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Endocrine Disruptor Screening Program
Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a program to screen all pesticide chemicals, and other chemicals under certain conditions, for their potential to produce effects in humans "that is similar to an effect produced by a naturally occurring estrogen, or other endocrine effect as [EPA] may designate." Although EPA was required to develop a program within 2 years of the 1996 amendment to the FFDCA, the Agency did not publish the initial list of chemicals for screening until June 2007. EPA is now developing the three components of the program simultaneously by (1) validating assays, (2) developing a list of chemicals for testing, and (3) developing policies and procedures to implement the EDSP. Since mid-2007, EPA has proposed a list of chemicals and the policies and procedures it proposes to use to implement the EDSP. EPA has also published an Information Collection Request analysis for comment (see below).
Draft List of Chemicals Selected for Initial EDSP Screening Under FFDCA §408(p), EPA must “provide for the testing of all pesticide chemicals” (and other chemicals under certain conditions), and on June 18, 2007, EPA published in the Federal Register a proposed initial list of chemicals for screening. The list consists of 64 active ingredients and nine High Production Volume (HPV) pesticide inert ingredients that EPA selected based on human exposure potential. These chemicals will be subjected to an initial battery of screening assays. Based on a weight-of-evidence evaluation of the results, some chemicals will then be select for more rigorous “Tier 2 testing” that would include dose-respose assessments. On February 11, 2008, CPDA submitted comments on the list to the EPA docket, noting that (1) EPA properly emphasized the listed chemicals are not known or suspected endocrine disruptors, and (2) EPA should use the screening results only to evaluate where modifications or improvements could be made to the EDSP and test battery.
On December 13, 2007, EPA proposed in the Federal Register complex policies and procedures for implementing the EDSP. EPA’s “preferred approach” for requiring production of Tier-1 screening data is to issue FFDCA §408(p) test orders to the technical registrant of an active ingredient and to the manufacturer or importer of an inert ingredient. Registrants would receive test orders pursuant to the authority of both Section §408(p) and FIFRA §3(c)(2)(B) to ensure they are eligible for cost sharing and dispute resolution procedures. However, inert manufacturers and importers of food-use inerts would receive test orders only under §408(p), which provides cost sharing and data compensation for chemicals having tolerances or tolerance exemptions by application of §408(i). Manufacturers and importers of non-food use inerts would have to submit data jointly with a registrant to secure data compensation. For data compensation purposes, “catch-up” §408(p) test orders would be sent to inert manufacturers and importers who enter the marketplace after initial orders have been issued. CPDA submitted comments on various aspects of the proposed policies and procedures, and specifically asked the EPA to postpone testing of inert ingredients until proper policies and procedures for them have been developed.
EDSP Information Collection Request
Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act (PRA), EPA solicited comments on the proposed Information Collection Request (ICR) for the initial list of chemical candidates in the EDSP. Under PRA, the Agency must estimate the total "burden," or costs, associated with collecting the required information. "Burden" includes the “time, effort, or financial resources expended by persons to generate, maintain, or provide information to or for a Federal Agency.” The Office of Management and Budget (OMB) will not approve a “collection” until EPA provides an ICR that describes the information collection activities in detail. CPDA submitted comments on the proposed ICR, noting specifically that EPA has not provided the “specific, objectively supported estimate of burden” required by OMB’s Information Quality Guidelines (5 CFR 1320.8(a)), and grossly underestimated the burden to the regulated entities conducting the Tier 1 batteries.
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Chemical Producers & Distributors Association
1730 Rhode Island Ave., Suite 812 + Washington, DC 20036 + Phone: 202.386.7407 + Fax: 202.386.7409
