/>iOn October 31, 2024, U.S. Environmental Protection Agency (EPA) Administrator Michael S. Regan signed a final rule revising the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of the five persistent, bioaccumulative, and toxic (PBT) chemicals addressed in final rules issued under the Toxic Substances Control Act (TSCA) in January 2021. According to the pre-publication version of the final rule (which is only available on EPA’s website), after receiving additional comments, EPA “has determined that revisions to the decaBDE and PIP (3:1) regulations are necessary to address implementation issues and to further reduce the potential for exposures to decaBDE and PIP (3:1) for humans and the environment to the extent practicable.” EPA notes that it is not revising the chemical-specific provisions for the other three PBT chemical substances addressed in 40 C.F.R. Part 751, Subpart E (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD), and pentachlorothiophenol (PCTP)). The final rule will take effect 60 days after publication in the Federal Register.
Background
On January 6, 2021, EPA issued final rules under TSCA Section 6(h) for five PBTs — 2,4,6-TTBP (86 Fed. Reg. 866); decaBDE (86 Fed. Reg. 880); HCBD (86 Fed. Reg. 922); PCTP (86 Fed. Reg. 911); and PIP (3:1) (86 Fed. Reg. 894). After EPA issued the final rule, it received comments from stakeholders that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones to robotics used to manufacture semiconductors. EPA announced on March 8, 2021, that it sought additional public input on the final rules. EPA requested comment on several issues, including the newly raised compliance issues associated with the final PIP (3:1) rule. In March 2022, EPA issued a final rule extending the compliance dates to October 31, 2024, for the prohibitions on PIP (3:1) when used in some articles. 87 Fed. Reg. 12875. On May 3, 2023, EPA announced its intent to extend the January 6, 2023, compliance date on the prohibition on the processing and distribution of decaBDE for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation. EPA also issued a related temporary “Enforcement Statement,” indicating that it does not intend to pursue violations of this prohibition on processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, “as long as the entities involved are diligently seeking to qualify their alternative products in accordance with Nuclear Regulatory Commission (NRC) regulations and guidance.” As reported in our October 12, 2024, blog item, in September 2024, EPA extended the Enforcement Statement. On November 24, 2023, EPA proposed to amend the regulations for decaBDE and PIP (3:1). 88 Fed. Reg. 82287. More information on EPA’s proposed rule is available in our November 27, 2023, memorandum.
decaBDE
Signage Required in Regulated Areas
EPA proposed to require a label on existing plastic shipping pallets that contain decaBDE to provide notice that personal protective equipment (PPE) is required during the recycling of the pallets. After receiving comments that the labels would likely not be present at the time of recycling and since exposure to decaBDE in plastic shipping pallets that are in use and moving throughout commerce is not expected, EPA determined that labeling of decaBDE-containing plastic shipping pallets is not practicable. To reduce potential exposures to decaBDE during the recycling of decaBDE-containing plastic shipping pallets, EPA is requiring signage in the regulated area. EPA states that a sign must be posted at every entry point into the regulated area that clearly, prominently, in multiple languages as appropriate, and in an easily readable font size, contains the following text:
Decabromodiphenyl (decaBDE) (CASRN 1163-19-5), a chemical that has been identified as a persistent, bioaccumulative, and toxic (PBT) chemical by the U.S. Environmental Protection Agency, may be present in this regulated area. All persons in this regulated area who recycle plastic shipping pallets that contain decaBDE are required to wear personal protective equipment, including respiratory protection that is at least as protective as a NIOSH-approved N95 respirator with an assigned protection factor (APF) of 10 and dermal protection of gloves that are chemically resistant to decaBDE, per regulations at 40 CFR 751.405(e).
Worker Protections Required for Certain Activities Involving decaBDE
EPA proposed to require inhalation and dermal PPE during certain ongoing uses listed at 40 C.F.R. Sections 751.405(a)(2) and 751.405(b). To ensure exposures to workers are reduced to the extent practicable during domestic manufacturing and processing of decaBDE and decaBDE-containing products and articles, EPA is adopting at 40 C.F.R. Section 751.405(e) worker protection requirements to address potential respiratory and dermal exposure to workers during ongoing activities involving decaBDE, specifically certain activities where the prohibitions phase-ins have not passed (i.e., manufacture and processing of decaBDE for use in replacement parts and the manufacture of such parts and the processing through recycling of plastic pallets). In addition, EPA made minor modifications to new Section 751.405(e)(6) “to ensure it is clear what is being excluded and what is not (i.e., the processing of decaBDE for recycling is not included) and 751.405(b) clarifying that processing of decaBDE for recycling was not excluded.”
Prohibiting Release to Water during the Manufacturing, Processing, and Distributing of decaBDE and decaBDE-Containing Products
EPA proposed to prohibit releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products and proposed to require all persons to follow any regulations that may apply and best management practices for preventing the release of decaBDE to water. EPA states that after one commenter expressed concern regarding the lack of specificity around the “best management practices” clause and receiving no additional information on how a prohibition on releases to water could best be achieved through best management practices, it is not including the “best management practices” clause in the final rule. EPA is prohibiting releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products, and such persons are required to follow applicable regulations that may apply for preventing the release of decaBDE to water. According to EPA, applicable regulations may include restrictions on discharges under the Clean Water Act (CWA), Safe Drinking Water Act (SDWA), or analogous state laws. EPA notes that it is not amending the 2021 PIP (3:1) final rule restrictions on release to water, however, and the requirement to follow “best management practices” is retained.
Extend the Compliance Deadline for Processing and Distribution in Commerce of decaBDE-Containing Wire and Cable Insulation for Use in Nuclear Power Generation Facilities
EPA proposed to extend the compliance date, limited to processing and distribution in commerce of decaBDE-containing wire and cable insulation and the components containing the wire and cable in nuclear power generation facilities (including test and research reactors), until after the end of the service life of the wire and cable. EPA received several comments in support of the extended compliance date for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities. The final rule implements the proposed compliance date extension for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities.
Require Export Notification for decaBDE-Containing Wire and Cable for Nuclear Power Generation Facilities
EPA proposed to amend the current rule to require a TSCA Section 12(b) export notice for the export of decaBDE-containing wire and cable for nuclear power generation facilities. EPA notes that decaBDE is listed on Annex A of the Stockholm Convention on Persistent Organic Pollutants (the POPs Convention), which prohibits the production, use, import, and export of decaBDE and decaBDE-containing products and articles for Parties to the listing decision for decaBDE, unless otherwise subject to a specific exemption. Because there is no specific exemption under the POPs Convention for decaBDE-containing wire and cable for nuclear power generation facilities, EPA did not expect import or export for this use to occur. EPA states that it has since learned that there is a need for export of decaBDE-containing articles for this purpose, and EPA is including this provision in the final rule. Although articles are generally exempt from the requirement to provide notices of export under TSCA Section 12(b), the final rule amends the 2021 decaBDE regulations to require a TSCA Section 12(b) export notice for the export of decaBDE-containing wire and cable for nuclear power generation facilities. According to EPA, the notice requirement was triggered 30 days after publication of the proposed rule, pursuant to TSCA Section 12(b) and 40 C.F.R. Sections 707.60(a)(3) and 707.65(a)(1)(i) and (b). The notification to EPA of such intent to export will not provide consent by the importing countries for import of the shipment, and importing countries may choose to not permit import of such shipment. Consistent with 40 C.F.R. Section 751.7(a), the provisions of Subpart D of 40 C.F.R. Part 707 still apply to any export notifications required for decaBDE and PIP (3:1) under TSCA Section 6(h). EPA is not requiring export notification for any other articles.
Recordkeeping Requirements
The final rule increases the recordkeeping requirement from three to five years and removes the 30-day timeframe to make records available for decaBDE. In the 2021 decaBDE final rule, EPA required that all persons who manufacture, process, or distribute in commerce decaBDE and products and articles containing decaBDE maintain ordinary business records related to compliance with the prohibitions and restrictions for three years and to make records available within 30 days upon request. EPA states that due to the additional requirements in this rulemaking, specifically those pertaining to worker safety, it “considers that the five-year time frame regarding recordkeeping and removal of the 30-day time frame to make records available upon request is more appropriate. Furthermore, this is consistent with the time frame associated with other TSCA section 6(a) rulemakings that include worker protection requirements.” Owners and operators are required to document respiratory protection used and PPE program implementation and retain those records for five years. The final rule modifies the workplace protection records requirements for decaBDE to require that the owner or operator provide potentially exposed persons and their designated representatives an opportunity to observe records related to the basis of the PPE or other control measure selection, including potential monitoring results that are representative of the potentially exposed person’s exposure.
PIP (3:1)
Exclusions and Phase-In Prohibitions
EPA states that it reviewed the determinations underlying the exclusions from prohibition in the January 2021 PIP (3:1) final rule to consider whether to adopt new restrictions for activities currently excluded, consistent with the statutory directive to reduce exposure to the extent practicable. According to EPA, for many of the exclusions, it “determined that there were no technically feasible alternatives or that the time and cost to identify, research, and replace PIP (3:1) in supply chains were impracticable.” Where EPA received information that transition from PIP (3:1) to an alternative has already occurred or could occur within a reasonable transition period, EPA has determined the modifications are practicable and is therefore revising the PIP (3:1) regulations:
- Lubricants and greases: The final exclusion covers only processing and distribution in commerce of PIP (3:1) for use in lubricants and greases for aerospace use and turbine engines, PIP (3:1)-containing products for use in lubricants and greases for aerospace use and turbine engines, and PIP (3:1)-containing lubricants and greases for use in aerospace and turbine applications. The final rule includes a prohibition phase-in of 15 years for non-aerospace and non-turbine applications. The processing and distribution in commerce of PIP (3:1) for use in lubricants and greases, PIP (3:1)-containing products for use in lubricants and greases, and PIP (3:1)-containing lubricants and greases, excluding aerospace and turbine uses, likewise will be subject to a 15-year phased-in prohibition.
- New and replacement parts for motor vehicles: The final rule replaces the existing exclusion at 40 C.F.R. Section 751.407(b)(1)(iii) for use of PIP (3:1) and PIP (3:1)-containing products in new and replacement parts for motor vehicles with: (1) a 15-year phase-in prohibition of processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new motor vehicles (i.e., newly produced vehicles) and manufacturing and processing of PIP (3:1)-containing parts for such new vehicles; and (2) a 30-year phase-in prohibition on processing and distribution in commerce of PIP (3:1) and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in replacement parts for motor vehicles, and manufacturing and processing of PIP (3:1)-containing replacement parts for such vehicles. EPA notes that this final prohibition does not apply to PIP (3:1)-containing parts that are subject to a new exclusion (e.g., wire harnesses and circuit boards). In addition, the final rule amends Section 751.407(a)(2)(v) to correct an error in the proposed regulatory text. Proposed 751.407(a)(2)(v) reads “. . . all persons are prohibited from all processing and distribution in commerce of PIP (3:1) for use in parts for new motor vehicles, including heavy machinery, and manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products for use in parts for new motor vehicles, including heavy machinery, PIP (3:1)-containing parts for such new vehicles, and the new motor vehicles, including heavy machinery in any parts.” (Emphasis added.) EPA states that it intended to prohibit new motor vehicles from being manufactured with PIP (3:1)-containing parts, unless those parts were subject to another exclusion or alternative phase-in prohibition, not to prohibit the distribution in commerce of motor vehicles that may occur in the secondary market. In addition, EPA amended the language in the phase-in prohibitions to reference “heavy motorized machinery” instead of “heavy machinery,” as originally proposed.
- New and replacement parts for aerospace vehicles: EPA amended the regulations to allow longer time periods for the phase-in prohibitions for the use of PIP (3:1) in new and replacement parts for aerospace vehicles.
- Wire harnesses and circuit boards: The final rule includes a new exclusion from the prohibition at 40 C.F.R. Section 751.407(b)(1)(iii) for the processing and distribution in commerce of PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and wire harnesses and circuit boards containing PIP (3:1).
- Marine antifouling coating product: The final rule includes, at 40 C.F.R. Section 751.407(a)(2)(vii), a five-year compliance deadline for the prohibition of processing and distribution in commerce of PIP (3:1) for use in a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-registered marine antifouling coating product for Department of Defense (DOD) uses only.
- Manufacturing equipment and semiconductor manufacturing industry: EPA is adding a compliance deadline extension of ten years after the publication of the final rule for processing and distribution in commerce of PIP (3:1), manufacturing, processing, and distribution in commerce of PIP (3:1)-containing products, and manufacturing and processing of parts for use in new manufacturing equipment, including in the semiconductor industry, and additional time for the same activities for use in replacement parts for equipment used in those industries. EPA notes that it is also expanding the categories of equipment covered by this approach so that the new compliance deadlines will include electronic equipment, heating, ventilation, air-conditioning, and refrigeration equipment, water-heating equipment, and power generating equipment, including outdoor power equipment. EPA is amending the existing compliance deadline to provide an additional ten years for new parts for these additional categories, except for consumer electronic equipment, which is still subject to the October 31, 2024, deadline. EPA notes that these phase-in prohibitions do not apply to articles subject to exclusions, in particular wire harnesses and circuit boards.
Precedence of Phase-In Prohibitions
In response to comments, the final rule amends paragraph 40 C.F.R. Section 751.407(a)(2) to clarify that other phase-in prohibitions with longer-term deadlines in subparagraphs to paragraph 40 C.F.R. Section 751.407(a)(2) or exclusions in paragraph 40 C.F.R. Section 751.407(b) may allow the ongoing manufacture, processing, and/or distribution in commerce, where the terms of the longer-term phase-in or exclusion applies. The terms of the phase-in prohibition with a longer term for continued processing and distribution in commerce, for example, must expressly apply, however.
Worker Protections Required during Manufacturing and Processing of PIP (3:1)
Where PPE is required, the final rule requires implementation of a PPE program in alignment with certain elements of the Occupational Safety and Health Administration (OSHA) General Requirements for PPE at 29 C.F.R. Section 1910.132 and Respiratory Protection requirements in 29 C.F.R. Section 1910.134. For the manufacturing and processing of PIP (3:1) and PIP (3:1)-containing products for use in new and replacement parts for motor vehicles, including heavy machinery, and aerospace vehicles, the final rule requires respiratory protection that must be at least as protective as a National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirator (APF 10). For processing of PIP (3:1) and PIP (3:1)-containing products for use in the manufacturing of cyanoacrylate adhesives, the final rule requires respiratory protection that must be at least as protective as a NIOSH-approved APF 50 respirator, except when the PIP (3:1) or PIP (3:1)-containing product is contained in a closed system. For all other activities covered, the final rule requires respirators that are at least as protective as a NIOSH-approved APF 10 air-purifying half mask respirator.
Manufacturing (Including Import) of PIP (3:1)
The final rule modifies several exclusions from prohibition in the 2021 PIP (3:1) rule. These modifications include narrowing the scope of certain exclusions, adding prohibition phase-in dates, and in some cases creating new exclusions from prohibition for certain uses. EPA states that in narrowing the scope of certain exclusions, it proposed to prohibit the import of the PIP (3:1)-containing articles and PIP (3:1)-containing products for those uses. According to EPA, this is to restrict the ability for these prohibited PIP (3:1)-containing articles and PIP (3:1)-containing products for those uses to be imported where they are no longer allowed to be produced in the United States. EPA is adopting these phase-in prohibitions on manufacturing, including import, for certain uses under 40 C.F.R. Section 751.407(a)(2) and has edited the regulatory text to make it clear what is prohibited and excluded. The final rule does not include a general prohibition on the manufacturing of PIP (3:1), consistent with the 2021 PIP (3:1) rulemaking, “due to the number of excluded activities which EPA has found it impracticable to prohibit.” EPA notes that the absence of a general prohibition on manufacture of PIP (3:1) or PIP (3:1)-containing products or articles does not allow for ongoing distribution in commerce of imported products and articles where such distribution in commerce is expressly prohibited by another provision in Section 751.407; where EPA has prohibited the distribution in commerce of a PIP (3:1) or PIP (3:1)-containing product or article, such prohibition would be applicable to any attempted importation of such PIP (3:1) or PIP (3:1)-containing product or article.
Recordkeeping Requirements and Downstream Notification
The final rule increases the recordkeeping requirement from three to five years and removes the 30-day timeframe to make records available. EPA states that due to the additional requirements in the rulemaking, specifically those pertaining to worker safety, it “considers the five-year time frame regarding recordkeeping and removal of the 30-day time frame to make records available is more appropriate. Furthermore, this five-year time frame aligns with the statute of limitations for civil penalty enforcement (28 U.S.C. 2462), and it is consistent with the time frame associated with other TSCA section 6(a) rulemakings that include worker protection requirements.” Owners and operators are required to document the respiratory protection used and PPE program implementation and retain those records for five years. The final rule modifies the workplace protection records requirements for PIP (3:1) to require that the owner or operator provide potentially exposed persons and their designated representatives an opportunity to observe records related to the basis of the PPE or other control measure selection, including potential monitoring results that are representative of the potentially exposed person’s exposure.
The final rule also amends the downstream notification statement that must accompany shipments of PIP (3:1) or PIP (3:1)-containing products to conform to the terms of the prohibitions in the final rule. EPA is providing a three-month transition period to update safety data sheets (SDS) and an 18-month transition period for updating labels. EPA states that it believes this transition period should allow time to clear products with old labels through channels of trade.
Continued Distribution of PIP (3:1)-Containing Articles and Continued Processing and Distribution of PIP (3:1)-Containing Articles for Repair and Maintenance
EPA is amending the regulatory text covering PIP (3:1) in a number of different ways to address public comments. First, the rule amends the proposed regulatory text for a number of activities addressed in 40 C.F.R. Section 751.407(a)(2) and adds an additional regulatory provision in 40 C.F.R. Section 751.407(b) to make clear that the general prohibition in 40 C.F.R. Section 751.407(a)(1) and the general phase-in prohibition for articles at 40 C.F.R. Section 751.407(a)(2)(iii) do not apply to the distribution in commerce of certain PIP (3:1)-containing articles and the finished goods containing such articles, like cars, aerospace vehicles, and complex equipment. EPA states that it was not its intent to use its TSCA Section 6(a) authorities to restrict the continued distribution and sale of such parts for such complex articles, where the manufacture and process of the part complies with the phase-in prohibition in 40 C.F.R. Section 751.407(a)(2).
The final rule adds 40 C.F.R. Section 751.407(b)(1)(viii) to allow processing and distribution in commerce for maintenance and repair of existing PIP (3:1)-containing articles. The final rule amends the provisions in Section 751.407 to exclude processing and distribution in commerce of an article for the purpose of repair or maintenance, where PIP (3:1) has not been newly added. EPA notes that this exclusion is limited to processing where the PIP (3:1) is not newly added in any part and it is limited to repair and maintenance of a PIP (3:1)-containing article. According to EPA, it also differs from the existing “end user” provision in 40 C.F.R. Section 751.401(b)(1), which allows the distribution in commerce of the chemical substance, or products and articles that contain the chemical substance, that have previously been sold or supplied to an end user. The “end user” provision does not include processing as a part of the exclusion, and it applies only to an individual or entity that purchased or acquired the finished good for purposes other than resale.
Regulatory Threshold Level for decaBDE and PIP (3:1)
EPA states that it believes that setting a regulatory threshold level for unintentional decaBDE and PIP (3:1) present in products and articles at less than 0.1 percent by weight “is a practicable solution, particularly for situations involving complex supply chains.” According to EPA, the 0.1 percent regulatory threshold level “provides certainty for entities that do not intentionally add decaBDE or PIP (3:1), but where it may be unintentionally present in their supply chains below the regulatory threshold level due to cross-contamination.” EPA notes that the regulatory threshold level of 0.1 percent applies to products and articles measured by weight, except for any amount present due to an excluded use or phased-out use that has not yet reached its compliance deadline. For complex assemblies of articles, the regulatory threshold level applies to each article individually (i.e., each part) and not to the complex assembly as a whole.
Commentary
Bergeson & Campbell, P.C. (B&C®) acknowledges EPA’s achievement with issuing the final rule. We were surprised that EPA did not issue a press release for this accomplishment, as it did on November 20, 2023, for the proposed amendments to the regulations for decaBDE and PIP (3:1). EPA seems to have opted instead for a quiet release of the pre-publication copy of the final rule in the form of an update to its PBT web page. We look forward to the rule’s publication in the Federal Register.
EPA provided some relief (notably to the nuclear power industry and electronics industry), while also narrowing the exclusions for vehicles (converting an exclusion to the prohibitions to a defined phase-out period). EPA also strengthened workplace exposure protections. EPA wisely provides a de minimis threshold for both decaBDE and PIP (3:1), providing relief to U.S. customers that have found that foreign suppliers are unable or unwilling to certify the true absence of either decaBDE or PIP (3:1). We are also relieved that EPA states in the rule that maintenance activities are excluded from the final rule. Without this relief, the rule seemed to prohibit repair or maintenance of articles that might contain decaBDE or PIP (3:1). One odd aspect of the final rule is that EPA provides that some uses that are eligible for an exclusion or phase-out are exempt from the workplace protection (including related label and recordkeeping) requirements, while other uses are not. EPA does not explain why the disparate treatment, an anomalous situation that we had hoped EPA would have explained.
The future of the final rule is, however, uncertain at this point given the forthcoming change in the administration. Readers may recall that on January 20, 2021, the Biden-Harris Administration issued Executive Order (EO) 13990, which states in part under Section 1 that “the Federal Government must be guided by the best science and be protected by processes that ensure the integrity of Federal decision-making.” EO 13990 requires the following:
The heads of all agencies shall immediately review all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to, the policy set forth in section 1 of this order.
For any such actions identified by the agencies, the heads of agencies shall, as appropriate and consistent with applicable law, consider suspending, revising, or rescinding the agency actions.
B&C notes that the hazard and exposure and use assessments for all five PBTs were developed under the Trump-Pence Administration. As discussed above, the original five PBT rules were also issued on January 6, 2021, by the departing Trump-Pence Administration. At that time, the supply chain impacts of the rules on decaBDE and PIP (3:1) were not readily apparent as they are now. B&C mentions EO 13990 because we anticipate that the forthcoming Trump-Vance Administration will issue a comparable order. If this is the case, stakeholders impacted by the final rule on decaBDE and PIP (3:1) may voice concerns to newly appointed and receptive political appointees on the impacts of the final rule and the need for de-regulatory revisions to the forthcoming restrictions. On the other hand, those in the nuclear power and electronics industry have a critical need for the relief provided in this updated rule (relative to the current rule), providing a strong incentive to leave the rule in place and protect it from Congressional Review Act action.
Another uncertainty is whether the updated rule addresses the concerns raised by the Alaska Community Action on Toxics (ACAT) and the Yurok Tribe, et al. in their lawsuits challenging the PBT rule. The court had granted EPA’s motion for a voluntary remand without vacatur. Once the rule is final, the litigants may re-file their appeals and seek the court’s view as to whether the new rule reduces the manufacturing, import, processing, use, and disposal of the PBTs to the extent practicable as required by the statute.
