Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act

Please note that the incorrect comments were attached to the first set pf submitted comments: 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 Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act" (hereinafter "Proposed TSCA Prioritization Rule"). The Proposed TSCA Prioritization Rule was published in the Federal Register on January 17, 2017 and appears at 82 Fed. Reg. 4,825. 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 are subject to the Proposed TSCA Prioritization Rule and will be subject to the rules provisions. TFI offers the following comments on the Proposed TSCA Prioritization Rule: TFI Executive Summary The TSCA chemical prioritization process will impact companies in several ways. TFI's primary concerns are summarized below: The Agency must accept the data prepared for REACH and the HPV Challenge Program for prioritizing chemicals. Amended TSCA requires that EPA begin to prioritize existing chemical substances as either high priority or low priority for purposes of determining which substances for which they will conduct risk evaluations. The proposed rule is biased toward prioritizing most chemicals as high priority and/or prioritizing chemicals that are data rich. As such, it is likely that chemicals manufactured and/or used by companies could be selected for risk evaluation by EPA. This will result in the potential for: oPossible market deselection due to the high priority designation; oEPA test orders or rules to generate potentially costly toxicity (data from which could be equivocal and potentially problematic) and exposure data to address perceived data gaps; oEventual restrictions of uses or outright bans based on exposure scenarios not relevant for those uses. Vague and unclear agency process for prioritization creates the potential for public policy and subjective agency politics to sway the outcome of the process with no transparency or accountability. This also contributes to the uncertainty. The agency must provide more clarity to the process that will be used to prioritize existing substances. This include defining key terms and concepts applied during the prioritization 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 Section 26 of 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 Section 26 of LCSA have been met along with an explanation of how they have been met. The EPA must revise its approach to low priority designation to resolve the concern that the process will result in a majority of existing substances prioritized as high priority, requiring risk evaluation. This bias potentially dilutes the EPA's resources and its effectiveness to control the greatest risk as quickly as possible as intended by the statute. EPA must revise its approach to scoping the prioritization and risk evaluation processes to align with the intent of the statute that the prioritization 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 prioritization or risk evaluation on an inactive sub…

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 Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act" (hereinafter "Proposed TSCA Prioritization Rule"). The Proposed TSCA Prioritization Rule was published in the Federal Register on January 17, 2017 and appears at 82 Fed. Reg. 4,825. 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 are subject to the Proposed TSCA Prioritization Rule and will be subject to the rules provisions. TFI offers the following comments on the Proposed TSCA Prioritization Rule: TFI Executive Summary The TSCA chemical prioritization process will impact companies in several ways. TFI's primary concerns are summarized below and in the attached comments: The Agency must accept the data prepared for REACH and the HPV Challenge Program for prioritizing chemicals. Amended TSCA requires that EPA begin to prioritize existing chemical substances as either high priority or low priority for purposes of determining which substances for which they will conduct risk evaluations. The proposed rule is biased toward prioritizing most chemicals as high priority and/or prioritizing chemicals that are data rich. As such, it is likely that chemicals manufactured and/or used by companies could be selected for risk evaluation by EPA. This will result in the potential for: oPossible market deselection due to the high priority designation; oEPA test orders or rules to generate potentially costly toxicity (data from which could be equivocal and potentially problematic) and exposure data to address perceived data gaps; oEventual restrictions of uses or outright bans based on exposure scenarios not relevant for those uses. Vague and unclear agency process for prioritization creates the potential for public policy and subjective agency politics to sway the outcome of the process with no transparency or accountability. This also contributes to the uncertainty. The agency must provide more clarity to the process that will be used to prioritize existing substances. This include defining key terms and concepts applied during the prioritization 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 Section 26 of 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 Section 26 of LCSA have been met along with an explanation of how they have been met. The EPA must revise its approach to low priority designation to resolve the concern that the process will result in a majority of existing substances prioritized as high priority, requiring risk evaluation. This bias potentially dilutes the EPA's resources and its effectiveness to control the greatest risk as quickly as possible as intended by the statute. EPA must revise its approach to scoping the prioritization and risk evaluation processes to align with the intent of the statute that the prioritization 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 prioritization or risk evaluation on an inactive substance. EPA must adhere to the statutory mandate that the Metals F…