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Procedures for Chemical Risk Evaluation under the Toxic Substances Control Act

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The Fertilizer Institute filings
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The Fertilizer Institute filed 1 comment on this docket between Mar 21, 2017 and Mar 21, 2017. 49 other organizations filed here. The comment window closed 2098d ago.

What The Fertilizer Institute filed (1)

Mar 21, 2017· Comment submitted by Ed Thomas, Director, Regulatory Affairs, The Fertilizer Institute (TFI)· EPA-HQ-OPPT-2016-0654-0011

The Fertilizer Institute (TFI), on behalf of its member companies, submits the attached comments on the U.S. Environmental Protection Agency's (EPA or Agency) proposal "Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act" (hereinafter "Proposed TSCA Risk Evaluation Rule"). The Proposed TSCA Risk Evaluation Rule was published in the Federal Register on January 19, 2017 and appears at 82 Fed. Reg. 7,562. Statement of Interest TFI represents the nation's fertilizer industry including producers, importers, retailers, wholesalers and companies that provide services to the fertilizer industry. TFI members provide nutrients that nourish the nation's crops, helping to ensure a stable and reliable food supply. TFI's full-time staff, based in Washington, D.C., serves its members through legislative, educational, technical, economic information and public communication programs. All of TFI's manufacturing members have substances that may be evaluated under the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act Proposed Rule. TFI offers the following comments on the Proposed TSCA Risk Evaluation Rule: TFI Executive Summary The TSCA chemical risk evaluation process will impact companies in several ways. TFI's primary concerns are summarized below and in the attached comments: The Agency must accept the use of data prepared for REACH and the High Production Volume Challenge Program for the risk evaluation process. If a chemical substance of interest to a company is designated as high priority during the prioritization process and subject to this risk evaluation process that results in a determination of unreasonable risk, a risk management rule would be required. Business concerns include: oPotential for market deselection due to the determination of unreasonable risk. oEPA's mandate is to ensure risk management rules result in the elimination of the unreasonable risk. The range of outcomes could include warnings and labeling, restrictions on certain end uses and/or possible bans of some or all uses of the chemical substance. oIncreased cost in the manufacture, distribution and/or use of the products due to increased controls that may be necessary to continue to manufacture, distribute and use the product. oPotential business interruption if risk management rules require conditions that cannot be met or that are not economically feasible to continue manufacturing, distributing or using the substance. oAlthough not dispositive, a determination of unreasonable risk may be used as a basis for litigation related to a chemical substance. Vague and unclear agency process for risk evaluation creates the potential for public policy and subjective agency politics to sway the outcome of the process with no transparency or accountability. There is a risk that decisions will be made that are not supported by sound science. The agency must provide more clarity to the process that will be used to do risk evaluations of existing substances. This includes defining key terms and concepts applied during the risk evaluation process, updating out-of-date agency guidance, and ensuring intra-agency collaboration results in the use of data to which the same rigorous standards have been applied as expected by the Lautenberg Chemical Safety for the 21st Century Act ("LCSA"). The agency must provide a level of transparency sufficient to demonstrate that the scientific standards and other expectations in LCSA have been met along with an explanation of how they have been met. EPA must revise its approach to scoping the risk evaluation process to align with the intent of the statute that the risk evaluation process assures that the Agency's focus on priority chemicals is on the conditions of use that raise the greatest potential for risk. This should include prohibition from initiating risk evaluation on an inactive substance.

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Abstract

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process by which the Agency will determine whether a chemical substance presents unreasonable risk on injury to health or the environment. This is to be done without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. The draft rule establishes the steps that must be completed for a risk evaluation of either those chemicals identified as high priority or in an approved request from a manufacturer. The rule enumerates the components of an evaluation including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. Additionally, the draft rule provides the form and manner for which manufacturers may submit a request for an Agency conducted risk evaluation and how those requests will be evaluated by the Agency.

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Co-filers (49)

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