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Final Rule: Record Keeping under the Public Health Security

MSK Client Alert
November 2006

On December 9, 2004, the U.S. Food and Drug Administration (FDA or "agency") published in the Federal Register final regulations on the establishment and maintenance of records for food "non-transporters" and "transporters" under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act").See Final Regulation Implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—Establishment and Maintenance of Records for Foods, 69 FR 71562 (Dec. 9, 2004) ("Record Keeping Rule") (last viewed Dec. 10, 2004); see also Pub. Law 107-188 (June 12, 2002).  

The first notice sets forth the regulations (21 CFR §§1.326-1.368) that implement FDA’s new record keeping requirements imposed by the Bioterrorism Act on persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States.  A number of exclusions are available under the regulations, which are identified briefly below.  These regulations require both non-transporters and transporters to establish and maintain certain records that will allow FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, 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." Note that these regulations focus on FDA’s requirements for the covered entities to establish and maintain certain information/records for food as well as the covered entities whose records are to be made available for viewing and copying upon the agency’s request when the evidentiary burden is met. 

On the same date, FDA issued guidance explaining the circumstances in and procedures by which FDA intends to request access to records under the Bioterrorism Act’s record keeping authorities.  See Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security Bioterrorism Preparedness and Response Act of 2002,(Dec. 9, 2004) (last viewed Dec. 10, 2004) (Guidance).  

The new regulations and Draft Guidance both relate to and implement food record keeping authority established by the Bioterrorism Act and both are triggered by the same circumstances—namely, 

…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 FDA in making such a determination. 69 FR at 71657.    

The newly published regulations are final rules that will be the subject of public meetings in early 2005 at which FDA will explain them.  We will be attending the first public meeting, scheduled for January 13, 2005, and will provide our analysis of FDA’s discussion upon your request.  

Highlights of the Final Regulations

The following significant observations are readily observable from the current record keeping proposal: 

General Requirements Under the Record-keeping Regulations: 21 CFR Part 1, Subpart J - Establishment, Maintenance and Availability of Record (§§1.326-1.368) 

The regulations identify the specific information that covered persons are required to establish and maintain.  The required information is different for transporters and non-transporters of food.

Records Required to be Established and Maintained 

The following records, or information contained in records, must be established and maintained by non-transporters of food:  

If you are a non-transporter, the following records must be established and maintained:

If you are a transporter, you must establish and maintain the following records for all food you receive or release: 

The regulations do not require the creation of new documents or duplication of existing records if the information is already contained in existing records. If the information does not already exist, new records with the requisite information must be created at the time of receipt and release of the food.  The regulations do not require covered entities to establish or maintain records, or to make available records, that are:  "recipes for food; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales)."   

The regulations set forth the record retention periods for the required information.  There are different record retention periods whether or not one is a transporter. The retention periods are as short as six (6) months and as long as two (2) years after the date on which the food is received or released.  The length of each retention period relates to the type of entity (non-transporter or transporter) and the degree of risk of spoilage, loss of value, or loss of palatability for the food to which the records relate.  

Access to Records 

The persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S., and who are required by these regulations to establish/maintain the specific records/information required, must make these records/information "readily available for inspection and photocopying or other means of reproduction . . . as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice."  21 CFR §1.361.  FDA is authorized to gain access to these records "[w]hen 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."  Section 1.363 provides that failure to comply with the requirements of these new regulations is a prohibited act under section 301 of the Food Drug and Cosmetic Act.  

Draft Guidance for Records Access Authority: 

The December 9, 2004 Federal Register Notice of the availability of this draft guidance indicates that it "is intended to clarify the circumstances under which FDA may access and copy records under the [Bioterrorism Act]…and establishes procedures to exercise its authority." 69 FR 71657.    

Section B of The Draft Guidance addresses the question, "What records may investigators access and copy under the Bioterrorism Act’s authority?"  Guidance at 3. 

Depending upon the circumstances, FDA’s authority … may apply to some or all records that are required to be kept by [the new recordkeeping regulations], 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 basisId. at 3-4 (emphasis added).  

Section D addresses the procedures FDA will follow when it is necessary to access records under the authority of the Bioterrorism Act and pursuant to the new food record-keeping regulations.  It describes certain FDA internal procedures, including specific internal notifications, concurrences, consultations, and coordination.  See id., section D, at 4.  

Section E of the Draft Guidance answers the question, "How does FDA intend t o make a request to access or copy records under the Bioterrorism Act?" in this way:  

Once FDA … 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.  Id. at 4. 

The Draft Guidance addresses the issue of confidentiality of "protected information in records it obtains. Basically, FDA invokes its general statutory and regulatory authority to obtain and obligation to protect certain "non-public confidential commercial or trade secret information."  It states that "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."  Guidance at 5. 

 Effective Dates 

 This regulation is effective February 7, 2005; the compliance date is December 9, 2005 except for small businesses (with between 11 and 499 employees) have until June 9, 2006, and for very small businesses (with between 1 and 10 employees) until December 9, 2006.

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