Pesticide Analytical Manual Vol I SECTION 101 101: REGULATORY POLICY The expressed purpose of the Pesticide Analytical Manual is to publish analytical methodology used by the FDa in enforcing pesticide tolerances. To understand FDAs application of methodology published in the manual, it is important to understand pesticide tolerance regulations and related FDA regulatory operations Material in Chapter I reflects FDA regulatory policies that affect its application of analytical methodology 101 A: REGULATORY AUTHORITY Infor n related to and the characteristics of pesticide tolerances include the follo a tolerance is the maximum concentration of a pesticide residue that is legally permitted to remain in a food. The tolerance is not expected to be exceeded if the pesticide's registered use directions are followed The statutory authority for the Environmental Protection Agencys (EPAs)establishment of tolerances is provided by sections 408 and 409 of the Federal Food, Drug, and Cosmetic Act. Tolerances established by EPA are set forth in Title 40 of the Code of federal Regulations(CFR), Part 180 for raw agricultural commodities, Part 185 for processed food, and Part 186 for animal feed. The concentration of toler- ances listed in 40 CFR 180, 185, and 186 is expressed in terms of ppm (i.e ng pesticide residue/kg food). In addition, certain pesticides are exempted from the need for tolerances; such exemptions are listed in 40 CFR 180.1001 a tolerance for a pesticide residue on a raw agricultural commodity, e.g tomatoes,also applies to processed forms of that commodity, e.g., canned tomatoes. In cases where processing may concentrate the residue, a food additive regulation may be issued in 40 CFR Part 185 to establish a higher tolerance on that processed commodity, e.g., tomato paste A tolerance regulation specifies the composition of pesticide residue for which the limit applies; i.e., a tolerance can apply to the parent form of the active ingredient only, parent compound plus one or more metabolites and/or degradation products, one or more metabolites and/or degrada- tion products only, or some chemical moiety that can be measured analyti cally for calculating the pesticide residue. a chemical entity not specified y the tolerance regulation is not included in the residue for tolerance enforcement purposes(Section 104) A tolerance regulation also specifies each individual food (e.g, apples) food group(e.g, citrus fruit) to which the limit applies No tolerance exists for a residue on a commodity unless the commodity itself or the group to which it belongs is speci In the examination of a food lot to determine whether it complies with tolerances, it is necessary to provide a sample for analysis that is represen- tative of the lot in order to determine the average pesticide residue content mittal No.94101/94 m FDA 2905a(6/92 101-1Pesticide Analytical Manual Vol. I SECTION 101 Transmittal No. 94-1 (1/94) Form FDA 2905a (6/92) 101–1 101: REGULATORY POLICY The expressed purpose of the Pesticide Analytical Manual is to publish analytical methodology used by the FDA in enforcing pesticide tolerances. To understand FDA’s application of methodology published in the manual, it is important to understand pesticide tolerance regulations and related FDA regulatory operations. Material in Chapter 1 reflects FDA regulatory policies that affect its application of analytical methodology. 101 A: REGULATORY AUTHORITY Information related to and the characteristics of pesticide tolerances include the following: A tolerance is the maximum concentration of a pesticide residue that is legally permitted to remain in a food. The tolerance is not expected to be exceeded if the pesticide’s registered use directions are followed. The statutory authority for the Environmental Protection Agency’s (EPA’s) establishment of tolerances is provided by sections 408 and 409 of the Federal Food, Drug, and Cosmetic Act. Tolerances established by EPA are set forth in Title 40 of the Code of Federal Regulations (CFR), Part 180 for raw agricultural commodities, Part 185 for processed food, and Part 186 for animal feed. The concentration of toler￾ances listed in 40 CFR 180, 185, and 186 is expressed in terms of ppm (i.e., mg pesticide residue/kg food). In addition, certain pesticides are exempted from the need for tolerances; such exemptions are listed in 40 CFR 180.1001. A tolerance for a pesticide residue on a raw agricultural commodity, e.g., tomatoes, also applies to processed forms of that commodity, e.g., canned tomatoes. In cases where processing may concentrate the residue, a food additive regulation may be issued in 40 CFR Part 185 to establish a higher tolerance on that processed commodity, e.g., tomato paste. A tolerance regulation specifies the composition of pesticide residue for which the limit applies; i.e., a tolerance can apply to the parent form of the active ingredient only, parent compound plus one or more metabolites and/or degradation products, one or more metabolites and/or degrada￾tion products only, or some chemical moiety that can be measured analyti￾cally for calculating the pesticide residue. A chemical entity not specified by the tolerance regulation is not included in the residue for tolerance enforcement purposes (Section 104). A tolerance regulation also specifies each individual food (e.g., apples) or food group (e.g., citrus fruit) to which the limit applies. No tolerance exists for a residue on a commodity unless the commodity itself or the group to which it belongs is specified. In the examination of a food lot to determine whether it complies with tolerances, it is necessary to provide a sample for analysis that is represen￾tative of the lot in order to determine the average pesticide residue content