LEGAL RULEMAKING PETITION TO THE
UNITED STATES ENVIRONMENTAL PROTECTION AGENCYAMERICAN BIRD CONSERVANCY;BEYOND PESTICIDES;MASSACHUSETTS POLLINATORNETWORK; MAINE ORGANICFARMERS AND GARDENERS
ASSOCIATION; NORWALK RIVER
WATERSHED ASSOCIATION;PESTICIDE ACTION NETWORKNORTH AMERICA; NORTHEASTORGANIC FARMING
ASSOCIATION; NORTHEASTORGANIC FARMING
ASSOCIATION OF VERMONT;NORTHWEST CENTER FOR
ALTERNATIVES TO PESTICIDES;RURAL VERMONT; TOXIC FREE
NC;; and TOM NELTNER
including and represented by
CENTER FOR FOOD SAFETY
600 California Street, Suite 12-013
San Francisco, CA 94108;
Petitioners,
Filed With:MICHAEL REGAN,
ADMINISTRATOR
Environmental Protection Agency
Office of the Administrator, Mail Code:
1101A
1200 Pennsylvania Ave., NW
Washington, D.C. 20004

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Docket Number _________TABLE OF CONTENTSINTRODUCTION AND SUMMARY ............................................................................ 1
PETITION REQUESTS ................................................................................................ 4
PETITIONERS ............................................................................................................ 11
LEGAL BACKGROUND ............................................................................................. 17
FACTUAL BACKGROUND ........................................................................................ 23
I.

Characteristics of PFAS ......................................................................... 23

II.

PFAS in Pesticide Products. .................................................................. 29

III.

EPA’s Shifting PFAS Definition. ........................................................... 35

IV.

EPA’s Efforts to Address PFAS Generally. ........................................... 38

ARGUMENT ................................................................................................................ 45I.

EPA Must Cancel All Active and Inert PFAS Ingredients
Currently Registered. ............................................................................. 47
A.

EPA Admits Numerous Active Ingredients Qualify as PFAS. .. 48

B.

EPA Has Admitted Several Inert Ingredients Qualify
as PFAS. ....................................................................................... 50

C.

EPA Must Cancel Active and Inert Ingredients in the PFASClass Due to Unreasonable Risks to Human Health and theEnvironment in Violation of FIFRA. .......................................... 51

D.

Immediate Suspension of PFAS Ingredient Registrations
Pending Cancellation Is Necessary to Prevent an Imminent
Hazard. ......................................................................................... 56

E.

1.

Continued Use of PFAS Ingredients During Cancellation
Proceedings Is Likely to Result in Unreasonable Adverse
Effects on the Environment. ............................................. 57

2.

Continued Use of PFAS Will Involve Unreasonable
Hazard to the Survival of Endangered or Threatened
Species. .............................................................................. 58

EPA Must, at a Minimum, Initiate a Special Review. ............... 60
ii

II.

III.

IV.

V.

FIFRA Regulations Must Prohibit PFAS Ingredients in Pesticides. ... 63
A.

FIFRA Regulations Require a Ban on Further PFAS
Registrations. ............................................................................... 64

B.

Researchers Have Identified Major Costs Associatedwith PFAS. ................................................................................... 66

EPA Should Amend Regulations to Specifically Require
Assessment of PFAS Chemicals’ Unique Impacts in Determining“Unreasonable Adverse Effects” Under FIFRA. ................................... 71
A.

EPA Has the Authority to Issue Regulations to Require
Specific Long-Term Data on PFAS Ingredients’ Persistencein Formulations with PFAS Ingredients. ................................... 72

B.

Current Regulations Fail to Require Adequate Information
on PFAS. ...................................................................................... 72

C.

EPA’s Failure to Implement Regulations to Mandate
Assessment of PFAS Chemicals’ Unique Impacts in
Pesticides Violates the APA. ....................................................... 76

EPA Must Amend FIFRA Regulations to Prohibit the Use of
Fluorinated HDPE and Fluorinated Polypropylene Containers. ......... 77A.

EPA Has Identified Significant Leaching from HDPE
Fluorinated Containers into Pesticides. ..................................... 77

B.

EPA Must Use Its Authority to Ban HDPE andPolypropylene Fluorinated Containers. ...................................... 83

EPA Must Require Registrants to Report PFAS Contamination. ....... 84
A.

FIFRA Requires Reporting of Toxicologically Significant
Contaminants Such as PFAS. ..................................................... 85

B.

EPA Is Aware of Widespread PFAS Contamination in
Pesticides. .................................................................................... 86C.

EPA Must Amend Its Guidance to Clarify PFAS Contamination
Is of Toxicological Significance. ................................................... 87

D.

EPA Must Act to Stop the Sale of Pesticides Contaminatedwith PFAS by All Means Possible, Including the Issuanceof Stop Sale, Use or Removal Orders. ......................................... 88
iii

VI.

Any EPA Activities or Programs Regarding PFAS in Pesticides
Oversight Must Comply with the ESA. ................................................. 89
A.

The ESA Applies to Agency Actions Taken Pursuant to FIFRA,
and EPA Must Comply with ESA Section 7 With Regard to a
Program for PFAS in Pesticides.................................................. 92

B.

PFAS Environmental Impacts and Potential Impacts on
Protected Species ......................................................................... 94C.

ESA Conclusion and Actions Requested ..................................... 95

CONCLUSION............................................................................................................. 95iv

GLOSSARY
Administrative Procedure Act

APA

Clean Air Act

CAA

Clean Water Act

CWA

Emergency Planning and Community Right-to-Know Act

EPCRA

Endangered Species Act

ESA

Environmental Protection Agency

EPA

Federal Insecticide, Fungicide, Rodenticide Act

FIFRA

Hexafluoropropylene oxide dimer acid

HFPO-DA

High-density polyethylene

HDPE

Maximum Contaminant Level

MCL

Maximum Contaminant Level Goal

MCLG

Per- and polyfluoroalkyl substances

PFAS

Perfluorooctanoic acid

PFOA

Perfluorooctane sulfonic acid

PFOS

Perfluorobutanoic acid

PFBA

Perfluoropentanoic acid

PFPeA

Perfluorohexanoic acid

PFHxA

Perfluoroheptanoic acid

PFHpA

Perfluorononanoic acid

PFNA

Perfluorodecanoic acid

PFDA

Perfluoroundecanoic acid

PFUdA
v

Perfluorohexane sulfonate

PFHxS

Resource Conservation and Recovery Act

RCRA

Safe Drinking Water Act

SDWA

Significant New Use Rule

SNUR

Toxic Substances Control Act

TSCA

United States Department of Agriculture

USDA

United States Geological Survey

USGS

vi

CITIZEN PETITION TO THE U.S. ENVIRONMENTAL PROTECTIONAGENCY SEEKING CANCELLATION AND SUSPENSION OF SEVERAL
EXISTING REGISTRATIONS OF PESTICIDE INGREDIENTS THAT AREPFAS CHEMCIALS AND REQUIRING RULEMAKING REGARDING PFASCHEMICAL ASSESSMENT AND PFAS IN PESTICIDE CONTAINERS
INTRODUCTION AND SUMMARY
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C.
§136 et seq., mandates that the Environmental Protection Agency (EPA) regulatepesticide use in the United States to ensure no “unreasonable adverse effects on theenvironment.” 1 But despite referring to perfluoroalkyl and polyfluoroalkyl
substances, or PFAS chemicals, as an “urgent public health and environmental
issue facing communities across the United States,” 2 and, in some instances, “highly
toxic and present[ing] unreasonable risks,” 3 EPA has failed to take any significant
action on these chemicals’ use in pesticides under FIFRA.

1 7 U.S.C. § 136a(c)(5).

2 U.S. Env’t Prot. Agency, PFAS Strategic Roadmap: EPA’s Commitments to

Action 2021-2024 (Oct. 2021), https://www.epa.gov/system/files/documents/202110/pfas-roadmap_final-508.pdf [hereinafter PFAS Strategic Roadmap].
3 U.S. Env’t Prot. Agency, EPA Orders Issued to Inhance Technologies Related
to Long-Chain PFAS Significant New Use Notices, Reviewing New Chemicals Under
the Toxic Substances Control Act (TSCA) (updated December 14, 2023),
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-acttsca/epa-orders-issued-inhance [hereinafter EPA Orders to Inhance]; see also U.S.
Env’t Prot. Agency, Framework for TSCA New Chemicals Review of PFAS
Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs), Public
Webinar (September 6, 2023), https://www.epa.gov/system/files/documents/202309/13313_PFAS%20Framework%20Webinar_9-12-2023_508.pdf at 14 (describing a“Not Likely” determination for PFAS) [hereinafter Framework for TSCA].
1Instead, EPA has continued registering active ingredients that qualify as
PFAS, 4 is maintaining other registrations of PFAS active and inert ingredients, 5
and is allowing the use of fluorinated high-density polyethylene (HDPE) andpolypropylene storage containers that leach PFAS into pesticides. 6 This cannot
stand under FIFRA: EPA itself has stated it “must leverage the full range ofstatutory authorities to confront the human health and ecological risks of PFAS.” 7
Accordingly, this Petition requests that EPA do just that: cancel existingregistrations for inert and active ingredients that qualify as PFAS, amend FIFRA
regulations to prohibit PFAS in pesticide formulations and containers, oralternatively, require assessment of PFAS chemicals’ unique environmental
impacts.
Numerous studies have found high PFAS levels in widely used pesticides in
the United States. 8 PFAS chemicals are a subset of fluorinated chemicals, which
4 See Notice of Pesticide Registration, EPA Reg. Number 86203-28 (Jan. 14,2021) (unconditional registration of new active ingredient broflanilide by EPA).
5 Jeff Dawson and Anne Overstreet, Presentation at NPIRS & ALSTAR
Spring Conference, U.S. Env’t Prot. Agency (Apr. 12, 2023),
https://www.npirs.org/ref/conference/2023_Washington_DC_Presentation_on_PFAS_(EPA-Dawson-Overstreet).pdf [hereinafter Dawson].
6 BERLIN PACKAGING, Fluorination (Oct. 20, 2019),
https://www.berlinpackaging.com/fluorination/; Tom Neltner, Beyond Paper: PFAS
Linked to Common Plastic Packaging Used for Food, Cosmetics, and Much More,
Env’t Defense Fund (updated Aug. 11, 2021),
https://blogs.edf.org/health/2021/07/07/beyond-paper-pfas/.
7 PFAS Strategic Roadmap, supra n.2, at 5.
8 See, e.g., Tom Perkins, Toxic ‘Forever Chemicals’ Detected in Commonly
Used Insecticides in US, Study Finds, The Guardian (Oct. 7, 2022),
https://www.theguardian.com/environment/2022/oct/07/forever-chemicals-foundinsecticides-study; Steven Lasee, et al., Targeted Analysis and Total Oxidizable
Precursor Assay of Several Insecticides for PFAS, J. HAZARDOUS MATERIALS LETTERS
2

possess strong carbon-fluorine bonds. 9 That means such chemicals are both highly
stable and useful in pesticide products to extend shelf life and provide an evencoating, as well as in pesticide containers to reduce permeation. 10 But it also means
they do not readily biodegrade; rather, their strong molecular bonds can takehundreds of years to break down, with certain PFAS linked to public health andenvironmental concerns nationwide, leaching into soil and groundwater, andincreasing risks of testicular and kidney cancers, reproductive disorders, thyroid
disease, high cholesterol levels, reduced immune response, and increased
susceptibility to COVID-19. 11
As a result, EPA has committed to addressing PFAS contamination in theenvironment. Specifically, EPA Administrator Regan recently assured the publicthat EPA is “laser focused on protecting people from [PFAS] pollution and holding
polluters accountable.” 12 But EPA’s only actions under FIFRA have been its
December 2022 decision to remove twelve PFAS chemicals and its February 2024

(2022),
https://www.sciencedirect.com/science/article/pii/S266691102200020X#tbl0005.
9 Meg Wilcox, Pesticides are Spreading Toxic ‘Forever Chemicals,’ Scientists
Warn, Scientific American (June 15, 2022),
https://www.scientificamerican.com/article/pesticides-are-spreading-toxic-lsquoforever-chemicals-rsquo-scientists-warn/.
10 Monica Amarelo, Maine Data Unveils Troubling Trend: 55 PFAS-related
Chemicals in over 1,400 Pesticides, EWG (Jun. 6, 2023), https://www.ewg.org/newsinsights/news-release/2023/06/maine-data-unveils-troubling-trend-55-pfas-relatedchemicals.
11 Wilcox, supra n.9.
12 U.S. Env’t Prot. Agency, EPA Administrator Regan Announces
Comprehensive National Strategy to Confront PFAS Pollution (Oct. 18, 2021),
https://www.epa.gov/newsreleases/epa-administrator-regan-announcescomprehensive-national-strategy-confront-pfas.
3proposal to remove another from its list of approved inert ingredients, none of whichwere even in use. 13 EPA’s actions and inactions have led to ongoing PFAS
contamination and public health impacts as a result, harming Petitioners’ interests.
PETITION REQUESTS
Pursuant to the Right to Petition Government Clause contained in the First
Amendment of the United States Constitution, 14 the Administrative Procedure Act(APA), 15 and FIFRA § 136d(b), 16 Petitioners request the Administrator of EPA totake the following actions: 17
1. Cancel registrations for all active and inert ingredients that meetthe definition of PFAS pursuant to FIFRA § 136d(b), in accordancewith the United States Geological Survey (USGS) definition, see 15
U.S.C. § 8931(2)(B), and state-based definitions of PFAS as “a class offluorinated organic chemicals that contain at least one fully
fluorinated carbon atom,” and cease registering any more.
2. Suspend the registrations for active and inert ingredients that
qualify as PFAS under the 15 U.S.C. § 8931(2)(B) definition, pending
completion of cancellation proceedings pursuant to FIFRA §136d(c)(1).

13 87 Fed. Reg. 76,488 (Dec. 14, 2022); 89 Fed. Reg. 14, 646 (Feb. 28, 2024).
14 U.S. CONST. amend. I.
15 5 U.S.C. § 553(e).

16 This section provides authority for EPA to cancel a pesticide registration “if

it appears to the Administrator that a pesticide or its labeling or other material
required to be submitted does not comply with the provisions of this subchapter or,
when used in accordance with widespread and commonly recognized practice,generally causes unreasonable adverse effects on the environment.” 7 U.S.C. §136d(b).
17 EPA lacks regulations for handling public petitions related to pesticides, aproblem it has been urged by its Inspector General to cure. See U.S. Env’t Prot.
Agency, EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in
a Transparent and Efficient Manner, IG Report No. 16-P-0019 (Oct. 27, 2015),
www.epa.gov/sites/production/files/2015-10/documents/20151027-16-p-0019.pdf.
4

3. Alternatively, clarify pesticide registration regulations at 40 C.F.R. §152.112 to explicitly require EPA to consider PFAS chemicals’ uniquelong-term impacts on human health and the environment, as EPA
has required in other contexts.
Amend 40 C.F.R. 152.112 to add the following underlined paragraph:§ 152.112 Approval of registration under FIFRA sec. 3(c)(5).
EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only
if:(a) The Agency has determined that the application is complete and isaccompanied by all materials required by the Act and this part, including,but not limited to, evidence of compliance with subpart E of this part;(b) The Agency has reviewed all relevant data in the possession of
the Agency (see §§ 152.107 and 152.111);(c) The Agency has determined that no additional data are necessary to
make the determinations required by FIFRA sec. 3(c)(5) with respect tothe pesticide product which is the subject of the application;(d) The Agency has determined that the composition of the product is such as
to warrant the proposed efficacy claims for it, if efficacy data are required tobe submitted for the product by part 158 or part 161 of this chapter, as
applicable.
(e) The Agency has determined that the product will perform its intended
function without unreasonable adverse effects on the environment, and that,when used in accordance with widespread and commonly recognized practice,
the product will not generally cause unreasonable adverse effects on theenvironment;(f) The Agency has determined that the product is not misbranded as thatterm is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its
labeling and packaging comply with the applicable requirements of the Act,
this part, and parts 156 and 157 of this chapter;(g) If the proposed labeling bears directions for use on food, animal feed, or
food or feed crops, or if the intended use of the pesticide results or may
reasonably be expected to result, directly or indirectly, in pesticide residues(including residues of any active or inert ingredient of the product, or of any
metabolite or degradation product thereof) in or on food or animal feed, allnecessary tolerances, exemptions from the requirement of a tolerance, andfood additive regulations have been issued under FFDCA sec. 408, and(h) If the product, in addition to being a pesticide, is a drug within themeaning of FFDCA sec. 201(q), the Agency has been notified by the Food andDrug Administration (FDA) that the product complies with any requirements
imposed by FDA.

5

(i) In accordance with paragraph (e) of this section, the Agency must identify
PFAS ingredients in pesticides and account for their persistence in theenvironment and bioaccumulation potential in its assessment.
4. As an alternative to cancellation, amend data requirements under 40
C.F.R. 158.630(d) to require registrants to submit data on PFAS
ingredient persistence in the environment, as well as environmental
fate/bioaccumulation, toxicokinetic, and human health and/or
environmental toxicity data specific to PFAS chemicals.
5. Amend the definitions in 40 C.F.R. § 158.300 to include the USGS andstate-based definitions of PFAS at 15 U.S.C. § 8931(2)(B).
Amend 40 C.F.R. § 158.300 to add the following underlined paragraph:
PFAS means “a class of fluorinated organic chemicals that contain at least
one fully fluorinated carbon atom.”
6. Alternatively, create a PFAS in Pesticides Guidance Document.
This petition proposes the creation of a guidance document similar toprevious guidelines the agency has developed, for example EPA’s 2014 Bee
Guidance. 18 This guidance document will recommend reporting under FIFRA
section 6(a)(2) for any PFAS contamination in pesticides. It will specify that
EPA finds PFAS contamination “toxicologically significant,” requiring
registrants to report contamination to EPA immediately under 40 C.F.R. §159.179(b). If action is not immediately taken by the registrant to remove thecontaminated, adulterated product from the market, EPA will issue a “stopsale, use, or removal” order.
Additionally, should EPA refuse cancellation of all PFAS ingredients, theseguidelines will further direct the agency in the practices required toincorporate the analysis and data required in the above amended regulations(along with the broader scientific literature) into the risk assessment process.
This guidance document should provide guidance to risk assessors forevaluating the potential risk of PFAS in pesticides to the environment andpublic health. This includes information on the phases of the assessment (i.e.,analysis and risk characterization) and specifics on a tiered approach bywhich additional information can be requested from the registrant.
Importantly, this guidance document should outline an approach that18 U.S. Env’t Prot. Agency, Office of Pesticide Programs, Guidance forAssessing Pesticide Risks to Bees (June 19, 2014),
https://www.epa.gov/sites/default/files/201406/documents/pollinator_risk_assessment_guidance_06_19_14.pdf.
6effectively incorporates studies in the published literature and does notarbitrarily discount those studies. Specifically, this guidance document
should discuss and implement a methodology that the EPA can use to ensure
incorporation of all available science, not just registrant studies.
7. Amend nonrefillable container standard regulations to prohibit useof fluorinated HDPE containers, as well as polyethylene andpolypropylene containers.
Amend 40 C.F.R. § 165.25 to add the following underlined paragraph:§ 165.25 Nonrefillable container standards.
(a) What Department of Transportation (DOT) standards do mynonrefillable containers have to meet under this part if my pesticide
product is not a DOT hazardous material? A pesticide product that does
not meet the definition of a hazardous material in 49 CFR 171.8 mustbe packaged in a nonrefillable container that, if portable, is designed,
constructed, and marked to comply with the requirementsof 49 CFR 173.4, 173.5, 173.6, 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.
203, 173.213, 173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, andpart 180 that are applicable to a Packing Group III material, or, if subject toa special permit, according to the applicable requirements of 49 CFR part
107 subpart B. The requirements in this paragraph apply tothe pesticide product as it is packaged for transportation in commerce.
(b) What DOT standards do my nonrefillable containers have to meet
under this part if my pesticide product is a DOT hazardous
material?
(1) If your pesticide product meets the definition of a hazardous
material in 49 CFR 171.8, the DOT requires your pesticide product tobe packaged according to 49 CFR parts 171-180 or, if subject to a
special permit, according to the applicable requirements of 49 CFRpart 107 subpart B.
(2) For the purposes of these regulations, a pesticide product thatmeets the definition of a hazardous material in 49 CFR 171.8 mustbe packaged in a nonrefillable container that, if portable, is designed,
constructed, and marked to comply with the requirements of 49 CFR
parts 171-180 or, if subject to a special permit, according to theapplicable requirements of 49 CFR part 107 subpart B. The
requirements in this paragraph apply to the pesticide product as itis packaged for transportation in commerce.
(c) What will EPA do if DOT proposes to change any of the crossreferenced regulations? If the DOT proposes to change any of theregulations that are incorporated in paragraphs (a) and (b) of this7

section, EPA will provide notice of the proposed changes and an opportunity
to comment in the Federal Register. Following notice and comment, EPA willtake final action regarding whether or not to revise its rules, and the extent
to which any such revision will correspond with revised DOT regulations.
(d) What standards for closures do my nonrefillable containers haveto meet? If your nonrefillable container is a rigid container witha capacity equal to or greater than 3.0 liters (0.79 gallons), if the container is
not an aerosol container or a pressurized container, and if the container isused to distribute or sell a liquid agricultural pesticide, each nonrefillable
container must have at least one of the following standard closures:(1) Bung, 2-inch pipe size (2.375 inches in diameter), external
threading, 11.5 threads per inch, National Pipe Straight (NPS)
standard.
(2) Bung, 2-inch pipe size (2.375 inches in diameter), external
threading, 5 threads per inch, buttress threads.
(3) Screw cap, 63 millimeters, at least one thread revolution at 6
threads per inch.
(4) Screw cap, 38 millimeters, at least one thread revolution at 6
threads per inch. The cap may fit on a separate rigid spout or on a
flexible pull-out plastic spout.
(e) What standards for dispensing do my nonrefillable containers
have to meet? If your nonrefillable container has a capacity of 5 gallons (18.9
liters) or less, if the container is not an aerosol container, apressurized container, or a spray bottle, and if the container holds a
liquid pesticide, your nonrefillable container must do both of the following:(1) Allow the contents of the nonrefillable container to pour in acontinuous, coherent stream.
(2) Allow the contents of the nonrefillable container to be poured witha minimum amount of dripping down the outside of the container.
(f) What standards for residue removal do my nonrefillable
containers have to meet? Each nonrefillable
container and pesticide formulation combination must meet the applicable
residue removal standard of this section.
(1) If the nonrefillable container is rigid and has a capacity less thanor equal to 5 gallons (18.9 liters) for liquid formulations or 50 pounds(22.7 kilograms) for solid formulations and if the pesticide product's
labeling allows or requires the pesticide product to be mixed with aliquid diluent prior to application (that is, if the pesticide is dilutable),each container/formulation combination must be capable of attaining
at least 99.99 percent removal of each active ingredient when tested
using the EPA test procedure “Rinsing Proceduresfor Dilutable Pesticide Products in Rigid Containers.”8(2) The test must be conducted only if the pesticide product isa suspension concentrate or if EPA specifically requests the records ona case by case basis.
(3) For the rigid container/dilutable product standard in paragraph(f)(1) of this section, percent removal represents the percent of theoriginal concentration of the active ingredient in
the pesticide product when compared to the concentration of that
active ingredient in the fourth rinse. Percent removal is calculated by
the formula:percent removal = [1.0 - RR] x 100.0, where RR = rinsate ratio = Active
ingredient concentration in fourth rinsate/Original concentration ofactive ingredient in the product.
(g) Can I obtain a waiver from or a modification to any of thenonrefillable container standards? Yes, it is possible for you to obtain awaiver from or a modification to the nonrefillable container standards, as
follows:(1) EPA may waive or modify the requirements of paragraph (a) of thissection regarding the DOT standards for pesticide products that are
not DOT hazardous materials if EPA determines that an alternative(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in therequirements of paragraph (a) of this section.
(2) EPA may waive or modify the requirements of paragraph (b) of thissection regarding the DOT standards for pesticide products that are
DOT hazardous materials if EPA determines that an alternative(partial or modified) set of standards or pre-existing requirements
achieves a level of safety that is at least equal to that specified in therequirements of paragraph (b) of this section. EPA will modify or waive
the requirements of paragraph (b) of this section only after consultingwith DOT to ensure consistency with DOT regulations and exemptions.
(3) EPA may approve a non-standard closure (that is, a closure notlisted in paragraph (d) of this section) if EPA determines that both of
the following conditions are satisfied:(i) The non-standard closure is necessary for the proper mixing,loading, or application of the pesticide product.
(ii) The non-standard closure offers exposure protection tohandlers during mixing and loading that is the same or greaterthan that provided by the standard closures.
(4) EPA may waive or modify the container dispensing capability
standards in paragraph (e) of this section if EPA determines that atleast one of the following conditions is satisfied:(i) The product is typically removed from the container by amethod other than pouring.

9

(ii) Compliance with the container dispensing capability
standards would increase exposure to
the pesticide container handler.
(5) EPA may waive or modify the requirements of paragraph (f) of thissection regarding the residue removal standard if EPA determines thatboth of the following conditions are satisfied:(i) The residue remaining in the container would not cause an
unreasonable adverse effect on the environment; and(ii) The product offers significant benefits and cannot be
economically reformulated or repackaged.
(h) How do I obtain a waiver from or a modification to any of thenonrefillable container standards? To obtain a waiver from or amodification to any of the nonrefillable container standards, you must submit
a written request for a waiver or a modification to the EPA to the following
address: Office of Pesticide Programs (7504P); U.S. Environmental Protection
Agency; Ariel Rios Building; 1200 Pennsylvania Avenue, N.W., Washington,
DC 20460. You cannot distribute or sell the pesticide product ina nonrefillable container that does not comply with all of the nonrefillable
container standards unless and until EPA approves the request for thewaiver or modification in writing. You must include two copies of thefollowing information (which may be part of an application for registration oramended registration) with your written request:(1) The name and address of the registrant; the date; and the name,title, signature, and phone number of the company official making therequest.
(2) The name and EPA registration number of the pesticide product for
which the waiver or modification is requested.
(3) A statement specifying the requirement or requirements fromwhich you are requesting a waiver or a modification.
(4) A description of the nonrefillable container or containers for which
the waiver or modification is requested.
(5) Documentation or justification to demonstrate that the applicablewaiver or modification criteria in paragraph (g) of this section aresatisfied.
(g) What materials are prohibited for use in all nonrefillable
containers? Nonrefillable containers may not be fluorinated HDPE or
polypropylene containers or any material that contains PFAS chemicals.
Failure by the Administrator to take the requested actions would severely
harm Petitioners’ interests. It would also violate FIFRA’s mandates and constitutearbitrary and capricious agency action. In view of the severity of the impacts the10Petitioners are suffering, EPA must act on the requests in this Petition within 180
days of its filing date.
PETITIONERSPetitioner Center for Food Safety (CFS) is a nonprofit membershiporganization of over one million farmer and consumer members with a mission toempower people, support farmers, and protect the environment from the harmful
impacts of industrial agriculture. Through legal, scientific, and grassroots action,
CFS serves to protect and promote the right to safe food and the environment.
Accordingly, since its inception over 25 years ago, one of CFS’s flagship programs
has focused on pesticides, combining multiple tools in support of its mission
including public and policymaker education, outreach, and campaigning. CFS
disseminates a wide array of informational materials to government agencies,
lawmakers, nonprofits, and the public regarding the effects of pesticides on humanhealth and the environment. These educational and informational materials
include, but are not limited to news articles, policy reports, white papers, legal
briefs, press releases, newsletters, product guides, action alerts, and fact sheets.
CFS often has provided expert testimony to policymakers on the potentially harmful
agrichemical impacts associated with industrial monoculture cropping systems,
including the increased use of pesticides and chemical fertilizers. When necessary,
CFS also engages in public interest litigation to address the impacts of industrial
food production and pesticides on its members, the environment, and the public
interest.
11

Petitioner American Bird Conservancy (ABC) is a 501(c)(3) dedicated toconserving birds and their habitat across the Americas. ABC restores bird habitat,
performs original research, works cooperatively with federal and state agencies, andleads coalitions of stakeholders to reverse the 3 billion bird decline North America iscurrently experiencing. ABC also seeks legal, regulatory, and legislative solutions to
the issues of lethal and sublethal pesticide poisoning on birds.
Petitioner Beyond Pesticides is a Washington, D.C. based, nonprofit
organization that works to protect public health and the environment from theadverse effects of pesticide production, transportation, use, storage, and disposal.
Beyond Pesticides has members in fifty states and the District of Columbia. Beyond
Pesticides promotes safe air, water, land, and food and works to protect publichealth and the environment by encouraging a transition away from the use of toxic
pesticides, including chemicals like PFAS that are at issue in this petition. To
achieve its goals, Beyond Pesticides provides the public with resources andinformation on the hazards associated with pesticides, including PFAS. Beyond
Pesticides' Gateway on Pesticide Hazards and Safe Pest Management provides the
public with easy access to current and historical information on pesticide hazards,
and safe and organic pest management; drawing on and linking to numerous
independent and governmental sources and organizations that provide pesticiderelated science and policy information. Beyond Pesticides’ Pesticide-Induced
Disease Database (PIDD), with over 1,400 studies, facilitates access toepidemiologic and laboratory studies based on real world exposure scenarios that12

link pesticides to public health effects, including asthma, autism and learning
disabilities, birth defects and reproductive dysfunction, endocrine system
disruption, diabetes, Parkinson's and Alzheimer's diseases, and several types ofcancer. When necessary, Beyond Pesticides also engages in public interest litigation
to address the impacts of pesticides on the environment, its members, and the
public interest. Many of the members of Beyond Pesticides are adversely affected by
PFAS; members have purchased products or live, work, and recreate where
pesticides with PFAS have and/or are being used, or will be, applied.
Petitioner Massachusetts Pollinator Network’s (MAPN) mission is to expand
pollinator habitat and reduce the use of pesticides through the creation of astatewide network that connects and supports the growing number of individuals,
communities, organizations, and research groups working to protect pollination
systems across the Commonwealth.
Petitioner Maine Organic Farmers and Gardeners Association (MOFGA) is a
501(c)(3) nonprofit headquartered in Unity, Maine. MOFGA is a broad-based
community working to build a food system that is healthy and fair for all. Througheducation, training and advocacy, MOFGA is helping farmers thrive, making more
local, organic food available, and building sustainable communities. The
organization's wholly owned subsidiary, MOFGA Certification Services, LLC,
certifies 525 organic farmers and processing operations, representing roughly $120
million in sales. MOFGA has been deeply engaged in advocacy efforts to address theescalating problem of PFAS contamination on farmland in Maine and across the13country. One successful state policy that MOFGA strongly supports is Maine PFAS
pesticides law, which requires pesticide manufacturers to disclose the presence of
PFAS in their products, report whether their products have been stored influorinated containers and eliminate PFAS from their formulations by 2030. The
threat of PFAS-contamination of farmland is of highest importance to the MOFGA
community. Several MOFGA-certified organic farms have been at the center of an
ongoing crisis caused by PFAS-contaminated wastewater treatment sludge
designated “biosolids” and used as soil amendments. Since 2016, when PFAS was
first found to have contaminated soil, water and subsequently milk at a Maine dairy
farm, the state has been at the forefront investigating and remediating PFAS
contamination of farmland. Administrators in Maine’s Department ofEnvironmental Protection (DEP); Department of Agriculture, Conservation andForestry (DACF); and Department of Health and Human Services (DHHS) have
responded to widespread PFAS contamination with broad, non-partisan support
from the Maine Legislature. Since 2021, the DEP and DACF have beensystematically testing soil and water in locations known to have been permitted forsludge or septage application, and DHHS has been testing food and drinking waterand providing alternative drinking water or filtration for contaminated residential
wells. MOFGA has provided extensive technical, financial and emotional support tofarmers across the management spectrum (i.e., conventional and organic) who arenavigating this unprecedented challenge. MOFGA believes that the U.S.

14

government agencies must take swift action to eliminate PFAS from the U.S. foodand agriculture system.
Petitioner Norwalk River Watershed Association is a nonprofit membershiporganization that accomplishes its mission by engaging community volunteers to
help restore native trees, shrubs, wildflowers and grasses to the riverbanks,
meadows, parks, and forests of the watershed; working to expand community accessto the river, the surrounding open space, and its trails; supporting research andlegislative policy that protects biodiversity, clean air, and water; and promoting
education, cooperation, and action on the part of the stakeholders in the sevenwatershed towns in CT (Ridgefield, Redding, Wilton, New Canaan, Weston, andNorwalk) and NY (Lewisboro).
Petitioner Pesticide Action Network North America (PANNA) is a non-profit
organization that uses grassroots science, strategic communications and coalition
organizing to build power with communities across the U.S. and around the world
to confront the harms of industrial agriculture and build solutions. PANNA’s
mission is to end reliance on hazardous pesticides and achieve health, resilience andjustice in food and farming. PANNA has over 65,000 members and supporters andwas founded in 1984. It is one of five regional centers who cooperate to transform
systems of food and farming across the globe.
Petitioner Northeast Organic Farming Association (NOFA) is a regional
federation of seven independent state Chapters in NY, VT, NH, MA, CT, RI and NJ.
Beyond their work on state initiatives, the Chapters work together regionally,

15

nationally and internationally via the NOFA Interstate Council (NOFA-IC), which
is a separate 501(c)(3) organization. Further, under the auspices of NOFA-IC the
Interstate NOFA Policy Program coordinates and carries out joint initiatives under
the auspices of NOFA-IC. Founded in 1971, NOFA is one of the oldest organic
farming education and advocacy groups in the country.
Petitioner Northwest Center for Alternatives to Pesticides (NCAP) is theleading Northwest voice for non-toxic pest and weed solutions. We promote safe pest
and weed alternatives for the health of people and the environment. NCAP has beenat the forefront of advocating for disclosure and review of inert ingredients inpesticide formulations and supports this effort in hopes that it helps the EPA
prioritize meaningfully addressing this timely issue.
Petitioners Rural Vermont is a nearly 40 year old member-based organization
which organizes, educates and advocates in collaboration with local and global
movements to strengthen the social, ecological and economic health of the agrariancommunities that connect us all. Rural Vermont envisions a just and equitableworld rooted in reverence for the earth and dignity for all. This abundant andgenerous way of life celebrates our diversity and interdependence, in which
communities of microorganisms, animals, plants, and humans tend one another andnurture generations to come.
Petitioner Toxic Free NC’s mission is to engage North Carolina in initiatives
that advance environmental health and justice by advocating for safe alternatives
to harmful pesticides and chemicals. Established in 1986 in response to a16community pesticide poisoning in rural Gorgas, NC, Toxic Free NC has steadfastly
been the leading pesticide education and outreach organization in North Carolina
for almost four decades.
Petitioner Tom Neltner is a chemical policy expert with experience inindustry, academia, government, and advocacy. He has coauthored three petitions
to the Food and Drug Administration (FDA) regarding PFAS, including the foodadditive petition that prompted FDA to revoke its rules in 2016 that allowed use of
PFOA as a food contact substance in paper. He has also coauthored the pending
citizen petition asking FDA to revoke its food contact authorizations for PFAS
where the chemicals may bioaccumulate in people and the environment.
LEGAL BACKGROUNDFIFRA is the primary statute under which EPA regulates the distribution,
sale, and use of pesticides. FIFRA defines a “pesticide” as “any substance or mixtureof substances intended for preventing, destroying, repelling, or mitigating any
pest[.]” 19 When a pesticide is sold or distributed, it is generally referred to as a“pesticide product.” FIFRA generally prohibits the sale or distribution of a pesticide
product unless it has first been “registered” under FIFRA Section 3. 20
FIFRA authorizes EPA to register a pesticide only upon determining that it“will perform its intended function without unreasonable adverse effects on theenvironment,” and that “when used in accordance with widespread and commonly

19 7 U.S.C. § 136(u).
20 Id. § 136a(a).

17

recognized practice it will not generally cause unreasonable adverse effects on theenvironment.” 21 The statute defines “unreasonable adverse effects on theenvironment” to include “any unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs and benefits of the use ofany pesticide.” 22 “Environment” “includes water, air, land, and all plants and man
and other animals living therein, and the interrelationships which exist among
these.” 23 When EPA applies this risk-benefit balancing test, it may only register apesticide if it finds that the risks associated with the use of a pesticide are justified
by the benefits of such use. 24
FIFRA tasks EPA with dictating what information applicants must submit to
support pesticide registrations and assessing that data to determine whether thepesticide will perform its intended function while meeting the safety standard. 25 A
pesticide registration application must include, among other things, “the complete
formula of the pesticide” and “a full description of the tests made and the results
thereof upon which [safety and efficacy] claims are based, or alternatively a citation
to [relevant safety and efficacy] data.” 26 EPA requires a “confidential statement of

21 Id. § 136a(c)(5)(C), (D); 40 C.F.R. § 152.112(e).
22 7 U.S.C. § 136(bb).
23 7 U.S.C. § 136(j).

24 Wa. Toxics Coal. v. Env’t Prot. Agency, 413 F.3d 1024, 1032 (9th Cir. 2005)(explaining that FIFRA uses a “cost-benefit analysis to ensure that there is no
unreasonable risk created for people or the environment from a pesticide.”).
25 7 U.S.C. § 136a(c)(2); Id. § 136a(c)(5)(C).
26 Id. § 136a(c)(1)(D, F); see also U.S. Env’t Prot. Agency, Pesticide
Registration Manual, Ch. 2, https://www.epa.gov/system/files/documents/202108/pesticide-registration-manual-chapter-2.pdf (“The purpose of these data18

formula” that includes all active and inert ingredients and impurities in a given
pesticide formula or formulation. 27 EPA has broad discretion to require supporting
data for pesticide applications and to require additional data for registeredpesticides to maintain registration. 28 An application for registration is incomplete if
it contains insufficient information for EPA to determine if a pesticide is safe. 29
Registration of a pesticide—conditional or otherwise—cannot continue on the basisof an incomplete application. 30
EPA’s regulations provide a myriad of data requirements and specificconsiderations. For example, EPA must consider the “human dietary risk fromresidues” 31 for pesticides used on food products. EPA must also use “studies ...
pertain[ing] to leaching” to assess “potential environmental hazards related to ...
habitat loss of wildlife resulting from pesticide residue movement or transport in
the environment” 32; “mutagenicity studies” to assess “hazards to ... domestic
animals” 33; and “aerobic ... metabolism studies” to assess “the persistence of [the]pesticide” in the environment. 34 Data requirements for applicants also include
testing on residue chemistry to estimate human exposure to pesticides, acuterequirements is to demonstrate that the product will not cause unreasonable
adverse effects.”).
27 Pesticide Registration Manual, supra n.26, at ch. 2 (citing 7 U.S.C. §136a(c)(1)(D)).
28 7 U.S.C. § 136a(c)(2)(A)-(B).
29 40 C.F.R. § 152.104.
30 See id. § 152.105.
31 7 U.S.C. § 136(bb).
32 See 40 C.F.R. § 158.130(h)(4).
33 See id. § 158.130(d).
34 See id. § 158.130(h)(3).
19

human hazard, sub chronic human hazard, chronic human hazard, reentry hazard,
and spray drift evaluation, as well as oncogenicity, teratogenicity, neurotoxicity,and reproductive effects in humans. 35
In order for EPA to register a pesticide, its entire formulation must meet
FIFRA’s registration standard. 36 In enacting FIFRA, Congress understood that
pesticides are generally comprised of active ingredients 37 that “will prevent,destroy, repel, or mitigate any pest,” 38 as well as inert ingredients “which [are] not
active.” 39 EPA maintains a list of approved inert ingredients for use in pesticide
products. 40 A pesticide formulation is a mixture of one or more active ingredients—
the pesticide formula, along with other chemicals, statutorily defined and commonly
known as inert ingredients. 41 The mixture of the pesticide formula and inert
ingredients is often referred to simply as the pesticide or the pesticide
formulation. 42 Though inert ingredients may or may not have a direct effect on thetarget species, they can be toxic, biologically active and potentially hazardous. 43

35 See id. § 158.130.

36 7 U.S.C. § 136(u) (defining ”pesticide” as a ”substance or mixture of

substances”); id. § 136a(c)(5) (providing for “pesticide” registrations).
37 See 40 C.F.R. § 158.300 (defining “formulation” to mean the process of
mixing active and inert ingredients to create a final pesticide product).
38 7 U.S.C § 136(a)(1).
39 Id. § 136(m); see also 40 C.F.R. §152.3 (defining an inert ingredient as “anysubstance ... other than an active ingredient, which is intentionally included in apesticide product.”).
40 U.S. Env’t Prot. Agency, InertFinder,
https://ordspub.epa.gov/ords/pesticides/f?p=INERTFINDER:1:0::NO:1::.
41 National Research Council, Assessing Risks to Endangered and Threatened
Species from Pesticides, at 65 (National Academies Press, 2013).
42 Id.
43 Id. at 66.
20

To use a pesticide, the pesticide formulation is often added to a tank or othercontainer containing adjuvants. 44 Adjuvants differ from inerts because applicators
add them to a tank mixture in the field at the time they apply the pesticide, rather
than when formulating the pesticide in the laboratory. 45 Both “[i]nerts andadjuvants are comprised of an extremely broad array of chemicals, including
carriers, stabilizers, sticking agents, and other materials added to facilitate
handling or application.” 46 However, EPA’s testing requirements for inerts andadjuvants remains elusive: EPA’s guidance documents for developing new pesticide
inerts do not contain a specific list or detail the required tests for approval;
however, inerts and adjuvants can and should be subject to the same types of tests
that are required for active ingredients. 47
Once EPA registers a pesticide, FIFRA provides EPA with ongoing oversightauthority, and EPA may at any time propose cancellation or suspension if it

44 Id. at 65.
45 Id. at 66.
46 Id.

47 Id. at 120.

21

appears a pesticide does not meet FIFRA’s safety standard. 48 FIFRA also allows
EPA to suspend registrations that cause an “imminent hazard.” 49
FIFRA also governs the storage, disposal, transportation, and recall of
pesticides. Specifically, FIFRA mandates that “the Administrator shall …
promulgate regulations for the design of pesticide containers that will promote thesafe storage … of pesticides.” 50 EPA may require applicants to submit data abouttransportation and storage methods and may require certain procedures be followed
for storage or disposal of containers that used to contain pesticides, and can also
require certain recycling procedures for containers. 51 FIFRA authorizes EPA topromulgate regulations for the design of pesticide containers to ensure safe disposal
and reuse. 52 Pesticide manufacturers must monitor whether EPA uses theseauthorities to recall containers or products containing PFAS. 53

48 See 7 U.S.C. § 136d (“If it appears to the Administrator that a pesticide or

its labeling or other material required to be submitted does not comply with theprovisions of this subchapter or, when used in accordance with widespread andcommonly recognized practice, generally causes unreasonable adverse effects on theenvironment, the Administrator may issue a notice of the Administrator's intent
either--(1) to cancel its registration or to change its classification together with thereasons (including the factual basis) for the Administrator's action, or (2) to hold ahearing to determine whether or not its registration should be canceled or its
classification changed.”).
49 Id. § 136d(c)(1) (“If the Administrator determines that action is necessary
to prevent an imminent hazard during the time required for cancellation or change
in classification proceedings, the Administrator may, by order, suspend theregistration of the pesticide immediately.”).
50 7 U.S.C. § 136q(e)(1).
51 Id. § 136q(a).
52 Id. § 136q(b), (e).
53 Id. § 136q(b).
22

FACTUAL BACKGROUND
I.

Characteristics of PFAS.
PFAS are a series of man-made chemical compounds that persist in theenvironment for long periods of time. Commonly referred to as “forever chemicals,”
PFAS chemicals possess strong carbon-fluorine bonds, rendering them highly stable
and resistant to heat, oil, grease, stains, and water. 54 As a result, manufacturers
often use these chemicals in clothing, furniture, food packaging, cookware, cleaningproducts, insulation, paint, and even cosmetics. 55
Despite their commercial usefulness, PFAS chemicals pose numerous welldocumented risks to human health and the environment. Because of their molecular
structure, PFAS do not break down naturally, instead traveling through soils andwaterways and building up, or bioaccumulating, in plants, wildlife, and soils. 56 For
humans, the pathways to PFAS exposure are numerous, including via consumer
products, contaminated air or drinking water, or food grown in PFAS-contaminatedsoil, also referred to as dietary exposure. 57 PFAS chemicals’ persistence in the

54 U.S. Food and Drug Administration, Per- and Polyfluoroalkyl Substances(PFAS) (Apr. 29, 2024), https://www.fda.gov/food/environmental-contaminantsfood/and-polyfluoroalkyl-substances-pfas.
55 Per- and Polyfluoroalkyl Substances (PFAS) and Your Health: How can I be
exposed?, Agency For Toxic Substances And Disease Registry (ATSDR) (lastreviewed Nov. 1, 2022), https://www.atsdr.cdc.gov/pfas/health-effects/exposure.html[hereinafter ATSDR Exposure].
56 U.S. Env’t Prot. Agency, Our Current Understanding of the Human Healthand Environmental Risks of PFAS, https://www.epa.gov/pfas/our-currentunderstanding-human-health-and-environmental-risks-pfas [hereinafter Our
Current Understanding]; U.S. Food and Drug Administration, supra n.54.
57 ATSDR Exposure, supra n.55.
23

environment, along with dietary exposures due to food contact substances, 58 has
resulted in 99% of Americans having certain PFAS chemicals in their blood. 59
This exposure is harmful: Certain PFAS have been linked to adverse
reproductive health effects, developmental effects in children, increased risk ofcertain cancers, and immunosuppression. 60 Among the thousands of chemicals in
the PFAS class, PFOA and PFOS, remain two of the most studied PFAS compounds
in various applications. 61 And as with other PFAS chemicals, PFOA and PFOS
persist in the environment, and exposure can lead to high cholesterol, changes inliver enzymes, decreased immune response to vaccination, thyroid disorders,pregnancy-induced hypertension and preeclampsia, and cancer (testicular and
58 See Katherine Bourzac, Unexpected ‘Forever Chemicals’ Found in Food

Packaging, Scientific American (Mar. 19, 2024),
https://www.scientificamerican.com/article/61-unexpected-pfas-forever-chemicalsfound-in-food-packaging/.
59 Env’t Working Grp., What Are PFAS Chemicals?,
https://www.ewg.org/pfaschemicals/what-are-forever-chemicals.html (last visited
May 14, 2024); see also Report: Up to 110 Million Americans Could Have PFASContaminated Drinking Water, Env't Working Grp. (May 22, 2018),
https://www.ewg.org/research/report-110-million-americans-could-have-pfascontaminated-drinking-water.
60 Our Current Understanding, supra n.56; see also Economic Analysis for the

Final Per- and Polyfluoroalkyl Substances National Primary Drinking Water Regulation,
U.S. Env’t Prot. Agency, EPA-815-R-24-001, 6-27 (Apr. 2024),
https://www.epa.gov/system/files/documents/2024-04/pfas-npdwr_final-rule_ea.pdf[hereinafter Economic Analysis] (noting health effects from numerous PFAS);

Penelope Rice et al., Comparative analysis of the toxicological databases for 6:2
fluorotelomer alcohol (6:2 FTOH) and perfluorohexanoic acid (PFHxA), Food andChemical Toxicology (Mar. 17, 2020),
https://www.sciencedirect.com/science/article/pii/S027869152030137X/pdfft?md5=20
5a8a0a1a4dca9c29060c397408d2ba&pid=1-s2.0-S027869152030137X-main.pdf.
61 U.S. Env’t Prot. Agency, Technical Fact Sheet—Perfluorooctane Sulfonate(PFOS) and Perfluorooctanoic Acid (PFOA) (Nov. 2017),
https://19january2021snapshot.epa.gov/sites/static/files/201712/documents/ffrrofactsheet_contaminants_pfos_pfoa_11-20-17_508_0.pdf.
24

kidney for PFOA, liver and thyroid for PFOS). 62 Moreover, EPA has found PFOA
and PFOS Likely to Be Carcinogenic to Humans. 63 These impacts can result fromexposure to extremely low levels: any level above zero for PFOA and PFOS in
drinking water, according to EPA itself, 64 posing “substantial danger to publichealth or welfare or the environment.” 65

62 87 Fed. Reg. 54,417 (Sept. 6, 2022); PFOS (Perfluorooctane Sulfonate or

Perfluorooctane Sulfonic Acid, Proposition 65: Your Right to Know(last visited May
16, 2024), https://www.p65warnings.ca.gov/fact-sheets/pfos-perfluorooctanesulfonate-or-perfluorooctane-sulfonic-acid; Per- and Polyfluoroalkyl Substances(PFAS) and Your Health: What are the health effects of PFAS?, ATSDR (lastreviewed Nov. 1, 2022), https://www.atsdr.cdc.gov/pfas/health-effects/index.html[hereinafter ATSDR Health Effects].
63 U.S. Env’t Prot. Agency, Maximum Contaminant Level Goals for

Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS) in
Drinking Water (Apr. 2024), https://www.epa.gov/system/files/documents/202404/mclg-doc-for-pfoa-pfos_final-508.pdf.
64 In June 2022, EPA released new data and draft analyses indicating thatthe levels at which negative health effects could occur are much lower thanpreviously understood when EPA issued the 2016 health advisories for PFOA andPFOS (70 parts per trillion or ppt previously). See U.S. Env’t Prot. Agency, Drinking
Water Health Advisories for PFAS (last viewed May 16, 2024),
https://www.epa.gov/system/files/documents/2022-06/drinking-water-ha-pfasfactsheet-communities.pdf. In June 2022, EPA’s advisory levels were 0.004 ppt for
PFOA and 0.02 ppt for PFOS. Id. EPA admitted that “negative health effects may
occur with concentrations of PFOA or PFOS in water that are near zero and below
EPA’s ability to detect at this time.” U.S. Env’t Prot. Agency, EPA Announces New
Drinking Water Health Advisories for PFAS Chemicals, $1 Billion in Bipartisan
Infrastructure Law Funding to Strengthen Health Protections (June 15, 2022),
https://www.epa.gov/newsreleases/epa-announces-new-drinking-water-healthadvisories-pfas-chemicals-1-billion-bipartisan.
65 87 Fed. Reg. 54,417 (Sept. 6, 2022). In September 2022, EPA proposed
designating these two chemicals as hazardous substances under the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) due to their“substantial danger to public health or welfare or the environment.” 87 Fed. Reg.
54,417 (Sept. 6, 2022).
25

PFOA and PFOS exposure can also result in decreased fertility, increased
risk of high blood pressure or pre-eclampsia in pregnant women, and decreased
birth weight in infants. 66 Even low doses may cause developmental delays and othergrowth deficits, while the highest levels of exposure may be associated with birthdefects and neonatal mortality. 67 Additionally, numerous studies provide evidenceof associations between birth weight and/or other developmental effects andexposure to other PFAS such as PFBA, PFDA, PFHxS, PFHxA, HFPO-DA, PFNA,PFUnA, and PFBS. 68
Numerous studies have also linked certain PFAS to increased risk of kidney,
prostate, or testicular cancer, as well as increased risk of obesity, thyroid disease,liver damage, and endocrine disruption. 69 Further some PFAS can weaken the
immune system, leading to reduced ability to fight off infection and decreased
vaccine response. 70 Studies have shown higher mortality risk for COVID-19 in a
population heavily exposed to PFAS (including PFOA, PFOS, PFHxS, PFBS, PFBA,PFPeA, PFHxA, and PFHpA) via drinking water, and other studies have indicatedgeneral immunosuppressive effects of PFBA in the lungs. 71 And EPA has also
admitted PFOA, PFOS, PFNA, PFDA, and PFHxS may result in cardiovascular

66 ATSDR Health Effects, supra n.62.

67 Joint Subcommittee On Environment, Innovation, And Public Health, Per-And Polyfluoroalkyl Substances Strategy Team Of The National Science And
Technology Council, Per- And Polyfluoroalkyl Substances (PFAS) Report, at 33(Mar. 14, 2023) [hereinafter White House Report].
68 Economic Analysis, supra n.60.
69 White House Report, supra n.67, at 32-34.
70 ATSDR Health Effects, supra n.62.
71 Economic Analysis, supra n.60, at 6-29.
26

effects, including high cholesterol, high blood pressure, and other cardiovasculardisease. 72
PFAS contamination poses similar risks to wildlife. Because PFAS canbioaccumulate in animal tissue, exposure can spread quickly between species, or“biomagnify.” 73 For example, in one North Carolina river, researchers found
fourteen PFAS chemicals throughout every level of the food chain, although there
was no “known industrial input” of these chemicals along the river. 74 The effects of
exposure to certain PFAS in both livestock and wildlife largely mirror the adverse
health outcomes in humans, such as liver disease, thyroid disease, reproductive
issues, and developmental barriers. 75
Specifically, PFOS threatens avian species by significantly decreasing
hatching success, 76 a significant threat considering researchers have recorded highlevels of PFAS chemicals in migratory birds more than ninety miles from the72 Id. at 6-17-18, 6-20, 6-27-28.

73 White House Report, supra n.67, at 37-38.

74 Greg Cope, PFAS Present Throughout the Yadkin-Pee Dee River Food

Chain, NC STATE UNIVERSITY NEWS (June 5, 2020),
https://news.ncsu.edu/2020/06/pfas-food-chain.
75 PFAS and Pets and Livestock Health, MICHIGAN PFAS ACTION RESPONSETEAM (last visited April 10, 2024),
https://www.michigan.gov/pfasresponse/faq/categories/pfas-and-pets-and-livestockhealth.
76 Meg Sedlak et al., San Francisco Estuary Institute, Per And Polyfluoroalkyl
Substances (PFAS) in San Francisco Bay: Synthesis and Strategy, RMP
CONTRIBUTION NO. 867, at 37 (June 2018),
https://www.sfei.org/sites/default/files/biblio_files/PFAS%20Synthesis%20and%20St
rategy.pdf.
27

nearest source. 77 PFAS contamination also threatens plant species and soil health,as bioaccumulation of numerous PFAS chemicals can damage plant cell structureand disturb critical biochemical processes, such as photosynthesis and gene
expression. 78 Further, some PFAS resist microbial degradation and linger in thesoil, leading to a significant reduction in microbial biodiversity. 79
It is worth noting that these myriad concerns regarding PFAS impacts are
not new. For decades, scientists have raised concerns about the extensive and welldocumented adverse effects of PFAS. 80 As far back as 1950, 3M’s studies showedthat PFAS chemicals could build up in the general public’s blood. 81 And by the
1960s, 3M and DuPont’s animal studies revealed that PFAS chemicals could pose
health risks. 82 However, it was not until the 1990s that EPA began investigating

77 Univ. of R. I., PFAS in seabirds: Narragansett Bay, Massachusetts Bay,Cape Fear, SCIENCEDAILY (Sept. 23, 2020),
https://www.sciencedaily.com/releases/2020/09/200923164617.htm.
78 Juiyi Li et al., Exposure routes, bioaccumulation and toxic effects of perand polyfluoroalkyl substances (PFASs) on plants: A critical review, 158 ENV’T INTL.
1, 11-13 (2022).
79 Lifeng Cao et al., Occurrence of PFASs and its effect on soil bacteria at afire-training area using PFOS restricted aqueous film-forming, 25 ISCIENCE (Apr.
15, 2022).
80 Jeffrey Kluger, Companies Knew the Dangers of PFAS ‘ForeverChemicals’—and Kept Them Secret, Time (June 1, 2023),
https://time.com/6284266/pfas-forever-chemicals-manufacturers-kept-secret/.
81 Jared Hayes, For Decades, Polluters Knew PFAS Chemicals weredangerous but Hid Risks from Public, EWG (Aug. 29, 2019),
https://www.ewg.org/research/decades-polluters-knew-pfas-chemicals-weredangerous-hid-risks-public.
82 Id.
28

PFAS and the general public became aware of the health impacts PFAS pose,
spurring EPA’s work to reduce PFAS contamination today. 83
II.

PFAS in Pesticide Products.
PFAS presence in pesticides generally results from manufacturers

introducing one or more trifluoromethyl (-CF3) group(s) in pesticides’ molecular
structures to boost their alleged efficacy. 84 The chemical engineering resulting inthis fluorinated backbone with strong carbon-fluoride bonds, “improves both thehydrophobic (water repellent) and lipophobic (fat/oil repellent) properties ofsubstances, 85 and therefore their stability.”86 The pesticide industry specificallylauds this latter property, as it results in longer periods of efficacy, allegedly
diminishing spraying frequency. However, “stability” also equates to persistence:these chemicals linger in the environment far longer than other chemicals.
In the United States, independent testing has revealed high levels of certain
PFAS chemicals in pesticides. 87 A 2022 study found seven out of ten insecticides
contained PFAS chemicals, with one insecticide, Spiromesifen, containing PFOS at

83 U.S. Env’t Prot. Agency, Risk Management for Per and Polyfluoroalkyl

Substances (PFAS) Under TSCA (last visited May 21, 2024),
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/riskmanagement-and-polyfluoroalkyl-substances-pfas.
84 PAN Europe and Générations Futures, Europe’s Toxic Harvest: Unmasking
PFAS Pesticides Authorized in Europe, at 6 (Nov. 2023), https://www.paneurope.info/sites/paneurope.info/files/public/resources/reports/PFAS%20Pesticides%20report%20Novemb
er%202023.pdf.
85 Id.
86 Id.; see also Wilcox, supra n.9.
87 Perkins, supra n.8.
29

a level as high as 19m parts per trillion (ppt), 88 a sharp contrast to EPA’s Maximum
Contaminant Level Goal of zero. 89 EPA originally reported in May 2023 that it later
evaluated the same ten pesticide products included in this study and found no
PFAS. 90 However, internal documents revealed that EPA did find evidence of PFOS
as well as other types of PFAS in the products. 91
Other studies have found similarly high amounts of PFAS in pesticides: A
May 2023 study found 510 ppt of PFOA in Malathion 5EC, an amount over 100,000
times higher than EPA’s Maximum Contaminant Level for drinking water of fourppt, 92 as well as 680 ppt perfluoroheptanesulfonic acid (PFHpS). 93 The same study
88 Lasee, supra n.8.

89 U.S. Env’t Prot. Agency, Per- and Polyfluoroalkyl Substances (PFAS): Final

PFAS National Primary Drinking Water Regulation, Safe Drinking Water Act (lastviewed May 21, 2024), https://www.epa.gov/sdwa/and-polyfluoroalkyl-substancespfas.
90 U.S. Env’t Prot. Agency, EPA Completes Scientific Testing of Pesticide
Products for PFAS (May 30, 2023), https://www.epa.gov/pesticides/epa-completesscientific-testing-pesticide-productspfas#:~:text=Released%20on%20May%2030%2C%202023&text=EPA%20did%20not%20find%20any,the%20summary%20of%20its%20findings.
91 Carey Gillam, US regulator accused of “egregious” misconduct in PFAS
testing of pesticides (May 28, 2024), https://www.thenewlede.org/2024/05/usregulator-accused-of-engaged-in-egregious-misconduct-in-pfas-testing-of-pesticides/;Letter from PEER to EPA (May 28, 2024), https://peer.org/wpcontent/uploads/2024/05/5_28_24_Information-Quality-Act-Demand-for-Correctionfinal-Signed-TWSL.pdf; see also https://www.thenewlede.org/wpcontent/uploads/2024/05/PFAS-in-pesticides-FOIA.pdf.
92 Beyond Pesticides, Report Adds to Evidence of Widespread PFAS Contamination

Calls for Removal of Products (May 4, 2023),
https://beyondpesticides.org/dailynewsblog/2023/05/report-adds-to-evidence-ofwidespread-pfas-contamination-calls-for-removal-of-products/.

93 Eurofins Lancaster Laboratories Environment Testing LLC, Analytical

Report: PFAS Pesticide Testing, Client: Biological Diversity, Job Number: 410113812-1 (Mar. 28, 2023),
https://www.biologicaldiversity.org/campaigns/pesticides_reduction/pdfs/J113812-130

also found 1,500 ppt perfluorobutanoic acid (PFBA) in Oberon 2SC, 94 as well as 350
ppt of perfluorobutanesulfonic acid (PFBS) 95 in Intrepid 2F, the most widely used
insecticide in California, applied to over 1.3 million cumulative acres of California
land per year. 96 Testing completed in 2020 also showed 250 ppt of PFOA in Anvil
10+10, sprayed on over 2.2 million acres the year prior in Massachusetts alone 97
and 3,500 ppt of PFOA in pesticide, Permanone 30-30, used statewide in Marylandfor its mosquito control program. 98

UDS-Level-2-Report-Final-Report.pdf. PFHpS can cause serious health effects,
including cancer, endocrine disruption, accelerated puberty, liver and immune
system damage, and thyroid changes. EWG, Perfluoroheptane Sulfonic Acid
(PFHpS), EWG’s Tap Water Database—2021 Update (last viewed May 21, 2024),
https://www.ewg.org/tapwater/contaminant.php?contamcode=E312.
94 Id. In laboratory animal studies, exposure to high levels of PFBA resulted
in thyroid and liver effects, such as increased thyroid and liver weight, changes inthyroid hormones, decreased cholesterol, and cellular changes in both organs. Other
effects of PFBA exposure included delayed development and decreased red blood
cells and hemoglobin. Minnesota Dept. of Health, Perfluorobutanoic Acid (PFBA)
and Water (Apr. 2022),
https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pf
bainfo.pdf.
95 Analytical Report: PFAS Pesticide Testing, supra n.93, at 8. EPA itself has
admitted to numerous adverse health impacts of PFBS. Env’t Prot. Agency, Learn
About the Human Health Toxicity Assessment for PFBS (last visited May 21, 2024),
https://www.epa.gov/chemical-research/learn-about-human-health-toxicityassessment-pfbs.
96 Center for Biological Diversity, 2021-top-100-pesticide-products-CA_acrestreated,
https://www.biologicaldiversity.org/campaigns/pesticides_reduction/pdfs/2021-top100-pesticide-products-CA_acres-treated.pdf (last visited Jun. 18, 2024).
97 Public Employees for Environmental Responsibility, Press Release: Aerially
Sprayed Pesticide Contains PFAS (Dec. 1, 2020), https://peer.org/aerially-sprayedpesticide-contains-pfas/.
98 Eurofins: Environment Testing America, Analytical Report, Client: PEER,
Project/Site: Permanone 30-30, https://peer.org/wpcontent/uploads/2021/03/3_24_21-Permanone-J31526-1-UDS-Level-2-Report-FinalReport.pdf.
31

In addition to pesticide ingredients, fluorinated HDPE containers used forstorage contaminate pesticides with PFAS. 99 EPA has found eight different PFAS in
HDPE containers in two separate studies, including PFOA, PFBA, PFPeA, PFHxA,
PFHpA, PFNA, PFDA, and PFUdA. 100 These containers can also leachhexafluoropropylene oxide dimer acid, a replacement for PFOA. 101 EPA has
concluded that, while PFAS were not intentionally added to the HDPE containers,
the fluorination process produced PFAS 102—the same process commonly used totreat polypropylene containers. 103
As a result, the agricultural application of pesticides containing PFAS not
only increases the risk of bioaccumulation in the crops and the soil and, in turn,
dietary exposure for the public and wildlife, but also further contaminates theenvironment through aerial drift and runoff. The half-life of some fluorinatedpesticides can reach up to two years for certain premium products, while EPA

99 Dawson, supra n.5, at 16, 19.

100 Thuy Nguyen, U.S. Env’t Prot. Agency, Memorandum: EPA’s Analytical

Chemistry Branch PFAS Testing Rinses from Selected Fluorinated and NonFluorinated HDPE Containers (Mar. 4, 2021),
https://www.epa.gov/sites/default/files/2021-03/documents/results-of-rinsatessamples_03042021.pdf; Thuy Nguyen, Memorandum: Results of EPA’s Analytical
Chemistry Branch Laboratory Study of PFAS Leaching from Fluorinated HDPE
Containers (Aug. 12, 2022), https://www.epa.gov/system/files/documents/202209/EPA%20PFAS%20Container%20Leaching%20Study%2008122022_0.pdf.
101 PEER, supra n.97.
102 See Env’t Prot. Agency, Press Release: EPA Takes Action to Investigate
PFAS Contamination (Jan. 14, 2021), https://www.epa.gov/newsreleases/epa-takesaction-investigate-pfas-contamination [hereinafter January 2021 EPA Press
Release].
103 BERLIN PACKAGING, supra n.6; Neltner, supra n.6.
32

defines pollutants with a half-life of only sixty days or more as “persistent.” 104
PFAS-polluted groundwater can then travel far from the original application site,and contaminate soils long after application. 105 These attributes create massive
potential to damage ecosystems as a result of recognized persistence,
bioaccumulation potential, and ecotoxicological effects. 106 For example, a study
found correlation between the bioaccumulation of fluorinated pesticides inhoneybees and events of mass mortality of honeybee colonies in Italy. 107 There havealso been examples of bioaccumulation in fish and shrimp. 108 Additionally, recent
evidence of acute and chronic immunotoxicity has been reported for several

104 Id. Several recently registered fluorinated pesticides are very persistent,such as pydiflumetofen, registered in May 2018 (DT50 of 2416 days), see Diogo A.
M. Alexandrino, et al., Revisiting Pesticide Pollution: The Case of FluorinatedPesticides, 292 Env’t Pollution 1, 4-5 (Jan. 1, 2022),
https://www.sciencedirect.com/science/article/pii/S0269749121018972; see also
https://www.regulations.gov/document/EPA-HQ-OPP-2015-0775-0029; bixafen
registered in December 2018 (DT50 of 500 days), see Alexandrino, supra n.104, at 5;
see also https://www.regulations.gov/document/EPA-HQ-OPP-2016-0538-0017;
mefentrifluconazole registered in June 2019 (DT50 of 268 days), see Alexandrino,supra n.104, at 5; see also https://www.regulations.gov/document/EPA-HQ-OPP2018-0002-0044; or fluxapyroxad registered in May 2012 (DT50 of 183 days), see
Alexandrino, supra n.104, at 5; see also https://www.regulations.gov/document/EPAHQ-OPP-2010-0421-0020.
105 Sheena Scruggs, PFAS—A Problem in North Carolina
Drinking Water, Environmental Factor, National Institute Of Environmental
Health Sciences (Mar. 2019), https://factor.niehs.nih.gov/2019/3/feature/2-featurepfas.
106 Alexandrino, supra n.104.
107 Marianna Martinello, et al., A survey from 2015 to 2019 to investigate theoccurrence of pesticide residues in dead honeybees and other matrices related tohoneybee mortality incidents in Italy, 12 DIVERSITY 1, 15 (Dec. 2019),
https://doi.org/10.3390/d12010015.
108 Alexandrino, supra n.104, at 5.
33

fluorinated pesticides, including bifenthrin (included on EPA’s PFAS Master List,
discussed infra). 109
This contamination finds its way into the food system, leading to theconcerning health impacts described supra. 110 Multiple studies have establishedthat crops uptake certain PFAS that the public can ingest. 111 The Food and Drug
Administration began systematic testing of PFAS in food in 2019 and has detected

109 Wilcox, supra n.9.

110 Steven Lasee, et al., The Effects of Soil Organic Carbon Content on Plant

Uptake of Soil Perfluoro Alkyl Acids (PFAAs) and the Potential Regulatory
Implications, 40 Environmental Toxicology and Chemistry 832 (Mar. 2021),
https://setac.onlinelibrary.wiley.com/doi/abs/10.1002/etc.4786; Irene Navarro, et al.,Uptake of perfluoroalkyl substances and halogenated flame retardants by crop
plants grown in biosolids-amended soils, 152 Env’t Research 199 (Jan. 2017),
https://www.sciencedirect.com/science/article/abs/pii/S0013935116308490.
111 Lasee, supra n.110; Navarro, supra n.110; E. Bizkarguenaga, et al.,Uptake of perfluorooctanoic acid, perfluorooctane sulfonate and perfluorooctane
sulfonamide by carrot and lettuce from compost amended soil, Sci. Total Env’t (Nov.
2016),
https://www.sciencedirect.com/science/article/abs/pii/S004896971631453X?via%3Dih
ub; Steven Lasee, et al., Plant uptake of PFAAs under a maximum bioavailability
scenario, Environmental Toxicology and Chemistry, at 1-6 (2019),
https://setac.onlinelibrary.wiley.com/doi/full/10.1002/etc.4571; A. Blaine, et al.,Uptake of Perfluoroalkyl Acids Into Edible Crops via Land Applied Biosolids: Field
and Greenhouse Studies, 47 Env’t Science and Technology (2013),
https://cfpub.epa.gov/si/si_public_record_report.cfm?Lab=NHEERL&dirEntryId=30
7369.
34

PFAS chemicals in fruits, vegetables, seafood, and dairy, 112 but has yet to set any
limits to safeguard human health. 113
III.

EPA’s Shifting PFAS Definition.
The number of pesticide ingredients classified as PFAS in the United Statesheavily depends on EPA’s shifting definitions. 114 EPA’s first working definition of
PFAS appeared on its website in 2021, with no scientific antecedents or public
review, and included chemicals that have “at least two adjacent carbon atoms,
where one carbon is fully fluorinated and the other is at least partiallyfluorinated.” 115 This definition included 6,504 PFAS, only half of the 12,034 PFAS
listed in EPA’s own Computational Toxicology database at the time. 116

112 FDA, Analytical Results for PFAS in 2018-2021 Dairy Farm Sampling(Parts Per Trillion) (June 2021),
https://www.fda.gov/media/127850/download?attachment; FDA, Analytical resultsfor PFAS in 2018 Produce Sampling (Parts Per Trillion) (Oct. 2019),
https://www.fda.gov/media/127848/download?attachment; FDA, Analytical Resultsfor PFAS in 2022 Seafood Survey (Parts Per Trillion) (July 2022),
https://www.fda.gov/media/159570/download?attachment.
113 U.S. Food and Drug Administration, supra n.54.
114 See generally EPA PFAS Working Definition Emails, https://peer.org/wpcontent/uploads/2023/08/7_23_EPA_PFAS_Working_Definition_fragments.pdf.
115 FOIA Document 1 (March 2020, internal emails reveal industry pushingfor a limited definition of PFAS to protect their products); Tom Perkins, EPA’s New
Definition of PFAS Could Omit Thousands of ‘Forever Chemicals, The Guardian(Aug. 18, 2023), https://www.theguardian.com/environment/2023/aug/18/epa-newdefinition-pfas-forever-chemicals.
116 Perkins, supra n.115; PEER, EPA Sued Over Failure to Explain its
Narrow PFAS Definition (Apr. 28, 2022), https://peer.org/epa-sued-over-failure-toexplain-its-narrow-pfas-definition/.
35

Many experts described this initial definition as significantly underinclusivecompared to state and international definitions. 117 It specifically excludes ultrashort-chain PFAS (C=2 or 3), despite their extremely high persistence in theenvironment. EPA had been advised that “the narrative that short-chain PFAS aresafe is steadily repeated by the fluorochemical industry, but the narrative detracts
from efforts to manage the entire PFAS class and continues the cycle of developing‘regrettable substitutions.’” 118 Nevertheless, EPA took a further step away frommanaging the entire PFAS class in August 2023 when it decided to define PFAS ona “case-by-case” basis during rulemakings and agency actions, instead of using one
definition for all program areas. 119
In contrast, the United State Geological Survey performance standard
broadly defines PFAS as “a perfluoroalkyl substance or a polyfluoroalkyl substancewith at least one fully fluorinated carbon atom” 120; the U.S. National Defense
Authorization Act (NDAA) includes the PFAS Act of 2019, defining PFAS as any
compound with at least “one fully fluorinated carbon” 121; and many states, including
Colorado, Washington, Maine, Maryland, New York, and California 122 define PFAS

117 FOIA Document 9.

118 FOIA Document 2; see also FOIA Document 9.
119 Perkins, supra n.116.
120 15 U.S.C. § 8931.

121 H. Rep. No. 116-333 (2019).

122 Various state statutes define PFAS as “a class of fluorinated organic

chemicals containing at least one fully fluorinated carbon atom.” See, e.g., C.R.S. 255-1302; Rev. Code Wash. § 70A.350.010; 32 M.R.S. § 1732; Md. Environment CodeAnn. § 6-1601; NY CLS ECL § 37-0101; Cal. Health & Safety Code § 109000.
36

as “a class of fluorinated organic chemicals containing at least one fully fluorinatedcarbon atom.” 123 This definition encompasses a broader range of compounds.
In the context of pesticide ingredients, the “one fully fluorinated carbon”
definition encompasses up to 200 pesticide ingredients. 124 In Maine alone, it covers
55 active ingredients and 1400 pesticide products, which Maine will prohibit
starting in 2030, following its ban on pesticides that include intentionally added
PFAS and pesticides contaminated with PFAS. 125 And in Minnesota, the definition
covers over ninety-one pesticide active ingredients. 126 For example, this definition
covers bifenthrin, 127 a highly stable, fluorinated insecticide with a half-life ranging
from 97 to 345 days, 128 and the main ingredient in over 600 pesticide formulations
today. 129 In 2020, EPA concluded in its human health risk assessment that, when
consumed at levels designated as safe, dietary exposure of bifenthrin was not of

123 Id.

124 See generally id.

125 EWG, Maine data unveils troubling trend: 55 PFAS-related chemicals inover 1,400 pesticides (June 6, 2023), https://www.ewg.org/news-insights/newsrelease/2023/06/maine-data-unveils-troubling-trend-55-pfas-related-chemicals; Me.
Rev. Stat. Ann. Tit. 32, §1732 (5-C).
126 Minnesota Department of Agriculture, Active and Inert PFAS,
https://www.mda.state.mn.us/environment-sustainability/active-inert-pfas (lastviewed May 22, 2024).
127 Due to its potential health and environmental risks, bifenthrin has beenbanned in the European Union, while EPA has even classified it as a possible
human carcinogen. See Danette Drew, et al., Memorandum from Health Effects
Division of EPA to Pesticide Re-evaluation Division, Revised Draft Human Health
Risk Assessment for Registration Review of Bifenthrin, U.S. Env’t Prot. Agency, at
28 (Mar. 25, 2020), https://www.regulations.gov/document/EPA-HQ-OPP-2010-03840279.
128 Id.; see also Wilcox, supra n.9.
129 Wilcox, supra n.9.
37

concern, 130 yet recent testing has revealed elevated amounts of bifenthrin innumerous agricultural crops, exceeding the agency’s safety levels. 131
IV.

EPA’s Efforts to Address PFAS Generally.
EPA is well aware of PFAS chemicals’ many risks, as its work on PFAS began

six years ago following a National Leadership Summit on PFAS that brought
together more than 200 federal, state, and local leaders to discuss steps to address
PFAS contamination. 132 As a result of these meetings and approximately 120,000
public comments, EPA developed the 2019 PFAS Action Plan, 133 which outlined thetools EPA planned to use in addressing PFAS in drinking water, cleaning up PFAS
contamination, expanding monitoring of PFAS manufacturing, increasing PFAS
scientific research, and promoting effective enforcement tools. 134 Specifically, under
this plan, EPA initiated the process to develop a national primary drinking water
regulation for PFOA and PFOS; sought comment regarding a potential designation
for PFOA, PFOS, and other PFAS chemicals as CERCLA hazardous substances andhazardous waste under RCRA; and released several assessments. 135

130 Drew, supra n.127, at 27.
131 Wilcox, supra n.9.

132 U.S. Env’t Prot. Agency, Aggressively Addressing PFAS at EPA (Jan. 7,2020), https://www.epa.gov/newsreleases/aggressively-addressing-pfas-epa.
133 Id.; U.S. Env’t Prot. Agency, EPA’s Per-and Polyfluoroalkyl Substances(PFAS) Action Plan, EPA 823R18004 (Feb. 2019),
https://19january2021snapshot.epa.gov/sites/static/files/201902/documents/pfas_action_plan_021319_508compliant_1.pdf.
134 Id.
135 U.S. Env’t Prot. Agency, EPA Delivers Results on PFAS Action Plan (Jan.
19, 2021), https://www.epa.gov/newsreleases/epa-delivers-results-pfas-action-plan.
38

Over two years later, in October 2021, EPA continued its work to respond to
PFAS chemicals’ grave public health and environmental impacts through its PFAS
Strategic Roadmap: EPA’s Commitments to Action 2021-2024, setting forth its“whole-of-agency” approach to address PFAS. 136 In the Roadmap, EPA described
PFAS as an “urgent public health and environmental issue facing communities
across the United States,” and admitted that “the risks posed by PFAS demand that
the Agency attack the problem on multiple fronts at the same time.” 137 Later, EPA
Administrator Regan discussed the Roadmap’s purpose, stating:“For far too long, families across America – especially those inunderserved communities – have suffered from PFAS in their water,
their air, or in the land their children play on. This comprehensive,
national PFAS strategy will deliver protection to people who are
hurting, by advancing bold and concrete actions that address the fulllifecycle of these chemicals. Let there be no doubt that EPA islistening, we have your back, and we are laser focused on protecting
people from pollution and holding polluters accountable.” 138
In response to this critical issue, the Roadmap set forth timeframes for EPA
actions to address PFAS under various statutory authorities including the Toxic
Substances Control Act (TSCA), Resource Conservation and Recovery Act (RCRA),
Comprehensive Environmental Response, Compensation and Liability Act(CERCLA), Safe Drinking Water Act (SDWA), Clean Water Act (CWA), and Clean
Air Act (CAA), but not FIFRA. The Roadmap describes EPA’s approach as centeredon the following strategies: (i) consideration of the full lifecycle of PFAS; (ii) a focus

136 PFAS Strategic Roadmap, supra n.2.
137 Id.

138 U.S. Env’t Prot. Agency, supra n.12.

39

on prevention of PFAS entering the environment as a "foundational step" toreducing potential risks; (iii) investment in scientific research to ensure sciencebased decision-making; (iv) accountability for polluters; and (v) prioritization ofprotecting disadvantaged communities.
Accordingly, EPA took several actions to address PFAS contamination. First,
just before publishing the Roadmap in July 2020, EPA promulgated a significant
new use rule (SNUR) under TSCA for long-chain perfluoroalkyl carboxylate(LCPFAC) and PFOS chemical substances. 139 This final rule required notification to
EPA at least ninety days before manufacturing, importing, or processing thesechemical substances for significant new uses, including (1) the manufacturing,
importing, or processing of a subset of LCPFAC chemical substances for any usethat was not an ongoing use as of December 31, 2015, (2) the manufacturing,
importing, or processing of all other LCPFAC chemical substances for which there
were no ongoing uses as of January 21, 2015, (3) the importing of a subset of
LCPFAC chemicals as part of a surface coating on articles, and (4) the importing of
PFOS as part of carpets. 140 The required SNUR initiated EPA’s evaluation ofpotential risks associated with the significant new uses, such as “high cholesterol,increased liver enzymes, decreased vaccination response, thyroid disorders,pregnancy-induced hypertension and preeclampsia, and cancer (testicular and139 85 Fed. Reg. 45,109 (July 27, 2020).

140 Id.; 40 C.F.R. §§ 721.10536, 721.9582.

40

kidney)” 141 to determine whether the “chemical presents an unreasonable risk of
injury to health or the environment.” 142
Specific to fluorinated HDPE containers, in March 2022, EPA sent a letter toall fluorinated HDPE container manufacturers, informing them that the creation ofincidental PFAS during the manufacturing process, or on containers to be imported,
constituted a significant new use under this rule, requiring manufacturers to notify
EPA. At the time, EPA already believed that “[g]iven [its] current understanding of
PFAS, … PFAS are unlikely to receive a determination of ‘not likely’ to present an
unreasonable risk.” 143 And sure enough, the first evaluation EPA conducted on asignificant new use of HDPE fluorinated containers found they are “highly toxic andpresent unreasonable risks,” 144 resulting in an EPA order to a manufacturer,
Inhance, LLC, discussed infra, to stop manufacturing PFOA, PFNA, and PFDA
produced from the fluorination of HDPE. 145
Second, in September 2022, EPA proposed to designate PFOA and PFOS as
CERCLA hazardous substances, as substantial evidence exists that they present“substantial danger … to the public health or welfare or the environment,” inaccordance with CERCLA section 102(a). 146 Specifically, EPA explained that PFOA
and PFOS qualify as hazardous substances because they bioaccumulate, and their

141 85 Fed. Reg. 45,113 (July 27, 2020).
142 15 U.S.C. § 2604(a)(3)(A).

143 Framework for TSCA, supra n.3, at 14.

144 EPA Orders to Inhance, supra n.3; see also Framework for TSCA, supran.3, at 14.
145 Id.
146 See 87 Fed. Reg. 54,415-54,442 (Sept. 6, 2022).
41

“water-solubility allows them to migrate readily from soil to groundwater,”contaminating both surface and groundwater sources of drinking water for long
periods of time and threatening human health. 147 EPA further detailed humanhealth impacts including “effects on the immune system, the cardiovascular system,
human development (e.g., decreased birth weight), and cancer.” 148 Thus, consideringthat “PFOA and PFOS are common contaminants in the environment because of
their release into the environment since the 1940s and their resistance todegradation,” 149 EPA found these chemicals to meet the requirements of “hazardous
substances” under CERCLA.
Third, EPA finalized a rule to require enhanced PFAS reporting to the Toxics
Release Inventory under the Emergency Planning and Community Right-to-Know
Act (EPCRA), designating PFAS as “chemicals of special concern” andacknowledging that PFAS are harmful, even at low levels, because of their highpersistence in the human environment. 150 EPA did so out of “concern for evenrelatively small quantities of PFAS, and PFAS’ persistence in the environment andgrowing evidence showing potential adverse human health effects.” 151 EPA has also
pledged to designate nine PFAS as “hazardous constituents” under RCRA, including

147 Id. at 54,424.
148 Id.

149 Id. at 54,426.

150 Changes to Reporting Requirements for Per- and Polyfluoroalkyl

Substances and to Supplier Notifications for Chemicals of Special Concern,
Community Right-to-Know Toxic Chemical Release Reporting, 80 Fed. Reg. 74,360(Oct. 31, 2023) (to be codified at 40 C.F.R. pt. 372).
151 Id. at 74,365.
42

PFOA, PFOS, PFBS), HFPO–DA, PFNA, PFHxS, PFDA, PFHxA, PFBA, which
would make these PFAS subject to investigation and cleanup activities at permitted
hazardous waste facilities. 152
And finally, most recently, in April 2024, EPA issued final National Primary
Drinking Water Regulation for six PFAS, establishing legally enforceable Maximum
Contaminant Levels (MCLs) and Maximum Contaminant Level Goals (MCLGs), for
six PFAS in drinking water including PFOA, PFOS, PFHxS, PFNA, and HFPO-DA
as contaminants with individual MCLs, and PFAS mixtures containing at least two
or more of PFHxS, PFNA, HFPO-DA, and PFBS. 153 The MCLGs represent “the levelof a contaminant in drinking water below which there is no known or expected risk
to health,” and the MCLs are enforceable standards for the highest level of acontaminant that is allowed in drinking water, set as close to MCLGs as feasibleusing the best available treatment technology.
Specifically, for PFOA and PFOS, EPA set an MCL of four parts per trillion
and a Maximum Contaminant Level Goal of zero as a result of its determinationthat PFOS and PFOA are Likely to Be Carcinogenic to Humans. 154 Regarding271).

152 89 Fed. Reg. 8606 (Feb. 8, 2024) (to be codified at 40 C.F.R. pts. 261 and
153 Final PFAS National Primary Drinking Water Regulation, supra n.89;

U.S. Env’t Prot. Agency, Maximum Contaminant Level Goals (MCLGs) for Three
Individual Per- and Polyfluoroalkyl Substances (PFAS) and a Mixture of Four
PFAS, EPA-815-R-24-004 (Apr. 2024),
https://www.epa.gov/system/files/documents/2024-04/pfas-hi-mclg_final508.pdf(describing toxicity of numerous PFAS and impacts on human health).
154 Maximum Contaminant Level Goals for PFOA and PFOS, supra n.63, at
27.
43

PFOA, EPA found “[t]he strongest evidence of an association between PFOA
exposure and cancer in human populations is from studies of kidney cancer.” 155
Under the Guidelines for Carcinogen Risk Assessment, EPA determined that PFOA
is Likely to Be Carcinogenic to Humans, as a result of evidence of kidney andtesticular cancer in humans and LCTs, PACTs, and hepatocellular adenomas inrats. 156 And regarding PFOS, EPA stated that the available epidemiology studies
report elevated risk of liver, bladder, kidney, prostate, and breast cancers after
chronic PFOS exposure in some studies from plausible epidemiological evidence
alone. 157
For PFHxS, PFNA, and HFPO-DA as contaminants with individual MCLs,
and PFAS mixtures containing at least two or more of PFHxS, PFNA, HFPO-DA,
and PFBS, EPA set both the MCL and MCLG at ten parts per trillion. In support,
EPA described associations between PFBS exposure and thyroid, developmental,
and kidney effects based on studies in animals; 158 between PFNA exposure andadverse effects on the liver, development, and reproductive and immune systems; 159
and between PFHxS exposure and reported health effects on the liver, thyroid,development, as well as potential breast cancer risk. 160

155 Id. at 8-9; see also Learn about the Human Health Toxicity Assessment for

PFBS, supra n.95.
156 Maximum Contaminant Level Goals for PFOA and PFOS, supra n.63, at
12-13.
157 Id. at 17.
158 Id. at 2-5.
159 MCLGs for Three Individual Per- and Polyfluoroalkyl Substances, supra
n.153, at 2-8.
160 Id. at 2-11.
44

ARGUMENT
Despite EPA’s repeated acknowledgement of PFAS as hazardous chemicals
and its regulatory action in other contexts, EPA has yet to address the“unreasonable” risks 161 of PFAS in pesticides under FIFRA. Instead, EPA has
admitted several active and inert ingredients qualify as PFAS but has nonethelessfailed to initiate any cancellation proceedings or suspensions, beyond cancellinginert ingredients no longer in use. 162 Further, EPA has failed to amend its
regulations to thoroughly address these acknowledged impacts of PFAS and toprohibit fluorinated HDPE and polypropylene pesticide containers, despite
repeatedly acknowledging their harms.
EPA must immediately act to cease the ongoing intentional spraying of PFAS
on our nation’s soils to safeguard human health and the environment as FIFRA
mandates. First, EPA must cancel all active and inert ingredients in pesticides that
qualify as PFAS chemicals. This reason for this is self-explanatory: FIFRA provides
that cancellation is warranted when EPA finds that a registered pesticide has“unreasonable adverse effects on the environment,” meaning “any unreasonable risk
to man or the environment, taking into account the economic, social, andenvironmental costs and benefits of the use of any pesticide.” 163 Considering that
EPA has described the entire PFAS class as “an urgent public health and

161 EPA Orders to Inhance, supra n.3; see also Framework for TSCA, supran.3, at 14.
162 Dawson, supra n.5, at 16, 19.
163 7 U.S.C. § 136d(b); id. § 136(bb).

45environmental issue” 164 and even designated PFOS and PFOA as hazardous
substances that may present “substantial danger … to the public health or welfare
or the environment,” 165 EPA must cancel and suspend these registrations. At aminimum, EPA must initiate special review to determine whether to cancel theseregistrations, as PFAS ingredients in pesticides undoubtedly “may pose a risk ofserious acute injury to humans or domestic animals.” 166
Second, EPA must amend its FIFRA regulations to prohibit future
registrations of pesticides with ingredients that qualify as PFAS, as any benefits
from PFAS use cannot possibly outweigh the high costs. These chemicals’
persistence and bioaccumulation result in numerous adverse effects on theenvironment, as well as human health and massive economic and societal costs, far
exceeding short-term industry profits.
Third, EPA should define PFAS in its FIFRA regulations and, alternative tocancellation, amend the regulations for clarity to require consideration of PFAS
chemicals’ unique impacts on the environment. Specifically, EPA should define
PFAS in its regulations as “a class of fluorinated organic chemicals containing atleast one fully fluorinated carbon atom,” 167 and require additional data and testingfor persistent, bioaccumulative, and toxic chemicals in the PFAS class, as it does

164 PFAS Strategic Roadmap, supra n.2, at 5.

165 See 87 Fed. Reg. 54,415-54,442 (Sept. 6, 2022).
166 40 C.F.R. § 154.7(a)(1).

167 Conference Committee Report on S.F. NO. 1955,

https://www.revisor.mn.gov/bills/text.php?number=SF1955&version=0&session=ls9
3.0&session_year=2023&session_number=0&type=ccr.
46

under TSCA. EPA should also amend its data requirements to include physicalchemical property testing, other testing such as environmental
fate/bioaccumulation, toxicokinetic, and human health and/or environmental
toxicity testing to ensure the agency has adequate information on PFAS’s uniquecharacteristics before making registration decisions.
Fourth, EPA must amend FIFRA regulations to prohibit fluorinated HDPE
and polypropylene containers for pesticide storage. FIFRA mandates that EPA
ensure “safe storage” of pesticides, 168 yet EPA has failed to act despite repeatedly
admitting that these widely used pesticide containers leach PFAS chemicals into
pesticides.
And finally, EPA must explicitly require reporting of PFAS contamination.
EPA’s numerous statements, assessments, and Roadmap make plain that PFAS are“toxicologically significant” contaminants, requiring mandatory reporting under
FIFRA. If registrants fail to report, EPA must then issue a stop sale, use, or
removal order to immediately halt the sale of adulterated pesticides, as FIFRA
mandates.
I.

EPA Must Cancel All Active and Inert PFAS Ingredients Currently
Registered.
FIFRA prohibits the registration and use of pesticides that cause“unreasonable adverse effects on the environment.” 169 As detailed supra, EPA

168 7 U.S.C. 136q(e)(1)(A).
169 Id. § 136a(c)(5)(C).

47

possesses a mountain of evidence demonstrating that PFAS ingredients havecaused and continue to cause unreasonable risk to humans and the environment,
and furthermore, that the benefits of their continued use do not outweigh the costs.
These ongoing harms present an imminent hazard, which EPA itself has foundnecessary to address in all other contexts yet has failed to address under FIFRA. As
a result, and pursuant to its obligations under FIFRA, EPA must now cancel all
registrations of pesticides with ingredients that qualify as PFAS and suspend all
registrations pending completion of cancellation proceedings.
A.

EPA Admits Numerous Active Ingredients Qualify as PFAS.

EPA itself has repeatedly acknowledged that at least several active
ingredients qualify as PFAS, though the exact number depends on EPA’s repeatedly
shifting definition explained supra. 170 However, even under its own narrow
definition from 2021, EPA admitted at least four active ingredients qualify as
PFAS, with its Master List including lufenuron, novifluron, tetraconazole, andpyrifluquinazon as PFAS. 171 And just last April, EPA again confirmed that four

170 Documents obtained through FOIA may shed light on this narrow

definition. In March 2020, internal emails show industry pressuring state
regulators for a limited definition of PFAS to protect their products. See FOIA
Document 1. And July 2020 internal EPA emails debate including short-chained
PFAS in the definition because “the narrative that short-chain PFAS are safe issteadily repeated by the fluorochemical industry, but the narrative detracts from
efforts to manage the entire PFAS class and continues the cycle of developing‘regrettable substitutions.” FOIA Document 2.
171 FOIA Document 3; see also Wilcox, supra n.9. However, it should be notedthat just months later in March 2021, EPA boldly claimed no active pesticide
ingredients qualified as PFAS. Internal emails from around this time explained thisstark contradiction by stating: “Each pesticide product submitted for registration is48

active ingredients qualify as PFAS: broflanilide, pyrifluquinazon, tetraconazole, andhexaflumuron. 172 In fact, despite its 2019 Action Plan, EPA’s most recent
registration of an active PFAS ingredient occurred on January 14, 2021, when EPA
unconditionally registered broflanilide, despite the chemical plainly qualifying as
PFAS under the definition of “a perfluoroalkyl substance or a polyfluoroalkyl
substance with at least one fully fluorinated carbon atom,” 173 and EPA itself
classifying it as a PFAS. 174 EPA even proposed new uses for broflanilide in April
2022, following its more recent Roadmap. 175
Yet far beyond the four active ingredients EPA listed, state-based estimatessuggest the number of PFAS active ingredients remains in the hundreds. Under the
USGS’s definition of “fully fluorinated carbon,” 15 U.S.C. § 8931(2)(B), which
informed Minnesota’s definition of PFAS as “a class of fluorinated organic chemicals
containing at least one fully fluorinated carbon atom,” 176 ninety-one pesticide active

evaluated considering all the ingredients in the product, including both active andinert ingredients. Pesticide active ingredients on the list are included because they
have small subcultural elements similar to those of the substructures that informed
the creation of the PFAS Master List. Pesticides that have small PFAS substituents
could produce PFAS through various processes. However, current registeredpesticides do not contain ingredients that have structures or properties comparable
to prominent PFAS.”
172 Dawson, supra n.5.
173 Notice of Pesticide Registration, supra n.4 (unconditional registration of
broflanilide by EPA).
174 Dawson, supra n.5.
175 See 87 Fed. Reg. 24,556 (Apr. 26, 2022).
176 Minnesota Department of Agriculture, supra n.126.
49

ingredients qualified as PFAS as of February 2024 in Minnesota alone. 177 And in
Maine, this definition covers 55 active ingredients and 1400 pesticide products. 178
B.

EPA Has Admitted Several Inert Ingredients Qualify as PFAS.

Evidence also suggests that currently registered inert ingredients inpesticides qualify as PFAS. In March 2023, testing commissioned by the Center for
Biological Diversity found PFAS in three out of seven agricultural pesticides tested,
two of which, PFBS and PFHpS, are not known to leach from fluorinatedcontainers. 179 Specifically, Oberon 2SC was found to contain 1,500 ppt
perfluorobutanoic acid (PFBA), while Intrepid 2F—the most widely-used insecticide
product in California—had 350 ppt of perfluorobutanesulfonic acid (PFBS). 180
Further, recent research from the United States Department of Agriculture (USDA)
indicates inert PFAS ingredients in pesticides: Having detected PFAS in plants
grown in their research laboratory greenhouse, the USDA carried out further

177 Id.

178 Amarelo, supra n.10; see also

https://www.mainelegislature.org/legis/bills/getPDF.asp?paper=HP1501&item=4&s
num=130;
https://www.mainelegislature.org/legis/statutes/32/title32sec1732.html#:~:text=5%2
DA.,one%20fully%20fluorinated%20carbon%20atom.
179 Although not as clearly from inert ingredients, the study also found
Malathion 5EC to contain 510 parts-per-trillion (ppt) PFOA, a level over 100,000
times higher than the level EPA considers safe in drinking water (0.004 ppt).
180 Over 1.7 million pounds of Intrepid 2F were applied on 1.3 million acres ofCalifornia land in 2021. Over 22,000 pounds of Oberon 2SC and over 15,000 poundsof Malathion were also applied. These pesticides are used most heavily in
California’s Central Valley, which also has elevated levels of PFAS in drinking
water. See, e.g., Jeremy Tanner, Map: Fresno Among U.S. Cities with High Levels of’Forever Chemicals‘ in Tap Water, YourCentralValley.com (Aug. 26, 2023),
https://www.yourcentralvalley.com/news/u-s-world/map-fresno-among-u-s-citieswith-high-levels-of-forever-chemicals-in-tap-water/.
50

analysis for PFAS in the potting soil, water, fertilizer, insecticides, and other plants
and found the source of PFAS contamination to be the insecticides used on the soil,
which did not have PFAS as active ingredients. 181
In April 2023, EPA also confirmed that at least two inert ingredientscurrently registered qualify as PFAS. 182 But EPA’s only actions to address this issue
consisted of a December 2022 notice, announcing the removal of twelve inert
ingredients from EPA’s list of approved ingredients, and a February 2024 noticeproposing removal of one other, despite the fact that none of these inert ingredientswere still in use. 183
C.

EPA Must Cancel Active and Inert Ingredients in the PFASClass Due to Unreasonable Risks to Human Health and theEnvironment in Violation of FIFRA.

Cancellation is warranted when EPA finds that when “used in accordancewith widespread and commonly recognized practice,” a registered pesticide has“unreasonable adverse effects on the environment,” that is “any unreasonable risk
to man or the environment, taking into account the economic, social, andenvironmental costs and benefits of the use of any pesticide.” 184 Here, EPA mustcancel all registrations of PFAS active and inert ingredients because the uses forwhich they are approved continue causing unreasonable risk to humans, theenvironment, and endangered and threatened species. Stated another way, how

181 Lasee, supra n.8.

182 Dawson, supra n.5.

183 87 Fed. Reg. 76,488 (Dec. 14, 2022); 89 Fed. Reg. 14,646 (Feb. 28, 2024).
184 7 U.S.C. § 136d(b); Id. § 136(bb).

51

PFAS are “used in accordance with widespread and commonly recognizedpractice,” 185 continues causing unreasonable risk to humans, the environment, andendangered and threatened species.
The continued use of PFAS ingredients actively endangers human health. As
described supra, the medical scientific community, not to mention EPA itself,
overwhelmingly agrees that certain PFAS causes numerous adverse human healthimpacts, including associations with testicular and kidney cancers, reproductive
disorders, thyroid disease, high cholesterol levels, reduced immune response, andin-creased susceptibility to COVID-19. 186 EPA has characterized the entire PFAS
class as “an urgent public health and environmental issue” 187 and even designed
PFOS and PFOA as hazardous substances that may present “substantial danger tothe public health or welfare or the environment.” 188
EPA has previously cancelled other pesticide ingredients for similar reasons.
For instance, EPA cancelled the registration of carbofuran in 2009 because of“unacceptable” ecological, dietary, and worker risks posing “unreasonable adverse
effects.” 189 Likewise, in 2012, EPA cancelled the registration of methyl iodide after apetition prompted EPA and the producer, Arysta, to take a second look at the

185 Id. § 136a(c)(5)(D).
186 Wilcox, supra n.9.

187 PFAS Strategic Roadmap, supra n.2, at 5.

188 87 Fed. Reg. 54,415-54,442 (Sept. 6, 2022).

189 U.S. Env’t Prot. Agency, Carbofuran Cancellation Process, Pesticides:

Reregistration,
https://archive.epa.gov/pesticides/reregistration/web/html/carbofuran_noic.html.
52

unreasonable risks of the product. 190 Methyl iodide, too, has strong links to cancer,
reproductive complications like late-term miscarriages, and neurological disorders,
its toxicity far greater than EPA recognized when it initially registered the productin 2007. 191
Further, the harms associated with PFAS ingredients’ registered uses are by
no means limited to humans, and EPA admitted as much when it acknowledged theecological risks in other contexts. PFAS can enter the environment throughproduction or waste streams and persist, causing adverse reproductive,
developmental, and immunological effects in animals as well. 192 Specifically, EPA
itself has explained that PFOA and PFOS are hazardous due to bioaccumulationand their water-solubility, which allows them to easily move from soil to water,
contaminating both surface and groundwater for long periods of time. 193
Most concerning, however, is the danger certain PFAS pose to federally
protected endangered and threatened species. A literature review 194 of 220 peerreviewed studies documenting PFAS contamination in wildlife found levels of

190 Beyond Pesticides, Methyl Iodide Uses To Formally End in the U.S., Daily

News Blog (Nov. 28, 2012),
https://beyondpesticides.org/dailynewsblog/2012/11/methyl-iodide-uses-to-formallyend-in-the-us/.
191 Id.
192 U.S. Env’t Prot. Agency, Understanding PFAS in the Environment (Dec.
21, 2018), https://www.epa.gov/sciencematters/understanding-pfasenvironment#:~:text=PFAS%20can%20enter%20the%20environment,effects%20in%
20animals%20and%20humans.
193 87 Fed. Reg. 54,424 (Sept. 6, 2022).
194 Env’t Working Group, Global danger: Wildlife at risk from PFAS exposure,https://www.ewg.org/interactive-maps/pfas_in_wildlife/map/.
53

several PFAS, including PFOS and PFOA, present in numerous endangered andthreatened species, including the West Indian manatee, 195 Hawksbill turtle, 196
leatherback sea turtle, 197 Florida manatee, 198 Kemp’s ridley sea turtle, 199 green sea
turtle, 200 and Southern Resident Killer Whales. 201 Paired with the myriad of
information on harms to wildlife more generally, described supra, these findings
indicate grave concerns for listed species.
Petitioners believe that the facts pertinent to balancing the risks and benefitsof PFAS active ingredients are peculiarly within the knowledge of the EPA, andthus the burden should not fall to Petitioners to conduct such balancing test inorder to prove cancellation is warranted. 202 Nevertheless, Petitioners do so based on

195 Kady Palmer, et al., Per- and polyfluoroalkyl substances (PFAS) in plasmaof the West Indian manatee (Trichechus manatus), 140 MARINE POLLUTION
BULLETIN 610 (Mar. 2019), https://pubmed.ncbi.nlm.nih.gov/30803684/.
196 Jennifer M. Keller, et al., Perfluoroalkyl Contaminants in Plasma of Five
Sea Turtle Species: Comparisons in Concentration and Potential Health Risks, 31
ENV’T TOXICOLOGY AND CHEMISTRY 1223 (Jun. 2012),
https://setac.onlinelibrary.wiley.com/doi/10.1002/etc.1818.
197 Id.
198 Emily K. Griffin, Evaluation of Different Extraction Methods for the
Analysis of Per- and Polyfluoroalkyl Substances in Dried Blood Spots from theFlorida Manatee (Trichechus manatus), 40 ENV’T TOXICOLOGY AND CHEMISTRY 2726,(Oct. 2021), https://pubmed.ncbi.nlm.nih.gov/34293220/.
199 Keller, supra n.196.
200 Id.
201 Kiah Lee et al., Emerging Contaminants and New POPs (PFAS andHBCDD) in Endangered Southern Resident and Bigg’s (Transient) Killer Whales(Orcinus orca): In Utero Maternal Transfer and Pollution Management Implications,
57 ENV’T SCIENCE TECHNOLOGY 360 (Dec. 2022),
https://pubs.acs.org/doi/10.1021/acs.est.2c04126.
202 “[T]he ordinary rule, based on considerations of fairness, does not place
the burden upon a litigant of establishing facts peculiarly within the knowledge of
his adversary.” Ellis v. Housenger, 252 F. Supp. 3d 800, 809 n.7 (N.D. Cal. 2017)(citing Campbell v. United States, 365 U.S. 85, 96 (1961)).
54

the evidence before them in an attempt to demonstrate the impossibility of EPA
concluding the purported benefits of PFAS active ingredients outweigh the risks.
The costs resulting from PFAS use, described further infra, are numerous andsignificant and cannot be outweighed by the putative benefits of continued use. 203
For example, regarding broflanilide, EPA’s registration decision offers insight into
what the agency views as its benefits: namely a benefit for popcorn and sweet corn
growers only, as they do not rely on Bacillus thuringiensis (Bt) traited varieties for
production. 204 EPA also noted broflanilide’s benefit of providing yet anotherpesticide for growers to use in their rotations. 205 However, these two factors are
more than counterbalanced by the costs just discussed. While broflanilide may
provide an additional tool, the negative human health and ecological impacts ofcontinued PFAS contamination far outweighs its minor benefits.
So, while Petitioners fail to see how PFAS active ingredients offer any
durable benefits, even if EPA concludes some benefits exist, such benefits simply
cannot outweigh the laundry list of costs and irreparable environmental and publichealth harm EPA has already recognized from PFAS contamination. Cancellation of
all PFAS ingredient registrations is not only warranted but absolutely critical to

203 See also Public Employees for Environmental Responsibility et al., Petition

for Rulemaking to Amend EPA’s 1984 Pesticide Regulation that Waived Efficacy
Data Requirements (2023).
204 Env’t Prot. Agency, Registration Decision for the New Active Ingredient
Broflanilide (Jan. 13, 2021), https://www.regulations.gov/document/EPA-HQ-OPP2018-0053-0050.
205 Id.
55

safeguard the public, farmers, farmworkers, children, the environment, andimperiled wildlife.
D. Immediate Suspension of PFAS Ingredient Registrations Pending
Cancellation Is Necessary to Prevent an Imminent Hazard.
Because cancellation takes time, EPA may suspend the registration of apesticide immediately if it finds it necessary “to prevent an imminent hazard during
the time required for cancellation.” 206 An imminent hazard exists if during the timerequired for cancellation the continued use of a pesticide would (1) “be likely toresult in unreasonable adverse effects on the environment” or (2) “involve
unreasonable hazard to the survival of a species declared endangered or
threatened” by the Endangered Species Act (ESA). 207 “[C]ancellation ... proceedings
may take one or two years to complete.” 208 Courts have explained that an“‘imminent hazard’ is not limited to a concept of crisis[.]” 209 Rather, “[i]t is enough if
there is substantial likelihood that serious harm will be experienced during the year
or two required.’” 210
As is laid out in great detail supra, the continued registration and use of
PFAS ingredients in pesticide products continues resulting in unreasonable adverse
effects on the environment and likely presents an unreasonable hazard to the

206 7 U.S.C. § 136d(c)(1).
207 Id. § 136(l).

208 Ellis, 252 F. Supp. 3d at 806 (citing Love v. Thomas, 858 F.2d 1347, 1350

(9th Cir. 1988), cert. denied, 490 U.S. 1035 (1989)).
209 Env’t Def. Fund v. EPA, 510 F.2d 1292, 1297 (D.C. Cir. 1975) (citing Env’t
Def. Fund v. EPA, 465 F.2d 528, 540 (D.C. Cir. 1972)).
210 Id.
56

survival of hundreds of endangered and threatened species. These harms are
occurring now and will continue to occur during the one to two years it will take
EPA to complete cancellation proceedings for PFAS ingredient registrations. Thus,
it is well within EPA’s authority to take action and suspend PFAS ingredientregistrations, and Petitioners urge EPA to do so.
1. Continued Use of PFAS Ingredients During Cancellation
Proceedings Is Likely to Result in Unreasonable Adverse
Effects on the Environment.
As is detailed supra, the currently approved uses of PFAS are causing
unreasonable adverse effects on the environment, including “unreasonable risk to
man [and] the environment,” and these effects, coupled with the costs of PFAS
chemicals’ continued use, heavily outweigh any benefit the PFAS ingredients offer.
Extensive research demonstrates that PFAS are harmful to human health even atminuscule concentrations. 211 EPA itself has categorized certain PFAS as“hazardous” due to “effects on the immune system, the cardiovascular system,
development (e.g., decreased birth weight), and cancer.” 212 These unreasonable
adverse effects are happening now. PFAS ingredients continue leaching through soil

211 Changes to Reporting Requirements for Per- and Polyfluoroalkyl

Substances and to Supplier Notifications for Chemicals of Special Concern;
Community Right-to-Know Toxic Chemical Release Reporting, 80 Fed. Reg. 74,360(Oct. 31, 2023) (to be codified at 40 C.F.R. pt. 372) (acknowledging that PFAS are
harmful, even at low levels, because of their high persistence in the humanenvironment).
212 Id.; U.S. Env’t Prot. Agency, Technical Fact Sheet: Drinking Water Health
Advisories for Four PFAS (PFOA, PFOS, GenX chemicals, and PFBS ), June 2022,
https://www.epa.gov/system/files/documents/2022-06/technical-factsheet-fourPFAS.pdf.
57into groundwater, the public continues consuming PFAS-contaminated foods, and
PFAS chemicals continue impacting both human health and the health of wildlife.
While some PFAS impacts take time to manifest (e.g., cancer), the PFAS
applications that are linked to cancer are occurring and will continue to frequently
occur during the time required for cancellation if EPA does not suspend
registrations. Preventing 1-2 years of further contamination of soils, food, anddrinking water may very well prevent an eventual diagnosis, safeguard avulnerable child from an impaired immune system, and may mean the difference
between a family being able to have a child or not. Petitioners urge EPA tosafeguard public health now and not delay action any further.
2. Continued Use of PFAS Will Involve Unreasonable Hazard
to the Survival of Endangered or Threatened Species.
FIFRA does not define unreasonable hazard, and no court has clearlyinterpreted the meaning of the phrase to date. Thus, Petitioners reasonablyinterpret the phrase based on its plain language and the Northern District ofCalifornia’s discussion of the standard in Ellis v. Housenger, 213 to mean when thesurvival of an endangered or threatened species will be directly or indirectly
threatened.
The facts pertinent to any effects certain PFAS might have on endangered or
threatened species are peculiarly within the knowledge of the EPA and other expert

213 See Ellis, 252 F. Supp. 3d at 809 n.6 (detailing that a claim of

unreasonable hazard alone is insufficient and that the failure to “cite to a study or
article” to show an unreasonable hazard to the survival of an endangered or
threatened species renders such showing invalid).
58

agencies, and thus Petitioners alone should not bear the burden of proving thereality of unreasonable hazard. 214 Nevertheless, Petitioners note that a myriad ofstudies have found harm to wildlife from PFAS contamination. 215 And as describedsupra, numerous endangered species have been found with certain PFAS inthem, 216 including the West Indian manatee, 217 Hawksbill turtle, 218 leatherback sea
turtle, 219 Florida manatee, 220 Kemp’s ridley sea turtle, 221 green sea turtle, 222 andSouthern Resident Killer Whales. 223
Only formal consultation will confirm whether the potential adverse effects
are likely to jeopardize the continued existence of a species or destroy or adversely
modify critical habitat. However, as is noted supra, many of these determinations
are supported by strong evidence, providing no doubt that an imminent hazard
exists. Ongoing unreasonable adverse effects on the environment undeniably exist.
And all evidence to date points to an unreasonable hazard to the survival of likely
hundreds or thousands of endangered and threatened species. EPA should
accordingly suspend the registration of all PFAS ingredient registrations pending

214 Id. at 809 n.7 (N.D. Cal. 2017) (citing Campbell v. United States, 365 U.S.

85, 96 (1961) (“[T]he ordinary rule, based on considerations of fairness, does notplace the burden upon a litigant of establishing facts peculiarly within theknowledge of his adversary.”).
215 See supra n.73-n.75 and accompanying text.
216 See supra n.194-n.201 and accompanying text.
217 Palmer, supra n.195.
218 Keller, supra n.196.
219 Id.
220 Griffin, supra n.198.
221 Keller, supra n.196.
222 Id.
223 Lee, supra n.201.
59

cancellation to safeguard human health, the environment, and threatened andendangered species.
E.

EPA Must, at a Minimum, Initiate a Special Review.

Finally, if EPA is not convinced by the wealth of its own research recounted
supra detailing PFAS chemicals’ dangers, Petitioners implore EPA to initiate a
special review and undertake its own evaluation of PFAS ingredients’ effects on theenvironment. The purpose of Special Review is “to help the Agency determine
whether to initiate procedures to cancel, deny, or reclassify registration ofa pesticide product because uses of that product may cause unreasonable adverse
effects on the environment.” 224 Special review is warranted for the foregoingreasons: 225(a) The Administrator may conduct a Special Review of a pesticide use if hedetermines. . .that the use of the pesticide. . .:(1) May pose a risk of serious acute injury to humans or domestic animals.
(2) May pose a risk of inducing in humans an oncogenic, heritable genetic,
teratogenic, fetotoxic, reproductive effect, or a chronic or delayed toxic
effect, which risk is of concern in terms of either the degree of risk toindividual humans or the number of humans at some risk, based upon:(i)
Effects demonstrated in humans or experimental animals.
(ii)
Known or predicted levels of exposure of various groups ofhumans.
(iii) The use of appropriate methods of evaluating data and relatingsuch data to human risk.
(3) May result in residues in the environment of nontarget organisms at
levels which equal or exceed concentrations acutely or chronically toxic
to such organisms, or at levels which produce adverse reproductive

224 40 C.F.R. § 154.1.

225 As is noted supra, “[t]he Administrator may evaluate a pesticide use under

the criteria of § 154.7 either on his own initiative, or at the suggestion of any
interested person.” 40 C.F.R. § 154.10 (emphasis added).
60effects in such organisms, as determined from tests conducted on
representative species or from other appropriate data.
(4) May pose a risk to the continued existence of any endangered or
threatened species designated by the Secretary of the Interior or the
Secretary of Commerce under the Endangered Species Act of 1973, as
amended.
(5) May result in the destruction or other adverse modification of any
habitat designated by the Secretary of the Interior or the Secretary ofCommerce under the Endangered Species Act as a critical habitat forany endangered or threatened species.
(6) May otherwise pose a risk to humans or to the environment which is ofsufficient magnitude to merit a determination whether the use of thepesticide product offers offsetting social, economic, and environmental
benefits that justify initial or continued registration.
(b) In making any determination that a pesticide use satisfies one of the criteria
for issuance of a Special Review specified by paragraph (a) of this section, theAdministrator shall consider available evidence concerning both the adverse
effect in question and the magnitude and scope of exposure of humans andnontarget organisms associated with use of the pesticide. 226
PFAS ingredients implicate more than one of the above detailed criteria for
special review; in fact, they implicate practically all the above criteria. First, PFAS
ingredients pose a significant risk of oncogenic, teratogenic, and reproductive
effects. As detailed above, exposure to certain PFAS has been linked to negative
reproductive health effects, developmental effects in children, and increased cancer
risks for decades. Evidence of these effects in humans has been documented using
epidemiological studies, an appropriate methodology for estimating population-level
exposures. 227 And these effects are severe in both “degree” and “number”—PFAS
226 40 C.F.R. § 154.7.

227 Pheruza Tarapore, Perfluoroalkyl Chemicals and Male Reproductive

Health: Do PFOA and PFOS Increase Risk For Male Infertility?, 18 INT’L J. ENV’T
RESEARCH PUBLIC HEALTH 3794, (Apr. 2021),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038605/; Wei Wang, et al., The
Effects of Perfluoroalkyl and Polyfluoroalkyl Substances on Female Fertility: A
Systematic Review and Meta-Analysis, 216 ENV’T RESEARCH 114718 (Jan. 2023),
61

have impacts that long outlast their intended uses, as they do not break down in theenvironment, instead accumulating in soils, waterways, plants, and wildlife andcreating multiple pathways to PFAS exposure. The USGS estimates that forty five
percent of the nation’s drinking water is contaminated with PFAS; 228 therefore, the“number of humans at some risk” from PFAS exposure is certainly a “concern”
warranting Special Review.
Second, widespread data indicates that PFAS contamination does result in
toxic residues in nontarget organisms and the environment. PFAS are known tobioaccumulate in flora and fauna alike because of their persistence, 229 leading tochronically toxic and reproduction-disrupting levels of PFAS in many organisms. 230
Bioaccumulation of certain PFAS at toxic levels has been demonstrated in PFAS for
many aquatic species, 231 warranting Special Review.

https://pubmed.ncbi.nlm.nih.gov/36334833/#:~:text=Conclusion%3A%20Based%20o
n%20the%20evidence,in%20odds%20ratio%20for%20infertility.
228 U.S. Geological Survey, National News Release: Tap Water Study Detects
PFAS ‘Forever Chemicals’ Across the US (July 2023),
https://www.usgs.gov/news/national-news-release/tap-water-study-detects-pfasforever-chemicals-acrossus#:~:text=At%20least%2045%25%20of%20the,by%20the%20U.S.%20Geological%2
0Survey.
229 Certain PFAS can bioaccumulate in the human body. Our Current
Understanding, supra n.56.
230 Brittany P. Rickard, et al., Per-and Poly-Fluoroalkyl Substances (PFAS)
and Female Reproductive Outcomes: PFAS Elimination, Endocrine-MediatedEffects, and Disease, 465 TOXICOLOGY (2022),
https://www.sciencedirect.com/science/article/pii/S0300483X2100353X; Wang, supra
n.227; Tarapore, supra n.227.
231 Tingting Ma, et al., Toxicity of Per- and Polyfluoroalkyl Substances to
Aquatic Vertebrates, FRONTIERS ENV’T SCIENCE (Jan. 2023),
https://www.frontiersin.org/articles/10.3389/fenvs.2023.1101100/full.
62

Finally, PFAS certainly pose risks to humans, the environment, and federally
listed species large enough to warrant proper analysis of whether their benefits
outweigh the great risks associated with their continued use in pesticide products.
As discussed in detail throughout this petition, certain PFAS are associated withsevere human health effects, including cancers, reproductive disorders,developmental effects in children, and immunosuppression, as well as similarharms to wildlife. These severe effects surely are of sufficient magnitude to warranta proper cost-benefit analysis, and such stark reality should demonstrate thedanger PFAS ingredients in pesticides pose and the urgency this situationnecessitates.
II.

FIFRA Regulations Must Prohibit PFAS Ingredients in Pesticides.
In addition to canceling and suspending existing inert and active ingredientregistrations, EPA must also cease any future registrations of PFAS ingredients inpesticides. As stated supra, FIFRA authorizes EPA to register a pesticide only upondetermining that the pesticide “will perform its intended function without
unreasonable adverse effects on the environment.” 232 And EPA itself has stated
that, “[g]iven [its] current understanding of PFAS … some PFAS are unlikely toreceive a determination of ‘not likely’ to present an unreasonable risk.” 233
Specifically, in the FIFRA context, EPA has already eliminated PFAS inert
ingredients because they are “an urgent public health and environmental issue in

232 7 U.S.C. § 136a(c)(5)(C).

233 Framework for TSCA, supra n.3, at 14.

63the United States” 234 and to “better protect human health and the environment.” 235This is unsurprising, given EPA’s laundry list of human health and ecologicalimpacts from PFAS that render PFAS an unreasonable risk nationwide, warranting
prohibition under FIFRA. EPA must then stick to its statutory mandate and cease
registration of any additional PFAS ingredients.
A.

FIFRA Regulations Require a Ban on Further PFAS
Registrations.

In registering pesticides, the core baseline statutory standard EPA applies is
the “unreasonable adverse effects” standard. 236 EPA must deny applications forregistration when “necessary to prevent unreasonable adverse effects on theenvironment.” 237 FIFRA defines “unreasonable adverse effects on the environment”
to mean “any unreasonable risk to man or the environment, taking into account theeconomic, social, and environmental costs and benefits of the use of any
pesticide.” 238 EPA and the courts have interpreted FIFRA’s “unreasonable adverse
effect” standard to require EPA to conduct a cost-benefit analysis “to ensure that
there is no unreasonable risk created for people or the environment from a

234 Pesticides: Proposed Removal of Per-and Polyfluoroalkyl SubstanceChemicals From Approved Inert Ingredient List for Pesticide Products, 87 Fed. Reg.
56,051 (Sept. 13, 2022).
235 U.S. Env’t Prot. Agency, Pesticides: Per-and Polyfluoroalkyl Substances(PFAS) in Pesticide and Other Packaging, https://www.epa.gov/pesticides/pfaspackaging#:~:text=In%20December%202022%2C%20the%20Agency,in%20any%20r
egistered%20pesticide%20product.
236 7 U.S.C. § 136(bb).
237 Id. §136a(a).
238 7 U.S.C. §136(bb).
64pesticide.” 239 Thus, EPA balances the claimed benefits against the pesticide’s
economic, social, and environmental costs. 240 Congress anticipated that EPA’s
careful balancing of costs and benefits would “take every relevant factor that the[agency] can conceive of into account.” 241
Specifically, FIFRA requires that EPA assess a pesticide’s persistence, 242 thecore issue with PFAS. 243 And its regulations also mandate that applicants submit
information specific to seven basic categories: product performance, toxicology,
hazards to nontarget organisms, applicator and post-application human exposure,pesticide spray drift evaluation, environmental fate, and residue chemistry to aid

239 Pollinator Stewardship Council v. U.S. Env’t Prot. Agency, 806 F.3d 520,

522-23 (9th Cir. 2015) (quoting 7 U.S.C. § 136(bb)).
240 See 7 U.S.C. § 136(bb) (defining “unreasonable adverse effects on theenvironment” to include “any unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs and benefits of the use ofany pesticide”).
241 S. REP. NO. 92-838, at 10 (1972), reprinted in 1972 U.S.C.C.A.N. 3,993,
4,032. Congress intended for EPA, among other relevant factors, to carefully
consider “hazards to farmworkers, hazards to birds and animals and children yet
unborn . . . . the need for food and clothing and forest products, forest and grassland
cover to keep the rain where it falls, prevent floods, provide clear water . . . .
aesthetic values, the beauty and inspiration of nature, the comfort and health ofman.” Id.
242 FIFRA specifically mentions data on persistence, requiring EPA to makepublic data on pesticides’ “safety to fish and wildlife, humans and other mammals,
plants, animals, and soil, and studies on persistence, translocation and fate in theenvironment, and metabolism.” 7 U.S.C. § 136h(d)(1).
243 Ian T. Cousins, et al., The High Persistence of PFAS Is Sufficient for Their
Management as a Chemical Class, 22 ENV'T SCIENCE PROCESS IMPACTS 2307 (2020),
https://pubs.rsc.org/en/content/articlelanding/2020/em/d0em00355g (identifying
PFAS as “the most environmentally persistent substances among organic
chemicals,” and connecting this persistence with increased probabilities of effects).
65the agency in determining whether a product has unreasonable adverse effects on
the environment. 244
B.

Researchers Have Identified Major Costs Associated withPFAS.

As discussed supra, PFAS contamination results in extensive environmental
and human health costs, weighing against any purported benefits. PFAS chemicals’
persistence and bioaccumulation lead to numerous adverse effects on theenvironment, as well as human health, that EPA itself has found critical to addressin numerous other contexts.
However, ubiquitous exposure to PFAS chemicals also results in massive
economic and societal costs, far exceeding short-term industry profits. On a global
scale, the societal cost of using toxic PFAS totals about $17.5 trillion annually, fromseveral environmental and public health impacts. 245 First, PFAS exposure results inastronomical healthcare costs. A 2024 study attributed $22.4 billion healthcare
costs in the United States during 2018 to PFAS exposure, 246 while another recent

244 FIFRA specifically mentions data on persistence, requiring EPA to makepublic data on pesticides’ “safety to fish and wildlife, humans and other mammals,
plants, animals, and soil, and studies on persistence, translocation and fate in theenvironment, and metabolism.” 7 U.S.C. § 136h(d)(1).
245 Tom Perkins, Societal Cost of ‘Forever Chemicals’ About $17.5tn Across
Global Economy-Report, The Guardian (May 12, 2023),
https://www.theguardian.com/environment/2023/may/12/pfas-forever-chemicalssocietal-cost-new-report; Shannon Kelleher, Research Ramps up but PFAS Pollution
Remains Tough to Tackle, The New Lede (Jan 21, 2024),
https://www.thenewlede.org/2024/01/research-ramps-up-but-pfas-pollution-remainstough-to-tackle/.
246 Leonardo Trasande, et al., Chemicals Used in Plastic Materials: An
Estimate of the Attributable Disease Burden and Costs in the United States, 8 J.
66

study estimates as much as $62.6 billion annually, 247 considering a broad range ofhealth consequences across the lifespan. Similarly, the Nordic Council of Ministers
estimates that the direct healthcare costs from exposure to PFAS in Europe alone
are €52-84 billion annually. 248 From its National Primary Drinking Water
Regulations alone, EPA predicts reductions in drinking water will save $1.5 billion
annually in healthcare costs due to fewer cancers, lower incidents of heart attacks
and strokes, and reduced birth complications, 249 although the benefit estimates arelikely greater as several health benefits could not be quantified, including
developmental, cardiovascular, liver, immune, endocrine, metabolic, reproductive,
musculoskeletal, and carcinogenic effects. 250 And these costs are not paid by thepolluter; they are borne by ordinary people, health care providers, and taxpayers.

ENDOCRINE SOCIETY (Jan. 2024),
https://academic.oup.com/jes/article/8/2/bvad163/7513992?login=true.
247 Vladislav Obsekov, et al., Leveraging Systematic Reviews to Explore
Disease Burden and Costs of Per-and Polyfluoroalkyl Substance Exposures in the
United States, 15 EXPOSURE AND HEALTH 373 (2023),
https://link.springer.com/article/10.1007/s12403-022-00496-y; see also Alissa
Cordner, et al., The True Cost of PFAS and the Benefits of Acting Now, 55 ENV’T
SCIENCE AND TECHNOLOGY 9630 (2021),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8296683/ (estimating healthcare
costs of $37–59 billion annually in the United States).
248 Gretta Goldenman, et al., The Cost of Inaction: A Socioeconomic Analysis
of Environmental and Health Impacts Linked to PFAS, Nordic Council of Ministers,
at 15 (2019), https://norden.divaportal.org/smash/get/diva2:1295959/FULLTEXT01.pdf.
249 U.S. Env’t Prot. Agency, Fact Sheet: PFAS National Primary Drinking
Water Regulation, at 2, https://www.epa.gov/system/files/documents/2024-04/pfasnpdwr_fact-sheet_general_4.9.24v1.pdf; see also U.S. Env’t Prot. Agency, Final
Rule: Economic Analysis for the Final Per-and Polyfloroalkyl Substances National
Primary Drinking Water Regulation, EPA-815-R-24-001 (Apr. 2024),
https://www.epa.gov/system/files/documents/2024-04/pfas-npdwr_final-rule_ea.pdf.
250 Id.
67

Furthermore, PFAS chemicals’ indirect social costs are extensive, considering
lost wages, lost years of life, reduced quality of life, increased stress, anxiety, anddepression, and subsequent impacts on families and communities. 251 Such social
costs are more difficult to quantify, but nonetheless weigh against continued use of
PFAS in pesticides.
Second, the cost of remediating PFAS contaminated sites also lies in thebillions. 252 The process of determining how to clean up these sites is labor-intensive,
time-consuming, and expensive: each sample test of soil and water already costs
hundreds of dollars, and few remediation options exist. 253 Further, the landfilling ofcontaminated soil involves transportation costs, and PFAS are only sequestered forthe lifespan of the landfill. 254 Just last year, an investigation revealed that Europe’s
17,000 sites contaminated with PFAS cost an estimated €2000 billion. 255
PFAS contamination also reduces property values of homes andbusinesses. 256 The discovery of water contamination, or even the perceived risk of

251 Cordner, supra n.247.
252 Id.
253 Id.
254 Id.

255 Gary Dagorn, et al., ‘Forever Pollution’: Explore the Map of Europe’s PFAS

Contamination, LE MONDE (Feb. 23, 2023), https://www.lemonde.fr/en/lesdecodeurs/article/2023/02/23/forever-pollution-explore-the-map-of-europe-s-pfascontamination_6016905_8.html; Chem Sec, The Top 12 PFAS Producers in theWorld and the Staggering Societal Costs of PFAS Pollution (May 25, 2023),
https://chemsec.org/reports/the-top-12-pfas-producers-in-the-world-and-thestaggering-societal-costs-of-pfas-pollution/.
256 Michelle M. Marcus & Rosie Mueller, Unregulated Contaminants in
Drinking Water: Evidence from PFAS and Housing Prices, Working Paper 31731,
NATIONAL BUREAU OF ECONOMIC RESEARCH (Revised April 2024),
https://www.nber.org/system/files/working_papers/w31731/w31731.pdf.
68potential contamination, can depress property values and stigmatize neighborhoods,
potentially leading to lower home values and blocking residents from selling
properties, particularly when contamination achieves a level of public notoriety. 257
And farms in areas with PFAS-contaminated water or soil may need todestroy harvests or products, or even to cease operation. This contamination has
already happened on a major scale: Currently, PFAS have contaminated an
estimated 20 million acres of U.S. cropland. 258 For example, an organic farm near
Colorado’s Fort Peterson Air Force Base completely ceased production after learningthat its irrigation water was highly contaminated. 259 And in Maine, PFAS
contamination forced more than fifty farms to pause or cease operations in 2022. 260
PFAS contamination has also harmed dairy farmers, as they have been forced todump contaminated milk and even euthanize their herds. 261
257 AEI Consultants, PFAS and Real Estate: An In-Depth Guide,

https://aeiconsultants.com/pfas-real-estate/ (last viewed May 29, 2024); Cordner,supra n.247.
258 Jared Hayes, EWG: ‘Forever Chemicals’ May Taint Nearly 20 Million
Cropland Acres, Env’t Working Group (Apr. 14, 2022), https://www.ewg.org/newsinsights/news/2022/04/ewg-forever-chemicals-may-taint-nearly-20-million-croplandacres.
259 The Associated Press, The Toxins in Peterson Air Force Base Firefighting
Foam Tainted Aquifer, Lawsuit Claims, Air Force Times (Mar. 12, 2019),
https://www.airforcetimes.com/news/your-air-force/2019/03/13/toxins-used-inpeterson-air-force-base-firefighting-foam-tainted-aquifer-lawsuit-claims/; Cordner,supra n.247.
260 Kirsten Lie-Nielsen, PFAS Shut Main Farms Down. Now, Some are
Rebounding, Civil Eats (Oct. 2, 2023), https://civileats.com/2023/10/02/pfas-shutmaine-farms-down-now-some-are-rebounding/.
261 Megan Gleason, Battle Between New Mexico and U.S. Air Force To Track
Toxic Chemicals Drags On, SOURCE NM (Apr. 17, 2023),
https://sourcenm.com/2023/04/17/battle-between-new-mexico-and-us-air-force-totrack-toxic-chemicals-drags69

Third, another high remediation cost comes from water purification, a costestimated at €238 billion in the EU alone. 262 Specifically, EPA estimates thatcompliance with its final National Primary Drinking Water Regulation will cost
approximately $1.5 billion annually, using granular activated carbon, anion
exchange, high-pressure membrane technologies, reverse osmosis, andnanofiltration. 263 These costs often fall onto public utilities, their ratepayers, andstate and local governments rather than chemical manufacturers and other
responsible parties, 264 leaving vulnerable communities 265 to struggle in coveringsuch high expenditures. And beyond the actual water treatment, communities also
incur costs of testing and monitoring the contamination, informing the public,
gathering information on treatment alternatives, and studying the feasibility of
infrastructure investments.
In light of these costs, any benefits from PFAS ingredients cannot outweigh
the risks. On a broader scale, industry only needs 8% of PFAS for “essential”
purposes, 266 none of which include pesticide formulations (or, as discussed infra,

on/#:~:text=Outflows%20from%20Cannon%20AFB%20contaminated,and%20cleani
ng%20up%20PFAS%20chemicals.
262 The Top 12 PFAS Producers, supra n.255 ; see also Chem Sec, AnnualSocietal Costs From the Use of PFAS (May 2023),
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fchemsec.org%2
Fapp%2Fuploads%2F2023%2F05%2FMay-2023-ChemSec-PFAScosts.xlsx&wdOrigin=BROWSELINK.
263 Fact Sheet, supra n.249.
264 Cordner, supra n.247.
265 Id.
266 Perkins, supra n.245.
70

pesticide containers). 267 As a result, EPA must adhere to its own regulations andexplicitly prohibit all active and inert ingredient registrations of PFAS in the
FIFRA regulations.
III.

EPA Should Amend Regulations to Specifically Require Assessmentof PFAS Chemicals’ Unique Impacts in Determining “Unreasonable
Adverse Effects” Under FIFRA.
As an alternative to explicitly prohibiting PFAS ingredients, EPA shouldamend its regulations to clearly consider PFAS chemicals’ unique impacts on theenvironment. Again, FIFRA plainly does not allow EPA to register pesticides with“unreasonable adverse effects on the environment.” 268 But to properly make such a
determination for PFAS chemicals with “significant health concerns, widespreadenvironmental exposures, and environmental persistence” 269 EPA requires morecomprehensive testing than FIFRA regulations currently require, due namely to
PFAS’s bioaccumulation potential. Even small PFAS releases into the environment
over time can contribute to considerable exposure and potential risk. 270 Accordingly,
as under TSCA, EPA should amend its FIFRA regulations to ensure data submitted

267 Ian T. Cousins et al., The Concept of Essential Use for Determining When

Uses of PFASs Can Be Phased Out, 11 ENV’T SCIENCE PROCESSES IMPACTS (2019),
https://pubs.rsc.org/en/content/articlelanding/2019/em/c9em00163h.
268 7 U.S.C. § 136a(c)(5)(C).
269 U.S. Env’t Prot. Agency: Office of Pollution Prevention and Toxics, TSCA
Section 5 Order for a Significant New Use of Certain Chemical Substances, at 2
(Dec. 21, 2023), https://www.epa.gov/system/files/documents/2023-12/sn-23-00020004-0005_order-signature-copy_12-01-2023_marked_redacted.pdf.
270 U.S. Env’t Prot. Agency, Framework for TSCA New Chemicals Review of
PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs),
at 6 (Jun. 28, 2023), https://www.epa.gov/system/files/documents/202306/PFAS%20Framework_Public%20Release_6-28-23_Final_508c.pdf.
71for pesticides with PFAS ingredients, inert or active, capture all effects andpotential unreasonable effects on the environment.
A.

EPA Has the Authority to Issue Regulations to Require SpecificLong-Term Data on PFAS Ingredients’ Persistence in
Formulations with PFAS Ingredients.

As a threshold matter, requiring thorough evaluation of PFAS ingredients isfully within EPA’s authority. FIFRA commands that EPA “shall” publish guidelines
for registration support information and shall revise them from time to time, 271 andauthorizes EPA to require additional data to maintain existing registrations. 272
FIFRA already mandates data on pesticides’ persistence in the environment andhuman health impacts, and it grants EPA broad discretion in determining datarequirements for pesticide registrations. 273 In line with FIFRA’s safety standard,
EPA possesses authority to promulgate regulations to collect data on all pesticide
ingredients and pesticide formulations, as well as evaluate their impact on theenvironment.
B.

Current Regulations Fail to Require Adequate Information on
PFAS.

271 7 U.S.C. § 136a(c)(2)(A).
272 Id. § 136a(c)(2)(B).

273 See id. § 136a(c)(2).

72

By its plain language, FIFRA already requires that EPA assess a pesticide’s
persistence, 274 the core issue with PFAS. 275 Specifically, EPA’s regulations mandatethat applicants submit information on product chemistry, as well as information
specific to seven basic categories: product performance, toxicology, hazards tonontarget organisms, applicator and post-application human exposure, pesticide
spray drift evaluation, environmental fate, and residue chemistry, to aid the agency
in determining whether a product has unreasonable adverse effects on theenvironment. 276
But despite already requiring data on persistence, environmental fate, andhuman health, EPA’s regulations remain insufficient to evaluate PFAS for several
reasons. First, EPA itself has already recognized under TSCA that it must evaluate
PFAS ingredients differently in determining if they pose “unreasonable” risks.
Specifically, under TSCA EPA requires additional data and testing for persistent,
bioaccumulative, and toxic (PBT) chemicals in the PFAS class to determine whether“the relevant chemical substance or significant new use presents an unreasonable

274 FIFRA specifically mentions data on persistence, requiring EPA to makepublic data on pesticides’ “safety to fish and wildlife, humans and other mammals,
plants, animals, and soil, and studies on persistence, translocation and fate in theenvironment, and metabolism.” 7 U.S.C. § 136h(d)(1).
275 Cousins, supra n.243 (identifying PFAS as “the most environmentally
persistent substances among organic chemicals,” and connecting this persistencewith increased probabilities of effects).
276 FIFRA specifically mentions data on persistence, requiring EPA to makepublic data on pesticides’ “safety to fish and wildlife, humans and other mammals,
plants, animals, and soil, and studies on persistence, translocation and fate in theenvironment, and metabolism.” 7 U.S.C. § 136h(d)(1).
73

risk of injury to health or the environment.” 277 EPA explained in its Frameworkthat it must evaluate PBT PFAS qualitatively due to factors associated with PBTPFAS, including the known widespread background levels of PFAS present
throughout both the environment and humans, as well as the highly persistent andbioaccumulative nature of most well-studied PFAS. 278
In other words, EPA already knows it needs to qualitatively consider the
potential extent of exposures to the general population, consumers, and theenvironment, throughout the lifecycle of the PFAS. This differs from quantitative
assessment, as quantitative assessment provides only a “snap-shot” of the exposure
at one point in time and fails to accurately reflect the overall environmental andhuman health risks PFAS pose over time. 279 There is no reason why EPA should not
require this assessment in the FIFRA context to safeguard human health and theenvironment, as required.
Second, relatedly, the data requirements lack sufficient requirements forapplicants on PFAS ingredient persistence and the unique effects of PFAS on
human health and the environment, 280 despite EPA itself specifically stating that
extensive testing is necessary for the intentional release of PFAS. Just lastSeptember, EPA made plain that when the “release of the substance is essential toits use or unavoidable because of the nature of the use,” it likely requires “a full

277 15 U.S.C. § 2604(a)(3)(A).

278 Framework for TSCA New Chemicals Review of PMNs and SNUNs, supra

n.270, at 7.
279 Id. at 6.
280 See 40 C.F.R. § 158.630(d).

74suite of testing” under TSCA for EPA to ensure no unreasonable risks. 281 This “fullsuite” includes physical-chemical property testing, other testing such asenvironmental fate/bioaccumulation, toxicokinetic, and human health and/or
environmental toxicity testing. 282 EPA should clarify that FIFRA also requires thisdata, and EPA must review ingredient registrations with this data in mind.
And finally, EPA’s regulations fail to define PFAS, allowing EPA to pick andchoose which PFAS ingredients to study qualitatively and with the full suite of
testing instead of providing a uniform requirement. As a result, EPA must amend
the definitions in 40 C.F.R. § 158.300 to include the state-based and USGS
definitions of PFAS as “a class of fluorinated organic chemicals that contain at least
one fully fluorinated carbon atom.” 283 While the 2019 EPA definition includes atleast four active pesticide ingredients approved by EPA, this definition includes
more than 200 other approved pesticide ingredients, 284 which all require extensive
study to ensure no unreasonable adverse environmental effects.
In sum, considering EPA’s own explanations under TSCA for intentional
release of PFAS chemicals into the environment, it only follows that PFAS
ingredients in pesticides sprayed nationwide also require careful assessment of theunique characteristics. 285 Both TSCA and FIFRA hold EPA to the same standard of

281 Framework for TSCA, supra n.3, at 25-26.
282 Id.

283 See, e.g.,15 U.S.C. § 8931(2)(A).
284 Wilcox, supra n.9.

285 This is especially true, considering EPA already considers one PFAS in

pesticides “unreasonable” under this new Framework. See infra; see also Framework
for TSCA New Chemicals Review of PMNs and SNUNs, supra n.270, at 9.
75

no “unreasonable” risks to human health or the environment. Without following
EPA’s own reasoning under the TSCA Framework, EPA cannot adequately
determine a pesticide with PFAS ingredients poses no “unreasonable adverse effects
to the environment.” 286
C.

EPA’s Failure to Implement Regulations to Mandate
Assessment of PFAS Chemicals’ Unique Impacts in Pesticides
Violates the APA.

Because FIFRA requires that pesticide products meet FIFRA’s safety
standard, and EPA has not yet clarified that additional data requirements apply to
PFAS ingredients, EPA is violating the APA. By failing to require data that
adequately captures PFAS chemicals’ environmental persistence andbioaccumulation, as it has in other contexts, EPA has unlawfully withheld and/or
unreasonable delayed agency action required by FIFRA. Especially considering EPA
acknowledges the grave harms posed by PFAS ingredients as described supra andits admissions that several inert and active ingredients qualify as PFAS, theagency’s failure to comprehensively require and collect safety data on PFAS
ingredients is unreasonable and contrary to law. EPA cannot reasonably determinethat a pesticide has no unreasonable adverse effects on the environment if it does
not adequately consider PFAS chemicals’ persistence and bioaccumulation
potential. Requirements for additional testing and data of PFAS chemicals’ unique
impacts would provide the required remedy.

286 7 U.S.C. § 136a(c)(5)(C).

76

IV.

EPA Must Amend FIFRA Regulations to Prohibit the Use of
Fluorinated HDPE and Fluorinated Polypropylene Containers.
EPA must also amend FIFRA regulations at 40 C.F.R. § 165.25 to prohibit

fluorinated HDPE and polypropylene containers for pesticide storage. FIFRA
mandates that EPA “shall … promulgate regulations for the design of pesticidecontainers that will promote the safe storage and disposal of pesticides.” 287 But EPA
has repeatedly admitted that the most widely used pesticide containers—
fluorinated HDPE containers used for 20% of pesticide products 288—leach PFAS
into pesticides and has nonetheless failed to act. And evidence suggests fluorinatedpolypropylene containers may leach PFAS chemicals as well due to the similar
fluorination process. 289 This cannot possibly accord with the statutory mandate for“safe storage,” nor does it comport with EPA’s stated intention to “leverage the fullrange of statutory authorities to confront the human health and ecological risks of
PFAS.” 290 As a result, EPA must amend its FIFRA regulations to prohibit the use offluorinated HDPE and polypropylene containers.
A.

EPA Has Identified Significant Leaching from HDPE
Fluorinated Containers into Pesticides.

287 7 U.S.C. § 136q(e)(1)(A).

288 U.S. Env’t Prot. Agency Office of Chemical Safety and Pollution

Prevention, News Releases from Headquarters: EPA Takes Action to Investigate
PFAS Contamination (Jan. 14, 2021),
https://www.maine.gov/dacf/php/pesticides/documents2/bd_mtgs/mar21/6o-EPAPFAS-files-combined.pdf.
289 BERLIN PACKAGING, supra n.6.
290 PFAS Strategic Roadmap, supra n.2, at 5.
77

EPA has known of the grave human health and environmental risks
fluorinated HDPE containers pose for at least four years. In accordance with theDecember 2019 National Defense Authorization Act for Fiscal Year 2020’s mandate
to “publish interim guidance on the destruction and disposal of perfluoroalkyl andpolyfluoroalkyl substances and materials containing perfluoroalkyl andpolyfluoroalkyl substances,” 291 EPA began working on a draft guidance regarding
proper disposal of fluorinated HDPE pesticide containers almost five years ago. 292
However, this guidance never made it into EPA’s published guidance document 293
due to EPA’s concerns that the guidance might somehow conflict with regulations
under FIFRA regarding pesticide containers, although internal emails reveal
internal disagreement over this issue. 294
But later that summer in 2020, Public Employees for Environmental
Responsibility (PEER) notified both EPA and the Massachusetts Department ofEnvironmental Protection of its testing results for a handful of publicly available
herbicides and insecticides, including the widely used mosquito control productAnvil 10+10, a pesticide aerially sprayed in 25 states. 295 In the course of their
testing, PEER found 250 ppt of PFOA and 260-500 ppt of hexafluoropropylene oxide

291 15 U.S.C. § 8961(a).
292 FOIA Document 4.

293 U.S. Env’t Prot. Agency, Interim Guidance on the Destruction and

Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing
Perfluoroalkyl and Polyfluoroalkyl Substances: Interim Guidance for Public
Comment (Dec. 18, 2020), https://www.epa.gov/system/files/documents/2021-11/epahq-olem-2020-0527-0002_content.pdf.
294 FOIA Document 4.
295 January 2021 EPA Press Release, supra n.102.
78

dimer acid in the pesticide, the latter of which is a replacement for PFOA, neither ofwhich were an Anvil ingredient. 296 Later that year, in December 2020, theMassachusetts Department of Environmental Protection conducted its own testingof Anvil 10+10 and also found levels of multiple PFAS substantially exceeding thestate’s drinking water limits, several of which were present at 700 ppt. 297
In October 2020, EPA submitted an information request to the manufacturer,
Clarke Mosquito Control Products Inc., to gather more information about thepesticide’s production and distribution. 298 EPA also began to study the fluorinated
HDPE containers used to store Anvil 10+10, 299 and soon after, confirmed thepresence of eight different PFAS chemicals at levels ranging from 20,000 to 50,000
ppt in the containers. 300 EPA then issued a subpoena against Inhance Technologies,
LLC under TSCA on January 14, 2021 regarding the fluorination process used totreat the containers. 301

296 PEER, supra n.97.

297 David Abel, Toxic “Forever Chemicals” Found in Pesticide Used on

Millions of Mass. Acres When Spraying for Mosquitoes, Boston Globe (Dec. 1, 2020),
https://www.bostonglobe.com/2020/12/01/metro/toxic-forever-chemicals-foundpesticide-used-millions-mass-acres-when-sprayingmosquitos/?p1=BGSearch_Advanced_Results.
298 January 2021 EPA Press Release, supra n.102.
299 Id.
300 U.S. Env’t Prot. Agency, EPA Releases Testing Data Showing PFAS
Contamination from Fluorinated Containers (March 5, 2021),
https://www.epa.gov/newsreleases/epa-releases-testing-data-showing-pfascontamination-fluorinated-containers.
301 Id.; see also EPA Takes Action to Investigate PFAS Contamination, supra
n.288 (naming Inhance as the company supplying containers from Anvil).
79

Nearly a year later, on March 16, 2022, EPA notified manufacturers,
processors, distributors, users and those that dispose of fluorinated HDPE
containers and similar products via an open letter that containers contaminatedwith certain long-chain PFAS may constitute a violation of its SNUR under TSCA,
described supra. 302 Following that notice, the Department of Justice filed acomplaint against just one company, Inhance, the manufacturer of the Anvil 10+10
containers for failure to comply with TSCA. 303
Nearly three years later, on December 1, 2023, EPA ordered InhanceTechnologies LLC, to cease manufacturing PFAS in the production of its fluorinatedhigh-density polyethylene HDPE plastic containers because they are “highly toxic
and present unreasonable risks that cannot be prevented other than throughprohibition of manufacture.” 304 Specifically, EPA’s risk assessment noted thebioaccumulation potential of the chemicals in humans, 305 the chemicals’ persistence

302 U.S. Env’t Prot. Agency, Press Release: EPA Continues to Take Actions toAddress PFAS in Commerce (Mar. 16, 2022), https://www.epa.gov/newsreleases/epacontinues-take-actions-address-pfas-commerce [hereinafter March 2022 EPA Press
Release].
303 U.S. Env’t Prot. Agency, Press Release: EPA Completes Scientific Testingof Pesticide Products for PFAS (May 30, 2023), https://www.epa.gov/pesticides/epacompletes-scientific-testing-pesticide-products-pfas [hereinafter May 2023 EPA
Press Release].
304 EPA Orders to Inhance, supra n.3; see also Framework for TSCA, supran.3, at 14.
305 U.S. Env’t Prot. Agency Office of Pollution Prevention and Toxics New
Chemicals Division Risk assessment Branches/Industrial Chemistry Branch, Risk
Assessment of the Per-and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006
and SN-23-0008-0011, at 15 (Nov. 30, 2023),
https://www.epa.gov/system/files/documents/2023-12/11-30-23-final-clean-inhancerisk-assessment-of-9-pfas-snuns_marked_redacted.pdf.
80

in the environment, 306 toxicity for aquatic organisms, 307 and significant humanhealth concerns. 308 Accordingly, EPA concluded that “all nine SNUN substances[were] persistent, bioaccumulative, and toxic.” 309 However, the Fifth Circuit has
since vacated that order, allowing Inhance to continue fluorinating HDPE
containers for pesticide storage and for the ongoing use of these “highly toxic”
containers for storage. Inhance Technologies, L.L.C. v. EPA, No. 23-60620, at *13(5th Cir. 2024) (“The EPA may not contort the plain language of TSCA’s Section 5 todeem a forty-year-old ongoing manufacturing process a ‘significant new use’ subject
to the accelerated regulatory process provided by that part of the statute.”).
More recently, another EPA study in September 2022 again confirmed theleaching potential of certain PFAS from HDPE containers. 310 Internal emails from
April 2021 described the testing process, in which both the interior and the exteriorof the container were rinsed with methanol, and the rinsates were analyzed using
standard EPA methods. 311 This study confirmed that eight different PFAS in theinterior walls of fluorinated HDPE containers can leach into formulated liquid
products, with higher total amounts seen in products formulated in organic solvents

306 Id. at 15-17.
307 Id. at 18.

308 Id. at 19-21.
309 Id. at 30.

310 U.S. Env’t Prot. Agency, Press Release: EPA Releases Data on Leaching of

PFAS in Fluorinated Packaging (Sept. 8, 2022), https://www.epa.gov/pesticides/epareleases-data-leaching-pfas-fluorinated-packaging [hereinafter September 2022
EPA Press Release].
311 FOIA Document 5.
81such as methanol, compared with water-based products. 312 For both methanol- andwater-based products, the study also showed continued gradual leaching of PFAS
over time. 313
And beyond HDPE containers, evidence points to PFAS leaching fromfluorinated polypropylene containers as well. Each year, the fluorination of plastic
is commonly used to treat hundreds of millions of HDPE and polypropylene
containers, including large drums. 314 And this fluorination process can lead tothe inadvertent creation of PFAS in both materials. 315
Throughout the course of the agency’s investigation on pesticide storage
containers, EPA advised manufacturers to report PFAS contamination under
FIFRA section (6)(a)(2) but noted that EPA could not mandate reporting because
PFAS is only of “potential toxicological significance.” 316 Around that same time,
EPA also encouraged the pesticide industry to explore “alternative packaging
options, like steel drums or non-fluorinated HDPE [containers].” 317
EPA’s study of pesticide containers is ongoing, and the agency claims it
remains committed to using “all available regulatory and non-regulatory tools todetermine the scope of this emerging issue and its potential impact on human

312 September 2022 EPA Press Release, supra n.310.
313 Id.

314 Amy A. Rand and Scott A. Mabury, Perfluorinated Carboxylic Acids inDirectly Fluorinated High-Density Polyethylene Material, ENV’T SCIENCE ANDTECHNOLOGY (2011), https://pubs.acs.org/doi/10.1021/es1043968.
315 Neltner, supra n.6.
316 FOIA Document 6; FOIA Document 7.
317 FOIA Document 6.
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health and the environment.” 318 EPA has advised any company that finds PFAS in
their product to “notify EPA and take action to remove the contaminated product”
no later than thirty days after the PFAS chemical is discovered. 319 EPA’s website
currently admits that FIFRA pesticide container regulations do not specificallyaddress the fluorination of plastic containers, despite the agency’s grave
concerns. 320
B.

EPA Must Use Its Authority to Ban HDPE and Polypropylene
Fluorinated Containers.

Because FIFRA requires safe storage for pesticides, EPA’s failure to prohibit
pesticide storage in fluorinated HDPE and polypropylene containers violates
FIFRA. The Fifth Circuit’s decision 321 to vacate EPA’s order to Inhance provides
even more support for the necessity of banning these containers under FIFRA: In
issuing that order, EPA itself characterized these fluorinated HDPE containers as“highly toxic” and “present[ing] unreasonable risks” 322 due to bioaccumulation
potential in humans, 323 the chemicals’ persistence in the environment, 324 toxicity foraquatic organisms, 325 and significant human health concerns. 326 FIFRA’s plain
language provides unequivocal authority for EPA to ban these very containers to

318 FOIA Document 8 at 4.

319 PFAS in Pesticide and Other Packaging, supra n.235.
320 Id.

321 Inhance Technologies, L.L.C. v. EPA, No. 23-60620, at *13 (5th Cir. 2024).
322 EPA Orders to Inhance, supra n.3 (emphasis added).
323 Risk Assessment of PFAS, supra n.305, at 15.
324 Id. at 15-17.
325 Id. at 18.

326 Id. at 19-21.

83

ensure “safe storage” of pesticides, not just covering Inhance’s product, but all
containers that leach PFAS into pesticides.
Furthermore, EPA has historically viewed its authority over “safe storage” toinclude preventing contamination in storage containers. Specifically, theregulations largely focus on ensuring proper rinsing so that a prior pesticide mix inthe storage container does not contaminate the next pesticide. 327 It only follows
then that EPA’s regulations must also prevent “highly toxic” PFAS contaminationfrom fluorinated HDPE and polypropylene containers to adequately safeguard
human health and the environment; refusal to do so would constitute arbitrary andcapricious agency action under the APA.
V.

EPA Must Require Registrants to Report PFAS Contamination.
In addition to requiring detailed evaluations for PFAS before approving theiruse in pesticides and prohibiting HDPE and polypropylene fluorinated containers,
EPA must also inform registrants in a guidance document that it does consider
PFAS of “toxicological significance.” EPA’s numerous statements, assessments, andRoadmap make plain that PFAS are “toxicologically significant” contaminants,
requiring mandatory reporting under FIFRA. After EPA informs registrants of the
toxicological significance, if registrants fail to report, EPA must then issue a stop
sale, use, or removal order to immediately halt the sale of adulterated pesticides, as
FIFRA mandates.

327 See 40 C.F.R. § 156.146.

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A.

FIFRA Requires Reporting of Toxicologically Significant
Contaminants Such as PFAS.

FIFRA section (6)(a)(2) requires that “[i]f at any time after the registration ofa pesticide the registrant has additional factual information regarding
unreasonable adverse effects on the environment of the pesticide, the registrant
shall submit such information to the Administrator.” 328 FIFRA regulations thenprovide that such information includes “[d]etection of … contaminates, impurities
described in § 159.179.” 329 This regulation, in turn, specifies that contaminants or
impurities a registrant has not previously identified as part of the pesticide
product's approved composition “must be reported … if the contaminant or impurity
is present in the product in any of the following quantities,” including “[q]uantities
that EPA considers, and so informs registrants, to be of toxicological significance,”“[q]uantities that the registrant considers to be of toxicological significance,” or“[q]uantities above a level for which the registrant has information indicating thatthe presence of the contaminant or impurity may pose a risk to health or theenvironment. 330 EPA explained that this reporting requirement exists to “ensurethat the Agency is informed when registrants learn of toxicologically significant new
breakdown products or when they learn of higher levels of contamination than werepreviously known to be associated with their pesticide products.” 331

328 7 U.S.C. § 136d(a)(2).

329 40 C.F.R. § 159.155(a)(5).
330 Id. § 159.179(b).

331 Reporting Requirements For Risk/Benefit Information, 62 Fed. Reg.

49,370-01 (Sept. 19, 1997).

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Furthermore, along with the other data applicants must submit prior toregistration, applicants must also submit data on “the impurities that may bepresent in the product, and why they may be present.” 332 This includes information
about “the starting materials, technical grade of active ingredient, inert ingredients,
and production or formulation process.” 333 And for PFAS, which EPA must consider“toxicologically significant,” applicants must include “an expanded discussion of thepossible formation of the impurity and the amounts at which it might bepresent.” 334
B.

EPA Is Aware of Widespread PFAS Contamination in
Pesticides.

EPA has been aware of PFAS contamination in pesticides for years, as
described supra. But rather than requiring registrants and applicants to report,
EPA has only encouraged optional reporting. In internal March 2021 emails, EPA
discussed what pesticide manufacturers should do if they find PFAS in theirproducts, stating only that manufacturers “should” report under FIFRA section(6)(a)(2), but that EPA cannot mandate reporting because PFAS is only “of potential
toxicological significance.” 335 And EPA’s current website echoes that decision: “EPA
considers any level of PFAS to be potentially toxicologically significant and maytrigger 159.179(b) in the Code of Federal Regulations.” 336

332 40 C.F.R. § 158.340.
333 Id.
334 Id.

335 FOIA Document 7.

336 PFAS in Pesticide and Other Packaging, supra n.235; see also FOIA

Document 8 (draft of earlier version of webpage).
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C.

EPA Must Amend Its Guidance to Clarify PFAS Contamination
Is of Toxicological Significance.

EPA must clarify through a guidance document that it does consider PFAS
contamination of toxicological significance, as the agency itself has repeatedly
stated in other contexts that some PFAS are toxicologically significant at any level.
EPA’s regulations then plainly mandate reporting for “[q]uantities that EPA
considers, and so informs registrants, to be of toxicological significance,”“[q]uantities that the registrant considers to be of toxicological significance,” or“[q]uantities above a level for which the registrant has information indicating thatthe presence of the contaminant or impurity may pose a risk to health or theenvironment.” 337 At the very least, EPA has already provided information on its
website indicating risks to human health and the environment: EPA has multiple
webpages with information on the harms of PFAS. 338 As described supra, EPA wentso far as to designate PFAS as “chemicals of special concern” out of “concern foreven relatively small quantities of PFAS, and PFAS’ persistence in the environmentand growing evidence showing potential adverse human health effects.” 339 EPA has
also stated that even small releases into the environment over time can contributeto considerable exposure and potential risk due to PFAS chemicals’ propensity to

337 40 C.F.R. § 159.179(b).

338 See, e.g., Our Current Understanding, supra n.56.
339 80 Fed. Reg. 74,365 (Oct. 31, 2023).

87

bioaccumulate. 340 And EPA’s Maximum Contaminant Level Goals for PFOS andPFOA are zero, as EPA has found no amount of exposure to the compound is safe. 341
Further, failing to require reporting would defeat the purpose of theregulation: to “ensure that the Agency is informed when registrants … learn of
higher levels of contamination than were previously known to be associated with
their pesticide products.” 342 EPA has announced large scale efforts to address PFAS
contamination using all the tools it has at its disposal. Allowing registrants to evade
this reporting requirement because EPA has only advised that PFAS are of“potential toxicological significance” rather than “toxicological significance” allows
the widespread contamination to continue unimpeded nationwide.
D.

EPA Must Act to Stop the Sale of Pesticides Contaminatedwith PFAS by All Means Possible, Including the Issuance ofStop Sale, Use or Removal Orders.

If a registrant fails to immediately withdraw a PFAS-contaminated pesticide,
EPA should issue an order to stop the sale or use of the pesticide. FIFRA specificallyrenders unlawful the sale of adulterated pesticides, such as those contaminatedwith PFAS, 343 and provides authority for the Administrator to issue a ‘‘stop sale,use, or removal’’ order to any person who owns, controls, or has custody of pesticides
sold in violation of FIFRA. 344 And a pesticide contaminated with PFAS undoubtedly
340 Framework for TSCA New Chemicals Review of PMNs and SNUNs, supra

n.270, at 6.
341 See Final PFAS National Primary Drinking Water Regulation, supra n.89.
342 Reporting Requirements For Risk/Benefit Information, 62 Fed. Reg 49,381(Sept. 19, 1997).
343 7 U.S.C. § 136j(a)(1)(E).
344 7 U.S.C. § 136k(a).
88qualifies as “adulterated,” as “its strength or purity falls below the professed
standard of quality as expressed on its labeling under which it is sold.” 345 EPA
should therefore remove these toxic and dangerous chemicals from the market,
using its FIFRA authority, to safeguard human health and the environment.
VI.

Any EPA Activities or Programs Regarding PFAS in Pesticides
Oversight Must Comply with the ESA.
The ESA obligates federal agencies “to afford first priority to the declared

national policy of saving endangered species.” 346 To that end, EPA must adhere to
the numerous substantive and procedural provisions designed to protect threatened
and endangered species in its activities or programs to address the critical issue of
PFAS in pesticides.
One such provision, section 7, requires federal agencies to “insure that any
action authorized, funded, or carried out by such agency … is not likely tojeopardize the continued existence of [endangered or threatened species] or result in
the destruction or adverse modification of [critical] habitat.” 347 Thus, before
engaging in any type of activity that may have direct or indirect effects on
endangered species or critical habitat, agencies must “consult” either the Fish andWildlife Service (FWS) or the National Marine Fisheries Service (NMFS) in order toevaluate the impact of such agency action. 348 FWS regulations implementing section§7(a)(2) state that such formal or informal consultation must be initiated whenever

345 Id. § 136(c).

346 Tenn. Valley Auth. v. Hill, 437 U.S. 153, 185 (1978).
347 16 U.S.C. § 1536(a)(2).
348 Id.

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an agency determines its action may affect a listed species, and that ongoing actions
must be re-evaluated when species that may be affect by those actions are listed. 349
The Act’s consultation provision applies to “activities or programs of any kind
authorized, funded, or carried out, in whole or in part, by Federal agencies in the
United States or upon the high seas.” 350 The concept of agency action has been
given broad application by the courts and agency regulations, including thepromulgation of regulations, the granting of licenses, and actions directly or
indirectly causing modifications to land, water, or air. 351 Other examples ofactivities include the creation of interim management strategies and in some cases
guidelines and revised criteria. 352
Further, section 7(a)(1) includes an affirmative grant of authority, mandatingthat agencies “utilize their authorities in furtherance of the purposes of this chapter
by carrying out programs for the conservation of [listed] species.” 353 Section 7(a)(1)
imposes a judicially reviewable obligation upon all agencies to carry out programs

349 50 C.F.R. §§ 402.14, 402.16.
350 Id. § 402.02.
351 Id.

352 See, e.g., Env’t Def. Ctr. v. Bureau of Ocean Energy Mgmt., 36 F.4th 850(9th Cir. 2022) (issuing guidelines for oil treatment is an action); Pac. Rivers
Council v. Thomas, 30 F.3d 1050 (9th Cir. 1994) (revising criteria for future forest
management is an action); Lane Cnty Audubon Soc’y v. Jamison, 958 F.2d 290 (9thCir. 1992) (setting criteria for selection of logging land is an action).
353 16 U.S.C. § 1536(a)(1).
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for the conservation of endangered and threatened species, prohibiting total
inaction. 354
And section 7(d) prohibits EPA from making any irretrievable andirreversible commitments of resources “which [have] the effect of foreclosing theformulation or implementation of any reasonable and prudent alternative
measures” deemed necessary to avoid jeopardy or adverse modification after
initiating consultation. 355 While non-jeopardizing activities may proceed duringconsultation processes, none deemed irreversible may continue, nor those thatwould prevent alternatives identified during consultation.
FWS regulations under the ESA require agencies to review their action “atthe earliest possible time to determine whether any action may affect listed
species.” 356 The threshold for the requirement to make the determination ofwhether a particular agency action may affect a listed species is triggered where “anendangered or threatened species may be present in the area of the proposed
action.” 357

354 See, e.g., Sierra Club v. Glickman, 156 F.3d 606, 617-18 (5th Cir. 1998);

Nat’l Wildlife Fed’n v. Norton, 332 F. Supp. 2d 170, 186 (D.D.C. 2004) (Section
7(a)(1) confers discretion, but that “discretion is not so broad as to excuse total
inaction.”); Defs. of Wildlife v. Sec’y, U.S. Dep’t of the Interior, 354 F. Supp. 2d 1156,
1174 (D. Or. 2005)(“[C]ompliance is not committed to agency discretion by law.”).
355 16 U.S.C. § 1536(d).
356 50 C.F.R. § 402.14(a).
357 City of Sausalito v. O’Neill, 386 F.3d 1186, 1215 (9th Cir. 2004); PacificRivers Council v. Thomas, 30 F.3d 1050, 1055 (9th Cir. 1994) (agency actions ‘mayaffect’ the protected salmon where “the plans set forth criteria for harvesting
resources within the salmon’s habitat”).
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A.

The ESA Applies to Agency Actions Taken Pursuant to FIFRA,
and EPA Must Comply with ESA Section 7 With Regard to a
Program for PFAS in Pesticides.

Accordingly, any “agency action” EPA takes with regard to PFAS in
pesticides triggers section 7 consultation procedures. EPA should now, “at theearliest possible time” consult with the applicable wildlife agency to determine
whether its actions regarding PFAS in pesticides may affect listed species. 358
EPA must comply with the ESA when acting under FIFRA: “FIFRA does notexempt the EPA from complying with ESA requirements when the EPA registers
pesticides. Indeed, a pesticide registration that runs against the clear mandates of
the ESA will most likely cause an unreasonable adverse effect on the environment
under FIFRA.” 359 Rather, the ESA “applies to any pesticide that may harm
endangered or threatened species or their habitats: Before registering a pesticide,
EPA must consult with the statutorily specified agencies that have expertise on
risks to species’ survival.” 360 EPA has a procedural duty to evaluate pesticide
registrations’ effects “in consultation with and with the assistance of” the agencies
that—unlike EPA—Congress designated as having endangered species expertise
any time EPA determines its actions “may affect” protected species or critical
habitat. 361 “[T]he strict substantive provisions of the ESA justify more stringent

358 50 C.F.R. § 402.14(a).

359 Defs. of Wildlife v. EPA, 882 F.2d 1294, 1299 (8th Cir. 1989).

360 Ctr. for Biological Diversity v. EPA, 56 F.4th 55, 60 (D.C. Cir. 2022).
361 16 U.S.C. § 1536(a)(2); 50 C.F.R. §§ 402.14(a), 402.01(b).

92enforcement of its procedural requirements, because [they] are designed to ensurecompliance with the substantive provisions.” 362
Under the ESA, EPA must also base its decisions on “the best scientific andcommercial data available.” 363 “The obvious purpose of the [best available science
requirement] is to ensure that the ESA not be implemented haphazardly, on thebasis of speculation or surmise.” 364 A failure by the agency to utilize the best
available science is arbitrary and capricious.
These consultation requirements also apply to programmatic actions under
FIFRA, including a “proposed program, plan, policy, or regulation providing aframework for future proposed actions,” are subject to programmaticconsultation. 365 A programmatic action “approves a framework for the developmentof future action(s) that are authorized, funded, or carried out at a later time,” andthus, “any take of a listed species would not occur unless and until those future
action(s) are authorized, funded, or carried out.” 366 Any later project-specificconsultation “does not relieve the Federal agency of the requirements forconsidering the effects of the action or actions as a whole.” 367

362 Thomas v. Peterson, 753 F.2d 754, 764 (9th Cir. 1985) (emphasis inoriginal), abrogated on other grounds by Cottonwood Env’t Law Ctr. v. U.S. Forest
Serv., 789 F.3d 1075, 1088-89 (9th Cir. 2015).
363 16 U.S.C. § 1536(a)(2); 50 C.F.R. § 402.14(g)(8) (“In formulating its
Biological Opinion, any reasonable and prudent alternatives, and any reasonable
and prudent measures, the Service will use the best scientific and commercial data
available.”).
364 Bennett v. Spear, 520 U.S. 154, 176 (1997).
365 50 C.F.R. § 402.02 (defining “programmatic consultation”).
366 Id. (defining “framework programmatic action”).
367 Id. § 402.14(c)(4).
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B.

PFAS Environmental Impacts and Potential Impacts on
Protected Species.

As described supra, the use of PFAS in pesticides sprayed nationwide makes
it increasingly likely that protected species and their critical habitat may beaffected by the increasing PFAS contamination in the environment. Many PFAS arepersistent, bioaccumulative, and toxic, with risks to fish and wildlife. The chemicals
are linked to tumors in animals, lower reproductive success in birds, and liver,kidney and immunological effects in laboratory animals. Because many PFAS
bioaccumulate (get taken up in organisms) and biomagnify (increase inconcentrations up the food chain), the chemicals can have impacts on fish andwildlife. For example, a recent study found the median level of total targeted PFAS
in fish from rivers and streams was 9,500 nanograms per kilogram, while themedian in the Great Lakes was 11,800 nanograms per kilogram. 368 As a result, thepresence of PFAS in listed species such as the West Indian manatee, 369 Hawksbill
turtle, 370 leatherback sea turtle, 371 Florida manatee, 372 Kemp’s ridley sea turtle, 373

368 Nadia Barbo, et al., Locally Caught Freshwater Fish Across the UnitedStates are Likely a Significant Source of Exposure to PFOS and Other
Perfluorinated Compounds, 220 ENV'T RESEARCH (2023),
https://www.sciencedirect.com/science/article/pii/S0013935122024926?via%3Dihub.
369 Palmer, supra n.195.
370 Keller, supra n.196.
371 Id.
372 Griffin, supra n.198.
373 Keller, supra n.196.
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green sea turtle, 374 and Southern Resident Killer Whales 375 indicate grave concerns
for listed species from PFAS contamination.
C.

ESA Conclusion and Actions Requested.

Accordingly, EPA must act as soon as possible, using the best available
science, to protect endangered and threatened species by complying with the ESA,
including by consulting with the appropriate wildlife agency about the impacts onprotected species of EPA’s oversight actions, including inter alia any pesticide
registration or classification decisions for PFAS ingredients, as well as carrying out
a program for the protection of endangered and threatened species from PFAS in
pesticides. And in the meantime, EPA may not make any irretrievable andirreversible commitments of resources.
CONCLUSION
For the reasons stated herein Petitioners request that EPA cancel andsuspend the registrations of any pesticide ingredients that qualify as PFAS, in
addition to amending its registration regulations to explicitly prohibit PFAS in
pesticides. Petitioners also request that EPA clarify in its regulations that PFAS
are prohibited and change its definition of PFAS to accord with the USGS and statebased definitions of PFAS as “a class of fluorinated organic chemicals that containat least one fully fluorinated carbon atom.” Petitioners further request that EPA
prohibit the use of fluorinated HDPE and polypropylene containers, which leach

374 Id.

375 Lee, supra n.201.

95

PFAS into pesticides and that EPA mandate reporting of pesticide products
contaminated with PFAS. Petitioners request these changes in order for EPA tocomply with its statutory duty to protect human health and the environment fromthe unreasonable adverse effects of pesticides.

Cc:
Jeffrey M. Prieto, General Counsel
U.S. Environmental Protection Agency
Office of General Counsel, Mail Code 2310A
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
prieto.jeffrey@epa.gov
Michal Ilana Freedhoff, Assistant Administrator
U.S. Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention, Mail Code 7101M
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
freedhoff.michal@epa.gov
Edward Messina, Director
U.S. Environmental Protection Agency
Office of Pesticide Programs, Mail Code: 7501P
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
messina.edward@epa.gov
Charles Smith, Division Director
U.S. Environmental Protection Agency
Office of Pesticide Programs, Mail Code: 7501P
Registration Division
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
smith.charles@epa.go

96