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The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart, unless otherwise specified. For the purposes of this subpart, the following definitions also apply:
Analyst means an individual who analyzes samples.
Corrective action means an action taken by an accreditation body or laboratory to investigate and eliminate the cause of a deficiency so that it does not recur.
Directed food laboratory order means an order issued by FDA under § 1.1108 requiring food testing to be conducted under this subpart by or on behalf of an owner or consignee.
Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act, except that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
Food testing and testing of food means the analysis of food product samples or environmental samples.
Laboratory accreditation for analyses of foods (LAAF)-accreditation means a determination by a recognized accreditation body that a laboratory meets the applicable requirements of this subpart to conduct food testing under this subpart using one or more methods of analysis.
LAAF-accredited laboratory means a laboratory that a recognized accreditation body has determined meets the applicable requirements of this subpart and has been LAAF-accredited to conduct food testing under this subpart using one or more methods of analysis.
Owner or consignee means any person with an ownership or consignment interest in the food product or environment that is the subject of food testing conducted under § 1.1107(a).
Recognition means a determination by FDA that an accreditation body meets the applicable requirements of this subpart and is authorized to LAAF-accredit laboratories under this subpart.
Recognized accreditation body means an accreditation body that FDA has determined meets the applicable requirements of this subpart and is authorized to LAAF-accredit laboratories under this subpart.
Representative sample means a sample that accurately, to a statistically acceptable degree, represents the characteristics and qualities of the food product or environment from which the sample was collected.
Sampler means an individual who collects samples.
Sampling firm means an entity that provides sampling services.
Scope of LAAF-accreditation refers to the methods of analysis for which the laboratory is LAAF-accredited.
Street address means the full physical address, including the country. For purposes of this rule, a post office box number alone is insufficient; however, a post office box number may be provided in addition to the street address.
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