Rqap glp examination study references the following is a listing of suggested quality assurance references. Fifra 14b1 and 2 include the requirement that the violation be committed knowingly. Fifra provides epa with the authority to oversee, among other things, the registration, distribution, sale and use of pesticides. Comparison chart of fda and epa good laboratory practice glp regulations and the oecd. Not only does this situation constitute a potential violation of the glp regulations 40 cfr 160. The federal insecticide, fungicide and rodenticide act fifra gives epa the authority to regulate the registration, distribution, sale and use of pesticides. Good laboratory practice regulations drugs and the. All pesticides distributed or sold in the united states must be registered licensed by epa. Good laboratory practices advisories compliance monitoring the laboratory inspectiondata audit program monitors the regulated community, who periodically raise questions related to the interpretation of the good laboratory practices glp regulations. Electronic code of federal regulations ecfr title 40. International pesticide product registration requirements. On september 15, 2014, epa filed a consent agreement and final order cafo which simultaneously commences and resolves an administrative proceeding against e. Federal insecticide, fungicide, and rodenticide act wikipedia. Good laboratory practice standards inspection manual environmental protection agency, u.
Fifra means the federal insecticide, fungicide and rodenticide act as amended 7 u. Since devices are not subject to the regis tration requirements under fifra, regulation of them falls entirely on the office of enforcement, which must determine if they comply with the other requirements of the federal insecticide, fungicide, and rodenticide act to which they are subject. Enforcement response policies and guidance enforcement us epa. The laboratory inspectiondata audit program monitors the regulated community, who periodically raise questions related to the interpretation of the good laboratory practices glp regulations. Recent changes in the interpretation and enforcement of 21 cfr part 11 have shifted the focus of good laboratory practice glp regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. Code of federal regulations annual edition sudoc class number. This list is not allinclusive and candidates should not limit their study to only those references listed below. The fifra glp regulations provide further that epa may refuse j to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with the glp regulations. Good laboratory practices standards compliance monitoring program. Federal insecticide, fungicide, and rodenticide act fifra. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Epas good laboratory practice standards glps compliance monitoring program ensures the quality and integrity of test data submitted to the agency in support of a pesticide product registration under the federal insecticide, fungicide and rodenticide act fifra, section 5 of the toxic substances control act tsca, and pursuant to testing consent agreements and test rules issued under section 4 of tsca.
Jan 11, 2017 epas good laboratory practice standards glps compliance monitoring program ensures the quality and integrity of test data submitted to the agency in support of a pesticide product registration under the federal insecticide, fungicide and rodenticide act fifra, section 5 of the toxic substances control act tsca, and pursuant to testing consent agreements and test rules issued under. Pesticide applicator core exam prep fifra and the epa. Summary of the federal insecticide, fungicide, and. The federal insecticide, fungicide, and rodenticide act fifra is a united states federal law that set up the basic u. Apr 01, 2019 the information on this page is current as of april 1 2019. An act is committed knowingly by a person who has the general intent to do the actions constituting the violation. The listing is not inclusive of all policy and guidance that may be relied upon in developing enforcement actions. It is administered and regulated by the united states environmental protection agency epa and the appropriate environmental agencies. Nov 30, 2016 enforcement response policies and guidance listed below are epas enforcement response policies relating to violations or noncompliance with the environmental statutes and regulations. Fifra applies to all types of pesticides, including. Good laboratory practices standards compliance monitoring.
The federal insecticide, fungicide, and rodenticide act fifra or the act was first passed in 1947 and has been amended numerous times, most recently by the pesticide registration improvement extension act of 2012. Eags product chemistry team combined with the outstanding reputation of eags quality assurance unit have extensive expertise and experience in the characterization of test articles to meet compliance with epa fifra and tsca and fda good laboratory practice regulations. Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity. Title 40 protection of environment chapter i environmental protectionagencycontinued subchapter e pesticide programs part 160 good laboratory practice standards.
For more information visit our webpage or contact us. Federal insecticide, fungicide, and rodenticide act. Epa issued a stop sale, use or removal order ssuro to the e. The federal insecticide, fungicide, and rodenticide act fifra provides for federal regulation of pesticide distribution, sale, and use. Glp characterization product chemistry eag laboratories. Good laboratory practice standards inspection manual. Nov 29, 2016 enforcement response policy erp for the federal insecticide, fungicide, and rodenticide act fifra good laboratory practices glp regulations sets forth procedures for determining appropriate enforcement response for violations of the federal insecticide, fungicide, and rodenticide act good laboratory practice standards glps found at 40. Comparison chart of fda and epa good laboratory practice glp. Do the glps apply to validation trials conducted to confirm the analytical.
Federal insecticide, fungicide and rodenticide act compliance. Civil cases and settlements by statute enforcement us epa. This report examines the extent to which epa 1 inspects for glp compliance laboratories that test pesticides and the challenges epa faces in doing so, 2 uses the information obtained through glp. Title 40 protection of environment chapter i environmental protectionagencycontinued subchapter e pesticide programs part 160. Good laboratory practice compliance inspections of. This 3 hr glp webinar will cover some of the major requirements, definitions and elements of the various glp regulations, and the fdaoecd glps. Good laboratory practices advisories study director. Federal insecticide, fungicide and rodenticide act. Comparison chart of fda and epa good laboratory practice glp regulations and the oecd principles of glp. Enforcement response policy erp for the federal insecticide.
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