Orientation and Training
Food and Drug Administration
The statutory authority for control of pesticide residues in food began with the Food and Drug Act of 1906 and was strengthened with passage of the Federal Food, Drug, and Cosmetic Act (FD&C) of 1938. In 1954, the Pesticide Chemical Amendment (Public Law 518) was passed. The amendment provided a new, more effective procedure for controlling residues of pesticide chemicals used on raw agriculture commodities (which include dairy products, eggs, and fish). The Secretary was given authority to establish tolerances in or on commodities and to require petitions from manufacturers requesting the establishment of tolerances. Data required in these petitions include name, composition, and chemical identity of the pesticide and its residues; residue data from actual applications of the pesticide; toxicity studies; and analytical methods for determining residues. Data requirements and a summary of FDA activities in this area can be found in "FDA Papers," Vol. 2, No. 7, September 1968.
In 1970, the function of establishing tolerances for pesticide chemicals was transferred to the Environmental Protection Agency (EPA). FDA continues to have regulatory responsibility for enforcing the tolerances.
Under the FD&C Act, a raw agricultural commodity is considered adulterated if it bears or contains a pesticide chemical that is "unsafe" within the meaning of section 408. A chemical is "unsafe" unless its quantity is within limits of prescribed tolerances or unless it has been exempted from the tolerance requirement. Tolerances and exemptions, based on usage, stability, and toxicological properties of the residue, are found in 40 CFR Part 180.
The earliest analytical methods were procedures based on classic elemental analysis, spectrophotometric, biochemical, and biological methods. During the 1950s and early 1960s, chromatographic methods, with greater sensitivity and the capability of distinguishing residues within a given class, were introduced. As a result of constantly improving analytical procedures, "negligible residue" tolerances, defined in 40 CFR Part 180.1(1), are now established for selected crops and residues. "Negligible residue" tolerances replaced the prior concept of "zero" tolerance for chemicals of high toxicity.
Analytical procedures, compiled in the FDA Pesticide Analytical Manual (PAM) and the Official Methods of Analysis of the AOAC, demand a high level of analytical skill and technique in order to provide meaningful regulatory results. To develop these skills, the trainee will perform the exercises in this section, which follow sections of PAM, Volume I. In order to demonstrate proficiency in this area, the trainee will analyze both regulatory and fortified samples. The trainer will assign the exercises.
Finally, the trainer will discuss today’s revision of ORA-LAB.010, Guidance for the Analysis and Documentation to Support Regulatory Action On Pesticide Residues. This document presents the minimum provisions for preparation of supportive pesticide regulatory analytical packages. The principles apply not only to pesticides, but also to all regulatory packages submitted to headquarters.