May 4, 2010 Linda Bruemmer Director, Environmental Health Division Minnesota Department of Health P.O. Box 64975 St Paul, MN 55164‐0975 Re: Minnesota Chemicals of High Concern List RE: Concerns & Recommendations Regarding Minnesota Chemicals of High Concern List Dear Ms. Bruemmer, On behalf of a Coalition of the trade associations listed below (the Coalition), we appreciate the opportunity to participate in Minnesota’s efforts to advance its Green Chemistry and Design Initiative as described in Omnibus Bill HF 21231, which was signed into law by Governor Pawlenty in August of 2009. We respectfully submit this letter expressing some concerns with some of the proposed sources2 to be used in populating Minnesota’s Chemical of High Concern list (to be published on July 1, 2010) and proposing some recommendations on how to develop this list and future priority chemical designations. We urge the Department to consider these recommendations, as this list will be crucial in identifying priority chemicals and defining chemicals policy in Minnesota. The Coalition supports policies that stimulate Green Chemistry innovation and the development of greener technologies. A prioritization of chemicals must be done in a way that is informative and focuses on those substances that are of greatest, known concern to human health and the environment. Generally, we support:  Safety‐based prioritization to identify chemicals of highest concern through exposure, use, and hazard data,  A “weight‐of‐evidence” approach to chemicals prioritization that evaluates all authoritative information on hazard traits, and considers the most severe hazards first, and 1
Omnibus Bill HF 2123 ‐https://www.revisor.leg.state.mn.us/bin/bldbill.php?bill=H2123.4.html&session=ls86 (relevant Sec.47‐52, 63)
Minnesota’s Department of Health (MDH) and Minnesota’s Pollution Control Agency (MPCA) January 15 Interim Report ‐
http://www.pca.state.mn.us/publications/lrg‐gen‐7sy10.pdf
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 A process of informed substitution that considers the functional impacts of alternative technologies as well as the technological and commercial feasibility for evaluating “safer” chemicals. It is our belief that by using these key elements to identify, prioritize, assess, and manage high priority chemicals; the Department will be able to focus its limited resources on the chemicals and exposures of greatest impact to human health. Our specific comments below discuss these key issues and specific recommendations in the context of the mandates of this statute and provide specific input on the data sources under consideration for the Chemicals of High Concern list. 1. Authoritative Sources This program must be based on sound science, which is not driven by a particular agenda or perspective. Therefore, it should rely on conclusions and information from “authoritative” sources to develop the Chemicals of High Concern list and to set priority chemicals. Generally, an authoritative entity or body should be defined as a government agency or formalized scientific organization that satisfies all of the following requirements: 1. It characterizes chemicals pursuant to an open, deliberative and transparent scientific process in which stakeholders are able to participate formally, and communicate directly with the authoritative body through written and oral comments. 2. It does not engage in advocacy. 3. It bases its characterization of chemicals on a weight‐of‐evidence approach. To the extent available, it considers multiple reliable studies, conducted by different laboratories, at different times, and involving not only different strains but different species and gives full consideration to mode of action, confounding factors, maternal toxicity, historical controls and any other scientific information that may be relevant to understanding the potential effects of chemicals on health and the environment. 4. It publishes its characterizations of chemicals through governmental regulations, periodic reports, monographs or peer‐reviewed publications. Section 52 of Article 1 (116.9407 – Participation in Interstate Chemicals Clearinghouse (ICC)) gives Minnesota Department of Health (MDH) the authority to engage in the ICC partnership among states, to share information on approaches to managing, organizing, prioritizing, and evaluating chemicals and safer alternatives AND on chemical data (e.g., use, hazard, risk, environmental/health impacts). However, such an entity does not exist as currently envisioned. Such an entity would need to be formally chartered as an objective scientific entity, sanctioned by a government, which has prioritized chemicals through an open and public stakeholders’ process. In the future if this organization is created, the Department should rigorously ensure that the information from these efforts reference authoritative sources and should make sure it is using the most up‐to‐date version. 2
Within this consideration, it should be acknowledged that no source list is perfect, especially when applied for a purpose for which it was not originally intended. Clearly some are better and more relevant than others. Section 48 (c) of the Statute provides useful guidance in directing the Department to some authoritative entities for chemicals known to present the hazards of concern. Most of the statutory sources are highly regarded. The U.S. Environmental Protection Agency (EPA), California Prop 65 chemicals identified under section 25249.8(b) and chemicals that will be identified within European Union’s Registration, Evaluation, Authorization and restriction of Chemicals (REACH) Annex XIV are credible. However, there are a few that remain questionable. For example, other state‐based lists such as Maine’s published list of chemicals of high concern and Washington Department of Ecology’s list have not been subject to stakeholder input and have not even been adopted, in the case of Washington State. The Appendix following these comments provides specific issues that need to be considered when MDH evaluates whether or not to use these sources for this effort. If the Department chooses to rely on these prioritizations, these concerns should be addressed and accommodated before a chemical is brought forward as a chemical of high concern in Minnesota. 2. Chemicals of High Concern List According to Sec. 48 c, d (116.9402 – Identification of Chemicals of High Concern), MDH may establish a list of chemicals of high concern by compiling substances from a wide set of global regulatory generated lists (e.g., California Environmental Protection Agency, the Washington Department of Ecology, the United States Department of Health, the United States Environmental Protection Agency, the United Nation's World Health Organization, and European Parliament Annex XIV concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)). The Department should determine priorities starting with the statutory criteria, but also go further. The statutory criteria are a useful start (e.g., screening MDH’s list of chemicals of high concern with EPA’s High Production Volume (HPV) chemicals), but they are not sufficient to do an appropriate job in screening for top‐priorities. Further steps to focus priorities and improve the quality and outcome of the process can be accomplished simply by:  Screening for chemicals actually made and used in the U.S. – for example, the EPA Inventory Update Rule (IUR) information source3, use pattern and threshold considerations should be included to improve the quality and outcome of the process;  Ensuring that data used for evaluations are scientifically credible and reliable4; and, 3
Aggregated exposure and use data are publicly accessible through EPA’s Inventory Update Rule (IUR).
(http://cfpub.epa.gov/iursearch/index.cfm?s=chem) From this page, the 2006 IUR Manufacturing, Processing and
Use database files can be downloaded. For additional background on the design of the IUR and EPA’s Report,
please visit: http://www.epa.gov/oppt/iur/tools/data/index.html.
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Reliable studies are studies or data generated according to valid acceptable testing guidelines in which the test
parameters documented are based on specific testing guidelines or in which all parameters described are comparable
to a guideline method. Also, studies that are well-documented and scientifically acceptable may be considered
reliable as well. Where such studies or data are not available, the results from accepted models and quantitative
structure-activity relationships (QSAR) approaches, validated in keeping with the Organization for Economic
Cooperation and Development (OECD) principles of validation for regulatory purposes, may be considered.
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 Using additional information that identifies the actual potential for harm from a chemical. Using these general criteria will help generate a more focused and applicable list of Chemicals of High Concern and, consequently, a more focused list of Priority Chemicals. The following offers a recommendation for MDH on clear criteria and on a set of global Authoritative Body source lists to support identification of candidate CMR/PBT chemicals. After including a screen for volume and use, MDH is encouraged to include multiple Notice‐and‐Comment opportunities to then designate priority chemicals for further evaluation. KNOWN PBT Criteria "Chemicals known as persistent in the environment, bioaccumulative and toxic" has typically included chemicals that meet the following criteria: 1. Persistent in the environment means the chemical has a half‐life, as measured by reliable studies, equal to or greater than 180 days in water, or 180 days in soil, or 180 days in sediment, or 2 days in air. 2. Bioaccumulate means the chemical has a bioaccumulation factor (BAF) or bioconcentration factor (BCF), as measured by reliable studies, greater than 5000. 3. Toxic means a chemical has, as measured by repeat dose studies for mammalian toxicity or by acute or chronic studies for aquatic organisms, a subchronic oral No Observed Effect Level (NOEL) or No Observed Adverse Effect Level (NOAEL), value less than or equal to 10 mg/kg bw/day for mammals; or, LC50 or EC50 less than or equal to 1.0 mg/L (for acute toxicity) or a No Observed Effect Concentration (NOEC) less than or equal to 0.1 mg/L (for chronic toxicity) for aquatic species. Recently in scientific circles there continues to be a discussion of these factors and how to evaluate PBTs. We recommend that Minnesota’s consideration of this issue should also reflect the most up‐to‐
date scientific thinking about how to evaluate PBTs and POPs. In 1997 and again in 2008 the Society for Environmental Toxicology and Chemistry (SETAC), sponsored workshops on PBT/POPs substances (aka “Pellston Workshop”)5. The workshops helped advance the science of PBT characterization by reaching consensus on how to better identify PBTs and POPs at an early stage, using new scientific information and tools, rather than simply defaulting to criteria that have been in place since the late 1970s. This workshop included leading scientists from academia, government, regulatory bodies and industry. Follow‐up from the 2008 workshop is underway. Minnesota should consider this scientific discussion on PBTs and POPs to assure that the most up to date, reliable scientific methods are applied to creating the list of chemicals of high concern. Sources  EPA. Chemicals included should be from EPA’s several PBT related programs—EPCRA 313 PBT Program (http://www.epa.gov/tri/lawsandregs/pbt/pbtrule.htm) and the Waste Minimization Program (http://www.epa.gov/osw/hazard/wastemin/priority.htm)  Canada PBT. Chemicals included should be the chemicals categorized as Environmental PBT appearing in the "Top 200 Challenge" high priority Domestic Substances List (DSL) categorized 5
The Executive Summary of the Proceedings of the Workshop are available at
http://www.setac.org/sites/default/files/ExecutiveSummary.pdf
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chemicals and on which action has been taken under Canada’s Chemical Management plan to restrict use of the chemical. (http://www.chemicalsubstanceschimiques.gc.ca/challenge‐
defi/list‐eng.php) EU PBT. Chemicals included should be those PBT's "fulfilling criteria" from the EU review process. (http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=pbt) KNOWN CMR Criteria “Chemicals known to cause cancer in humans" means chemicals that have been classified in (i) the International Agency for Research on Cancer ("IARC") category 1 or (ii) an equivalent category in a similar classification system promulgated by another authoritative body such as US EPA, California Proposition 65, the National Toxicology Program Report on Carcinogens, or the European Union. "Chemicals known to cause mutagenic effects in humans" means chemicals classified in (i) the European Union Category 1A under Annex VI, part 3 of Regulation (EC) 1272/2008 or (ii) an equivalent category in a similar classification system promulgated by another authoritative body. “Chemicals known to cause reproductive harm" means chemicals that have been classified as known reproductive or developmental toxicants by an authoritative body such as US EPA, California Proposition 65, the National Toxicology Program Center for Evaluation of Risks to Human Reproduction (CERHR), or the European Union. Relevant Sources  EPA Carcinogens. This has been collected since 1986 and the main challenge is that the ranking terminology has changed 4 or 5 times, most recently in 2005. Chemicals included should be those classified as Known Category A. (http://www.epa.gov/opp00001/health/cancerfs.htm)  NTP Report on Carcinogens. Chemicals included should be those classified as Known to Cause Cancer in Humans (http://ntp.niehs.nih.gov/?objectid=72016262‐BDB7‐CEBA‐
FA60E922B18C2540)  Prop 65. Chemicals included should be Carcinogens and Repro/Developmental toxicants that were identified under section 25249.8(b) (http://www.oehha.ca.gov/prop65.html)  IARC. Chemicals included should be those classified 1.
(http://monographs.iarc.fr/ENG/Classification/index.php)
 NTP CERHR. Chemicals included should be those identified as Serious Concern for
reproductive/developmental toxicity. (http://cerhr.niehs.nih.gov/index.html)
 EU CMR Classification. Chemicals included should be those previously classified as Category 1 under Annex I of Directive 67/548/EEC and now in transition to be classified as Category 1A under Annex VI,part 3 of Regulation (EC) 1272/2008. (http://ecb.jrc.ec.europa.eu/classification‐
labelling/)  EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals’ (REACH) Substance of Very High Concern (SVHC). SVHC is a list of substances in Annex XIV subject to authorization under Regulation (EC) No 1907/2006 of the European Parliament concerning REACH. Chemicals recommended as Candidates to be Substances of Very High Concern in the EU's REACH Program which will include CMR, PBT and substances with "equivalent level of concern";  Endocrine Disruption. Consideration in regards to endocrine disruption may be given to new information emanating from EPA’s Endocrine Disruptor Screening Program’s Tier 2 Testing AND from substances of “equivalent level of concern” added to EU’s SVHC list. 5
3. Designation of Priority Chemicals. MDH should provide an opportunity for Notice and Comment prior to confirming a designated chemical as a priority chemical. This preliminary Notice‐and‐Comment step will afford interested stakeholders the opportunity for a showing of data that would help ascertain whether or not a chemical meets the scientific criteria (i.e., CMR/PBT) and/or volume and/or use criteria. To make Minnesota’s list workable, the process for identification of candidate priority chemicals should be a dynamic, on‐going and iterative one, with the most severe hazards being considered first. a. PRIORITIZATION CRITERIA To ensure that an effective prioritization mechanism exists and consistent criteria are applied to identify the “priority chemicals of highest concern” from Minnesota’s published list of chemicals of high concern, consideration must be given to severity of exposure and to the severity of the hazard of the chemical. Although the statute limits the scope to intentionally‐added ingredients and priority chemicals used in the processing of the final children’s product that are present in the final product, it does not provide weighted criteria identifying those chemicals of highest concern from MDH anticipated “chemical of high concern” list. MDH should narrow its list of chemicals for consideration by identifying/prioritizing the chemicals of high concern into high, medium, and low priority categories so as to avoid an entirely arbitrary process of picking and choosing a priority chemical, which would undermine the credibility of this process. Chemicals should be prioritized with respect to the traits/characteristics they exhibit. The most severe human health hazard traits, such as chemicals known to cause cancer, or developmental or reproductive harm (CMR), and most severe environmental concerns, chemicals that are persistent, bioaccumulative and toxic (PBT), would be consensus criteria. Chemicals categorized as “known” or “presumed” (Category 1) hazards should be prioritized higher than those categorized as “suspected”. Chemicals with multiple severe hazards should be prioritized higher than those with single hazards. b. SELECTING PRIORITY CHEMICALS There are priority‐setting criteria in the Statute that can all be useful in providing indicators of potential exposure. But they are not real indications of the potential or likelihood of harm. For instance, the CDC has said that the presence of a chemical in biomonitoring does not indicate that there is a likelihood of harm. So these indicators from the statutory language are useful, but not sufficient for prioritizing chemicals. There are additional factors such as information about Chemical Product Use, Level of Chemical in Product including Threshold Level, Level of actual exposure, Weight‐of‐Evidence and others that can and should be included in the priority setting before an evaluation is required for a particular chemical/use combination. These factors will establish a more complete and acurate picture of the use and severity of a chemical of concern. For instance:  Information from US EPA’s 2006 Inventory Update Rule (IUR) as suggested above. The Minnesota effort should use this to screen for chemicals actually made or imported into the US and used in the U.S. consumer products. Briefly, the last IUR shows 6200 chemicals being manufactured or imported into the US and over 2200 chemicals reported as used in consumer and commercial products, the very products targeted in Minnesota. For several reasons, the 6
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IUR information is neither perfect, nor complete but it’s the best resource currently available. Aggregated, non‐confidential data from the 2006 IUR can be downloaded from US EPA's website at http://cfpub.epa.gov/iursearch/index.cfm?s=chem. Priority setting should consider a chemical’s use pattern. The types of products in which it is used have a major impact on exposure to the chemical. There are large orders of magnitude of difference in exposure through different product uses and even through different product forms. This means many orders of magnitude in the potential for harm. This should be taken into account in selecting priority chemicals before establishing requirements for an alternatives assessment/evaluation. Priority setting should also consider the level of chemical in product, which affects exposure. In this regard, there is a critical need for establishing a de minimis or threshold concentration in products for regulation for which there’s no current provision. Such provisions are standard in a variety of chemical and product safety laws. With ever improving analytical capability and ever lower detection limits, vanishingly small and insignificant levels can be identified that are meaningless in regard to protecting children’s health. Europe’s REACH chemical law applies a default 0.1% de minimis level in products, which applies broadly, even to Substances of Very High Concern that become banned. This level is also used in worker and transportation applications in Europe and North America and should be adopted by Minnesota. Priorities should be identified by taking into consideration all factors, such that the highest priority chemical would be one with the highest hazards AND greatest potential for significant exposure. On statutory and other priority‐setting criteria, several relate to scientific measurements. Any proposed regulations should provide requirements for the scientific stature of information sources, the use of good laboratory practices, and the quality of studies. The Department should ensure that any data used throughout the process is credible and scientifically sound. The Organization for Economic Cooperation and Development (OECD) has set global standards for testing protocols (http://www.oecd.org/department/0,3355,en_2649_34377_1_1_1_1_1,00.html) and for judging reliability, relevance and adequacy of studies (http://www.oecd.org/document/7/0,3343,en_2649_34379_1947463_1_1_1_1,00.html). 4. Scope As indicated in the statute, MDH should focus on exposures that present the greatest risk to human health and the environment. While the logic of focusing on products intended for children and vulnerable populations is reasonable, the lack of identification and prioritization of product categories/uses of highest concern will be challenging for any recommendations that come from this process. MDH should effectively prioritize chemical uses contributing to exposures of real concern, rather than trying to create recommendations that encompass the universe of children’s products. To help create a successful green chemistry program, the product categories should be narrowed significantly and more focused to those products that result in identified exposures to priority chemicals. 5. De Minimis & Intentionally Added There must be consideration of de minimis thresholds and intentionally‐added chemicals to help identify/prioritize priority chemicals of highest concern. Based upon commonly accepted international de minimus thresholds (See European REACH Legislation Article 7) the Coalition believes a level of 0.1% 7
of a total product’s weight should be referenced as a threshold for evaluation of chemicals within this program. Because of modern detection technology, it is impossible to have “zero” presence of any substance in a product. Naturally occurring substances and trace elements cannot be totally eliminated from any products. Additionally, the testing costs to determine trace levels of all chemicals theoretically in a product would be cost‐prohibitive for any company. Therefore, a workable policy proposal must focus the scope of regulatory efforts on intentional chemical ingredients with established de minimis threshold concentrations. With regard to de minimis, California’s Proposition 65 establishes “safe harbor levels” or no significant risk levels (NSRLs) for carcinogens and maximum allowable daily levels (MADLs) for chemicals that cause reproductive toxicity. Prop. 65 defines these levels as: “The NSRL is the daily intake level calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question. The MADL is the highest level at which the chemical would have no observable adverse reproductive effect assuming exposure at 1,000 times that level. The NSRLs and MADLs are promulgated in Title 22, California Code of Regulations (CCR), Sections 12705 and 12805, respectively, to assist interested parties in determining whether warnings are required for exposures to listed chemicals”6 An “intentionally added ingredient” would be any “element, chemical compound organic or inorganic substance of a particular molecular identity, which is intentionally used by a product manufacturer or component supplier to impart a functional purpose on product including (a) any combination of such substances used in whole or in part as a result of a chemical reaction or occurring in nature, and (b) any element or uncombined radical”. (Adapted from the definition of chemical substance from TSCA, 15 USC 2602. The most meaningful health and environmental benefits will be achieved by targeting exposures to intentionally added chemicals in products above a de minimis threshold of 0.1% within a product’s total weight. 6. Stakeholder Input To ensure transparency, there should continue to be a role for “consultative” stakeholder processes to providing ongoing review and comment by interested stakeholders. The Impacted Stakeholder Coalition greatly appreciates the opportunity to share this input with Minnesota’s Department of Health and Minnesota’s Pollution Control Agency. We look forward to continued engagement throughout this process and remain committed to assisting the Department in developing credible, deliberate, and workable lists for both chemicals of high concern and priority chemicals. If you have any questions or comments, please feel free to contact either Kevin Fisk with the Grocery Manufacturers Association at 616‐984‐6209 or Andy Hackman with the Toy Industry 6
http://oehha.ca.gov/prop65/getNSRLs.html
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Association at 646‐520‐4851 as representatives of the Coalition. We look forward to our continued work together on this important public policy initiative. Respectfully Submitted by the Following Organizations: American Chemistry Council Consumer Specialty Products Association Grocery Manufacturers Association Personal Care Products Council Soap and Detergent Association Toy Industry Association Cc: Nancy Rice, MDH Larry Gust, MDH Rita Messing, MDH Enc: Appendix: Comments on Chemicals of Concern from Other Jurisdictions 9
Appendix: Comments on Chemicals of Concern from other Jurisdictions a. Maine Department of Environmental Protection’s (DEP) Published List of Chemicals of High Concern7 While the Maine Department of Environmental Protection’s (DEP) list of Chemicals of High Concern represents an extensive effort similar to the efforts stipulated for Minnesota under this statute, DEP’s list has several notable flaws that should not be duplicated. Additionally, the list was not developed with stakeholder input or public comment. Specifically, below are several areas where Maine’s DEP misinterpreted certain prioritization efforts in other jurisdictions, or included lists that would not meet the “authoritative bodies” criterion discussed above. i. CANADA Maine selected the "PBiT" interim categorization list from Canada, a total of 393 chemicals. This includes all chemicals modeled as PBT, including those that even Canada indicates are Low and Medium Confidence outcomes. After Canada completed categorization, the list of likely PBTs numbered 77. Since that time, Canada’s detailed assessments are further narrowing the scope, with action being taken on some chemicals of known concerns while others have been set aside. Maine should use Canada’s final list, focusing on those chemicals and uses where risk management action has been taken. Most of the chemicals on the interim list were not included in Canada's final "Top Priority Challenge" 200 chemicals for further data collection and regulatory action. This is an uneven source and should be changed to include only Canada's top priority PBiT's, a total of 77 chemicals. ii. OSLO‐PARIS CONVENTION (OSPAR) Maine selected two lists from OSPAR, the Convention that seeks to protect the North Sea from pollution. The first is OSPAR's full list of 310 substances of possible concern; the second is OSPAR's list for "Priority Action" of 50 chemicals. Since OSPAR criteria for Bioaccumulation and Persistence is lower and not aligned with the criteria of any other regional or national jurisdiction (i.e., the lowest threshold for the bioaccumulation concentration factor (BCF)), (Cut‐Off Values for the Selection Criteria of the OSPAR Dynamic Selection and Prioritisation Mechanism for Hazardous Substances8) neither list should be a source for Maine or Minnesota’s published list of chemicals of high concern. Since it is old, it doesn’t take into account findings through the European Union’s PBT process where a detailed review was conducted. That EU process resulted in 23 chemicals that fulfilled PBT criteria, not 310. Maine and other states should use the updated EU PBT list and not the OSPAR list. iii. EU ENDOCRINE DISRUPTION PROGRAM The EU Endocrine Disruption list was published in 1999. Starting from a nominated group of over 500 chemicals, a set of 194 was identified by a consultant as having "evidence of endocrine disruption activity". Little has been done since then to narrow this list to those of possible concern, including the absence of a deliberative regulatory technical process to have an in‐depth review of the data from all interested stakeholders and to take a more rigorous decision. It does not represent any level of scientific consensus. In fact, the EU's Science Advisors on the EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) did “not find the source material, methodology and selection 7
8
See: http://www.maine.gov/dep/oc/safechem/highconcern/
See: http://www.ospar.org/documents/DBASE/DECRECS/Agreements/05-09e_Cut-off-value%20agreement.doc 10
criteria used to be scientifically adequate” and concluded “that there are important shortcomings in the present approach”. (EU CSTEE, Opinion on BKH Consulting Engineers Report, http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out73_en.print.htm). Absent the in‐
depth review and lack of any other significant improvements since 1999, this is a weak source and should be removed. iv. ENDOCRINE DISRUPTION (ED) ENDPOINT There is a strong point of view from many scientists that ED is a mode of action, not a toxicological endpoint. The potential to interact with the endocrine system does not necessarily constitute a risk and does not necessarily translate to an adverse physiological effect. The EU CSTEE states that: “It is important to realize that endocrine disruption is not a toxicological endpoint per se as is cancer or allergy, but that it is a descriptor for a functional change that may lead to adverse health effects. Rather, endocrine disruption should be seen in the context of well‐established endpoints, primarily reproductive toxicity and impaired development.” (EU CSTEE, Opinion on BKH Consulting Engineers Report http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out73_en.print.htm) Maine DEP’s published list already captures reproductive/developmental endpoints. The selected sources of endocrine disrupting chemicals that Maine DEP used to populate the published list of chemicals of high concern should be removed. Nevertheless, Maine’s “Toxic Chemicals in Children’s Products” statute does identify legitimate sources for endocrine disruption (i.e., chemicals identified as known or likely endocrine disruptors using validated protocols in EPA’s Endocrine Disruptor Screening Program; chemicals listed on the basis of endocrine‐disrupting properties in Annex XIV, List of Substances Subject to Authorization, Regulation (EC) No 1907/2006 of the European Parliament concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)). Maine DEP should have limited their focus on endocrine disruption to these identified sources in their respective statute. v. EPA’s TOXICS RELEASE INVENTORY (TRI) The data table in Maine DEP’s published list of chemicals of high concern included two columns that relate to EPA's TRI PBT's. Although some are similar, for the most part, different chemicals are indicated in each one. The incorrect list should be excluded. b. Washington Department of Ecology (DoE)9 The Department of Ecology has taken an in depth approach to scanning the globe for hazard and exposure information and a relatively thoughtful series of steps in coming to decisions about primary versus secondary sources to determine 177 high priorities. In some areas, these prioritizations seem to be generally reasonable decisions. However, at this time this list is for exploratory purposes only, and has not been formally adopted. This list must go through notice and comment and has yet to receive input from stakeholders. Initial concerns with this list are as follows:  Transparency. After a very clearly laid out step by step narrowing process, DoE moved from 177 chemicals to 66 in the pilot. While the lower number makes it more workable, there does not appear to be any published rationale for it. Selection was clearly not made due to the most 9
http://www.ecy.wa.gov/programs/swfa/cspa/pdf/ChemicalReportingList.pdf
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"hits"‐‐some are found in over 10 databases, some in only 1. The selection process must be more transparent. It is because of these concerns that stakeholders have requested additional dialogue with DoE and with Dr. Karr at the University of Washington who designed the algorithm that was used to develop this list.  Hazard Severity. There does not seem to be a "severity" consideration to consider a chemical that has multiple hazards or shows up on multiple lists, and, thus, of higher priority.  "Known" Hazards. The legislation focuses attention on high priority chemicals that "...on the basis of credible scientific evidence as known to do one or more of the following...". The known criterion would appropriately narrow the focus to the very highest hazard priorities. However, many of the sources DoE used to begin with did not adhere to this “known” hazard criterion.  Inappropriate Hazard Source Lists. The WA list and its sources should become a de facto standard for other jurisdictions only when sources are authoritative in nature and the list was generated on both hazard and exposure information. The Department of Ecology started with a very large global set of lists, some inappropriate either because of not being authoritative in nature or because of not adhering to the “known” standard. Some of the inappropriate starting sources include: o EPA’s Voluntary Children's Chemical Evaluation Program (VCCEP) (screened list); o National Toxicology’s Program (NTP) Carcinogens‐Suspected list (not “known”); o IRIS 1986 Category B1 probable ‐ based on human data (not “known”); o IRIS 1986 Category B2 probable ‐ based on human and animal data (not “known”); o IRIS 1986 Category C possible (not “known”); IRIS 2005 Suggestive Evidence (not “known”); o Prop 65 Cancer Labor Code listings (not authoritative); o EU Endocrine Disruptors Cat 1 and Cat 2 (these lists were never finalized); o EU Chemicals identified for Risk Assessment (only if regulatory actions taken once the risk assessments were completed); o OSPAR lists (did not follow open deliberative process); o IARC Group 2a Probable Carcinogens (not “known”); o IARC Group 2b Possible Carcinogens (not “known”); and o Neuro‐developmental toxicants identified by Grandjean & Landrigan in The Lancet (not authoritative). Specific lists that were ultimately used that remain a concern are the EU Endocrine Disruptor, OSPAR Priority Action, the Labor Code chemicals in Prop 65 for the reasons stated above.  Exposure Sources. The overall concern in this part of the prioritization is that ANY hit in any of the sources is sufficient to place the chemical on the list. There does not seem to be a consideration of multiple sources, and there is no consideration of the levels found and whether they are a potential risk. The sources raise some possible concerns. The reliability of the biomonitoring data from a Danish Birth Cohort needs to be ascertained. On drinking water, the department seems to have selected certain published studies without indicating the process for selection. For consumer products, Danish and Dutch surveys were used rather than EPA’s IUR. Additionally, the following journals “Environmental Science and Technology (ES&T)”, “Environmental Health Perspectives (EHP)”, and “Toxicological Sciences” were scanned, and any chemical exposure mentioned in those sources were included. 12
 Sources beyond IUR/Use in Children's Products Creating Listing. Of the 66 chemicals selected for the pilot just 35 were identified in the 2006 IUR as used in US Consumer/Commercial Products; 32 were in CDC's biomonitoring. These overlap so there are a dozen or more on the list from other "questionable" sources. The other factors that drove the rest of the listings include use of EU Endocrine Disruption and OSPAR listings, and some of the alternative (non‐
CDC) biomonitoring and air/water/house dust sources. c. Oregon’s Priority Persistent Pollutant List10 The Oregon approach to toxics was pragmatic in that they limited it to chemicals for which there was an analytical method available. From an initial list of about 400 chemicals (including a lot of pesticides), the Oregon Department of Environmental Quality (DEQ) narrowed it down to 118 chemicals for their SB 737 monitoring program. DEQ used PBT Profiler to screen the list of chemicals. Beyond that, Oregon is considering developing some trigger levels for pollutants on its List “to determine if effluent monitoring results will require development of a pollution reduction plan.” Although this is an essential step in focusing in on priority chemicals at concentrations of concern, there must also be a de minimis 0.1% threshold level in consumer products for intentionally‐added ingredients (and contaminants), to avoid unnecessary regulations for chemicals in consumer product uses that pose little, if any, risk to the consumer. [Such provisions are standard in a variety of chemical and product safety laws. With ever improving analytical capability and ever lower detection limits, vanishingly small and insignificant levels can be identified that are meaningless in regards to protecting children’s health. Europe’s REACH chemical law applies a default 0.1% de minimis level in products, which applies broadly, even to Substances of Very High Concern that become banned. This level is also used in worker and transportation applications in Europe and North America and should be adopted by Minnesota.] 10
http://www.deq.state.or.us/WQ/SB737/
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