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By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham

On December 21, 2018, the U.S. Environmental Protection Agency’s (EPA) Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) Nancy B. Beck, Ph.D., signed a Federal Register document denying a Toxic Substances Control Act (TSCA) Section 21 petition requesting that EPA amend the Chemical Data Reporting (CDR) rule to increase asbestos reporting, exclude asbestos from certain exemptions, and lift Confidential Business Information (CBI) claims on asbestos information reported under the CDR rule.  Due to the government shutdown, the notice has not yet been published in the Federal Register, but EPA has posted a prepublication version.  EPA’s carefully reasoned response to the request is set forth in the notice.  

The petition was filed on September 27, 2018, by the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental Working Group, Environmental Health Strategy Center, and Safer Chemicals, Healthy Families (Petitioners).  According to EPA, Petitioners requested the following specific amendments to the existing CDR rule to collect information for the ongoing asbestos risk evaluation being conducted under TSCA Section 6(b) (required to be completed by December 22, 2019), and, if necessary, any subsequent risk management decisions under TSCA Section 6(a):

  1. Amend the CDR rule to require immediate submission, “from January 1, 2019, to April [30], 2019,” of reports on asbestos for the 2016 reporting cycle. 
  2. Amend the naturally occurring chemical substance exemption at 40 C.F.R. § 711.6(a)(3) to make the exemption inapplicable to asbestos;
  3. Amend the articles exemption at 40 C.F.R. § 711.10(b) to require reporting pursuant to the CDR rule for all imported articles in which asbestos is present at detectable levels;
  4. Amend the CDR rule to exclude asbestos from the exemption at 40 C.F.R. § 711.10(c) to require the reporting of asbestos as a byproduct or impurity;
  5. Amend the reporting threshold for CDR at 40 C.F.R. § 711.8(b) to set a reporting threshold of ten pounds for asbestos; and
  6. Amend 40 C.F.R. § 711.8 to add processors of asbestos and asbestos-containing articles as persons required to report under the CDR rule.

In addition to the above requests, Petitioners also requested that EPA use its authority under TSCA Sections 14(d)(3) and 14(d)(7) to lift CBI claims on asbestos information reported under the CDR rule.  EPA responds in detail as to why it is denying each of these requests.  A short summary is below.

  1. 2016 Reporting Cycle:  EPA states that based on the extensive research and data gathering already conducted during the asbestos risk evaluation process, EPA believes that “the requested amendments to the CDR rule would not lead to the reporting of new information that would contribute to EPA’s ongoing asbestos risk evaluation or, if needed, subsequent risk management decision(s)” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require immediate past reporting of the manufacturing and use of asbestos under the CDR rule for the 2016 reporting cycle.”
  2. Naturally Occurring Substances Exemption:  EPA states that removing the exemption for reporting on naturally occurring substances for asbestos would not provide any additional data to EPA “given that the purpose of domestic manufacturing or importing of raw asbestos is to make asbestos diaphragms, for which EPA already has use and exposure information” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the naturally occurring chemical substances exemption for asbestos under the CDR rule.”
  3. Articles Exemption: EPA states that it believes that lifting the articles exemption for the reporting of asbestos under the CDR rule “would not provide any new use information that would inform the ongoing risk evaluation or any subsequent risk management decisions, if needed” and that Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the articles exemption for asbestos under the CDR rule.”
  4. Reporting as a Byproduct or Impurity:  EPA states that it does not believe that making the requested amendment to the CDR rule would result in “reporting of asbestos as an impurity or a byproduct, for uses that are known or reasonably ascertainable,” that Petitioners “have not provided evidence that there are such known uses that are ongoing but remain outside the scope of the asbestos risk evaluation,” and “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the byproducts and impurities exemptions for asbestos under the CDR rule.”
  5. Reporting Threshold of Ten Pounds:  EPA states that Petitioners “fail to show that lowering the reporting threshold would provide any new information to EPA” and, therefore, finds that the Petitioners “have failed to set sufficient facts to establish that it is necessary to issue the requested amendment to lower the CDR reporting threshold for asbestos.”
  6. Adding Processors to CDR:  EPA states that it does not believe that “requiring processors of asbestos under the CDR rule will provide useful information not already in its possession,” Petitioners “have failed to indicate what additional information EPA would collect by requiring asbestos processors to report under the CDR rule” and, therefore, EPA finds that the Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require processors of asbestos to report under the CDR rule.”
  7. Lifting CBI Claims:  EPA states that Petitioners’ request to lift CBI claims on asbestos information reported under the CDR rule is "not appropriate for a TSCA Section 21 petition, as a TSCA Section 21 only pertains to the “issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5(e) or (f),” therefore, a TSCA Section 21 petition “is not a vehicle to petition EPA to initiate an action under TSCA section 14.”  Further, EPA states that it believes that “disclosure of CBI would have no practical relevance to the risk evaluation or risk determination as the CBI claims are limited and EPA retains the ability to characterize the information without revealing the actual protected data.”

Please look for the full analysis in our upcoming memorandum that will be posted on our Regulatory Developments page. 


 

By Lynn L. Bergeson and Carla N. Hutton

On August 29, 2018, the Democrats on the House Committee on Energy and Commerce issued a press release announcing that they have renewed their request for a hearing on the U.S. Environmental Protection Agency’s (EPA) implementation of the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act to the Toxic Substances Control Act (TSCA).  The Democrats note this is the fourth request they have made for hearings to be held on EPA’s management of toxic chemicals.  According to the press release, the Democrats “remain concerned that EPA’s implementation of the reformed TSCA program contradicts the new law’s language and intent and undermines public confidence in the program.”  The press release states that the Democrats “are concerned that EPA is ignoring its own scientific evidence and the recommendations of its experienced career staff regarding TSCA implementation at the expense of public health.  They point to a recent report from the New York Times that found EPA officials proposed a rulemaking to review applications for use of asbestos in consumer products over the objections of EPA attorneys and scientists.”  The Democrats “also charge that EPA has abandoned its statutory mandate to review all new and existing chemicals known or foreseeable uses and exposure putting human health and the environment at risk,” possibly resulting in an incomplete evaluation of the health and environmental risk of a number of “extremely toxic chemicals, including asbestos, perchloroethylene (PERC), methylene chloride, and trichloroethylene (TCE).”  The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Environment Subcommittee Ranking Member Paul Tonko (D-NY), Raul Ruiz (D-CA), Scott Peters (D-CA), Gene Green (D-TX), Diana DeGette (D-CO), Jerry McNerney (D-CA), Tony Cardenas (D-CA), Debbie Dingell (D-MI), and Doris Matsui (D-CA).


 

By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment.  Links and short summaries are provided below.

EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019.  Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register.  The problem formulation documents are:

  1. Asbestos
  2. 1-Bromopropane (1-BP);
  3. Carbon Tetrachloride;
  4. 1,4-Dioxane;
  5. Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
  6. Methylene Chloride;
  7. N-Methylpyrrolidone (NMP);
  8. Perchloroethylene;
  9. Pigment Violet 29; and
  10. Trichloroethylene (TCE).

EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information.  Comments will be due 45 days after publication in the Federal Register.  Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.  

For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos.  EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use.  Comments will be due 60 days after publication in the Federal Register.

More information on the first ten chemical evaluations is available on our blog.  A more detailed analysis will be available next week on our regulatory developments webpage.