Attachment 2- Public Comment- Earth Justice

May 28, 2021
Via Regulations.gov
Dr. Michal Freedhoff
Principal Deputy Assistant Administrator
Office of Chemical Safety and Pollution Prevention
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Re:

Agency Information Collection Activities; Recordkeeping and Reporting
Requirements for Allegations of Significant Adverse Reactions to Human
Health or the Environment, Docket No. EPA-HQ-OPPT-2015-0688

Dear Dr. Freedhoff:
Earthjustice, Environmental Defense Fund, Environmental Working Group and Natural
Resources Defense Council submit these comments on the Environmental Protection Agency’s
(“EPA”) Information Collection Request for Recordkeeping and Reporting Requirements for
Allegations of Significant Adverse Reactions to Human Health or the Environment (the “ICR”). 1
The ICR solicits comment on EPA’s information gathering under Section 8(c) of the Toxic
Substance Control Act (“TSCA”), which authorizes EPA to collect from “[a]ny person who
manufactures, processes, or distributes in commerce any chemical substance or mixture … records
of significant adverse reactions to health or the environment … alleged to have been caused by the
substance or mixture.” 2 Such records include, but are not limited to, “records of consumer
allegations of personal injury or harm to health, reports of occupational disease or injury, and
reports or complaints of injury to the environment submitted to the manufacturer, processor, or
distributor in commerce from any source.” 3 Congress enacted Section 8(c) to provide EPA with
access to information—including worker and consumer complaints about a chemical’s harmful
effects—that is often not publicly available and might otherwise escape EPA’s notice. This
information is particularly important for EPA’s TSCA prioritization decisions, risk evaluations,
and risk management rules, each of which calls for a robust understanding of a chemical’s effects
on human health and the environment.
However, EPA has rarely used its Section 8(c) data gathering authority in the past, and,
according to the ICR, the Agency only intends to issue “one additional [8(c)] notice per year
during the three year ICR collection period” 4—a period in which EPA must complete at least 23
TSCA risk evaluations, issue 10 risk management rules, and designate at least one new high1

Agency Information Collection Activities; Proposed Renewal of an Existing Collection and Request for Comment;
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or
the Environment, 86 Fed. Reg. 16,347 (Mar. 29, 2021).
2
15 U.S.C. § 2607(c).
3
Id.
4
EPA, Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act
(PRA) (“ICR Supporting Statement”) at 8–9 (Mar. 16, 2021), https://www.regulations.gov/document/EPA-HQOPPT-2015-0688-0009.

priority substance for each risk evaluation it completes. EPA’s decision not to collect 8(c) data is
misguided and inconsistent with EPA’s statutory obligation to consider “reasonably available
information” when preparing prioritization decisions, risk evaluations and risk management
rules. 5 We urge EPA to issue 8(c) data requests for every chemical undergoing risk evaluation
and risk management, as well as for per- and polyfluoroalkyl substances (“PFAS”) and for any
chemicals identified as a candidate or proposed for high-priority designation under TSCA in the
future.
The benefits of collecting 8(c) data far outweigh the costs to reporting entities and EPA.
Under Section 8(c), companies are already required to maintain “[r]ecords of … adverse
reactions to the health of employees … for a period of 30 years from the date such reactions were
first reported … .” 6 All other 8(c) records, including consumer complaints, must be “retained for
a period of five years from the date the information contained in the record was first reported.” 7
Those records are thus readily accessible, and EPA can compel their production with a Federal
Register Notice or a letter to the reporting entity; EPA does not need to undergo rulemaking
procedures or issue an order. 8 In the ICR, EPA conservatively estimates that a company’s
response to an 8(c) data request would take of total of eight hours, or approximately $600 of staff
time, per report:
EPA estimates that a management level company official will spend one hour
reviewing the Federal Register notice or letter from EPA to determine whether the
company manufactures (including imports) or processes substances subject to the
reporting requirement. Technical personnel would then spend an estimated two hours
conducting a search of the company’s TSCA section 8(c) files for any relevant
allegation records. Once the file search is complete, EPA estimates that a managerial
employee would spend two hours preparing a transmittal letter and other explanatory
material to accompany the allegation records. An upper-level management official
would spend an additional two hours reviewing these materials. One hour of clerical
labor would be required to prepare and mail the response. A total of eight hours is
expended per report (five managerial hours, two technical hours and one clerical
hour). The unit cost for reporting, per report, is $605.53. 9
Section 8(c) records are particularly relevant to TSCA prioritization decisions, risk
evaluations, and risk management rules, three processes in which EPA is statutorily required to
consider “reasonably available information” related to a chemical’s hazards and exposures. 10
According to EPA, Section 8(c) “provides a mechanism to identify previously unknown
chemical hazards” by “reveal[ing] patterns of adverse effects which otherwise may not be
otherwise noticed or detected.” 11 While 8(c) reports may not be sufficient, standing alone, to
5

See, e.g., 15 U.S.C. § 2625(k) (requiring EPA to consider “reasonably available information” when conducting risk
evaluations and issuing risk management rules).
6
Id. § 2607(c).
7
Id.
8
40 C.F.R. § 717.17(b).
9
ICR Supporting Statement at 10, supra note 4.
10
15 U.S.C. § 2625(k).
11
EPA, “Data Development and Information Collection to Assess Risks” (last updated Feb. 17, 2021),
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/data-development-and-information-collection-

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measure a chemical’s risks, they can identify effects that warrant additional analysis and
potential regulation, and can also help EPA identify facilities, materials, or products that use or
release the chemical, and populations that have been harmed by it. Moreover, EPA’s TSCA
regulations define “reasonably available information” as “information that EPA possesses or can
reasonably generate, obtain, and synthesize for use in risk evaluations, considering the deadlines
specified in TSCA.” 12 Under this definition, 8(c) records are “reasonably available,” because
they can be reasonably obtained by EPA within the statutory deadline for a risk evaluation or risk
management rule.
Despite the benefits of Section 8(c) reporting, and TSCA’s mandate to consider
reasonably available information, EPA has hardly ever used its 8(c) authority. Since finalizing
regulations implementing Section 8(c) in 1983, EPA has issued only two data requests under that
Section, covering two chemicals and two chemical categories. 13 In contrast, EPA estimates that
companies receive more than 5,500 reports of adverse reactions under Section 8(c) each year,
which would total more than 200,000 total reports over that period. 14 EPA lacks access to the
overwhelming majority of that data, solely because it never asked for it. Under the ICR, EPA
intends to maintain this hands-off approach over the years ahead, with plans to issue only “one
additional [8(c)] notice per year,” despite EPA’s heightened need for chemical safety data during
that period. 15
We urge EPA to make greater use of its Section 8(c) data collection authority, and to
issue requests for 8(c) reports covering the following groups of chemicals:
•

•

All chemicals currently undergoing TSCA risk evaluations: EPA is currently
conducting 23 risk evaluations, which are designed “to determine whether a chemical
substance presents an unreasonable risk of injury to health or the environment.” 16
Section 8(c) records can identify previously unknown chemical uses, hazards, and
exposures, and call attention to health effects that may warrant further analysis in a
risk evaluation.
All chemicals for which EPA is developing risk management rules: EPA is also
preparing risk management rules for the 10 chemicals that underwent risk evaluations
in the last administration. Those rules require the consideration of “the effects of the
chemical substance … on health and the magnitude of the exposure of human
beings,” both of which would be informed by available information in 8(c) records. 17

assess-risks. The scope of recordkeeping under Section 8(c) is broader than reporting under TSCA Section 8(e),
which covers only information that reflects “substantial risk of injury to health or the environment.” 15 U.S.C.
§ 2607(e) (emphasis added); see also EPA, Questions and Answers Concerning the TSCA Section 8(c) Rule at 24
(July 1984), https://www.complywithtsca.com/pdf%20files/previews/1dQandA.pdf (“Section 8(c) allegations … can
also report lesser effects experienced by a group, or repeatedly by an individual,” which would not be reported under
Section 8(e).).
12
40 C.F.R. § 702.33.
13
ICR Support Statement at 8, supra note 4.
14
Id.
15
Id. at 9.
16
15 U.S.C. § 2605(b)(4)(A).
17
Id. § 2605(c)(2)(A)(i).

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•

•

All chemicals that are identified as candidates or proposed for a “high priority”
designation in the future: EPA reports that it intends to conduct “preliminary analyses
of prioritization candidates for pre-prioritization phase” over the coming year. 18 The
“pre-prioritization” process will identify chemicals that may be subject to “high
priority” designations and TSCA risk evaluations in the future. Once EPA identifies a
potential high priority chemical through the pre-prioritization or prioritization
process, EPA should immediately use its 8(c) authority to collect relevant information
about that chemical.
PFAS chemicals: According to EPA, “[u]nderstanding the scope of PFAS exposure
including sources, pathways, populations exposed, and levels of exposure is critical to
effectively characterizing the potential human health and environmental risks
associated with these compounds.” 19 In addition, while all PFAS are persistent and
many of the PFAS that have been studied share common health effects, “for most
PFAS there is limited or no toxicity information.” 20 A Section 8(c) records request
could help to fill that data gap and provide information that could inform EPA’s
broader efforts to prioritize, evaluate, regulate, or remediate PFAS. 21 Notably, some
of the earliest indications of PFAS toxicity came from the impacts on workers in
PFAS manufacturing plans, the very type of information covered by Section 8(c).

In short, Section 8(c) is an important but underutilized tool that can assist EPA in its
TSCA implementation efforts. We encourage EPA to make greater use of its 8(c) authority in the
future, and we appreciate the opportunity to submit the foregoing comments. For additional
information about the issues raised in these comments, please contact Jonathan Kalmuss-Katz at
[email protected].
Respectfully submitted,
Earthjustice
Environmental Defense Fund
Environmental Working Group
Natural Resources Defense Council

18

EPA Office of Pollution Prevention & Toxics, Strategic Plan FY 2021 – FY 2023 at 22 (May 2021),
https://insideepa.com/sites/insideepa.com/files/documents/2021/may/epa2021_1033.pdf.
19
EPA, EPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan at 10 (Feb. 2019),
https://www.epa.gov/sites/production/files/2020-01/documents/pfas_action_plan_feb2020.pdf.
20
Id.
21
Because TSCA provides that “any action authorized or required to be taken by the Administrator under any
provision of this [Act] with respect to a chemical substance or mixture may be taken … with respect to a
category of chemical substances or mixtures,” EPA may issue a single request all Section 8(c) records for the class
of PFAS, as opposed to for individual PFAS chemicals. 15 U.S.C. § 2625(c).

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