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| [Code of Federal Regulations] |
| [Title 21, Volume 1] |
| [CITE: 21CFR1] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL
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| PART 1 | GENERAL ENFORCEMENT REGULATIONS |
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Subpart R - Laboratory Accreditation for Analyses of Foods
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General Provisions
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Sec. 1.1101 What documents are incorporated by reference in this subpart
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(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is available from the source listed elsewhere in this section. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) International Organization for Standardization (ISO), Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
(1) ISO/IEC 17011:2017(E), Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies, Second edition, November 2017, IBR approved for §§ 1.1113(a) and (c), 1.1114(b), 1.1120(c), 1.1131(a).
(2) ISO/IEC 17025:2017(E), General requirements for the competence of testing and calibration laboratories, Third edition, November 2017, IBR approved for §§ 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b) and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).
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Sec. 1.1102 What definitions apply to this subpart?
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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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Sec. 1.1103 Who is subject to this subpart?
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(a) Accreditation bodies. An accreditation body is subject to this subpart if it has been or is seeking to be recognized by FDA to LAAF-accredit laboratories to conduct food testing under this subpart.
(b) Laboratories. A laboratory is subject to this subpart if it has been or is seeking to be LAAF-accredited by a recognized accreditation body to conduct food testing under this subpart.
(c) Owners and consignees. An owner or consignee is subject to this subpart if it is required to use a LAAF-accredited laboratory to conduct food testing under this subpart.
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General Requirements
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Sec. 1.1107 When must food testing be conducted under this subpart?
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(a) Food testing must be conducted under this subpart whenever such testing is conducted by or on behalf of an owner or consignee:
(1) In response to explicit testing requirements that address an identified or suspected food safety problem, which are contained in the following provisions:
(i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
(ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and (b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
(iii) Bottled drinking water. Section 129.35(a)(3)(i) of this chapter (for the requirement to test five samples from the same sampling site that originally tested positive for Escherichia coli );
(2) As required by FDA in a directed food laboratory order issued under § 1.1108;
(3) To address an identified or suspected food safety problem and presented to FDA as part of evidence for a hearing under section 423(c) of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a mandatory food recall order, as part of a corrective action plan under section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order under section 304(h)(4)(A) of the Federal Food, Drug, and Cosmetic Act.
(4) In support of admission of an article of food under section 801(a) of the Federal Food, Drug, and Cosmetic Act; and
(5) To support removal from an import alert through successful consecutive testing.
(b) When food testing is conducted under paragraph (a) of this section, analysis of samples must be conducted by a laboratory that is LAAF-accredited for the appropriate analytical method by a recognized accreditation body under this subpart.
(c) Food testing conducted on articles of food offered for import into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section may only be conducted after the articles offered for import have arrived in the United States unless the owner or consignee has written approval from FDA that a sample taken prior to arrival is or would be a representative sample of the article offered for import into the United States.
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Sec. 1.1108 When and how will FDA issue a directed food laboratory order?
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(a) FDA may require the owner or consignee to conduct food testing, or to have food testing conducted on their behalf, under this subpart to address an identified or suspected food safety problem, as FDA deems appropriate.
(b) The directed food laboratory order will specify the food product or environment to be tested; whether the food testing may be conducted using a LAAF-accredited laboratory that is owned, operated, or controlled by the owner or consignee; the timeframe in which the food testing must be conducted; and the manner of the food testing, such as the methods that must be used.
(c) The directed food laboratory order will contain all the elements required by § 16.22(a) of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter. An affected owner or consignee may request a regulatory hearing on a directed food laboratory order pursuant to § 1.1174.
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Sec. 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
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FDA will place on its website a publicly available registry listing of:
(a) Recognized accreditation bodies, including for each: the name, contact information, and duration of recognition of the recognized accreditation body;
(b) Accreditation bodies that have a change in recognition, including for each: the name of the accreditation body, the specific change in recognition (i.e., probation, revocation of recognition, denial of renewal of recognition, relinquishment of recognition, or expiration of recognition) and the effective date of the change;
(c) LAAF-accredited laboratories, including for each: the name, contact information, and scope of LAAF-accreditation, and the name and contact information of the recognized accreditation body that has LAAF-accredited the laboratory; and
(d) Laboratories that have a change in LAAF-accreditation, including for each: the name of the laboratory, the specific change in LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal of LAAF-accreditation by the recognized accreditation body, probation or disqualification by FDA, or relinquishment of LAAF-accreditation), and the effective date of the change.
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Sec. 1.1110 What are the general requirements for submitting information to FDA under this subpart?
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(a) All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified. If FDA requests inspection or submission of records that are maintained in any language other than English, the recognized accreditation body or LAAF-accredited laboratory must provide an English translation within a reasonable time.
(b) A program applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during any onsite assessments of the applicant by FDA.
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FDA Recognition of Accreditation Bodies
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Sec. 1.1113 What are the eligibility requirements for a recognized accreditation body?
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A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).
(b) Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of "Testing: ISO/IEC 17025."
(d) Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.
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Sec. 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?
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(a) Application for recognition or renewal of recognition. An accreditation body seeking initial recognition or renewal of recognition must submit an application to FDA demonstrating that it meets the eligibility requirements in § 1.1113.
(b) Documentation of conformance with requirements. The accreditation body must submit documentation of conformance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) and separate documentation of ILAC membership and ILAC MRA signatory status demonstrating competence to ISO/IEC 17011:2017(E) with a scope of "Testing: ISO/IEC 17025," in meeting the requirements of § 1.1113(a) through (c). The accreditation body also must submit documentation of its compliance with § 1.1113(d).
(c) Signature. An application for recognition or renewal of recognition must be signed in the manner designated by FDA by an individual authorized to act on behalf of the applicant for purposes of seeking recognition or renewal of recognition.
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Sec. 1.1115 How will FDA evaluate applications for recognition and renewal of recognition?
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(a) Review of application for recognition or renewal of recognition. FDA will review an accreditation body's application for recognition or renewal of recognition for completeness and notify the applicant of any insufficiencies. FDA generally will review accreditation body applications for recognition or renewal of recognition in the order in which completed applications are received; however, FDA may prioritize the review of specific applications to meet program needs.
(b) Evaluation of application for recognition or renewal of recognition. FDA will evaluate a complete application for recognition or renewal of recognition to determine whether the applicant meets the requirements for recognition. Such evaluation may include an onsite evaluation of the accreditation body. If FDA does not reach a final decision on an application for renewal of recognition before an accreditation body's recognition expires, FDA may extend the existing term of recognition for a specified period of time or until FDA reaches a final decision on the application for renewal of recognition.
(c) Grant of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been approved and will include any conditions associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an accreditation body for a period not to exceed 5 years from the date of recognition, except under the circumstances described in paragraph (b) of this section.
(e) Denial of application for recognition or renewal of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been denied and will state the basis for such denial and describe the procedures for requesting reconsideration of the application under § 1.1171.
(f) Notice of records custodian after denial of an application for renewal of recognition. Within 10 business days of the date of FDA's issuance of a denial of an application for renewal of recognition, the applicant must provide the name and contact information of the custodian who will maintain required records and make them available to FDA under § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.
(g) FDA notice to LAAF-accredited laboratories. FDA will promptly notify all laboratories LAAF-accredited by the accreditation body whose application for renewal of recognition was denied, informing them of such denial.
(h) Public notice of denial of an application for renewal of recognition of an accreditation body. FDA will provide public notice on the website described in § 1.1109 of the issuance of a denial of an application for renewal of recognition and will include the date of the issuance of such denial.
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Sec. 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
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(a) Notice to FDA of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify FDA of its intention to leave the program, specifying the date on which the relinquishment or expiration will occur. The recognized accreditation body must provide the name and contact information of the custodian who will maintain and make available to FDA the records required by § 1.1124 after the date of relinquishment or the date recognition expires, as applicable. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.
(b) Notice to LAAF-accredited laboratories of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify the laboratories it LAAF accredits of its intention to leave the program, specifying the date on which relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of recognition. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment or expiration of recognition of an accreditation body.
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Sec. 1.1117 How may an accreditation body request reinstatement of recognition?
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(a) Application following revocation of recognition. An accreditation body that has had its recognition revoked by FDA (as described in § 1.1131) may seek reinstatement by submitting a new application for recognition under § 1.1114. The accreditation body must also submit evidence to FDA with its application to demonstrate that the issues resulting in revocation of recognition have been resolved, including evidence addressing the cause or condition of the grounds for revocation of recognition. The evidence also must identify measures that have been implemented to help ensure that such cause or condition is unlikely to recur.
(b) Application following relinquishment or expiration of recognition. An accreditation body that previously relinquished its recognition or allowed its recognition to expire (as described in § 1.1116) may seek reinstatement by submitting a new application for recognition under § 1.1114.
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Requirements for Recognized Accreditation Bodies
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Sec. 1.1119 What are the conflict of interest requirements for a recognized accreditation body?
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(a) In addition to meeting the impartiality and conflict of interest requirements of § 1.1113(a), a recognized accreditation body must:
(1) Ensure that the recognized accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) does not own or have a financial interest in, manage, or otherwise control any laboratory (or any affiliate, parent, or subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs (c) and (d) of this section; and
(2) Prohibit, subject to the exceptions in paragraph (e) of this section, officers, employees, or other agents involved in LAAF-accreditation activities of the recognized accreditation body from accepting any money, gift, gratuity, or other item of value from any laboratory the recognized accreditation body LAAF-accredits or assesses for LAAF-accreditation.
(b) The financial interests of any children younger than 18 years of age or a spouse of a recognized accreditation body's officers, employees, and other agents involved in LAAF-accreditation activities are considered the financial interests of such officers, employees, and other agents involved in LAAF-accreditation activities.
(c) An accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) may have an interest in a publicly traded or publicly available investment fund (e.g., a mutual fund), or a widely held pension or similar fund if the accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) neither exercises control nor has the ability to exercise control over the financial interests held in the fund.
(d) A recognized accreditation body's agent that is a contract assessor will be permitted to own or have a financial interest in, manage, or otherwise control a LAAF-accredited laboratory if all of the following circumstances apply:
(1) The contract assessor's primary occupation is owning or having a financial interest in, managing, or otherwise controlling a LAAF-accredited laboratory;
(2) The assessor contracts with the recognized accreditation body to provide assessment services on an intermittent or part-time basis;
(3) The contract assessor does not assess the LAAF-accredited laboratory that the assessor owns or has a financial interest in, manages, or otherwise controls; and
(4) The contract assessor and the recognized accreditation body inform any laboratory that the contract assessor may assess or reassess for LAAF-accreditation that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory. The laboratory seeking LAAF-accreditation assessment or reassessment must acknowledge that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory and be provided the option to be assessed by a different representative of the recognized accreditation body.
(e) The prohibited items of value specified in paragraph (a)(2) of this section do not include:
(1) Money representing payment of fees for LAAF-accreditation services or reimbursement of direct costs associated with an onsite assessment or reassessment of the laboratory; or
(2) Meal of de minimis value provided during the course of an assessment or reassessment and on the premises where the assessment or reassessment is conducted, if necessary for the efficient conduct of the assessment or reassessment.
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Sec. 1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
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(a) A recognized accreditation body must conduct an initial assessment of a laboratory seeking LAAF-accreditation in accordance with the requirements of this subpart, to determine whether the laboratory meets the requirements of § 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the initial assessment must be conducted onsite, although certain assessment activities may be conducted remotely if it will not aid the assessment to conduct them onsite.
(c) If, within the previous 2 years, the recognized accreditation body conducted an onsite assessment of the laboratory in accordance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) to assess whether the laboratory meets the requirements of ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), then the initial assessment under this section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).
(d) A recognized accreditation body must oversee the performance of a laboratory it LAAF-accredits in accordance with the requirements of § 1.1113(a), except as otherwise provided by this subpart, to determine whether the LAAF-accredited laboratory continues to meet the applicable requirements of this subpart.
(e) A recognized accreditation body must conduct a reassessment of a LAAF-accredited laboratory in accordance with this subpart at least every 2 years. Such reassessment must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid in the reassessment to conduct the activities onsite.
(f) If the recognized accreditation body conducted the initial assessment of the LAAF-accredited laboratory remotely in accordance with paragraph (c) of this section, the recognized accreditation body must conduct its first reassessment of the LAAF-accredited laboratory no later than 2 years after the recognized accreditation body last conducted an onsite assessment of the laboratory.
(g) The reassessment at the end of the LAAF-accredited laboratory's ISO/IEC 17025:2017-accreditation cycle, which the recognized accreditation body must conduct in accordance with this subpart, must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid the reassessment to conduct them onsite.
(h) Any assessments or reassessments conducted by a recognized accreditation body in addition to the assessments or reassessments referred to in paragraphs (a), (e), and (g) of this section may be conducted remotely if it will not aid the assessment or reassessment to conduct it onsite.
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Sec. 1.1121 When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
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(a) Corrective action. A recognized accreditation body may require corrective action using the procedures described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 8.7 to address any deficiencies identified while assessing and overseeing a LAAF-accredited laboratory.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to the recognized accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit the results of the corrective action to the recognized accreditation body.
(3) The recognized accreditation body will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that a laboratory it LAAF-accredits has not effectively implemented corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may temporarily suspend the LAAF-accredited laboratory for one or more LAAF-accredited methods, and require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of the grounds for the suspension, the LAAF-accredited methods subject to the suspension, and all deficiencies that must be addressed via the process described in paragraph (a) of this section.
(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.
(3) The recognized accreditation body will review the corrective action required under paragraph (b) of this section and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it demonstrates to the recognized accreditation body's satisfaction that the LAAF-accredited laboratory has successfully implemented appropriate corrective action.
(5) If the recognized accreditation body determines that a LAAF-accredited laboratory on suspension has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may reduce the scope of or withdraw the LAAF-accreditation of the laboratory under paragraph (c) of this section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A recognized accreditation body must reduce the scope of or withdraw the LAAF-accreditation of a laboratory it LAAF-accredits when the laboratory substantially fails to comply with this subpart. When only certain methods within the laboratory's scope of LAAF-accreditation are affected by the noncompliance, the recognized accreditation body may reduce the scope of the laboratory's LAAF-accreditation for only those affected methods. If all methods are affected, the recognized accreditation body must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-accreditation. (1) The recognized accreditation body must notify the laboratory of any reduction of scope or withdrawal of LAAF-accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or withdrawal of LAAF-accreditation as described in § 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-accreditation is effective.
(2) The recognized accreditation body must notify FDA of the reduction of scope or withdrawal of LAAF-accreditation under this section in accordance with the requirements in § 1.1123(d)(4). FDA will provide notice of the reduction of scope or withdrawal of the laboratory's LAAF-accreditation on the website described in § 1.1109.
(e) Records request associated with suspension, reduction of scope, or withdrawal of LAAF-accreditation. To assist the recognized accreditation body in determining whether a suspension, reduction of scope, or withdrawal of LAAF-accreditation is warranted under this section, the recognized accreditation body may require the submission of records that the LAAF-accredited laboratory is required to maintain under § 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's LAAF-accreditation, the laboratory is immediately ineligible to conduct any food testing under this subpart. If the recognized accreditation body reduces the laboratory's scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods to which the reduction of scope applies to conduct food testing under this subpart.
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Sec. 1.1122 What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
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A recognized accreditation body must consider a laboratory's appeal regarding a decision to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation in accordance with the requirements of § 1.1113(a). Appeals must be reviewed and decided by a competent person(s) free from bias or prejudice who has not participated in the LAAF-accreditation decision and is not the subordinate of a person who participated in the LAAF-accreditation decision. For the purposes of appeals, the competent person(s) may be external to the recognized accreditation body.
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Sec. 1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
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(a) General requirements. All reports and notifications required by this section must include:
(1) The name, street address, telephone number, and email address of the recognized accreditation body associated with the report or notification, and the name of an appropriate point of contact for the recognized accreditation body, and
(2) If the report or notification concerns a LAAF-accredited laboratory, the name, street address, telephone number, and email address of the LAAF-accredited laboratory, and the name of an appropriate point of contact for the LAAF-accredited laboratory.
(b) Internal audit reports. A recognized accreditation body must submit to FDA a report of the results of the internal audit conducted pursuant to § 1.1125 within 45 calendar days of completing the audit. The audit report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective action taken or planned, including the timeline for such corrective action; and
(4) A statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited.
(c) Changes affecting recognition. A recognized accreditation body must notify FDA within 48 hours when the recognized accreditation body is aware of a change that would affect the recognition of such accreditation body, and the notification must include:
(1) A description of the change, and
(2) If the change is one made by the recognized accreditation body, an explanation of the purpose of the change.
(d) Changes in LAAF-accreditation. A recognized accreditation body must notify FDA and submit a certificate reflecting the scope of accreditation within 48 hours when any of the following occur:
(1) The recognized accreditation body grants or extends LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation granted, and
(iii) The effective date of the grant or extension;
(2) The recognized accreditation body denies LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation denied, and
(iii) The grounds for the denial;
(3) The recognized accreditation body receives notice that a laboratory it LAAF-accredits intends to relinquish its LAAF-accreditation and the laboratory has not provided notice to FDA 60 calendar days prior to relinquishment as required under § 1.1140. The recognized accreditation body's notification must include:
(i) The scope of LAAF-accreditation to which the relinquishment applies, as applicable, and
(ii) The effective date of the relinquishment;
(4) The recognized accreditation body reduces the scope of or withdraws the LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the reduction applies,
(ii) The grounds for the reduction of scope or withdrawal, and
(iii) The effective date of the reduction of scope or withdrawal;
(5) The recognized accreditation body suspends or lifts the suspension of a LAAF-accredited laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the suspension applies,
(ii) The grounds for the suspension or for lifting the suspension, and
(iii) The effective date of the suspension or date the suspension is lifted.
(e) Laboratory fraud. A recognized accreditation body must notify FDA within 48 hours if the recognized accreditation body knows that a laboratory it LAAF-accredits has committed fraud or submitted material false statements to FDA, and the notification must include:
(1) A description of the basis for the recognized accreditation body's knowledge of the fraud or material false statements,
(2) A description of the fraud or material false statements, and
(3) The action(s) taken by the recognized accreditation body with respect to such LAAF-accredited laboratory.
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Sec. 1.1124 What are the records requirements for a recognized accreditation body?
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(a) In addition to meeting the requirements of § 1.1113(a) related to records, a recognized accreditation body must maintain, for 5 years after the date of creation of the records, records created while it is recognized demonstrating its compliance with this subpart, including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the scope of, renew, deny, reduce the scope of, or withdraw LAAF-accreditation or to suspend or lift the suspension of a LAAF-accredited laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and withdrawals of LAAF-accreditation, final decisions on such appeals, and the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA under § 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements for assessment activities by contract assessors with certain financial interests described in § 1.1119(d).
(b) A recognized accreditation body must make the records it is required to maintain by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the recognized accreditation body must make such records promptly available at the physical location of the recognized accreditation body or at another reasonably accessible location. If FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) A recognized accreditation body must not prevent or interfere with FDA's access to the records the LAAF-accredited laboratories it LAAF-accredits are required to maintain under § 1.1154.
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Sec. 1.1125 What are the internal audit requirements for a recognized accreditation body?
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As part of the internal audit a recognized accreditation body is required to conduct pursuant to § 1.1113(a), the recognized accreditation body must audit its compliance with the requirements of § 1.1113(d).
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FDA Oversight of Recognized Accreditation Bodies
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Sec. 1.1130 How will FDA oversee recognized accreditation bodies?
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(a) FDA will evaluate each recognized accreditation body to determine its compliance with the applicable requirements of this subpart no later than:
(1) Year 4 of a 5-year recognition period; or
(2) The midpoint of a recognition period less than 5 years.
(b) An FDA evaluation of a recognized accreditation body may include review of records, an onsite evaluation of the accreditation body, and onsite reviews of one or more LAAF-accredited laboratories the recognized accreditation body LAAF-accredits, with or without the recognized accreditation body present. Certain evaluation activities may be conducted remotely if it will not aid in the evaluation to conduct them onsite.
(c) FDA may conduct additional evaluations of a recognized accreditation body at any time to determine whether the recognized accreditation body complies with the applicable requirements of this subpart.
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Sec. 1.1131 When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
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(a) Corrective action. FDA may require corrective action to address any deficiencies identified while evaluating a recognized accreditation body under this subpart.
(1) FDA will notify the recognized accreditation body of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the recognized accreditation body to submit a corrective action plan and timeframe for implementation to FDA for approval.
(2) The recognized accreditation body must handle FDA's notification as a complaint under ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) section 7.12, implement appropriate corrective action under ISO/IEC 17011:2017(E) section 9.5, and submit both the results of the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the recognized accreditation body whether the corrective action is acceptable.
(b) Probation. If FDA determines that a recognized accreditation body has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the recognized accreditation body on probation and require corrective action under paragraph (a) of this section.
(1) FDA will notify the recognized accreditation body of the grounds for the probation and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that the recognized accreditation body is on probation and will provide notice of the probation on the website described in § 1.1109.
(3) FDA will review the corrective action and will notify the recognized accreditation body whether the corrective action is acceptable.
(4) A recognized accreditation body shall remain on probation until the recognized accreditation body demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may revoke recognition of the recognized accreditation body under paragraph (c) of this section.
(c) Revocation of recognition. FDA will revoke the recognition of an accreditation body if it fails to meet the requirements of this subpart, if FDA determines the accreditation body has committed fraud or submitted material false statements to FDA, or if FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified.
(d) Revocation of recognition procedures. (1) FDA will issue a notice of revocation of recognition to the recognized accreditation body that will include the grounds for revocation, the date on which revocation is effective, the procedures for requesting a regulatory hearing on the revocation under § 1.1173, and the procedures for requesting reinstatement of recognition under § 1.1117.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that recognition has been revoked and will provide notice of the revocation of recognition of an accreditation body on the website described in § 1.1109.
(3) Within 10 business days of the date of issuance of revocation, the accreditation body must provide the name and contact information of the custodian who will maintain records and make them available to FDA as required by § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required by § 1.1124 will be located.
(e) Effect of probation or revocation of recognition on the accreditation body. (1) A recognized accreditation body that is put on probation by FDA must continue to oversee laboratories that it has LAAF-accredited under this subpart and may continue to LAAF-accredit laboratories under § 1.1120.
(2) An accreditation body that has had its recognition revoked by FDA may not LAAF-accredit laboratories under this subpart or continue to oversee the laboratories it has previously LAAF-accredited while the accreditation body is not recognized.
[86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022]
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LAAF-Accreditation of Laboratories
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Sec. 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?
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(a) A laboratory that is LAAF-accredited or seeking LAAF-accreditation must demonstrate it is capable of conducting each method of food testing for which it is or will be LAAF-accredited by meeting all of the following requirements:
(1) For each method, the laboratory is accredited by a recognized accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101).
(2)(i) Except as provided in paragraph (a)(2)(ii) of this section, the laboratory has successfully passed a proficiency test provided by a competent proficiency testing organization within the last 12 months for each method within the scope of LAAF-accreditation.
(ii) If the laboratory determines there is no proficiency testing program available or practicable for a method, it may use a comparison program. A laboratory must request approval from the recognized accreditation body regarding the determination prior to using a comparison program in lieu of an annual proficiency test. The laboratory is required to demonstrate competency through participation in the comparison program.
(iii) A laboratory must submit all proficiency test and comparison program results, regardless of outcome, to the recognized accreditation body within 30 calendar days of receipt.
(3) The laboratory ensures that its procedures for monitoring the validity of the results of testing it conducts under this subpart include the use of reference materials or quality control samples with each batch of samples it tests under this subpart.
(b) Will comply with all additional requirements for LAAF-accredited laboratories under this subpart while LAAF-accredited.
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Sec. 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
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(a) Application for LAAF-accreditation. A laboratory seeking LAAF-accreditation or extension of its scope of LAAF-accreditation must submit its application for LAAF-accreditation to a recognized accreditation body identified on the website described in § 1.1109. The recognized accreditation body will review and assess the application in accordance with the requirements of this subpart. If the laboratory seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one or more methods within its scope of LAAF-accreditation reduced by a recognized accreditation body or has been previously disqualified by FDA, the laboratory must meet the additional requirements specified by § 1.1142(a).
(b) Documentation of conformance with ISO/IEC 17025:2017(E). The laboratory may use documentation of conformance with ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), as applicable and supplemented as necessary, in meeting the applicable requirements of this subpart.
(c) Duration of accreditation. If a LAAF-accredited laboratory maintains compliance with all requirements of this subpart, including accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-accreditation will not end until reduced in scope, withdrawn, relinquished, or the laboratory is disqualified, under this subpart.
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Sec. 1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
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(a) Notice to FDA and the recognized accreditation body of intent to relinquish. A LAAF-accredited laboratory must notify FDA and its recognized accreditation body at least 60 calendar days before voluntarily relinquishing LAAF-accreditation or any method within the scope of LAAF-accreditation. The notice must include the date on which relinquishment will occur. If the laboratory will relinquish all methods within its scope of LAAF-accreditation, the notification must also include the name and contact information of the custodian who will maintain the records required by § 1.1154 after the date of relinquishment. The contact information for the records custodian must include an email address and the street address where the records required by § 1.1154 will be located.
(b) Public notice of voluntary relinquishment of accreditation. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment of LAAF-accreditation of a laboratory.
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Sec. 1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
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If a recognized accreditation body has its application for renewal of recognition denied, relinquishes its recognition or allows its recognition to expire, or has its recognition revoked, any laboratory LAAF-accredited by the accreditation body must take either the actions in paragraph (a) of this section or the action in paragraph (b) of this section no later than 30 calendar days after receiving the notice to the LAAF-accredited laboratory required under § 1.1115(g), § 1.1116(b), or § 1.1131(d)(2):
(a)(1) The LAAF-accredited laboratory must submit to FDA documentation of the LAAF-accredited laboratory's most recent internal audit, required under § 1.1154(a)(5), documentation showing compliance with the conflict of interest requirements in § 1.1147, and documentation of the most recent proficiency test or comparison program result for each test method within the laboratory's scope of LAAF-accreditation, to show compliance with § 1.1138(a)(2); and
(2) The laboratory must become LAAF-accredited by another recognized accreditation body before the laboratory's ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) accreditation lapses or not later than 1 year after the LAAF-accredited laboratory receives the applicable notice under § 1.1115(g), § 1.1116(b), or § 1.1131(d)(2), whichever is sooner.
(b) The LAAF-accredited laboratory initiates relinquishment of its LAAF-accreditation under § 1.1140, with the relinquishment to occur within 90 calendar days.
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Sec. 1.1142 How does a laboratory request reinstatement of LAAF-accreditation?
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(a) Application following reduction of scope or withdrawal of LAAF-accreditation by a recognized accreditation body or disqualification by FDA. A laboratory that has had any methods within its scope of LAAF-accreditation reduced or has had its LAAF-accreditation withdrawn by a recognized accreditation body or that has been disqualified by FDA may seek reinstatement of LAAF-accreditation by submitting a new application for LAAF-accreditation to a recognized accreditation body under § 1.1139. The laboratory must also:
(1) Notify FDA prior to submitting a new application for LAAF-accreditation to the recognized accreditation body, including in the notification the name of the laboratory, contact information for the laboratory, the name of the recognized accreditation body to which the laboratory will be submitting the application, and the date that the laboratory expects to submit the new application for LAAF-accreditation; and
(2) Demonstrate, to the satisfaction of the recognized accreditation body to which it is submitting the new application, that the grounds for the reduction of scope or withdrawal of LAAF-accreditation or disqualification have been resolved and that the laboratory has implemented measures to prevent such grounds from recurring.
(b) Application following voluntary relinquishment of LAAF-accreditation. A laboratory that voluntarily relinquished any methods within the scope of its LAAF-accreditation pursuant to § 1.1140, may seek reaccreditation by submitting a new application for LAAF-accreditation to a recognized accreditation body under § 1.1139.
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Requirements for LAAF-Accredited Laboratories
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Sec. 1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
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(a) In addition to the impartiality and conflict of interest requirements in § 1.1138(a)(1), a LAAF-accredited laboratory must, subject to the exceptions in paragraph (b) of this section, prohibit the LAAF-accredited laboratory's employees, contractors, and agents involved in food testing under this subpart and related activities from accepting any money, gift, gratuity, or other item of value from the owner or consignee of the food that is being tested or will be tested by the LAAF-accredited laboratory.
(b) The prohibited items of value in paragraph (a) of this section do not include:
(1) Payment of fees for food testing under this subpart and related services;
(2) Reimbursement of direct costs associated with the food testing by the LAAF-accredited laboratory; and
(3) With respect to a LAAF-accredited laboratory that is owned by the owner or consignee of the food that is or will be tested, payment of the officer's, employee's, contractor's, or agent's compensation in the normal course of business.
(c) The LAAF-accredited laboratory must require the owner's or consignee's payment to the LAAF-accredited laboratory of fees for food testing services and reimbursement of direct costs associated with food testing to be independent of the outcome of the test results.
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Sec. 1.1149 What oversight standards apply to sampling?
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(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.
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Sec. 1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?
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In addition to the sample analysis requirements of § 1.1138(a):
(a) The analysis must be conducted on either the sample received from the sampling firm or, if appropriate, on a representative sample of the sample received from the sampling firm.
(b) The analyst must:
(1) Be qualified by appropriate education, training, and/or experience to conduct the analysis;
(2) Have appropriately demonstrated their ability to perform the method properly in the specific context of the food testing to be conducted; and
(3) Be in compliance with the conflict of interest requirements of §§ 1.1138(a) and 1.1147.
(c) The method used to conduct the food testing must meet the requirements of § 1.1151.
(d) The LAAF-accredited laboratory must document the testing information and test results to the extent necessary to account for all information that is required to be included in a full analytical report (see § 1.1152(d)).
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Sec. 1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
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In addition to the requirements of § 1.1138(a), a LAAF-accredited laboratory must meet the following requirements:
(a) The method of analysis used to conduct food testing under this subpart must be:
(1) Fit for purpose;
(2) Within the laboratory's scope of LAAF-accreditation;
(3) Appropriately validated for use in such food testing, in accordance with paragraph (c) of this section; and
(4) Appropriately verified by the LAAF-accredited laboratory for use in such food testing, in accordance with paragraph (d) of this section.
(b) Food testing must be conducted using the specified method:
(1) Under § 1.1107(a)(1), if the Federal Food, Drug, and Cosmetic Act or implementing regulations prescribe a test method.
(2) Under § 1.1107(a)(2), if the directed food laboratory order prescribes a test method.
(c)(1) A LAAF-accredited laboratory must validate methods in accordance with the requirements of § 1.1138(a).
(2) A LAAF-accredited laboratory performing validation of a method under this subpart must record the information required by § 1.1138(a) and the supporting analytical data.
(d)(1) Before a LAAF-accredited laboratory conducts food testing under this subpart using a method for a specific intended use for which the method has been validated, but for which the LAAF-accredited laboratory has not previously applied the method under this subpart, the LAAF-accredited laboratory must have verified it can properly perform the method for the specific intended use.
(2) A LAAF-accredited laboratory performing verification of a method under this subpart must record the method that is the subject of the verification, the intended purpose of the analysis, the results of the verification, the procedure used for the verification, supporting analytical data, and whether the LAAF-accredited laboratory is able to properly perform the method.
(e) A LAAF-accredited laboratory may submit a written request to FDA requesting permission to use a method outside of its scope of LAAF-accreditation for food testing. FDA may approve the request if both following conditions are satisfied:
(1) A new method or methodology has been developed and validated but no reasonably available laboratory has been LAAF-accredited to perform such method or methodology, and
(2) The use of such method is necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.
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Sec. 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
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(a) General requirements. (1) All notifications, results, reports, and studies required to be submitted to FDA by a LAAF-accredited laboratory under this subpart must:
(i) Include the name and street address of the LAAF-accredited laboratory;
(ii) Identify a point of contact for the LAAF-accredited laboratory, including email and telephone number, whom FDA may contact with questions or comments;
(iii) Display an identification unique to the test results, report, notification, or study; and
(iv) Be true, accurate, unambiguous, and objective.
(2) The LAAF-accredited laboratory that conducts the analysis of the sample under this subpart is responsible for the submission of all notifications, results, reports, and studies to FDA as required by this section.
(3) If the LAAF-accredited laboratory becomes aware that any aspect of the submitted material is inaccurate, the LAAF-accredited laboratory must immediately inform FDA and submit a corrected version. Such corrections must meet the requirements for amendments to reports specified by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.8.8.
(4) Any opinions and interpretations in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements of conformity to a specification or standard in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
(b) Test results. (1) The LAAF-accredited laboratory must submit the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA regarding testing conducted under § 1.1107(a)(2) or (3).
(2) The test results must be clear and identify:
(i) The name and street address of the owner or consignee for which the testing was conducted,
(ii) As appropriate, the U.S. Customs and Border Protection entry and line number(s), and
(iii) The associated notifications, reports, and studies required to be submitted with the test results under this subpart.
(c) Documentation required to be submitted with test results. The following documentation must be included with each full analytical report (see paragraph (d) of this section) and each abridged analytical report (see § 1.1153) submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the food testing conducted as developed or obtained by the LAAF-accredited laboratory in accordance with § 1.1149;
(2) Written documentation of the sampler's qualifications or an indication that the sampler's qualifications have been submitted previously, in accordance with § 1.1149(a)(1);
(3) For any validation studies required by § 1.1151(c)(1), the documentation required by § 1.1151(c)(2);
(4) For any verification studies required by § 1.1151(d)(1), the documentation required by § 1.1151(d)(2);
(5) The justification for any modification to or deviation from the method(s) of analysis used and documentation of the LAAF-accredited laboratory's authorization for the modification or deviation; and
(6) A certification from one or more members of the LAAF-accredited laboratory's management certifying that the test results, notifications, reports, and studies are true and accurate; and that the documentation includes the results of all tests conducted under this subpart. The certification must include the name, title, and signature of any certifiers.
(d) Full analytical report contents. In addition to the documentation required to be submitted with all test results (see paragraph (c) of this section), a full analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
(2) Documentation of references for the method of analysis used;
(3) Name and signature of the analyst who conducted each analytical step, including any applicable validation and verification steps, and the date each step was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms, charts, graphs, observations, photographs of thin layer chromatographic plates, and spectra. References must be in color when appropriate and presented in a clear order;
(6) Identification of the source and purity of reference standards used, and, as applicable: Certified reference materials, certified reference cultures traceable to a nationally or internationally recognized type culture collection (including concentration, units, preparation, and storage conditions), and reference standard preparation information (including who prepared the reference standard, date of preparation, expiration date, chemical balance, and solvent used);
(7) A copy of the label from any immediate container sampled, if available, and any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of the analysis, including discarded, unused, or re-worked data, with the justification for discarding or re-working such data, corresponding supporting data, and quality control results (including the expected result and whether it is acceptable), all identified with unique sample identification, date, and time, associated with the test;
(9) Any other relevant additional supporting information such as the storage location of analyzed samples, appropriate attachments such as instrument printouts, computer generated charts and data sheets, and photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate of analysis for standards and software; and
(12) The following information about the qualifications of each analyst involved in the analysis conducted under this subpart, if the LAAF-accredited laboratory has not previously submitted documentation of the analyst's qualifications to FDA or the analyst's qualifications have significantly changed since the LAAF-accredited laboratory last submitted documentation of the analyst's qualifications to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records for the applicable methods that the analyst is qualified to perform, including the dates of such training and the name of the trainer or training provider; and
(iii) Any other documentation of the analyst's ability to perform the method properly in the context of the food testing to be conducted, pursuant to § 1.1150(b).
(e) Additional information about non-standard methods. If the LAAF-accredited laboratory conducts the analysis using a method that is not published in a reputable international or national standard or that is otherwise not publicly and readily available, upon request by FDA the LAAF-accredited laboratory must submit documentation of the method to FDA.
(f) Immediate notification of significant changes. The LAAF-accredited laboratory must notify FDA and the recognized accreditation body that LAAF-accredited the laboratory of changes that affect the LAAF-accreditation of the laboratory within 48 hours, including a detailed description of such changes, and an explanation of how such changes affect the LAAF-accreditation of the laboratory. LAAF-accredited laboratories are not required to notify FDA of changes that a recognized accreditation body must provide to FDA under § 1.1123(d).
(g) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under this section, FDA may consider the related food testing to be invalid.
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Sec. 1.1153 What are the requirements for submitting abridged analytical reports?
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(a) Requesting permission. A LAAF-accredited laboratory may request permission to submit abridged analytical reports for each major food testing discipline: Biological, chemical, and physical.
(1) FDA will grant permission to submit abridged analytical reports for a single major food testing discipline if all of the following conditions are met:
(i) The LAAF-accredited laboratory is not on suspension or probation for any method within the major food testing discipline that is the subject of its request (see § 1.1121(b) or § 1.1161(b));
(ii) The LAAF-accredited laboratory has successfully implemented any required corrective action under § 1.1121(a) or § 1.1161(a); and
(iii) The last five full analytical reports for the major food testing discipline contain no shortcomings that call into question the validity of the test results or repeated administrative errors.
(2) FDA will notify the LAAF-accredited laboratory if permission is granted or denied.
(b) FDA review of abridged analytical reports. (1) FDA will review all abridged analytical reports submitted.
(2) FDA will notify the LAAF-accredited laboratory if FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors, will require corrective action under § 1.1161(a), and may revoke permission to submit abridged analytical reports for the specific major food testing discipline.
(3) If FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors in abridged analytical reports from a LAAF-accredited laboratory that has previously had its permission to submit abridged analytical reports revoked for any major food testing discipline, FDA may put the LAAF-accredited laboratory on probation for one or more methods under § 1.1161(b). Under § 1.1162(a), a laboratory on probation for one or more methods may not submit abridged analytical reports for the major food testing disciplines of which the probationary methods are a part.
(4) A LAAF-accredited laboratory that has had permission to submit abridged analytical reports revoked for one or more major food testing disciplines may request permission to submit abridged analytical reports as described in paragraph (a) of this section for each major food testing discipline.
(c) Contents of abridged analytical reports. In addition to the documentation required to be submitted with all test results (see § 1.1152(c)), an abridged analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d); and
(2) Quality control results (including the expected result and whether it is acceptable).
(d) Exceptions. FDA may require additional documentation or a full analytical report from a LAAF-accredited laboratory permitted to submit abridged analytical reports in the following circumstances:
(1) FDA may require a full analytical report related to an FDA investigation or FDA enforcement proceeding.
(2) Occasionally, for the purposes of auditing abridged analytical reports and otherwise protecting the public health and the integrity of this food testing program, FDA will require additional documentation or a full analytical report within 72 hours of FDA's request.
(e) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under paragraph (c) of this section, FDA may consider the related food testing to be invalid.
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Sec. 1.1154 What other records requirements must a LAAF-accredited laboratory meet?
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(a) In addition to the records requirements of § 1.1138(a), a LAAF-accredited laboratory must maintain, for 5 years after the date of creation, records created and received while it is LAAF-accredited that relate to compliance with this subpart, including:
(1) Documents related to the LAAF-accredited laboratory's grant of LAAF-accreditation (and, if applicable, extensions and reductions of scope of LAAF-accreditation) from its recognized accreditation body, including all required proficiency test and comparison program records for each method within the scope of LAAF-accreditation under § 1.1138(a)(2);
(2) Documentation of food testing the LAAF-accredited laboratory conducted under this subpart sufficient to account for all information required by § 1.1152(d), in accordance with § 1.1150(d);
(3) All documents that the LAAF-accredited laboratory was required to submit to FDA under §§ 1.1152 and 1.1153, and associated correspondence between the LAAF-accredited laboratory (and its officers, employees, and other agents) and the owner or consignee (and its officers, employees, and other agents) regarding food testing under this subpart;
(4) All requests for food testing from an owner or consignee that would be conducted under this subpart;
(5) Documentation of any internal investigations, internal audits, and corrective action taken to address any problems or deficiencies related to activities under this subpart;
(6) All documentation related to suspension, probation, reduction of scope, or withdrawal of LAAF-accreditation, or laboratory disqualification under this subpart; and
(7) Documentation of changes to its management system or food testing activities that may affect its compliance with this subpart.
(b) Make the records required by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the laboratory must make such records promptly available at the physical location of the laboratory or at another reasonably accessible location. If the authorized officer or employee of FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) Ensure that significant amendments to records described by this section can be tracked to previous and original versions. If such a significant amendment is made, both the original document and amended document must be maintained by the LAAF-accredited laboratory during the time period for which the amended document must be maintained under this subpart. The laboratory must also document the date of amendment, the personnel responsible for the amendment, and a conspicuous indication on the original document stating that the document has been altered and that a more recent version of the document exists.
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FDA Oversight of LAAF-Accredited Laboratories
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Sec. 1.1159 How will FDA oversee LAAF-accredited laboratories?
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(a) FDA may review the performance of LAAF-accredited laboratories at any time to determine whether the LAAF-accredited laboratory continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the LAAF-accredited laboratory that, if not corrected, would warrant corrective action, probation, or disqualification under § 1.1161.
(b) In evaluating the performance of a LAAF-accredited laboratory, FDA may review any of the following:
(1) Records the LAAF-accredited laboratory is required to maintain under this subpart;
(2) Records the recognized accreditation body that LAAF-accredited the laboratory is required to maintain under this subpart;
(3) Information obtained by FDA during a review of the LAAF-accredited laboratory conducted pursuant to paragraph (c) of this section;
(4) Information obtained by FDA during an evaluation of the recognized accreditation body that LAAF-accredits the laboratory;
(5) Analytical reports and test results submitted to FDA; and
(6) Any other information obtained by FDA, including during FDA's inspections or investigations of one or more owners or consignees.
(c) FDA may conduct an onsite review of a LAAF-accredited laboratory at any reasonable time, with or without a recognized accreditation body (or its officers, employees, and other agents) present, to review the performance of a LAAF-accredited laboratory under this subpart. Certain review activities may be conducted remotely if it will not aid in the review to conduct them onsite.
(d) FDA may report any observations and deficiencies identified during its review of LAAF-accredited laboratory performance under this subpart to the recognized accreditation body.
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Sec. 1.1160 How will FDA review test results and analytical reports?
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(a) If FDA finds that any test result, analytical report, related documents, or the associated analysis contains deficiencies or otherwise indicates that any aspect of the food testing is not being conducted in compliance with this subpart, FDA will notify the LAAF-accredited laboratory that submitted the analytical report of any deficiency and may:
(1) Require the laboratory to correct the test result, analytical report, related documents, or the associated analysis;
(2) Revoke permission to submit abridged reports for that major food testing discipline under § 1.1153(b);
(3) Require a corrective action under § 1.1161(a);
(4) Consider the analysis to be invalid; and/or
(5) Notify the owner or consignee of the deficiency.
(b) FDA may report any deficiencies identified during its review of any test results, reports, and related documents under this subpart to the recognized accreditation body that LAAF-accredits the laboratory.
(c) Nothing in this subpart shall be construed to limit the ability of FDA to review and act on information received about food testing, including determining the sufficiency of such information and testing.
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Sec. 1.1161 When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
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(a) Corrective action. FDA may require corrective action to address any deficiencies identified while reviewing a LAAF-accredited laboratory's performance under this subpart.
(1) FDA will notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to FDA for approval.
(2) The LAAF-accredited laboratory must handle FDA's notification as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.9, implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Probation. If FDA determines that a LAAF-accredited laboratory has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the LAAF-accredited laboratory on probation for one or more methods and require corrective action under paragraph (a) of this section.
(1) FDA will notify the LAAF-accredited laboratory and its recognized accreditation body of the grounds for the probation, the method(s) covered by the probation, and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.
(2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in § 1.1109.
(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory and its recognized accreditation body whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory will remain on probation until the LAAF-accredited laboratory demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a LAAF-accredited laboratory on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may disqualify the LAAF-accredited laboratory under paragraph (c) of this section.
(c) Disqualification. FDA may disqualify a LAAF-accredited laboratory from submitting analytical reports under this subpart for one or more methods for good cause, which may include any of the following reasons:
(1) Deliberate falsification of analytical reports, testing results, or other records submitted to FDA.
(2) Failure of a LAAF-accredited laboratory on probation to effectively implement corrective action or otherwise address identified deficiencies.
(3) Other failure to substantially comply with this subpart where the laboratory's recognized accreditation body has not reduced the scope of or withdrawn LAAF-accreditation of the laboratory.
(d) Disqualification procedures. (1) FDA will issue a notice of disqualification to a LAAF-accredited laboratory and its recognized accreditation body, which will include:
(i) The grounds for disqualification;
(ii) The method or methods to which the disqualification applies;
(iii) The date the disqualification will be effective;
(iv) The procedures for requesting a regulatory hearing on the disqualification under § 1.1173; and
(v) The procedures for requesting reinstatement after disqualification under § 1.1142.
(2) FDA will provide notice of a LAAF-accredited laboratory's disqualification on the website described in § 1.1109.
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Sec. 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
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(a) A LAAF-accredited laboratory that FDA has put on probation for one or more methods is permitted to continue to conduct food testing under this subpart; however, a LAAF-accredited laboratory that is on probation for one or more methods is not permitted to submit abridged analytical reports for the major food testing discipline of which the probationary methods are part.
(b) If FDA disqualifies a LAAF-accredited laboratory for all methods within its scope of LAAF-accreditation, the laboratory is immediately ineligible to conduct food testing under this subpart. If FDA disqualifies a LAAF-accredited laboratory for specific methods within the scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods for which the laboratory has been disqualified to conduct food testing under this subpart.
(c) With respect to food testing conducted by the laboratory prior to its disqualification, FDA may refuse to consider results and associated reports of food testing conducted under this subpart if the basis for the disqualification of the laboratory indicates that the specific food testing conducted by the laboratory may not be reliable.
(d) Within 10 business days of the date of issuance of disqualification, the laboratory must provide the name and email address of the custodian who will maintain and make available to FDA the records required by § 1.1154, and the street address where the records will be located.
(e) Within 10 business days of the date of issuance of a notice of probation or disqualification, the laboratory must notify any owners or consignees for which it is conducting food testing using methods for which it is being placed on probation or disqualified under this subpart, that it is on probation or has been disqualified.
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Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions Under This Subpart
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Sec. 1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
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(a) Timing of request. An accreditation body may seek reconsideration of FDA's decision to deny its application for recognition or renewal of recognition under § 1.1114, or reinstatement of recognition under § 1.1117, no later than 10 business days after the date of the issuance of such denial.
(b) Submission of request. The request to reconsider an application under paragraph (a) of this section must be signed by the accreditation body, as appropriate, or by an individual authorized to act on its behalf. The accreditation body must submit the request, together with any supporting information, to FDA in accordance with the procedures described in the notice of denial.
(c) Notification of FDA's decision. After completing its review and evaluation of the request for reconsideration and any supporting information submitted pursuant to paragraph (b) of this section, FDA will notify the accreditation body of its decision to grant or deny recognition upon reconsideration.
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Sec. 1.1173 How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
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(a) Request for hearing. No later than 10 business days after the date FDA issued a revocation of recognition of an accreditation body pursuant to § 1.1131 or disqualification of a LAAF-accredited laboratory under § 1.1161, the accreditation body, laboratory, or an individual authorized to act on the accreditation body's or laboratory's behalf, may submit a request for a regulatory hearing, conducted pursuant to part 16 of this chapter, on the revocation or disqualification. The notice of revocation issued under § 1.1131 or notice of disqualification issued under § 1.1161, as applicable, will contain all the elements required by § 16.22(a) of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a regulatory hearing under this subpart must be submitted with a written appeal that responds to the bases for the FDA decision described in the written notice of revocation or disqualification, together with any supporting information. The request, appeal, and supporting information must be submitted to FDA in accordance with the procedures described in the notice of revocation or disqualification.
(c) Effect of submitting a request for a regulatory hearing on an FDA decision. The submission of a request for a regulatory hearing under this subpart will not operate to delay or stay the effect of a decision by FDA to revoke the recognition of an accreditation body or disqualify the LAAF-accredited laboratory unless FDA determines that delay or a stay is in the public interest.
(d) Presiding officer. The presiding officer for a regulatory hearing under this subpart will be designated after a request for a regulatory hearing is submitted to FDA.
(e) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing under this subpart pursuant to § 16.26(a) of this chapter when no genuine or substantial issue of fact has been raised.
(f) Conduct of regulatory hearing. (1) If the presiding officer grants a request for a regulatory hearing, the hearing will be held within 10 business days after the date the request was filed or, if applicable, within a timeframe agreed upon in writing by the accreditation body or laboratory, and the presiding officer and FDA.
(2) The presiding officer must conduct the hearing in accordance with part 16 of this chapter, except that, pursuant to § 16.5(b) of this chapter, the procedures for a regulatory hearing apply only to the extent that such procedures are supplementary and do not conflict with the procedures specified for regulatory hearings under this subpart. Accordingly, the following requirements of part 16 of this chapter are inapplicable to regulatory hearings conducted under this subpart: The requirements of § 16.22 (Initiation of regulatory hearing); § 16.24(e) (timing) and (f) (contents of notice); § 16.40 (Commissioner); § 16.60(a) (public process); § 16.95(b) (administrative decision and record for decision); and § 16.119 (Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of recognition or laboratory disqualification is considered a final agency action under 5 U.S.C. 702.
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Sec. 1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
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(a) Request for hearing. No later than 3 business days after FDA has issued the directed food laboratory order, an owner or consignee may submit a request for a regulatory hearing, conducted pursuant to part 16 of this chapter, on the directed food laboratory order. The directed food laboratory order will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a regulatory hearing must be submitted with a written appeal that responds to the bases, as appropriate, for FDA's determinations described in the directed food laboratory order, together with any supporting information. The request, appeal, and supporting information must be submitted in accordance with the procedures described in the directed food laboratory order.
(c) Presiding officer. The presiding officer for a regulatory hearing under this subpart will be designated after a request for a regulatory hearing is submitted to FDA.
(d) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing under this subpart pursuant to § 16.26(a) of this chapter.
(e) Conduct of regulatory hearing. (1) If the presiding officer grants a request for a regulatory hearing, such hearing will be held within 2 business days after the date the request was filed or, if applicable, within a timeframe agreed upon in writing by the requestor and the presiding officer and FDA.
(2) The presiding officer may require that a hearing conducted under this subpart be completed within 1 business day, as appropriate.
(3) The presiding officer must conduct the hearing in accordance with part 16 of this chapter, except that, pursuant to § 16.5(b) of this chapter, the procedures for a regulatory hearing described in part 16 of this chapter apply only to the extent that such procedures are supplementary and not in conflict with the procedures specified for the conduct of regulatory hearings under this subpart. Accordingly, the following requirements of part 16 of this chapter are inapplicable to regulatory hearings conducted under this subpart: § 16.22 (Initiation of regulatory hearing); § 16.24(e) (timing) and (f) (contents of notice); § 16.40 (Commissioner); § 16.60(a) (public process); § 16.95(b) (administrative decision and record for decision); and § 16.119 (Reconsideration and stay of action).
(4) A decision by the presiding officer to affirm the directed food laboratory order is considered a final agency action under 5 U.S.C. 702.
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Electronic Records and Public Disclosure Requirements
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Sec. 1.1199 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
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Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
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Sec. 1.1200 Are the records obtained by FDA under this subpart subject to public disclosure?
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Records obtained by FDA under this subpart are subject to the disclosure requirements under part 20 of this chapter.
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Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
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