David French of the International Foodservice Distributors Association (IFDA) provided testimony June 25 to the House Subcommittee on Health in reference to the Implementation of the Food Security Provisions of the Public Health Security and Bioterrorism Preparedness and Response Act. French is the senior vice president of government relations at IFDA.During his testimony, French noted that IFDA strongly supports the purposes of the Bioterrorism Act, and that all IFDA members are committed to safeguarding the quality, safety and integrity of the products that they distribute.
“The FDA’s implementation of the food provisions of the 2002 law has gone much more smoothly than expected, but the foodservice industry remains concerned about the upcoming FDA record-keeping rule,” said French. “The industry is concerned about language in the proposed rule that suggests that lot numbers be used to track products. This will result in costly and unnecessary changes to distributor information systems without any significant improvements in the speed or efficiency of recalls. IFDA is also concerned that FDA’s proposed rule does not allow firms a reasonable amount of time to produce records in the event of an investigation.”
French also noted that the FDA’s implementation of the three initial phases of the Bioterrorism Act’s food provisions has been done in a responsive manner and he commended the agency for its cooperation. Following his testimony, French took questions from members of the committee.
Following are the formal comments submitted by French to the House Subcommittee on Health:
“Mr. Chairman, Mr. Waxman and members of the Committee, I am David French, senior vice president of government relations for the International Foodservice Distributors Association, and I thank you for the opportunity to testify today regarding the Food and Drug Administration’s implementation of the food provisions of the Bioterrorism Act of 2002. IFDA strongly supports the purposes of the Bioterrorism Act, and our members are committed to safeguarding the quality, safety and integrity of the products that they distribute.
“IFDA is a trade organization representing foodservice distributors throughout the U.S., Canada and internationally. IFDA’s 130 members include broadline and specialty foodservice distributors that supply food and related products to restaurants and institutions in the ‘food away from home’ business. IFDA members operate more than 550 facilities, and sell more than $75 billion in food and related products. The average IFDA member has approximately $50 million in annual sales and handles slightly more than two million cases of foodservice product per year. Formerly a division of Food Distributors International, IFDA was established as an independent trade association on January 1, 2003.
“In general, I can report that the implementation of the food provisions of the 2002 law has gone much more smoothly than expected. But before I comment on what the FDA has done well, I want to spend a moment discussing the looming threat of the FDA’s record-keeping rule. The record-keeping rule is generally viewed as the most difficult and burdensome of the regulations required by the Bioterrorism Act.
“As you know, the interim final rule on record maintenance and record inspection has been delayed for several months. IFDA is hopeful that the FDA has been using this time to undertake a substantive rewrite of the proposed rule, because our industry has expressed many serious reservations about the initial FDA proposal. I’d like to briefly mention a few of the problems we saw in the proposed rule.
“The Bioterrorism Act calls for food firms to maintain records of their transactions for some length of time and to make these records available to FDA to assist in trace-back and trace-forward investigations. On its face, these seem to be reasonably simple requirements. After all, foodservice distributors typically retain records for at least two years. Food firms also routinely conduct voluntary recalls of misbranded or adulterated food products, so all parts of the food distribution business have experience with conducting trace back and trace forward investigations.
“Unfortunately, rather than building on the existing systems that food companies employ to keep track of product and to conduct recalls, the FDA proposed a rigidly bureaucratic and one-size-fits-all rule. If key elements of the proposal find their way into the final rule, many of the companies in our industry will be facing multimillion dollar information system upgrades that will yield no significant improvement in the effectiveness of food investigations and recalls. I would add that compliance is a serious matter insofar as failure to maintain the required records, or failure to provide access to these records within the required time frame, subjects a company to civil and criminal liability.
“One element of the proposed rule that concerns us is the requirement that companies retain the lot number ‘or other identifier’ for each article of food that they send or receive. A requirement to record lot numbers is problematic for foodservice distributors. Distributors handle food in pallets and cases. A single pallet may contain food from multiple lots, and the lot numbers often appear only on the individual food packages. There is no government or industry standard for location or presentation of lot numbers, so they may appear on product packages or on cases, may be embedded in the UPC code or stand alone, and may take a variety of forms. In many cases, a requirement to record lot numbers would mean that distributors must break open pallets and cases and search for the lot numbers to record. This is a key point, and an issue that has the people in charge of logistics and operations in IFDA member companies worried.
“Therefore, we have requested that FDA give companies considerable discretion to determine what is an appropriate identifier. Most distributors track food by purchase order number. All foods have a purchase order and purchase order number. If a manufacturer recalls a product or if it is necessary to trace a food shipment for any other reason, it is an easy matter to determine a purchase order number, trace the product and remove it from commerce.
“Another significant concern that the foodservice industry has raised regarding the proposed rule involves the time frames for production of required records. The proposed rule sets very short time frames within which companies are required to make records available to FDA in response to an official request — only four hours if the request is made during normal business hours. Moreover, it is not entirely clear from the proposed rule when the clock begins to run. Section 306 of the Bioterrorism Act makes failure to produce records within this time frame a ‘prohibited act.’ Under the Federal Food, Drug and Cosmetic Act, a ‘prohibited act’ is a criminal offense, and company executives can be held personally criminally liable.
“Given the serious consequences of non-compliance, we view the imposition of a hard-and-fast four-hour time frame as unreasonable. While these records can be retrieved quickly in an emergency, a 4-hour deadline during normal business hours (or an 8-hour deadline outside of normal business hours), as proposed by FDA, is not feasible. IFDA agrees that FDA must have quick access to records in the event of an emergency. Imposition of criminal liability for violation of such a short time frame, however, is inappropriate. Instead, FDA should require that records be made available in a reasonable period of time. As the courts have been able to determine what constitutes reasonable times and places for FDA inspection under FD&C Act section 704, so, too, can the courts apply a reasonableness standard to the time frames for records access.
“A third concern we have deals with the circumstances of records access. We are concerned that FDA pay heed to the legislative history regarding when it may obtain access to records. According to one of the sponsors of the Bioterrorism Act, John Shimkus (R-IL), FDA ‘shall ensure that adequate procedures are in place to ensure agency personnel will not have access to records without a specific reason and need for such access, and that possession of all copies of records will be strictly controlled….’ Cong. Rec. E2388 (Dec. 20, 2001). Because the Bioterrorism Act gives FDA access to highly sensitive commercial information, it is important that the new records access authority be used appropriately and not abused and that strong protection be put in place to prevent inappropriate release of sensitive information. While the Bioterrorism Act requires that FDA take appropriate measures to prevent unauthorized disclosure of trade secret or confidential information, the proposed rule did not address this issue.
“The FDA is three-fourths of the way through the rulemaking process. The interim final rules on registration and prior notice and the final rule on administrative detention have all been written, and the foodservice distribution industry is generally pleased with the significant cooperation and understanding that the FDA has shown in responding to the industry’s concerns. FDA has done an impressive job of listening and responding to various workability issues raised by numerous comments during the rulemaking process, and the agency should be commended for this.
“In the brief experience that our companies have had with these rules, they have reported very few supply disruptions or concerns. Smooth implementation of the first three regulations is due to several factors. First, in the case of the prior notice rule in particular, FDA made a serious effort to address industry concerns raised during the rulemaking and the interim final rule was far less onerous than the proposed rule. Second, FDA has been phasing in enforcement of the prior notice and registration rules, so implementation problems may become more noticeable in the near future when full enforcement begins. Third, the prior notice rule has little direct impact on foodservice distributors, since with a few exceptions, foodservice firms do not import product directly. Instead, they work with importers and brokers who handle transactions with foreign suppliers. Importers may also be keeping their inventories larger than usual in order to minimize disruptions. Finally, firms in our industry, following FDA guidance, generally work with known suppliers. These suppliers are likely to be larger and more capable of working within the FDA rules.
“While we are generally pleased with implementation of the first three rules under the Bioterrorism Act, there are some serious concerns. With regard to the prior notice rule, as previously mentioned, FDA is phasing in enforcement of the rule. We are currently in a period of enforcement discretion and educational outreach. Unfortunately, no real education is happening. While FDA is keeping track of and posing data on the number of inadequate prior notices it receives, FDA is not telling industry why these prior notices are deficient. We hope that FDA will step up its educational efforts before full enforcement of the prior notice rule begins on August 13.
“In addition, our members are reporting significant problems with FDA failing to make timely inspection decisions along the Canadian border. It is not clear whether this problem is related to the Bioterrorism Act and prior notice or simply a reflection of a sizable number of new, inexperienced inspection personnel on the job; but we have heard that many products imported from Canada are not receiving timely decisions from FDA. In some cases, FDA investigators are taking an inordinate amount of time to decide whether to sample imported product. As the legislative history of the Bioterrorism Act makes clear, FDA review of prior notice ‘should not delay or unnecessarily disrupt the flow of commerce.’ Cong. Rec. E2389 (Dec. 20, 2001). We understand that implementation involves a learning curve for FDA as well as industry, and we hope that these delays will disappear.”