By Lynn L. Bergeson and Carla N. Hutton
On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Both direct final rules will be effective on October 26, 2018. Written adverse comments on one or more of the SNURs must be received by September 26, 2018. If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date. In addition to the direct final rules, EPA published proposed rules for both the direct final rules. 83 Fed. Reg. 43606, 83 Fed. Reg. 43607. Comments on the proposed rules are due September 26, 2018.
By Jessie Nguyen and Lynn L. Bergeson
On August 1, 2018, the U.S. Senate Committee on Environment and Public Works (EPW Committee) held a hearing entitled “Examining EPA’s Agenda: Protecting the Environment and Allowing America’s Economy to Grow.” Testifying at the hearing was Andrew Wheeler, the U.S. Environmental Protection Agency’s (EPA) Acting Administrator. Witness testimony and an archive of the hearing are available online. The hearing was intended to provide Wheeler with the opportunity to present himself for the first time in front of the EPW Committee as the Acting Administrator, and to update the EPW Committee on EPA’s agenda since the resignation of Scott Pruitt, EPA’s former Administrator. Wheeler’s testimony highlighted three main priorities for EPA moving forward: (1) regulatory certainty between EPA and state/local governments; (2) improvement of programs within EPA; and (3) increased transparency in risk communication.
During the questioning, Wheeler informed the EPW Committee that the clean-up of the Chesapeake Bay and the prevention of future lead contamination are high priorities for the Agency. When questioned by Senator John Boozman (R-AR) about EPA’s relationship with stakeholders, Wheeler stated that clear communication between EPA and its stakeholders is essential before implementing any regulatory action. EPA is also committed to working with other government agencies to enhance their regulatory process.
Next, the Trump Administration’s decision to roll back auto fuel efficiency and emissions standards, as well as the partial revocation of California’s ability to set its own emissions standards, was met with strong objection from Democratic Senators. Senator Edward Markey (D-MA) stated that the oil industry is “scared to death that $1 trillion will stay stranded in the pockets of consumers. That’s why the Trump Administration is moving to roll back these standards.” Wheeler stated his belief that the roll back in emissions standards has saved American consumers $500 billion dollars and 12,000 lives. Moving forward, Wheeler wants to come up with a “50-states solution” for emissions standards to address the issue of air pollutants and reduce cross-state pollution.
The topic of chemicals was brought up by Senator Cory Booker (D-NJ) as he is concerned that EPA’s failure to consider all sources of exposure for risk assessment will pose an unreasonable risk to human health -- especially to vulnerable populations such as children, pregnant women, and the elderly. Senator Booker urged EPA to ban trichloroethylene (TCE) on the applications for which proposed rules were issued and ban methylene chloride since they are known carcinogens with recognized health hazards. Wheeler said EPA is moving forward with the assessment of these chemicals, but he declined to promise on a definitive timeframe. Similarly, Senator Shelley Moore Capito (R-WV) urged EPA to release the toxicological report on perfluorooctane sulfonate (PFOS) and set a safety level for PFOS in soil and water.
In response to a question on clean energy by Senator Sheldon Whitehouse (D-RI), Wheeler stated he will not give preferential treatment for one source of energy over another; EPA’s role is to regulate pollutants, not to identify a preferential fuel source. Other miscellaneous topics included Wheeler’s commitment to not abuse his hiring authority. He expressed a willingness to notify the EPW Committee on EPA’s hiring process. In response to Senator Tammy Duckworth’s (D-IL) request, EPA will also make a commitment to reduce lead exposure.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 37702. EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination. The rule will be effective on October 1, 2018. Written adverse comment must be received by August 31, 2018. If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule.
Please see the full memorandum for more information on this rulemaking and a commentary that details a few of the differences specific to these SNURs.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program. The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry innovations. In 2015, OIG reported that award results submitted to the EPA’s Pollution Prevention (P2) Program from PGCCA recipients were not adequately supported or transparent. In its audit, OIG found that EPA discontinued the use of unverified PGCCA results in EPA performance metrics, but “a lack of documented controls presents risk that these data may be used in the future.”
Please see the full memorandum for more information including a short history on performance metrics of the Green Chemistry Program.
By Susan M. Kirsch
On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C. The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and representative from the environmental non-governmental organization (NGO) community. The goals of the Summit were:
- To share information on efforts to characterize risks from PFAS and to develop monitoring and remediation technologies/techniques;
- To identify near-term actions to address current state and local challenges; and
- To develop risk communication strategies to address public concerns and questions surrounding PFAS.
EPA broadcast the opening remarks and perspectives delivered by EPA Administrator Pruitt; Peter Grevatt, Director of the Office of Ground Water and Drinking Water; Jeff Morris, Director of the Office of Pollution Prevention and Toxics (OPPT); Craig Butler, Direct of the Ohio Environmental Protection Agency and Chair of the Environmental Council of the States (ECOS) Water Committee; and Jessica Bowman, Senior Director of Global Fluoro-Chemistry, at the American Chemistry Council. During his remarks, Pruitt announced that EPA will soon classify two fluorochemicals, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS), as hazardous substances, and that EPA will begin to development maximum contaminant levels (MCL) for PFOA and PFOS under the Safe Drinking Water Act. PFOA and PFOS are largely legacy chemicals that were the subject of voluntary phase out by chemical manufacturers. The presence of PFOA and PFOS at former manufacturing sites and detections in groundwater and drinking water have raised public health concerns and made headlines over the last several months, particularly in Northeast states.
Butler’s remarks highlighted the key questions that ECOS and state participants hoped to have addressed by EPA over the course of the Summit, including any plans for MCL development, guidance on contaminated site remediation and PFAS analytical methods, and EPA’s plan to address data and knowledge gaps about PFOA and PFOS, as well as the alternative short-chain PFAS chemistry that makes up the majority of current and new uses of PFAS. States are eager for direction and assistance from EPA on standard-setting and, in the absence of federal standards, some states have begun to set their own standards. A copy of the ECOS statement is available here.
Grevatt shared plans for further co-regulator discussions and community engagement as part of an EPA “roadshow” beginning in late June in Portsmouth, New Hampshire. Morris provided an overview of the rigors of the pre-market review process under the Toxic Substances Control Act (TSCA) and OPPT’s ongoing work to better understand the diverse range of PFAS in the marketplace.
EPA intended for the Summit to serve as a formal launch of an ongoing dialogue with states, the public, and industry on PFAS, and more details will likely be shared in the coming weeks and months. A recording of the May 22, 2018, broadcast is available on EPA’s YouTube channel. Copies of the slide presentations from the Summit are available on EPA’s PFAS Summit website.
By Richard E. Engler, Ph.D. and Margaret R. Graham
On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018. 83 Fed. Reg. 22978. EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. EPA posted these determinations on its website when they were made. The statements of findings, all related to premanufacture notices (PMN), and their website links are:
- EPA Case Number: P-16-0415; chemical name: generic: polyurethane; polymer exemption flag (generic name); intended uses: coating for oil and gas industry; known and reasonably foreseen use(s): paint additive and coating additive.
- EPA Case Number: P-18-0002; chemical name: generic: phosphinic acid, P,P-alkyl-, salt (generic name); intended use(s) (specific): chemical intermediate for a non-halogenated flame retardant; known and reasonably foreseen use(s): chemical intermediate; flame retardant.
- EPA Case Number: P-18-0021; chemical name: generic: dicarboxylic acids, polymers with substituted poly (substituted alkendiyl), 3-hydroxy-2-(hydroxyalkyl)-2-alkylalkenoic acid, 5-substituted-1-(substituted alkyl)-1,3,3-trialkyl carbomonocyle, alkanediol, alkane-triol, alcohol blocked compounds with aminoalcohol; polymer exemption flag (generic name); intended use(s) (generic): paint; known and reasonably foreseen use(s): adhesive and sealant chemical.
- EPA Case Numbers: P-18-0044 - 0045:
- P-18-0044: chemical name: generic: fatty acids (generic name); intended use(s) (generic): intermediate species known and reasonably foreseen use(s): chemical intermediate; lubricant and lubricant additive; viscosity adjustor; coating.
- P-18-0045: chemical name: generic: fatty acids, alkyl esters; intended use(s) (generic): application coating; known and reasonably foreseen use(s): lubricant intermediate; mold release agent; plasticizer; processing aid.
- EPA Case Number: P-18-0083; chemical name: specific: 2-propenoic acid, telomers with bualc.-2-[(2-propen-1-yloxy)methyl]oxirane reaction products, sodium bisulfite and sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate(1:1), sodium salts, peroxydisulfuric acid([(HO)S(O)2]2O2) sodium salt (1:2)-initiated. (CASRN: 2118944-42-4); intended use(s) (generic): dispersant additive; known and reasonably foreseen use(s): chelating agent.
P-18-0044, P-18-0045, and P-18-0083 are notable in that EPA identified a hazard other than “low hazard” for health or the environment and nevertheless concluded that exposures were low enough that the substances are not likely to present an unreasonable risk under the reasonably foreseeable conditions of use. In the cases of P-18-0044 and P-18-0045, EPA identified health hazards, but EPA expects that exposures to the general population will be low and that there will not be consumer uses. Furthermore, EPA expects that workers will “use adequate personal protective equipment.” In the case of P-18-0083, EPA identified acute and chronic aquatic toxicity concentrations of concern of >20,000 and >1,000 parts per billion, respectively. Even though these do not meet EPA’s thresholds for “low hazard,” EPA does not expect releases to exceed those thresholds.
More information on TSCA’s implementation is available on our TSCA Reform News & Information web page.
By Lynn L. Bergeson and Margaret R. Graham
On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.” This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.
On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.” The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”
More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.
On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT):
- Maria Doa, Ph.D., Director of the Chemical Control Division (CCD) at OPPT since 2011, will move to the Office of Research and Development’s (ORD) Office of Science Policy. Prior to leading CCD, Dr. Doa was director of the National Program Chemicals Division (NPCD).
- Lynn Vendinello, Deputy Division Director of the CCD since 2014, will serve as the CCD Acting Director on an interim basis. Ms. Vendinello has held a number of management and supervisory positions in OPPT and EPA’s Office of Compliance.
- Tanya Mottley, Acting Deputy Director of OPPT, will resume her leadership role as Director of NPCD. Prior to leading NPCD, Ms. Mottley was the Director of OPPT’s Pollution Prevention Division (PPD).
- Bryan Symmes will resume his duties as NPCD Deputy Director.
- Tala Henry, Ph.D., Director of OPPT’s Risk Assessment Division (RAD) since 2013, will be the next Acting Deputy Director for OPPT. Prior to leading RAD, Dr. Henry led NPCD after serving as a toxicologist in RAD and the Office of Water.
- Cathy Fehrenbacher, now RAD Deputy Director, will serve as RAD Acting Director. Ms. Fehrenbacher has held exposure assessment-related supervisory positions with OPPT; she began her career at EPA as a senior industrial hygienist.
These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:
EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA. A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.
On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.
By Lynn L. Bergeson and Margaret R. Graham
On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)).
EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of their argument, and their argument. EDF’s arguments are as follows:
- The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.
- The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
- The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that: EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
- The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
- The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
- Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA). EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected. In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.” The portions of the final rule that EDF requests the court to vacate are as follows: the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.
EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders. More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.