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  1. Chemicals, Metals & Pesticides in Food

Pesticide Residue Monitoring Program Questions and Answers

Federal government agencies in the United States share responsibility for the oversight of pesticide chemical residues in or on food. Growers often use pesticides to protect their products from insects, weeds, fungi, and other pests. U.S. regulators help ensure that food treated with a pesticide is safe to eat by setting limits for any remaining residues based on safety standards and monitoring the presence of the residues in or on foods.

The U. S. Environmental Protection Agency (EPA) approves the use of pesticides and may establish tolerances for pesticide chemical residues that could remain in or on food. A tolerance is the EPA established maximum residue level of a specific pesticide chemical that is permitted in or on a human or animal food in the United States. EPA is responsible for establishing the tolerances, which are based on a federal safety standard, to limit the amount of pesticide chemical residues that remain in or on the food. Most of the tolerances EPA establishes are for raw agricultural commodities. For some pesticide chemical residues, EPA may establish a tolerance exemption. The EPA also provides a strong U.S. preventive control program by licensing pesticide applicators, conducting pesticide use inspections, and establishing and enforcing pesticide labelling provisions. The Food and Drug Administration is responsible for enforcing the EPA tolerances for domestic foods shipped in interstate commerce and foods offered for import into the U.S., except for meat, poultry, catfish, and certain egg products that are regulated by the U.S. Department of Agriculture.

FDA employs a three-fold strategy to enforce EPA’s tolerances for pesticide chemical residues in human and animal foods. In its regulatory pesticide residue monitoring program, FDA selectively tests a broad range of imported and domestic commodities for approximately 700 pesticide residues. FDA may also carry out focused sampling surveys for specific commodities or selected pesticide chemical residues of special interest. In addition, FDA monitors the levels of pesticide chemical residues in foods prepared for consumption in its Total Diet Study (TDS), an ongoing program that monitors contaminants and nutrients in the average U.S. diet.

What is FDA’s pesticide residue monitoring program?

The pesticide residue monitoring program is a compliance program used by FDA to monitor the level of pesticide chemical residues in domestic and imported foods to ensure that they do not exceed the EPA limits or tolerances. FDA monitors a broad range of foods samples (over 7000 in fiscal year 2016), using a multi-residue method that analyzes approximately 700 different pesticide chemical residues in a single analysis and selective residue methods that detect pesticide chemical residues not covered by the multi-residue method.

Annual reports have been prepared to summarize results of the FDA pesticide residue monitoring program since 1987. The annual reports and data published from 1993 to the present. Each report is available in the format used at the time it was written.

What is a tolerance?

A tolerance is the EPA established maximum residue level of a specific pesticide chemical that is permitted in or on a specific human or animal food in the United States.

Specific tolerances are listed in 40 Code of Federal Regulations (CFR) Part 180 titled: “Tolerances and Exemptions for Pesticide Chemical Residues in Food.”

What is an action level?

Food or feed may contain a pesticide chemical residue from sources of contamination that cannot be avoided by good agricultural or manufacturing practices, such as contamination by a pesticide that persists in the environment. In the absence of an EPA tolerance, or tolerance exemption, FDA may establish an “action level” for such unavoidable pesticide chemical residues. An action level is a recommended level of a contaminant not to exceed. An action level is not legally binding and FDA may take enforcement action on a case-by-case basis whether a contaminant is below, at, or above an action level.

What is a focused sampling assignment?

In addition to samples collected for routine regulatory monitoring, FDA may conduct special focused sampling assignments to target food commodities for analysis. Focused sampling is generally used to follow up on suspected problem areas or to acquire residue data on selected foods not usually covered during regulatory monitoring. Typically, samples collected for a focused assignment are analyzed using routine pesticide procedures; however, in some cases, targeted pesticide residues of interest are analyzed.

What is the Total Diet Study?

The FDA’s Total Diet Study (TDS) is an ongoing program that monitors contaminants and nutrients in the average U.S. diet. Prior to analysis, TDS foods are prepared as they would be consumed. For example, oranges are peeled and noodles are cooked.

Annual Pesticide Report (APR)

What is the Annual Pesticide Report (APR) and why does FDA release an APR?

FDA is required by statute (the Pesticide Monitoring Improvements Act of 1988) to prepare an annual summary of pesticide testing results. Statutes are laws that are written by Congress and then signed by the president; FDA has prepared annual reports since 1987.

What is a commodity?

A commodity is a product of agriculture. Examples of commodities are vegetables, fruits and grains.

What is a domestic sample?

A sample of a commodity produced and held for sale in the U.S.

What is an imported sample?

A sample of product, which originates from another country, generally collected when the food is offered for import into the U.S.

What are residues?

Residues are trace amounts of pesticide chemicals referred to as “pesticide chemical residues” that may remain in or on food after applying the pesticide.

What is a no-tolerance violation in the APR?

A no-tolerance violation is when a pesticide chemical residue is detected, quantified and confirmed in a commodity for which EPA has not established a tolerance or tolerance exemption for that particular pesticide/commodity combination.

What is an over-tolerance violation in the APR?

An over-tolerance violation is when pesticide chemical residues are detected at a level above the limits established by EPA for a specific food.

What is a violation rate in the APR?

The violation rate is the percentage of samples that contain at least one violative pesticide chemical residue.

Why is the import violation rate typically higher than the domestic violation rate?

Foods that are imported from other countries usually have a higher violation rate because other countries may allow the use of different pesticides or different amounts of pesticides than the U.S. allows.

What are multi-residue methods (MRMs) and selective residue methods (SRMs)?

Using multi-residue methods enables FDA to test for the presence of multiple (hundreds) pesticide chemical residues at one time in a food sample. Selective residue methods target a smaller number of specific pesticide chemical residues typically not included in the scope of the MRMs.

What is parts per million (PPM)?

PPM is one part out of 1 million parts, e.g., a residue of 1 ppm is equivalent to 1 µg of residue in one gram of a food sample.

What are Warning Letters?

A Warning Letter notifies industry about violations that FDA has documented from its testing of food samples or observed during its inspection of food facilities. The FDA expects most persons (e.g., individuals and firms) to voluntarily comply with the law, and determines, on a case-by-case basis, whether to initiate an enforcement action.

What is an Import Alert?

An Import Alert says that the imported food may present a safety problem. FDA issues an Import Alert when the Agency determines an imported food should not be allowed into the U.S. because, for example, it appears to be adulterated or misbranded.

What is Detention Without Physical Examination (DWPE)?

DWPE is when an imported food may be detained and not allowed into the U.S. based on information, other than the results of examination of samples, that the food appears to be adulterated or misbranded.