SOURCES SOUGHT
B -- Technical Reviews of Organic Substances
- Notice Date
- 8/11/2004
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Agriculture, Animal and Plant Health Inspection Service, Administrative Services Division/Contracting, 100 North 6TH Street Butler Square 5TH Floor, Minneapolis, MN, 55403
- ZIP Code
- 55403
- Solicitation Number
- SourcesSought-M-APHIS-04
- Response Due
- 8/23/2004
- Point of Contact
- Jose Gallagher, Contract Specialist, Phone 612-336-3206, Fax 612-370-2106, - Jose Gallagher, Contract Specialist, Phone 612-336-3206, Fax 612-370-2106,
- E-Mail Address
-
jose.l.gallagher@usda.gov, jose.l.gallagher@usda.gov
- Description
- This is a sources sought notification. This notice is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the notice will not be returned. Responses to this notice are not considered offers and cannot be accepted by the government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this notice. Interested parties are requested to respond to this statement with a response identifying interest in this notice and a brief technical capability statement addressing the organization?s ability to perform required services and experience with similar projects. Interested parties are also encouraged to identify any preexisting schedules they may have with the General Services -Administration (GSA). The United States Department of Agriculture (USDA) Agricultural Marketing Service?s National Organic Program (NOP) is seeking sources for qualified businesses to provide technical reviews of substances petitioned for evaluation for inclusion on or removal from the National List of Substances Allowed and Prohibited in Organic Production and Handling. Technical reviews may require expertise in agricultural production, handling, or processing or in scientific disciplines such as veterinary medicine, chemistry, food technology, microbiology, or toxicology. Frequently asked questions about the National Organic Program, the standard of proof and methodology for reviews are: 1.) What is the National Organic Program? The program was established on December 21, 2000, under the authority of the Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501 et seq.), as amended. The mission of the NOP is to develop, implement, and enforce national standards for the production, handling, and marketing of organically produced agricultural products. The NOP regulations (7 CFR 205 et seq.), including an initial list (National List) of synthetic substances that may be used and nonsynthetic substances that may not be used in organic crop and livestock production, and synthetic and nonsynthetic substances that may be used in organic handling, were fully implemented on October 21, 2002. OFPA defines a synthetic substance as ?a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.? Non-synthetic substances are all substances not meeting OFPA?s definition of a synthetic substance. OFPA provides that persons may petition the National Organic Standards Board (NOSB) to evaluate a substance for inclusion on or removal from the National List. OFPA authorizes the NOSB to develop and forward recommendations to the Secretary of Agriculture on proposed amendments to the National List. OFPA authorizes the convening of TAPs to provide scientific evaluation of the substances considered for inclusion on or removal from the National List. The results of the TAP evaluations are used by the NOSB in making their recommendations to the Secretary. 2.) What Specific Tasks Will the Contractor Perform? In general, the contractor will address a petitioned substance?s potential for adverse impacts on human health or the environment and its essentiality in organic operations. The contractor?s responses to these evaluation questions will be used by the NOSB in determining the compatibility of pesticides, animal drugs, and food additives approved under the statutory and regulatory authority of the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) with organic production and handling. 3.) What is the Standard of Proof in Answering the Evaluation Questions? Most of the petitioned substances will be pesticides, animal drugs, and food additives regulated by the EPA and/or FDA. The EPA and FDA review and approval processes, address all human, animal, and environmental risk factors through risk assessment protocols that include hazard identifications, hazard characterizations, exposure assessments, and risk characterizations. For example, before registering a new pesticide or new use for a registered pesticide, EPA must first ensure that the pesticide, when used according to label directions, can be used with a reasonable certainty of no harm to human health and without posing unreasonable risks to the environment. Similarly, under the FDA?s New Animal Drug Evaluation process, the new animal drug must be clinically tested for effectiveness and safety. If a product is intended for use in a food-producing animal, it must also be tested for safety to human consumers, and the edible animal products must be free of unsafe drug residues. Additionally, the FDA must review the safety of food and color additives before manufacturers and distributors can market them. To initiate this review, sponsors are required to submit a petition or notification that includes appropriate test data to demonstrate the safety of the intended use of the substance. Finally, each of these review processes reflects the requirements of the National Environmental Policy Act of 1969 (NEPA). The NEPA requires each Federal agency to assess, as an integral part of its decision making process, the environmental impacts of its actions and to ensure that the interested and affected public is informed of its environmental analyses. Therefore, the contractor should use, as a basis for responding to the evaluation questions, data from the petitioned substance?s original review and approval process under the statutory and regulatory authority of the EPA and the FDA as well as any subsequent data obtained through a review of widely recognized, first-tier, peer-reviewed scientific journals addressing human health, environment, nutrition, and conventional or organic agriculture production and handling. The contractor should ensure that all data sources used in preparing responses to the evaluation questions would be deemed trustworthy, reliable, and competent if contested in a legal or judicial proceeding. Any response to the questions by the contractor should reflect the conclusions reached in the majority of the literature reviewed. When the literature reviewed by the contractor is inconclusive, the contractor may provide a response to the evaluation questions based on an abundance of caution. In doing so, the contractor should clearly state his/her rationale for the abundance of caution response. To assist the contractor, the NOP will arrange with the National Agricultural Library for literature searches to be performed at no cost to the contractor. This action should enhance the contractor?s ability to perform literature searches of widely recognized, first-tier, peer-reviewed scientific journals on an as needed basis. Please provide responses to this notice no later than 23 August 2004.
- Record
- SN00641208-W 20040813/040811211655 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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