 17, 2010 9:36 AM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits of Groundwater
Nitika Moibi [email protected]
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed
changes in groundwater protections will result in even greater vulnerability and risk to public health. In particular, I
oppose the repeal of an HRL value for manganese and replacing it with the proposed health-
protective guidance (Risk Assessment Advice).
Sincerely,
James Koschak
1329 East Harvey Street
Ely, MN 55731
218.365.5019
[email protected]
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jane @ River Point Resort & Outfitting Co. <[email protected]>
Wednesday, November 17, 2010 9:34 AM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risk Limits Of Groundwater
Nitika Moibi [email protected]
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota, Department
of Health, specially the repeal of an HRL value for manganese and replacing it with the proposed health-protective
guidance (Risk Assessment Advice).
The proposed changes will place the Public at even greater health risk than with the current statute, and will effectively
give the mining industry and other corporate users of groundwater an advantage at the expense of a vulnerable Public, to
result in an increase of their profits.
Manganese is necessary for normal life but an extensive body of science over decades has shown the potential adverse
effects from both high level exposures in some industries that produce manganese alloys, mining, welding etc. but most
troubling is chronic exposure to lower levels of manganese that may cause psychiatric illnesses, mental confusion, loss of
appetite, impaired memory, Parkinson’s like symptoms and other neurological problems.
Much more attention is being paid to such exposure; for example certain baby formulas contain manganese and if
prepared with water also containing manganese, infants and children, who absorb more of the chemical than adults, may
develop toxicity.
As a member of the Public, who also understands the urgency of jobs’ creation in our state, I strongly urge you to
reconsider the proposed legislative changes. The reduction of health risk limits on groundwater will not benefit a
vulnerable Public that presently is already in the unfortunate position of being unwitting and un-consented subjects of
mining operations that use legal loopholes to their advantage.
Doesn’t the Public’s right to healthy groundwater supersede that of mining companies, et al., whose operational uses and
disturbances of groundwater may and will at some point result in demonstrable public health risk outcomes?
Keeping current protections – even increasing health risk limits – does not deprive the mining industry, et al., from
conducting operations, providing jobs, and making profits. All of these things are still possible; and protecting Public
health is not an example of wealth redistribution nor does it prevent companies from doing business or making profits.
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 92 of 189
It is well documented in scientific literature that for any and all mining operations, accidents will occur; that it is not
possible to predict when, where, and under what conditions unplanned incidences will occur, even when using the best
predictive models, metrics, and operational best practices.
It is in everyone’s best interests for the State of Minnesota, Department of Health to ensure that statues protect the Public
first, and corporate profits secondarily: In the present context, that means maintaining current legislated health risk limits
for groundwater.
Of particular concern to me is that the statute presently imposes only weak risk limits for
Manganese (Mn) in groundwater (HRL value ((in Part 4717.7500 adopted in 19931994)) (ug/L). This situation exists
primarily because of limited data sets based on empiric research of the effects and toxicology of Mn in groundwater.
However, development of new brain and health research technologies [i.e., neuroimaging, fMRI, et al.,] research is
presently being conducted to measure effects of Mn on general human health, and more specifically on chemical and
environmental assaults on neurobiological developmental processes and functionality.
Given the known toxicity of exposure to excessive manganese and given the animal and human research in recent years
pointing to adverse effects of chronic lower level exposure, it is incumbent on federal and state policy makers to set
standards that reflect the precautionary notion—that if potentially thousands-millions of persons, including infants,
children, are being exposed to a potentially toxic chemical, then standards should be set to minimize such exposure. Those
who would through their industrial activities produce and release into the environment such chemicals should not seek
favor through regulators to liberalize their pollution but they should have to prove by supporting the funding of long term
studies that chronic exposure to low concentrations of manganese is safe for infants and children.
To ignore empiric health data that is literally forthcoming, while at the same time adopting the proposed lowering of
health risk limits to groundwater (Updated Guidance Value ((ug/L)) from present 100 to 300), would endanger the Public
and suggest collusion between industry and government departments and agencies at the Public’s expense.
Sincerely,
Jane Koschak
PO Box 397
Ely, MN 55731
[email protected]
218.365.6625
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jane @ River Point Resort & Outfitting Co. <[email protected]>
Wednesday, November 17, 2010 9:24 AM
Moibi, Nitika (MDH)
Proposed Rule Changes to Health Risks Limits of Groundwater
Nitika Moibi [email protected]
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed
changes in groundwater protections will result in even greater vulnerability and risk to public health. In particular, I
oppose the repeal of an HRL value for manganese and replacing it with the proposed health-
protective guidance (Risk Assessment Advice).
Sincerely,
Steven Louis Koschak
PO Box 397
Ely, MN 55731
218.365.6625
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
[email protected]
Tuesday, November 16, 2010 9:34 PM
Moibi, Nitika (MDH)
[email protected]
Rule Changes to Health Risk Limits of Groundwater
Date: November 16, 2010 From: Tom Kram 1732 Alton Road New Brighton, MN 55112 To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975 Saint Paul, MN 55164-0975 [email protected] Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am
concerned about repeal of an HRL value for manganese and replacing it with the proposed
health-protective guidance (Risk Assessment Advice). Sincerely, Tom Kram
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Date:
Kristin Larsen <[email protected]>
Tuesday, November 16, 2010 9:07 PM
Moibi, Nitika (MDH)
Request for Hearing
November 16, 2010
From: Kristin Larsen
9424 W Branch Road
Duluth, MN 55803
To:
Nitika Moibi [email protected]
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota,
Department of Health, specially the repeal of an HRL value for manganese and replacing it with the proposed
health-protective guidance (Risk Assessment Advice). I request a public hearing on the matter.
The proposed changes will place the Public at even greater health risk than with the current statute, and will
effectively give the mining industry and other corporate users of groundwater an advantage at the expense of a
vulnerable Public, to result in an increase of their profits.
As a member of the Public, who also understands the urgency of jobs’ creation in our state, I strongly urge you
to reconsider the proposed legislative changes. The reduction of health risk limits on groundwater will not
benefit a vulnerable Public that presently is already in the unfortunate position of being unwitting and unconsented subjects of mining operations that use legal loopholes to their advantage.
Doesn’t the Public’s right to healthy groundwater supersede that of mining companies, et al., whose operational
uses and disturbances of groundwater may and will at some point result in demonstrable public health risk
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 99 of 189
outcomes?
Keeping current protections – even increasing health risk limits – does not deprive the mining industry, et al.,
from conducting operations, providing jobs, and making profits. All of these things are still possible; and
protecting Public health is not an example of wealth redistribution nor does it prevent companies from doing
business or making profits.
It is well documented in scientific literature that for any and all mining operations, accidents will occur; that it is
not possible to predict when, where, and under what conditions unplanned incidences will occur, even when
using the best predictive models, metrics, and operational best practices.
It is in everyone’s best interests for the State of Minnesota, Department of Health to ensure that statues protect
the Public first, and corporate profits secondarily: In the present context, that means maintaining current
legislated health risk limits for groundwater.
Of particular concern to me is that the statute presently imposes only weak risk limits for
Manganese (Mn) in groundwater (HRL value ((in Part 4717.7500 adopted in 19931994)) (ug/L). This situation
exists primarily because of limited data sets based on empiric research of the effects and toxicology of Mn in
groundwater. However, development of new brain and health research technologies [i.e., neuroimaging, fMRI,
et al.,] research is presently being conducted to measure effects of Mn on general human health, and more
specifically on chemical and environmental assaults on neurobiological developmental processes and
functionality.
To ignore empiric health data that is literally forthcoming, while at the same time adopting the proposed
lowering of health risk limits to groundwater (Updated Guidance Value ((ug/L)) from present 100 to 300),
would endanger the Public and suggest collusion between industry and government departments and agencies at
the Public’s expense.
Sincerely,
Kristin Larsen
[email protected]
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 100 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
K Larsen <[email protected]>
Thursday, December 02, 2010 4:53 PM
Moibi, Nitika (MDH)
Re: Minn. Dept. of Health - Acknowledgement of Correspondence Relating to Health Risk
Limits Rules for Groundwater (Minn. Rules, Chapter 4717, Part 7860 and 7500)
To: Nitika Moibi, MPP Planner Principal State Health Risk Assessment Unit Division of Environmental Health Minnesota Department of Health 625 Robert Street North St. Paul, MN 55164 Phone: (651) 201‐4907 Fax: (651) 201‐4606 [email protected] http://www.health.state.mn.us/divs/eh/risk/ Withdrawal of Hearing Request Date: December 2, 2010 I withdraw my request for a hearing regarding the Health Risk Limit (HRL) for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 based upon MDH guarantee that the current HRL will not be repealed, that a guidance value of 300 ug/L be removed from the MDH website, and THAT CITIZENS BE INFORMED OF ANY ONGOING DECISIONS REGARDING THE HRL FOR MANGANESE. Thank you, 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Elizabeth Kristin Larsen 9424 West Branch Road Duluth, MN 55803 On 11/24/2010 3:33 PM, Moibi, Nitika (MDH) wrote: Thank you for your interest and attention to the Minnesota Department of Health's proposed rules on Health Risk Limits
for Groundwater (Minn. Rules, Chapter 4717, Parts 7860 and 7500). We received your correspondence opposing the proposed repeal of guidance for manganese (Minn. Rules, Chapter 4717,
Part 7500, Subpart 61) after the comment period deadline, which ended on November 17, 2010, at 4:30 pm. However, based on the official comments we received urging us to review a very recent study about manganese’s
potential neurological effects,[1] MDH has decided to withdraw its proposed repeal of the existing guidance value of 100
µg /L for manganese. If sufficient requests for hearing are withdrawn, MDH will cancel the hearing scheduled for December 8, 2010. If the
hearing is canceled, I will send you an e-mail regarding the same, and if the hearing is held, I will e-mail you information
about the hearing process. You may contact me after December 3, 2010, to confirm whether we will be having a hearing or not. You are also
encouraged to subscribe to MDH’s electronic subscription list to receive updates on guidance, groundwater rules,
contaminants of emerging concern and other programs. Thank you for your interest in our work. Nitika Moibi Nitika Moibi, MPP Planner Principal State Health Risk Assessment Unit Division of Environmental Health Minnesota Department of Health 625 Robert Street North St. Paul, MN 55164 Phone: (651) 201‐4907 Fax: (651) 201‐4606 [email protected] http://www.health.state.mn.us/divs/eh/risk/  Please consider whether it is necessary to print this email 2
MDH Exhibit J5: 2010 HRL Rules Correspondence
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[1]
Bouchard MF, Sauvé S, Barbeau B, Legrand M, Brodeur M-È, et al. 2010 Intellectual Impairment in School-Age Children Exposed to Manganese from Drinking
Water. Environ Health Perspect doi:10.1289/ehp.1002321
3
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Lehman, Nicole <[email protected]>
Wednesday, November 17, 2010 10:02 AM
Moyer, Paul (MDH); Moibi, Nitika (MDH)
MDH Proposed Rule Change to MN's Manganese HRL:Comments
To whom it may concern,
I understand the Minnesota Department of Health (MDH) is considering repealing the manganese Health Risk
Limit. As scientists and professionals, I am sure you are aware there is a real and present danger of
manganese toxicity in drinking water resulting from sulfide mining and processing.
As a Minnesota citizen I pride the fact I live in a state where we have such an abundance of
groundwater. Many parts of the country have no choice and are forced to purify surface water and utilize it
for drinking water. In other instances, like right here in southeastern Minnesota, nitrate has already
contaminated our upper carbonate aquifer, the first available potable water supply to the point deeper
aquifers (Prairie du Chien group) are now our primary drinking water source. In addition, in Lewiston, MN
the Prairie du Chien aquifer, the cities drinking water source is already reporting between 6-8 mg/L of nitrate
contamination. This data suggests our state's valuable drinking water aquifer is in jeopardy. Through the
surface water and groundwater interactions that occur, surface waters from the northern portion of the state
where sulfide mining and processing occurs contribute to contamination of the state's surface water and
groundwater in the southern portion of the state, which is why I am concerned. Here in Minnesota, we have
the luxury of protecting our abundant supply of drinking water. Too often the state takes this natural
resource for granted. The MDH is the party held responsible for protecting not only my welfare, but the
welfare of citizens for the entire state of Minnesota.
The MDH should be protecting Minnesotans from industrial pollution, not eliminating standards that would
require pollution to be controlled. Repealing the Health Risk Limit will eliminate an important Rule protecting
Minnesota citizens from environmental protection. MDH has the power to stop this pollution and reduce the
exposure risk of Minnesotans being subjected to nervous system affects from manganese exposure. I
encourage the MDH to NOT repeal the manganese Health Risk Limit and think about the long-term consequences
of these actions.
Respectfully submitted,
Nicole E. Lehman
Rochester, MN
1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Attachments:
Paul Aasen <[email protected]>
Wednesday, November 17, 2010 1:43 PM
Moibi, Nitika (MDH)
Scott Strand; Paul Aasen; Diane Olson
MCEA Comment Letter on Proposed HRLs Rules
MCEA 11 17 2010 HRLs Comment Letter.pdf
Dear Ms. Moibi, Please find MCEA’s comments on the proposed HRLs rule amendments attached to this email. Please contact us if you have any issues receiving or opening the file. Thank you, Paul W. Aasen
Advocacy Director
Minnesota Center for Environmental Advocacy
26 East Exchange Street, Suite 206
Saint Paul, Minnesota 55101
(651) 287-4867
[email protected]
www.mncenter.org
"Since 1974, your legal and scientific voice protecting and defending Minnesota's environment."
NOTICE: This email may contain information that is privileged, confidential or otherwise protected from disclosure. If you
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MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 107 of 189
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Minnesota Center for Environmental Advocacy .
The legal'and scientific voice protecting and defending Minnesota's environment
26 !;last Exchange Street· Suite 206 ''
Saint Paul, MN 55101-1667
651.223.5969
651.223.5967 fax
November 17, 2010
[email protected]
·www.mncenter.org
Ms. Nikita Moibi
Mi~nesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Ppul, MN 55164-0975
[email protected] Founding Director , ;
Sigurd F. Olson
(1899-1982)
.
"
/
Board of Directors
Nancy Speer
Chair
Merritt Clapp-Smith
Vice Chair
.
,.·
''·
'
RE: Proposed Amendments to Rules Governing Health Risk Limits for Groundwater,
Minnesota Rules, Chapter 4717, Part 7860 and Part 7500..
.
.
K~:>ntWhite
Treasurer
' Bridget A. Hus.t ,
'Secretary
DearMs. Moibi: ·
Peter Bachman
The Minnesota Center for Environmental Advocacy {MCEA) has been involved as a .
stakeholder si.nce the public phase of this rule revision bega·n ih October 2001, MCtA
has submitted
oral and written comments on the rule t'o the
Minnesota Department
of.
.
.
.
Health (MDH) at variouspoints during this nine-year process. Continuing in _its role as a
stakeholder, MCEA has prepare'd these comm~nts on the MDH Proposed Permant;nt
Rules relating to Health Risk Limits for Groundwater.
·
•~mCarlson
John Helland
Cecily Hines
Douglas A. Kelley
Michael ,Kleber-J?iggs ..
'Mehmet Konar-Steenbe~g
Matt Samllel ·
•
Gene Jl.:lerriam
Steve Pira¥is
Irene Qual ters
.
'
Executive Director ·
Scott Strand
,
'
I
.
MCEA continues to be concerned tbat the number of chemical pollutants included in
. this rule revision has decreased during }he nine-year process. As of 2002, MDH had·
identified over 230 chemicals to po.tentiany include in the rule revision, either because
needed tci be updated
or because
there had· been
there was existing MDH 'gvidance that
.
. .
.­
requests for guidance from other Minnesota state agencies. The current proposed
changes address only 27 chemica_ls. Given the number and extent of chemic;als in use in .
our' society, more-chemicals, ngt fewer, need to be-addressed.
'
,
'
I'
-
.
.
.
­
For each draft of the proposed wle, ~hen MDH has published more t~an one HRL for a
MCEA has chosen td comment only on the chronic or cancer
HRL for
particular chemical,
'
.
'each chemical, whichever is lowest. This·is because the lowest quantitative fimit is the most protective, ,and therefore the most relevant to actual public health practice. MCEA has the following concerns about specific chemicals being addressed in this
proposal. Many of these comments are the same comments MCEA has offered in the
past, most recently in 200~:
Acetochlor ESA/OXA: MCEA believes that public health is best·seryed by maintaining the existing praCtic~ of addin!? the. concentrations of a parent chemical and its. MDH
Exhibit
J5:
Print~d on 100 percent post-consumer recycled paper
uslng
sJy inks
.. 2010 HRL Rules Correspondence
Page 108 of 189
MCEA 11/17/2010 Page 2
1
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1
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· degradate(s) and comparing the total to one limit] not multiple limits. Additionally in this case] the
parent compound] Acetochlor] has been shown to be an endocrine disruptor and a carcinogen
increasing the level of concern.
Alachlor: MCEA supported the 2004 HRL of o:7 ppb] but does not support the proposed of 5.0 ppb.
Atrazine: Scientific evidence supports a health-based guideline no higher than 1 ppb1 as compared to the proposed HRL of 3 ppb. Benzene: MCEA supported the 2004 HRL of 1.0 ppb 1 but does not support the proposed HRL of 2.0 ppb. Chloroform: MCEA supported the 2004 HRL of 20.0 ppb] but does not support the proposed HRL of 30.0 ppb.
Cis-1 1 2-dichloroethylene: MCEA supported the 2004 HRL of 20.0 ppb1 but do~s not support the proposed HRL of 50.0 ppb. Nitrates: MCEA does not support this HRL because it is based on an antiquated federal standard that does not sufficiently protect public health. . .
·
Pentachlorophenol: MCEA supported the 2004 HRL of 0.5 ppb] but does not supportthe proposed HRL
of 1.0 ppb.
I
1 1 1-Trichloroethane: MCEA does not support the proposed HRL because it is 45 times less protective
than the USEPA MCL and 15 times less protective than the 1993-1994HRL.
1
1
2-(2A~5-Trichlorophenoxy) propionic acid: MCEA supported the 2004 HRL of 20.0 ppb 1 but does not support the proposed HRL of50.0 ppb.
·
)
Vinyl chloride: MCEA supported the 2004 HRL of 0.08 ppb but does not support the. proposed HRL of
0.2 ppb. 1
Other considerations: MCEA urges MDH to follow the lead of other states and apply the 10-6 cancer risk level] in order to . provide Minnesotans with stronger protection from carcinogenic pollutants in drinking water.
Thank you for your work on drinking water protection and for considering our comments.
Paul W. Aasen
Advocacy Director
Minnesota Center for Environmental Advocacy
651-287-4867
[email protected]
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 109 of 189
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MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 110 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jan Mosman <[email protected]>
Tuesday, November 16, 2010 1:59 PM
Moibi, Nitika (MDH)
Fwd: letters to MDH
Categories:
Important
Date: November 16, 2010
From: Jan Heinig Mosman, Emily, Minnesota
To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
[email protected]
Re: Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota,
Department of Health.
The proposed changes will place the Public at greater health risk than with the current statute, and will effectively
give the mining industry along other for-profit corporate users of Minnesota’s groundwater an advantage at the
expense of a vulnerable Public.
I understand the urgency of job creation in Minnesota. I strongly urge you to reconsider the proposed legislative
changes. The reduction of health risk limits on groundwater will not benefit a Public that presently is already in the
position of being unwitting and un-consented subjects of mining operations that use legal loopholes to their
advantage.
Keeping current protections – even increasing health risk limits – does not deprive the mining industry, et al., from
conducting operations, providing jobs, and making profits. All of these things are still possible; and protecting Public
health is not an example of wealth redistribution nor does it prevent for-profit companies from doing business or
making profits.
It is well documented in scientific literature that for any and all mining operations, accidents will occur; that it is not
possible to predict when, where, and under what conditions unplanned incidences will occur, even when using the
best predictive models, metrics, and operational best practices.
Of particular concern to me is that the statute presently imposes only weak risk limits for
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 111 of 189
Manganese (Mn) in groundwater (HRL value ((in Part 4717.7500 adopted in 19931994)) (ug/L). This situation exists
primarily because of limited data sets based on empiric research of the effects and toxicology of Mn in groundwater.
However, development of new brain and health research technologies [i.e., neuroimaging, fMRI, et al.,] research is
presently being conducted to measure effects of Mn on general human health, and more specifically on chemical
and environmental assaults on neurobiological developmental processes and functionality.
To ignore empiric health data that is literally forthcoming, while at the same time adopting the proposed lowering of
health risk limits to groundwater (Updated Guidance Value ((ug/L)) from present 100 to 300), would endanger the
Public and suggest collusion between industry and government departments and agencies at the Public’s expense.
Sincerely,
Jan
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 112 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Date:
Jan Mosman <[email protected]>
Tuesday, November 16, 2010 6:08 PM
Moibi, Nitika (MDH)
Emily, Minnesota
November 16, 2010
From: Jan Heinig Mosman
To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
Proposed Rule Changes to Health Risk Limits of Groundwater
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota, Department of
Health.
The proposed changes will place the Public at even greater health risk than with the current statute, and will effectively give the
mining industry and other corporate users of groundwater an advantage at the expense of a vulnerable Public, to result in an
increase of their profits.
As a member of the Public, who also understands the urgency of jobs’ creation in our state, I strongly urge you to reconsider the
proposed legislative changes. The reduction of health risk limits on groundwater will not benefit a vulnerable Public that
presently is already in the unfortunate position of being unwitting and un-consented subjects of mining operations that use legal
loopholes to their advantage.
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 113 of 189
Keeping current protections – even increasing health risk limits – does not deprive the mining industry, et al., from conducting
operations, providing jobs, and making profits. All of these things are still possible; and protecting Public health is not an
example of wealth redistribution nor does it prevent companies from doing business or making profits.
It is well documented in scientific literature that for any and all mining operations, accidents will occur; that it is not possible to
predict when, where, and under what conditions unplanned incidences will occur, even when using the best predictive models,
metrics, and operational best practices.
Of particular concern to me is that the statute presently imposes only weak risk limits for Manganese (Mn) in groundwater
(HRL value ((in Part 4717.7500 adopted in 19931994)) (ug/L). This situation exists primarily because of limited data sets based
on empiric research of the effects and toxicology of Mn in groundwater. However, development of new brain and health
research technologies [i.e., neuroimaging, fMRI, et al.,] research is presently being conducted to measure effects of Mn on
general human health, and more specifically on chemical and environmental assaults on neurobiological developmental
processes and functionality.
To ignore empiric health data that is literally forthcoming, while at the same time adopting the proposed lowering of health risk
limits to groundwater (Updated Guidance Value ((ug/L)) from present 100 to 300), would endanger the Public and suggest
collusion between industry and government departments and agencies at the Public’s expense.
Sincerely,
Jan Heinig Mosman
Emily, MN
(952)934-7065
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 114 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jan Mosman <[email protected]>
Tuesday, November 16, 2010 6:54 PM
Moibi, Nitika (MDH)
PUBLIC HEARING REQUESTED
To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by the State of
Minnesota, Department of Health (MDH).
Furthermore, I rrequest that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health.
In particular, I am concerned about repeal of an HRL value for manganese and replacing it with the
proposed health-protective guidance (Risk Assessment Advice).
Sincerely,
Jan Heinig Mosman
44483 State Highway #6
Emily, MN 56447
(218)763-4018
(612)419-1787
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 115 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jan Mosman <[email protected]>
Tuesday, November 23, 2010 3:14 PM
Moibi, Nitika (MDH)
Re: Minn. Dept. of Health - Health Risk Limit Rules for Groundwater (Minn. Rules, chapter
4717) - Update on Proposed Repeal of Guidance on Manganese and Related Hearing
Requests
_________________________________________________________________________________________
___________________________________________________________
Withdrawal of Hearing Request
Full name: Jan Heinig Mosman
Address:44483 State Highway #6
Emily, MN 56447
[email protected]
(952)934-7065
(612)419-1787
(218)763-4018
Date:November 23, 2010
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing on the proposed rules on Health Risk Limits (HRLs) for Groundwater (Minnesota Rules, Chapter 4717, Parts 7860 and 7500). 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 116 of 189
Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201‐4907
Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/  Please consider whether it is necessary to print this email
[1] Bouchard MF, Sauvé S, Barbeau B, Legrand M, Brodeur M-È, et al. 2010 Intellectual Impairment in School-Age Children Exposed to Manganese from Drinking
Water. Environ Health Perspect doi:10.1289/ehp.1002321
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Pha Chia Yang <[email protected]>
Monday, November 08, 2010 8:42 PM
Moibi, Nitika (MDH)
Request for Hearing: Proposed Permanent Rules Relating to Health Risk Level
Nitika,
Please accept this email as a formal request for a public hearing on the proposed rule for the permanent rules
relating to health risk level. I oppose the entire set of rule.
Thanks.
Pha Chia Yang Moua
IDA Coordinator
Lutheran Social Service of MN
Eastside Financial Center
965 Payne Avenue
St, Paul, MN 55130
651-771-2566 ext. 253
Fax: 651-771-2930 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Alan Muller <[email protected]>
Wednesday, November 17, 2010 2:49 PM
Moibi, Nitika (MDH)
[email protected]; Paula Maccabee; Moyer, Paul (MDH)
Comment on groundwater contaminant HRL rulemaking
November 17, 2010
Ms.Nitika Moibi
Minnesota Dept. of Health
625 Robert Street North
P.O. Box 64975
St. Paul, MN 55164-0975
Re: Proposed Rule Changes to Health Risk Limits of some groundwater contaminants
Dear Ms. Moibi:
I spent over one-half hour on the phone today trying to reach someone in MDH who might explain the
Department's point of view on this action to repeal, or loosen, some Health Risk Limits for groundwater
contaminants. I was not able to reach anyone, the phone number on the "Supplemental Explanation ...."
document goes nowhere, and I can't even tell from the website, or the people I talked to, if a "Health Risk
Assessment Unit" even exists under than name. Curious....
According to this "Explanation" covering 27 chemical substances, it appears that 19 are proposed to receive
new or more restrictive HRLs, and 8 are to be loosened or repealed. I am concerned about all the movements
towards higher levels/reduced protections. It seems very counterintuitive that the HRL for acetone, for
example, should move from 700 ug/l to 4000.
I am particularly concerned about the proposed repeal of the Manganese HRL.
(300 for manganese already appears in the MDH official " Groundwater Values Table" although the rulemaking
to change it does not seem to have been completed. Is this proper?)
The "Explanation" states: "Because of the difficulty in establishing a concentration value for boron or
manganese that is low enough that it will not cause toxic effects in any individual, but not so low as to deprive
others of the beneficial aspects [emphasis added], MDH does not plan to establish an HRL for these
compounds." Actually, MDH is proposing to repeal an existing one set in the 1990s. What sort of reasoning is
this? Please advise me in detail of what "others" and "beneficial aspects" are referred to here.
The 300 microgram/liter value seems to correspond to current EPA "health-based" guidance, but this guidance
is a bit stale: Drinking Water Health Advisory for Manganese, January, 2004.
Since MDH proposed the manganese rollback, or repeal, an article appeared in Environmental Health
Perspectives, a peer-reviewed journal of the National Institute of Environmental Health Sciences: " Intellectual
Impairment in School-Age Children Exposed to Manganese from Drinking Water." The article has been on line
since Sept. 20, 2010.
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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From the abstract:
"Results: The median MnW [manganese levels in tap water] in children’s home tap water was 34 µg/L
(range: 1–2700 µg/L). MnH increased with manganese intake from water consumption, but not with
dietary manganese intake. Higher MnW and MnH were significantly associated with lower IQ scores. A
10-fold increase in MnW was associated with a decrease of 2.4 IQ points (95% confidence intervals: ­
3.9, -0.9; P < 0.01), adjusting for maternal intelligence, family income, and other potential confounders.
There was a 6.2-IQ point difference between children in the lowest and highest MnW quintiles. MnW
was more strongly associated with Performance IQ than Verbal IQ.
Conclusions: The findings of this cross-sectional study suggest that exposure to manganese at levels
common in groundwater is associated with intellectual impairment in children." [emphasis added by
Muller]
Note that the median water levels in this study were only 11 percent of the proposed Minnesota 300
micrograms/liter value.
The authors concluded:
"Because of the common occurrence of this metal in drinking water and the observed effects at low
manganese concentration in water, we believe that national and international guidelines for safe
manganese in water should be revisited."
While one paper may not be dispositive, it surely gives us a loud warning that the Minnesota Department of
Health is "revisiting" manganese levels in the wrong direction. The Manganese Health Risk Limit mostly likely
should be lowered, not raised.
Some more discussion in this Science Daily article.
Therefore, I recommend the following:
Given the appearance of new information in peer-reviewed literature, MDH should withdraw the proposed
rollbacks or repeals of groundwater HRLs, especially the one for manganese. In the alternative, MDH should
hold public hearings. At least one hearing should be held in the Metro area as pre-scheduled, and another "up
North" so as to be accessible to Minnesotans threatened by sulfide mining projects that would likely increase
manganese levels in groundwater they are drinking.
What can be more important than protection the health and intellectual development of Minnesota's children?
If these comments raise any questions please feel free to contact me.
Respectfully submitted,
Alan Muller
Energy & Environmental Consulting
113 W. 8th Street
Red Wing, MN, 55066
Box 69
One Stewart Street
Port Penn, DE, 19731
302.299.6783
[email protected]
Copy:
2
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 122 of 189
Paula Macabee, Esq.
Elanne Palcich
Nancy Hone
3
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 123 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Alan Muller <[email protected]>
Thursday, December 02, 2010 4:50 PM
Moibi, Nitika (MDH)
Winget, Patricia (MDH)
Withdrawal of rearing request
Dear Ms. Moibi:
After consulting with some of the other parties or commenters in this matter, I have decided to withdraw my
request for a public hearing--currently scheduled for December 8, 2010. This is with the understanding that
MDH intends to withdraw it's proposed repeal of the 100 mg/l HRL for manganese and promptly restore the
100 mg/l value in the " Groundwater Values Table" .
I appreciate that MDH has responded positively to these primary concerns raised in my comments. However, I
remain concerned about a number of substantive and procedural aspects of this proceeding. I do not believe
that allowable levels of harmful chemical substances in drinking water should be increased; such backsliding is
inherently undesirable. It appears to me that MDH needs to refocus it's priorities onto improved protection of
human health.
If this note raises any questions please contact me.
Yours very truly,
Alan Muller
Energy & Environmental Consulting
113 W. 8th Street
Red Wing, MN, 55066
Box 69
One Stewart Street
Port Penn, DE, 19731
302.299.6783
[email protected]
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MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Attachments:
Brad Sagen <[email protected]>
Wednesday, November 17, 2010 10:24 AM
Moyer, Paul (MDH); Moibi, Nitika (MDH)
Comments on Proposed HRL Revisions
NMW_Comments'HRL_11'17'10.pdf
Public comments by Northeastern Minnesotans for Wilderness on Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules, Chapter 4717, Part 7860 and Part 7500 are attached to this message. Bradley Sagen ‐‐ Bradley Sagen 13667 Deer RD Ely, MN 55731 218 365‐6461 [email protected] 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 126 of 189
northeastern minnesotans for wilderness
P.O. Box 625 Ely, MN 55731
November 17, 2010
Mr. Paul Moyer
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Submitted via electronic mail: "Paul Moyer" <[email protected]>;
"Nitika Moibi" <[email protected]>
RE: Proposed Amendments to Rules Governing Health Risk Limits for Groundwater,
Minnesota Rules, Chapter 4717, Part 7860 and Part 7500.
Dear Mr. Moyer:
The following comments are submitted by Northeastern Minnesotans for Wilderness (NMW). NMW is a
regional grassroots, wilderness advocacy group. NMW’s core mission is to preserve and protect
wilderness and wild places in the Minnesota Arrowhead Region, especially the BWCAW. Since its
founding in 1996 NMW has grown to represent over 400 members and supporters in Northeastern
Minnesota.
Because of our mission, NMW’s has a special concern for the relationship between the Health Risk
standards and proposed metallic sulfide mining operations in Northeastern Minnesota. Any weakening
of standards regarding manganese would have major negative consequences not only for public health
and safety, but for the pristine quality of the Boundary Waters Canoe Area Wilderness and other wild
places in the region.
NMW opposes the proposal by MDH to repeal the Health Risk Limit (“HRL”) pertaining to manganese
and preserve only informal risk assessment “advice” for this significant pollutant. Manganese in
drinking water poses a human health risk for neurological symptoms that has been well-documented by
the United States Environmental Protection Agency (“EPA”) and acknowledged by the MDH.
The current HRL of 100 ug/L for chronic exposure to manganese in drinking water, rather than a 300
ug/L limit, is appropriately protective of human health, given the increased susceptibility to excessive
manganese of infants, elderly people and persons with reduced liver function.
NMW further opposes the MDH proposal to address health concerns about neurological impairments
caused by manganese through informal risk assessment “advice” rather than a Health Risk Limit. HRLs
are the legal mechanism provided in Minnesota statutes and rules to address pollutants that impair human
health. This issue is especially relevant to proposals for copper sulfide mining activities proposed near
Minnesota drinking water wells and bodies of water used for municipal water supplies and private
consumption.
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 127 of 189
The Draft Environmental Impact Statement for the PolyMet NorthMet mine documents elevated
manganese in groundwater, surface water and drinking water wells downstream of the LTVSMC tailings
basin. Discharge of manganese from various sources at the PolyMet mine and tailings basin could
exacerbate the current contamination in drinking water if State rules that protect public health were to be
repealed. The PolyMet sulfide mine and any subsequent hard rock mining projects must conform to State
regulations to protect human health and water ecosystems. Weakening or eliminating standards to ease
the environmental review or permitting process is contrary to the public interest and would be based on
purely political considerations.
In support of our recommendations NMW hereby incorporates by reference the more extensive
comments and documentation in the letter on this subject submitted to you November 15 by Paula
Maccabee on behalf of Water Legacy.
Sincerely,
Bradley Sagen
NMW Chair
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Lois Norrgard <[email protected]>
Wednesday, November 17, 2010 2:12 PM
Moyer, Paul (MDH); Moibi, Nitika (MDH)
Comments - MN Rules Chpt 4717 Health Risk Limits for Groundwater
Dear Mr. Moyer and Ms Moibi
Please accept these comments regarding:
Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules, Chapter
4717, Part 7860 and Part 7500. Manganese.
I live in Bloomington MN and am active with many environment organizations – I donate time, energy, and
some funds because I care deeply about Minnesota’s air and water, wildlife and the health of our communities.
It is imperative that the Minnesota Department of Health place as it’s highest commitment and focus our public
health, especially the health of our children.
I request the Department to NOT repeal the manganese Health Risk Limit.
Presently we are facing one of the greatest threats to our water quality and drinking water, as well as surface
waters for fish and wildlife ever in Minnesota. I am concerned about the impacts that the new sulfide mining
that is being proposed for northern Minnesota will bring. Sulfide mining is toxic – acid mine drainage is a real
and present threat to our state. This cannot be overlooked. Among the metals leached by sulfide mining and
processing is manganese. Over-exposure to manganese is known to affect the nervous system, causing
Parkinson's like symptoms and impairing learning in children. Existing mine tailings and the proposed PolyMet
open pit sulfide mine leach manganese above Minnesota's current Health Risk Limits.
It is high time that our public agencies – including the Department of Health – use the best available science,
and prioritize the health of our citizens – above all else. Health Risk Limits are there for a very important
reason, the public trust is that our agencies will look out for the citizens of the state. It can be no other way.
I support these statements:
The Health Department should not repeal the manganese Health Risk Limit;
Manganese is dangerous to human health, causing impacts to the nervous system;
Repealing the Health Risk Limit will eliminate an important Rule protecting Minnesota citizens from
environmental pollution;
There is a real and present danger of manganese toxicity in drinking water resulting from sulfide mining
and processing;
The Health Department should be protecting Minnesotans from industrial pollution, not eliminating
standards that would require pollution to be controlled.
Thank you, please consider these comments carefully, our health is at stake.
The Health Risk Limits should be strengthened, not weakened or eliminated.
Lois Norrgard
10368 Columbus Circle
Bloomington MN 55420
952-881-7282
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 130 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Lois Norrgard <[email protected]>
Wednesday, November 17, 2010 3:11 PM
Lois Norrgard; Moyer, Paul (MDH); Moibi, Nitika (MDH)
RE: Additions - Comments - MN Rules Chpt 4717 Health Risk Limits for Groundwater
Dear Ms. Moibi,
I am requesting that the Minnesota Department of Health hold a public meeting on the proposed rule change for
Manganese, specifically the repeal of an HRL value for manganese and replacing it with the proposed healthprotective guidance (Risk Assessment Advice). Manganese is a known neurotoxin and it would be prudent to
keep the current standard of 100 µg/L HRL value rather than lower the standard to a 300 µg/L health-protective
guidance. In order to best shield Minnesotans from any possible ill effects of manganese exposure, the current
standard should be defended against the proposal to weaken it through a rule change.
Sincerely,
Lois Norrgard,
10368 Columbus Circle, Bloomington MN 55420
From: Lois Norrgard
Sent: Wednesday, November 17, 2010 2:12 PM
To: '[email protected]'; '[email protected]'
Subject: Comments - MN Rules Chpt 4717 Health Risk Limits for Groundwater
Dear Mr. Moyer and Ms Moibi
Please accept these comments regarding:
Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules, Chapter
4717, Part 7860 and Part 7500. Manganese.
I live in Bloomington MN and am active with many environment organizations – I donate time, energy, and
some funds because I care deeply about Minnesota’s air and water, wildlife and the health of our communities.
It is imperative that the Minnesota Department of Health place as it’s highest commitment and focus our public
health, especially the health of our children.
I request the Department to NOT repeal the manganese Health Risk Limit.
Presently we are facing one of the greatest threats to our water quality and drinking water, as well as surface
waters for fish and wildlife ever in Minnesota. I am concerned about the impacts that the new sulfide mining
that is being proposed for northern Minnesota will bring. Sulfide mining is toxic – acid mine drainage is a real
and present threat to our state. This cannot be overlooked. Among the metals leached by sulfide mining and
processing is manganese. Over-exposure to manganese is known to affect the nervous system, causing
Parkinson's like symptoms and impairing learning in children. Existing mine tailings and the proposed PolyMet
open pit sulfide mine leach manganese above Minnesota's current Health Risk Limits.
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It is high time that our public agencies – including the Department of Health – use the best available science,
and prioritize the health of our citizens – above all else. Health Risk Limits are there for a very important
reason, the public trust is that our agencies will look out for the citizens of the state. It can be no other way.
I support these statements:
The Health Department should not repeal the manganese Health Risk Limit;
Manganese is dangerous to human health, causing impacts to the nervous system;
Repealing the Health Risk Limit will eliminate an important Rule protecting Minnesota citizens from
environmental pollution;
There is a real and present danger of manganese toxicity in drinking water resulting from sulfide mining
and processing;
The Health Department should be protecting Minnesotans from industrial pollution, not eliminating
standards that would require pollution to be controlled.
Thank you, please consider these comments carefully, our health is at stake.
The Health Risk Limits should be strengthened, not weakened or eliminated.
Lois Norrgard
10368 Columbus Circle
Bloomington MN 55420
952-881-7282
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Winget, Patricia (MDH)
Thursday, December 02, 2010 3:12 PM
Moibi, Nitika (MDH); Moyer, Paul (MDH); Goeden, Helen (MDH)
FW: MDH rulemaking re HRLs
From: Lois Norrgard [mailto:[email protected]]
Sent: Thursday, December 02, 2010 2:52 PM
To: Winget, Patricia (MDH)
Subject: MDH rulemaking re HRLs
Hello Patricia,
I had earlier expressed interest in a hearing on the Maganese rulemaking. I saw your post that stated that the MDH has
notified the Revisor's Office that it is not repealing the present standards for Maganese - and I appreciate your response
to my comments and the decision to not move forward on this at this time. I will register on MDH's website for further
correspondence.
I am also cancelling my request for a public hearing at this time. Presently I am in Washington DC - if you have questions
please call me via cell at 612-998-6484.
Thanks,
Lois Norrgard
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Elanne Palcich <[email protected]>
Wednesday, November 17, 2010 12:28 AM
Moibi, Nitika (MDH)
Moyer, Paul (MDH)
Public Hearing Request for Manganese Rule Change
November 17, 2010
From: Elanne Palcich
29 SE 5th St.
Chisholm, MN 55719
To: Nitika Moibi
Minnesota Dept. of Health
625 Robert Street North
P.O. Box 64975
St. Paul, MN 55164‐0975
Re: Proposed Rule Changes to Health Risk Limits of Groundwater
I am requesting that the Minnesota Department of Health follow through on a public hearing (as proposed for December 8). Of special concern is the replacement of the 100ug/L HRL standard for manganese with 300ug/L as a guidance value only. This rule change is suspect, as is comes ahead of proposed manganese mining in the town of Emily, and ahead of proposed copper‐nickel sulfide mining in northeastern Minnesota. When industry exerts its influence upon our regulatory agencies, the entire fabric of protection of public health begins to change. We are thus finding ourselves living in an environment so toxic that chronic diseases and lower life expectancy is becoming the new norm.
The Health Department states that it does not plan to establish an HRL value for boron or manganese, because they cannot be certain of a standard that is low enough so that it will not cause toxic effects in any individual, but not so low as to deprive others of the beneficial effects.
Since people receive most of their manganese through food, since chronic diseases (especially of the nervous system) come from higher doses, and since the young and the elderly are most susceptible to toxic effects—
then it makes no sense whatsoever to allow for more manganese in the drinking water supply. People who need more manganese can receive it through food or supplements. However, how do bodies get rid of excess manganese that will be taken in through drinking water and through water that is used for cooking on a daily basis? The Health Department should be advocating for precautionary measures. Changing the standard to one of guidance value means that hardrock mining could add levels of manganese (or boron) to the water supply, and 1
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no standard whatsoever would have to be enforced. In other words, mining companies would be given free rein to pollute our water.
I also question the changes in the amount of acetone, vinylidene chloride, and 1.1 dichloroethane that would be allowed in our drinking water. There is no reference given to the cumulative effects of such chemicals upon the human body.
In fact, it grieves me that animal testing is necessary to determine the toxicity of such chemicals. Common sense would tell us that these chemicals are foreign substances and unable to be handled by our bodies. Our bodies do show a wondrous ability to clear and heal, but the sheer volume of toxic compounds is overloading our systems and our ability to excrete this overload.
The Minnesota Department of Health should be advocating for the reduction of all such toxins. The one thing that our body cannot survive without is clean water.
Again, I request a public hearing and I question the change in status of allowable manganese in our drinking water. I also have grave concerns about the cumulative effects of other toxins as listed in the rules changes.
I urge the Minnesota Department of Health to follow the moral standards of protecting the citizenry of this state from toxins in our drinking water.
Thank you.
Elanne Palcich
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Elanne Palcich <[email protected]>
Thursday, December 02, 2010 4:23 PM
Moibi, Nitika (MDH)
Fw: simple form
To: Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201‐4907 Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/ Withdrawal of Hearing Request Full name: Elanne Palcich Address: 29 SE 5th St. Chisholm, Minnesota 55719 Date: December 2, 2010 I withdraw my request for a hearing regarding the Health Risk Limit (HRL) for manganese in
Minnesota Rules, Chapter 4717, Part 7500, subpart 61 based upon MDH guarantee that the current
HRL will not be repealed, that a guidance value of 300 ug/L be removed from the MDH website, and
THAT CITIZENS BE INFORMED OF ANY ONGOING DECISIONS REGARDING THE HRL FOR
MANGANESE. 1
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I wish to be informed how to be on an emaillist and I believe there should be more ways to inform
the public and keep the process transparent.
The purpose of the MDH is to protect the public, not industrial profits.
Thank you.
Elanne Palcich
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Jeff Palkovich <[email protected]>
Wednesday, November 17, 2010 8:41 AM
Moibi, Nitika (MDH)
request for public hearing - HRL manganese levels
Date: November 17, 2010
From: Jeff Palkovich
7342 Mariner Drive
Maple Grove MN 55311 To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975 Saint Paul, MN 55164-0975 Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am
concerned about repeal of an HRL value for manganese and replacing it with the proposed health-protective
guidance (Risk Assessment Advice). Sincerely, Jeff Palkovich
612-599-3197 – mobile
[email protected]
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Judi Poulson <[email protected]>
Wednesday, November 17, 2010 9:55 AM
Moibi, Nitika (MDH)
manganese standard
I oppose the repeal of the manganese standard. It is dangerous and affects our lakes in MN.
Please consider the health risks.
Thanks
Judi Poulson
Fairmont, MN 56031
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Attachments:
Moyer, Paul (MDH)
Tuesday, November 16, 2010 3:03 PM
Moibi, Nitika (MDH)
FW: Comments on proposed amendments on HRL for Groundwater
ManganeseRuleChangeCommentsRefWatLeg11152010.doc;
WaterLegacyCommentHRLs(11_15_10)[1].pdf
Categories:
Important
Paul Moyer, MS
Minnesota Department of Health
651-201-4912
From: Le Lind [mailto:[email protected]]
Sent: Tuesday, November 16, 2010 3:00 PM
To: Moyer, Paul (MDH)
Subject: Comments on proposed amendments on HRL for Groundwater
Mr. Moyer,
Please accept the attached comments from Save Lake Superior Association on our opposition to the Proposed
Amendments to Rules Governing Health Risk Limits for Groundwater and related issues. These are particularly
relevant for NE MN in view of the great potential for water pollution from many pollutants including
manganese from mining and industrial waste emissions and storage. We incorporate and sign on to the attached
comments from Water Legacy submitted by Paula Maccabee on 11/15/2010.
Thank you for your attention.
LeRoger Lind
President, Save Lake Superior Association
P.O. Box 101
Two Harbors, MN 55616
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Mr. Paul Moyer
Minnesota Department of Health
625 Robert St N
P.O. Box 64975
Saint Paul, MN 55164-0975
11/16/2010
Ref: Proposed Amendments to Rules Governing Health Risk Limits for Groundwater,
Minnesota Rules, Chapter 4717, Part 7860 and Part 7500.
Dear Mr. Moyer,
I am writing on behalf of the Save Lake Superior Association to oppose the proposal of
the Minnesota Department of Health to repeal the Health Risk Limit pertaining to
manganese, Minn. R. 4717.7500, Subp.61 and further to preserve only informal risk
assessment for this pollutant. The potential for this pollutant to impair the ground and
surface water in the Lake Superior watershed from current and proposed mining projects,
especially copper-nickel sulfide mines, is huge based upon the PolyMet Northmet project
and other similar projects in the Duluth complex of sulfide ores. The cumulative effect of
this pollutant with other heavy metals and mercury during mining, processing and waste
storage will seriously affect the development of human fetuses and infants. This science
is well developed and recognized.
In addition to this request we hereby adopt and sign on to the comments of Water Legacy
as submitted by their attorney, Paula Goodman Maccabee on Nov 15, 2010. Applicable
Minnesota law and drinking water standard references are included therein.
Sincerely,
LeRoger Lind
President, Save Lake Superior Association
P.O. Box 101
Two Harbors, MN 55616
218-834-6137
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Attachments:
Le Lind <[email protected]>
Tuesday, November 16, 2010 9:59 PM
Moibi, Nitika (MDH)
Requesting Public Hearing on Manganese Groundwater Rule change
LetterToMDHReqestingHearingOnManganeseRuleChange11162010.doc
Ms Moibi,
Please accept the attached letter on a request for a hearing on the proposed amendment of the groundwater rule
on manganese.
Thank you.
LeRoger Lind
2948 E Castle Danger Rd
Two Harbors, MN 55616
218-834-6137
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Nitika Moibi [email protected]
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Re:
11/16/2010
Proposed Rule Changes to Health Risk Limits of Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by
the State of Minnesota, Department of Health (MDH) and request that the MDH conduct
a Public Hearing as these proposed changes in groundwater protections will result in even
greater vulnerability and risk to public health. In particular, I oppose the repeal of an
HRL value for manganese and replacing it with the proposed health-protective guidance
(Risk Assessment Advice).
Sincerely,
LeRoger Lind
2948 E Castle Danger Rd
Two Harbors, MN 55616
218-834-6137
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Le Lind <[email protected]>
Tuesday, November 30, 2010 12:31 AM
Moibi, Nitika (MDH)
Re: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related
Hearing Requests
Nitika Moibi,
We withdraw our request for the hearing on the manganese guidance with the understanding that the decision
and stipulation listed in your communication below will be in force. Thanks.
LeRoger Lind
Save Lake Superior Association
218-834-6137
From: "Moibi, Nitika (MDH)" <[email protected]>
To: "Moibi, Nitika (MDH)" <[email protected]>
Sent: Tue, November 23, 2010 4:09:27 PM
Subject: Minn. Dept. of Health - Clarification Regarding Guidance on Manganese and Related Hearing Requests
We are sending this follow up e-mail to clarify our previous communication to you regarding MDH’s decision to not
repeal the existing guidance of 100 µg/L for manganese from the current Health Risk Limit (HRL) rules.
We will update the Groundwater Values Table entry for manganese on the MDH website to reflect the 1993/94 HRL
value of 100 µg/L. Unfortunately, we cannot make this change until after December 3, 2010, as the entire MDH website is
currently being redesigned (see attached announcement).
Some commenters were concerned that the MDH website still showed the value of 300 µg/L. If this is a concern to you,
please consider withdrawing your hearing request with the stipulation that MDH will update the website to reflect this
decision (see suggested text below).
MDH plans to review manganese in the future, but until the review is complete, MDH will recommend a HRL of 100
µg/L. The HRL value of 100 µg/L will not be repealed from the current rules without a future rulemaking process.
We hope this clarifies your questions as you consider whether to withdraw your hearing request. Please respond by 4:30
p.m. on November 30, 2010, so that MDH can cancel the scheduled hearing and send out appropriate notices.
If you have additional questions, please let me know.
Thanks.
Nitika Moibi
Withdrawal of Hearing Request
Full name:
Address:
Date:
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit (HRL) for manganese in
Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing
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on the proposed rules on Health Risk Limits for Groundwater (Minnesota Rules, Chapter 4717, Parts 7860 and 7500),
provided MDH removes the guidance value of 300 µg/L from the MDH website at its earliest opportunity.
____________________________________________________________________________________________________________
________________________________________
Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201-4907
Fax: (651) 201-4606
[email protected]
http://www.health.state.mn.us/divs/eh/risk/
 Please consider whether it is necessary to print this email
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Dennis Szymialis <[email protected]>
Wednesday, November 17, 2010 1:30 PM
Moibi, Nitika (MDH)
Re: Public Hearing Request for Manganese Rule Change
Dear Ms. Moibi,
I am requesting that the Minnesota Department of Health hold a public meeting on the proposed rule change for
Manganese, specifically the repeal of an HRL value for manganese and replacing it with the proposed health-protective
guidance (Risk Assessment Advice). Manganese is a known neurotoxin and it would be prudent to keep the current
standard of 100 µg/L HRL value rather than lower the standard to a 300 µg/L health-protective guidance. In order to best
shield Minnesotans from any possible ill effects of manganese exposure, the current standard should be defended against
the proposal to weaken it through a rule change.
Furthermore, the State of Minnesota obsession with mining is our number one economic development problem which
prevents us from having a normal economy that creates jobs. Sulfide Mining in Minnesota is directly subsidized through
grants, loans, power rate agreements, and the withholding of mineral interests on tax forfeited property. It is the later
that I think is the
most costly. Northeastern Minnesota has the highest concentration of state owned mineral interests. The mere fact of of
this concentration indicates a lack of assessment equity. The additional suppression of valuation which passes on taxes to
other business and discourages business by undermining land location stability and desirability for investing in
infrastructure is a serious impediment to business location. This is a tax policy which burdens no other state or area
within Minnesota. This is the cost before a destruction of our environment is even considered.
It is not the right of myopic legislators and legislation to put the kind of economic risk of risky mining ventures on the
backs of the public by selling them with what would normally be a criminal fraud if done privately. It is not the job of
public utilities to take higher rates and put us at risk for the payment of electricity. Our Lieutenant Governor elect who
has invested in PolyMet and solicited others to invest told me during the campaign that she will leave it to the experts.
The fact is that she won't listen to the experts like Thomas Powers who is the former
Chair of the University of Montana Department of Economics and is the only unbiased and qualified expert to have
testified in front of the Minnesota legislature. The media refused during the campaign to publicize Yvonne Pretner Solon's
bias.
Even though manganese mining may not be sulfide mining it imposes, particularly through the utilization of a new
extraction process, economic and environmental risks to the public similar to that of the PolyMet Sulfide Mining Project.
No mining, including Sulfide or Manganese mining, is for the benefit of children or the Minnesota public when done in
Minnesota. Furthermore, the individual injustices permitted to private and public landowners through a direct degredation
of land values and utility by a callous legal and legislative system is a systemic injustice that is unforgivable and would
only be capable of being understood in the context of a totalitarian communist regime like Russia, or China.
Excerpted from‐ Manganese in drinking water: Study suggests adverse effects on children's intellectual abilities
at http://esciencenews.com/articles/2010/09/20/manganese.drinking.water.study.suggests.adverse.effects.childr
ens.intellectual.abilities
Lead author Maryse Bouchard explains, "We found significant deficits in the intelligence quotient (IQ) of children
exposed to higher concentration of manganese in drinking water. Yet, manganese concentrations were well
below current guidelines." The average IQ of children whose tap water was in the upper 20% of manganese
concentration was 6 points below children whose water contained little or no manganese. The analyses of the
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association between manganese in tap water and children's IQ took into account various factors such as family
income, maternal intelligence, maternal education, and the presence of other metals in the water. For co-author
Donna Mergler, "This is a very marked effect; few environmental contaminants have shown such a strong
correlation with intellectual ability." The authors state that the amount of manganese present in food showed no
relationship to the children's IQ.
"Because of the common occurrence of this metal (Manganese) in drinking water and the observed effects at low
concentrations, we believe that national and international guidelines for safe manganese in water should be
revisited." the authors conclude.
One wonders if the current attempt to weaken the Manganese standard is related to mining schemes in NE Minnesotafor Manganese and Copper-Nickel Sulfides. Manganese is often dispersed through the environment by mining
operations. The recent proposals across NE Minnesota should demand higher scrutiny and standards- not weaker. Our
agencies are tasked with protecting us, please do so.
Sincerely,
Dennis Szymialis
P.O. Box 161731
Duluth, Minnesota 55816
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Dennis Szymialis <[email protected]>
Thursday, December 02, 2010 12:48 PM
Moibi, Nitika (MDH)
Hearing Withdrawal Request
Full name: Dennis Szymialis Address: P.O. Box 161731, Duluth MN 55816
Date: December 2, 2010
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit (HRL) for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing on the proposed rules on Health Risk Limits for Groundwater (Minnesota Rules, Chapter 4717, Parts 7860 and 7500), provided MDH removes the guidance value of 300 μg/L from the MDH website at its earliest opportunity. After having the issue of manganese brought to my attention I have become concerned about some of the dramatic relaxation in standards for some of the other chemicals. Please keep in mind these concerns in making future changes in the standards.
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Bob Tammen <[email protected]>
Tuesday, November 16, 2010 8:40 PM
Moibi, Nitika (MDH)
Proposed Changes to Manganese Standard
Dear Ms. Moibi, I oppose repeal or weakening of the HRL value for manganese. Recent reports of a relationship between manganese and Mad Cow Disease call for caution rather than reckless changes to Minnesota standards. I request that the MDH conduct a public hearing on any proposed change to manganese standares. Sincerely, Robert Tammen PO Box 398 Soudan, MN 55782 218‐753‐2393 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 155 of 189
Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Bob Tammen <[email protected]>
Friday, December 03, 2010 9:30 AM
Moibi, Nitika (MDH)
MDH Manganese Hearing
Dear Ms. Moibi, I withdraw my request that MDH hold a hearing on Manganese standards. I am still concerned that State of Minnesota agencies are basing their activities on mining industry accomodation rather than citizen protection. Sincerely, Bob Tammen 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
carol russell <[email protected]>
Tuesday, November 16, 2010 11:22 PM
Moibi, Nitika (MDH)
Date: 17. November, 2010
From: Carol Russell Vastveit
4160 Finnøy
[email protected]
To:
Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
[email protected]
Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am concerned
about repeal of an HRL value for manganese and replacing it with the proposed health-protective guidance (Risk
Assessment Advice).
Sincerely,
Carol Russell Vastveit
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
helene vastveit <[email protected]>
Wednesday, November 17, 2010 12:38 AM
Moibi, Nitika (MDH)
Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
From: Helene Russell Vastveit Address: Udbyesgate 7, 7030 Trondheim Email: [email protected] To: Nitika Moibi Minnesota Department of Health 625 Robert Street North P.O. Box 64975 Saint Paul, MN 55164‐0975 [email protected] Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of Groundwater Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota, Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am concerned about repeal of an HRL value for manganese and replacing it with the proposed health‐protective guidance (Risk Assessment Advice). Sincerely, Helene Russell Vastveit 1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
kjetil vastveit <[email protected]>
Wednesday, November 17, 2010 3:44 AM
Moibi, Nitika (MDH)
Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater
Date: 11.17.2010
From: Kjetil Russell Vastveit
Address: 17th AVE SE MPLS 55414
Email: [email protected]
To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by the State of Minnesota,
Department of Health (MDH) and request that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health. In particular, I am
concerned about repeal of an HRL value for manganese and replacing it with the proposed health-protective
guidance (Risk Assessment Advice).
Sincerely,
Kjetil Russell Vastveit
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Attachments:
David L. Vegemast, P.A. <[email protected]>
Wednesday, November 17, 2010 11:59 AM
Moibi, Nitika (MDH)
Public Hearing Request
MoibiN.doc
Attached is a letter dated November 17, 2010
Thank you,
David L. Vegemast, J.D., C.P.A.
David L. Vegemast, P.A.
15600 Wayzata Blvd., Suite 305
Wayzata, MN 55391
Telephone: (952) 476-1515
Facsimile: (952) 476-7675
E-mail: [email protected]
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1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 164 of 189
November 17, 2010
Ms. Nitika Moibi
Minnesota Department of Health
625 Roberts Street North
P.O. Box 64975
St. Paul, MN 55164-0975
Transmittal via:
Email: [email protected]
Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk
Limits of Groundwater
Dear Ms. Moibi:
I oppose the proposed rule changes to health risk limits currently under consideration by
the State of Minnesota, Department of Health (MDH) and request that the MDH conduct a
Public Hearing as these proposed changes in groundwater protections will result in even greater
vulnerability and risk to public health. In particular, I am concerned about repeal of an HRL
value for manganese and replacing it with the proposed health-protective guidance (Risk
Assessment Advice).
Sincerely,
DAVID L. VEGEMAST, P.A.
David L. Vegemast
DLV/wew
MDH Exhibit J5: 2010 HRL Rules Correspondence
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MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Cc:
Subject:
Attachments:
Paula Maccabee <[email protected]>
Monday, November 15, 2010 9:48 AM
Moyer, Paul (MDH)
Moibi, Nitika (MDH)
Comments on HRL Proposed Changes - Manganese
WaterLegacyCommentHRLs(111510).pdf
Categories:
Important
Dear Mr. Moyer: Attached, please find the comments of WaterLegacy in connection with Proposed Amendments to Rules Governing Health Risk Limits for Groundwater, Minnesota Rules, Chapter 4717, Part 7860 and Part 7500. WaterLegacy is a grass‐
roots non‐profit organization dedicated to protecting Minnesota waters and the communities that depend on them. Our comments oppose the proposed repeal of the Health Risk Limit for manganese. Please acknowledge the receipt of WaterLegacy's comments. Please also do not hesitate to contact me if you have any questions regarding our comments. Sincerely, Paula Maccabee, Esq. JUST CHANGE LAW OFFICES 1961 Selby Ave. St. Paul MN 55104 phone: 651‐646‐8890 fax: 651‐646‐5754 Cell: 651‐775‐7128 e‐mail: [email protected] http://www.justchangelaw.com Attorney for Water Legacy 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 167 of 189
Paula Goodman Maccabee, Esq.
Just Change Law Offices
1961 Selby Ave., St. Paul, Minnesota 55104, [email protected]
Ph: 651-646-8890, Fax: 651-646-5754, Cell 651-775-7128
November 15, 2010
Mr. Paul Moyer
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
[email protected]
RE:
Proposed Amendments to Rules Governing Health Risk Limits for Groundwater,
Minnesota Rules, Chapter 4717, Part 7860 and Part 7500.
Dear Mr. Moyer:
This letter provides official comments on behalf of WaterLegacy concerning the Proposed
Amendments to Rules Governing Health Risk Limits for Groundwater. WaterLegacy is a
grassroots organization founded to protect Minnesota’s water resources and the communities,
human and biological, that depend on them. Our area of focus to date has been on sulfide
mining activities, so our comments pertain only to the proposed changes that are significant to
protection of drinking water from the pollution generated by sulfate mining.
On behalf of WaterLegacy, we strongly oppose the proposal by the Minnesota Department of
Health (“MDH”) to repeal the Health Risk Limit (“HRL”) pertaining to manganese, Minn. R.
4717.7500, Subp. 61, and preserve only informal risk assessment “advice” for this important
pollutant. Manganese in drinking water poses a human health risk for neurological symptoms
that has been well-documented by the United States Environmental Protection Agency
(“EPA”) and acknowledged by the MDH.
We believe that the current HRL of 100 ug/L for chronic exposure to manganese in drinking
water, rather than a 300 ug/L limit, is appropriately protective of human health, given the
increased susceptibility to excessive manganese of infants, elderly people and persons with
reduced liver function.
WaterLegacy, further, strongly opposes the MDH proposal to address health concerns about
neurological impairments caused by manganese in informal risk assessment “advice” rather
than a Health Risk Limit. HRLs are the legal mechanism provided in Minnesota statutes and
rules to address pollutants that impair human health. This issue is not academic, but highly
salient to proposals for copper sulfide mining activities proposed near Minnesota drinking
water wells and bodies of water used for municipal water supplies.
The Draft Environmental Impact Statement for the PolyMet NorthMet mine documents
elevated manganese in groundwater, surface water and drinking water wells downstream of
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Comments of WaterLegacy, Changes to HRL Rules
November 15, 2010
Page 2
the LTVSMC tailings basin. Discharge of manganese from various sources at the PolyMet
mine and tailings basin could exacerbate contamination in drinking water if State rules that
protect public health were to be repealed.
WaterLegacy takes the position that the PolyMet sulfide mine and any subsequent hard rock
mining projects must conform to State regulations to protect human health and water
ecosystems. Weakening or eliminating standards to ease the environmental review or
permitting process is contrary to the public interest and lacking in integrity.
1. Manganese in Drinking Water Poses a Human Health Risk.
The EPA has advised that adverse health effects can be caused by chronic over-exposure to
manganese and that manganese deficiency is rare because manganese is present in many
common foods. The EPA has concluded that the primary target organ for health effects from
manganese over-exposure is the nervous system and that epidemiological studies associate
adverse neurological effects with exposure to manganese from drinking water. (U.S. EPA,
Drinking Water Health Advisory for Manganese (2004), hereinafter “US EPA 2004,” p. 1.)
One epidemiological study cited by the EPA describes adverse neurological effects, including
decreased performance in school and on neurobehavioral examinations, in 11- to 13-year-old
children exposed to excess manganese through ingestion of contaminated water and
consumption of food made of wheat fertilized with contaminated water. The average
manganese concentration of the drinking-water was 0.241 mg/L for the exposed area
compared to the control level of 0.04 mg/L. (US EPA 2004, p. 16)
Other studies cited by the EPA suggest that elevated manganese exposure is associated with
neurological syndromes characterized by muscle atrophy and weakness, and by ataxia (lack of
muscle coordination) and oculomotor disturbances (impairment of eye function). Studies have
also associated manganese with amyotrophic lateral sclerosis (ALS) and with
neurotoxicological symptoms that resemble Parkinsonism. (US EPA 2004, pp. 17, 31).
The Minnesota Department of Health recognized in 2008 that ingestion of manganese had a
toxicological endpoint of “neurological effects” and that the Department’s provisional limit of
1000 ug/L (1.0 mg/L) for manganese was inadequately protective. (Manganese: Replacement
of the 1997 Health Based Value for Manganese in Groundwater, available at
http://www.health.state.mn.us/divs/eh/risk/guidance/gw/manganese.html).
High levels of manganese in drinking water are not just a matter of taste or aesthetic concern,
but pose a risk of serious adverse health effects to the neurological system for children and
adults.
2. The Limit of 100 ug/L for Manganese in Drinking Water is Appropriately Protective.
Minnesota’s current rules contain a 100 ug/L Health Risk Limit for manganese. Minn. R.
4717.7500, Subp. 61. Based on Minnesota law requiring a margin of protection for infants
and children, this limit should be retained.
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Comments of WaterLegacy, Changes to HRL Rules
November 15, 2010
Page 3
Minnesota’s law requires that safe drinking water standards established or revised by the
Commissioner of the Department of Health must “include a reasonable margin of safety to
adequately protect the health of infants, children, and adults” and must specifically take into
consideration the health outcome of “development of the brain and nervous system.” Minn.
Stat. §144.0751(a)(2).
The U.S. EPA 2009 Edition of Drinking Water Standards and Health Advisories includes a
secondary drinking water regulation of 50 ug/L (0.05 mg/L) for manganese and a 300 ug/L (0.3
mg/L) chronic health-based limit for manganese in drinking water.
The EPA acknowledges that the oral toxicity data from which the health risk assessment has
been derived is somewhat limited. (US EPA 2004, p. 31). Further, and particularly salient
under Minnesota law, the EPA has documented concerns about increased susceptibility of
certain populations, including children and infants. For infants younger than 6 months, the
EPA advises that the chronic exposure level should apply even for an acute exposure of 10
days “because of the concerns for differences in manganese content in human milk and
formula and the possibility of a higher absorption and lower excretion in young infants.” (US
EPA 2004, p. 2).
Considering both human and animal data, the EPA explained:
Manganese retention may be greater for young animals and infants due to the fact that
the biliary system, the primary route of excretion, is not completely developed in
human infants. . . When considered together, these data indicate that human infants, at
certain ages, may not have developed the capacity to completely excrete manganese
following ingestion.” (US EPA 2004, pp. 10-11, references omitted)
The EPA noted that the majority of studies have suggested that persons over 50 years of are
more susceptible to manganese neurotoxicity than the general population. (US EPA 2004, p.
20). The EPA summarized conditions that could increase sensitivity to manganese overexposure:
Individuals that have an impaired excretion and increased retention would be sensitive
to manganese toxicity. Reasons for such susceptibility are genetic make-up,
developmental stage, age, health and nutritional status. First, individuals with
decreased excretion or impaired liver function can be at risk from exposure to excess
manganese because the liver is the main organ for excreting manganese. This group
may include the elderly who may have declining organ function, the very young who
may have immature and developing organs, and those with liver disease. (US EPA
2004, p. 20)
Given the sensitivity of various populations to manganese and the clear direction in
Minnesota statutes to provide an adequate margin of protection for infants, children and
adults, it is appropriate to retain the 100 ug/L (0.1 mg/L) health risk limit for manganese to
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Comments of WaterLegacy, Changes to HRL Rules
November 15, 2010
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avoid adverse effects on the nervous systems of vulnerable infants, children and elderly
persons.
3. Minnesota Rules Must Include a Manganese Health Risk Limit.
The suggestion that contaminants to drinking water known to have adverse effects on human
health would no longer be reflected in Health Risk Limits is contrary to both Minnesota
statutes and rules.
Minnesota statutes set a goal of preventing the degradation of ground water. Minn. Stat.
103H.001. In connection with this goal, Minnesota statutes require that Health Risk Limits be
adopted by rules for substances degrading the groundwater, derived from U.S. EPA
information among other sources. Minn. Stat. 103H.201, Subd. 1 and Subd. 2 (a). Minnesota
statues define Health Risk Limits as “a concentration of a substance or chemical adopted by
rule of the commissioner of health that is a potential drinking water contaminant because of a
systemic or carcinogenic toxicological result from consumption.” Minn. Stat. 103H.005,
Subd. 3.
These statutes do not authorize the commissioner to repeal the HRL for a drinking water
contaminant with systemic human toxicity as proposed with respect to manganese in the
Statement of Need and Reasonableness (“SONAR”) and the Supplemental Explanation on
Proposed Repeal of Guidance for Selected Groundwater Contaminants (“Supplemental
Explanation”) in these Proposed Amendments to Rules.
Minnesota rules clarify that human health-based groundwater standards based on either cancer
or noncancer health effects must be reflected in promulgated Health Risk Limits, whether the
HRL will be used for regulatory or advisory purposes:
Health risk limits are for use by public agencies and private entities in Minnesota in
determining whether groundwater, impacted by human activity, is subject to
regulatory or advisory actions based on human health concerns. HRLs specify a
minimum level of quality for water used for human consumption, such as ingestion of
water, and do not imply that allowing degradation of water supplies to HRL levels is
acceptable. Minn. R. 4717.7810, Subp. 2(B).
Minnesota statutes and rules require that health risk assessment advice be reflected in HRLs
adopted in rules, not in some vague internal documentation that has no force of law. Adverse
human health consequences of manganese in drinking water are clearly established in
applicable EPA reports. To repeal the Health Risk Limit limiting this contamination and
resulting neurological impairment is not only inadequately protective of human health; it is
contrary to Minnesota law.
4. Protecting Drinking Water from Sulfide Mining Impacts Requires a Manganese HRL.
WaterLegacy’s concern about the proposed repeal of Health Risk Limits for manganese is not
academic. It is based on clear evidence that mining projects, including the proposed PolyMet
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Comments of WaterLegacy, Changes to HRL Rules
November 15, 2010
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NorthMet open pit mine, discharge levels of manganese that degrade groundwater quality and
impair human health. Environmental review documents from the PolyMet Project also
underscore the importance of reflecting limits on manganese in Health Risk Limits
appropriately adopted and retained in rules.
The PolyMet mine site would impact groundwater and municipal drinking water sources.
PolyMet’s proposed tailings disposal site – the LTCSMC Tailings Basin -- would also be
upgradient from numerous residential wells.
The PolyMet NorthMet Draft Environmental Impact Statement (“PolyMet DEIS”) reports that
the LTVSMC Tailings Basin has contaminated groundwater and surface water with
manganese. Downgradient monitoring wells in the surficial aquifer have a mean concentration
of 1,637 ug/L of manganese and downgradient residential drinking water wells have a mean
concentration of 579 ug/L, with a range as high as 4,710 ug/L. (PolyMet DEIS, p. 4.1-15,
Table 4.1-8). Surface discharges from various seeps at the LTVSMC Tailings Basin have
average manganese levels of 3,039 ug/L, 631 ug/L and 100,192 ug/L. Manganese
concentrations from surface discharge at the Tailings Basin range as high as 2,950,000 ug/L.
(PolyMet DEIS, p. 4.1-43, Table 4.1-30).
The PolyMet DEIS predicts that manganese concentrations along the Embarrass River are
likely to range between 453 ug/L and 455 ug/L. (PolyMet DEIS, p. 4.1-158, Table 4.1-84).
Maximum magnesium concentrations in flow from the waste rock stockpiles on the mine site
are predicted in deterministic modeling to be 900 ug/L for 50 to 2,000 years. (PolyMet DEIS,
p. 4.1-80).
In addition to documenting existing and potential groundwater contamination from
manganese as a result of mining activities, the PolyMet DEIS also suggests the importance of
reflecting health-based standards in Health Risk Limit rules. In discussing what standards
apply, the DEIS states, “Groundwater quality standards are USEPA primary (maximum
contaminant levels) and secondary drinking water standards and MDH Health Risk Limits.”
(PolyMet DEIS, p. 4.1-51). In considering the possibility that the Project would fail to comply
with water quality standards, the DEIS similarly states, “Antimony, manganese, and nickel
predicted to exceed USEPA primary Maximum Contaminant Levels (MCLs) or MDH Health
Risk Limits, potentially for the long term at the Mine Site.” (PolyMet DEIS, p. S-8).
Eliminating the Health Risk Limit for manganese would have the effect of removing a healthbased limit set to protect Minnesota citizens from industrial pollution. As the EPA explained
in evaluating the risks of manganese contamination, “This report indicates a median
manganese level of 16 ug/L in surface waters, with 99th percentile concentrations of 400 to
800 ug/L (Leahy and Thompson, 1994; USGS, 2001). Higher levels in aerobic waters are
usually associated with industrial pollution.” (US EPA 2004, p. 4)
CONCLUSION
On the basis of the preceding discussion, WaterLegacy respectfully requests that the
Minnesota Department of Health retain the 100 ug/L manganese Health Risk Limit. Given
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Comments of WaterLegacy, Changes to HRL Rules
November 15, 2010
Page 6
uncertainties regarding the data and clear requirements in Minnesota statutes to provide a
margin of safety to protect vulnerable populations, this standard should be retained to protect
infants, children, elderly people and people with compromised liver function.
WaterLegacy further maintains that health risk assessment “advice” regarding manganese
contamination in drinking water must be reflected in Health Risk Limits, according to the
language of Minnesota statutes and rules. Our objection to repeal of health-based rules and
use of some informal means of advice is not merely a formal legal objection. It is based on
very real risks of removing rules that protect Minnesota drinking water from dangerous
industrial pollution.
Finally, WaterLegacy is concerned that the repeal of manganese Health Risk Limits will be
used to allow mining activities, including the PolyMet NorthMet sulfide mine to proceed
without implementing designs and conditions that would protect drinking water from
exceeding safe limits. To the extent that repeal of groundwater standards has the effect of
easing an ongoing permitting process, WaterLegacy is concerned both about human health
impacts and about the integrity of Minnesota’s regulatory process.
It is not feasible for WaterLegacy’s counsel to participate in a proposed hearing scheduled for
December 8, 2010. If that date can be changed, we would request a hearing on the proposed
rule change as it pertains to manganese.
Please do not hesitate to contact me if you have any questions regarding our comments.
Sincerely,
Paula Goodman Maccabee
Attorney for Water Legacy
cc: Nikita Moibi ([email protected])
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Moyer, Paul (MDH)
Friday, December 03, 2010 9:26 AM
Moibi, Nitika (MDH)
FW: MDH - Rulemaking - Withdrawal of Hearing Request
Importance:
High
Paul Moyer, MS Minnesota Department of Health 651‐201‐4912 ‐‐‐‐‐Original Message‐‐‐‐‐ From: Paula Maccabee [mailto:[email protected]] Sent: Friday, December 03, 2010 9:05 AM To: Winget, Patricia (MDH) Cc: Moyer, Paul (MDH) Subject: MDH ‐ Rulemaking ‐ Withdrawal of Hearing Request Importance: High Dear Ms. Winget, Mr. Moyer: Thank you for your recent communication and the decision of the Minnesota Department of Health (MDH) to preserve the manganese Health Risk Limit at 100 ug/L. On the basis of the emails received from the MDH, WaterLegacy is withdrawing our request for a hearing on December 8, 2010. Based on the fall 2010 National Institutes of Health study previously referenced by the MDH in email dialogue, we believe that manganese in water may be metabolized differently than manganese in food and that the limit of 100 ug/L is needed to adequately protect children from neurological impairment. We trust that any future review of the manganese limit will provide protection to ensure that the intellectual potential of Minnesota children is not undermined by industrial pollution of drinking water. Thank you for letting us know that the MDH web site will reflect the 100 ug/L manganese HRL and that you have also already communicated to the Pollution Control Agency staff that the 100 ug/L HRL for manganese will remain in place as the current legal standard. WaterLegacy will subscribe to the electronic list you suggest. We will also notify the remaining citizens we contacted regarding this issue that we have withdrawn our hearing request. Please feel free to contact me if you have any questions. Sincerely, Paula Maccabee, Esq. JUST CHANGE LAW OFFICES 1961 Selby Ave. 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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St. Paul MN 55104 phone: 651‐646‐8890 fax: 651‐646‐5754 Cell: 651‐775‐7128 e‐mail: [email protected] http://www.justchangelaw.com Attorney for Water Legacy On 12/2/10 10:48 AM, "Winget, Patricia (MDH)" <[email protected]> wrote: > Dear Ms. Maccabbee: > > This confirms this morning's telephone conversation about MDH's > current rulemaking amending the Health Risk Limits (HRLs) in Minnesota > Rules 4717.7500. > > Water Legacy has persuaded MDH to leave the HRL for manganese at 100 > micrograms per liter in place until it completes a new study and > proposes a new HRL through formal rulemaking. This means that the HRL > remains in law and will not change and without a full public process > and an opportunity for all interested citizens to participate. MDH > has notified the Revisor's Office that it is not repealing subpart 61 > and requested a new proposed rule draft to reflect this decision. It > will also change the MDH Web site as soon as possible. > > MDH will keep anyone interested in this process informed through its > GovDelivery system, which sends an e‐mail to subscribers whenever MDH > makes changes to its Web site. They may subscribe by clicking on this > link and following the instructions: > https://service.govdelivery.com/service/subscribe.html?code=MNMDH_39 . > > You expressed concern about interim guidance of Health Based Values > (HBVs) and Risk Assessment Advice (RAA). These interim values > represent the most up‐to‐date scientific information available but > they do not replace an HRL, which MDH can do only through formal rulemaking. > > In addition, you asked about the complexity of calculating an HRL for > manganese, an element that is both beneficial to humans in small > amounts but toxic in larger ones. According to MDH's toxicologists, > manganese is particularly difficult since the key is a person's total > intake and its source is primarily diet, not water. Also the > beneficial and toxic values are close together and can overlap, > depending on the individual in question. That is, what might be > beneficial to one person is toxic to another. You are correct that this poses a challenge to calculate a proper HRL for manganese. > Nonetheless, MDH will study manganese but the HRL will remain at 100 > micrograms per liter until MDH changes it through rulemaking. 2
MDH Exhibit J5: 2010 HRL Rules Correspondence
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> > Given these assurances, will you please withdraw your request for a > hearing and ask the Water Legacy members to do the same so that MDH > can cancel the hearing? We need to hear from people by noon tomorrow, > December 3. If we do not receive sufficient notices, we will go to > hearing as scheduled on December 8. Since we are not repealing the HRL > for manganese, however, manganese would no longer be an issue at the > hearing, which will focus on the proposed HRLs for the other chemicals and the SONAR. > > Thank you for your courtesies. > > Patricia Winget > MDH Legal Counsel and Rules Coordinator > 651.201.5748 > > > > > 3
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Darril Wegscheid <[email protected]>
Tuesday, November 16, 2010 5:15 PM
Moibi, Nitika (MDH)
PUBLIC HEARING REQUESTED
To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently under consideration by the
State of Minnesota, Department of Health (MDH).
Furthermore, I rrequest that the MDH conduct a Public Hearing as these proposed changes in
groundwater protections will result in even greater vulnerability and risk to public health.
In particular, I am concerned about repeal of an HRL value for manganese and replacing it
with the proposed health-protective guidance (Risk Assessment Advice). Sincerely,
/s/ Darril Wegscheid
1407 Wachtler Ave
Mendota Hts., MN 55118
651-503-8414 1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
[email protected]
Wednesday, November 17, 2010 8:05 AM
Moibi, Nitika (MDH)
Request Letter for Public Hearing
Date: November 17, 2010 From: Ken Winters 1575 Northrop St., Falcon Heights, MN 55018 To: Nitika Moibi Minnesota Department of Health 625 Robert Street North P.O. Box 64975 Saint Paul, MN 55164‐0975 Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of Groundwater Dear Ms Moibi: I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota, Department of Health (MDH), and I am requesting that the MDH conduct a Public Hearing regarding these proposed changes in groundwater protections because they will result in even greater vulnerability and risk to the public's health.
Sincerely, Ken Winters 1
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Mary Winters <[email protected]>
Tuesday, November 16, 2010 12:52 PM
Moibi, Nitika (MDH)
Request for Public Hearing
Date: November 16, 2010
From: Mary Winters
1575 Northrop Street
Saint Paul, MN 55108
[email protected]
To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
[email protected]
Re: Request for a Public Hearing on the Proposed Rule Changes to Health Risk Limits of
Groundwater
Dear Ms Moibi:
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota,
Department of Health (MDH), and I am requesting that the MDH conduct a Public Hearing regarding these proposed
changes in groundwater protections because they will result in even greater vulnerability and risk to the Public’s
health.
Sincerely,
Mary Winters
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Mary Winters <[email protected]>
Tuesday, November 16, 2010 12:57 PM
Moibi, Nitika (MDH)
Comment Letter on Proposed Changes to Rule of Health Risk Limits to Groundwater
Date: November 16, 2010
From: Mary Winters
1575 Northrop Street
Saint Paul, MN 55108
[email protected]
To: Nitika Moibi
Minnesota Department of Health
625 Robert Street North
P.O. Box 64975
Saint Paul, MN 55164-0975
[email protected]
Re: Proposed Rule Changes to Health Risk Limits of Groundwater
Dear Ms Miobi:
I oppose the proposed rule changes to health risk limits currently being considered by the State of Minnesota,
Department of Health.
The proposed changes will place the Public at even greater health risk than with the current statute, and will
effectively give the mining industry along other for-profit corporate users of Minnesota’s groundwater an advantage
at the expense of a vulnerable Public.
I am a member of the Public, who also understands the urgency of jobs’ creation in Minnesota. I strongly urge you to
reconsider the proposed legislative changes. The reduction of health risk limits on groundwater will not benefit a
vulnerable Public that presently is already in the unfortunate position of being unwitting and un-consented subjects
of mining operations that use legal loopholes to their advantage.
Doesn’t the Public’s right to healthy groundwater supersede that of mining companies, et al., whose operational
uses and disturbances of groundwater may and will at some point result in demonstrable public health risk
outcomes?
1
MDH Exhibit J5: 2010 HRL Rules Correspondence
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Keeping current protections – even increasing health risk limits – does not deprive the mining industry, et al., from
conducting operations, providing jobs, and making profits. All of these things are still possible; and protecting Public
health is not an example of wealth redistribution nor does it prevent for-profit companies from doing business or
making profits.
It is well documented in scientific literature that for any and all mining operations, accidents will occur; that it is not
possible to predict when, where, and under what conditions unplanned incidences will occur, even when using the
best predictive models, metrics, and operational best practices.
It is in everyone’s best interests for the State of Minnesota, Department of Health to ensure that statues protect the
Public first and corporate profits secondarily: In the present context, that means maintaining current legislated health
risk limits for groundwater.
Of particular concern to me is that the statute presently imposes only weak risk limits for
Manganese (Mn) in groundwater (HRL value ((in Part 4717.7500 adopted in 19931994)) (ug/L). This situation exists
primarily because of limited data sets based on empiric research regarding the effects and toxicology of Mn in
groundwater. However, using recent developments of brain and health research technologies [i.e., neuroimaging,
fMRI, et al.,] research is presently being conducted to measure effects of Mn on general human health, and more
specifically on the effects of chemical and environmental assaults on neurobiological developmental processes and
functionality.
To ignore empiric health data that is literally forthcoming, while at the same time adopting the proposed lowering of
health risk limits to groundwater (Updated Guidance Value ((ug/L)) from present 100 to 300), would endanger the
Public and suggest collusion between industry and government departments and agencies at the Public’s expense.
Thank you for your attention to this matter.
Sincerely,
Mary Winters
2
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Moibi, Nitika (MDH)
From:
Sent:
To:
Subject:
Mary Winters <[email protected]>
Thursday, December 02, 2010 5:40 PM
Moibi, Nitika (MDH)
Re: Response to questions about MDH's Proposed Rules - Manganese
Dear Ms Moibi, I am withdrawing my request for a public hearing on the intent to change HRLs for several chemicals, among them manganese. However, most of my questions were unanswered in your email response, and I would like to add that it would be a great service to the public if you were to agree to meet with concerned public citizens in order that we might ask and have answered all of our questions regarding this recent attempt to change HRLs. I would also like to mention that it seems to be a good time, right now, for MDH to change its entire approach to protecting the publicʹs health to being proactive, rather than the traditional reactive stance. Now that would demonstrate real sustainability!____________________________________________________________________________
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Withdrawal of Hearing Request
Full name: Mary K Winters
Address: 1575 Northrop St.
St Paul, MN 55108
Date: 12‐02‐2010
Based on MDH’s decision dated November 22, 2010, to not repeal the Health Risk Limit for manganese in Minnesota Rules, Chapter 4717, Part 7500, subpart 61 from the current rules, I withdraw my request for a public hearing on the proposed rules on Health Risk Limits (HRLs) for Groundwater (Minnesota Rules, Chapter 4717, Parts 7860 and 7500). 1
MDH Exhibit J5: 2010 HRL Rules Correspondence
Page 185 of 189
Nitika Moibi, MPP
Planner Principal State
Health Risk Assessment Unit
Division of Environmental Health
Minnesota Department of Health
625 Robert Street North
St. Paul, MN 55164
Phone: (651) 201‐4907
Fax: (651) 201‐4606
[email protected] http://www.health.state.mn.us/divs/eh/risk/  Please consider whether it is necessary to print this email
[1] Bouchard MF, Sauvé S, Barbeau B, Legrand M, Brodeur M-È, et al. 2010 Intellectual Impairment in School-Age Children Exposed to Manganese from Drinking
Water. Environ Health Perspect doi:10.1289/ehp.1002321
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Moibi, Nitika (MDH)
To:
Subject:
Moyer, Paul (MDH)
RE: Oppositionto the repeal of the manganese standard
From: Guy A. Wolf [mailto:[email protected]]
Sent: Wednesday, November 17, 2010 8:20 AM
To: Moyer, Paul (MDH)
Subject: Oppositionto the repeal of the manganese standard
Mr. Moyer,
My father-in-law's brother worked in Manganese mines in Colorado. He died in their early 60's. And my father-in-law died in his early 60's. Both had
advanced cases of Parkinson's disease. There is no doubt that our family believes that their early deaths were attributable to their work in these mines. Please
do not repeal the manganese standard in MN, we ask that you instead increase the standard.
Sincerely,
Guy Wolf
N3421 Mohawk Valley Road
Stoddard, WI. 54658
OPPOSING THE REPEAL OF THE MANGANESE STANDARD TO THE DEPARTMENT OF HEALTH TODAY
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MDH Exhibit J5: 2010 HRL Rules Correspondence
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MDH Exhibit J5: 2010 HRL Rules Correspondence
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