March 19, 2019

March 19, 2019

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March 18, 2019

Subscribe to Latest Legal News and Analysis

EPA Denies TSCA Section 21 Petition Seeking Increased Asbestos Reporting

On December 21, 2018, the U.S. Environmental Protection Agency (EPA) denied a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA initiate rulemaking to amend the TSCA Chemical Data Reporting (CDR) rule to increase reporting of asbestos. EPA denied the September 27, 2018, petition on the grounds that the petitioners, 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, did not demonstrate that it is necessary to amend the CDR rule. EPA posted a pre-publication version of the Federal Register notice. Due to the government shutdown, EPA has not yet published its response in the Federal Register.

Background

Petitioners state that they support a “robust and comprehensive” risk evaluation of asbestos under TSCA Section 6(b), followed by rulemaking to ban asbestos under TSCA Section 6(a). Petitioners requested initiation of a rulemaking under TSCA Section 8(a) to amend the CDR rule. According to the petition, the requested CDR amendments would accomplish three purposes:

  1. Remove the exemption for CDR reporting for naturally occurring asbestos, thereby requiring reporting on importation and use of asbestos and asbestos-containing products in the U.S.;
  2. Lower the reporting threshold, eliminate exemptions for impurities and articles, and require reporting by processors to assure that EPA has the information on asbestos necessary to meet its TSCA responsibilities; and
  3. Determine that reports submitted on asbestos are not subject to protection as confidential business information (CBI) because disclosure is necessary to protect against an unreasonable risk of injury to health under TSCA Section 14(d)(3).

Petitioners note that EPA selected asbestos as one of the initial ten chemicals to undergo risk evaluations under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. In June 2018, EPA issued a problem formulation document outlining how EPA plans to conduct the risk evaluation. According to petitioners, EPA’s description of the asbestos uses that will be addressed in the risk evaluation “is limited, vague and incomplete and the Agency acknowledges that ‘the import volume of products containing asbestos is not known.’”

Petitioners describe the CDR rule as EPA’s primary tool under TSCA for obtaining basic information on the manufacture, importation, and use of chemicals and the nature and extent of exposure to these substances. Petitioners note that EPA advised a major asbestos importer and user (Occidental Chemical) that “asbestos is exempt from CDR reporting because it is a ‘naturally occurring substance.’” Petitioners claim that the “loophole in the rule has resulted in a troubling -- and wholly avoidable -- lack of reliable information about who is importing asbestos and in what quantities, where and how asbestos is being used in the US, and who is being exposed and how that exposure is occurring.” They ask EPA to close the CDR reporting “loophole” for asbestos by amending the CDR rule so asbestos is subject to reporting and to frame these reporting requirements broadly to assure that they capture all imports and domestic uses of asbestos and asbestos-containing products.

Reasons for EPA’s Denial

EPA states that, after “careful consideration,” it has denied the petition. Below is a summary of the reasons EPA provides for its decision.

Require Immediate Reporting of Asbestos to CDR for the 2016 Reporting Cycle

EPA does not believe that the requested amendments would result in the reporting of any information that is not already available and known to EPA. EPA states that, after more than a year of research and stakeholder outreach, EPA believes that it is aware of all ongoing uses of asbestos and already has the information that EPA would receive if EPA were to amend the CDR requirements. Furthermore, even if EPA believed that the requested amendments would collect information on any unidentified ongoing uses, EPA would not be able to promulgate such amendments and require reporting in time to inform the ongoing risk evaluation or, if needed, any subsequent risk management decision(s). EPA notes that even if it amended the CDR rule, and chemical manufacturers could reasonably ascertain and provide the newly required information, EPA would be receiving information on manufacturing, import, and processing for conditions of use that may no longer be ongoing conditions of use. EPA compared the 2012 and 2016 U.S. Geological Survey Minerals Yearbook for asbestos, and found that “a number of importers of raw asbestos and asbestos-containing articles are exiting or have already exited the market.” EPA concluded that all or a significant part of the information they would report for activities undertaken during the 2016 CDR submission period (i.e., 2012-2015) “would likely consist of conditions of use that are no longer ongoing, and, thus, uninformative for the risk evaluation.”

Lift Exemption for Naturally Occurring Chemical Substances for Asbestos

In the notice, EPA “emphasizes that manufacturers and importers of asbestos are already required to report asbestos under the CDR rule if they meet the production volume threshold of 2,500 pounds and do not qualify for an exemption (including the naturally occurring substances exemption).” During the last CDR reporting cycle, two companies reported the import of asbestos for use in the chlor-alkali industry to make asbestos diaphragms. EPA states that it believes that the chlor-alkali industry is the only importer of raw, bulk asbestos, and that EPA already has sufficient volume, import, use, and hazard data from the industry to conduct the risk evaluation.

According to EPA, petitioners “mistakenly seem to believe that no domestically manufactured or imported asbestos is currently required to be reported under the CDR rule as a result of the exemption for naturally occurring substances.” EPA notes that while it found that the exemption for naturally occurring substances applied under the specific circumstances described in Occidental’s letter, it “did not find that the exemption applied for all ‘manufacturers or importers of asbestos or asbestos-containing products’ as claimed by petitioners.”

Require Reporting of Imported Articles Containing Asbestos

Under 40 C.F.R. Section 711.10(b), import of a chemical substance as part of an article is not subject to reporting under the CDR rule. A chemical substance is considered to be imported “as part of an article” if the substance is not intended to be removed from that article and has no end use or commercial purpose separate from the article of which it is a part. EPA states that although petitioners correctly noted that “a large number of the asbestos-containing products historically in use [were] articles,” these uses, as well as most uses of asbestos, have ceased and thus are not being evaluated as part of the ongoing asbestos risk evaluation. As identified in the problem formulation document for asbestos, currently imported articles include asbestos-containing sheet gaskets, other gaskets and packing, aftermarket automotive brakes/linings, other vehicle friction products, brake blocks, asbestos cement products, and woven products. EPA does not believe amending the CDR rule would be helpful in collecting additional import information on articles.

Petitioners requested that EPA require reporting for “all imported articles in which asbestos is present at detectable levels.” The information that manufacturers are required to report under the CDR rule is limited to information “known to or reasonably ascertainable” by the reporter, however, and EPA could not require manufacturers to test these products for the purposes of CDR reporting under TSCA Section 8. Because information reported under the CDR rule is limited to that which is “known to or reasonably ascertainable” by the reporter, even if EPA were to require the reporting of asbestos-containing articles, importers would rely on information readily available to them, such as safety data sheets (SDS) or other documentation provided by their foreign supplier. EPA states that it does not believe that making the requested amendment to the CDR rule would result in importers reporting articles that are not already known to EPA because it has conducted its own research to analyze SDSs and other evidence to determine the conditions of use of asbestos for the risk evaluation.

Lift the Byproduct and Impurity Exemption for Asbestos

Under 40 C.F.R. Section 720.30(g), a byproduct is exempt from reporting if its only commercial purpose is for use by public or private organizations that: (1) burn it as a fuel; (2) dispose of it as a waste, including in a landfill or for enriching soil; or (3) extract component chemical substances from it for commercial purposes.” Under 40 C.F.R. Section 720.30(h), any impurity or any byproduct that is not used for a commercial purpose is not subject to reporting. EPA states that, based on its extensive outreach and research in connection with developing the ongoing asbestos risk evaluation, it is unaware of any examples of asbestos as a byproduct. Thus, EPA anticipates there would be no new information reported if it were to lift the byproduct exemption for asbestos.

EPA states that petitioners requested that the exemptions be made inapplicable to asbestos “since the low levels of asbestos that have been found in makeup and crayons may be unintended contaminants that comprise byproducts and impurities.” According to EPA, these findings were made only after independent laboratory testing of final consumer products, however, and “petitioners make no attempt to explain why they believe these findings are the result of the manufacture of asbestos as a byproduct or impurity such that it would be reportable under the CDR rule if the Agency required such reporting.” EPA reiterates that the information required when reporting on a chemical is limited to information that is “known to or reasonably ascertainable” by the manufacturer.

Lower Asbestos Reporting Threshold to Ten Pounds

According to EPA, since asbestos is no longer mined in the U.S. and the only importation of raw asbestos is for production of asbestos diaphragms, for which yearly imports for each site well exceed the threshold of 2,500 pounds, lowering the reporting threshold would not provide additional information. EPA states that it believes that it already has sufficient import data from the chlor-alkali industry to support conducting the risk evaluation. While petitioners claim that the current reporting threshold “is too high in view of the absence of any safe level of exposure to asbestos and the need for comprehensive use and exposure information for the ongoing risk evaluation,” they fail to show that lowering the reporting threshold would provide any new information to EPA.

Add Processors of Asbestos to CDR

The CDR rule does not currently require processors of any chemical substances to report. EPA states that it knows of only two ongoing uses of asbestos that constitute processing: (1) the processing of raw asbestos into diaphragms; and (2) the fabrication of gaskets from imported asbestos-containing sheet gaskets. According to EPA, it well understands information on these uses as a result of direct communication with these processors. Accordingly, EPA does not believe that requiring processors of asbestos under the CDR rule will provide useful information not already in EPA’s possession.

Lift CBI Claims for All Reports to CDR for Asbestos

EPA states that petitioners’ request is not appropriate for a TSCA Section 21 petition. Under TSCA Section 21, any person can petition EPA to initiate a rulemaking proceeding for 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 5(f). Under this express statutory language, therefore, a TSCA Section 21 petition is not a vehicle to petition EPA to initiate an action under TSCA Section 14.

Moreover, according to EPA, even if petitioners could use the TSCA Section 21 mechanism to request an action under TSCA Section 14, they have not made a sufficient case for lifting CBI protections as described by either TSCA Sections 14(d)(3) or 14(d)(7). TSCA Section 14(d)(3) states that CBI “shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment.” The asbestos risk evaluation is ongoing for the uses reported under the CDR rule, and EPA has yet to determine if these uses pose an unreasonable risk. In the absence of an unreasonable risk finding for a condition of use, EPA cannot make a determination whether disclosure is necessary under TSCA Section 14(d)(3). TSCA Section 14(d)(7) states that CBI “may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding.” EPA states that it believes that disclosure of CBI would have no practical relevance to the risk evaluation or risk determination, however, as the CBI claims are limited and EPA retains the ability to characterize the information without revealing the actual protected data.

Commentary

EPA’s explanations and bases for denying the petitioned actions are legally compelling, well reasoned, and provide a clear and defensible rationale for its decision to deny the petition. It seems clear that EPA is expressing its belief there is not a significant gap in the understanding available to it on asbestos import, uses, and exposures, including from asbestos in imported articles, as a byproduct or impurity, from processing, and other aspects in the petition, such that the petitioned actions are justified. EPA also makes cogent arguments about the time that will elapse between the requested rulemaking (i.e., changing the CDR exemptions and reporting thresholds for asbestos and requiring retrospective reporting for the previous two CDR reporting periods) and when any data would be available to EPA for its review and consideration. EPA argues that, as a practical matter, changing the CDR reporting rules and requiring retrospective reporting will not yield little, if any, additional useful information.

One of the examples that petitioners include is an example of risk that may arise from the presence of asbestos as an impurity in “cosmetics.” Although EPA does not so state in its response, cosmetics and cosmetic ingredients are excluded from TSCA authority by TSCA Section 3(2)(B)(vi). Cosmetics are regulated by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetics Act. Even if EPA were to grant petitioners’ requests, cosmetic manufacturers and importers would have no obligation to report under CDR.

Whether EPA’s rationale and decision to deny the petition will be found acceptable by petitioners remains to be seen.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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