By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
By Lynn L. Bergeson and Carla N. Hutton
On July 29, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 36728. EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action. For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1). Comments are due September 27, 2019. Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.
By Lynn L. Bergeson and Kathleen M. Roberts
In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420. See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”
Starting on August 26, 2019, which is 90 days after the effective date of the final rule, a company that manufactures, processes, or distributes in commerce methylene chloride is required to provide notification to downstream users of the consumer use paint remover restrictions via Safety Data Sheets (SDS). We write to emphasize that this notification requirement applies to all manufacturers, processors, or distributors of methylene chloride and is not limited only to those companies engaged with paint remover products. The EPA rulemaking provides the following specific text that must be included in the SDS:
- SDS Section 1.(c): “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
- SDS Section 15: “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
More information is available in our July 22, 2019, memorandum, “Communication and Recordkeeping Requirements Related to EPA Ban on Consumer Use Paint Removers Containing Methylene Chloride Go in Effect on August 26, 2019.”
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 28, 2019, announcing that the EPA Safer Choice Program is accepting submissions for its 2019 Safer Choice Partner of the Year Awards. 84 Fed. Reg. 31066. The Safer Choice Program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, “without sacrificing quality or performance.” Toward this end, according to EPA, the Safer Choice Program certifies products containing ingredients that have met the Program's “specific and rigorous human health and environmental toxicological criteria.” The Safer Choice Program allows the use of its label on products that perform and contain safer ingredients, as determined by expert evaluation. According to EPA, recognition by the Safer Choice Program represents a high level of achievement in formulating products that are safer for people and the environment. EPA states that the purpose of the Partner of the Year Awards “is to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown outstanding achievement in the design, manufacture, selection, and use of products with safer chemicals.” All Safer Choice stakeholders and Program participants in good standing are eligible for recognition. According to the notice, interested parties must inform the Program that they would like to be considered for an award and submit supporting information. Submissions are due July 31, 2019. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2019.
By Lynn L. Bergeson and Carla N. Hutton
On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) for its failure to initiate an asbestos reporting rule under Section 8(a) of the Toxic Substances Control Act (TSCA). The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos. More information on the petition is available in our February 1, 2019, blog item, and more information on EPA’s denial is available in our January 4, 2019, blog item.
According to the coalition, the rulemaking they requested is necessary under TSCA, and the denial of their petition was arbitrary and capricious and violates EPA’s obligations under TSCA. The coalition asks the court to compel EPA to initiate a rulemaking and issue a new asbestos reporting rule to:
- Eliminate “naturally occurring substance” as an exemption for asbestos reporting;
- Require processors of asbestos, as well as manufacturers, including importers, of the chemical substance to adhere to reporting requirements;
- Ensure that the impurities exemption in the Chemical Data Reporting (CDR) rule does not apply to asbestos; and
- Require reporting with respect to imported articles that contain asbestos.
The coalition includes the Attorneys General of California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Washington, and the District of Columbia.
By Lynn L. Bergeson and Carla N. Hutton
On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler requesting information on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The letter notes that the Lautenberg Act was intended to enact reforms addressing “longstanding structural problems” with the Toxic Substances Control Act (TSCA). According to the letter, EPA’s implementation of the Lautenberg Act “has deviated dramatically from Congress’ intent and the new law’s requirements.” The Senators’ letter requests EPA’s responses to a number of questions regarding the following areas of concern:
- Section 4: EPA’s failure to use its enhanced information authorities under TSCA. Under the Lautenberg Act, EPA can now acquire information where needed to review new chemicals or to prioritize or review the risks of a chemical already on the market. The law also makes clear that EPA can require the development of real-world exposure information. According to the Senators, in the nearly three years since enactment of the Lautenberg Act, “EPA has not once used these new authorities, and seems to be avoiding using them at all costs -- even where there are critical information gaps.”
- Section 5, Part 1: EPA’s failure to protect workers when reviewing new chemicals under TSCA. The Lautenberg Act strengthened EPA’s authority to regulate chemicals that may present risks to workers “by explicitly naming workers as a ‘potentially exposed or susceptible subpopulation’ and requiring that EPA consider and address potential risks to workers when assessing new or existing chemicals.” According to the Senators, EPA is failing to use TSCA’s health standard, which is more stringent than the Occupational Safety and Health Administration’s (OSHA) workplace standards, to determine whether any of the new chemicals “may present an unreasonable risk” to workers. Where EPA finds a new chemical does or may present serious risks to workers, it is allowing that chemical onto the market without imposing any conditions to protect the workers. EPA’s “only justification for this is that it simply ‘expects’ that workers will protect themselves from harmful workplace exposures by wearing personal protective equipment (PPE) that the company is not required to provide or train workers to use properly.” This deference to OSHA regulations “allow[s] workers to be exposed to chemical risks that are a thousand or more times higher than are acceptable under TSCA.
- Section 5, Part 2: EPA’s failure to adequately identify and review “reasonably foreseen” conditions of use when reviewing new chemicals under TSCA. When reviewing a new chemical, the Lautenberg Act directs EPA to examine the chemical under its “conditions of use” -- “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” According to the Senators, “EPA has attempted to skirt this requirement for an integrated assessment of both intended and reasonably foreseen conditions of use in several ways that are contrary” to TSCA’s requirements:
- For most new chemicals that EPA has reviewed in recent months, it simply asserts there are no such reasonably foreseen uses;
- For those new chemicals where EPA identifies a reasonably foreseen use, it merely states, without providing any analysis, that it expects that use to present no greater risk than the intended use. By doing this, EPA not only fails to demonstrate that the reasonably foreseen use is not likely to present an unreasonable risk, it also fails to consider that the combination of use could present such a risk; and
- For the remaining new chemicals where EPA does identify a reasonably foreseen use and identifies some potential concern with that use, EPA has separately promulgated a significant new use rule (SNUR) that requires a company to notify EPA prior to engaging in that reasonably foreseen use. In these SNURs, EPA has not made clear that it would assess the potential exposure and risks from that use in combination with the already approved intended uses as part of its review of any such notice, however.
The Senators note that none of these recent policy changes to EPA’s examination of new chemicals’ conditions of use has been made public or subject to a public comment opportunity.
- Section 6: EPA’s failure to assess even known conditions of use and pathways of exposure in conducting risk evaluations of existing chemicals under TSCA. The Lautenberg Act requires EPA to evaluate potential risks arising from activities across the entire lifecycle of a chemical, considering all “known” and “reasonably foreseen” circumstances, not just those “intended” by a company making or using a chemical. The letter states that EPA “has sought in numerous ways to limit the scope of its risk evaluations and risk determinations.” In its final Risk Evaluation Rule, EPA “asserted sweeping authority to pick and choose what activities and what exposures it includes in its risk evaluation of a chemical.” According to EPA, it can ignore any exposure to a chemical that also falls under the authority of another agency, such as OSHA, regardless of whether that agency has actually taken any action to mitigate the risks of the chemical. EPA also stated that it will exclude “legacy” activities associated with a chemical. EPA has begun to conduct risk evaluations that exclude most or all pathways of exposure to a chemical that falls under the jurisdiction of another statute administered by EPA.
- Section 14: EPA’s failure to provide timely public access to non-confidential information and access by eligible parties to confidential business information under TSCA. The Lautenberg Act amended Section 14, enhancing requirements for companies’ assertion and substantiation, and EPA’s review of confidential business information (CBI) claims; for providing public access to chemical information; and for providing expanded access to CBI. Although these provisions were immediately effective, nearly three years after enactment, “there is little evidence that EPA is effectively implementing these provisions or requiring compliance with them.”
The letter is well written if not quite one-sided. Complicated issues require thoughtful analysis, and this letter demands a clear and compelling response from industry advocates that may well respectfully disagree with the Senators’ position on many of the points made in the letter. We suspect this letter may well be a point of discussion at Monday’s TSCA at Three conference.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel. EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to as phthalates, which are used as plasticizers in the production of plastic and plastic coatings to increase flexibility and were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
Within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), EPA states that it must notify the public of receipt of this request under 40 C.F.R. Section 702.37(e)(2); and 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. 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). More information on Manufacturer Requests is available on EPA’s website.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA. EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing. EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.
EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:
- Verify the asserted CBI claims are correct and consistent; and
- Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.
EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around. Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™. When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such. A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments. B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.
Do not wait until May 30. Begin developing and practicing good CBI practices today.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule. The pre-publication version of the notice is available here. Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive. Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.
Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory. Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX). Upon receiving such notification, EPA will change the designation of substances from inactive to active.
For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.