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December 2004
The latest version of this document issued in November 2005. Below is an earlier version.
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 45 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Rudaina Alrefai*, Division of Compliance Information and Quality Assurance (HFC-240), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6815* e-mail: *.
Additional copies are available from:
Division of Compliance Information and Quality Assurance (HFC-240)
Office of Enforcement
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel)
240-632-6815*
(* Updated phone: 240-632-6860)
http://www.fda.gov/ohrms/dockets/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
December 9, 2004
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this draft guidance.
This draft guidance is intended for regulated food industry and FDA personnel. The purpose of this draft guidance document is to clarify the circumstances under which FDA may access and copy records under the Bioterrorism Act, and describe the procedure that FDA intends to follow to exercise its authority to inspect records under sections 414(a) and 704(a) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act").
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Legal Authority
Section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act") (PL 107-188), signed into law on June 12, 2002, created a new section 414, "Maintenance and Inspection of Records," in the FD&C Act. Under this new authority, the Secretary of Health and Human Services (the Secretary) may by regulation establish requirements for persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain food records. These records identify the immediate previous sources and the immediate subsequent recipients of food. In addition, section 414(a), "Records Inspection," and section 704(a), "Factory Inspection" authorize the Secretary to access and copy all records related to an article of food if: (1) the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist the Secretary in making such a determination. FDA plans to carry out its authority to inspect all records and other information described in section 414 in a similar manner as FDA’s authority to perform inspections of facilities (i.e., upon presentation of appropriate credentials and a written notice at reasonable times, within reasonable limits, and a reasonable manner.)
On December 9, 2004, FDA issued a final rule, entitled "Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002", in which the agency established recordkeeping requirements for persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain food records.
Furthermore, the rule (21 CFR 1.361) specifies the following record availability requirements:
When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction.
FDA can use this authority whenever the statutory criteria are satisfied, whether or not terrorism is known or suspected. That is, FDA can access and copy records if: (1) the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist the Secretary in making such a determination.
FDA employees will not invoke this authority during inspections unless the requirements for record access under the Bioterrorism Act are satisfied.
Depending upon the circumstances, FDA's authority under sections 414 and 704(a) may apply to some or all records that are required to be kept by regulation under section 414(b), as well as any other appropriate records already maintained by the entity. Records associated with an article(s) of food that meet the statutory criteria will be requested. These records may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such food that are maintained by or on behalf of an entity subject to the recordkeeping regulation. The records may be in any format (including paper and electronic formats) and at any location. Because the circumstances of a particular event are case specific, the scope of a record request will vary on a case-by-case basis.
FDA's authority under sections 414 and 704(a) does not apply to records excluded under section 414(d) (e.g., recipes for food, financial data, pricing data, personnel data, research data, or sales data other than shipment data regarding sales) and records from farms and restaurants.
Under the authority in Section 306 of the Bioterrorism Act, FDA may access records when FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. In those situations when it is necessary to access records under this authority, before any requests for such records access are made by FDA to any affected party, FDA intends to follow these internal procedures:
Once FDA follows the procedures in section D above and makes the necessary determination, an investigator or other FDA personnel upon presentation of credentials will submit a written notice, FDA 482 - Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA's legal authority to obtain these records. FDA may request additional records related to the implicated food article at a later time under the same authority.
Information obtained under the records access provisions of sections 414(a) and 704(a) may include, but is not limited to, a company’s non-public confidential commercial or trade secret information. Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), FD&C Act (21 U.S.C. 331(j)), and Freedom of Information Act, (5 U.S.C. 552) and the agency’s information disclosure regulations at 21 CFR Parts 20 and 21 govern the agency’s disclosure of information to the public. FDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information, such as any trade secret or confidential commercial information. FDA personnel may disclose non-public information otherwise protected from disclosure to the public, if that disclosure is permitted by law and FDA’s procedures. For example, FDA’s regulations (set forth in 21 C.F.R. parts 20 and 21) permit agency officials to disclose certain non-public information to other federal, state, local, or foreign government officials, or to FDA’s contractors, when that disclosure is carried out according to law and FDA’s procedures.
(1) This draft guidance has been prepared by the Division of Compliance Information and Quality Assurance, Office of Enforcement at the Food and Drug Administration.
The latest version of this document issued in November 2005.