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.
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By Lynn L. BergesonCarla N. Hutton, Charles M. Auer, and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016.  EPA would also accept such notices for chemical substances that were processed.  The recent TSCA amendments require EPA to designate chemical substances on the TSCA Inventory as either “active” or “inactive” in U.S. commerce.  EPA states in the pre-publication version of the proposed rule that it would use these notifications to distinguish active substances from inactive substances.  EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory.  EPA also proposes to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume.  According to the proposed rule, upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active.  The proposed rule includes the procedures to submit retrospective and forward-looking activity notifications, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality.  Publication of the proposed rule will begin a 60-day comment period.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.


 
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By Lynn L. Bergeson and Carla N. Hutton

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  According to a pre-publication version of the final 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 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.  The final rule will be effective 120 days after publication in the Federal Register.  The final rule states that EPA has prepared a detailed response to public comments that will be available in the rulemaking docket.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase nanotechnology.


 
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The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.

 

June 22, 2016

TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA

 

September 22, 2016

Proposition 65:  OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations

 

August 8, 2016

TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors

 

June 29, 2016

TSCA Reform:  EPA Publishes First Year Implementation Plan

 

April 8, 2015

K-REACH:  List of Priority Existing Substances Submitted for Consultation

 

December 20, 2016

TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking

 

January 6, 2016

EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid

 

January 8, 2016

EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA

 

February 10, 2016

Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide

 

October 19, 2016

Brazil Delays Promulgation of Final Industrial Chemicals Regulation

 

October 6, 2015

EPA Announces Revisions to Its Worker Protection Standard

 

September 28, 2016

EPA Announces Regulatory Determinations on MCANs and PMNs

 

January 13, 2016

EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open

 

December 1, 2016

Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws

 

 

Top Articles Authored by B&C:

 

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

 

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

 

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

 

L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.

 

 

Coming first quarter 2017 from ABA Books:

 

Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).


 
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By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

  • Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
  • Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
  • The addition of a limit test option to several acute invertebrate toxicity tests;
  • Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
  • Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The final test guidelines may be of unique interest to TSCA stakeholders.  The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing.  This change facilitates test plan design, including tiered approaches for initial testing for premanufacture notices (PMN).  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.

Bergeson & Campbell, P.C (B&C®) will prepare a more detailed comparison soon.


 
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By Lynn L. Bergeson and Charles M. Auer

On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register.  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule is effective on the date of publication, December 21, 2016.

The final rule appears to amend the Section 6 procedural requirements such that they align with the amended requirements under new TSCA.  While the procedural simplifications in new TSCA were a useful change that should better enable regulatory action on existing chemicals, EPA will need to exercise care in its future rulemaking to meet the procedural requirements that remain in Section 6, as well as satisfy the relevant provisions in Section 26.  More information regarding this final rule is available in our memorandum TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking.


 
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By Lynn L. Bergeson, Charles M. Auer, Kathleen M. Roberts, and Margaret R. Graham

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”

In a webinar presented by Bergeson & Campbell, P.C. (B&C®) earlier this fall, we noted the significance of this rulemaking for many entities subject to reporting requirements under TSCA’s Chemical Data Reporting (CDR) provisions under Section 8(a).  A “byproduct” is defined as a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.  EPA is of the view that byproducts without a separate commercial value are nonetheless produced for the purpose of obtaining commercial advantage since they are part of the manufacture of a chemical substance produced for commercial purpose.  Accordingly, byproducts are considered manufactured substances under TSCA and must be listed on the TSCA Inventory and, therefore, reportable under the CDR -- unless they are exempt.  Byproducts are exempt from Inventory listing and CDR reporting if their only commercial purpose is use by public or private organizations that burn it as a fuel, dispose of it as a waste, or extract component chemical substances from it for commercial purposes.

EPA has interpreted “extract component chemical substances from it” narrowly and has determined the exemption is voided if an extraction process involves a chemical reaction.  Stakeholders have long asserted that this interpretation discourages recycling programs that necessarily involve a chemical reaction, processes that are frequently used to extract commercially valuable metals or other materials from byproducts that would otherwise be destined for disposal.  The speed with which EPA has moved to implement this provision reflects EPA’s interest in ensuring this regulatory disconnect is addressed before the next CDR reporting cycle in 2020.

The notice states that the main purpose of the NRC is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language.  The notice provides a clear and comprehensive discussion of the negotiated rulemaking process and procedures, initially identifies specific parties that may be interested in participation, and requests comment on the extent to which the approaches described in the notice are adequate and appropriate.  The notice should be carefully reviewed by any entity having an interest in this issue.  Comments are due by January 17, 2017

We note in addition that the notice specifically discusses the Section 8(a) CDR rule as being relevant to the negotiation.  While we agree that the CDR is clearly of interest, we note that the negotiation as structured applies to any rule under Section 8(a), such as the Preliminary Assessment Information Rule (PAIR) (40 C.F.R. Part 712) and any chemical-specific Section 8(a) rules (40 C.F.R. Part 711).  At the same time, the negotiation as described in new TSCA is limited to Section 8(a) and does not address the issues of Inventory listing and potentially associated Section 5 notification requirements for inorganic byproducts.  We note also that as a FACA Committee, the NRC can consider and, by consensus, determine its interest in also picking up these closely related issues for discussion and attempt to develop a consensus approach.


 
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By Lynn L. Bergeson and Margaret R. Graham

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice requesting public comment on whether a revision of the current size standard definitions for small manufacturers and processors, that are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA), is warranted at this time.  Under amended TSCA Section 8(a)(3)(C), the EPA Administrator, after consultation with the Administrator of the Small Business Administration (SBA), is required to “(i) review the adequacy of the standards prescribed under subparagraph (B); and (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.”

EPA states in the notice that its preliminary determination is that revisions to currently codified size standards for TSCA Section 8(a) are indeed warranted due to “the magnitude of the increase in the [Producer Price Index (PPI) for Chemicals and Allied Products] since the last revision of the size standards and the current annual sales standard is comparatively low given current revenue-based size standards developed by SBA.”

The need to review and update the definition is long overdue.  Stakeholders have been seeking a more appropriate definition for years recognizing that the existing metric is dated and has not kept pace with the passage of time, posing unintended regulatory consequences. EPA is to be commended for its rapid response to yet another new TSCA mandate.

Comments must be received on or before January 17, 2017.


 
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By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On December 7, 2016, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of the Toxic Substances Control Act (TSCA), due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities.  The proposed action is significant for several reasons, including that it represents the first use in a very long time of TSCA Section 6 as well as the first Section 6 control action taken under new TSCA.  Specifically, EPA is proposing to prohibit the use of TCE in “aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.”  We look forward to a close reading of the proposed rule and to evaluating the arguments, the policy points, and the evidence provided by EPA to satisfy the various legal requirements, including those under Section 6(c) and Section 26.

EPA’s online Fact Sheet on TCE lists questions and answers as related to the proposed rule.  In response to Question 3, What are the potential risks of TCE to people?, EPA states that its 2014 risk assessment found TCE to be “carcinogenic to people through all routes of exposure, which include inhalation, dermal (skin), and ingestion.”  The pre-publication of the proposed rule is available on EPA’s website.  Once it has been published in the Federal Register, comments must be submitted within 60 days of publication. 


 
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By  Lynn L. Bergeson and Molly R. Blessing


As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA).  Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m.  Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.

EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.”  Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.

More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.

Commentary

As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders.  Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”

Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.

This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B))  that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).”  The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination.  We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).  

While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.


 
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By Lynn L. Bergeson and Charles M. Auer

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are:

1,4-dioxane
1-bromopropane
Trichloroethylene (TCE)
Carbon tetrachloride
Hexabromocyclododecane (HBCD)
Methylene chloride
Pigment violet 29
Perchloroethylene (PERC)
N-methyl-2-pyrrolidone (NMP)
Asbestos

EPA is required under TSCA Section 6(b)(2)(A) to announce the chemicals within 180 days of enactment, or by December 19, 2016.

Interestingly, several of the chemicals are the subject of Section 6 rules that are currently undergoing review by the Office of Management and Budget (OMB).  These include TCE, methylene chloride, and NMP.  Assuming that EPA continues with these rules (relying on the savings provision at TSCA Section 26(p)(3) to use the completed risk evaluations on these chemicals in taking the Section 6 actions), the inclusion of the chemicals on the list may suggest that EPA will broaden the risk evaluations to include other conditions of use beyond those in the completed risk assessments.

For more on the chemicals listed and additional information: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca.


 
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By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  During the meeting, interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMN), microbial commercial activities notices (MCAN), and significant new use notices (SNUN), under TSCA Section 5.  EPA states that information obtained during this meeting and from submitted written comments will be considered as it works to implement the new requirements and increase efficiency in its review process under TSCA. 

There has been considerable concern with the impact of new TSCA on EPA’s New Chemicals Program.  EPA is to be recognized for seeking stakeholder input, and interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can reasonably achieve from the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016.  Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658.  More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.


 
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By Lynn L. Bergeson and Margaret R. Graham

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called “high priority” chemicals.  This is the second rule of three Framework Action rules that amended TSCA has directed EPA to issue in final within one year of enactment, or by mid-June 2017.  The Inventory rule, which will require industry reporting of chemicals manufactured/processed in the previous ten years, is expected to be sent to OMB soon.  Whether election transition issues will complicate and perhaps slow the review process is unclear but certainly not unlikely.

More information on the implementation of amended TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.


 
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The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription):

  • Trump’s EPA transition team will likely receive "massive briefing books" on each of the agency’s programs, including air pollution, water, waste and pesticides, according to Jim Aidala, a senior government affairs consultant with Bergeson & Campbell P.C. in Washington D.C. Aidala, who worked at the EPA from 1993 through 2001, including a stint as Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (now Office of Chemical Safety and Pollution Prevention), told Bloomberg BNA in an interview conducted before the election that those briefing books will need to include updates on pending litigation and decisions that need to be made early in the administration. Aidala highlighted a number of pending decisions that need to be made under the amended Toxic Substances Control Act (Pub. L. No. 114-182) that was signed into law in 2016. For the new chemicals law, the incoming EPA team will need to be briefed on necessary implementation activities, including prioritization of chemicals for review and new hiring to expand the agency’s chemicals program, Aidala said.

Career Staff Cooperation Expected

  • Aidala, in a follow-up interview conducted Nov. 9, said that there may be some ‘‘initial skepticism’’ between some at the EPA and the Trump transition team. During the primaries, Trump said he’d like to eliminate the agency, but later backed off on that promise and said he planned to refocus the EPA on its ‘‘core mission’’ of focusing on clean air and safe drinking water. However, Aidala noted many of the mid-level and senior career staff at the EPA have been at the agency long enough that they’ve seen Administrations of both political parties come and go. ‘‘Career staff across the government are professionals,’’ he said. ‘‘There is a general duty to tell the leadership what is important and what is not.’’ 

 
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By Lynn L. Bergeson

On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency.  Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals.  As stated in our memorandum TSCA Reform:  EPA Publishes First Year Implementation Plan, this rule is the first of three “Framework Action” rules that the Frank L. Lautenberg Chemical Safety for the 21st Century Act (new TSCA) has directed EPA to issue in final within one year of enactment, or by mid-June 2017.  For all three of these rules, the interim milestone for the proposed rules is mid-December 2016; therefore, it is anticipated that the three other rules will soon be sent to OMB for review as well. The two others are:

  • Risk Evaluation Process Rule:  A Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals; and
  • Inventory Rule:  Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.

There is a fourth Framework Action rule that new TSCA has directed EPA to issue as well, but it does not have a deadline for issuance in final; new TSCA only species the mid-June 2017 date as a goal:

  • Fees Rule:  EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.

More information on the implementation of new TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.


 
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By Zameer Qureshi

Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), presented at Chemical Watch Enforcement Summit Europe in Brussels on November 4, 2016.  Topics covered by Ms. Bergeson included “A New [Toxic Substances Control Act (TSCA)] and Expanded Enforcement and Product Liability Opportunities,” “Next Generation Compliance and Implications for Businesses,” and “eDisclosure -- The New Normal?”

Ms. Bergeson informed attendees of the significant amendments made to chemical regulation in the U.S. by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA).  She indicated that new TSCA amends TSCA in a number of ways and provided delegates with useful detail on the significant amendments made by new TSCA, stating that new TSCA: 

  1. Resets the Chemical Inventory based on industry-supplied data;
  2. Requires screening assessments for all “active substances”;
  3. Mandates risk evaluation for all “high-priority” substances and risk management for some substances;
  4. Compels substantiation of confidential business information (CBI) claims; and
  5. Authorizes testing order authority (i.e., the U.S. Environmental Protection Agency (EPA) can compel chemical testing in addition to the more traditional test rule and consent order testing procedures).

Ms. Bergeson utilized a slide entitled “New Compliance Mandates = New Enforcement Opportunities” to address EPA’s expanded authority under new TSCA (e.g., Section 4 test orders, Section 5 new chemical safety “determinations,” and Section 6 prioritization).  She expressed that EPA’s expanded authority under new TSCA gives rise to significant opportunities for enforcement of allegations of non-compliance when Section 4 test orders are issued. 

Regarding testing, Ms. Bergeson stated “the [U.S.] testing program has relevance for people anywhere in the world” as chemical manufacturers can be expected to be ordered to test, and manufacturers include importers.  Ms. Bergeson expressed that more testing will trigger an enhanced need to consider reporting under new TSCA Section 8(e).  She described the possible outcomes of new chemical safety “determinations” by EPA under Section 5 and indicated that as a consequence of new TSCA “we’re going to see lots and lots of new [Significant New Use Rules (SNUR)].”  Additionally, Ms. Bergeson stated “[Chemical Data Reporting (CDR)] requirements and Section 8 requirements are much more robust now.” 

Drawing on her experience and current information from EPA, Ms. Bergeson analyzed “Next Generation Compliance” and provided insights to attendees on what it means for industry.  She relied on a diagram from EPA that indicates Next Generation Compliance encompasses an intersection of “Regulation and Permit Design,” “Advanced Monitoring,” “Electronic Reporting,” “Transparency,” and “Innovative Enforcement.”  Ms. Bergeson stated “Next Gen Compliance is an Obama Administration initiative” and emphasized the relevance of the U.S. presidential election for the future of Next Generation Compliance by stating “Next Generation Compliance will likely grow under the Clinton Administration or may die on the vine under a Trump Administration.”  She then discussed each of the individual components of Next Generation Compliance. 

Regarding Regulation and Permit Design, Ms. Bergeson stated that EPA’s goals were to “make permits clearer,” promote self-monitoring and third-party reporting, make compliance easier than non-compliance, and leverage market forces and incentives. 

Ms. Bergeson stated that the expansion of “Advanced Monitoring Technologies” means there are new tools that can assist industry.  She described the usefulness of real-time monitoring (i.e., knowing about releases into the environment on a real-time basis), facility feedback loops, fenceline and community monitoring, and remote sensing.  Ms. Bergeson noted, as a potential drawback of Advanced Monitoring, that “technologies that have not necessarily been vetted” are finding their way into enforcement consent agreements.  She then indicated that while this may be fine, the reliability of such technologies for regulatory purposes is untested and reliance on such technologies in regulatory contexts should not replace more traditional notice and comment rulemaking.

Ms. Bergeson stated “Electronic Reporting is a huge part of Next Generation Compliance; the era of submitting paper [is over],” and informed delegates that “information technologies enable new solutions, but invite concerns regarding accuracy and regulatory reliability.”  She stated “Electronic Reporting does not always go as intended and greatly facilitates finding non-compliance.”  Ms. Bergeson referenced the relevant EPA memorandum and informed attendees that Electronic Reporting is the default mechanism for providing information under new TSCA, and stated that Ohio Discharge Monitoring Report Electronic Reporting “checks submissions overnight and sends notices” if there are problems, thereby allowing the permittee to make corrections and resubmit.

Regarding Innovative Enforcement, Ms. Bergeson expressed that EPA is using Next Generation tools in enforcement settlements, and that Innovative Enforcement enhances targeting and data analysis to identify and address the most serious violations.  She stated “we really like new technologies, but if a technology is new it may not be standardized, making reliance on it necessarily more focused to enforcement and not rulemaking purposes.”  Additionally, Ms. Bergeson informed delegates that there is “a little concern in the regulated community in the U.S.” that some of the new technologies evolving from Innovative Enforcement efforts could undermine the notice and comment rulemaking process if these technologies are used for purposes beyond consent orders.

Ms. Bergeson stated that EPA’s “eDisclosure” portal provides companies with a new way to self-report violations of environmental law and is intended to “streamline confessions” by the “legal and corporate community,” and described the two-tier system within EPA’s eDisclosure portal and stated that for some violations “you can get on with your life.” 

Ms. Bergeson stated “we always urge [B&C] clients to fix the problem immediately … The issue arises in some contexts of ‘do we tell EPA?’”  She then informed delegates of the underpinning principles of eDisclosure by stating “it is believed that self-confessing should be rewarded.”  Ms. Bergeson advised that companies can seek to reduce penalties by self-confessing, but the decision to self-confess is always fact dependent, and then indicated that the future of eDisclosure could be significantly impacted by the outcome of the U.S. presidential election.

Ms. Bergeson addressed “Design and Use of Safer Chemicals” and told attendees that EPA has “tried very hard” to promote Safer Chemicals through Green Chemistry, Safer Choice Labels, and the Safer Chemical Ingredient List, and that “creative technologies that are better, cheaper, and less toxic” are actively encouraged by EPA and welcomed by the U.S. chemical regulatory community.

Ms. Bergeson expressed that the implications of new TSCA are significant for the chemical manufacturing, importing, and downstream user sectors and provided beneficial “Closing Thoughts” to attendees.  She stated that chemical manufacturers, importers, and downstream users need to:  

  1. Read and understand the law and engage in “trade associations’ implementation activities”;
  2. Assess chemical product inventories;
  3. Manage the “business and optics” of chemical assessment, management, and substitution;
  4. Assess CBI options; and
  5. Manage chemical data information carefully.

Ms. Bergeson stated that the “implications of new TSCA are paradigm shifting … In the next two to five years we’re going to see opportunities for non-compliance.”  Regarding CBI, Ms. Bergeson stated “we need to be very cognizant … Some of the changes are very subtle and it is an area ripe for enforcement … Assertion of CBI is at a higher standard -- EPA will be very vigilant.”  Ms. Bergeson emphasized EPA’s “much richer implementation authority” under new TSCA and informed delegates that Next Generation enforcement and eDisclosure tools “add to the pressure” on the U.S. chemical industry to monitor carefully chemical portfolios.

Ms. Bergeson answered a number of questions on new TSCA and EPA’s likely enforcement of it.  In response to a delegate’s question relating to the capacity of EPA to manage enforcement of new TSCA, she stated that EPA requires greater resources and is currently recruiting.  Ms. Bergeson answered questions from attendees on timelines for pending rules from EPA and highlighted EPA’s interest in expediting its rulemaking on fees.  She indicated that fees will be higher under new TSCA.  Ms. Bergeson responded to a question regarding the scope of new TSCA by clarifying that new TSCA relates to industrial chemicals and that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) will continue to maintain their previous regulatory scope.  Ms. Bergeson indicated that the only exception is found under TSCA Section 8(b)(10), which requires any or all mercury or mercury compounds, or any intentional use of mercury in a manufacturing process to be reported to EPA under the mercury inventory and reporting provisions, regardless of whether the use  of the mercury or mercury compound is regulated under FIFRA or FFDCA.


 
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