Chapter 1 Regulatory Operations.pdf.pdf
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1、SECTION 100 Pesticide Analytical Manual Vol. I 1001 Transmittal No. 98-1 (10/97) Form FDA 2905a (6/92) Table of Contents pagedate 101:Regulatory Policy 101 A:Regulatory Authority101-11/94 101 B:Regulatory Operations101-21/94 101 C:Monitoring101-31/94 References101-31/94 102:Preparation of Analytical
2、 Samples 102 A:Introduction102-11/94 102 B:Portion of Food Commodity to102-11/94 be Analyzed Raw Agricultural Commodities102-11/94 Processed Foods102-41/94 102 C:Compositing and Comminuting the102-51/94 Laboratory Sample Chapter 1 Regulatory Operations Chapter 2 General Analytical Operations and Inf
3、ormation Chapter 3 Multiclass MRMs Chapter 5 GLC Chapter 4 Selective MRMs Chapter 6 HPLC SECTION 100 Transmittal No. 98-1 (10/97) Form FDA 2905a (6/92) 1002 Pesticide Analytical Manual Vol. I pagedate 102 D:Handling Samples for Special Analyses102-61/94 102 E:Retention of Reserve Portions102-61/94 R
4、eferences102-61/94 103:Method Application in Regulatory Analysis 103 A:Introduction103-11/94 103 B:Choice of Method103-11/94 PAM103-11/94 Other “Official” Methods103-21/94 Other Published Methods103-21/94 103 C:Tentative Identification103-31/94 103 D:Residue Quantitation103-31/94 103 E:Confirmation
5、of Identity103-41/94 103 F:Documentation103-61/94 Analytical Reports103-61/94 Chromatograms103-71/94 Chromatographic Data103-71/94 References103-81/94 104:Analytical Results 104 A:Introduction104-11/94 104 B:Reporting104-11/94 Portion of Commodity104-11/94 Nature of the Residue104-21/94 Residues Mea
6、sured from Derivative104-21/94 or Breakdown Product Significant Figures104-31/94 Trace104-31/94 Confirmation104-41/94 104 C:Determining Compliance with Regulations104-41/94 General Rule for Multicomponent Residues104-41/94 Special Situations104-41/94 References104-51/94 105:Analytical Limits of Quan
7、titation 105 A:Definition105-110/97 105 B:Calculation105-110/97 105 C:Implementation105-210/97 105 D:Factors Affecting Target Limits of Quantitation105-210/97 SECTION 100 Pesticide Analytical Manual Vol. I 1003 Transmittal No. 98-1 (10/97) Form FDA 2905a (6/92) pagedate Figures 102-a:Fraction of Che
8、ese Units to Take for102-51/94 Compositing Tables 102-a:Portion of Raw Agricultural Commodity102-21/94 to be Analyzed for Pesticide Residues 102-b:Portion of Processed Food to be Analyzed102-49/96 for Pesticide Residues 103-a:Information Provided by Use of Element-103-51/94 Selective Detectors 104-a
9、:Portion of Commodity for Calculation104-21/94 and Reporting of Residue Levels 105-a:Examples of Method Specifications105-410/97 Used to Calculate Lqs SECTION 100 Transmittal No. 98-1 (10/97) Form FDA 2905a (6/92) 1004 Pesticide Analytical Manual Vol. I Pesticide Analytical Manual Vol. ISECTION 101
10、Transmittal No. 94-1 (1/94) Form FDA 2905a (6/92)1011 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 i
11、mportant 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 toleranc
12、es 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 pesticides registered use directions are followed. The statutory authority for the Environmental Protection Age
13、ncys (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
14、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 pes
15、ticide 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 process
16、ed 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 met
17、abolites 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 reg
18、ulation 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
19、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 Pesticide Analytical Manual Vol. ISECTION 101 1012 Transmittal No. 94-1 (1/94) Form FDA 2905a (6/92) of the lot. Tolerances ap
20、ply to that sample or a representative portion of that sample. Unless otherwise specified in a tolerance regulation, each tolerance ap- plies to the whole portion of a food commodity that moves in commerce. In practice, however, some food commodities (mainly raw agricultural commodities) require fur
21、ther definition as to the portion of commodity to which a tolerance applies and which is to be analyzed. In summary, a tolerance provides a means of ascertaining that a pesticide was properly used. If a pesticide residue is found to exceed a tolerance or be present in a food for which there is no to
22、lerance, then the pesticide was not used in a manner consistent with the tolerance. Under Sections 402 (a) (2) (B) or (C) of the Federal Food, Drug, and Cosmetic Act, this constitutes a violation of the law; i.e., the food commodity is adulterated because it contains an “unsafe” or illegal pesticide
23、 residue. 101 B: REGULATORY OPERATIONS To fulfill its responsibility to enforce regulations on pesticide residues in foods, FDA maintains a comprehensive pesticide program, including the analysis of food for enforcement of pesticide tolerances. Although the majority of samples ana- lyzed contain no
24、violative residues, sample handling must be consistent for all analyzed samples, because it is impossible to know in advance which samples will contain violative residues. Accordingly, the following procedures must be followed by FDA laboratories to establish that a product contains illegal pesticid
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