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 Margaret R. Graham

On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules:  (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), 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 (issued January 19, 2017); and (2) to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N-methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping (issued January 19, 2017).  82 Fed. Reg. 20310.

This is the second extension of the comment period for the proposed rule to ban TCE use in vapor degreasing and the first extension of the comment period for the proposed rule to ban the uses of NMP and methylene chloride for consumer and most types of commercial paint and coating removal.  Comments on both proposed rules are now due on May 19, 2017.  


 

On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management.  On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing processes.  This article summarizes key changes to TSCA and explains their likely impacts on the manufacturing sector.


 

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.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register reopening the comment period on the risk evaluation scoping efforts under the Toxic Substances Control Act (TSCA) for the ten chemical substances that were designated on December 19, 2016:

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

The prepublication version is available on the Federal Register website.  The initial notice, issued in the Federal Register on January 19, 2017, announced a public meeting which took place on February 14, 2017, and solicited “comments to receive input and information to assist the Agency in its efforts to establish the scope of risk evaluations under development for the ten chemicals substances.”  This notice will extend the comment period for 14 days, from March 1, 2017, to March 15, 2017, in response to a request from the interested public.  

More information is available in our blog items EPA To Hold Public Meeting on Uses and Conditions of Use for the Initial Ten Chemicals to be Evaluated under TSCA Section 6 and EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation

 


 

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 and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment period for the two recently proposed rules issued under Section 6 of the Toxic Substances Control Act (TSCA) to ban certain uses of trichloroethylene (TCE):  proposed rule to ban certain uses of TCE in aerosol degreasing and as a spot cleaner in dry cleaning facilities (issued December 16, 2017); and proposed rule to regulate the use of TCE in vapor degreasing (issued January 19, 2017).  EPA is extending the comment period for the proposed ban on TCE as an aerosol degreaser and for spot cleaning in dry cleaning facilities from the initial deadline of February 14, 2017, to March 16, 2017, and for the proposed ban on TCE as a commercial vapor degreaser from the initial deadline of March 20, 2017, to April 19, 2017.  EPA did not state any information on why it was extending the deadline, but requests for extensions were filed in both dockets.

More information on the proposed rules is available in our memorandum EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a) and in our blog item EPA Proposes Prohibiting Use of TCE.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing it will be holding a public meeting to receive public input and information on uses and conditions of use for the initial ten chemicals to be evaluated under Section 6(b)(2)(A) of the amended Toxic Substances Control Act (TSCA) on February 14, 2017, from 9:00 a.m. to 3:00 p.m. (EST), at the Ronald Reagan Building and International Trade Center, Polaris Room, 1300 Pennsylvania Avenue Northwest, Washington, DC 20004.  82 Fed. Reg. 6545.  EPA states that the information it gathers on uses and the conditions of use will assist it in identifying potential exposure scenarios for the ten chemicals.

Registration is available online and remote access will be available for registered participants.  Public dockets for each chemical have been established. Written comments and materials will also be accepted in these dockets on www.regulations.gov.  EPA requests for them to be submitted by March 1, 2017.

Additional information, including links to the public dockets, is available on EPA’s website and in our blog item EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.


 

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

On January 11, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; 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.  EPA is proposing under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit these uses due to its determination that there are “significant health risks associated with TCE use in vapor degreasing,” and they present “an unreasonable risk to human health.”  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. More information on the final rule is available in our memorandum on our website under the key phrase TSCA.


 

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).


 

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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