Daily Rules, Proposed Rules, and Notices of the Federal Government
If your comments contain any information that you consider to be CBI or otherwise protected, please contact the DFO listed under
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
When submitting comments, remember to:
1. Identify the document by docket ID number and other identifying information (subject heading,
2. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
4. Describe any assumptions and provide any technical information and/or data that you used.
5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
6. Provide specific examples to illustrate your concerns and suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline identified.
You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2012-0818 in the subject line on the first page of your request.
• Organic and analytical chemistry (expertise focused on developing criteria for physical chemical properties that cannot be easily tested in
• Quantitative structural-activity relationship (QSAR) models and estrogen receptor (ER) expert systems development.
• High-throughput data generation and analysis (expertise focused on how this methodology can be applied to assess toxicity potential of environmental compounds with a range of potency).
• Application of QSAR models and expert systems in prioritization processes for regulatory toxicity testing programs.
The selection of scientists to serve on FIFRA SAP is based on the function of the panel and the expertise needed to address the Agency's charge to the panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency except the EPA. Other factors considered during the selection process include availability of the potential panel member to fully participate in the panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on FIFRA SAP. Numerous qualified candidates are identified for each panel. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the panel. In order to have the collective breadth of experience needed to address the Agency's charge for this meeting, the Agency anticipates selecting approximately 12-15 ad hoc scientists.
FIFRA SAP members are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The EPA will evaluate the candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP Web site at
FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the SAP. As a peer review mechanism, FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.
Under the 1996 FFDCA, section 408(p), and Safe Drinking Water Act, section 1457, EPA is required to screen all pesticide chemicals (active and inert ingredients) and only those drinking water contaminants to which a “substantial population” is exposed for the
In 2009, EPA developed the Estrogen Receptor (ER) Expert System (ERES) to help prioritize candidate chemicals specific to an estrogen receptor (ER) mediated pathway for testing in the Tier 1 Endocrine Disruptor Screening Program. The ERES was initially developed for pesticide, food use inert ingredients and antimicrobial pesticides and predicts ER binding affinity based on data derived from two types of
EPA incorporated the 2009 SAP's recommendations and is expanding the ERES training set through the use of chemical read across techniques (i.e., using data from a tested chemical for a particular property or effect to a similar untested chemical) and
While this SAP is focused on the estrogenic toxicity pathway, the recommendations may be more broadly applied for additional toxicity pathways (e.g., androgen and thyroid). In addition, this SAP review will establish a solid foundation upon which the agency seeks to build upon as we advance the use of these computational toxicology tools beyond EDSP chemical prioritization and into Tier 1 data replacement.
EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available at least 15 days prior to the meeting. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, at
FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP Web site or may be obtained from the OPP Docket or at
Environmental protection, Pesticides and pests.