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EPA Announces Public Comment Period on Joint Petition Addressing EDSP Submitted by CPDA, HSIA and PETA Requesting that the Agency Comply with the Paperwork Reduction Act In the February 29, 2012 Federal Register, EPA published a notice announcing that it has accepted for public comment a joint petition filed by the Chemical Producers & Distributors Association, along with the Halogenated Solvents Industry Alliance, Inc. and People for the Ethical Treatment of Animals requesting that the Agency comply with the requirements of the Paperwork Reduction Act (PRA) and the Office of Management and Budget’s Terms of Clearance for the approved Information Collection Request for 67 pesticide chemicals under the Endocrine Disruptor Screening Program (EDSP). The December 7, 2011 petition requests that EPA demonstrate the practical utility of this information collection before expanding the EDSP to include screening of additional chemicals. CPDA and the other co-petitioners make two specific assertions as follows: 1) the Agency has not demonstrated that the EDSP Tier 1 screening information collection is non-duplicative of information already available to EPA, and 2) by failing to provide the scientific support on which to make the necessary distinction that a chemical “may” or “may not” have the potential to interact with the endocrine system, the Agency has not demonstrated that the Tier 1 assays have practical utility. By extension, EPA’s failure to meet these requirements impedes its ability to administer the EDSP in a sound, scientific manner as called for under the Federal Food, Drug & Cosmetic Act. The public comment period closes on May 29, 2012. Comments must be identified by docket number EPA-HQ-OPP-2012-0061 and may be submitted electronically at www.regulations.gov. The petitioners argue that to ensure compliance with the mandates of the PRA, EPA must demonstrate that any proposed collection of information is not duplicative of information otherwise accessible to the Agency. The petitioners maintain that while EPA did provide List 1 test order recipients the opportunity to submit existing data or other scientifically relevant information (OSRI) in accordance with OMB’s directive, the Agency failed to provide adequate guidance in a timely manner that would clearly articulate the scientific basis for assessing the sufficiency of OSRI. The petitioners explained that all initial List 1 chemical test order responses, including OSRI, were due to the Agency by the spring of 2010. However, EPA’s final Weight-of-Evidence (WoE) Guidance document was not issued until September 2011. During that intervening period, EPA rejected 323 of the 412 (78%) of the OSRI submissions reviewed. The petitioners emphasized that without having published the Guidance prior to its review of OSRI submitted in response to List 1 chemical test orders, the Agency cannot justify the OSRI determinations it made at that time. The petitioners also questioned the adequacy and practical utility of the Tier 1 Battery referencing the lack of scientific consensus on the validity of the Tier 1 assays. The petitioners emphasized that unless the Tier 1 assays can be shown to be scientifically supportable, reliable, and sufficient to provide the information EPA needs to make a “may” or “may not” determination on whether a chemical has the potential to interact with endocrine systems, the practical utility of the assays cannot be demonstrated. In addition, the petitioners called upon EPA to revise the WoE Guidance so as to ensure that it provides a reproducible, transparent, and science based approach to evaluating OSRI and screening assay results across reviewers, chemicals and laboratories. Finally, the petitioners recommended that EPA review and revise the Tier 1 Battery, including the use of OSRI, before requiring the screening of additional chemicals. To read a copy of the petition, click here. A copy of the Federal Register notice announcing the public comment period is available here. |
