By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.

One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for perchloroethylene.  As reported in our December 17, 2020, memorandum, of the 61 conditions of use that EPA reviewed for perchloroethylene, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders.  The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.  EPA found no unreasonable risks to the environment.

The second Panel will focus on a risk management rulemaking for n-methylpyrrolidone (NMP).  As reported in our December 29, 2020, memorandum, of the 37 conditions of use that EPA reviewed for NMP, EPA found that 26 present unreasonable risks to workers and consumers.  These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use.  These uses also include an unreasonable risk to consumers from one consumer use.  EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial and commercial and consumer applications.  EPA also determined that NMP does not present an unreasonable risk to the environment and the general population.

EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.  According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their companies, communities, or organizations and advise the Panels on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rules’ requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by January 19, 2021.

EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulations.

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By Lynn L. Bergeson and Carla N. Hutton
 
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894).  TSCA required EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.  EPA identified these five PBT chemicals for expedited action, following criteria outlined in TSCA.  The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce for the following:

• DecaBDE:  A flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications;
   
• PIP (3:1):  A plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles;
   
• 2,4,6-TTBP:  An intermediate/reactant in processing, and it is incorporated into formulations destined for fuel and fuel-related additives;
   
• HCBD:  A chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons; and
   
• PCTP:  A chemical used to make rubber more pliable in industrial uses.

The final rules will be effective February 5, 2021.  More information on the final rules is available in our December 23, 2020, memorandum, “EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene.  The final risk evaluation determined that there are unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders from 59 out of 61 conditions of uses:

• Consumers and Bystanders:  EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene.  Common consumer uses include as a dry cleaning solvent; in cleaning and furniture care products; automotive care products like brake cleaners, lubricants, and greases; and adhesives in arts and crafts.  The risk to consumers from perchloroethylene’s use in dry cleaning is from short-term skin exposure to items cleaned with perchloroethylene; and
   
• Workers and ONUs:  EPA found unreasonable risks to workers from all but two occupational uses of perchloroethylene.  Additionally, EPA found unreasonable risks from most commercial uses of perchloroethylene to workers nearby but not in direct contact with perchloroethylene (known as ONUs).  This includes an unreasonable risk to workers and ONUs when domestic manufacturing or importing perchloroethylene; processing as a reactant and intermediate; incorporation into cleaning and degreasing products; uses in a variety of industrial and commercial applications such as degreasing, dry cleaning, in adhesives and sealants, and in paints and coatings; and disposal.  The primary health risk identified in the final risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The conditions of use in the final risk evaluation that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.

EPA found no unreasonable risks to the environment.  The next step in the process required by the Toxic Substances Control Act (TSCA) is developing a plan to address the unreasonable risks identified in the final risk evaluation.  EPA states that it “is moving immediately to risk management for this chemical and will work as quickly as possible to propose and finalize actions to protect against the unreasonable risks.”  Potential actions EPA could take to address these risks include regulating how perchloroethylene is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.  EPA notes that as with any chemical product, it “strongly recommends that users of products containing perchloroethylene continue to carefully follow all instructions on the product’s label and safety data sheet.”  More information will be available in a forthcoming memorandum that will be posted on our website.

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on November 30, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.  One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for carbon tetrachloride.  As reported in our November 4, 2020, memorandum, EPA reviewed 15 conditions of use, “all of which are associated with industrial and commercial work and primarily involve the manufacturing of other chemicals.”  EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of use.  EPA found no unreasonable risks to the environment.  According to EPA, there are no consumer uses of this chemical.  The second Panel will focus on a risk management rulemaking for trichloroethylene (TCE).  As reported in our November 24, 2020, memorandum, of the 54 conditions of use that EPA reviewed, EPA found that 52 present an unreasonable risk to workers, ONUs, consumers, and bystanders.  EPA determined that distribution in commerce and consumer use of TCE in pepper spray do not present an unreasonable risk.  EPA also found no unreasonable risks to the environment.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations. 

According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their company, community, or organization and advise the Panels on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rules’ requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by December 14, 2020.

EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulations.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C^® Consortia Management, L.L.C. (BCCM).  According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
 
EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.”  Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
 
Within 15 business days of receiving a facially complete request, EPA must notify the public of receipt of the request under 40 C.F.R. Section 702.37(e)(2).  Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  The docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions.  During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).

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By Christopher R. Blunck
 
On November 25, 2020, the U.S. Environmental Protection Agency (EPA) released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act.  According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the purpose of research and development.”  EPA stated it is committed to ensuring this list is accurate and that it planned to use this updated list to begin invoicing for fees in early November.  EPA also stated that due to the public health emergency, EPA is exploring options for payment flexibilities.
 
On September 4, 2020, EPA published a Federal Register notice announcing the final lists identifying the manufacturers (including importers) of the 20 chemical substances that have been designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 55283.
 
More information is available in our September 4, 2020, memorandum, “EPA Publishes Final Scope Documents and List of Manufacturers Subject to Fees for Risk Evaluations of High-Priority Chemicals.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 9, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for the cyclic aliphatic bromide cluster (HBCD).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for HBCD.  As reported in our September 28, 2020, memorandum, EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the processing, use, and disposal of HBCD, largely from building and construction materials.  EPA’s website states “EPA did not find unreasonable risks to the general population or consumers.” Nevertheless, in the risk evaluation document, EPA did find unreasonable risk from fish ingestion at the high-end exposure in one scenario.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by November 23, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulation.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA).  For manufacturer-requested risk evaluations under TSCA Section 6, the manufacturers requesting the risk evaluation are responsible for payment of the associated fees.  The fee for a manufacturer-requested risk evaluation of a chemical included in the 2014 update to the TSCA Work Plan is 50 percent of total actual costs, with a $1,250,000 initial payment.  D4 is included in the 2014 update to the TSCA Work Plan.  EPA notes that if the request is not withdrawn within 30 days, D4 will enter the TSCA risk evaluation process.

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By Christopher R. Blunck and Lynn L. Bergeson

In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce.  In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21.  EPA goes on to state “[‌u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.”  The acknowledgement letter further states that “EPA will, however,  consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” 

As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.  A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that concluded on June 17, 2020.  After hearing closing arguments, Judge Chen asked plaintiffs and EPA to consider how to reach an agreement.  According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.”  Plaintiffs offered to submit a new petition to EPA that contains all of the evidence presented at trial, including the expert declarations, expert testimony, and exhibits.  EPA contends that plaintiffs’ proposal to “package” the evidence presented at trial as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would be insufficient to reach a finding of unreasonable risk.”  EPA maintains that “meaningful review of a new petition based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs” should include:  (1) a systematic review; (2) raw data for the key studies upon which plaintiffs rely; and (3) the data underlying plaintiffs’ risk calculations, including their benchmark dose (BMD) analysis.  Plaintiffs are willing to provide the data underlying Dr. Grandjean’s risk calculations, but “cannot agree to the other two requirements.”  The joint statement states that first, plaintiffs maintain that they have already presented sufficient evidence to demonstrate an unreasonable risk under TSCA and are unwilling to do a new systematic review above and beyond what their experts have already done.  Second, plaintiffs maintain that they do not have the ability to provide the “raw data” for the key studies upon which they rely because the data are not theirs, and that EPA is thus asking for something that plaintiffs cannot provide.  Finally, plaintiffs do not believe that the raw data are necessary for EPA to evaluate the published peer-reviewed studies, and, indeed, requiring these data is “contrary to the health protective goals of TSCA.”
 
On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition.  Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.”  According to the plaintiffs, EPA articulated this policy shift in its March 18, 2020, supplemental notice of proposed rulemaking (SNPRM) regarding “Strengthening Transparency in Regulatory Science” in which “EPA proposed limiting, or excluding altogether, its reliance on any peer reviewed study -- no matter how relevant or well regarded -- if the underlying raw data [are] not made publicly available.”  Plaintiffs cite a “detailed analysis signed by dozens of Harvard scientists,” which states that “EPA’s new policy ‘is based on a profoundly misguided view of how the scientific process works’ and ‘unnecessarily impedes EPA’s ability to base its internal analyses and regulatory decisions on the best available science.’  Further, the rule ‘adopts a partial and biased approach to transparency that systematically favors industry science over academic science.’”
 
EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.”  According to EPA, by releasing the raw data and a detailed explanation of their statistical methods, the authors of the studies “could satisfy incongruities and ensure the scientific record is clear.”  EPA states that it “takes the position that a meaningful substantive review, as contemplated by the Court, of the evolving scientific evidence published since Plaintiffs submitted their 2016 petition should include raw data for the key studies upon which Plaintiffs rely and, according to Dr. Grandjean’s trial testimony, is forthcoming.”  EPA reiterates that its position “is based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs as necessary to support a potential TSCA section 6(a) rulemaking” and not, as alleged by plaintiffs, “a broader policy shift.”
 
The court held a status conference on August 6, 2020, via Zoom.  The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so.  The next status hearing will be held November 5, 2020.

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