2024年5月18日发(作者：普通台式电脑有蓝牙吗)

CPG Sec. 575.100 Pesticide Residues in Food

and Feed - Enforcement Criteria

BACKGROUND:

The regulation of food and feed containing pesticide residues is governed by sections 402, 408,

and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) as set forth in the following:

Tolerances for Pesticides:

Section 408 of the FFDCA authorizes the Environmental Protection Agency (EPA) to establish a

tolerance for the maximum amount of a pesticide residue that may be legally present in or on a

raw agricultural commodity. This section also authorizes EPA to exempt a pesticide residue in a

raw agricultural commodity from the requirement of a tolerance. A tolerance or tolerance

exemption is required when EPA grants registration under the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA) for the use of a pesticide in food and feed production in the United

States. Registration of a pesticide is not, however, a prerequisite for establishing a tolerance. For

example, EPA may establish a temporary tolerance under section 408(j) to permit the

experimental use of a non-registered pesticide, or EPA may establish a tolerance for a pesticide

residue resulting from the use of the pesticide in food or feed production in a foreign country.

Tolerances and exemptions from tolerances established by EPA for pesticide residues in a raw

agricultural commodities are listed in 40 CFR Part 180.

Food Additive Regulations for Pesticides:

A tolerance or tolerance exemption for a pesticide residue in a raw agricultural commodity also

applies to the processed form of the commodity when ready to eat. (See section 402(a)(2)(C) of

the FFDCA.) However, if a pesticide is to be used on a processed food or feed, or if conformity

with residue present in or on a raw agricultural commodity in conformity with its tolerance under

section 408 concentrates during processing to a level when ready to eat that is greater than the

tolerance for the raw agricultural commodity, a food additive regulation is required. In either

instance, EPA is authorized under section 409 of the FFDCA to establish a food additive

regulation for the maximum amount of a pesticide residue that may be legally present in a

processed food or feed.

Food additive regulations issued by EPA for pesticide residues in processed food and feed appear

in 21 CFR Part 193 and in 21 CFR Part 561, respectively.

Enforcement of Tolerances and Food Additive Regulations for Pesticides:

The Food and Drug Administration (FDA) is responsible for the enforcement of pesticide

tolerances and food additive regulations established by EPA. This enforcement authority is

derived from section 402(a)(2)(B) and of the FFDCA. Under this section a raw agricultural

commodity or a processed food or feed is deemed to be adulterated and subject to FDA

enforcement action if it contains either:

- A pesticide residue at a level greater than that specified by a tolerance or food additive

regulation; or

- A pesticide residue for which there is no tolerance, tolerance exemption, or food additive

regulation.

There are exceptions to FDA enforcing an adulteration charge under section 402 for a pesticide

residue in a food or feed that is not subject to a tolerance, tolerance exemption, or food additive

regulation. The exceptions include:

- Unavoidable Pesticide Residues: Food or feed may contain a pesticide 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 a tolerance,

tolerance exemption, or food additive regulation, FDA may establish an "action level" for such

unavoidable pesticide residues. An action level specifies the level below which FDA exercises its

discretion not to take enforcement action. An action level established by FDA is based on EPA's

recommendation, which follows the criteria of Section 406 of the FFDCA. (See 21 CFR Parts

109 and 509 for information on FDA policy and procedures for establishing action levels for

unavoidable food and feed contaminants.) Food or feed found to contain an unavoidable

pesticide residue at a level that is at or greater than an action level is subject to FDA enforcement

action. FDA action levels currently in effect for unavoidable pesticide residues in food and feed

are listed in Attachment B.

-EPA Emergency Exemptions: EPA is authorized by section 18 of FIFRA to grant an exemption

from the registration requirements for the use of a non-registered pesticide under emergency

conditions. (See 40 CFR Part 166.) Neither FIFRA nor the FFDCA have explicit provisions for

establishing an "emergency tolerance" for a pesticide residue resulting from an emergency

exemption granted-by EPA for food or feed use. Under a formal agreement between the U.S.

Department of Agriculture, EPA, and FDA (50 FR 2304), however, EPA will recommend an

enforcement level for residues of a pesticide granted an emergency exemption. FDA will use the

recommended enforcement level to determine compliance with the FFDCA. (See FDA Field

Management Directive No. 136.)

FDA will also consider taking enforcement action for violation of sections 402(a)(2)(B) or

402(a)(2)(C) in the following situations: