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.
By Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham
On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt. In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.” In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA. Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks. Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth. These issues/economic opportunities included: investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).
Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos). Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.” In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources.
Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater. She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS. She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.” Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue. Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him. In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River. Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue. Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.
Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform: specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days. Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days). EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward: How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”
Several Senators indicated their intention to submit additional questions for the record. Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website. The full hearing is available on the EPW Committee’s website.
By Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!
By Christopher R. Bryant and Lynn L. Bergeson
On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year. A Cmty. Voice v. EPA, No. 16-72816. The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.” The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action. The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued. The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard.
While not entirely surprising given the Circuit, the decision relies on a seldom used remedy that rarely succeeds in judicial settings. It reflects the court’s sharp rebuff of the Administration’s apparent decision to delay action on the lead standard. Given the many challenges EPA’s Office of Pollution Prevention and Toxics will face in the New Year, complying with the court’s order will not be easy.