Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, Maryland 20852

Re: 2001 Program Priorities for the Center for Food Safety and Applied Nutrition (Docket No. 98N-0359)

Dear Sir or Madam:

The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration’s (FDA’s) request for comments concerning the establishment of program priorities for the Center for Food Safety and Applied Nutrition (CFSAN) in the year 2001. 65 Fed. Reg. 39415 (June 26, 2000). We agree that the touchstone for the priority-setting process should be benefit to the consumer. Id. at 39415. With this in mind, we have recommended means to improve food safety, clarify labeling to inform consumers, and increase consumer education programs. In addition, we have made two suggestions regarding improvements to the regulatory process. Finally, we urge the Agency to issue a proposal to improve the regulatory oversight system for foods produced through biotechnology. Our recommendations are discussed more fully below and generally follow the outline of CFSAN’s 2000 Program Priorities document.

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 $300 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.

I. Food Safety Initiative

A. Clearance of Irradiation for Ready-to-Eat Foods(CFSAN § I. 1.2. Risk Management)

Irradiation is an important tool in the effort to improve the safety of the food supply.   We were pleased that the Agency revisited the issue of labeling irradiated foods last year. In response to FDA’s advance notice of proposed rulemaking (64 Fed. Reg. 7834 (Feb. 17, 1999)), we expressed our support for the use of informative labeling to advise consumers that certain foods have been irradiated. Moreover, we recommended that FDA clarify the regulation to expressly permit the use of labeling that connects the irradiation process with its benefits, e.g., “Irradiated to kill harmful bacteria.”

With respect to ready-to-eat foods, FMI is pleased to be a member of the Food Irradiation Coalition, which submitted a petition to FDA last August. The petition asks the Agency to amend the food additive regulations to permit the use of irradiation in the treatment of certain refrigerated, frozen, or dried food products derived from meat, poultry, fruits or vegetables to help control microbial pathogens and infectious protozoa. We urge the Agency to review and act on the petition quickly so that irradiation will be available as a food safety tool for ready-to-eat food products.

An equally important element to ensuring the ultimate use of irradiation will be educating consumers about the benefits of irradiation and de-bunking the myths that have developed around food irradiation. In this regard, we have welcomed the opportunity to assist the Agency in the development of an educational brochure. However, we recognize that more extensive educational efforts are likely to be necessary before the public will accept irradiation as a food safety tool without reservation.

B. Safety of Imported Produce
(CFSAN § I. 1.2. A.2. Imports)

In keeping with the Government Accounting Office’s recommendations, FDA should develop a comprehensive surveillance system for monitoring imported produce at U.S. borders. See, e.g., “Food Safety: Opportunities to Redirect Federal Resources and Funds Can Enhance Effectiveness” (GAO/RCED-92-224, August 1998). However, an effective program cannot simply begin and end there; FDA must develop and implement a program to evaluate foreign food regulatory systems and to inspect processing plants and production facilities in other countries. That is, the Agency should not neglect the “farm” end of the farm-to-table continuum for imported produce. Ensuring that imported fruits and vegetables are produced in accordance with sound food safety principles will shift the emphasis to preventing food safety problems rather than simply trying to detect them at U.S. borders.

C. Food Code
(CFSAN § I. 1.2. A.6. Food Code)

The CFSAN 2000 Priorities Program identified two goals for the Food Code: (1) achieving adoption of the Food Code in 35 percent of U.S. states and (2) resolution of controversial issues.

FMI supports the goal of widespread Food Code adoption and we are pleased that twenty states have now adopted the model Food Code. FMI has had a longstanding commitment to the Food Code and its development; a substantial delegation of our food retailer members and FMI staff regularly attend and participate in Conference for Food Protection meetings. Moreover, through FMI’s Food Code Monitoring Project -- a service that we offer to our members -- we have compiled substantial information on the status of Food Code adoption in the fifty states, as well as comparisons of the versions adopted with the model Food Code.1   We urge FDA to continue its commitment to seeking widespread adoption of the Food Code throughout the U.S. in 2001, and we would be pleased to work with the Agency in this undertaking.

Several issues embodied within the Food Code have been challenged repeatedly by industry and regulatory agencies as lacking sufficient scientific justification. These issues include cooling and hot holding temperature parameters, time as a controlling factor and the definition of “potentially hazardous food.”

The Food Code’s definition of “potentially hazardous food” is illustrative of the issue. See U.S. Public Health Service, Food Code § 1-201.10(B)(61) (1999). The Food Code’s definition relies in part on the acidity level and water activity of foods to identify foods that are potentially hazardous. However, the results of recent research and outbreaks indicate that this view does not account for the synergistic effects of additives and preservatives, which may reduce the potential for the food to pose a hazard without otherwise affecting acidity or water activity. The data also suggest that some foods that are currently exempted from the potentially hazardous food definition on the basis of acidity or water activity (e.g., citrus juices, cooked ready-to-eat products, and certain fruits and vegetables) might, in fact, be hazardous.

In response to the challenges raised by regulators and industry, FDA intends to develop position papers that will be incorporated into the Food Code’s annex. However, unless the Food Code itself is amended, any recommendations contained in the annex will not likely receive the proper notice from states that intend to incorporate the Food Code. Therefore, FDA’s proposed resolution will be ineffective. To ensure that the highest scientific standards underlie the Food Code, in 2001, the Agency should commit to resolving the controversial issues through the Conference for Food Protection and amending the Food Code itself accordingly.

D. Produce Risk Assessment
CFSAN § I. 1.3. Risk Assessment and Risk Identification)

FDA should collaborate with USDA and academia to conduct a thorough risk assessment of produce items in order to identify control gaps and determine practical interventions. A comprehensive farm-to-table approach is necessary to ensure the safety of produce since many fruits and vegetables are ready-to-eat foods that may not be cooked prior to consumption. Accordingly, reasonable interventions should be developed and the appropriate points of implementation on the production chain should be identified to ensure the safety of the produce supply. FDA applied this approach in the development of Good Agricultural Practices that can be used at the point of production; the approach should be expanded to the balance of the farm-to-table continuum.

E. Listeria monocytogenes Research
(CFSAN § I. 1.3. A.1. Listeria monocytogenes)

Research should be conducted to determine effective control and detection methods for Listeria monocytogenes (Lm) at the distribution and retail stages of the food production continuum. Although a fair amount of data is available on methods to control Lm at the processing stage, more information is needed on practical interventions with respect to Lm at retail. The risk assessment could also establish acceptable levels of Lm based on product groupings in keeping with similar actions initiated by Canada and Europe. FDA should also continue to support the National Food Processors Foundation Lm survey of isolates taken from foods purchased at retail.

F. Consumer Education
(CFSAN § I. 1.4. Risk Communication, Education, Training)

Food safety education is an essential component of a strong food safety system. In this regard, FMI is proud to be a founding member of the Partnership for Food Safety Education (Partnership), which is responsible for the FightBAC!TM Campaign, as well as many other food safety initiatives, including two educational programs for children in elementary school. We encourage FDA to continue its involvement with the Partnership and to pursue additional food safety education programs, such as the secondary school food safety curriculum mentioned in the 2000 Priorities document.

II. Major Program Areas

A. Assessment of Consumer Warnings and Labeling
(CFSAN § II. 2.2. Nutrition, Health Claims and Labeling)

Under the current regulations, FDA requires or has proposed consumer warning labels on a variety of different food products, such as unpasteurized juice and shell eggs. In addition, the U.S. Department of Agriculture (USDA) requires warning labels on certain meat and poultry products under the Federal Meat Inspection Act and the Poultry Products Inspection Act. Each of the warning labels is visually and substantively different. Although some element of differentiation is necessary, there is little doubt that the multitude of warnings is confusing to consumers overall. The proliferation of warning labels on food and other consumer products has led consumers to discount or disregard the warnings. Moreover, labeling, in and of itself, does little to protect the public health.

Therefore, the Agency should develop a clear and coordinated policy for when and how warning labels are used on foods. Furthermore, FDA should, in conjunction with the other food safety agencies, develop a more uniform design for warning labels for those instances in which the Agency determines that such a label is appropriate. For example, the Partnership for Food Safety, of which FDA is a member, has developed food safety messages and icons that might form the basis for a uniform food safety labeling system.

III. Cross-Cutting Areas

A. Foods Produced through Biotechnology
(CFSAN § II. 3.4. A.1. Biotechnology)

Foods and food ingredients produced through biotechnology have long been part of the U.S. consumer’s diet. These foods have always been and continue to be subject to the stringent adulteration and labeling standards spelled out in the Federal Food, Drug, and Cosmetic Act, which apply to all foods, regardless of the method of production. In response to concern regarding the safety and labeling of foods produced through biotechnology, FDA held a series of public hearings over the past year and, in May, announced the outline of an enhanced regulatory oversight system for these foods.

In FY 2001, we urge FDA to adopt a system that will require pre-market review of biotech foods and ingredients to ensure continued consumer confidence in the food supply. Moreover, we recommend that FDA issue a guidance document for a voluntary labeling program that substantially reflects the petition submitted to the Agency in May, 2000 by FMI, the Grocery Manufacturers of America, and several allied food industry trade associations. We further urge FDA to enhance the transparency of the oversight process. Submissions and data should be posted on the Agency’s website so that the public will be fully apprised.

Perhaps most importantly, FDA must take responsibility for its policy and provide clear information to the public on the safety and regulation of biotech foods. Overall food safety is a primary mission of the Food and Drug Administration, which carefully regulates a majority of the daily American diet. In keeping with its overall mission, FDA has invested significant resources in ensuring that foods produced with biotechnology are likewise safe. In FY 2001, FDA must make a renewed commitment to communicate this information directly to the public in a clear and comprehensive manner. To facilitate direct communication with the public, FDA might use any or all of the following methods: posting a clear statement of policy on the Agency’s website; direct interviews with the media; and issuance of an FDA brochure on bioengineered foods that might be offered directly to consumers through a variety of channels, including neighborhood grocery stores.2   

B. Regulatory Process
(CFSAN § III. 3.5. Regulatory Processes)

We recommend the following two additions to the “Regulatory Processes” section of the 2001 program: (1) the development of a Retail Advisory Committee and (2) industry participation in the development of the integrated food safety system program.

1. Retail Advisory Committee

FDA currently receives advice and guidance from several joint advisory committees, some of which serve both FDA and USDA. Given the increased focus on retail food safety issues, we recommend that FDA jointly develop a “Retail Advisory Committee” with USDA’s Food Safety and Inspection Service (FSIS) to provide guidance to the agencies on the operational and practical issues relevant to food safety at the retail level. The Committee might be comprised of members from the supermarket, distribution, restaurant, and food technology industries, along with federal and state regulators, and consumer group representatives.

Existing advisory committees, such as the National Advisory Committee on Microbiological Contamination of Foods (NACMCF), would also benefit from the insight of the retail perspective. For example, the NACMCF recently considered the merits of gloved and bare-hand contact of food in the retail setting. However, none of the committee members represents the retail sector. In light of the growing attention that food safety in the retail setting is receiving at the federal level, an increased presence of retail members on the federal advisory committees will help to formulate better food safety recommendations and bring new knowledge and expertise not currently available on the federal committees. Increased expertise will help to ensure that our food safety system will continue to provide safe food for consumers.

2. Integrated Food Safety System

FDA and AFDO are cooperating in the development of an integrated food safety system that will incorporate and define the roles of the federal, state, and local agencies in the pursuit of food safety at retail. As we understand it, under the integrated system, FDA will develop and clarify uniform policies, and the state and local governments will take the lead in enforcing those policies. The purpose of the system is to identify and eliminate redundancies.

FMI agrees that the approach set forth under the integrated food safety system is a sound one. However, we also believe that industry should assist in the development of the program. Industry participation would assure that the resulting programs are applicable to “real-world” food retail settings, and that they are clearly understood by the industry. Participation by industry members will also establish industry “buy-in” to greater assure the success of the program. A better overall program can be achieved by government/industry collaboration. As a program priority for 2001, CFSAN should commit to the development of the integrated food safety system and should permit industry to assist in this endeavor. A strong program will best ensure food safety for the consumer.

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We trust that you will agree that CFSAN should attend to the areas identified above in 2001 in order to further strengthen the food safety system for consumers. We hope that you will incorporate these issues into the coming year’s workplan. If you have any questions regarding our recommendations, or if we may be of assistance in any way, please do not hesitate to call on us.

Sincerely,



Tim Hammonds
President and CEO

Enclosure



1   We are pleased to note that the Agency intends to work with Association of Food and Drug Officials (AFDO) to survey state and local jurisdictions regarding their adoption of the Food Code. 65 Fed. Reg. 47736 (Aug. 3, 2000). If we may be of assistance via our Food Code Monitoring Project or in any other way, we would be pleased to help.

2   For your information, we have enclosed a copy of “Bioengineered Food and You,” a pamphlet prepared by FMI and distributed to consumers by our members. The brochure prominently features FDA’s policy and website information.