[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24824-24831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07492]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0029; FRL-11666-01-OCSPP]


Polychlorinated Biphenyls (PCBs); TSCA Section 21 Petition for 
Rulemaking Under TSCA Section 6; Reasons for Agency Response; Denial of 
Requested Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for agency response.

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SUMMARY: This action announces the availability of the Environmental 
Protection Agency (EPA or the Agency) response to a petition received 
on January 4, 2024, from the Washington State Department of Ecology 
(the petitioner), asking EPA to initiate rulemaking under the Toxic 
Substances Control Act (TSCA) to safeguard public health against PCBs 
in consumer products. EPA shares the petitioner's concerns regarding 
risks to human health and the environment posed by PCBs, and the Agency 
continues to work towards better understanding and reducing exposures 
to PCBs. However, the petitioner failed to point with any

[[Page 24825]]

specificity to deficiencies in the Agency's 1984 final rule and 
determination of no unreasonable risk under TSCA. As a result, the 
petitioner has not provided adequate justification--based on the 
rulemaking process and record for the 1984 final rule and information 
provided or otherwise available to the Agency--to support reassessing 
the limits on allowable inadvertent PCBs in consumer products. Thus, 
EPA finds that the petition is insufficiently specific, and that the 
petitioner did not meet their burden under TSCA of establishing that it 
is necessary to amend the 1984 final rule. These deficiencies, among 
other findings, are detailed in this notice and serve as the reasons 
for the Agency's denial of the petition. As necessary and appropriate 
to supplement ongoing Agency efforts, EPA may consider information 
gathering activities under TSCA to collect data needed to better 
understand and characterize exposure and risk associated with 
inadvertently generated PCBs.

DATES: EPA's response to this petition was signed April 3, 2024.

ADDRESSES: The docket for this petition, identified by docket 
identification (ID) number EPA-HQ-OPPT-2024-0029, is available online 
at https://www.regulations.gov. Additional instructions on visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For general information contact: The 
TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 
14620; telephone number: (202) 554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who manufacture (including 
import), process, distribute in commerce, use, or dispose of PCBs. 
Since other entities may also be interested, EPA has not attempted to 
describe all the specific entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA 
to initiate a proceeding for the issuance, amendment, or repeal of a 
rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA 
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth 
the facts which it is claimed establish that it is necessary to 
initiate the action requested. EPA is required to grant or deny the 
petition within 90 days of its filing. If EPA grants the petition, the 
Agency must promptly commence an appropriate proceeding. If EPA denies 
the petition, the Agency must publish its reasons for the denial in the 
Federal Register. A petitioner may commence a civil action in a U.S. 
district court seeking to compel initiation of the requested proceeding 
within 60 days of a denial or, if EPA does not issue a decision, within 
60 days of the expiration of the 90-day period.

C. What criteria apply to a decision on this TSCA section 21 petition?

1. Legal Standard Regarding TSCA Section 21 Petitions
    TSCA section 21(b)(1) requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary'' to initiate 
the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, in addition to a 
petitioner's burden under TSCA section 21 itself, TSCA section 21 
implicitly incorporates the statutory standards that apply to the 
requested actions. Accordingly, EPA has reviewed this TSCA section 21 
petition by considering the standards in TSCA section 21 and in the 
provisions under which actions have been requested.
2. Legal Standard Regarding TSCA Section 6(e)
    TSCA section 6(e)(1) gives EPA authority to promulgate rules 
regarding the disposal and marking of PCBs. 15 U.S.C. 2605(e)(1). TSCA 
section 6(e)(2) and (e)(3) generally prohibit the manufacture, 
processing, distribution in commerce, and use (other than totally 
enclosed use) of PCBs. 15 U.S.C. 2605(e)(2) and (e)(3). Under TSCA 
section 6(e)(2)(B), EPA may by rule authorize the use of PCBs in other 
than a totally enclosed manner if EPA finds that such use will not 
present an unreasonable risk of injury to health or the environment. 15 
U.S.C. 2605(e)(2)(B). Under TSCA section 6(e)(3)(B), EPA may grant by 
rule an exemption from the general prohibitions in TSCA section 
6(e)(3)(A) on the manufacturing, processing, and distribution in 
commerce of PCBs if EPA finds that such activities would not result in 
an unreasonable risk of injury to health or the environment, and good 
faith efforts have been made to develop a chemical substance which does 
not present an unreasonable risk of injury to health or the environment 
and which may be substituted for PCBs. 15 U.S.C. 2605(e)(3)(B). As 
provided in TSCA section 6(e)(5), section 6(e) does not limit EPA's 
authority to take action on PCBs under any other provision of TSCA or 
any other federal law. 15 U.S.C. 2605(e)(5).
3. Legal Standard Regarding TSCA Section 26
    To the extent that EPA makes a decision based on science, TSCA 
section 26(h) requires EPA, in carrying out TSCA sections 4, 5, and 6, 
to use ``scientific information, technical procedures, measures, 
methods, protocols, methodologies, or models, employed in a manner 
consistent with the best available science,'' while also taking into 
account other considerations, including the relevance of information 
and any uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires 
that decisions under TSCA sections 4, 5, and 6 be ``based on the weight 
of the scientific evidence.'' 15 U.S.C. 2625(i). TSCA section 26(k) 
requires that EPA consider information that is reasonably available in 
carrying out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).

II. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On January 4, 2024, EPA received a TSCA section 21 petition (Ref. 
1) from the Washington State Department of Ecology. The petition 
requests EPA in general to ``initiate rulemaking to safeguard public 
health against polychlorinated biphenyls . . . in consumer products'' 
(Ref. 1, p. 1). More specifically, the petition asks that ``EPA 
commence rulemaking to eliminate the current allowances for PCBs in 
consumer products'' (Ref. 1, p. 1) via five actions: ``1. Commence 
rulemaking to reassess limits on allowable inadvertent PCBs found in 
consumer products . . . as detailed in the definitions of [`]excluded 
manufacturing process['] and [`]recycled PCBs['] found in 40 CFR 761.3. 
. . . 2. Adopt a new rule that identifies use of pigments containing 
PCBs as a [`]use['] of PCBs. . . . 3. In collaboration with state and 
tribal governments, establish new, lower limits on allowable 
inadvertent PCBs in consumer products. . . . 4. In collaboration with 
state and tribal governments, establish priority consumer products that 
will be subject to lower allowable limits of inadvertent PCBs at an 
earlier date. . . . 5. In collaboration with state and tribal 
governments, reassess limits on all allowable PCBs found in commercial 
products, as detailed in 40 CFR 761, et

[[Page 24826]]

seq., and establish a rulemaking schedule for the adoption of revised 
regulations'' (Ref. 1, p. 3).
    For the purposes of assessing the petition within the scope of TSCA 
section 21, EPA is interpreting these requests generally and 
collectively as requesting the Agency to initiate a proceeding for the 
amendment of a final rule issued under TSCA section 6(e) in 1984 (Ref. 
2) (see Ref. 1, p. 4: ``This petition requests EPA to reassess rules 
adopted June 27, 1984, pursuant to authority under [TSCA section 6], 
thereby making it subject to a Section 21 petition.''). More 
specifically, EPA is interpreting this request to amend the definitions 
of ``excluded manufacturing process'' and ``recycled PCBs'' at 40 CFR 
761.3, established in the 1984 final rule, to the extent that they 
refer to and establish limits for ``PCBs in products leaving any 
manufacturing site or imported into the United States'' and ``PCBs in 
paper products leaving any manufacturing site processing paper 
products, or in paper products imported into the United States.'' EPA 
is also interpreting this request to amend the exemptions for excluded 
manufacturing processes and recycled PCBs at 40 CFR 761.1(f)(2) and 
(3), also established in the 1984 final rule, to the extent that they 
refer to ``[p]ersons who . . . use products containing PCBs generated 
in excluded manufacturing processes defined in Sec.  761.3'' and 
``[p]ersons who . . . use products containing recycled PCBs defined in 
Sec.  761.3.''
1. Request for Rulemaking Associated With Limits for Inadvertently 
Generated PCBs in ``Consumer Products''
    The petition requests that EPA take three actions related to the 
authorized limits for inadvertently generated PCBs in consumer 
products: (1) Commence rulemaking to reassess limits on allowable 
inadvertent PCBs in consumer products; (2) Collaborate with state and 
tribal governments to establish new, lower regulatory limits on 
inadvertent PCBs in consumer products and identify appropriate test 
methods; and (3) Collaborate with state and tribal governments to phase 
in lower limits on inadvertently generated PCBs in consumer products, 
starting with priority consumer products. The requested actions include 
collaboration with state and local governments, which EPA believes is 
attendant to the petitioner's general request for rulemaking under TSCA 
section 6. The Agency's policy on conducting rulemaking encourages 
appropriate and meaningful consultation with external stakeholders, 
including state, tribal and local officials. As the petitioner is 
seeking to amend an existing rule under TSCA section 6, this Federal 
Register document addresses this request.
2. Request for Rulemaking Associated With ``Use of Pigments Containing 
PCBs''
    The petition requests that EPA adopt a new rule that identifies the 
use of pigments containing inadvertent PCBs to be a ``use'' of PCBs, 
subject to the applicable limitations under 40 CFR 761.20(a). EPA 
interprets this request as the petitioner seeking to amend an existing 
rule under TSCA section 6; this Federal Register document addresses 
this request.
3. Request for Rulemaking Associated With ``All Allowable PCBs Found in 
Commercial Products''
    The petition requests that EPA collaborate with state and tribal 
governments to reassess limits on allowable non-inadvertent PCBs in 
commercial products. The requested action includes collaboration with 
state and local governments, which EPA believes is attendant to the 
petitioner's general request for rulemaking under TSCA section 6. The 
Agency's policy on conducting rulemaking encourages appropriate and 
meaningful consultation with external stakeholders, including state, 
tribal and local officials. As the petitioner is seeking to amend an 
existing rule under TSCA section 6, this Federal Register document 
addresses this request.

B. What support did the petitioner offer?

    To support the requests for rulemaking under TSCA section 6(e), the 
petitioner provided a discussion of legislative and regulatory 
authorities related to PCBs and inadvertently generated PCBs (Ref. 1, 
pp. 5-6), as well as information on the historical manufacture and uses 
of PCBs (Ref. 1, pp. 7-8), impacts of PCBs on human health and the 
environment, including sensitive species (Ref. 1, pp. 8-11), the 
presence of and potential for exposure to inadvertently generated PCBs 
in consumer products (Ref. 1, pp. 11-14), and the availability of safer 
alternatives to paints and inks that contain inadvertently generated 
PCBs (Ref. 1, pp. 14-15). The petitioner also provided a bibliography 
of references cited (Ref. 1, pp. 16-20). The Agency appreciates the 
information provided in the petition and finds it generally consistent 
with decades of peer-reviewed and published data on PCBs.

III. Disposition of TSCA Section 21 Petition

A. What is EPA's response?

    EPA shares the petitioner's concerns regarding risks to human 
health and the environment posed by PCBs, including information related 
to indigenous populations in Washington State and to sensitive species 
like orcas and seals, and the Agency continues to work towards better 
understanding and reducing exposures to PCBs. However, as described in 
Unit III.B.1., the petitioner failed to point with any specificity to 
deficiencies in the Agency's promulgation of the 1984 final rule and 
determination of no unreasonable risk under TSCA section 6(e). As a 
result, the petitioner has not provided adequate justification--based 
on the rulemaking process and record for the 1984 final rule, as well 
as information provided or otherwise available to the Agency--for 
reassessing the limits on allowable inadvertent PCBs in consumer 
products. Thus, EPA finds that the petition is insufficiently specific 
and that the petitioner did not meet their burden under TSCA section 
21(b)(1) of establishing that it is necessary to amend the 1984 final 
rule under TSCA section 6(e). Therefore, after careful consideration, 
EPA has denied this TSCA section 21 petition. As necessary and 
appropriate to supplement ongoing Agency efforts (see Unit III.B.1.e.), 
EPA may consider information gathering activities under TSCA (e.g., 
TSCA sections 4 or 8) to collect data needed to better understand and 
characterize exposure and risk associated with inadvertently generated 
PCBs.
    A copy of the Agency's response, which consists of the letter to 
the petitioner and this document, is posted on the EPA TSCA petition 
website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#PCBs. The response, the petition (Ref. 1), and 
other information is available in the docket for this TSCA section 21 
petition (see ADDRESSES).

B. What was EPA's reason for this response?

    TSCA section 21 provides for the submission of a petition seeking 
the initiation of a proceeding for the issuance, amendment, or repeal 
of a rule under TSCA section 6. The petition must set forth the facts 
which it is claimed establish that it is necessary to initiate the 
action requested. 15 U.S.C. 2620(b)(1). EPA considered whether the 
petition established that it is necessary to amend the 1984 TSCA 
section 6(e) final rule establishing definitions of

[[Page 24827]]

``excluded manufacturing process'' and ``recycled PCBs'' at 40 CFR 
761.3 and exemptions for excluded manufacturing processes and recycled 
PCBs at 40 CFR 761.1(f)(2) and (3). For EPA to be able to conclude 
within the statutorily-mandated 90 days of receiving the petition that 
the initiation of a proceeding for the amendment of the 1984 final rule 
is necessary, the petition needs to be sufficiently clear and robust.
    EPA evaluated the information presented in the petition and 
considered that information in the context of the applicable 
authorities and requirements of TSCA sections 6, 21, and 26. 
Notwithstanding that the burden is on the petitioner to set forth the 
facts which it is claimed establish that it is necessary for EPA to 
initiate the action requested, EPA nonetheless also considered relevant 
information that was reasonably available to the Agency during the 90-
day petition review period. As detailed further in Units III.B.1., 2., 
and 3., EPA finds that the petition is insufficiently specific and that 
the petitioner did not meet their burden under TSCA section 21(b)(1) of 
establishing that it is necessary to amend the 1984 final rule under 
TSCA section 6(e). These deficiencies, among other findings, are 
detailed in this notice.
1. Necessity of Rulemaking Associated With Limits for Inadvertently 
Generated PCBs in Consumer Products
    The ``primary issue'' (Ref. 1, p. 4) raised by the petitioner is 
the ``Recommendation of the Parties for a Final EPA Rule on Inadvertent 
Generation of PCBs'' (hereinafter ``consensus proposal''), which formed 
part of the framework for the finding of no unreasonable risk in the 
1983 proposed rule ``Polychlorinated Biphenyls (PCBs); Exclusions, 
Exemptions and Use Authorizations; Proposed Rule'' (Ref. 3), and 1984 
final rule, ``Toxic Substances Control Act; Polychlorinated Biphenyls 
(PCBs) Manufacturing, Processing, Distribution in Commerce, and Use 
Prohibitions; Exclusions, Exemptions, and Use Authorizations'' (Ref. 
2), and led to the establishment of the definitions for ``excluded 
manufacturing process'' and ``recycled PCBs'' (see 40 CFR 761.3). The 
former definition contains the allowance related to inadvertently 
generated PCBs in consumer products in general: ``The concentration of 
inadvertently generated PCBs in products leaving any manufacturing site 
or imported into the United States must have an annual average of less 
than 25 [parts per million (ppm)], with a 50 ppm maximum'' (see 40 CFR 
761.3). The latter definition contains a similar allowance for PCBs 
that appear in the processing of paper products from PCB-contaminated 
raw materials: ``The concentration of PCBs in paper products leaving 
any manufacturing site processing paper products, or in paper products 
imported into the United States, must have an annual average of less 
than 25 ppm with a 50 ppm maximum'' (see 40 CFR 761.3). The petitioner 
states ``[t]here is no indication in the 1984 rulemaking notice that 
the limits proposed [in the consensus proposal] and adopted by EPA are 
based on any specific scientific study or reasoning.'' (Ref. 1, p. 4). 
The Agency disagrees with this characterization.
a. 1983 Proposed Rule for Inadvertently Generated PCBs
    In the 1983 proposed rule (Ref. 3), EPA described the litigation 
and related processes that led to the submission of the consensus 
proposal to the Agency, as well as the receipt of comments and 
information related to inadvertently generated PCBs and recycled PCBs. 
The Agency also described how it determined that it was appropriate to 
use, in part, the consensus proposal as a framework for rulemaking, 
based on ``data analyses EPA had completed when it received the 
consensus proposal'' (Ref. 3). EPA also described modifications that 
EPA intended to make to the underlying framework linked to the 
consensus proposal, including consideration of recycled PCBs and lower 
concentration limits for certain products with a greater potential for 
exposure, as well as the rejection of provisions that could result in 
high level releases of PCBs in air, water, or products that could cause 
injury to health or the environment (Ref. 3).
    The Agency then summarized several approaches it considered and 
rejected in its effort to ``provide regulatory relief from the 
prohibitions of section 6(e) for PCBs at very low levels that do not 
present unreasonable [risks] to public health,'' including the 
exemption process of TSCA section 6(e)(3)(B) and developing regulatory 
limits on concentration levels for each chemical process in which 
inadvertently generated PCBs are generated (Ref. 3). EPA also 
considered the use of ``generic exposure assessments'' that could be 
used to estimate ``risks of cancer and reproductive/developmental 
health'' and, ultimately ``in developing generic exclusions, if 
warranted, based on a determination that particular classes of 
processes generating PCBs at low levels would not present unreasonable 
risks'' (Ref. 3). The generic risk assessments were then focused on a 
group of 70 chemical processes determined to have a high potential for 
PCB generation, which the Agency narrowed from an initial list of 
approximately 200 chemical processes with a potential for generating 
PCBs (Ref. 3). EPA then acknowledged that ``[t]he generic exposure 
assessment approach is less resource-intensive than the chemical-
specific approach; however, it is protective of human health and the 
environment'' (Ref. 3). In addition, EPA explained ``[t]he regulatory 
strategy initially pursued by EPA, based on generic exclusions, is more 
detailed and specific than the consensus approach which sets a simple 
regulatory limit. EPA has adopted the generic exclusion approach in 
developing this rulemaking; however, EPA's approach supports the 
regulatory framework submitted . . . in the consensus proposal'' and 
``in using the consensus proposal to develop this proposed rule, EPA 
has also used the Closed and Controlled Waste Manufacturing Processes 
Rule as a framework. Furthermore, the PCB analytical chemistry 
methodology developed to determine PCB concentration under that rule 
serves this proposed rule'' (Ref. 3).
    The Agency then declared ``EPA has considered the consensus 
proposal in terms of the required findings of sections 6(a) and 6(e) of 
TSCA and has decided to adopt an unreasonable risk test to support this 
proposed rule. By adopting this approach, EPA believes . . . that the 
Agency is consistent with congressional intent and is reasonably 
regulating inadvertently generated and recycled PCBs'' (Ref. 3). The 
Agency then arrived at its determination of no unreasonable risk 
(including the listing of applicable risk and hazard assessments and a 
regulatory impact analysis) by stating ``[a]fter the Closed and 
Controlled Waste Manufacturing Processes rule was published, EPA 
completed quantitative risk assessments for PCBs. Based on the risk 
assessment for carcinogenicity as well as information on reproductive/
developmental effects, environmental effects, and costs, EPA has 
determined that the manufacture, processing, distribution in commerce, 
and use of PCBs below the limits proposed in the consensus proposal 
would not present an unreasonable risk of injury to human health or the 
environment'' (Ref. 3). EPA then concluded ``[b]ased on the risk 
assessments conducted by EPA and the consensus proposal, the Agency is 
proposing to exclude from the prohibitions of section 6(e) of TSCA 
those activities (including manufacture, processing, distribution in 
commerce,

[[Page 24828]]

and use) that meet'' a list of criteria (Ref. 3) that would become the 
requirements listed in the definition of ``excluded manufacturing 
process'' at 40 CFR 761.3, including the current concentration limits 
for inadvertently generated PCBs in products. EPA also evaluated the 
risk of exposure to recycled PCBs and concluded that ``these risks are 
substantially similar to those risks for the inadvertently generated 
PCBs'' and therefore proposed to establish the same concentration 
limits for recycled PCBs in products (Ref. 3).
b. 1984 Final Rule for Inadvertently Generated PCBs
    In the 1984 final rule (Ref. 2), the Agency largely repeated the 
discussion of its process to reach the no unreasonable risk 
determination presented in the 1983 proposed rule, but also provided a 
summary of the general comments submitted. The comments discussed 
mentioned recommendations to modify the proposed rule and supporting 
documents, including requested edits to the nomenclature for specific 
consumer products (i.e., ``detergent bars'' and ``plastic building 
materials''), uncertainty among commenters about which Aroclor products 
were to be included under the definition of ``recycled PCBs,'' the 
limit of quantification for Aroclor PCBs in water, and the designation 
of certain chemical processes as having a high potential to 
inadvertently generate PCBs (Ref. 2). The Agency also stated that the 
``majority of the comments received in this rulemaking generally agreed 
with the exclusions proposed'' (Ref. 2). Absent from this summary were 
comments that questioned or otherwise challenged key aspects of the 
process the Agency used, including the framework involving the 
consensus proposal, to reach the no unreasonable risk determination 
(Ref. 2).
c. 2010 Advance Notice of Proposed Rulemaking
    In 2010, EPA issued an advance notice of proposed rulemaking 
(ANPRM) for the use and distribution in commerce of certain classes of 
PCBs and PCB items, as well as other PCB regulations (Ref, 4). Among 
the items in the ANPRM's request for public comment was reassessment of 
definitions of ``excluded manufacturing process'' and ``recycled PCBs'' 
(Ref. 4). EPA stated the ``objective of this ANPRM is to announce the 
Agency's intent to reassess the current use authorizations for certain 
PCB uses to determine whether they may now pose an unreasonable risk to 
human health and the environment. This reassessment will be based in 
part upon information and experience acquired in dealing with PCBs over 
the past 3 decades'' (Ref. 4). Related to the definitions of ``excluded 
manufacturing process'' and ``recycled PCBs,'' as well as other topics 
related to inadvertently generated PCBs, EPA received an array of 
comments available in the docket at https://www.regulations.gov/docket/EPA-HQ-OPPT-2009-0757. Commenters seeking to lower or eliminate 
allowances for excluded manufacturing processes mentioned concerns 
related to PCBs in dyes, pigments, and inks in imported products; 
elimination of all federal exclusions or exceptions for inadvertently 
generated PCBs; the status of monochloro[hyphen]biphenyls and 
dichloro[hyphen]biphenyls from total PCB regulation due to lower 
potential for bioaccumulation and human health toxicity; and lowering 
the allowable concentration of PCBs in dyes, inks and pigments using a 
phased approach and in concert with federal and state actions involved 
in developing water quality criteria and implementation. Commenters 
seeking to maintain the allowances for excluded manufacturing processes 
offered that establishing a 1 ppm threshold would eliminate three 
important pigment groups from commerce and affect color printing, 
paint, and plastics due to the absence of technology to eliminate PCBs 
in all organic pigments to a level below 1 ppm; and raised concerns 
that U.S. pigment and product manufacturers could be at additional 
competitive disadvantage versus pigment and product importers. After 
reviewing comments received, the Agency took no actions related to the 
definitions of ``excluded manufacturing process'' and ``recycled 
PCBs,'' which remain as defined in the 1984 final rule (Ref. 2).
 d. Petition's Lack of Specificity in Citing Flaws in EPA's 1984 
Determination of No Unreasonable Risk
    As described in Unit III.B.1.a. and b., the Agency articulated in 
both the 1983 proposed rule and 1984 final rule how and why it used, in 
part, the consensus proposal as part of the rule framework, as well as 
its additional processes to gather information and perform scientific 
and regulatory analyses to support its no unreasonable risk 
determination for excluded manufacturing processes and recycled PCBs. 
As part of the discussion, EPA described its own assessment of the 
consensus proposal, as well as the statements of the organizations that 
negotiated and presented it. Through the course of the rulemaking, the 
Agency solicited, received, and responded to public comment on various 
aspects and processes set forth in the proposed and final rules, as 
well as supporting documents. In addition, the 2010 ANPRM provided 
opportunity for public comment on the definitions of ``excluded 
manufacturing process'' and ``recycled PCBs'' (Ref. 4).
    Thus, while the petitioners assert that the 1984 final rule does 
not indicate that the ``limits proposed [in the consensus proposal] and 
adopted by EPA are based on any specific scientific study or 
reasoning'' (Ref. 1, p. 4), the rulemaking record shows that EPA 
applied a pragmatic, transparent, and appropriate scientific approach 
to reach its no unreasonable risk determination. As described in Unit 
III.B.1.a., the 1983 proposed rule (Ref. 3) describes in detail the 
Agency's scientific risk assessments; and copies of these documents are 
included in the docket for this notice (see EPA-HQ-OPPT-2024-0029). The 
petitioner did not provide details about how the Agency failed to meet 
its burden when it promulgated the 1984 final rule. In fact, the 1984 
final rule states how the Agency carefully considered each of the 
factors for determining unreasonable risk and concluded that the 
exclusions for inadvertently generated PCBs and recycled PCBs are 
``based on a finding that such PCBs present no unreasonable risk of 
injury to human health and the environment'' (Ref. 2).
    Furthermore, the 1984 final rule requires that manufacturers or 
importers of products containing inadvertently generated PCBs must 
notify EPA within 90 days if those products contain greater than 2 ppm 
PCB concentration in any resolvable gas chromatographic peak (see 40 
CFR 761.185). Since 1994, EPA has received about 80 notices from 28 
companies, and the frequency of such notifications has been decreasing; 
EPA has not received any new notice in several years. The infrequency 
of notification indicates that there may be little ongoing manufacture 
or import of products containing inadvertently generated PCBs at 
concentrations greater than 2 ppm PCBs. Similarly, after issuing the 
2010 ANPRM and receiving comments on the definitions of ``excluded 
manufacturing process'' and ``recycled PCBs,'' the Agency did not find 
a compelling rationale to take immediate action to reassess the no 
unreasonable risk determination. Therefore, based on the robust 
rulemaking record for the 1984 rule, and limited information indicating 
that EPA's unreasonable risk determination supporting the rule was 
flawed or is now outdated, the Agency has decided

[[Page 24829]]

not to reassess the limits for inadvertently generated PCBs or recycled 
PCBs at this time. Nonetheless, EPA recognizes the concerns related to 
human health and the environment posed by PCBs in general and is 
working towards better understanding those concerns, as described in 
Unit III.B.1.e.
e. Information Provided and Substantial Ongoing and Expected Agency 
Actions
    As previously mentioned, the Agency appreciates the information 
provided in the petition and finds it generally consistent with decades 
of peer-reviewed and published data on PCBs. In a discussion of EPA 
actions, activities, and regulations (Ref. 1, pp. 3-4), the petitioner 
focuses on the legislative, regulatory, and adjudicative milestones 
spanning the enactment of TSCA to the 1984 final rule. The petitioner 
also summarizes comprehensive information developed by EPA, other 
government authorities, and scientific researchers, which contribute to 
the collective scientific knowledge about the characteristics, sources, 
exposure pathways, and environmental and human health effects of PCBs. 
In addition, EPA is mindful of the information submitted regarding the 
impacts of PCBs among sensitive wildlife and human populations in 
Washington, including local indigenous populations whose diet typically 
consists of greater amounts of fish than other communities. EPA also 
notes the petitioner's acknowledgment that among the 209 identified PCB 
congeners, which have ``different physical properties, toxicity, and 
environmental fates, [. . .] there are characteristics that are 
applicable to all PCBs [and the] petition is based on these common 
characteristics'' (Ref. 1, pp. 5-6). Finally, EPA finds that the 
product category for which the petitioner provides the bulk of the 
information for inadvertently generated PCBs is paints and printing 
inks, as well as other components of those products (e.g., pigments and 
dyes).
    Throughout the implementation of TSCA section 6(e), the Agency has 
generated and collected a large amount of information related to PCBs. 
In addition, the widespread presence of PCBs in the environment is 
reflected by the manner in which EPA programs study, regulate, and 
enforce the PCB program under TSCA and other authorities across 
multiple offices within the Agency. The Agency's Integrated Risk 
Information System (IRIS) established in 1994 a non-cancer reference 
dose for oral exposure (RfD) for the PCB mixture Aroclor 1254 of 20 ng 
PCB/kg body weight per day and an RfD for Aroclor 1016 of 70 ng PCB/kg 
body weight per day. A 1996 weight-of-evidence characterization 
classified PCBs as a probable human carcinogen, and IRIS currently 
provides cancer dose oral slope factors of 2 per mg PCB/kg body weight 
per day (high risk and persistence, upper bound), 0.4 per mg PCB/kg 
body weight per day (low risk and persistence), and 0.07 per mg PCB/kg 
body weight per day (lowest risk and persistence). Additionally, the 
IRIS program is currently in the process of updating its non-cancer 
assessment of PCB mixtures available at https://iris.epa.gov/ChemicalLanding/&substance_nmbr=294.
    While EPA has substantial information on PCBs in general, 
inadvertently generated PCBs remain an area of interest for the Agency. 
EPA is currently studying and anticipates continuing to study the 
complex issues involved in the generation, release, exposure, hazards, 
and risks to human health and the environment associated with 
inadvertently generated PCBs. For example, EPA has a workgroup on 
inadvertently generated PCBs, with members from the Office of Land and 
Emergency Management (OLEM), the Office of Research and Development 
(ORD), and EPA Regions, that has been conducting and assessing water 
samples from watersheds in EPA Region 10 and other watersheds in the 
United States.
    Before proposing more stringent regulations on the inadvertent 
generation of PCBs in consumer products, EPA would seek to further 
understand the complexities and contributions of individual PCB 
congeners associated with inadvertently generated PCBs that may be 
present in U.S. waters. At present, there are not sufficient data to 
assess such PCB congeners. However, in a step toward addressing this 
deficiency, in 2014, the Agency requested toxicity testing for PCB-11, 
a PCB congener often associated with inadvertent PCB generation, 
through the National Toxicology Program (NTP) at the National Institute 
of Environmental Health Sciences (NIESH). As of November 2021, NTP had 
completed several steps for evaluating toxicity in liver cells: (1) 
Evaluated and compared activation of three different receptors in rat 
and human hepatocytes; (2) Performed hepatocyte clearance on rat and 
human hepatocytes; and (3) Estimated rat and human equivalent exposures 
at the point of departure.
    In 2016 (Ref. 5) and again in 2022 (Ref. 6), the Agency's Office of 
Water promulgated science-based federal human health criteria for PCBs 
and other pollutants in Washington surface waters pursuant to the Clean 
Water Act. The implementation of those criteria is ongoing.
    EPA's Office of Chemical Safety and Pollution Prevention operates 
the Pollution Prevention (P2) program, which supports the development 
and implementation of P2 solutions through grant programs, technical 
assistance, and by connecting researchers, industry experts, and others 
to develop innovative solutions to environmental challenges. In October 
2019, the Washington State Department of Ecology used EPA P2 grant 
funds to host a workshop (see https://www.epa.gov/sites/default/files/2021-04/documents/p2-pcb-factsheet-508.pdf and https://srrttf.org/?page_id=10745) on inadvertently generated PCBs in partnership with EPA 
Region 10, the Spokane River Regional Toxics Task Force (SRRTTF), the 
Color Pigments Manufacturers Association, Northwest Green Chemistry, 
the Bullitt Foundation, and industry representatives to discuss 
opportunities to reduce inadvertently generated PCBs in inks and 
pigments and the downstream products and processes using those inks and 
pigments. The workshop helped establish lines of communication between 
chemical manufacturers, product manufacturers, purchasers, and end-of-
life managers with the intention of formulating actionable steps to 
stimulate innovation and create markets for safer products. Since the 
October 2019 workshop, participants have continued to participate on 
working groups facilitated by Northwest Green Chemistry.
    In EPA Region 10, the regional PCB and P2 programs have 
collaborated to address inadvertently generated PCBs. The programs have 
worked together to evaluate potential options for reducing 
inadvertently generated PCBs in products and to support state 
environmental agencies, ORD, and industry experts in developing 
upstream P2 approaches to reduce the release of inadvertently generated 
PCBs into the environment. In addition, the EPA regional PCB and P2 
programs and inadvertently generated PCBs workgroup collaborated with 
the EPA Small Business Innovation Research Grant program, which 
provides research and development funding to small businesses to 
support commercialization of innovative technologies that help support 
EPA's mission of protecting human health and the environment, to 
solicit proposals in 2020 for innovative coloration technologies that 
do not result in the

[[Page 24830]]

generation of inadvertently generated PCBs. Collaboration led to 
furthering research of innovative technologies that seek to develop 
PCB-free pigments (Refs. 7 and 8).
    ORD, with support from the EPA PCB and P2 programs, is conducting 
testing to determine the range of concentrations of inadvertently 
generated PCBs within consumer products, with a special emphasis on 
children's products. Since 2017, ORD has led cross-Agency efforts to 
conduct consumer product testing for inadvertently generated PCBs. In 
2022, EPA staff from across the Agency published findings related to 
concentrations, fate and transport, and a preliminary exposure 
assessment associated with inadvertently generated PCBs in consumer 
products (Ref. 9). In that publication, the authors stated ``[w]hether 
the solution lies in preferred purchasing programs, green chemistry, 
effluent controls, regulatory changes, or elsewhere, understanding the 
fate, transport, and exposure pathways is a critical step in designing 
the ultimate solution'' and ``[t]his research will be foundational for 
additional future research to better understand the concentrations, 
fate, and transport of [inadvertently generated PCBs] in yellow 
pigmented consumer products and their cumulative risk assessment'' 
(Ref. 9). The authors also mentioned ``data generated from this study 
will be valuable to contextualize the toxicity data for PCB-11 
generated by the NTP, once it is released'' (Ref. 9). As summarized 
above, the NTP toxicity testing for PCB-11 remains ongoing.
    Thus, after assessing information provided by the petitioner, as 
well as information otherwise available, the Agency cannot conclude 
that it currently has information necessary to reassess the limits on 
allowable inadvertent PCBs in consumer products. For example, EPA is 
interested in new information pertaining to the toxicity of PCB-11 
(including data on how PCB-11 bioaccumulates in fish), how PCBs in 
products leach to water, and efforts to reduce uncertainties in the 
data associated with testing inadvertently generated PCBs in consumer 
products.
    TSCA section 21 requires a petitioner to set forth the facts which 
it is claimed establish that it is necessary to issue, amend, or repeal 
a rule under TSCA section 6. As described in Unit III.B.1., the 
petitioner failed to point with any specificity to deficiencies in the 
Agency's promulgation of the 1984 final rule and determination of no 
unreasonable risk under TSCA section 6(e). In addition, while EPA 
acknowledges that pigments and dyes are the most reported product 
category per reporting and recordkeeping requirements for 
manufacturers, importers, processors, distributors, and users of 
inadvertently generated PCBs (see 40 CFR 761.1(f)), the petitioner's 
focus on paints, printing inks, pigments, and dyes and omit other 
categories of reported consumer products. This renders the petitioner's 
request applicable to all consumer products to be overly broad. As a 
result, the petitioner has not provided adequate justification--based 
on the rulemaking process and record for the 1984 final rule, as well 
as information provided or otherwise available to the Agency--for 
reassessing the limits on allowable inadvertent PCBs in consumer 
products. Nonetheless, as necessary and appropriate to supplement the 
ongoing efforts previously listed (including the new information EPA 
cited to be of interest), the Agency may consider information gathering 
activities under TSCA (e.g., TSCA sections 4 or 8) to collect data 
needed to better understand and characterize exposure and risk 
associated with inadvertently generated PCBs.
2. Necessity of Rulemaking for ``Use of Pigments Containing PCBs''
    The petitioner requests that EPA ``adopt a regulation that 
identifies the use of pigments containing inadvertent PCBs to be a 
[`]use['] of PCBs, subject to the applicable limitations under 40 CFR 
761.20(a) . . . [or] identify use of pigments containing inadvertent 
PCBs is a [`]use['] of PCBs when an alternate process is available and 
does not create inadvertent PCBs'' (Ref. 1, p. 2). The petitioner 
advocates that ``non-essential uses of PCBs be eliminated'' and 
``scientific evidence demonstrates that PCBs in pigments result in both 
human exposures and environmental contamination'' (Ref. 1, p. 2). The 
petitioner provides several studies that attribute human exposure and 
environmental releases of PCBs to inadvertently generated PCBs linked 
to pigments, paints, inks, and dyes, and--more specifically--PCB-11 
(Ref. 1, pp. 11-13). The petitioner also provides information on the 
availability of ``low-PCB or PCB-free'' paints and printed material 
products, as well as organizations that have implemented purchasing 
policies to prohibit certain products based on PCB concentration levels 
(Ref. 1, pp. 14-15). As such, the petitioner argues ``there is 
insufficient justification to allow continued use of processes that 
knowingly create PCBs in paints, inks, and pigments'' (Ref. 1, p. 15).
    Although the petitioner generally requests that EPA adopt a new 
rule identifying the use of pigments containing inadvertently generated 
PCBs to be a use of PCBs, the existing regulations at 40 CFR 
761.1(f)(2) and (3), established in the 1984 final rule, already 
identify the use of products containing PCBs generated in excluded 
manufacturing processes and the use of products containing recycled 
PCBs as uses of PCBs exempt from the general use prohibition in 40 CFR 
part 761, subpart B. Moreover, 40 CFR 761.20(a)(2) provides that a use 
authorization is not required to use PCBs resulting from an excluded 
manufacturing process or recycled PCBs, provided that all applicable 
conditions of 40 CFR 761.1(f) are met. Therefore, as stated in Unit 
II.A.2., EPA is interpreting this request as one seeking to amend the 
exemptions at 40 CFR 761.1(f)(2) and (3) to the extent they exempt the 
use of pigments containing inadvertently generated PCBs from the 
general prohibition against the use of PCBs.
    As stated in Unit III.B.1.e., the Agency is aware of and intends to 
continue to gather and assess information related to the generation, 
release, exposure, hazards, and risks to human health and the 
environment associated with inadvertently generated PCBs. The 2022 
study conducted by EPA staff acknowledged PCB-11, as well as other 
congeners found in pigments and consumer products such as PCB-5, PCB-8, 
PCB-12, PCB-13, PCB-15, PCB-28, PCB-35, PCB-36, PCB-40, PCB-52, PCB-56, 
PCB-77, PCB-206, PCB-207, PCB-208, and PCB-209 (Ref. 9). That study was 
designed to ``to collect data to quantify the transport of 
[inadvertently generated PCBs] from consumer products to the 
environment'' and generated the ``first data on migration pathways of 
[inadvertently generated PCBs] from consumer products into the 
environment and potential routes of human exposure.'' Those efforts 
also included: ``(1) Identification of [inadvertently generated PCBs] 
from 39 consumer products purchased on the current retail market; (2) 
Selection of PCB-11 as the major [congener] to be studied for fate and 
transport and exposure assessment; (3) Measurement of PCB-11 emissions 
from consumer products; (4) Investigation of PCB-11 migration from the 
source to settled dust; and (5) Preliminary assessment of potential 
exposure to PCB-11'' (Ref. 9). The study found that ``generated data 
enhances our ability to predict [inadvertently generated PCB] 
exposure'' and could ``assist the regional efforts of the SRRTTF and 
state and local partners

[[Page 24831]]

who are trying to find upstream solutions to [inadvertently generated 
PCB] contamination'' (Ref. 9). Finally, as mentioned in Unit 
III.B.1.e., the study generally concluded that more information was 
required to better understand and characterize the concentrations, 
fate, transport, exposure, hazard, and risk associated with 
inadvertently generated PCBs in pigmented consumer products.
    Similarly, after assessing information provided by the petitioner, 
as well as information otherwise available and in light of ongoing and 
expected Agency actions, EPA cannot conclude that it currently has 
information necessary to reassess the exemptions for the use of 
pigments containing inadvertently generated PCBs.
3. Necessity of Rulemaking for ``All Allowable PCBs Found in Commercial 
Products''
    The petitioner requests that EPA ``reassess limits on any PCBs 
currently allowed in all commercial products, including instances where 
EPA has determined the PCBs are [`]totally enclosed['] or result from 
an [`]excluded manufacturing process['] (Ref. 1, p. 2). The petitioner 
also asks that EPA set a ``rulemaking schedule for the adoption of 
revised regulations'' (Ref. 1, p. 2). Thereafter, there is no 
discussion or data offered by the petitioner on such products or 
occurrences of PCBs beyond the enumerated requests.
    As stated in Unit III.B.1.e., the Agency is aware of and intends to 
continue to gather and assess information related to the generation, 
release, exposure, hazards, and risks to human health and the 
environment associated with inadvertently generated PCBs. However, 
aside from overall discussion of PCBs in general, the petitioner does 
not provide a clear argument or data to support this request. Thus, 
after assessing information provided by the petitioner, as well as 
information otherwise available and in light of ongoing and expected 
Agency actions, EPA cannot conclude that it currently has information 
necessary to reassess the limits on any PCBs currently allowed in all 
commercial products.

C. What were EPA's conclusions?

    TSCA section 21 requires a petitioner to set forth the facts which 
it is claimed establish that it is necessary to issue, amend, or repeal 
a rule under TSCA section 6. In general, the petitioner failed to point 
with any specificity to deficiencies in the Agency's promulgation of 
the 1984 final rule and determination of no unreasonable risk under 
TSCA section 6(e). Furthermore, the petitioner did not provide 
sufficiently complete scientific information (including hazard and 
exposure information indicating unreasonable risk) with regard to 
inadvertently generated PCBs to enable the Agency to make a 
determination that its approach in the 1984 rule was in error or ripe 
for revision. As a result, the petitioner is not able to provide 
adequate justification--based on the rulemaking process and record for 
the 1984 final rule, as well as information provided to or otherwise 
available to the Agency--for reassessing the limits on allowable 
inadvertent PCBs in consumer products. Similarly, after assessing 
information provided by the petitioner, as well as information 
otherwise available and in light of ongoing and anticipated Agency 
efforts, EPA cannot conclude that it currently has information 
necessary to reassess the exemptions for the use of pigments containing 
inadvertently generated PCBs or the limits on any PCBs currently 
allowed in all commercial products. Thus, EPA finds that the petition 
is insufficiently specific and that the petitioner did not meet their 
burden under TSCA section 21(b)(1) of establishing that it is necessary 
to amend the 1984 final rule under TSCA section 6(e). Accordingly, EPA 
denied the request to initiate a proceeding for the amendment of a rule 
under TSCA section 6(e).

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. State of Washington Department of Ecology. 2024. Petition under 
TSCA Section 21--Polychlorinated Biphenyls. January 4, 2024.
2. EPA. Toxic Substances Control Act; Polychlorinated Biphenyls 
(PCBs) Manufacturing, Processing, Distribution in Commerce, and Use 
Prohibitions; Exclusions, Exemptions, and Use Authorizations; Final 
Rule. Federal Register. 49 FR 28172, July 10, 1984 (TSH-FRL-2587-1).
3. EPA. Polychlorinated Biphenyls (PCBs); Exclusions, Exemptions and 
Use Authorizations; Proposed Rule. Federal Register. 48 FR 55076, 
December 8, 1983 (TSH-FRL-2456-6).
4. EPA. Polychlorinated Biphenyls (PCBs); Reassessment of Use 
Authorizations; Advance Notice of Proposed Rulemaking (ANPRM). 
Federal Register. 75 FR 17645, April 7, 2010 (FRL-8811-7).
5. EPA. Revision of Certain Federal Water Quality Criteria 
Applicable to Washington; Final Rule. Federal Register. 81 FR. 
85417, November 28, 2016 (FRL-9955-40-OW).
6. EPA. Restoring Protective Human Health Criteria in Washington; 
Final Rule. Federal Register. 87 FR 69183, November 18, 2022 (FRL-
7253.1-02-OW).
7. Cypris Materials, Inc. Easy to Apply, Tunable Structural Color: 
Color Without Pigments, Dyes, Metals, or PCBs. (May 31, 2022). 
Available at https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract_id/11249.
8. Kebotix, Inc. Machine-Learning-Assisted Development of 
Alternatives to Diarylide Pigments. (May 31, 2022). Available at 
https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract_id/11246/report/F.
9. Xiaoyu Liu, Michelle R. Mullin, Peter Egeghy, Katherine A. 
Woodward, Kathleen C. Compton, Brian Nickel, Marcus Aguilar, and 
Edgar Folk IV. Inadvertently Generated PCBs in Consumer Products: 
Concentrations, Fate and Transport, and Preliminary Exposure 
Assessment. Environ. Sci. Technol. 2022, 56, 17, 12228-12236. 
(August 9, 2022). Available at https://doi.org/10.1021/acs.est.2c02517.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: April 4, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-07492 Filed 4-8-24; 8:45 am]
BILLING CODE 6560-50-P