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By Lynn L. Bergeson

On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017.  On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.”  EPA is accepting comments in Docket ID EPA-HQ-OPPT-2016-0426 on the www.regulations.gov website.  More information on this proposed rule is available in our memorandum EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive).


 

By Charles M. Auer, James V. Aidala, and Lynn L. Bergeson

On February 27, 2017, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice that it was denying a Toxic Substances Control Act (TSCA) Section 21 petition that requested regulatory action under Section 6 to “prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies,” and that it was making available its response to the petition.  82 Fed. Reg. 11878.  The petition was received by EPA on November 23, 2016, and EPA had 90 days in which to respond by either granting or denying the requested action. 

  • EPA’s response was relatively comprehensive as it went through and provided its views on numerous aspects and issues at play including: 
  • EPA’s interpretation of the Section 6 provisions regarding conditions of use which asserts that TSCA requires EPA to comprehensively consider and address all conditions of use for a chemical or category of chemicals when considering and taking action under Section 6(a).  This point was first made in EPA’s proposed procedural rule for risk evaluations (82 Fed. Reg. 7562, Jan. 19, 2017) that is currently open for comment.
  • EPA’s belief that Congress, under the new law, did not intend to empower Section 21 petitioners for regulation under Section 6 to promote chemicals of particular concern and force expeditious action based on risks arising from individual uses of those chemicals (helpfully, in its response, EPA suggests use of a petition under the Administrative Procedure Act to the petitioners for such cases).
  • The scientific adequacy of the petitioners’ risks claims for the general public from exposure to fluoridation chemicals in drinking water.  EPA identified and discussed in some depth the numerous weaknesses it saw in health, exposure, and risk aspects.
  • The petitioners’ inadequate consideration of the public health benefits of fluoridation of drinking water.
  • Inadequate support by the petitioners for their belief that action was needed under TSCA rather than under the Safe Drinking Water Act, because of the latter’s purported limitations.

While comment could be offered on many of the points discussed in the decision, we limit our reactions to a few key points.  The first is that, given all of the work that is at play under new TSCA, we are frankly surprised that EPA saw the need for such a detailed and comprehensive response to the petitioners.  From our perspective, a much shorter and more focused response would have provided an adequate basis for the denial decision. 

The second is the way that EPA used its response as a platform to advocate for its interpretation that Section 6 requires that EPA consider all conditions of use in proceeding under that Section.  While this point was made in its proposed procedural rule for conducting risk evaluations, that rule was, as indicated, only a proposal and, moreover, it was issued under the prior Administration.  This decision, however, because it can be legally challenged by the petitioners, equates to a judicially reviewable act as the petitioners may commence a civil action in federal district court to compel EPA to initiate a rulemaking as requested in the petition.  Interesting, too, is the fact that the decision was issued under the new Trump Administration.  Given that the response was signed less than a month after the Inauguration, we do not want to over-interpret its significance (perhaps EPA was merely “reiterating” rather than “advocating” its position of record).  We also note in passing that it was signed on the same day that the new Administrator was sworn in (February 17).

Commentary

EPA’s response in this case is expansive and detailed, not only with respect to what EPA concluded the claimed risks of fluoride to be, but also regarding the considerable detail on what the agency apparently has concluded are required elements to qualify as sufficient to grant a Section 21 petition for TSCA Section 6(a) action in the future.  The granularity of the discussion is extraordinary.

That EPA disagreed over the possible risks of fluoride is not the most interesting part of the notice.  EPA’s response includes what in essence is the following argument about what is required to make a Section 21 argument that EPA can grant:  the petition must include a complete risk evaluation, including an analysis of all conditions of use, showing how the TSCA risk standard is exceeded, before EPA would grant the petition. 

EPA explicitly states, for example, that if a petition showed that a chemical use clearly exceeds the TSCA risk standard, and did not include all the conditions of use, EPA would still deny the petition to initiate action to control the risk.  The notice states (at 11880):

  • EPA recognizes that information on a single condition of use, could, in certain instances, suffice to demonstrate that a chemical substance, as a whole, presents an unreasonable risk.  Nonetheless, EPA concludes that such information does not fulfill a petitioner’s burden to justify “a rule under [TSCA Section 6],” under TSCA Section 21, since the information would merely justify a subset of an adequate rule.”

So even if a chemical use is shown to cause great harm, it would not merit EPA granting the petition since it is not a complete risk evaluation as EPA wishes to define it.  The notice explains EPA’s rationale for this position, essentially arguing that since EPA must assess “all conditions of use” in any control rule they might promulgate, then any outside petition must include all of the same homework before it can be granted.

This seems to obviate the very purpose of Section 21 petitions for Section 6 action, which in the past has been viewed as one way for the public to identify risks of concern to EPA which, for whatever reason, may not be on EPA’s radar.  This asserted view, that only a comprehensive risk evaluation considering all conditions of use will suffice, presents a very high threshold for action -- and seemingly an impossibly high threshold to move EPA to act.

The petitioners in this case may decide to challenge the EPA decision.  Activists concerned about the possible risks of fluoride have in the past been persistent and dogged about their cause.  In this decision, however, there is potentially more than a disagreement over possible risks of fluoride; there might also be arguments over what is or is not sufficient for Section 21 petitions to be granted, or possibly about EPA’s general interpretation, as elaborated in the denial notice and in the risk evaluation procedural rule, that new TSCA does not provide discretion for EPA to evaluate less than all conditions of use in new actions under Section 6.


 

Charles M. Auer and Oscar Hernandez, Ph.D. 

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC).  EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA Administrator appointed the 18 experts a mere eight days later on January 17 (a full five months ahead of the Congressional deadline), yet the announcement was held until its posting, over three weeks later, on February 9.  It thus is the case that the Obama Administration took very prompt steps to ensure that formation was completed during its period in office, perhaps in an effort to select a membership more to its liking and preferences. 

Based on our quick review of the affiliations of the 18 experts selected for the SACC, this seems to be the case.  Of the members, nine are associated with academic institutions, four with industry (with two from the pharmaceutical industry, one from a trade association (Toy Industry Association), and one a former Dow Chemical Company employee currently with Underwriters Laboratories), two with non-governmental institutions (American Cancer Society and the Humane Society), and three with federal and state government.  While there are no members hailing from an environmental advocacy group, similarly there are no members currently affiliated with a chemical company.

Regarding backgrounds, there is an emphasis on expertise associated with exposure and response research on susceptible populations, with nine members having explicit or related expertise on this topic, six of which are experts from academia.  In contrast, the panel does not seem to include a breadth of experience in exposure or risk assessment.  There are two members who previously chaired EPA’s Children’s Health Protection Advisory Committee, a group that in our view is better known for advocacy than rigorous science.    

As many readers will know, the chemical industry had offered critical comments on the slate of nominees that was announced by EPA in the December 9, 2016, Federal Register notice, but little consideration seems to have been given to those comments.  At a minimum, it seems self- evident that the current membership would not have been the selection made under the Trump Administration.  How all of this will play through under the new Trump Administration is yet to be seen but could get interesting.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) issued its 2017 Annual Report on Risk Evaluations.  Per Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year – both risk evaluations that will be initiated and that will be completed -- the resources necessary for completion, and the status and schedule for ongoing evaluations.

Per amended TSCA Section 6(b)(4), on December 19, 2016, EPA designated ten chemical substances for evaluation to determine whether they presented an unreasonable risk of injury to health or the environment.  Those chemicals are:

  • 1, 4 Dioxane;
  • Methylene Chloride;
  • 1-Bromopropane;
  • N-Methylpyrolidone;
  • Asbestos;
  • Pigment Violet 29;
  • Carbon Tetrachloride;
  • Trichloroethylene;
  • Cyclic Aliphatic Bromide Cluster (HBCD); and
  • Tetrachloroethylene.

The report provides an update pertaining to the risk evaluations of these ten chemicals.  Risk evaluations on these chemicals have already begun, and EPA anticipates issuing a scoping document for each of them by June 19, 2017.  The scoping document will include “the hazard(s), exposure(s), condition(s) of use, and the potentially exposed or susceptible subpopulation(s) the Administrator expects to consider in the evaluation.”  EPA has established a docket for each of the ten chemicals and is holding a public meeting on February 14, 2017, to present information on the specific uses and conditions of use for the chemicals.  EPA is currently accepting written comments and materials in the individual dockets until March 15, 2017.

Under Section 6(4)(G) of TSCA, EPA is required to complete these risk evaluations within three to three and a half years.  EPA’s initial report to Congress issued on January 18, 2017, detailed the resources it needed for completion of the risk evaluations.

More information on EPA’s proposed processes for prioritizing and evaluating chemicals beyond these first ten is available in our memoranda EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA and EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

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 and Margaret R. Graham

In January, the U.S. Environmental Protection Agency (EPA) issued its initial report to Congress on its capacity to implement certain provisions of the amended Toxic Substances Control Act (TSCA).  The report, prepared by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for the Committees on Energy and Commerce, and appropriations of the U.S. House of Representatives, and the Committees on Environment and Public Works, and Appropriations of the U.S. Senate, was directed to be provided within six months of enactment under Section 26(m)(1) of amended TSCA.  In the report, EPA states that it anticipates “ramping up from 10 risk evaluations in FY2017 to 15 in FY2018, reaching 20 by the end of FY2019,” which is necessary “to accomplish an ongoing pace of at least 20 EPA-initiated risk evaluations underway” by the end of calendar year (CY) 2019.  EPA also provides a table on page five, Table 1: TSCA Risk Evaluations, Numbers Underway and Resources Estimates, which presents estimates for its annual costs, calculated by dividing the average lifecycle costs of the actions by the number of years the statute provides for the agency to complete those actions, and then multiplying the result by the numbers of actions required/anticipated to be underway each year.  The total annual costs range from $12.3 million for FY2017 to $35.8 million for FY2021.  The report refers to the rule to implement the fee collection provisions, stating it is “currently under development,” but does not provide any more details on when it will be issued.

On January 30, 2017, President Trump issued a Memorandum for the Heads of Executive Departments and Agencies in the Federal Register which directs federal agencies to “support the expansion of manufacturing in the United States through expedited reviews of and approvals for proposals to construct or expand manufacturing facilities and through reductions in regulatory burdens affecting domestic manufacturing.”  82 Fed. Reg. 8667.  The memo will require the Secretary of the Department of Commerce (DOC) to conduct outreach to stakeholders concerning the impact of federal regulations on domestic manufacturing and to solicit comments for 60 days concerning “Federal actions to streamline permitting and reduce regulatory burdens for domestic manufacturers.”  DOC is also instructed to coordinate this process with the Secretaries of EPA, the U.S. Department of Agriculture (USDA), the U.S. Department of Energy (DOE), and the Administrator of the Small Business Administration (SBA), among others, and within 60 days after the process is completed, to submit a report setting forth a plan to streamline federal permitting processes for domestic manufacturing and “to reduce regulatory burdens affecting domestic manufacturers,” identifying “priority actions as well as recommended deadlines for completing actions.”

Also on January 30, 2017, President Trump issued an Executive Order on reducing regulation and controlling regulatory costs casually referred to as the “one in, two out” order which states that when executive departments and agencies “publicly propos[e] for notice and comment or otherwise promulgat[e] a new regulation, [they] shall identify at least two existing regulations to be repealed.”  The order also states that no incremental costs can be accrued for any new regulations unless required by law or advised in writing by the Director of the Office of Management and Budget (OMB).  For any costs that are accrued, it is directed for them to be “offset by the elimination of existing costs associated with at least two prior regulations.”  In the order, the OMB Director is tasked with providing guidance on implementation, as well as identifying the total amount of costs allowed for each agency “in issuing new regulations and repealing regulations for the next fiscal year.”  The regulations exempt from this order are: regulations issued with respect to a military, national security, or foreign affairs function; regulations related to agency organization, management, or personnel; and other categories exempted by the OMB Director. 


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On January 27, 2017, the U.S. Customs and Border Protection (CBP) issued in the Federal Register a notice of delay of an effective date of a final rule issued on December 27, 2016 (81 Fed. Reg. 94980).  The final rule announced amendments to CBP regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture.  82 Fed. Reg. 8590.  Specifically, the final rule amends CBP’s regulations under 19 C.F.R. Parts 12 and 127 to establish an electronic option for importers to file the required U.S. Environmental Protection Agency (EPA) TSCA certifications, to clarify and add certain definitions, and to eliminate the paper-based blanket certification process.  

The effective date of the final rule was initially set at January 26, 2017, but is now delayed until March 21, 2017, in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017, directing heads of executive departments and agencies temporarily to postpone the effective date for 60 days from the date of the memorandum, of all regulations that had been published in the Federal Register, but had not taken effect.  In the notice, CBP states that this additional time is not unwelcome, as it will allow affected entities more time to “become familiar with the increased flexibilities and new processes of the final regulations.”


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA also states that the action will “facilitate [its] implementation of TSCA section 14(g) to review all CBI claims for chemical identity, with limited exceptions, as well as to review a representative sample of at least 25% of other non-exempt claims.”  Information that is (or will be) submitted and claimed as CBI between June 22, 2016, and March 19, 2017 (inclusive), must be substantiated by September 19, 2017.  CBI claims made as part of an existing submission in EPA’s Central Data Exchange (CDX), such as a premanufacture notice (PMN), must be substantiated by amending the CDX submission.  Other information should be substantiated using the same mechanism (e.g., substantiate claims made on paper by submitting substantiations on paper).  This action will become effective on March 20, 2017.  More information on this notice will be available in our forthcoming memorandum on our website under the key phrase TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently published three Toxic Substances Control Act (TSCA) proposed framework rules:  TSCA Inventory Notification (Active-Inactive) Requirements (Jan. 13, 2017); Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (Jan. 17, 2017); and Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (Jan. 19, 2017).  Summaries, insights, and commentary from B&C’s TSCA experts on these rules are available in memoranda on the B&C website.  Below please find links to the memoranda:

B&C’s experts have also recently written up summaries and analysis related to the following other TSCA-related rulemakings:


 

By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Oscar Hernandez, Ph.D.

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use.  The process would not consider costs or other nonrisk factors.  Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under recent amendments to the Toxic Substances Control Act (TSCA).  The proposed rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  EPA proposes that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests.  The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests.  EPA posted a pre-publication version of the proposed rule on its website.  When the proposed rule is published in the Federal Register, it will begin a 60-day comment period.  This is the third foundational rule released during the week of January 9, 2017.  An in-depth memorandum on the proposed risk evaluation process, as well as memoranda regarding EPA’s proposed requirements for TSCA Inventory notification and prioritization process for reviewing existing chemicals, will be available on our website under the key phrase TSCA.


 
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