§ 1.1149 - What oversight standards apply to sampling?

§ 1.1149 What oversight standards apply to sampling?

(a) Documents. Before analyzing a sample, the LAAF-accredited laboratory must develop (if it collected the sample) or obtain (if another firm collected the sample) the following information to be submitted with test results (see § 1.1152(c)):

(1) Written documentation of the sampler's applicable qualifications by training and experience. A LAAF-accredited laboratory only needs to develop or obtain documentation of a sampler's qualifications the first time that sampler collects a sample for the LAAF-accredited laboratory under this subpart. If a LAAF-accredited laboratory has previously submitted the sampler's qualifications to FDA under § 1.1152(c), the LAAF-accredited laboratory may refer to its previously submitted qualifications.

(2) The written sampling plan used to conduct the sampling. The written sampling plan must identify the sampler and sampling firm and must list factors that will be controlled to ensure the sampling does not impact the validity of the subsequent analytical testing, including controlling for the representational nature of the sample; and

(3) A written sample collection report for each sample collected. The written sample collection report must include:

(i) The product code of the food product (if product is being sampled) or the location and a description of the environment (if environment is being sampled);

(ii) The date of the sampling;

(iii) The lot number, size, identity, and quantity of the sample;

(iv) Documentation of sample collection procedures and any sample preparation techniques; and

(v) Documentation of the chain of custody of the sample and of measures taken to ensure the validity of the subsequent analytical testing, including controlling for the representational nature of the sample.

(b) Potential consequences. If any of the requirements in paragraph (a) of this section is not met, FDA may consider the analysis of the sample to be invalid.

(c) Advance notice of sampling.

(1) If FDA determines that sampling conducted may materially differ from the sampling documented in the associated sampling plan or sample collection report, or if FDA determines that the sampling otherwise may have been improper, FDA may require the LAAF-accredited laboratory that analyzed the associated sample, and other LAAF-accredited laboratories that have analyzed samples previously collected by the sampling firm, to obtain from the sampling firm, and submit, or require the sampling firm to submit, an advance notice of sampling. The advance notice of sampling must be submitted to FDA at least 48 hours before each of the next 10 occasions that the sampling firm will collect a sample that the LAAF-accredited laboratory will analyze under this subpart.

(2) FDA may, as appropriate:

(i) Specify that the requirement applies to samples collected by a particular sampler;

(ii) Specify the type of food product or environment that requires advance notice of sampling under this subpart;

(iii) Determine that an amount of time other than 48 hours in advance is required, from a minimum of 24 hours up to 7 business days in advance;

(iv) Determine that a number of occasions other than 10 is required, from a minimum of 1 occasion to a maximum of 20 occasions;

(v) Notify affected LAAF-accredited laboratories that submission of additional notices of sampling are not required; and

(vi) Notify the owner or consignee that the advance notice applies to sampling for food testing being conducted on their behalf.

(3) The advance notice of sampling must contain:

(i) A unique identification for the advance notice of sampling;

(ii) The name of the LAAF-accredited laboratory that will conduct analysis of the sample;

(iii) The name and street address of the sampling firm that will conduct the sampling;

(iv) A primary contact (name and phone number) for the sampling firm;

(v) The reason why the food product or environment will be sampled;

(vi) The location of the food product or environment that will be sampled, including sufficient information to identify the food product or environment to be sampled;

(vii) As applicable, the U.S. Customs and Border Protection entry and line number;

(viii) The product code of the food product (if product is being sampled) or the location and a description of the environment (if environment is being sampled); and

(ix) The date and approximate time the sampling will begin.