Pesticides, Chemical Regulation, and
Right-to-Know Committee Newsletter
Vol. 14, No. 3
FROM THE CHAIR
Martha Marrapese
We had a great monthly call in March. Vice Chair for
Social Media Kirk Tracy, with the Association of Clean
Water Administrators (ACWA), led us through a
webinar on how to connect with ABA SEER on
LinkedIn and how to follow SEER on Twitter. We
want to drive PCRRTK discussion postings toward
LinkedIn and announcements toward Twitter. To
increase our committee’s visibility in SEER, we will not
open a PCRRTK group page on LinkedIn at this time.
We can always add this in the future. You can post
yourself or send your ideas to Kirk at [email protected]. Follow ABA SEER on Twitter
(@ABAEnvLaw) and follow our Social Media vice
chair (@kirktracy). Whoever you follow, whatever you
tweet, use the hashtag #PCRRTK to get information
shared. If you are interested in learning more, please
contact Kirk.
It is not too early to mark your calendars to attend the
SEER Fall Conference in Baltimore on October 9–12,
2013. SEER has a 500-attendee participation goal,
and there are several committee and state-based efforts
under way to maximize participation at the meeting.
PCRRTK is helping to develop a panel called “The
Corporate Supply Chain Goes Global: What You Need
to Know to Counsel Your Multinational Client,” just
one of an excellent series of programs and networking
opportunities at the meeting. We are also partnering
with the University of Baltimore School of Law to hold
a one-day seminar, Science and the Law, the day
before the Fall Conference.Stay tuned for more details.
June 2013
There are many cool things happening through SEER.
How many of us travel and wish we could purchase
carbon offsets to lower our impact on the
environment? Well, now you can. The Section
estimates that an average attendee will generate
approximately one metric ton of carbon emissions
attending one SEER conference. You can help offset
your carbon footprint by adding the cost of a one-ton
carbon credit—only $20—when you register for the
upcoming 21st Fall Conference in Baltimore. The
funds will be applied by our partner Native Energy
toward verifiable emission offset projects.
Another opportunity that may be of interest to you
through SEER is a program the Section and the U.S.
Environmental Protection Agency have designed, the
ABA-EPA Law Office Climate Challenge, to
encourage law offices to take simple, practical steps to
become better environmental and energy stewards. To
learn more about the challenge and enroll, visit the
ABA-EPA Law Office Climate Challenge page.
The SEER Year in Review (YIR) is now up and
online—check it out at http://www.americanbar.org/
groups/environment_energy_resources.html. Thank
you again to PCRRTK Vice Chairs Alicia Edwards,
Gable Gotwals, and Claudia O’Brien for steering the
ship, and all PCRRTK members who contributed to
our expanded presence in YIR this year. In recognition
of the fact that we are all volunteers, congratulations
for a job well done.
Finally, SEER accepted nominations until May 13 for
awards that recognize members and their
organizations. These awards include:
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
1
Pesticides, Chemical Regulation, and
Right-to-Know Committee Newsletter
Vol. 14, No. 3, June 2013
Lynn L. Bergeson, Editor
In this issue:
•
•
•
From the Chair
Martha Marrapese ......................................... 1
EPA’s Endocrine Disruptor Screening Program
Martha Marrapese and Greg Clark ............ 3
California Issues Latest Revisions to Proposed
Safer Consumer Products Regulations
Lawrence E. Culleen and
Shailesh Sahay ................................................ 5
Did You Know? Sometimes Seaweed Is a
Pesticide
Irene Hantman .............................................. 7
Issues in Organic Crop Labeling: Food
Processing Procedures May Decertify
Organic Crops
Chelsea Person .............................................. 9
•
The ABAAward for Distinguished Achievement in Environmental Law and Policy
The Environment, Energy, and Resources
Dedication to Diversity and Justice AwarThe
Environment, Energy, and Resources Government Attorney of the Year Award
The Law Student Environment, Energy, and
Resources Program of the Year Award
The State or Local Bar Environment, Energy,
and Resources Program of the Year Award
Go to www.ambar.org/EnvironAwards for full
nomination details and to see past recipients—or
contact me at [email protected] (202-4344123) to suggest nominations from among our
distinguished PCRRTK members. I will be happy to
work with you to put forward our colleagues for these
awards in recognition of their many accomplishments.
More of you have been contacting me through e-mail.
It is great to hear from you—keep it up. We only get
better if you get involved.
EPA Contemplates Future of Its Audit Policy
Lynn L. Bergeson .......................................... 11
Court of Appeals Issues Landmark Ruling
Vacating Biological Opinion Concerning
Effects of Three Pesticides on Salmon Species
Timothy D. Backstrom ................................. 13
Copyright © 2013. American Bar Association. All
rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, or
transmitted in any form or by any means,
electronic, mechanical, photocopying, recording,
or otherwise, without the prior written permission of
the publisher. Send requests to Manager,
Copyrights and Licensing, at the ABA, by way of
www.americanbar.org/reprint.
Any opinions expressed are those of the
contributors and shall not be construed to
represent the policies of the American Bar
Association or the Section of Environment,
Energy, and Resources.
www.ShopABA.org
2
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
EPA’S ENDOCRINE DISRUPTOR SCREENING
PROGRAM
Martha Marrapese and Greg Clark
The U.S. Environmental Protection Agency’s (EPA)
Endocrine Disruptor Screening Program (EDSP) is a
multiyear effort to meet the agency’s mandates under
the Federal Food, Drug, and Cosmetic Act
(FFDCA) and discretionary authority under the Safe
Drinking Water Act (SDWA) to test certain chemical
substances for endocrine effects. These include
effects on the estrogen, androgen, and thyroid
systems. In November 2012, EPA released a “master
list” of pesticide active and inert ingredients and listed
candidate SDWA drinking water contaminants that
could potentially be subject to endocrine screening.
By EPA’s accounting, the number of substances that
could be subject to screening amounts to approximately 1500 pesticide active ingredients, 5000 inert
ingredients, and 3600 chemicals regulated or having
the potential to be regulated under the SDWA. To
view the Endocrine Disruptor Screening Program
Universe of Chemicals, see http://www.epa.gov/
endo/pubs/edsp_chemical_universe_list_11_12.pdf.
Targeted chemicals in the EDSP are subject to a twotiered screening (Tier 1) and testing (Tier 2) process.
More specifically, Tier 1 screening includes five in
vitro assays and six in vivo assays. Tier 1 screening is
performed using the Office of Chemical Safety and
Pollution Prevention (OCSPP) Harmonized Test
Guidelines Series 890 designed to identify whether a
chemical has the potential to interact with the endocrine system. (OCSPP Harmonized Test Guidelines,
Series 890—Endocrine Disruptor Screening Program
Test Guidelines, available at http://www.epa.gov/
ocspp/pubs/frs/publications/Test_Guidelines/
series890.htm.) Tier 2 testing will be required based
on the results of Tier 1 screening. EPA is still in the
pre-validation stage, however, in the development of
the Tier 2 assays. (More information on the validation
of the Tier 1 and Tier 2 methods is available at http://
www.epa.gov/endo/pubs/assayvalidation/status.htm.)
To date, EPA’s EDSP activities have largely centered
on pesticide active and inert ingredients. The Office
of Pesticide Programs issued orders for Tier 1 screening
for the first group of 67 substances (58 actives and 9
high production volume inert ingredients) by issuing
orders between October 29, 2009, and February 26,
2010, under EPA’s FFDCA section 408(p)(5) authority
(available at http://www.gpo.gov/fdsys/pkg/FR-200910-21/pdf/E9-25352.pdf). Regulated parties were
provided two years to generate and submit the required
data, with some extensions due to laboratory capacity
issues.
The agency’s testing mandate arises from FFDCA
section 408(p). Section 408(p)(1) requires the agency
to “develop a screening program, using appropriate
validated test systems and other scientifically relevant
information, to determine whether certain substances
may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such
other endocrine effect as [EPA] may designate.” Section
408(p)(3) requires that EPA “shall provide for the
testing of all pesticide chemicals,’’ which are defined in
section 201 of the FFDCA as “any substance that is a
pesticide within the meaning of [FIFRA], including all
active and inert ingredients of such pesticide.” To meet
these requirements, section 408(p)(5) provides EPA
with the authority to issue an order to a registrant of a
substance for which testing is required or to a person
who manufactures or imports a substance for which
testing is required. In addition to EPA’s authority under
FFDCA, FIFRA section 3(c)(2)(B) provides that
registrants must submit additional data, upon notification
that EPA has determined that additional data are required to maintain an existing pesticide registration. The
agency has indicated that it views the directives in
FFDCA section 408(p)(1) and (3) as a statutory
determination that endocrine screening of all pesticide
chemicals is necessary to maintain existing pesticide
registrations.
Pre-screening and Prioritization
At the same time EPA released its master list of EDSP
chemicals in November 2012, the agency also published
General Validation Principles for prioritizing the
chemicals to be assessed under the EDSP, building on
the EDSP Comprehensive Management Plan released in June 2012. (U.S. Environmental Protection
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
3
Agency, Endocrine Disruptor Screening Program
Universe of Chemicals and General Validation
Principles, available at http://www.epa.gov/endo/
pubs/edsp_chemical_universe_and_general_
validations_white_paper_11_12.pdf; U.S. Environmental Protection Agency, Endocrine Disruptor
Screening Program Comprehensive Management
Plan, available at http://www.epa.gov/endo/pubs/
EDSP-comprehensive-management-plan.pdf) In
January 2013, EPA brought a revised prioritization
process before a FIFRA Scientific Advisory Panel
(SAP) for peer review (available at http://
www.gpo.gov/fdsys/pkg/FR-2012-11-16/pdf/201227816.pdf). In the near term, EPA intends to use
pesticide registration reviews, physico-chemical
properties, and exposure estimates in concert with a
computational toxicology approach in prioritization.
(U.S. Environmental Protection Agency, Endocrine
Disruptor Screening Program for the 21st Century
(EDSP21 Work Plan): The Incorporation of In
Silico Models and In Vitro High Throughput Assays
in the Endocrine Disruptor Screening Program
(EDSP) for Prioritization and Screening, at 5,
available at http://www.epa.gov/endo/pubs/
edsp21_work_plan_summary%20_overview_final.pdf.)
EPA will use quantitative structure-activity relationships
(QSAR) and high-throughput pre-screening (HTPS) to
prioritize the EDSP universe of chemicals, which may
later replace Tier 1 screening altogether. (EDSP21
Work Plan. See also Transcript of FIFRA SAP
Meeting Jan. 29 to 31, 2013, Docket Document No.
EPA-HQ-OPP-2012-0818-0036.) EPA also plans to
use the Estrogen Receptor Expert System (ERES)
developed by EPA to predict estrogen receptor
binding, which was previously reviewed by the FIFRA
SAP.
Outlook
Despite all the recent activity concerning the EDSP, the
near-term outlook for industry remains uncertain. Of
the 67 chemicals included in the first Tier 1 test order,
15 are no longer in the pesticide market due to the
significant cost of compliance. (Transcript of FIFRA
SAP Meeting Jan. 29 to 31, 2013, supra at 27.)
As noted, EPA has authority under the SDWA to issue
EDSP test orders to manufacturers and importers of
4
any substance that may be found in sources of drinking
water if EPA determines that a substantial population
may be exposed to that substance. In November
2010, EPA identified a second group of 134 chemicals
for screening, including additional pesticide active
ingredients as well as drinking water contaminants. This
list is available at http://www.epa.gov/endo/pubs/
prioritysetting/draftlist2.htm. The agency has not issued
test orders for the second group of EDSP chemicals.
Because the second testing group of EDSP chemicals
includes non-pesticide chemicals, EPA will utilize its
SDWA section 1457 authority in conjunction with its
FFDCA and FIFRA authority to issue test orders for
this group, and clarified with that announcement that a
parallel procedure would be followed for collecting test
data for non-pesticide substances (available at http://
www.gpo.gov/fdsys/pkg/FR-2010-11-17/pdf/201028812.pdf). EPA also has stated that if all manufacturers and importers of a chemical opt out of the pesticide
market, the agency will use its SDWA authority to issue
test orders if it believes data are still necessary.
When the test orders are issued, responding to the test
orders will be the responsibility of all manufacturers
and importers of the industrial chemicals that EPA has
determined may be found in sources of drinking water
or that degrade to chemical substances found in
sources of drinking water. Companies will either have
to agree to test or request an exemption from testing.
EPA will likely identify potentially affected manufacturers and importers using information submitted under
the Chemical Data Reporting Rule and the agency
plans proactively to contact these companies.
Upcoming FIFRA SAP meetings on May 21–24 and
July 30–August 2 of this year will assess whether the
Tier 1 battery is working as intended and establish how
EPA will conduct its weight-of-evidence evaluation of
Tier 1 results, respectively, available at http://
www.gpo.gov/fdsys/pkg/FR-2013-02-22/pdf/201303977.pdf and available at http://www.gpo.gov/
fdsys/pkg/FR-2013-04-17/pdf/2013-08921.pdf.
These meetings will provide stakeholders with further
insight into EPA’s near-term plans, as well as an
opportunity to provide input on the EDSP. The May
meeting should indicate whether EPA intends to modify
the Tier 1 battery prior to the issuance of test orders
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
for the second group of EDSP chemicals. Of greater
interest, the July meeting will address how EPA will use
the Tier 1 results to determine which chemicals will be
subject to Tier 2 testing.
The EDSP is a program gaining momentum. In the
coming months, stakeholders will have a better sense
for how the multiple policies and procedures released
in the past four years will impact affected parties in
practice.
Martha Marrapese is a partner with Keller and
Heckman LLP in Washington, D.C. Gregory Clark is
an associate with Keller and Heckman LLP in
Washington, D.C.
CALENDAR OF SECTION EVENTS
AMERICAN BAR ASSOCIATION
SECTION OF ENVIRONMENT,
ENERGY, AND RESOURCES
June 18, 2013
The Expanding Intersection Between
FERC and EPA
Webinar
CALIFORNIA ISSUES LATEST REVISIONS TO
PROPOSED SAFER CONSUMER PRODUCTS
REGULATIONS
Lawrence E. Culleen and Shailesh R. Sahay
On April 10, 2013, the California Department of Toxic
Substances Control (DTSC) published its latest (and
reportedly last) revised proposed “Safer Consumer
Products” regulations, also referred to as “Green
Chemistry” regulations. The proposed regulations are
available on the DTSC Web site at http://www.
dtsc.ca.gov/SCPRegulations.cfm. The proposed
regulations, if issued in final form, would create a
system through which DTSC identifies “Priority
Products” containing “Chemicals of Concern.”
Manufacturers, importers, or retailers of priority
products would then be required to conduct
alternatives analyses (AA) evaluating potential product
or chemical substitutes for the priority productchemical of concern combination. The following
summarizes major elements of the proposed
rulemaking.
March 20-22, 2014
43rd Spring Conference
Salt Lake City, UT
Applicability: The proposed regulatory requirements
potentially apply to manufacturers, importers, and
retailers of consumer products. The reach of the
potential requirements is broader than it may first
appear. While the proposed DTSC regulations on their
face apply to “consumer products,” DTSC’s sweeping
definition of “consumer products” applies to nearly all
products, not just those typically associated with
consumer use. The definition for “consumer product”
incorporated into the proposed safer consumer
products regulations is “a product . . . used, brought
[sic], or leased for use by a person for any purposes.”
Cal. Health & Safety Code § 25251(e) (emphasis
added). “Person” is defined to include not only
individuals but also corporations and other business
organizations. Cal. Health & Safety Code § 25118.
Thus, the definition of “consumer product” appears to
encompass potentially every product used in California
by any individual or business.
For full details, please visit
www.ambar.org/EnvironCalendar
www.ambar.org/EnvironSocialMedia
Despite their broad reach, the regulations contain at
least one important exemption. Specifically, the
proposed regulations exclude any product whose
August 8-13, 2013
ABA Annual Meeting
San Francisco, CA
October 9-12, 2013
21st Fall Conference
Hilton Baltimore
Baltimore, MD
February 5-11, 2014
ABA Midyear Meeting
Chicago, IL
Pesticides, Chemical Regulation, and Right-to-Know Committee, February 2013
5
manufacture ceased prior to the date the product is
listed as a priority product. Proposed Regulations (PR)
§ 69501.1(a)(24)(B). Thus, a potentially regulated
entity has the ability to avoid the requirements by
ceasing manufacture before a final listing.
Further, only retailers that sell directly to consumers
appear to be included in the regulatory scheme.
“Retailer” is defined by the proposed regulations as “a
person to whom a consumer product is delivered or
sold for purposes of sale or distribution by the person
to a consumer.” PR § 69501.1(a)(55) (emphasis
added). According to the revised Initial Statement of
Reasons (ISOR) that accompanies the proposed
regulations, the definition of retailer “does not include
wholesalers or suppliers that normally sell their
products to another business.” ISOR at 39.
Candidate Chemicals List: The green chemistry
regulations would establish an initial list of
approximately 1200 candidate chemicals. See PR §
69501.1(a)(19). To determine which chemicals are
placed on the initial candidate chemicals list, DTSC
proposes to automatically include chemicals present on
lists already established by other governmental entities,
for example, the list of persistent, bioaccumulative
toxins published by the Washington State Department
of Ecology. The proposal only allows entities to
challenge the inclusion of a chemical on the initial
candidate chemical list if all of the lists relied on by
DTSC no longer include the chemical.
DTSC has not yet published a draft version of the
candidate chemical list for public review, and has not
indicated that it will do so. Under the proposed
scheme, the candidate chemical list would be posted
within 30 days after the safer consumer products
regulations become effective. PR § 69502.3(a).
Priority Products List: Under the proposed
regulations, DTSC would publish a proposed priority
product list consisting of no more than five priority
products within 180 days of the effective date of the
regulations. PR § 69503.6(c). The list would also
identify one or more candidate chemicals that form the
basis for each priority product listing. A candidate
chemical that forms the basis for a priority product
6
listing is called a “chemical of concern.” PR §
69503.5(b)(2)(B). The regulations establish criteria for
the selection of priority products, including factors such
as potential health and environmental impacts and
exposure potential. PR §§ 69503.2, 69503.3. After
designation, responsible entities—i.e., manufacturers,
importers, or retailers—would have to notify DTSC
that their product is listed as a priority product.
Alternatives Analyses (AA): An AA must be
conducted for priority products by manufacturers,
importers, or retailers. See PR §§ 69505.5, 69505.5.
AAs must determine how best to limit exposures to or
otherwise mitigate adverse health and environmental
impacts posed by a priority product. The AA process
includes the identification of alternatives to the priority
product that meet its functional requirements while
eliminating or reducing the chemicals of concern in the
priority product or reducing or eliminating exposure to
the chemicals of concern. Thus, reductions in chemicalof-concern exposure could be achieved through
substitution of the chemical of concern in a priority
product or replacing the priority product itself. DTSC
may establish threshold concentrations of chemicals of
concern in a product below which AAs are not
required. PR § 69505.3. As an alternative to
completing an AA, an entity could remove a chemical
of concern from a product without replacing it or
remove the priority product from the market entirely.
PR § 69505.2.
Regulatory Responses: On the basis of its
evaluation of the AA, DTSC could issue regulations
limiting or prohibiting a priority product or its contents,
an action the proposed regulations refer to as a
“regulatory response.” PR art. 6. The response could
apply to the priority product in question, or to the
chemical or product replacing the chemical of concern
or priority product. Regulatory responses must
maximize use of alternatives of least concern, where
such alternatives are technically and economically
feasible. DTSC would give preference to regulatory
responses providing the greatest level of protection.
Potential regulatory responses include use restrictions
on a priority product, product sales prohibitions,
engineering or administrative controls, and mandated
research on additional green alternatives. DTSC is also
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
authorized to levy penalties for noncompliance with the
requirement to notify DTSC of the manufacture,
import, or retail sale of a priority product, deficiencies
in an AA, or failure to comply with the regulatory
response issued after the AA is completed.
Although the number of products initially governed by
the safer consumer products proposed regulation is
small (five or fewer in the initial listing), the breadth of
the scheme remains wide because of the inclusive
definition of consumer products and the list of as many
as 1200 candidate chemicals. Because of this large
scope, many California manufacturers, importers, and
retailers will have to track carefully the development of
the regulations to assess whether their products will be
listed. As is often the case, California again has with
this proposal positioned itself on the leading edge of
stringent chemical regulation.
Lawrence E. Culleen and Shailesh Sahay are
members of the environmental practice group in
the Washington, D.C., offices of Arnold & Porter
LLP (A&P).
Call for
Nominations
ABA Section of Environment,
Energy, and Resources
2013 ABA Award for Excellence in
Environmental, Energy, and Resources
Stewardship
The ABA Award for Excellence in Environmental,
Energy, and Resources Stewardship recognizes and
honors the accomplishments of a person, organization, or
group that has distinguished itself in environmental,
energy, and resources stewardship. Nominees must be
people, entities, or organizations that have made
significant accomplishments or demonstrated recognized
leadership in the areas of sustainable development,
energy, environmental, or resources stewardship.
Nomination deadline: June 17, 2013
This award will be presented at the 21st Fall Conference
in Baltimore in October 2013.
www.ambar.org/EnvironAwards
DID YOU KNOW? SOMETIMES SEAWEED IS A
PESTICIDE
Irene Hantman
A little known fact is seaweed is found in many agricultural products. Some are formally registered as pesticides, but most are marketed as fertilizers. Many of
these “fertilizer” products, however, are subject to
requirements under the federal pesticide statute, the
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). These products fall within FIFRA’s jurisdiction because they claim to produce an enhanced
physiological effect or because of their particular
composition and thus qualify as pesticides. Such
products are classified as “plant regulators” under
FIFRA.
Although not intuitively thought to be insecticides,
fungicides, or herbicides that are intended to kill or
repel pests, plant regulators are nonetheless considered
pesticides under FIFRA. FIFRA defines “plant regulator” as a “substance or mixture of substances intended,
through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for
otherwise altering the behavior of plants or the produce[.]” The U.S. Environmental Protection Agency
(EPA) also considers plant growth regulators (PGR),
plant hormones, biostimulants, and products that claim
PGR-related physiological effects to be plant regulators. Many manufacturers think it peculiar that plant
regulators are pesticides. Plant regulators are regulated
differently in Canada and the European Union. When
Congress included plant regulators in the 1959 FIFRA
amendments, it did so to address residue concerns.
Because of the lack of clarity on this issue, it is unclear
whether seaweed agricultural product producers fully
understand their FIFRA compliance obligations with
respect to plant regulators. According to publicly
available documents, it appears that only three companies have registered their products with EPA under
FIFRA. Yet EPA would probably consider dozens of
seaweed products to be plant regulators. Some of
these products claim to be biostimulants and to contain
plant hormones. Other entities explicitly describe tier
products as PGRs. Companies selling or distributing
seaweed-based agricultural products may wish to
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
7
review their product claims and EPA’s regulations and
guidance. To determine whether a product is a pesticide, a company should consider whether there is
evidence of pesticidal intent. EPA uses three criteria to
establish intent: (1) claims, (2) composition, and (3)
knowledge. Both claiming a plant regulator effect and
plant regulator composition are especially relevant to
the current marketplace.
Product Claims and Composition
Physiological effects: When determining whether a
product is a pesticide, EPA evaluates claims about the
product’s purpose or effect, as well as its composition.
Many seaweed products claim enhanced physiological
effects; for example, use will accelerate or retard
growth and maturation or otherwise alter plant behavior. EPA considers the following within the scope of
“pesticide” (i.e., plant regulator) claims: the ability to
control and regulate germination, root development,
nutrition uptake, flowering, and blossom set; the ability
to stimulate growth and development; the ability to
thicken, enlarge, and balance leaf growth; the ability to
stimulate cell division; and the ability to increase fruit
set. Consequently, simply describing a plant regulator
effect (e.g., ability to stimulate growth and development beyond what would be expected from simple
nutrition) on the product label could trigger agency
scrutiny.
Composition: Often these products also identify
active ingredients that EPA considers having “no other
uses except as plant growth regulators” (e.g., auxins,
cytokinins, gibberellins). EPA states in its regulations
that a substance that consists of or contains one or
more active ingredients and has no significant commercially valuable use as distributed or sold other than for
a pesticidal purpose (including plant regulator purposes) is a pesticide. The lack of other uses has
resulted in EPA making very broad statements in its
Label Review Manual, such as “[t]therefore, the
presence of any of those compounds generally causes
a product to be considered a plant growth regulator.”
By identifying the ingredient, the manufacturer has
potentially made a pesticidal claim. Because the
language in the Label Review Manual is so broad, it
prompts concern that some products merely containing
these compounds may be at risk, regardless of whether
the ingredients are listed on the product label.
8
Identifying product ingredients alone can trigger FIFRA
jurisdiction. Seaweed product labels often list auxins,
cytokinins, and gibberellins. As noted above, EPA has
found that these active ingredients have few, if any,
commercially viable purpose other than as plant
regulators. Therefore, referencing the presence of
those compounds will generally cause these products
to be considered plant growth regulators. Again,
merely listing these ingredients creates the risk of
enforcement action irrespective of whether the label
makes plant regulator physiological effect claims. The
legal rationale that EPA would rely upon is that the
listing of the ingredients is an “implied” pesticidal claim.
Jurisdiction
A small number of products with similar physiological
effects or that have similar compositions are eligible for
exclusion from the definition of pesticide.
Nutrient mixtures: Many of the physiological effects
produced by PGRs can also be produced by macroand micronutrients. For example, many traditional
fertilizers contain nutrients “essential for photosynthesis,
seedling development, and root formation and growth.”
Macronutrients are nitrogen, phosphorus, and potassium; micronutrients include metals such as copper,
iron, magnesium, manganese, molybdenum, and zinc.
Nutrients are excluded from the definition of plant
regulator. Only when these active ingredients, and only
these active ingredients, are the basis for the physiological claims, is a product clearly outside FIFRA
jurisdiction, however. An extensive body of plant
nutrition research supports such claims. And seaweed
does contain some macro- and micronutrients.
Anecdotal evidence suggests that part of the confusion
in the marketplace stems from the exclusion of plant
nutrients and “nutritional chemicals” from the definition
of plant regulator. Plant hormones and “biostimulants,”
however, are not nutritional chemicals. It is necessary
to go beyond the statutory language to understand the
definition of “plant nutrient.” 40 C.F.R. § 152.6(g)(1)
explains that only nutritional products comprised of
macro- and micronutrients are not plant regulators.
Vitamin hormones: The statute and regulations
exempt “vitamin-hormone [PGR] product[s]” for
horticultural use. Horticultural use means home garden-
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
ing and other non-agricultural production activities.
The regulation also requires that these products be
“intended for improvement, maintenance, survival,
health, and propagation of plants, and are not for pest
destruction and are nontoxic, nonpoisonous in the
undiluted package concentration.”
Recent Enforcement Activity
Manufacturers of seaweed-based agricultural products
face increased risk of enforcement for manufacturing,
distributing, and selling unregistered pesticide products.
EPA can pursue civil enforcement regardless of
whether manufacturers, distributors, and retailers
intentionally intended to sell pesticide products. EPA
considers plant regulator claims to be adequate evidence of intent, and FIFRA is a strict liability statute.
Several recent enforcement actions have targeted
agricultural seaweed products. A Region 7 press
release highlighted enforcement actions against three
Missouri pesticide distributors for the sale of seaweedbased plant growth regulators. The press release
stressed that PGRs are regulated as pesticides under
FIFRA. Notably, the consent agreement in one of the
cases, In Re AgXplore Int’l, LLC, Docket No.
FIFRA-07-2012-0029, describes six seaweed PGRs.
One product advertised that its ingredients promote
natural growth and fruiting processes and stimulate root
growth and development. Another product was
intended to promote fruit size and retention and provide earlier maturity. For these violations, AgXplore,
the distributor, was fined more than $230,000.
Conclusion
Seaweed can be registered as a fertilizer product with
state agriculture departments. As currently packaged,
some agricultural seaweed products may be at risk of
FIFRA enforcement. Manufacturers should review
product labels and marketing materials to assess
whether claims fall within FIFRA jurisdiction.
Irene Hantman is independent counsel at Verdant
Law.
ISSUES IN ORGANIC CROP LABELING: FOOD
PROCESSING PROCEDURES MAY DECERTIFY
ORGANIC CROPS
Chelsea Person
Organic crop production permits the use of few
disinfectant or pesticide products. Importantly, however, disinfection is a key part of crop production. For
example, disinfection significantly reduces food-borne
pathogens. Decisions about pesticide labeling, which is
the sole province of the U.S. Environmental Protection
Agency (EPA) Office of Pesticide Programs, are made
independent of organic standards.
New pesticide labeling requirements complicate the
use of many crop production disinfectants. A proposed
Agricultural Marketing Service (AMS) rule may
resolve the conflict between limitations on the use of
peracetic acid on “organic foods” and EPA’s implementing regulations governing products that contain this
ingredient.
Peracetic acid is contained in many crop production
disinfectants. Peracetic acid has not been identified as
an active ingredient in most of these products. The use
of peracetic acid in organic crop production is presently limited to fire blight control. Use for plant disease
and other pathogen control may be deemed as a
violation of U.S. Department of Agriculture (USDA)
organic standards. EPA regulations currently deem
peracetic a pesticide active ingredient thus triggering
the need for manufacturers to disclose the presence of
peracetic acid as an active ingredient in the product. As
a result, use of products critical to the prevention of
biofilm and food-borne pathogens will negate otherwise organic crop production. The proposed rule will
allow up to 5 percent concentration of peracetic acid in
these products.
The National Organic Standards Board (NOSB)
allows additions to the National List of Allowed and
Prohibited Substances (National List) only after any
individual or organization submits a petition to amend
the National List. Peracetic acid was added to the
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
9
National List in 2003 for disinfecting equipment, seed,
and plant material, and for the use of fire blight control.
In 2008, a petition to expand the use of peracetic acid
in organic production was submitted to AMS. The
petition responded to new EPA labeling requirements
for pesticides. The regulation requires labeling these
products with both hydrogen peroxide and peracetic
acid as active ingredients. Previously, these products
listed hydrogen peroxide as the sole active ingredient.
Under USDA organic regulations, hydrogen peroxide
is permitted for plant disease control in organic crop
production. Use of peracetic acid to control plant
disease is limited to fire blight control under the USDA
regulations. Peracetic acid has been reported to impact
adversely soil and crop environment under certain
conditions.
Fortunately for organic producers, AMS is acting to
address this gap. At a public meeting in 2009, the
NOSB reviewed the petition and issued a recommendation to allow greater use of peracetic acid. The
NOSB expressed interest in continuing the availability
of hydrogen peroxide products that would now be
required to identify peracetic acid as an active ingredient. The NOSB’s amendment would allow up to 5
percent concentration of peracetic acid in hydrogen
peroxide products. The 5 percent allowance would
resolve the regulatory conflict. AMS is now proposing
to implement the 2009 NOSB recommendation.
The rules governing the use of pesticide products in
organic production are complex. All ingredients, both
active and inert in pesticide products, and all uses of
those products must meet National Organic Program
(NOP) criteria for organic crop production. The
Organic Foods Production Act of 1990 requires the
secretary of agriculture to create a National List. The
National List identifies substances that may be used in
organic crop and livestock production. Generally, nonsynthetic substances are allowed, and synthetic substances are prohibited unless specifically allowed.
The National List adds, removes, and changes pesticides through a petition process. Once received,
petitions are reviewed by the NOSB based on criteria
in the Organic Foods Production Act, and makes
10
formal recommendations to USDA. These recommendations allow USDA to undertake rulemaking action to
amend. A NOSB subcommittee reviews every petition,
and then publishes a proposal with a request for public
comment. The NOSB then analyzes the comments,
votes on the petition, and makes a final recommendation to the NOP. USDA may not add a substance to
the National List without the NOSB’s recommendation, but it can reject its recommendation.
The current restrictions on peracetic acid seem contrary to the regulatory status of its chemical composition. Peracetic acid is not “manufactured.” It is formed
in situ, as a reaction between hydrogen peroxide and
acetic acid during production of the end-use product.
And acetic acid or vinegar is approved for organic
crop production. Peracetic acid breaks down to acetic
acid, oxygen, and water, which are generally recognized as safe (GRAS) by the U.S. Food and Drug
Administration for use in food production. This designation exempts these substances from usual Federal
Food, Drug, and Cosmetic Act food additive tolerance
requirements. GRAS is not necessarily organic, however.
Under USDA organic regulations, hydrogen peroxide
is also permitted for plant disease control in organic
crop production. Even synthetic acetic acid is approved for limited use in the NOP. The NOSB’s
recommendation to continue the use of hydrogen
peroxide pesticides and sanitizers would characterize
the small amount of peracetic acid in these products as
“formally allowed as inert.” Again, EPA does not
consider it inert.
Chemical sanitizers, like peracetic acid, are a critical
component of food production sanitation programs.
Automatic wash systems such as flumes are often used
to remove dirt and transport fruit and vegetables
around the processing plant. Flumes can cause a
number of bacteriological problems by spreading of
contamination, and allow biofilm formation. Sanitizers
like peracetic acid are used for microbial control during
these processes.
Additionally, peracetic acid is a component of many
biopesticides, which are important for managing
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
diseases in organic crops. Biopesticides target pests
such as bacterial cells, endospores, yeast, and mold
spores. Biopesticides usually are less toxic than conventional pesticides and break down to benign substances in the environment. Producers can use the
products according to label directions without concern
about accretion of toxins in the soil. They also typically
decompose quickly and can be effective in very small
quantities. Lower application rates mean lower exposure, and potential pollution problems may be avoided.
EPA encourages the development and use of
biopesticides because they generally pose fewer risks
than conventional pesticides.
Another indicator of their relative safety is that EPA
generally requires less data to register biopesticides
than conventional pesticides. This results in faster EPA
registration, often less than a year to 18 months,
compared to longer times for conventional pesticides.
Many biopesticides are defined as minimum risk
pesticides by FIFRA because their active and inert
ingredients are “demonstrably safe for the intended
use.” That is, these minimum risk pesticides are exempt
from the regulatory requirements of FIFRA because
they meet the requirements set forth in 40 C.F.R. §
152.25(f). Additionally, most minimum risk pesticides
can be used on organic crops because they meet the
NOP “natural” criteria. The Organic Foods Production
Act allows the use of “natural substances” in organic
production unless a substance is specifically prohibited
at 7 C.F.R. § 205.602.
Without the proposed rule, producers would be limited
in the use of biopesticides and sanitizers. Limiting these
products makes compliance with the NOP difficult,
increases costs to manufacturers through fees and
research related to registration, and increases pesticide
registration time. It may also increase the presence of
pathogens in food.
USDA accepted comments through March 7, 2013.
EPA expects to issue a final rule later this year.
Chelsea Person is a rising 3L at the University of
Maryland School of Law.
EPA CONTEMPLATES FUTURE OF ITS AUDIT
POLICY
Lynn L. Bergeson
In its April 30, 2012, publication, FY 2013 Office of
Enforcement and Compliance Assurance (OECA)
National Program Manager (NPM) Guidance,
OECA discusses its enforcement objectives and
program priorities for fiscal year (FY) 2013. In discussing notable changes for FY 2013 from FY 2012,
OECA lists budget challenges and states that it must
cut resources in certain areas: “Anticipating tight
budgets in FY 2013 and beyond, EPA’s enforcement
program needs to focus its limited resources on the
most pressing environmental and noncompliance
problems.” Among budget areas requiring reduction,
the U.S. Environmental Protection Agency (EPA) lists
the Audit Policy/Self-Disclosures program and states
the following:
Audit Policy/Self-Disclosures: Since
implementation of the Audit Policy began in
1995, EPA’s enforcement program has
increased its understanding of environmental
compliance auditing, and believes that
internal reviews of compliance have become more widely adopted by the regulated community, as part of good management. In addition, EPA has found that most
violations disclosed under the Policy are not
in the highest priority enforcement areas for
protecting human health and the environment. EPA believes it can reduce investment
in the program to a limited national presence without undermining the incentives for
regulated entities to do internal compliance
reviews to find and correct violations. As
we reduce investment in this program, EPA
is considering several options, including a
modified Audit Policy program that is selfimplementing.
The vagueness of these statements has given the
regulated industry pause and raised concerns that EPA
might be considering repeal of its Audit Policy. Re-
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
11
cently, the Corporate Environmental Enforcement
Council (CEEC) submitted to OECA a robust set of
comments, stating: “CEEC understands that the agency
is seriously considering eliminating the Audit Policy,
based on a desire to conserve and better deploy its
limited enforcement resources.” In its comments, the
CEEC sets forth compelling arguments why such an
effort would be misdirected and instead suggests
changes to the Audit Policy intended to increase its
efficiency while reducing the demand on EPA resources.
During an April 16, 2013, Environmental Law Institute
webinar, Andrew Stewart, the acting division director,
Special Litigation & Projects Division, OECA, confirmed that the current Audit Policy remains in effect.
Stewart further stated that OECA is assessing how to
update the Audit Policy, such that the types of disclosures are better aligned with EPA’s enforcement
priorities, thereby producing higher yielding and more
targeted results. While noncompliance that has resulted
in serious harm to the environment or imminent and
substantial endangerment is ineligible for penalty
mitigation under the Audit Policy, Stewart stated that
EPA believes many “serious violations” would remain
eligible.
Discussion
Many in industry believe EPA’s Audit Policy has been a
successful tool in encouraging prompt disclosure and
correction of noncompliance, with benefits including
reduced or no gravity-based penalties for qualifying
disclosures. The rewards associated with application of
the Audit Policy have exceeded the potential burden
the policy imposes on EPA. Thus, the rumblings that
have been expressed over the past six months or so
that EPA may be revisiting or eliminating the Audit
Policy have inspired concern and a good deal of
anxiety within the regulated community.
EPA does not appear at this time inclined to scuttle the
policy as much as recalibrate it to ensure it better aligns
with EPA’s enforcement priorities. Based on Stewart’s
remarks, it appears EPA’s intent is to modify the policy
to encourage more “focused” disclosures. It appears
that EPA wishes for disclosure of more “serious
12
violations” that are aligned with EPA’s enforcement
priorities, as well as disclosures that EPA could leverage into cross-industry corrective programs.
One recent related EPA effort is a pilot program for
electronic Audit Policy self-disclosure through EPA’s
central data exchange (CDX) system, which seeks to
diminish EPA’s resources for managing disclosures.
(More information about EPAAudit Policy electronic
self-disclosure is available at http://www.epa.gov/
oecaerth/incentives/auditing/edisclosure.html.) How
EPA would modify the Audit Policy to focus disclosures on noncompliance aligned with EPA’s enforcement priorities and according to what timetable remains
unclear. Interested parties should monitor these developments carefully, consider how they affect internal
compliance management practices, and seek to engage
EPA to ensure the Audit Policy remains a useful and
effective tool to industry’s compliance efforts and
EPA’s response to them.
Lynn L. Bergeson is managing partner of Bergeson
& Campbell, P.C. (B&C®), a Washington, D.C., law
firm focusing on conventional, nanoscale, and
bio-based industrial, agricultural, and specialty
chemical product regulation and approval
matters, environmental health and safety law,
chemical product litigation, and associated
business counseling and litigation issues. She is
president of The Acta Group, L.L.C., and
managing director of The Acta Group EU, Ltd, with
offices in Washington, D.C., and Manchester, UK,
and president of B&C® Consortia Management,
L.L.C. (BCCM) with offices in Washington, D.C.
Environment,
Energy, and Resources Law
The Year in
Review 2012
Year in Review Becomes
an All-Electronic Publication
The Year in Review 2012 is the first all-electronic
edition of the Section’s annual of significant
developments. The 2012 edition is now available
online.
www.ambar.org/EnvironYIR
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
COURT OF APPEALS ISSUES LANDMARK
RULING VACATING BIOLOGICAL OPINION
CONCERNING EFFECTS OF THREE PESTICIDES
ON SALMON SPECIES
Timothy D. Backstrom
On February 21, 2013, a three-judge panel of the
Fourth Circuit Court of Appeals issued a unanimous
landmark decision in Dow Agrosciences v. National
Marine Fisheries Service, setting aside a biological
opinion (BiOp) prepared by the National Marine
Fisheries Service (NMFS) that found that use of the
pesticides chlorpyrifos, diazinon, and malathion could
jeopardize the viability of certain species of salmon and
their habitat. The decision will have significant
implications for the government and registrants alike.
The court determined that the BiOp was arbitrary and
capricious because the NMFS failed to provide an
adequate explanation concerning three critical choices:
•
Use of a model that assumed salmon are
continuously exposed for 96 hours, without
explaining how this assumption correlates with
exposure conditions in the real world;
•
Use of older monitoring data for the three
pesticides that do not reflect the effect of
mitigation measures that were implemented
during reregistration; and
•
Inclusion in recommendations for additional
mitigation of uniform buffer zones for all types
of water, without regard to actual proximity to
key salmon habitat or adequate consideration
of the economic consequences.
This new decision will have far-reaching consequences
because of the large number of pesticides that may be
subject to referral to either NMFS or the Fish and
Wildlife Service (the Services) in connection with
previous actions by the U.S. Environmental Protection
Agency (EPA) during pesticide reregistration or future
actions by EPA during registration review. When EPA
takes such a registration action, Endangered Species
Act (ESA) section 7(a)(2) requires EPA to determine,
in consultation with the Services, that the action is not
likely to jeopardize the continued existence of any
endangered or threatened species. Current procedures
require EPA scientists to make an initial threshold
determination whether or not continued registration
“might” have such an effect, followed by referral to the
Services for a formal consultation in instances where
this threshold is met.
The new decision is an outgrowth of litigation
concerning the effect of pesticides on endangered or
threatened species that stretches back to 2001. In
Washington Toxics Coalition v. EPA, a district court
in Washington and the Ninth Circuit Court of Appeals
ordered EPA to determine whether it should have
consulted with NMFS concerning reregistration of 55
specific pesticides. EPA subsequently decided that 37
of these pesticides (including chlorpyrifos, diazinon,
and malathion) might affect the viability of specific
salmon species and initiated a formal consultation for
these 37 with NMFS.
The consultation process at the Services is
overburdened, so NMFS did not act promptly. This
delay resulted in another lawsuit, followed by a
settlement requiring NMFS to issue the delayed BiOp.
Following issuance of a draft BiOp and an opportunity
for comment, a final BiOp was issued on November
18, 2008. The manufacturers of the three affected
pesticides then brought the current case challenging the
BiOp in district court in Maryland.
The district court originally agreed with NMFS that the
BiOp would only be subject to judicial review in the
context of subsequent reregistration actions by EPA,
but the Fourth Circuit Court of Appeals reversed the
district court and held that the BiOp was indeed final
action subject to review under the Administrative
Procedure Act. The district court then issued a
decision on October 31, 2011, in which it granted
summary judgment to NMFS and affirmed EPA’s
obligation to review its reregistration decision for the
three pesticides in light of the BiOp.
The new decision by the court of appeals reverses the
district court once again. A key part of the new
decision discusses the principle that review of agency
Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013
13
action must be based on a contemporaneous rationale,
and that post hoc rationalizations are not permitted.
NMFS submitted a supplementary affidavit and
provided additional explanation of the rationale for the
BiOp in its brief, but the court of appeals states that it
was an error for the district court to consider this
information. Because the BiOp was 482 pages in
length, the court observed that “it can hardly be argued
that the administrative record was so lacking in
explanations as to necessitate reliance on a litigation
affidavit in conducting judicial review.”
In discussing the three specific issues where the
explanation provided in the BiOp was deficient, the
court notes that EPA itself criticized the 96-hour
exposure assumption as well as the reliance on old
monitoring data. The court also notes that the district
court itself “recognized that the BiOp was infirm in two
critical respects,” due to inadequate explanation in the
BiOp of the 96-hour exposure assumption and the
recommendation for uniform buffers as mitigation.
Based on the three specific deficiencies in the BiOp,
the district court is directed to remand the BiOp to
NMFS for further analysis and revision.
Discussion
This decision will likely cause the Services to
reevaluate the adequacy of scientific methodologies
they use in preparing BiOps, and will almost certainly
change the level of explanation for key analytical
assumptions that is considered to be sufficient. In turn,
these changes can be expected to exacerbate a
queuing problem with the ESA consultations for
pesticides that EPA has already initiated or committed
to consider initiating. Claims by the plaintiffs in Center
for Biological Diversity v. EPA in the district court in
California (also referred to as the “Mega-ESA” case)
that EPA improperly failed to consult concerning
hundreds of pesticides would further overburden the
Services, although EPA and industry groups have
argued that these claims are both untimely and
improperly pleaded.
This new decision can also be expected to lead to
further discussion of potential revisions to the existing
14
process for commencing and completing consultation
under the ESA, which many argue will become
increasingly dysfunctional without some sort of
legislative revision or reform. This decision could
provide some renewed impetus to proposals for
statutory changes, since the decision by itself does not
remove the requirement for compliance with the
current ESA. In addition, the anticipated release within
weeks of the National Academy of Sciences’ report on
the ESA assessment process for pesticides will further
impact any debate about whether the law or current
procedures should be changed. In the meantime,
discussion within the affected agencies may focus not
only on revisions to the procedures the Services use to
prepare BiOps, but also on the preliminary screening
methodologies that cause EPA to initiate so many
consultations in the first place.
Timothy D. Backstrom is of counsel at Bergeson &
Campbell, P.C. (B&C®), a Washington, D.C., law
firm focusing on conventional, nanoscale, and
bio-based industrial, agricultural, and specialty
chemical product regulation and approval
matters, environmental health and safety law,
chemical product litigation, and associated
business counseling and litigation issues. Tim’s
practice includes ESA and FIFRA.
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Pesticides, Chemical Regulation, and Right-to-Know Committee, June 2013