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October 13, 1999
Desk Officer for FDA
Office of Information and Regulatory Affairs Re:Comments on Proposed Information Collection and Recordkeeping
Burdens for FDA's Voluntary Pilot Program for Retail HACCP
Office of Management and Budget
New Executive Office Building
725 17th Street, NW
Room 10235
Washington, DC 20503
Dear Sir or Madam:
We are pleased to respond to the Federal Register notice announcing that the Food and Drug Administration (FDA) has submitted an information collection proposal to the Office of Management and Budget (OMB) in conjunction with a proposed voluntary pilot program that would employ Hazard Analysis Critical Control Point (HACCP) principles in retail food operations. 64 Fed. Reg. 49812 (Sept. 14, 1999). Based on our communications with the Agency, we understand that the purpose of the information collection is simply to allow FDA to obtain feedback from food retailers regarding the food safety programs that retailers have found to be effective, and that is not intended to be the first step toward a mandatory retail HACCP program.
Although we support the Agency's goal of obtaining information from industry regarding effective programs, we do not believe that FDA has met its burden under the Paperwork Reduction Act. Accordingly, OMB should not approve the proposed information collection at this time. Instead, we recommend that FDA work with industry to establish a Retail Advisory Committee, comprised of representatives from the various food retail sectors, government, and academia; a Retail Advisory Committee would be an appropriate forum for exchanging information without burdening industry.
FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $220 billion, which accounts for more than half of all grocery sales in the United States. FMI's retail membership is composed of large multi-store chains, small regional firms, and independent supermarkets. Our international membership includes 200 members from 60 countries
The Paperwork Reduction Act prohibits federal agencies from conducting or sponsoring a collection of information without first obtaining the approval of OMB. 44 U.S.C. § 3507. To obtain OMB approval of a collection of information, FDA must demonstrate that the Agency has taken every reasonable step to ensure that the proposed collection of information meets the following criteria: (1) is the least burdensome necessary; (2) does not duplicate information otherwise accessible to the Agency; and (3) has practical utility. 5 C.F.R. § 1320.5(d). FDA has not met its burdens in this regard; therefore, OMB must not approve the information collection request.
FDA must demonstrate that the information collection request is the least burdensome means of obtaining information regarding retail food safety programs. In fact, we believe that the development of a Retail Advisory Committee would provide the Agency with information on current industry retail food safety programs without burdening individual retailers with the proposed pilot program and attendant information collection. A Committee of this nature would also be able to provide information on a broader cross-section of retail activities than might be obtained from 50 self-selected program participants.
FMI and its members are committed to developing effective food safety programs for retail food stores. In this regard, and as FDA knows, the retail food sector is working to develop food safety models to explore the feasibility of using a HACCP-based approach at retail. A study of these models is scheduled to begin early in 2000 (after the 1999-2000 holiday season). Data from the study will be made available to interested parties, including FDA, and is the type of information that would best be disclosed and discussed through a mechanism such as a Retail Advisory Committee. Accordingly, the Agency's proposed information collection duplicates information that will be available to FDA shortly.
FDA has not provided sufficient information on the pilot program to allow OMB to assess whether the information that will be generated will have "practical utility." Specifically, the Agency states only that, "[T]he retail pilot participants will maintain a food safety program based upon HACCP principles for the duration of the pilot," and that FDA will study the information and data generated as a result. 64 Fed. Reg. at 49812. According to FDA's notice, the purpose of the pilot is "to encourage voluntary evolution of retail HACCP plans with the involvement of all stakeholders." 64 Fed. Reg. at 49813.
Without a more complete description of the proposed pilot and the specific information that the Agency intends to collect under the pilot, neither we nor OMB can assess its practical utility. However, given the current status of HACCP in the retail environment, we believe that the proposed pilot program and attendant information collection are premature. Specifically, a consensus regarding the scope and utility of HACCP at retail should be developed through a collaboration among FDA, academia, industry and trade associations to better define the scope of HACCP and any pilot program before the Agency imposes recordkeeping burdens on the retail sector.
FDA has provided minimal information regarding the particular recordkeeping requirements that would be imposed as a result of the proposed information collection. Accordingly, it is difficult to assess the accuracy of the Agency's burden estimate, especially in the absence of any substantiation from FDA regarding the basis for its estimate.
Specifically, FDA states that the agency "is seeking information through the pilot program on the amount and extent of recordkeeping that retail establishments have determined necessary to effectively implement and manage their systems" and that "each industry participant will determine the amount and type of records it needs to effectively verify that its system is working." 64 Fed. Reg. at 49813. No specific information is given regarding the particular type of recordkeeping that will be required; for example, any or all of the following might be required: hourly monitoring of the temperature in each refrigerator or freezer storage case; regular monitoring of temperature of each prepared food item; on-going monitoring of equipment cleanliness; and routine monitoring of equipment functionality.
Nonetheless, FDA estimates that the annual recordkeeping burden will be 7,000; the units are unclear, but the heading for the column in which the burden is estimated is "annual frequency per recordkeeping." Seven thousand records per year corresponds to 19 records per day. FDA estimates that each record will require 0.05 hours (or 3 minutes) to complete. Again, without further information on the types of recordkeeping that will be required, we cannot fully assess the accuracy of either the overall number of records that will be required or the time commitment that will be necessitated for each record entry. However, based on FDA's own seafood HACCP program, the recordkeeping burdens estimated by FDA for retail HACCP seem unrealistically low.
Section 1320.5(d)(2)(viii) prohibits OMB from approving a collection of information requiring respondents to submit proprietary, trade secret or other confidential information, unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law. In response to comments received from the National Restaurant Association expressing concern about this very issue, FDA responded that confidentiality agreements would be signed by involved parties and that the names and locations of the participating firms would be held as proprietary, unless authorized for release. 64 Fed. Reg. at 49813. Our members are concerned that these procedures will not adequately protect proprietary retailer information.
Section 1320.9(f) requires the agency to certify that each recordkeeping requirement indicates the length of time persons are required to maintain the records specified. FDA has not specified the length of time for which food retailers in the pilot program will be required to maintain records.
Section 1320.9(c)(1) requires the agency to certify that the collection of information reduces to the extent practicable the burdens on persons who shall provide information, including, with respect to small entities, the use of such techniques as establishing differing compliance or reporting requirements or timetables that consider the resources available to those who respond. Although FDA states that the Agency intends to encourage a full range of food retailers to participate, FDA has not discussed or considered methods to reduce the reporting requirements for smaller businesses. Rather, the implication is that small businesses can either choose to undertake the burdens that would be required by the pilot or not to participate at all. However, given the Agency's assertion that participation of small businesses is important, some accommodations should be made to allow these companies to participate.
For the foregoing reasons, we urge OMB to disapprove FDA's proposed information collection for the voluntary retail HACCP pilot program.
Sincerely,
George Green
Vice President
General Counsel
cc:Les Bluhm, FDA
John Kvenberg, FDA