[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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