Federal Register: December 9, 2004 (Volume 69, Number 236)
DOCID: FR Doc 04-26929
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CFR Citation: 21 CFR Parts 1 and 11
Docket ID: [Docket No. 2002N-0277]
RIN ID: RIN 0910-AC39
NOTICE: Part IV
DOCUMENT ACTION: Final rule.
Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
DATES: Effective Date: This final rule is effective February 7, 2005.
Compliance Dates: The compliance date is December 9, 2005; except that for small businesses employing fewer than 500, but more than 10 fulltime equivalent employees, the compliance date is June 9, 2005; and except that for very small businesses that employ 10 or fewer full time equivalent employees, the compliance date is December 11, 2006.
The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals. The requirement to establish and maintain records is one of several tools that will help improve FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the information will improve FDA's ability to quickly notify the consumers and/or facilities that might be affected by the outbreak.
Health and Human Services Department, Food and Drug Administration,
Table of Contents
I. Background and Legal Authority
II. Highlights of the Final Rule and Summary of the Significant Changes Made to the Proposed Rule
A. Highlights of This Final Rule
B. Significant Changes FDA Made to the Proposed Rule III. Comments on the Proposed Rule
A. General Comments
B. Foreign Trade Issues
C. Comments on Who is Subject to This Subpart? (Proposed Sec. 1.326)
D. Comments on Who is Excluded From All or Part of the Regulations in this Subpart? (Proposed Sec. 1.327)
E. Comments on What Definitions Apply to this Subpart? (Proposed Sec. 1.328)
F. Comments on Do Other Statutory Provisions and Regulations Apply? (Proposed Sec. 1.329)
G. Comments on Can Existing Records Satisfy the Requirements of this Subpart? (Proposed Sec. 1.330)
H. Comments on What Information is Required in the Records You Must Establish and Maintain to Identify the Nontransporter and Transporter Immediate Previous Source and Immediate Subsequent Recipients? (Proposed Sec. Sec. 1.337 and 1.345)
I. Comments on Who is Required to Establish and Maintain Records for Tracing the Transportation of All Food? (Proposed Sec. 1.351)
J. Comments on What Information is Required in the Transportation Records? (Proposed Sec. 1.352)
K. Comments on What Are the Record Retention Requirements? (Proposed Sec. 1.360)
L. Comments on What Are the Record Availability Requirements? (Proposed Sec. 1.361)
M. Comments on What Records Are Excluded From this Subpart? (Proposed Sec. 1.362)
N. Comments on What Are the Consequences of Failing to Establish and Maintain Records or Make Them Available to FDA as Required By This Subpart? (Proposed Sec. 1.363)
O. Comments on What Are the Compliance Dates for This Subpart? (Proposed Sec. 1.368)
IV. Analysis of Economic ImpactsFinal Regulatory Impact Analysis
A. Summary of the Costs and Benefits of the Final Rule
B. Description of Proposed Rule
C. General Comments
D. The Tradeoff Between Costs and Risk Reduction
E. Estimating the Benefits
G. Summary of the Costs and Benefits of the Final Rule and Policy V. Final Regulatory Flexibility Analysis
VI. Unfunded Mandates
VIII. Paperwork Reduction Act of 1995
IX. Analysis of Environmental Impact
I. Background and Legal Authority
The events of September 11, 2001, have highlighted the need to enhance the security of the infrastructure of the United States, including the food supply. Congress responded by enacting the Bioterrorism Act (Public Law 107188), which was signed into law on June 12, 2002. The Bioterrorism Act includes a provision in title III (Protecting Safety and Security of Food and Drug Supply), subtitle A Protection of Food Supply, section 306, which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 414, Maintenance and Inspection of Records (21 U.S.C. 350c). (In the regulation itself, which is codified in title 21 of the Code of Federal Regulations, the Federal Food, Drug, and Cosmetic Act is referred to as ``the act.'' Thus, when the regulation is quoted in this preamble, the term ``the act'' will be used to refer to the Federal Food, Drug, and Cosmetic Act. However, in this preamble, we refer to the Federal Food, Drug, and Cosmetic Act as ``the FD&C Act'' to distinguish it from the Bioterrorism Act.) Section 414(b) of the FD&C Act provides, in part, that the Secretary of Health and Human Services (the Secretary), may by regulation establish requirements regarding the establishment and maintenance, for not longer than 2 years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that are required to be kept by these regulations are those needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, to address credible threats of serious adverse health consequences or death to humans or animals. Section 306(d) of the Bioterrorism Act provides that the Secretary ``shall'' issue regulations establishing recordkeeping requirements under section 414(b) of the FD&C Act no later than 18 months after enactment of the Bioterrorism Act, that is, by December 12, 2003.
In addition, the Bioterrorism Act adds a new section 414(a) to the FD&C Act
that provides records inspection authority to FDA. Section 414(a) of the FD&C Act provides that, if 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, persons who manufacture, process, pack, distribute, receive, hold, or import food must provide access to records related to the food that are 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.
Section 306 of the Bioterrorism Act also amends section 704(a) of the FD&C Act (21 U.S.C. 374(a)) to authorize FDA inspections of all records and other information described in section 414 of the FD&C Act, when 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.
In addition, section 306(c) of the Bioterrorism Act amends section 301 of the FD&C Act (21 U.S.C. 331) to make it a prohibited act to refuse to permit access to, or copying of, any record as required by section 414 or 704(a) of the FD&C Act; or to fail to establish or maintain any record as required by section 414(b) of the FD&C Act; or to refuse to permit access to, or verification or copying of, any such required record; or for any person to use to his own advantage, or to reveal, other than to the Secretary or officers or employees of the Department of Health and Human Services, or to the courts when relevant in any judicial proceeding under the FD&C Act, any information acquired under authority of section 414 of the FD&C Act.
To implement these provisions, on May 9, 2003 (68 FR 25188), FDA
issued a proposed rule to require the establishment and maintenance of
records to identify the immediate previous sources and immediate
subsequent recipients of food. In addition to section 306 of the
Bioterrorism Act, which amends the FD&C Act as described previously,
FDA is relying on section 701(a) of the FD&C Act (21 U.S.C. 371(a)) in
issuing this final rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the FD&C Act.
II. Highlights of the Final Rule and Summary of the Significant Changes Made to the Proposed Rule
A. Highlights of this Final Rule
The highlights of this final rule are described briefly in the
following paragraphs, and are discussed in more detail later in the preamble of this document:
address of the transporter who transported the food to and from you.
(1) Establishing and maintaining the records listed in Sec. 1.352(a); or
(2) Establishing and maintaining specified information that is in the records required of roadway interstate transporters by the Department of Transportation's (DOT's) Federal Motor Carrier Safety Administration (FMCSA) contained in 49 CFR 373.101 and 373.103 as of the date of publication of this final rule; or
(3) Establishing and maintaining specified information that is in the records required of rail and water interstate transporters by the DOT's Surface Transportation Board (STB) contained in 49 CFR 1035.1 and 1035.2 as of the date of publication of this rule; or
(4) Establishing and maintaining specified information that is in the records required of international air transporters on air waybills by the Warsaw Convention as Amended at the Hague, 1995 and by Protocol No. 4 of Montreal, 1975 (Warsaw Convention); or
(5) Entering into an agreement with a nontransporter immediate previous source (if located in the United States) or immediate subsequent recipient (if located in the United States) to establish, maintain, or establish and maintain, the required records in options 1 or 2 of the previous paragraphs. The agreement must contain certain elements specified in Sec. 1.352(e).
to establish and maintain required records under agreements with
transporters) in the United States must retain records for 1 year for
any food having a significant risk of spoilage, loss of value, or loss
of palatability only after a minimum of 60 days after the date the transporter receives or releases the food.
B. Significant Changes FDA Made to the Proposed Rule
FDA made the following significant changes to the proposed rule:
they have possession, custody, or control of the food for the sole purpose of transporting, must comply with Sec. 1.352 of subpart J of this final rule.
* * * a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
III. Comments on the Proposed Rule
FDA received approximately 212 timely submissions in response to
the proposed rule, which raised approximately 220 major issues. To make
it easier to identify comments and FDA's responses to the comments, the
word ``Comment'' will appear in parentheses before the description of
the comment, and the word ``Response'' will appear in parentheses
before FDA's response. FDA has also numbered each comment to make it
easier to identify a particular comment. The number assigned to each
comment is purely for organizational purposes and does not signify the
comment's value or importance or the order in which it was submitted. A. General Comments
(Comment 1) Some comments state that it would be beneficial for the agency to provide the food industry with a model form that could be used to record all the required information, with the option for the industry to use this form or established recordkeeping systems. One comment requests that the agency develop and provide respective freeware that could be available as a compact disc (CD) or downloaded from the FDA Web site well in advance of the compliance date of the final rule. A few comments request that the regulations make clear that the model form is guidance and is not mandatory. One comment suggests that as a way to show that the model form is guidance, the agency should place the model form in an appendix to the regulations.
Several comments object to the inclusion of a model form in the regulations. The comments oppose using any ``onesize fits all'' generic form as an example or requirement. The comments suggest that affected businesses should decide the format in which the required records should be kept as dictated by specific business practices. The comments express concern that example forms might become informal requirements out in the field even though originally only meant as guidance.
One comment recommends that the agency provide further examples of [[Page 71566]]
scenarios, rather than model forms, where records would be in compliance and noncompliance with the final regulations.
In addition, several comments state that most food companies currently maintain the chainofdistribution information that is required by these regulations. However, the diversity and complexity of the food industry means that the information is maintained in many different ways and formats, ranging from computerized records systems to file folders of paper records. The recordkeeping systems are designed to provide the necessary information to remove food from the market and prevent more food presenting the same risk from entering the market. The comments state that the regulations should not prescribe any specific manner or form of maintaining the information. (Response) The provisions describe the specific information a covered entity must keep, but do not specify the form or type of system in which those records must be maintained. As stated in both the proposed and final Sec. 1.330, these provisions do not require duplication of existing records if those records contain all of the information required by subpart J of this final rule. If a person subject to these provisions keeps records of all of the information as required by subpart J in compliance with other Federal, State, or local regulations, or for any other reason, e.g., as a result of its own business practices, then those records may be used to meet these requirements. Such records may include, but are not limited to, purchase orders, bills of lading, invoices, and shipping documents. Moreover, entities do not have to keep all of the information required by this final rule in one set of records. If they have records containing some of the required information, they may keep those existing records and keep, either separately or in a combined form, any new data required by this final rule. There is no obligation to create an entirely new record or compilation of records containing both existing and new information, even if the records containing some of the required information were not created at the time the food was received or released.
Our intent is to have as little impact as possible on current
recordkeeping practices if those records can meet the requirements of
these regulations. FDA received numerous comments, as discussed further
in section III.G of this document on ``Can existing records satisfy the
requirements of this subpart?'' that agreed with this approach to not
specify the type and format of the records and to allow flexibility to
use existing recordkeeping systems. In addition, comments state that
individual companies are in a better position to decide in what format
records are needed based on knowledge of applicable business practices
and cost structures. For these reasons, FDA has not included a model form in this final rule.
(Comment 2) Several comments state that the food industry has repeatedly demonstrated the ability to identify and remove product from grocery store shelves very quickly. The comments suggest that the diversion of substantial resources that would be necessary to implement the agency's proposed regulations would not further food security, but instead would diminish the overall efficiency of the food distribution system, which is necessary to serve food safety and security needs and commercial purposes.
Further, some comments assert that the regulations are directed
toward enabling the Government to trace a product, rather than ensuring
that companies are able to trace the product through all the links in
the chain of custody of a food ingredient or product. The comments
state that the intent of the Bioterrorism Act was to ensure the
existence of a system that fully engages the institutional knowledge
and logical procedures that already enable the companies responsible
for the production and distribution of food to maintain an orderly and
efficient nationwide supply chain and that also currently make it
possible to effect rapid recalls when necessary. The comments state
that the proposed regulations fail to capitalize on the efficiencies of
time and resources available through effective public/private
coordination, exemplified by the efforts that currently support effective recalls.
(Response) FDA recognizes that some of the food industry currently has existing records that may satisfy all or part of these regulations; however, not all of the food industry is currently able to conduct such traceback investigations. Notwithstanding the ability of some of the food industry to conduct such investigations, Congress authorized FDA through the Bioterrorism Act to issue regulations requiring the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold or import food to enable FDA to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, to address credible threats of serious adverse health consequences or death to humans or animals. FDA believes the information required to be established and maintained in records in these regulations is necessary to enable FDA to conduct an efficient and effective tracing investigation, independent of what the food industry may be able to do. FDA reiterates that it is not dictating the form or type of system to be used to satisfy these requirements in these regulations. If the food industry already keeps all of the information required by this final rule, then existing records can be used to comply with this final rule. Further, FDA anticipates working closely with the food industry in any tracing investigation.
In addition, recently FDA was significantly hampered in identifying the source of contaminated food during a trace back investigation following a Hepatitis A outbreak due to contaminated green onions. This outbreak involved a distributor who purchased green onions from a variety of firms in no predictable pattern and distributed them without recording brand and lot information. The distributor did not keep records of the previous sources of the green onions, which might have indicated a particular supplier of green onions during the specified exposure time period. It was impossible for investigators to determine, from the distributor, the identity of the supplier of the green onions that were sent to the implicated restaurant, and therefore FDA had to spend time investigating all potential suppliers of the green onions to identify the one supplier that supplied the restaurant. Speedy trace back would have enabled FDA to prevent further distribution of contaminated products sooner, thereby preventing more illnesses.
Further, 20 percent of all tracing investigations are prematurely
terminated due to deficiencies in recordkeeping. A reduction of just
one premature termination could prevent at least 53 people from
becoming ill. Requiring adequate records to complete a tracing
investigation reduces traceback times by 8 days. This increased
efficiency facilitates preventive action in 15 to 18 percent of
outbreaks. The speed with which a tracing investigation can be
conducted is of vital importance in reducing the number of people who
could potentially become ill. Access to records that do not exist or
that do not contain sufficient information (with no requirement to
retain them or make them available in a timely fashion) is not an
efficient and effective way to conduct a tracing investigation during a public health emergency involving
serious adverse health consequences or death to humans or animals. (Comment 3) One comment states that established industry practice with regard to investigating product defects and conducting product recalls is consistent with the terms of the Bioterrorism Act allowing for the rapid identification of the immediate previous source and immediate subsequent recipient of foods. The comment asserts that the industry's response to the events of September 11, 2001, has strengthened these existing practices. The comment explains that as an inevitable result of industry's commitment to Responsible Care Security Code No. 7 and increased requests from customers, emphasis is now shifting from security at fixed plant sites and major distribution centers to security of products throughout the value chain. This shift in emphasis enhances industry's existing traceback capabilities. The comment asserts that the controls needed to effectively trace the source and recipient of foods are already in place.
(Response) As explained in the response to comment 2, these provisions are intended to help ensure that FDA has the information it needs to identify the immediate previous sources and immediate subsequent recipients of food to address credible threats of serious adverse health consequences or death to humans or animals.
(Comment 4) One comment asserts that when food presents a risk of serious adverse health consequences or death to humans or animals, a class I recall is used and can quickly eliminate problems, whereas recordkeeping, at best, will get a message to the retail locations where products were placed on sale to consumers. The comment questions the benefit of the copious amounts of information and possible implementation of an intricate new product tracking system required by the regulations. The comment asserts that class I recalls will continue to be the appropriate means by which a potential hazard is handled and that requiring the expenditure of significant resources to develop a new system in the absence of a Congressional mandate or a genuine need is questionable. The comment recommends that FDA continue to rely upon the proven capabilities of class I recalls and cooperation with the food industry. The comment suggests that FDA should develop a system to contact the appropriate companies to engage their assistance in addressing threats to the food supply, rather than requiring the onerous recordkeeping specified in the regulations.
(Response) This comment assumes that the contaminated food and its whereabouts are known completely, which may not always be the case. As such, the need exists for records to be able to trace forward fully to all locations where the food was shipped, as well as trace backwards to locate any similarly contaminated food shipped to all other locations. Moreover, class I recalls are voluntary measures only. In the Bioterrorism Act, Congress has given FDA the means both to establish requirements for establishment and maintenance of records, and to administratively detain, on its own initiative, food for which FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals (section 303 of the Bioterrorism Act). In addition, the records are needed not only to help remove contaminated food from the market place, but also to help identify the source of the contamination.
(Comment 5) A few comments state that, in the event of a serious product issue or lifethreatening situation, the only responsible action to take is to warn the public through the media to prevent further use or distribution of the product. The communication vehicle used to disseminate the warning should be based on the severity of potential harm or health consequences. Use of the media also is necessary to influence facilities to check their store stock and for consumers to check their refrigerators and pantries for the affected product.
(Response) FDA agrees that the use of warnings to the public about specific products is important. Indeed, FDA has used this approach many times. Nonetheless, records will ensure that FDA can perform trace forward to remove the problem food from the market and traceback to identify the source of the problem. These recordkeeping requirements will also enable FDA to identify the problem food more specifically and, thus, FDA can target its public warnings on the specific problematic food.
(Comment 6) A few comments request that the agency add a ``pipeline provision'' that allows the use of NA (not available) in place of information where ingredient records were not maintained. The comments state that many ongoing processing operations will have some ingredients on site that have been purchased and housed in facilities for some time prior to the implementation of these regulations. In these cases, it would be a significant manpower burden (or perhaps not possible at all) to obtain or attempt to recreate all the required information on the source of those ingredients. The comments note that these ingredients have been used in food production without incident and it would be unlikely they would be involved in an act of terrorism. (Response) There is no requirement to establish and maintain records for food ingredients you received before the compliance date of these regulations. Under that scenario, however, you must establish and maintain records of that food when you release it after the compliance date of the regulations. For example, if a commercial bread bakery receives flour, eggs, and salt before the compliance date of this final rule, it does not need to keep records of the immediate previous source of when it received that food. Once the bakery uses these ingredients to bake the bread and releases the bread to nonconsumers after the compliance date of the rule, the bakery must keep the records required by Sec. 1.345 of this final rule regarding the immediate subsequent recipients of the bread.
(Comment 7) One comment recommends the use of United Code Council standards, a system of globally recognized and implemented standards that enables traceability of products and identification of trading parties/recipients, through all locations of the supply chain. (Response) FDA does not agree. The agency has determined that the least burdensome way of issuing the recordkeeping requirements is to specify the information that must be contained in the records, but not the format in which the records are kept. Indeed, the agency received numerous comments that argued that covered entities should be allowed to use existing records and systems.
(Comment 8) One comment requests that source labeling, including countryoforigin labeling, be required as a component of an effective traceback program in the event of a food emergency. The comment states that some industries have already developed technologies such as barcodes, stamps, stickers, or tags to identify the source of produce as well as software to assist in more accurate traceback to the grower/ packer level.
(Response) FDA does not agree. At this time, FDA does not believe this information is necessary to enable a traceback. FDA believes the requirements of the final regulations for the establishment and maintenance of records to identify the immediate previous sources and immediate subsequent recipients of food in order to address credible threats of serious
adverse health consequences or death to humans or animals are sufficient.
(Comment 9) Some comments ask that the agency generate more publicity on the regulations and provide the industry with educational materials and training. One comment states that because food wholesale distributors have no significant contact with FDA personnel and procedures, they have a limited understanding of the requirements. One comment asks that the agency help promote and educate the industry abroad on the recordkeeping regulations. Another comment asks that FDA provide materials in other languages. One comment asks that the agency develop a strong communications program to disseminate the new regulations once they become final because the fresh produce industry and its transportation partners are highly diverse and fragmented. The comment states that independent truckers in particular need to be made aware of the regulations because the fresh produce industry in the United States relies heavily on independent truckers to move fresh fruits and vegetables to market quickly.
(Response) FDA conducted extensive outreach on the proposed recordkeeping rule, including having relevant FDA staff attend 6 international meetings and more than 100 domestic meetings to ensure that affected parties were aware of the Bioterrorism Act requirements. On May 7, 2003, FDA held a public meeting (via satellite downlink) to discuss the recordkeeping and administrative detention proposed rules. See 68 FR 16998 (April 8, 2003) or http://www.cfsan.fda.gov/dms/fsbttraz.html. Nearly 1,000 participants in North and South America and
the Caribbean viewed that live broadcast. The meeting was later rebroadcast to Europe, Asia, Africa, and the Pacific (areas in different time zones). FDA has also provided transcripts of the broadcast in English, French, and Spanish (the three official World Trade Organization languages) on the agency's Web site. In addition to this outreach to the affected industry, FDA has conducted outreach on the proposed rule to States.
FDA plans similar outreach directed to stakeholders following publication of the final rule implementing the recordkeeping provisions of the Bioterrorism Act. Our outreach will include the following:
More specifics regarding each of these will be included on FDA's
Web site at http://www.fda.gov/oc/bioterrorism/bioact.html.
(Comment 10) Several comments suggest that, to lessen the burden to
the food industry, FDA needs to coordinate with other local, Federal,
and State government security programs in establishing the final recordkeeping regulations.
(Response) In issuing these recordkeeping regulations, FDA has stated that records established and maintained as a result of local, State, or other Federal regulations, or as a matter of routine business practice, need not be duplicated if the records contain all the information required by these regulations. Further, if existing records contain some, but not all, of the required information, persons may supplement existing records with the additional information required under this final rule.
(Comment 11) One comment asks that the final rule require that upstream entities provide all the required information to downstream entities in the food distribution system. The comment states that distribution centers that receive and store food and retail outlets that hold and sell food do not know and should not be required to determine many of the information items required under the proposed regulation. The comment states that requiring that any information be passed through the system from the first point of distribution, preferably through electronic means, would alleviate some of the burden of the recordkeeping requirements on downstream entities.
(Response) The agency does not agree completely that distribution centers and retail outlets do not know many of the information items. The agency agrees, however, that including information pertaining to lot or code numbers of foods in the required records is not practical for distribution centers and retail outlets, given current business practices. FDA has, therefore, deleted this requirement. Instead, the final regulation now only requires that persons who manufacture, process, or pack food keep records on the lot or code number or other identifier of the food, and only to the extent this information exists. Moreover, to minimize the burden this regulation may have on affected parties, FDA is not specifying the form or format of the records that must be established and maintained and is not requiring electronic records.
(Comment 12) Several comments applaud the agency's efforts in proposing a rule that appears to be designed to work with the food industry as efficiently and effectively as possible to address credible threats without imposing undue burdens. One comment urges the agency to issue the final regulations as expeditiously as possible to enhance compliance with the provisions of the Bioterrorism Act. The comment states that, by finalizing the regulations in conjunction with the interim final rules entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' (the registration interim final rule) (68 FR 58894, October 10, 2003) and ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' (the prior notice interim final rule) (68 FR 58974, October 10, 2003), the education and training that will be necessary for compliance with the regulations can be done together and the internal policy and procedures for companies can be designed to meet all of the obligations under the final rule. The comment further states that this is the reason that Congress intended regulations to be issued within 18 months of the effective date of the Bioterrorism Act.
(Response) The agency has acted expeditiously in issuing all of the regulations under the Bioterrorism Act and has developed and published final regulations as quickly as possible. With respect to education and training, as stated previously, the agency intends to conduct extensive outreach to stakeholders for this final rule that is similar to outreach the agency conducted for the registration and prior notice interim final rules.
(Comment 13) One comment requests clarification regarding the level of recordkeeping that will be expected at each facility maintained by a vertically integrated company. The comment explains that a vertically integrated company has various facilities involved in the growing and processing of bulk ingredients as well as the manufacturing and marketing of finished products. Some of the requirements for recordkeeping could result in duplication of effort if each facility within the company is required to
maintain separate records, even though the overall records are available at company headquarters or some central location. One comment requests that the final rule clarify what is meant by the term ``released'' and the relationship of this term to holding legal title, or ownership of the food. Another comment suggests that FDA clarify that only at such time as the food leaves the possession and control of one firm and enters into the possession and control of another firm, whether or not via a transporter, would the recordkeeping requirement apply. The comment maintains that any other interpretation of the statute would impose a crushing burden of internal tracking systems and paperwork that would detract from most firms' abilities to do business and is well beyond the intent of the Bioterrorism Act.
(Response) The records required by these regulations are those that FDA needs for inspection to identify the immediate previous sources and the immediate subsequent recipients of food. ``Immediate previous source'' has been defined in Sec. 1.328 of the final rule to mean ``a person who owns food or who holds, processes, packs, imports, receives, or distributes food or food packaging, and that last had an article of food before transferring it to another person.'' Unless otherwise exempt (i.e., a farm), a ``vertically integrated company'' would be required to identify the sources of all food received from its immediate previous sources. Once the vertically integrated company receives the food and keeps information on its immediate previous sources, that vertically integrated company does not need to keep additional records until it releases the food to another person. Unless otherwise exempt, at the time the vertically integrated company releases the food, it is required to identify the immediate subsequent recipients of that food.
As an example, if a company buys food from its immediate previous source (company A), then the company further processes the food, holds the food, transports the food, and distributes the food to a grocery store, then the vertically integrated company would only have to keep records on its immediate previous source (company A) and its immediate subsequent recipient (grocery store). The vertically integrated company need not keep records of all the covered activities (manufacturing, processing, packing, transporting, etc.) conducted by that company while it has the food.
Of course, when the integrator has any records or other information
available to FDA under sections 414 and 704(a) of the FD&C Act, then
FDA would have access to those records if FDA has a reasonable belief
that the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
B. Foreign Trade Issues
(Comment 14) Several comments representing foreign governments and international associations agree in principle to the recordkeeping requirements provided the requirements are based on a sound risk assessment and do not restrict trade more than necessary to effectively address potential risks. Some comments note that there is no risk assessment provided to justify the proposed measures required by the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement). Several comments representing foreign governments and businesses request that FDA work with foreign governments to develop common standards and requirements and to facilitate trade flow. Some foreign comments argue that the result of the onerous recordkeeping burden in the regulations will be the elimination of many legitimate and safe food distribution businesses and a serious reduction in global food trade. One comment suggests that the regulations will adversely impact trade, as they are likely to increase uncertainty and costs for foreign exporters. Small and medium sized foreign companies in particular may be prevented from continuing to export to the United States for these reasons. One comment is concerned that the regulations may lead to the unintended consequence of foreign countries imposing the same requirements of U.S. goods in foreign trade.
(Response) FDA considers that these foreign trade comments are now moot, given the scope of these final regulations. These final regulations do not apply to foreign persons, except foreign persons transporting food in the United States, who are treated no differently than domestic food transporters under these final regulations. FDA does not believe that foreign persons who transport food in the United States will incur additional costs as a result of these regulations, because FDA assumes that they will choose to comply with Sec. 1.352 of this final rule by establishing and maintaining the records already required by FMCSA. See the response to comment 82, later in this document.
C. Comments on Who is Subject to This Subpart? (Proposed Sec. 1.326) 1. General
(Comment 15) Several comments seek clarification on who is covered by the proposed regulation. Comments ask if the provisions of the regulations apply to port facilities, such as warehouses, or storage and inspection facilities in land, sea, or airports that belong to private companies and government bodies for food control in the country of shipping and/or origin.
(Response) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to these regulations. ``Person'' is defined in section 201(e) of the FD&C Act (21 U.S.C. 321 (e)) and includes any ``individual, partnership, corporation, and association.'' Therefore, any person located in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico who manufactures, processes, packs, transports, distributes, receives, holds, or imports food is included within the term ``person''. ``Holding'' has been defined in Sec. 1.328 of the final rule to mean ``storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.'' Accordingly, port facilities, such as warehouses, or storage facilities that are located in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico are subject to these regulations as they are ``persons'' who are holding food.
(Comment 16) One comment seeks clarification on whether the proposed regulation applies to a carrier's freight brokers. The comment states that, although these brokers never have actual physical possession of freight, they act as the middleman for carriers and shippers and have knowledge of where the freight came from and where it went. A few comments ask that FDA clarify that customs brokers are excluded from the regulations. The comment indicates that because Sec. 1.326 of the proposed regulations applies to, inter alia, persons that ``import'' food, it could be interpreted to include customs brokers, who act only as agents for the importer. A comment notes that customs brokers have only the information needed to file an entry on behalf of the actual importer and to obtain release of the food from U.S. Customs and Border Protection (CBP). However, according to the comment, customs brokers do not own food or hold, process, pack, import, receive, or distribute food for purposes other than
transportation. The comment notes that applying the recordkeeping requirements to customs brokers would cause redundant and burdensome recordkeeping requirements for them.
(Response) FDA clarifies that the recordkeeping requirements do not apply to brokers who act only to facilitate distribution, sale, or transportation of food by processing information or paperwork associated with these functions. Brokers who do not directly manufacture, process, pack, transport, distribute, receive, hold, or import food are not subject to the requirements of the regulation. (Comment 17) One comment asks that FDA specify whether the regulation applies to the importer of record or to the initial U.S. recipient when the merchandise enters the country. The comment notes that this clarification could affect who is responsible for the establishment and maintenance of records.
(Response) The final rule applies to persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States, unless the person qualifies for an exclusion in Sec. 1.327 of the final rule. An importer of record or an initial U.S. recipient that is involved in one or more of the identified activities must establish and maintain the required records.
(Comment 18) Several comments express concern because the proposed regulation applies only to domestic, forhire transporters, and foreign transporters that enter the United States, as well as domestic private transporters, are not covered. Comments state that the regulation should apply uniformly to all transporters, foreign and domestic, for hire and private, to ensure that no group has an unfair competitive advantage.
(Response) All persons transporting food in the United States must meet the requirements of subpart J of this final rule, regardless of whether they are ``for hire'' or ``private.'' FDA notes, however, that if a manufacturer located in the United States transports the food in its own company trucks, then it must comply with the recordkeeping requirements for nontransporters as opposed to those applicable to transporters because FDA does not need the facility to keep duplicative records of the food while it is in that facility's control. However, if a foreign person, such as a person who manufactures food, transports food in the United States, it must comply with the requirements for transporters, even if it transports the food in the United States itself. This ensures that FDA will have the ability to traceback the food that is transported in the United States, even if the facility from which the food originates is an exempt foreign facility under subpart J.
(Comment 19) One comment notes that CBP's current requirements apply to trucking companies that transport imported food into the United States. The comment suggests that FDA coordinate with CBP to get data from them in the event of a threat to the nation's food supply, rather than develop its own distinct recordkeeping regulations. (Response) The records required to be kept by these regulations are those FDA needs to help identify the immediate previous sources and immediate subsequent recipients of food. Section 1.361 of the final rule allows FDA access to transporters' existing 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. When conducting a traceback, FDA needs access to the required records at each point in the distribution chain for the implicated food. Thus, FDA will expect to obtain applicable records from transportation companies in the distribution chain. Although FDA may contact, and coordinate tracebacks with, other Federal agencies, including CBP, the agency expects transportation companies to comply with the recordkeeping and access provisions of these regulations. FDA notes that entities keeping records to satisfy CBP's regulations may use those same records to satisfy some or all of the requirements of this final rule if those records contain some or all of the information required by subpart J of this final rule. Entities also can supplement existing records with any new data required by this regulation, instead of creating an entirely new record containing both existing and new information.
(Comment 20) A few comments ask FDA to clarify what constitutes ``holding'' food, who FDA considers to be ``holders of food,'' and under what circumstances food is being held in transport. The comment notes that the lack of clarity leaves a carrier's terminal operating facility, gas stations, truck stops, and even trucks themselves vulnerable to being considered as ``holders of food'' and thereby subject to burdensome reporting requirements. Comments also ask FDA to exclude trucks, truck terminals, and facilities from the definition of ``holding,'' stating that this would be consistent with the intent of the law and the realities of the trucking industry's business practices. One comment asks whether food held for short periods of time in a trucking terminal during crossdock operations meets the definition of ``holding.'' One comment states that there are certain areas in the supply chain that provide temporary space for food during transit and that these areas should not be considered to be ``holding'' or ``storing'' food and subject to the recordkeeping requirements. The comment notes that some sites serve as transitory staging areas where produce is momentarily held before transportation and that, because of the perishable nature of the product and the desire to transport the fresh commodity rapidly, produce moves from these staging areas as quickly as possible.
(Response) ``Holding'' means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. The recordkeeping requirements in Sec. Sec. 1.337 and 1.345 of this final rule apply to persons who ``hold'' food for purposes other than transportation. As defined in Sec. 1.328 of this final rule, a ``transporter'' is:
* * * a person who has possession, custody, or control of an article of food in the United States for the sole purpose of transporting the food, whether by road, rail, water, or air. Transporter also includes a foreign person that transports food in the United States, regardless of whether that person has possession, custody, or control of that food for the sole purpose of
transporting the food.* * *
Truck terminals or similar facilities that are part of the
transportation process and merely provide a location for trucks to
transfer possession, custody, or control to another entity are not
subject to the requirements in Sec. Sec. 1.337 and 1.345 of the final
rule, unless possession, custody, or control is transferred to that terminal or facility.
(Comment 21) One comment seeks clarification on whether a ``customer,'' such as an office complex, would be required to maintain records if it receives and stores a food, such
FOR FURTHER INFORMATION CONTACT
Nega Beru, Center for Food Safety and Applied Nutrition (HFS305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 3014361400.