By Lynn L. Bergeson and Carla N. Hutton
The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on late June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms. APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts. Comments are due July 30, 2018.
Our full memorandum provides some background, context, and a commentary regarding APHIS’ announcement.
By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).
The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA. EPA describes alternative test methods and strategies as different descriptors that have a common goal. The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard. The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints.
Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM). The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”
A much more detailed summary and analysis of this important issue is available in our memorandum.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing
Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online. This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.
On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”). EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance. EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity. More information on this guidance is available in our full memorandum.
By Kathleen M. Roberts, Jason E. Johnston, M.S., Sheryl Lindros Dolan, and Margaret R. Graham
On June 25, 2018, the U.S. Environmental Protection Agency (EPA) held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA's Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals. A list of those chemicals is available here. Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer reviewers and only two outside stakeholders providing oral comments. Below are some highlights/takeaways from the meeting:
- All five PBT chemicals being reviewed scored high for hazard;
- Two PBT chemicals were pulled from EPA action under the Toxic Substances Control Act (TSCA) Section 6 because manufacturers requested risk evaluations for them prior to the September 19, 2016, deadline;
- Four of the PBT chemicals scored high or moderate for exposure; one scored low (pentachlorothiophenol (PCTP));
- For exposure assessment, EPA split up information as “core exposure data” or “supplemental exposure data”: core exposure data would be environmental data, monitoring, biomonitoring, modeled concentrations, or modeled dose; and supplemental exposure data would be environmental fate, engineering data, or other information related to exposure information or pathways;
- EPA identified exposure scenarios -- looking at source/use, environmental pathways, and receptors;
- EPA did not conduct any new modeling on the chemicals but did use modeled data from published literature;
- EPA did not conduct an exhaustive literature search, review, or assessment of hazard data, it used data readily available, as described in the Human Health and Environmental Hazard Summary; the EPA document “Supplemental Information for the Exposure and Use Assessment of Five Persistent, Bioaccumulative and Toxic Chemicals” outlines the literature search process used for exposure data; and
- Exposure scenarios include both quantitative and qualitative information.
No written comments were submitted prior to the peer review webinar. Only three people signed up for oral comments, and one was not present online. The two public commenters noted concerns regarding the likelihood of exposure, including the potential for accidental exposures; the lack of EPA focus on susceptible subpopulations; EPA’s intent not to address exposures that are already regulated under other EPA programs; and the need to assess the risk of bias.
Per the language in amended TSCA, EPA must issue risk management proposals to reduce exposures to the extent practicable by June 19, 2019.
Any public comments submitted by July 23, 2018, will be shared with peer reviewers. Comments submitted between July 23, 2018, and August 17, 2018, will be available to EPA for consideration. All comments are due by August 17, 2018. A recording of the webinar, slides, and other materials from the meeting will be posted in Docket EPA-HQ-OPPT-2018-0314. There are currently six supporting documents posted:
Stay up-to-date on TSCA implementation issues via our Recent Regulatory Developments web page and our TSCAblog.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019. The final rule will be effective 60 days after publication in the Federal Register, which is scheduled for June 27, 2018.
The reporting requirements include activities that are established TSCA terms, including manufacture, import, distribution in commerce, storage, and export. EPA notes that the reporting requirements also apply to the otherwise intentional use of mercury in a manufacturing process. Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, are required to report amounts of mercury in pounds (lbs.) used in such activities during a designated reporting year. Reporters must also identify specific mercury compounds, mercury-added products, manufacturing processes, and how mercury is used in manufacturing processes, as applicable, from preselected lists. For certain activities, reporters must provide additional, contextual data.
The final reporting requirements do not apply to: (1) persons who do not first manufacture, import, or otherwise intentionally use mercury; (2) persons who only generate, handle, or manage mercury-containing waste; (3) persons who only manufacture mercury as an impurity; and (4) persons engaged in activities involving mercury not with the purpose of obtaining an immediate or eventual commercial advantage. Within the category of persons who must report, there are certain persons who are not required to provide specific data elements. To avoid reporting that is unnecessary or duplicative, the final rule includes certain exemptions for persons who already report for mercury and mercury-added products to the TSCA Section 8(a) Chemical Data Reporting (CDR) rule and the Interstate Mercury Education and Reduction Clearinghouse (IMERC) Mercury-Added Products Database, respectively.
More detail is provided in our June 25, 2018, memorandum regarding the provisions of the final rule, including EPA’s rationale for fulfilling specific statutory provisions and terms. While the final rule includes summaries of public comments received and EPA’s responses and determinations, EPA notes that some of these issues are discussed in greater detail in its Response to Comments. EPA states that its Response to Comments will be available in Docket EPA-HQ-OPPT-2017-0421, although it is not there at this time.
By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA). EPA lists the following milestones that it has completed at the two-year anniversary:
In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.” Speakers will include:
- Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
- Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
- Michael Gould, EH&S Committee Chairman, RadTech North America; and
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.” EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document into its guidance. EPA also issued a “Response to Comments Received on Points to Consider Posted for Comment November 2017.” EPA states that it expects that use of the guidance will result in “more robust submissions.” EPA encourages companies to contact its new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their premanufacture notices (PMN). According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process.
More information will be available in our detailed analysis to be issued in a memorandum later today and posted to our Recent Regulatory Developments web page.
By Lynn L. Bergeson and Margaret R. Graham
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals. Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update. The selected chemicals are:
- Decabromodiphenyl ethers (DECA);
- Hexachlorobutadiene (HCBD);
- Pentachlorothiophenol (PCTP);
- Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
- 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).
EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary. The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.” EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov.
The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only. Registration is available online. Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018. Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018.
More information, including the list of experts, is available on EPA’s TSCA Peer Review website.
By Lynn L. Bergeson, Carla N. Hutton, and Jessie Nguyen
On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to the Toxic Substances Control Act (TSCA):
- Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions (RIN 2070-AJ65): EPA promulgated a final rule under TSCA Section 5 to establish notification procedures for review of certain new microorganisms before they are introduced into commerce. EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting. Based on EPA’s evaluation of these petitions, EPA states that it made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met, and issued a proposed rule. EPA is developing a revised proposal that will address concerns raised by commenters, and is considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption. EPA intended to issue a notice of proposed rulemaking (NPRM) in May 2018;
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate (PFAS) Chemical Substances; Significant New Use Rule (SNUR) (RIN 2070-AJ99): EPA is developing a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances, and for perfluorooctanoic acid (PFOA) or its salts. On January 21, 2015, EPA proposed to amend a SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses. EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles. In addition, EPA proposed to amend a SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets. EPA intended to issue a supplemental NPRM in May 2018 following changes to TSCA brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA plans to issue a final rule in July 2019;
- Procedural Rule: Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C) (RIN 2070-AK21): EPA is developing a proposed rule to implement TSCA Section 8(b)(4)(C), which requires EPA to establish a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active TSCA Inventory. EPA intends to publish an NPRM in January 2019 and a final rule in December 2019;
- TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33): EPA will revise the reporting requirements to align better with new TSCA requirements. EPA intends to issue an NPRM in September 2018 and a final rule in September 2019;
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (RIN 2070-AJ94): On July 28, 2016, EPA issued a rule proposing changes to the applicable Significant New Uses of Chemical Substances regulations to align EPA’s regulations, where possible, with the final revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standards. EPA intends to issue a final rule in September 2018;
- Certain Nonylphenols (NP) and Nonylphenol Ethoxylates (NPE); SNUR (RIN 2070-AJ96): On October 1, 2014, EPA issued a proposed SNUR under TSCA Section 5(a)(2) for certain NPs and NPEs. EPA intends to issue a final SNUR in December 2018;
- Mercury; Reporting Requirements for the TSCA Mercury Inventory (RIN 2070-AK22): On October 26, 2017, EPA issued a rule proposing reporting requirements under TSCA Section 8(b)(10)(D) for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where mercury is defined as “elemental mercury” and “a mercury compound.” EPA intends to issue a final rule in June 2018; and
- Service Fees for the Administration of TSCA (RIN 2070-AK27): On February 26, 2018, EPA issued a rule proposing to implement TSCA Section 26(b)(1), which authorizes EPA to issue a rule to establish fees to defray the cost of administering Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances. EPA intends to issue a final rule in August 2018.
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2018, the New York State Department of Environmental Conservation (NYSDEC) released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites. New York states that it “will be the first state in the nation to require such disclosure and the State’s program goes beyond initiatives in other states by requiring the robust disclosure of byproducts and contaminants, as well as chemicals with the potential to trigger asthma in adults and children.” NYSDEC has posted the Household Cleansing Product Information Disclosure Program Certification Form and Program Policy and a response to comments.
Our recent memorandum provides an in-depth review of important information from the Disclosure Program Certification Form and Program Policy, including covered products and definitions, information to be disclosed, the lists of chemicals of concern covered by the Program, and the effective dates. With the first disclosures due July 1, 2019, manufacturers need to review the Program Policy and begin compiling information concerning the ingredients of their products.