From: Mullett, Randy - CNF [Mullett.randy@cnf.com] Sent: Tuesday, July 08, 2003 4:42 PM To: 'fdadockets@oc.fda.gov' Subject: Docket: 02N-0277 July 8, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Docket No. 02N-0277. Comments of CNF, Inc. Dear Sir or Madam: CNF, Inc. appreciates the opportunity to provide comments on the proposal of the Food and Drug Administration ("FDA") to implement section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act"), which provides for the establishment and maintenance of certain records related to the production and distribution of food for consumption in the United States. CNF, Inc. CNF Inc., through its operating subsidiaries, Con-Way Central Express, Con-Way Southern Express, Con-way Western Express, Con-Way Canada Express, Con-Way Mexico Express, Con-Way Now, Con-Way Full Load, Con-Way Air, Con-Way Logistics, Menlo Worldwide Forwarding, Menlo Worldwide Logistics, Menlo Worldwide Technologies, Menlo Worldwide Expedite!, and Vector SCM, is involved in practically all facets of the freight transportation industry. CNF is a $4.8 billion management company that is a leading provider of global supply chain services for a wide range of manufacturing, industrial, retail, and government customers. Effective supply chain management is increasingly important for businesses worldwide as competition drives them to reduce inventories and speed up cycle times. The value of the U.S. supply chain alone is estimated to be $900 billion, or 10 percent of gross domestic product. With more than 26,000 employees at 1000 locations in over 200 countries, the CNF companies collectively move 25 billion pounds of freight a year. This total includes literally thousands of FDA regulated shipments moving via truck and air each day General Comments CNF shares with the FDA the goal of enhancing the security of the food supply. , CNF supports and, as applicable, participates in the "Known Shipper" database program, C-TPAT, PAPS, and FAST. Our evaluation of FDA's proposals to implement the Bioterrorism Act has been heavily influenced by the commitment we share with FDA to provide a safe and secure food supply to the American people. Purpose The purpose of the proposed regulations is to improve the security of the U.S. food supply by enhancing the FDA's ability to oversee and monitor imported and domestic food shipments and thereby improve the security of the U.S. food supply. Although we agree with this objective, we believe that if implemented as currently written, these regulations will accomplish little if any real improvement over current regulations and policies. Additionally, we believe these regulations will cause significant economic harm to a large number of both large and small companies, as well as, serious economic damage to the United States. Section 306 of the Bioterrorism Act provides for access to records under certain specified circumstances and permits the FDA, by regulation, to require the establishment and maintenance of limited "chain of distribution" records. The proposal that FDA issued deals largely with the establishment and maintenance of records and only incidentally with the subject of records access. In these comments, CNF suggests some changes to the proposed requirements for the establishment and maintenance of records that will preserve the value of those records in tracing the movement of food while reducing the burden on the transportation industry. We also suggest some changes to the records access provisions of the proposal that will better take into account some of the practical considerations in records maintenance and retrieval. Finally, we urge FDA to add some provisions to the regulation that will provide procedural protection when FDA exercises the records access authority under section 306 of the Bioterrorism Act. Statutory Authority The proposed rule has been issued to implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Bioterrorism Act, P.L. 107-88, 116 Stat. 662 (June 12, 2002) (hereinafter "Act"). The Act contains several provisions to enhance the safety and security of the U.S. food supply. Throughout the many provisions of the Act, Congress specifically directs the FDA to issue regulations whereas, in other sections, it simply leaves the enactment of any regulations to the agency's own discretion. Under Section 306 (a), the Secretary of Health and Human Services may by regulation establish requirements regarding the establishment and maintenance of records. Therefore, a literal reading of this particular statutory language would conclude that the FDA is not required to issue the regulations at issue herein, but rather has discretion not to issue regulations or to determine other more appropriate means to further the purposes of the Act. This particular section also provides that FDA consult and coordinate with Other Government Agencies (OGA's) before issuing any regulations. Section 306 (a). It is therefore logical to assume that Congress intended for FDA to coordinate with other agencies to determine if such records already exist within OGA's in order to address credible threats of serious adverse health consequences or death to humans or animals. Upon such coordination, FDA should only issue additional recordkeeping regulations, if absolutely necessary. CNF respectfully submits that the information currently provided to FDA, the Bureau of Customs and Border Protection (CBP) and OGA's is sufficient for the FDA to further the purposes of the Act. FDA, however, takes a different reading of the Act. FDA is relying on Section 306 (d) of the Act that directs the agency to promulgate proposed and final regulations no later than December 12, 2003. 116 Stat. 670, §306 (d). FDA recognizes that the use of term "may" in one section and "shall" in another section creates ambiguity and specifically invites comments on such ambiguity. 68 Fed. Reg. 25189. CNF submits that Section 306 (d) and its deadline of December 12, 2003, would apply only if FDA elects to issue regulations and FDA's clear discretionary authority to issue recordkeeping regulations in the first place remains unchanged by Section 306 (d). One Size Does Not Fit All Many of the movements of food by truck into and within the United States are not done on a rigidly scheduled basis. Rather, these movements are done on demand, often on an expedited basis. This is also the case with many airfreight shipments. For ocean and rail, this scenario is somewhat different because they tend to adhere to rigid schedules. In addition, the way goods are shipped - whether they are foodstuffs or widgets or clothing - varies according to the transport mode used. In order to accommodate the operational differences among the transportation modes, and the different types of operations within each mode, CNF suggests that the FDA avoid implementing a "one size fits all" rule. Rather, we suggest, as is currently being done by CBP for the Trade Act of 2002 requirements, that the agency look at the operational capabilities and realities of the different modes to formulate mode-specific rules for record keeping. We also suggest that the agency work closely with OGA's to ensure that the recordkeeping rules for food do not in any way conflict with existing or planned CBP or DOT requirements. Unfair Competitive Advantage We are concerned that these proposed rules apply only to domestic, for-hire transporters. Foreign transporters that enter the United States as well as domestic private transporters are not covered. We believe these record-keeping rules should apply uniformly to all transporters: domestic and foreign; for-hire and private, to insure that no group has an unfair competitive advantage. Accordingly, Section 1.326 should be modified to list private and foreign transporters as subject to the records requirement. Detention CNF is extremely concerned with the uncertainty surrounding "detention" of a food shipment by FDA. While in the control of transporters, food shipments will be "moving targets" that will be in another location by the time a FDA request to detain is received. In many instances, unrelated shipments being transported in the same unit (truck, trailer, plane, etc.) will be impacted by any effort on the part of FDA to detain a shipment of foodstuffs. The proposed regulations do not provide sufficient means to obtain quick resolution when this issue occurs. FDA has also not sufficiently addressed liability issues that will result from incidents involving detention. We suggest that, rather than the proposed appeal protocols, FDA initiate proposals that provide an opportunity for emergency redress to be handled outside the court system. Establishment and Maintenance of Records a. Lot and Code Numbers Under the proposal, nontransporters (food manufacturers) and transporters would be required to maintain records of the movement of food that include the lot or code numbers of the food products produced and distributed. This requirement is neither feasible nor necessary and should be deleted from the final regulation. Under the proposal, FDA would appear to have determined that the modest grant of authority under the Bioterrorism Act to allow the maintenance of limited distribution records, should result in a "cradle to grave" record keeping system that would trace every package of food distributed in the United States literally to the very shelf in a specific retail establishment in which it is sold. FDA fails to appreciate that it is not possible to know this information without major adjustments in the way the food industry, transportation industry and retailers work. Moreover, FDA does not make the case that protecting the public from food products that present serious risks to the public health necessitates the maintenance of records with lot or production code information captured at every step of the process of producing and distributing food. Lot by lot tracking throughout the entire chain of food distribution is not possible. It is now commonly the practice within the food industry to track product from production to a warehouse by lot number. It is typically not the case, however, for the lot numbers to be tracked once the product leaves a warehouse and enters the retail environment. (We explain below why it is not necessary to have this information.) In some instances, products are delivered to the retail store directly by representatives of the food manufacturer. In the so-called "direct store delivery" situation, the transporter who picks up say, snack products, from the food manufacturer's warehouse, delivers the products directly to retailers and stocks the shelves. The supplier of the product and the transporter (who is a representative of the supplier) will be able to trace the movement of the product, with lot numbers, from the warehouse to the transportation vehicle. Neither of them, nor the retailer, however, will have the ability to determine the lot number of each bag of chips that are placed on the shelf of each retail establishment that the transporter visits with each load of product in his or her vehicle. It would require substantial technological innovation and reworking of this delivery system for it to be possible to capture the lot number of each product as it was delivered to each retail location. Moreover, the difficulty does not exist merely in the direct store delivery situation. In other situations, food manufacturers may use independent delivery persons who will pick up product from several manufacturers for delivery to retailers within a certain geographical area. There may well be as many as 75-100 different products on each truck. In this case, there will be a record that shows what lots of product were picked up by the independent delivery person and that delivery person will have a record of what retail establishments were visited during the course of a working day, but the delivery person has no capability to capture the lot numbers of the products of several different manufacturers whose products are being delivered. It is important for FDA to appreciate that the problem with the proposed requirement for lot by lot tracking is not merely the difficulty/impossibility of capturing the information with current technology and distribution systems and practices. The problem with the proposal is that while companies know that the information is not reasonably needed by it to address any public health event involving food products, FDA thinks it might need the information. This is an assumption that will result in a bureaucratic nightmare for food companies and transporters Even without the lot information down to the retail level, it is still possible to determine where particular lots of product that left warehouses are likely to be. When the food manufacturer knows that certain lots were in warehouse "x" on a specific date, it is possible to identify the specific retailers that received one of several lots of food. This is important because the manufacturer can then be said to have a record that identifies the immediate subsequent recipient of the food. To briefly summarize: (1) the food industry and transportation industry cannot now capture lot information to the retail level; (2) neither the food industry nor FDA needs the lot information to the retail level; and (3) the requirements of the Bioterrorism Act are met even without the lot information. b. Responsible Individual Under the proposal, FDA would require that in every transaction involving the movement of food through the entire chain of distribution, records be maintained which contain the identity of the "responsible individual." It is not clear from the proposal whether the "responsible individual" is the same as the "emergency contact person" for purposes of facility registration, sometimes the same, or never the same. It is equally unclear whether the term refers to the person who loaded a pallet of product onto a loading dock, the person who loaded it onto a truck, the driver of the truck and so forth. For transporters, it should be sufficient to require that the transporter designate a "responsible individual" and that a nontransporter who uses a specific transporter be able to identify that transporter. There is no demonstrated need for the record of each commercial transaction involving the distribution of food to contain the name of each individual involved in the manufacture, sale, and distribution of a food product whomever FDA intends for that person to be. c. Product Descriptions Under the proposal, records would be required to contain an "adequate description" of the food, including the brand name, specific variety, and how packaged (proposed 1.337, 1.345, and 1.352). Typically, this information is maintained now by the use of company-specific codes and abbreviations. It is unclear whether FDA intends to permit the use of codes and abbreviations to satisfy the proposed requirement. We strongly urge that FDA make clear in the final regulation that currently used descriptions are acceptable to identify the food with the specificity that FDA expects (that is brand, variety, how packaged) and to consider the large impact on the transportation community if they must make substantial changes in standard shipping documents (commercial bills of lading) to accommodate FDA's request. In short, there would be a large financial burden associated with eliminating the use of established procedures on existing commercial documents without commensurate benefit. d. Time Periods for Records Maintenance Under section 1.360, FDA proposes a one-year record retention period for records related to perishable foods not intended for conversion into nonperishable foods and two years for all other human foods. There are several problems with the proposed requirement. First, for transporters, the two primary documents involved in any shipment are the bill of lading and the delivery receipt. The Department of Transportation (DOT) has already established retention periods for these documents. FDA should consult with DOT to insure compatible requirements that do not require expensive creation of additional document management IT systems by the transportation industry. Second, the definition of perishable food is too narrow and limiting. There are many foods with a limited period of shelf life, but which are not strictly speaking "perishable." For example, a bag of chips is not perishable under the proposed FDA definition, but it will not remain on a store shelf for as long as canned soup. FDA should revisit the perishable/nonperishable distinction and provide clarity. It is unreasonable to assume that transporters are qualified to make such determinations. Third, under the proposal, records for perishable foods would have to be maintained for one year, unless the perishable foods were intended to be made into non-perishable foods. This requirement would thus impose an obligation on the person distributing perishable foods to determine the ultimate intended use of the foods. This is not feasible or routinely possible and places undue responsibility on the transporter if required to make such a determination. How is someone who distributes fresh produce in a position to know what every buyer (direct and indirect) intends to do with the produce purchased? The produce distributor may not even know what the persons who buy directly from him intend to do with the product, much less what persons several transactions away intend do to. Thus, as proposed, persons would have to assume that perishable foods were or might be made into non-perishable foods. They would have no choice but to apply the non-perishable record retention period. Records Access The proposal fails to include provisions necessary to ensure that the exercise of the records access authority under the Bioterrorism Act is Constitutional and otherwise in accordance with law. Moreover, there are several provisions of the proposal in which records access is addressed (time period for access in proposed 1.361), which are neither feasible nor needed. We address these issues in this section of these comments. a. A request for access to records must be accompanied by an explanation of the basis for the request. The proposal should be revised to provide that, whenever FDA exercises the records access authority under sections 414 or 704(a), it will provide a written statement which contains a summary of the evidence on which FDA relied in concluding that the standard for records access ("reasonable belief that an article of food is adulterated and presents a serious risk of adverse health consequences or death to humans or animals") has been met to the person from whom the records are sought. Without such a written statement, persons from whom records are sought will have no basis to assess the bona fides of the request itself or to determine whether the requested records are reasonably related to the risk that led the FDA to conclude that the high standard for records access had been met. Under the Bioterrorism Act, access to records requires that FDA possess a "reasonable belief." If FDA does not provide to the person whose records are sought an explanation of the evidence that provided the "reasonable belief," there will be no practical way for anyone to provide a check on the exercise of discretion by the FDA. How will anyone ever determine whether FDA had a "reasonable belief" as opposed to merely a belief or even an unreasonable one? On the other hand, if FDA provides such a statement to persons whose records are sought, there is the ability of such a person to assess the legitimacy of the request and, if not persuaded, decline to provide the requested access or, alternatively, seek judicial intervention to nullify the request. Without a statement, persons whose records are sought have to choose between: (1) providing the records merely because the agency asked for them; or (2) declining to provide access in order to determine whether the basis for the request is a "reasonable belief" (under the theory that the agency will seek judicial intervention to enforce its access rights). It is only when the agency has a "reasonable belief" that the exercise of its access authority is lawful; providing the suggested statement will thus help to ensure - FDA and the regulated industry - that the authority is being used responsibly. b. The Time to Provide Records Must Be Reasonable FDA has proposed entirely unreasonable time periods for providing access to records (proposed 1.361). CNF, and many other transporters, are not open twenty-four hours a day, seven days a week. If not clearly stipulated, FDA's proposed regulations will require the expense of adding additional staff "just in case" the FDA makes an off-hours request for information. Under that section, companies would have only four hours to provide records if the request is made between 8 a.m. and 6 p.m., Monday through Friday. The notion that companies should always be in a position to respond fully to a request for records within four hours has no foundation in either FDA's regulatory needs nor the practices and procedures of other regulatory agencies. It should be pretty obvious that the time that will be required to respond fully to a request for records is very much a function of the scope of the request and the timing of the request. There is a difference, for example, between a request made early in the day where the person who maintains the requested records has the bulk of the normal business day to respond and a request made at 5 p.m. (technically within the proposed 4-hour time to respond, but barely in the normal business day). CNF recognizes FDA's desire for a simple and straightforward rule on records availability. We suggest, however, that such a rule can be adopted only by ignoring the variety of circumstances in which records may be sought and the vast differences in the time required to produce say, three months worth of records and three days worth. We suggest that proposed section 1.361 be revised to delete the 4-hour and 8-hour time periods for making records available. Alternatively, FDA could revise that section to provide that the 4 and 8 hour time periods are illustrative only and acknowledge that the actual time to make records available will depend on a variety of things, including the scope of the request. It would certainly be reasonable to provide that persons must begin the process of making records available within 4 hours of a request made during the normal business day. Conclusion CNF recognizes the pressures on FDA from multiple directions to implement regulations that will insure the security of the U.S. food supply. Americans are more aware of security issues than at any time in recent memory, and a sense of urgency surrounds the issues. The transportation industry, however, faces pressure from those same consumers to deliver affordable products expeditiously. As the economy continues to struggle, additional strains place upon the supply chain will severely hamper any such efforts. The costs of complying with the proposed record keeping and recording requirements in their current form will be enormous. Even if the time and administrative cost of a single shipment is modest, the large numbers involved will, cumulatively, be a great administrative and financial burden for CNF. The large amount of data that must be accumulated, stored, and managed on all FDA regulated shipments will require development and implementation of new IT systems and the addition of support personnel. U.S. businesses simply cannot maintain viability if strapped with arduous and inefficient regulations. In closing, CNF applauds the FDA for a thorough and transparent process that included all effected parties. Thank you for the opportunity to present our views today. We look forward to working with you on this important policy decision. Respectfully submitted, C. Randal Mullett Director, Government Relations CNF, Inc. 3240 Hillview Ave. Palo Alto, CA 94303