Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
On September 6, 2017, at 10:00 a.m. (EDT), the House Science, Space, and Technology Subcommittees on Environment and on Oversight will hold a joint hearing on “Examining the Scientific and Operational Integrity of EPA’s IRIS Program.” The following witnesses are scheduled to testify:
President Trump’s proposed budget request for fiscal year 2018 would have eliminated EPA’s Integrated Risk Information System (IRIS) Program, although the IRIS Program is included in the final budget request. The EPA Science Advisory Board’s (SAB) August 29-30, 2017, meeting included an update from ORD’s National Center for Environmental Assessment on the IRIS Program. According to the presentation, IRIS is working to increase transparency and full implementation of systematic review; modernize the IRIS Program; modularize product lines; and enhance accessibility. Other IRIS improvements include implementing “next generation IRIS” and improved management practices. During the meeting, the SAB agreed to send a letter to EPA Administrator Scott Pruitt in support of the IRIS Program.
As reported in our August 25, 2017, blog item, the U.S. Environmental Protection Agency (EPA) will hold a webinar on September 7, 2017, on its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA). EPA will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:
EPA has established public dockets for each of the chemicals to facilitate receipt of information on exposure and use that may be useful to EPA’s rulemaking effort. EPA requests that any information be submitted to the dockets by December 9, 2017, so that the information can inform any regulatory action.
The U.S. Environmental Protection Agency (EPA) will hold a September 7, 2017, webinar to explain its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA). EPA states that the webinar will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:
Under TSCA Section 6(h), EPA is required to take expedited regulatory action to address risks and exposures from certain PBT chemicals. By June 22, 2019, EPA must propose rules for the above five PBT chemicals that have been identified under TSCA Section 6(h)(1). EPA is currently identifying where these chemicals are used and how people are exposed to them. Following EPA’s presentation, participants will have an opportunity to provide their comments on uses of these five chemicals.
On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA). According to OIG’s Project Notification, the specific objectives for this evaluation are to determine: (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to prioritize imported and manufactured chemicals for the purpose of identifying the potential for human health and environmental risks. The Project Notification asks Wendy Cleland-Hamnett, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, and Lawrence Starfield, Acting Assistant Administrator for the Office of Enforcement and Compliance Assurance, to provide the following information:
The Project Notification states that the anticipated benefits of the project are “reduced risks to human health and the environment from the monitoring and oversight of TSCA chemicals subject to the CDR rule reporting requirements.”
On August 18, 2017, the U.S. Environmental Protection Agency (EPA) announced that it would be holding a public workshop on the use of the paint remover methylene chloride in furniture refinishing on September 12, 2017, from 9:00 a.m. to 4:00 p.m. (EDT) at its Region 1 Headquarters in Boston, Massachusetts. It is holding the workshop in collaboration with the Small Business Administration (SBA) Office of Advocacy. The meeting aims to “facilitate an exchange of information on existing use practices and furniture refinishers’ experience, in general, with paint removal products and methods.”
EPA’s January 19, 2017, proposed rule proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal under Section 6 of the Toxic Substances Control Act (TSCA). EPA states that this workshop will allow “[f]ederal and state governments, industry professionals, furniture refinishing experts, non-government organizations, and academic experts, among others, [to] discuss the role of methylene chloride in furniture refinishing, potential alternatives, economic impacts, and other issues identified in EPA’s January 2017 proposed rule on methylene chloride,” and information learned from this workshop will allow it to “better understand current work practices and obtain additional information on the economic considerations involved in selecting chemical products for paint and coating removal in the furniture refinishing sector.”
EPA will open a docket at www.regulations.gov in Docket ID EPA-HQ-OPPT-2017-0139 upon publication of the notice of the meeting in the Federal Register, and will be accepting comments until November 12, 2017. Registration for the meeting is available online. Registrants can choose to attend in-person, via webinar, or via phone.
On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT). The third meeting will take place at the Ronald Reagan Building and International Trade Center, Oceanic Suite, 1300 Pennsylvania Avenue N.W., Washington, D.C. 20004, while the fourth meeting will be held at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue N.W., Washington, D.C. 20004. Both meetings are open to the public.
On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition. That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016. What is less clear is how EPA is making these determinations. The coalition’s mission is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process.
Joining the coalition is easy. We are asking for a flat fee of $1,000 per company for a 12 month period. We are not currently allowing trade associations to join. The chemical community has participated in ad hoc coalitions for years, so the drill is familiar. Dues will be used to:
More information is available in our memorandum Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition.”
As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA. The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form. More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.
On August 10, 2017, and on August 11, 2017, petitions for review of two of the U.S. Environmental Protection Agency’s (EPA) final “framework rules” issued under the amended Toxic Substances Control Act (TSCA) were filed in federal court. These six lawsuits seek review of the final rule Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA. The petitions were filed by Safer Chemicals, Healthy Families, et al. on August 10, 2017 (Cases 17-72260 and 17-72259); the Alliance of Nurses for Healthy Environments, et al. (including the Natural Resources Defense Council) on August 11, 2017 (Cases 17-1926 and 17-1927 (consolidated)); and the Environmental Defense Fund (EDF) on August 11, 2017 (Cases 17-2464 and 17-2403), in the U.S. Court of Appeals for the Ninth, Fourth, and Second Circuits, respectively. In the Ninth Circuit, the Petitioner’s Briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017; in the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017; in the Second Circuit, a briefing schedule has not been posted yet.
In its petitions for review, Safer Chemicals, Healthy Families, et al. state that they challenge the rules as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.” On the Safer Chemicals, Healthy Families’ website, the organization states that the petitions allege the rules “fail to provide the protections against unsafe chemicals that Congress required in the critical priority-setting and risk evaluation provisions of the new law, which are intended to ensure that unreasonable risks to health and the environment are fully assessed and eliminated.” In its petitions for review, EDF does not list any details as to why it is seeking review (nor do the rules require petitioners to do so), but on its website it states that “EPA has issued framework rules that violate the letter and intent of the law,” and that EDF has filed lawsuits challenging those rules and “will continue to monitor EPA’s actions to ensure EPA complies with the law and protects public health.” The petitions for review filed by the Alliance of Nurses for Healthy Environments, et al. do not list any details as to why they are seeking review.
EPA Publishes TSCA Framework Final Rule on TSCA Inventory Notification (Active-Inactive) Requirements; Sets Dates for Retrospective Reporting
On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is effective as of August 11, 2017 (the date of publication).
As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016. Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018. The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.
More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
THE WAIT IS OVER: TSCA Framework Final Rule on TSCA Inventory Notification (Active-Inactive) Requirements Scheduled For Publication
On August 11, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is scheduled to become effective on August 11, 2017 (the date of publication).
This rule, signed by EPA on June 22, 2017, establishes, among other requirements:
More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
By Lynn L. Bergeson and Margaret R. Graham
EPA states it is committing to the following operating principles in its review of new chemicals:
EPA states it will continue to improve of its TSCA new chemicals program in the following ways:
EPA states it needs to be more transparent in how it makes decisions on new chemicals under TSCA, and will be instituting the following to implement that goal:
EPA Nominates Additional Candidates for Science Advisory Committee on Chemicals; Requests Public Comments
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a notice on further nominations to the Science Advisory Committee on Chemicals (SACC). EPA’s notice provides the names and affiliations of 64 additional candidates currently under consideration for appointment to SACC. Biographical sketches for these candidates will be are posted on EPA’s website.
EPA will also be considering the 29 candidates for membership previously identified in the December 9, 2016, Federal Register notice -- their biographical sketches are available here. EPA states that it “anticipates selecting approximately six additional SACC members with specific expertise and perspectives representing industry, labor, animal protection, government, public health, and public interest groups.” EPA is inviting comments on the candidates to be used to assist in the selection process. Comments are due September 5, 2017.
More information on these new nominations is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals. More information on the SACC is available on our blog under key word SACC.
On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included many items under the Toxic Substances Control Act (TSCA), including six in the final rule stage, ten in the proposed rule stage, and one in the prerule stage. The six items in the final rule stage are:
The ten items in the proposed rule stage are:
The one item in the prerule stage is:
On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register:
These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published. EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations:
More information on these final rules and the guidance are available in our memorandum EPA Issues Final TSCA Framework Rules.