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.

By Lynn L. Bergeson and Carla N. Hutton

On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB).  The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA must “carry out and publish in the Federal Register an inventory of mercury supply, use, and trade” in the U.S.  The Lautenberg Act defines mercury as “elemental mercury” or “a mercury compound.”  The inventory was to be published no later than April 1, 2017, and every three years thereafter, as supported by a rule authorized in the Lautenberg Act.  As reported in our March 29, 2017, blog item, EPA published an initial inventory report on March 29, 2017.  For subsequent inventories, EPA is authorized to promulgate a rule to “assist in the preparation of the inventory” so that “any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine.”  EPA expects future triennial inventories of mercury supply, use, and trade to include data collected directly from such persons.  In future inventories, EPA also will “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  EPA must promulgate a final rule by June 22, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.”  While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations.  EPA must publish the final rule in the Federal Register by June 22, 2017.

More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations.  EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation.  Comments were due March 20, 2017; 70 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions.  Per EO 12866 (Oct. 4, 1993), federal agencies are directed to prepare a “Regulatory Plan (Plan) of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form in that fiscal year or thereafter,” which they usually do semi-annually, in the spring and the fall.  This memo reiterates the directives of past executive orders on the regulatory agendas, but also includes new directives and focus, referring largely to the directives in the January 30, 2017, Executive Order (EO), Reducing Regulation and Controlling Regulatory Costs

The memorandum states that the Unified Agendas should “describe all regulations under development or review during the 12 months following publication.  Agencies should include, at a minimum, any plans to publish or otherwise implement an Advance Notice of Proposed Rulemaking (“ANPRM”), a Notice of Proposed Rulemaking (“NPRM”), or a Final Rule,” but also requests them to reflect attention to the following:

  • The total incremental costs of any new significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017, shall, to the extent permitted by law, be fully offset as of September 30, 2017; and
  • Agencies should, for each new significant regulatory action that imposes costs and that an agency plans to issue on or before September 30, 2017, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017.

In an effort to “facilitate the fiscal year 2018 regulatory budget planning process,” the memorandum requests that spring 2017 submissions also include “a preliminary estimate of the total costs or savings associated with each of your planned fiscal year 2018 significant regulatory actions and offsetting deregulatory actions.”  The memorandum also lists suggested steps that it states will improve an agency’s Unified Agenda, including:

  • Considering whether the listing of “long-term” entries benefits readers, especially for those for which no substantial activity was expected within the coming year;
  • Removing entries that agencies do not realistically intend to take action on over the next 12 months, especially ones that the agency does not have the resources to take action on; and
  • Other more administrative suggestions, such as categorization; consistency of agency data; accuracy of timetable information; and abstract information for the entries that informs readers of the reason the rulemaking is under development and what the agency intends to accomplish.

Agencies must submit all of their Unified Agenda materials by March 31, 2017


 

By Lynn L. Bergeson and Margaret R. Graham

On March 1, 2017, President Trump’s Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, was published in the Federal Register. 82 Fed. Reg. 12285.  This EO follows closely on the heels of his previous EO concerning government regulations (EO 13771), but is different in that it is intended to further and enforce President Trump’s EO as well as EO’s issued in prior administrations, instead of creating an entirely new set of directives.  EO 13777 directs the head of every agency (except those receiving a waiver) to designate an agency official as its Regulatory Reform Officer (RRO), who will “oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms,” including the following initiatives and policies:

  • EO 13771 of January 30, 2017 (Reducing Regulation and Controlling Regulatory Costs), regarding offsetting the number and cost of new regulations;
  • EO 12866 of September 30, 1993 (Regulatory Planning and Review), as amended, regarding regulatory planning and review;
  • Section 6 of Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review), regarding retrospective review; and
  • The termination, consistent with applicable law, of programs and activities that derive from or implement EOs, guidance documents, policy memoranda, rule interpretations, and similar documents, or relevant portions thereof, that have been rescinded.

The EO also establishes Regulatory Reform Task Forces (RRTF), consisting of the agency RROs and other designated agency officials, which will evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement, or modification. Each RRFT is tasked with identifying regulations that:

  • Eliminate jobs, or inhibit job creation;
  • Are outdated, unnecessary, or ineffective;
  • Impose costs that exceed benefits;
  • Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
  • Are inconsistent with the requirements of Section 515 of the Treasury and General Government Appropriations Act of 2001, or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
  • Derive from or implement EO’s or other Presidential directives that have been subsequently rescinded or substantially modified.

Within 90 days of the EO, the RRTFs are also directed to provide a report to the agency head detailing the agency’s progress toward the following goals:

  • Improving implementation of regulatory reform initiatives and policies pursuant to Section 2 of this order; and
  • Identifying regulations for repeal, replacement, or modification.

Agencies that generally issue very few or no regulations may be eligible for a waiver, but the agency head must file a request with the Director of the Office of Management and Budget (OMB) for a waiver, and waivers can be revoked at any time.  More information on EO 13771 and OMB’s Guidance on same is available in our blog items EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations and OMB Issues Guidance on Implementation of “One In, Two Out” Executive Order.         


 

By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham

On February 2, 2017, Dominic J. Mancini, Acting Administrator of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued interim guidance in a questions and answers format (Q&A) to implement President Trumps’s recent Executive Order (EO) regarding the costs of agency rulemaking, Memorandum:  Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, Titled “Reducing Regulation and Controlling Regulatory Costs.”  More information on the EO is available in our blog item EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations.

The OMB memorandum, issued for regulatory policy officers and executive departments and agencies and managing and executive directors of certain agencies and commissions, states that it explains three requirements specified in the EO:

  1. That every agency must identify two existing regulations to be repealed when they promulgate a new rulemaking;
  2. That there can be no incremental costs (no greater than zero) for any new regulations or for the repeal of any regulations for fiscal year (FY) 2017, unless otherwise required by law or consistent with advice provided in writing by the OMB Director; and
  3. In furtherance and in relation to # 1, if there are any new incremental costs, they will be offset by the elimination of the existing costs of at least two prior regulations.

Agencies planning to issue one or more significant regulatory action on or before September 30, 2017 (the end of FY 2017), are directed to provide:  (1) “[a] reasonable period of time before the agency issues that action, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017”; and (2) “[f]ully offset the total incremental cost of such new significant regulatory action as of September 30, 2017.” 

The memorandum’s Q&As cover 23 questions under three categories:  Coverage; Accounting Questions; and Process and Waiver Questions.  A few of the stated answers include:

  • The requirements only apply to significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017;
  • New significant guidance or interpretive documents will be addressed on a case-by-case basis;
  • Regulatory actions issued before January 20 that are vacated or remanded by a court after that date will not qualify for savings, but regulatory actions overturned by subsequently enacted laws will qualify, on a general basis;
  • Costs should be measured as the opportunity cost to society, and be annualized as defined in and in accordance with OMB Circular A-4, a Memorandum on Regulatory Analysis issued in 2003;
  • Regulatory actions should be eliminated before or on the same schedule as the new regulatory action they offset (to the extent feasible);
  • Regulatory savings by a component in one agency can be used to offset a regulatory burden by a different component in that same agency; and
  • An agency that is not able to generate sufficient savings to account for its regulatory actions may submit a request to the OMB Director to request a transfer of savings from another agency. 

Commentary

This guidance about the meaning and implementation of the EO will provide greater direction to the broad goals of the Trump Administration’s desire to “reduce regulation.”  On its face, this “2 for 1” directive is a clear message to the agencies to reduce the regulatory burdens of their work, mostly regardless of the particular mission or underlying legislative requirements of the affected programs.

One obvious target of such effort is the U.S. Environmental Protection Agency (EPA), widely criticized during the Trump campaign and in the party platform as causing harm to the economy and hindering economic growth.  Like any broad campaign rhetoric that becomes more substantive as the specifics are rolled out, it is interesting to see what the possible exceptions are or to speculate where implementing the broad rhetorical goal will lead to unpredictable outcomes.  An example might be how reductions in record-keeping costs in one EPA program might offset new regulatory costs in another:  this ironically may give new internal value to some parts of EPA which have routinely been more heavy-handed in imposing regulatory requirements.  “Burdensome and unnecessary” requirements imposed by the enforcement office may be of help in the ability to propose new water program regulations -- or any number of odd fellow combinations may come to the surface. 

Other unanticipated consequences will also include those regulations that are actively supported by the affected regulated entity.  The pesticide industry is one example where a regulation establishing the allowable amount of a pesticide used on food -- the tolerance -- is essential for completing the registration process allowing the use of a new pesticide.  So this kind of regulation fosters innovation and economic return to the industry, and without this regulation, the product will not make it to market.  So the new Administration policies must allow for and distinguish between a sort of “good” regulation and a “bad” regulation -- all fitting within the broad rhetorical directive of a “2 for 1” approach to reducing regulatory burdens.


 

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.


 

On August 11, 2016, the Bloomberg BNA Daily Environment Report quoted Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), on the implication of additional fees created by Toxic Substance Control Act (TSCA) reform.

Companies that pay the costs of generating toxicity, exposure and other data should not be “double billed” through additional fees to review the resulting information, said Walls and Kathleen Roberts, vice president of Bergeson & Campbell Consortia Management, LLC.


 

On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell P.C. (B&C®), in the article, “Give EPA Detailed New Chemical Notices, Attorneys Advise.”

Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed,” Lynn Bergeson, managing partner of Bergeson & Campbell PC said during a July 14 webinar the firm organized.

[…]

Both the old and newly amended TSCA say the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson said, referring to Section 2601(b)(3).

The new law makes “very consequential changes” to the new chemicals provisions of TSCA as the EPA will have to carefully balance the requirements imposed by different sections of the law, she said.


 

On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), in the article “Give EPA Detailed New Chemical Notices, Attorneys Advise.”

Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed,” Lynn Bergeson, managing partner of Bergeson & Campbell PC said during a July 14 webinar the firm organized.

Bergeson, Marrapese and Rosenberg discussed the implications of these new decisions and criteria and the impact they may have on the chemical industry's ability to innovate new products.

Both the old and newly amended TSCA say the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson said, referring to Section 2601(b)(3).

The new law makes “very consequential changes” to the new chemicals provisions of TSCA as the EPA will have to carefully balance the requirements imposed by different sections of the law, she said.


 
 1 2 >