Establishment,
Maintenance, and Availability of Records
Under
the Bioterrorism Act
The Food and Drug Administration (FDA) has published a proposed rule to implement section 306 (establishment, maintenance, and availability of records) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). 68 Fed. Reg. 25,188 (May 9, 2003) (copy attached.) Comments on the proposed rule must be submitted to FDA by July 8, 2003.[1]
The proposed rule would require that domestic persons who manufacture, process, pack, transport, distribute, receive, hold, or import food intended for human or animal consumption in the United States (and certain foreign facilities that manufacture, process, pack, or hold food intended for human or animal consumption in the United States) establish and maintain records sufficient to identify the immediate previous source and immediate subsequent recipient of such food. The proposed rule would also require that these records be made available to FDA when the agency 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.
The purpose of the proposed rule is to give FDA the information it needs to quickly conduct a tracing investigation with respect to food that is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. For example, if FDA determines that an outbreak of foodborne illness was caused by a particular ingredient in a food, the proposed rule would enable FDA to trace back to the source of the contaminated ingredient and trace forward to other recipients of that ingredient.
This memorandum summarizes the proposed rule. The preamble states that FDA is inviting comment on all provisions of the proposed rule. In addition, FDA specifically requests comment on certain provisions, which are noted below. While reading this memorandum, it is important to keep in mind the following points:
· This proposed rule would affect large segments of the U.S. food industry, as well as many foreign food companies.
· While this proposed rule is mandated by Section 306 of the Bioterrorism Act,[2] it goes beyond the provisions of the Bioterrorism Act in certain respects. For example, the Bioterrorism Act gives FDA access to records for the purpose of “determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.” Yet, the records access provisions of the proposed rule do not appear to acknowledge this limitation. It is possible that FDA may have exceeded its statutory authority. The food industry may wish to raise this issue in comments to FDA, or bring a legal challenge to the final rule on these grounds.
Contents
Who Is Subject to the Proposed Rule?
Who Is Exempt from the Proposed Rule?
What Records Must Be Maintained?
What Records Are Excluded?
Where and In What Form Must the Records Be Maintained?
What Is the Record Retention Period?
Relationship to Other Record keeping Requirements
When Would The Record Keeping Requirements Become Effective?
When Must These Records Be Made Available to FDA?
What Records Must Be Made Available to FDA?
Consequences of Failure to Comply
Submitting Commemts
The proposed rule would apply to the following:
· Domestic persons who manufacture, process, pack, transport, distribute, receive, hold, or import food intended for human or animal consumption in the United States, unless they qualify for exemption. “Domestic person” is defined to mean any person (including institutions such as schools and hospitals) located in any State or Territory, the District of Columbia, or Puerto Rico.
· Foreign facilities that manufacture/process, pack, or hold food intended for human or animal consumption in the United States, unless they qualify for exemption. In effect, the proposed record keeping requirements would apply to foreign facilities required to register with FDA under Section 305 of the Bioterrorism Act.
The proposed rule would define “food” as it is defined in Section 201(f) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 321(f)). This is a very broad definition that includes, for example: shell eggs; raw agricultural commodities for use as food; animal feed, including pet food; food and feed ingredients and additives; dietary supplements; beverages, including alcoholic beverages and bottled water; live food animals; and substances that migrate into food from food packaging and other articles that contact food.[3]
FDA has tentatively concluded that the Bioterrorism Act requires record keeping by domestic persons that engage exclusively in intrastate commerce. However, the agency realizes that regulation of foods exclusively in intrastate commerce raises constitutional questions, and FDA is seeking comments on whether it has the authority to require record keeping by persons engaged only in intrastate commerce. FDA also seeks comments on how many persons engaged only in intrastate commerce are not covered by one of the other exemptions from record keeping.
The proposed rule provides for both total and partial exemptions. The following would be totally exempt from the proposed rule:
· Farms. The proposed rule would define “farm” as “a facility in one general physical location devoted to the growing of crops for food, the raising of animals for food (including seafood), or both.” Examples include fruit orchards, hog farms, dairy farms, feedlots, and aquaculture facilities. The definition includes: (1) facilities that pack or hold food (e.g., harvested crops), provided that all such food is grown or raised on that farm or is consumed on that farm; and (2) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. However, a facility that grows crops and/or raises animals and manufacture/processes food that is sold for consumption off the facility does not qualify for this exemption.[4]
· Restaurants. The proposed rule would define “restaurant” as “a facility that prepares and sells food directly to consumers for immediate consumption.” Examples include cafeterias, lunchrooms, cafes, fast food establishments, food stands, taverns, bars, catering facilities, and hospital kitchens.[5] The term “restaurant” also encompasses pet shelters, kennels, and other facilities that provide food to animals. Facilities that provide food to interstate conveyances (e.g., airplanes, passenger trains, cruise ships), rather than directly to consumers, are not restaurants and would not qualify for this exemption.
· Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) are exempt with respect to such food. However, persons who manufacture, process, pack, transport, distribute, receive, hold, or import food that is jointly regulated by FDA and USDA (e.g., TV dinners containing both meat and fish) would be required to keep records with regard to food regulated by FDA.
· Foreign facilities, if food from the foreign facility subsequently undergoes further manufacturing/processing (including packaging) of more than a de minimis nature at another foreign facility outside the United States. Thus, any foreign facility that will be required to register with FDA under Section 305 of the Bioterrorism Act and the proposed rule on registration of food facilities (68 Fed. Reg. 5378; see our memorandum dated February 5, 2003) would also be subject to this proposed rule. FDA is requesting comments on its proposal that facilities conducting de minimis activities must maintain records.
The following would be partially exempt from the proposed rule:
· Persons who manufacture, process, pack, transport, distribute, receive, hold, or import pet food and who are not subject to the record keeping provisions of the FDA regulations prohibiting animal protein in ruminant feed (21 C.F.R. § 589.2000) would be exempt from the record keeping provisions of the proposed rule, but not from its records access provisions.[6]
· Retail facilities would be exempt from maintaining records of immediate subsequent recipients, but would be subject to the other provisions of the proposed rule. The proposed rule would define “retail facility” as “a facility that sells food products directly to consumers only.” Examples include grocery and convenience stores, vending machines, and commissaries. Facilities, such as warehouse clubs, that sell both directly to consumers and to distributors and wholesalers would not qualify for this exemption. Although not entirely clear, it would appear that warehouse clubs and “cash-and-carry” stores would not be required to keep records of immediate subsequent recipients when food is sold directly to consumers.
· Retail facilities that employ 10 or fewer full-time equivalent employees; that are located in the same general physical location as a farm; and that sell unprocessed food grown or raised on that farm or on another farm in the same general location (or processed foods, such as jams, if all of the ingredients used in the processed food were grown or raised on that farm) are excluded from the record keeping provisions of the proposed rule, but not from its records access provisions, with respect to such food. FDA is soliciting comments on this exemption.
· Fishing vessels that do not engage in processing are exempt from the record keeping provisions of the proposed rule, but not from its records access provisions.
If an entity conducts both exempt and non-exempt activities at the same location, the entity would be required to keep records only with respect to its non-exempt activities. For example, if a farm grows tomatoes and processes the tomatoes into tomato paste for sale off of the farm, then it would be required to maintain records of the immediate previous sources of all ingredients used in the tomato paste (other than the tomatoes themselves) and records of the immediate subsequent recipients of the finished tomato paste product.
“Nontransporters” (i.e., persons who own food or who hold, process, pack, import, receive, or distribute food for purposes other than transportation) would be required to maintain the following records:
These records must include information “reasonably available to you to identify the specific source of each ingredient that was used to make every lot of finished product.” FDA is aware that some food processors commonly commingle raw ingredients, such as flour, from a number of suppliers, making it difficult or impossible to identify a specific source of raw materials to a specific finished product. FDA does not intend to require that processors reconfigure their operations or use dedicated storage facilities. However, the proposed rule would require processors “to capture the information that is reasonably available to you to connect finished products with the immediate previous source of each of the food products used to make that finished product.” 68 Fed. Reg. at 25,196. FDA realizes that, in some cases, processors may be able to do no more than narrow down the number of potential sources and may not be able to identify one specific source.
Thus, if you are a nontransporter, you would be required to keep records on all of the following: the nontransporter that had the food before you, the transporter that delivered the food to you, the transporter that took the food from you, and the nontransporter that received the food from you. FDA “recognizes that requiring nontransporters to keep records on both previous and subsequent transporters and nontransporters is potentially burdensome” and that “there could be other interpretations” of the Bioterrorism Act. 68 Fed. Reg. at 25,194. FDA is requesting comments on whether its proposed approach is a reasonable interpretation of the statute and on the extent to which it would impose new burdens on firms. The agency says that it is open to “alternative record keeping arrangements that would allow for the complete and efficient investigation of food-related emergencies.” Id. FDA specifically requests comments on whether an approach that creates incentives for nontransporters to keep records on all transporters that transport food between nontransporters would be a reasonable interpretation of the statute.
Domestic persons who are “transporters” (i.e., persons who have possession, custody, or control of food for the sole purpose of transporting the food) would be required to maintain the following records:
· The name of the firm and of the responsible individual, address, telephone number, and (if available) fax number and E-mail address of the person who had the food immediately before you (whether such person is another transporter or a nontransporter), and the date you received the food from that person;
· The name of the firm and of the responsible individual, address, telephone number, and (if available) fax number and E-mail address of the person who had the food immediately after you (whether such person is another transporter or a nontransporter), and the date you delivered the food to that person;
· An adequate description of the type of food, including brand name and specific variety (e.g., brand X cheddar cheese);
· The lot or code number or other identifier (to the extent such information exists);
· The quantity of food and how it is packaged (e.g., 25 lb carton); and
· Identification of each and every mode of transportation (e.g., company truck, private carrier, rail, air) and the individual responsible (i.e., the person responsible for that vehicle and that particular shipment) for each mode of transportation, from the time you first received the food until the time you delivered it.[9]
FDA is requesting comments on whether all transporters, including small independent transporters, have the capability to maintain the required records for the proposed 1-2 year retention period.
The proposed rule would specifically exclude the following records from its record keeping provisions: recipes for food, financial data, pricing data, personnel data, research data, and sales data (other than shipment data regarding sales). The proposed rule would define “recipe” as “the quantitative formula used in the manufacturing of the food product, but not the identity of the individual ingredients of the food.”[10]
The proposed rule would permit records to be kept in any format, provided such records contain all required information. A firm’s existing records, such as purchase orders, bills of lading, and shipping documents, may be used to satisfy this new record keeping requirement. The proposed rule is also flexible as to the type of system in which records are maintained. Electronic records are acceptable. Moreover, electronic records maintained to comply with this proposed rule would be exempt from compliance with 21 C.F.R. Part 11; however, records kept for other purposes but also used to comply with the proposed rule, would not be exempt from Part 11. FDA’s intent is to have as little impact as possible on current record keeping practices. However, FDA is seeking comments on whether the final rule should include a model form that can be used to record all required information.
The proposed rule would require records to be kept at the establishment where the covered activities described in such records occurred (i.e., onsite) or at a reasonably accessible location. Records may be stored offsite, provided they can be retrieved and made available to FDA within the time frame specified in the proposed rule.
Under the proposed rule, required records must be created at the time the covered activity occurs and must be retained for the following periods:
The proposed rule would define “perishable food” as “food that is not heat-treated, not frozen, and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 [calendar] days under normal shipping and storage conditions.” This definition is modeled on the definition of “perishable commodity” in FDA’s Regulatory Procedures Manual, and includes such foods as fluid milk (unless it has been ultrapasteurized), live fish and shellfish, and fresh fruits and vegetables. If a firm is uncertain whether a perishable food is intended for processing into a nonperishable food, it should retain records for two years. FDA is seeking comments on the proposed definition of “perishable foods,” on the impact of this provision, and whether persons subject to the proposed rule always or usually know at the time perishable food is released whether or not it is intended to be processed into nonperishable food.
The proposed record keeping requirements are in addition to any existing record keeping requirements under other regulations, such as those applicable to juice, low acid canned foods, infant formula, bottled water, color additives, animal feed, and medicated animal feed.
All businesses, except small businesses and very small businesses, would have to comply six months after publication of a final rule. Small businesses (those with more than 10 but fewer than 500 full-time equivalent employees) would have 12 months to comply, and very small businesses (those with 10 or fewer full-time equivalent employees) would have 18 months to comply. The Bioterrorism Act requires that FDA publish a final rule by December 12, 2003.
Under the proposed rule, these records must be made available to FDA for inspection and copying (or other means of reproduction) 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.”[11] FDA notes that the records access provisions of the Bioterrorism Act are self-executing, so the requirement to make these records available to FDA is already in effect and does not require implementing regulations.
Under the proposed rule, records must be made available to FDA within four hours if the request is made between 8:00 a.m. and 6:00 p.m. Monday through Friday, or within eight hours if the request is made at any other time. If records are maintained offsite, they must be retrieved and provided onsite within the specified time period. According to the preamble, the “most common problem encountered by FDA in a tracing investigation has been a lack of ready access to records.” 68 Fed. Reg. at 25,199.
FDA appears to be asserting records access authority greater than that conferred by the Bioterrorism Act. First, the proposed rule does not provide that FDA must present a written notice of records inspection. Section 306(a) of the Bioterrorism Act gives FDA access to all records “needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals” upon presentation by FDA of “appropriate credentials and a written notice.”[12] Second, the proposed rule appears to take the position that FDA may obtain access to these records whenever it 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.” However, the Bioterrorism Act and its legislative history appear to limit FDA’s records access to situations in which records are needed for the purpose of determining whether an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or for the purpose of conducting a tracing investigation. The Bioterrorism Act does not authorize access for other purposes. The proposed rule does not appear to acknowledge this limitation.
The proposed rule would give FDA access to “any records and other information accessible to FDA under section 414 or 704(a) of the act.” It is not clear why the proposed rule refers to the statutory provisions rather than the record keeping provisions of the proposed rule.
The legislative history of the Bioterrorism Act suggests that Congress did not intended to authorize access to consumer complaints. The Conference Report states that the Bioterrorism Act would not permit access to correspondence.
The failure to establish and maintain records required by the proposed rule, or refusal to permit access to or verification of such records, is a prohibited act under Section 301 of the FDC Act (21 U.S.C. § 331).
FDA is unsure whether the proposed rule would have a significant economic impact on a substantial number of small businesses. FDA requests comments on the effect of the proposed rule on small businesses. In particular, FDA seeks comments on whether setting staggered compliance dates that would allow small businesses more time to comply would be consistent with Section 305 of the Bioterrorism Act.
Submit Comments Electronically
Submit Written Comments:
Submit written comments in duplicate [individuals may submit one copy] to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 ATTN: Docket No. 02N-0277
The other proposed rules issued by FDA to implement the Bioterrorism Act have been analysed by Olsson, Frank & Weeda for the Food Institute and are available to you at no charge. Click here to view the other analyses.
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[1] Comments on FDA’s estimate of the cost to industry of the proposed information collection must be submitted to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs by June 8, 2003.
[2] The record keeping, as opposed to the records access, provisions of the proposed rule arguably are not mandated by the Bioterrorism Act. As FDA notes, Section 306(a) provides that FDA “may” by regulation establish record keeping requirements, while Section 306(d) states that FDA “shall” do so. Despite this inconsistency, FDA believes it is required to issue such regulations, but the agency is requesting comments on this question.
[3] “Substances that migrate into food from food packaging” include immediate food packaging, but not outer food packaging. While Section 306 of the Bioterrorism Act gives FDA authority to require record keeping with respect to “food, including its packaging,” FDA is proposing not to require record keeping for outer food packaging. However, FDA is seeking comments on whether the level of risk to human and animal health from potential contamination of outer food packaging is high enough to warrant its inclusion in the final rule.
[4] However, a facility that grows crops and/or raises animals and also manufactures/processes food and sells it directly to consumers (e.g., at a roadside stand) would qualify for the partial exemption for retail establishments. Retailers need only keep records identifying the immediate previous source.
[5] Although not specifically mentioned by FDA in the preamble to the proposed rule, school cafeterias appear to qualify for this exemption.
[6] FDA is requesting comments on whether the proposed rule provides adequate tools to trace animal feed affected by a terrorist attack or other food-related emergency. Specifically, FDA solicits comments on the following questions: (1) Should all types of animal feed entities be exempt from all of the proposed rule? (2) Should all pet food entities be exempt from all or part of the proposed rule? (3) Should all pet food entities, not just those subject to the ruminant feed rule, be subject to the record keeping provisions of the proposed rule? (4) Should FDA use criteria other than the scope of the ruminant feed rule to determine which pet food entities are exempt and, if so, what should those criteria be?
[7] This information must pertain to the specific location where the covered activity occurred, not a corporate headquarters. For example, if a food was processed at a processing plant, shipped to a packing facility, and then transported to a retail store all of which are owned by the same corporation, the proposed record keeping requirements would apply to each of the three facilities. FDA requests comments on whether this requirement to keep records on intra-corporate transfers would impose new burdens on firms or whether firms keep such records currently.
[8] See footnote 7 above.
[9] FDA is seeking comments on whether the “individual responsible” should be the operator of the conveyance or whether it can be someone within the corporation with overall responsibility for the vehicle and the food being transported.
[10] Under the proposed rule, FDA would have access to records regarding the ingredients used in a food product, but not to the quantities of ingredients used to make the product. Thus, the proposed rule would appear to give FDA access to records about all ingredients used in a food product, including ingredients that are not required to be declared on the label, such as incidental additives, and ingredients that may be declared using generic terms, such as spices and flavorings.
[11] The standard of “serious adverse health consequences or death” is the same standard that FDA uses for Class I recalls. See 21 C.F.R. § 7.3(m)(1).
[12] The Bioterrorism Act contains two records inspection authorities: Sections 306(a) (adding FDC Act § 414) and 306(b) (amending FDC Act § 704(a)). However, the legislative history of the Bioterrorism Act makes clear that FDC Act § 704(a) “would provide the Secretary no greater access (either in circumstances during which records access is permitted, the types of records that may be accessed, or protections afforded records that are obtained)” than FDC Act § 414. Conference Report (May 22, 2002), at 5. In the preamble to the proposed rule, FDA requests comments on the interconnection between these two provisions.