CFSAN Priority-Setting Meeting Summary June 24-25, 1998
Dr. Friedman, Acting FDA Commissioner, opened the meeting and welcomed attendees. He talked about the increasingly complex task the agency faces in ensuring the safety of the nation’s food supply -- e.g., the vast increase in the number of imported products; the emergence of new foodborne microorganisms; and changes in the demographics of our population as we age and as we eat out more. All of this focuses attention on the Center for Food Safety and Applied Nutrition (CFSAN), its mission and its resource needs. In the absence of sufficient resources, program priorities must be established and the priorities must be balanced, risk-based, and focussed on protection of public health.
Dr. Friedman noted that this meeting serves as one of many activities undertaken by the agency to solicit input in accordance with section 406(b) of the Food and Drug Administration Modernization Act (FDAMA) of 1997. Section 406(b) states that within one year of enactment (i.e., November 1998), "the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act." A public docket has been established (98N-0339) for the submission of comments on this plan from FDA’s stakeholders.
Speaking globally, Dr. Friedman asked the audience to think about FDA’s mission to promote and protect the public health, and to help the agency find the right combination of initiatives and improvements that can advance our mission. He highlighted several areas that have been identified agencywide as deserving considerably greater attention: (1) in the area of application reviews, we need to find solutions to gaps posed by the steadily rising workload in the face of static budget projections; (2) we need to find better, smarter, faster ways to ensure the safety and quality of the marketed products that are under our jurisdiction; (3) we need to improve the reporting of adverse events and injuries; (4) we need greater scientific expertise; and (5) we need to continue to reach out to our stakeholders and provide reliable, understandable information about the products we regulate.
Mr. Levitt, CFSAN Director, spoke about the allocation of resources in the Center since 1978, the year in which resources were at a peak. He pointed out that the number of full time equivalent (FTE) positions had decreased 20% since the peak in 1978 -- from 995 FTE’s to 791 FTE’s. Moreover, if increases targeted to specific program areas -- imports, seafood, nutrition labeling, and the food safety initiative -- are excluded, the Center’s base resources have declined by a third (995 to 666). Furthermore, during this 20-year timeframe, CFSAN received many new responsibilities resulting from the enactment of significant new legislation: the Infant Formula Act in 1980; the Pesticide Monitoring Improvements Act in 1988; the Nutrition Labeling and Education Act in 1990; the Dietary Supplement in 1992; the Dietary Supplement Health and Education Act in 1994; the Food Quality Protection Act of 1996; and most recently, FDAMA in 1997. The Center is also encumbered with many new responsibilities as a result of international trade agreements and government-wide mandates such as the Regulatory Flexibility Act. Accordingly, Mr. Levitt stated that there is clearly a gap between resource availability and reasonable work product expectations. Mr. Levitt emphasized the need to have an open and participatory priority-setting process. Throughout the process, he stressed the importance of keeping focused on where we do the most good for consumers.
By way of example, Mr. Levitt reviewed how work priorities are assigned in the regulations program. The highest priority are those regulations that enhance consumer safety, such as those issued to carry out the President’s Food Safety Initiative (FSI); second, those regulations that are mandated by statute; third, health-related product labeling regulations; fourth, regulations that will improve efficiency of operations; and lastly, those additional regulations that have a major positive impact.
Before commencing with the first panel, Mr. Levitt reiterated that at this time, the Center is most interested in receiving comments regarding program priorities outside of FSI, as other venues have been available for interested persons to provide input regarding implementation of the initiative across the Federal Government. Lastly, Mr. Levitt reviewed the six questions outlined in the Federal Register notice announcing the meeting. Oral and written comments on CFSAN program priorities should address these questions:
- With respect to products under the jurisdiction of CFSAN, do you believe there are issues that directly affect consumer safety that are not being adequately addressed?
- Beyond implementation of FSI, which program areas and/or activities do you believe should be top priorities for CFSAN and why?
- Should the same criteria used to prioritize CFSAN’s regulations be used in other CFSAN program areas?
- What areas should be the highest priority for conducting research?
- What level of priority do you believe should be given to international activities?
- What level of priority should be given to addressing issues of economic fraud in the food supply?
Lastly, Mr. Levitt noted that the public docket (98N-0359) would remain open for the submission of written comments until July 15, 1998.
Panel 1 -- State Affiliations
Association of Food and Drug Officials: Mr. Corby began by discussing AFDO’s vision for a vertically integrated national food safety effort. Success of the vertical (i.e., top-to-bottom) system starts with federal leadership -- i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors, etc. In return, the states will conduct inspections, investigate consumer complaints, analyze samples, etc. AFDO agrees that FSI is the Center’s highest priority and strongly supports activities that implement the initiative. Beyond FSI, AFDO made the following recommendations:
CFSAN must be the scientific leader in food safety and must respond to requests for assistance from the states in a timely manner.
CFSAN must be adequately funded and staffed to conduct research because research provides the greatest opportunity to be proactive.
CFSAN should reassemble the HACCP core committee to determine whether a universal HACCP regulation for the food processing industry is warranted.
CFSAN should redirect resources for economic fraud and mislabeling issues.
CFSAN should work with state programs to monitor imported foods. Mr. Corby noted that in AFDO"s vision of a vertically integrated regulatory system, FDA should devote more attention to imports while states deal more with domestic concerns.
In closing, Mr. Corby stated his belief that partnerships and cooperative agreements are only effective on an interim basis and that a new framework and additional funding will be needed to fully implement a vertically integrated national food safety regulatory system.
International Shellfish Sanitation Conference: Mr. Moore addressed the six questions in the FR notice:
- Regarding safety, Mr. Moore identified three issues that continue to warrant considerable attention: sporadic outbreaks of Norwalk virus from overboard discharge of human waste; Virbrio vulnificus; and Vibrio parahemolyticus.
- Beyond FSI, highest priority programs should be product safety assurance and outreach, and activities that support these programs such as research and enforcement.
- Regarding criteria for prioritizing programs, highest priority should be programs that affect the health of the general population.
- Highest priority for research should be alternative indicators; rapid methods for specific pathogens; biotoxin identification; and risk-assessment models.
- International activities should be a high priority because of the increasing number of imported foods. Mr. Moore noted that states can’t adequately assess the safety of imported foods. Of particular concern is the safety of imported thermally processed shellfish, the effectiveness of processing practices and the adequacy of biotoxin monitoring in foreign countries.
- Economic fraud issues that have food safety implications should also have a high priority.
Mr. Moore mentioned two shellfish-specific priorities: HACCP implementation, and development of program evaluation criteria and training to ensure consistency and uniformity in state programs. Mr. Moore concluded by saying that a key to success of FSI and HACCP was for the Center to nurture relationships in cooperative programs.
Panel 2 - Broad-Based Trade Associations
American Frozen Food Institute: Mr. Garfield stated that CFSAN needed a uniform, consistent approach to address risks of public health significance. He recommended that the Center follow five principles in its priority-setting process: (1) base efforts to reduce risk on science and fact-based risk assessments; (2) adopt flexible and responsive regulations that encourage research and innovation.; (3) recognize that industry is responsible for the integrity of its products; (4) seek clear, consistent and performance-based regulations; (5) educate all food handlers in the distribution chain on food safety practices.
For example, Mr. Garfield questioned why FDA proposed to mandate HACCP for all juice products since most are pasteurized, and not a public health risk. He suggested that concerns with juice could be addressed through GMP’s, voluntary HACCP programs, and federal and state inspection programs.
In establishing priorities, Mr.Garfield urged the Center to rely more on scientific and fact-based risk assessments in deciding which issues directly affect consumer safety. He specifically identified three areas that he believes warrant high priority for the Center: (1) streamlining the process for approval of food and color additive petitions; (2) modifying food standards that are out-of-date and inhibit innovation; and (3) strengthening CFSAN’s leadership role in Codex activities. Lastly, on the question of research, Mr. Garfield urged the Center to make the development and application of methods to quantify exposure and risk a high priority.
Grocery Manufacturers of America: In his opening remarks, Mr. Ziller encouraged the Center to work cooperatively, efficiently, and effectively with other government bodies, the states, and food industry to address key food safety and regulatory issues. Mr. Ziller stressed six key points for CFSAN’s consideration in its priority-setting:
- Major decisions on prioritization of food safety issues should be based on sound science and risk assessment.
- Greater research efforts should be focussed on emerging foodborne pathogens, quantitative risk assessment, practical detection methods, faster analysis, and identification of sources and the means of prevention of contamination in foods with pathogens. Mr. Ziller stressed the importance of working cooperatively to avoid duplication and to identify where gaps may be filled outside FDA.
- Greater and more effective food safety educational efforts for food preparers and food service at retail and in the home should be undertaken.
- Health contributions in the diet for maintaining health and preventing disease should have as high a priority as food safety concerns. Accordingly, Mr. Ziller recommended changing the first priority to "enhance consumer health and safety."
- Efforts must be made to harmonize the regulation of the global food supply for the benefit of consumer health and safety as well as the facilitation of U.S. food trade. Accordingly, CFSAN should devote increased resources to Codex activities.
- FDA should modernize food standards and exercise a visible and effective enforcement presence where there is egregious economic fraud, such as in the adulteration of high value juices.
National Fisheries Institute: In response to the first question about safety issues, Mr. Collette recommended that the Center re-evaluate the provision of seafood HACCP which exempts fishing vessels that do not process their catch. As some fishing vessel operators sell directly to consumers, retail food stores and/or restaurants, he believes they should be covered by the HACCP regulation.
Mr. Collette suggested that research and education be two of the Center’s highest priority programs and that they be undertaken in cooperation with academia and industry. Development of a uniform curriculum by the Seafood-HACCP Alliance to train industry and FDA investigators in the principles of HACCP was mentioned as an excellent example of a collaborative educational effort. Mr. Collette urged that a high priority also be given to development of educational programs for consumers, with a special emphasis on reaching children, young adults, and other vulnerable populations. With respect to research, Mr. Collette stated his belief that research on risk assessment be as high a priority as research of methods development.
In the international arena, Mr. Collette recommended that FDA play an active role in Codex to ensure that international standards and guidelines are consistent with U.S. requirements, and that FDA move aggressively to negotiate effective international agreements for on-site seafood HACCP inspections. Lastly, Mr. Collette urged CFSAN to enhance oversight of economic violations.
Panel 3 -- Consumers
Center for Science in the Public Interest: Dr. Jacobson endorsed FSI as the Center’s top priority and added that he believes the Center needs more authority and money to effectively implement the initiative. Outside of FSI, Dr. Jacobson urged the Center to consider the health impact of its programs and in areas that may not directly affect health, that FDA protect consumers against deception and economic harm. More specifically, Dr. Jacobson recommended that improving the nutritional quality of the American diet be a top CFSAN priority. In this context, he made three recommendations for CFSAN action: (1) improve nutrition labeling to include trans-fat on the label; (2) promptly approve well-founded health claims that would promote an overall healthier diet; and (3) take action against deceptive label claims.
Regarding dietary supplements, CSPI recommended that CFSAN build a record detailing the need for greater authority to protect the public from unsafe and misleadingly labeled products. In the area of food additives, Dr. Jacobson stated that FDA’s approval process lacked sufficient rigor. He urged the agency to defend the Delaney clause and to carefully scrutinize GRAS substances.
On broader issues, Dr. Jacobson recommended that the Center reconstitute its Food Advisory Committee to increase its credibility and to include consumer activists for balance. In the area of international affairs, Dr. Jacobson cautioned the Center to ensure that trade concerns do not supercede health concerns and that safety and labeling standards be harmonized in an upward fashion to reflect the best consumer protection and public health requirements from around the world. With respect to food standards, Dr. Jacobson stated that they should not be eliminated -- consumers need food standards and most of the industry supports them.
Lastly, Dr. Jacobson urged the Center to seek additional funding, either through general revenues or by imposing registration fees on food manufacturers. In the meantime, he urged the Center to publicize the fact that it cannot adequately do its job without additional resources.
Panel 4 -- Food Additives
Enzyme Technical Association: Ms. Zeman identified four activities that she believes should be a high priority for the Center:
- CFSAN should conclude its review of GRAS petition 3G0016, a petition that seeks GRAS affirmation for many enzymes used in biotechnology.
- CFSAN should finalize the GRAS notification regulation. Ms. Zeman stated that the GRAS petition process is too resource-intensive and should be replaced with a more streamlined notification system.
- CFSAN should continue its consultation program for biotechnology products.
- CFSAN should immediately renew its contract with the Food Chemicals Codex. She stated that the Food Chemicals Codex will be totally unfunded as of October, 1998. If this ceased to exist or is not updated, Ms. Zeman stated that the agency would need to revise all regulations that reference the Codex and continuously monitor the specifications and methodologies contained in those revisions.
Calorie Control Council: Mr. Cristol urged CFSAN to adopt as its highest priority the approval of new food additives and approval of additional uses of approved food additives. He also urged the Center to pay increased attention to the affirmation of long-pending GRAS petitions. He noted support for a simplified GRAS notification procedure that would allow FDA to redirect resources from the GRAS affirmation process to the food additive approval process, but he thought the traditional process should remain as an option. Mr. Cristol also urged the Center to expedite approval of appropriate nutrient content and health claim petitions and citizens’ petitions related to food labeling. Lastly, Mr. Cristol noted that it is critical for FDA to promote harmonization and that improved leadership in the Codex would be most helpful.
Alliance of Food Additive Producers: On behalf of eight companies that produce the majority of food additives, Ms. Graves-Moore stated that the Center needs to significantly improve its food additive approval process. She stated the current system lacks efficiency, predictability and accountability and committed resources necessary to approve new food additives. To this end, the Alliance of Food Additive Producers strongly supports legislation that would amend the food additive rulemaking process, establish specific agency performance goals and authorize user fees for the sole purpose of food additive review and approval. Ms. Graves-Moore noted that the Alliance’s proposal does not change the safety standard or FDA’s scientific approach to safety evaluations but would improve timeliness and predictability. With regards to specific process efficiencies, Ms. Graves-Moore noted that enhanced communication would be the goal, with greater emphasis on pre-submission consultations. They would also envision an informal rulemaking process to replace the current formal rulemaking process, a change that would need legislation.
Panel 5 - Cosmetics
Cosmetic, Toiletry and Fragrance Association: Mr. Kavanaugh expressed disappointment with recent budget cuts in the Center’s cosmetics program. It is his belief that the cuts would undermine what has been an effective and credible cosmetic regulatory program. He stated that CTFA would support efforts to obtain additional funds that are necessary to maintain a credible cosmetic program, including additional field resources. A particular concern is that program cuts may limit the Center’s ability to participate in the Cosmetic Ingredient Review. Mr. Kavanaugh believes that a credible program must include compliance, safety and science. The most important of these being compliance. Mr. Kavanaugh urged the Center to reverse its decision to cancel inspection and compliance programs for cosmetics.
Mr. Kavanaugh hopes to see voluntary industry programs expanded and strengthened, particularly the Voluntary Cosmetic Reporting Program. Lastly, Mr. Kavanaugh stated that the Center should give top priority to international activities to ensure that FDA maintains the international leadership required to foster harmonization of regulatory requirements for cosmetics throughout the world.
Independent Cosmetic Manufacturers and Distributors Association: Ms. Jones and Ms. Baden addressed the questions in the June 3 FR notice:
- Regarding safety, she stated her belief that failure to restore adequate funding to the Center’s cosmetics program will directly affect consumer safety. Specifically, she discussed the impact of the 1996 decision to eliminate the adverse reaction reporting part of the voluntary reporting program.
- Regarding priorities, Ms. Jones noted that adequate funding of the cosmetics and colors program should be a top priority.
- While Ms. Jones agreed with the priority-setting criteria used in the regulations program, she added that the Center should also consider as a priority those activities that minimize consumer deception.
- With respect to research, Ms. Baden stated that the highest priority should be to obtain adequate research funding.
- Ms. Baden also noted that additional funds are necessary for the Center to effectively address international issues.
Panel 6 - Focused Trade Associations
International Dairy Foods Association: Ms. Frye stated that she does not believe a mandatory HACCP program should be enacted for dairy products.
She noted that the Federal-State cooperative programs for milk have been successful but could be improved by utilizing science-based concepts to evaluate food safety. She would like to see the programs move away from check-list inspections and prescriptive plant processing regulations and more towards a voluntary HACCP-based system.
With respect to the questions, Ms. Frye offered the following comments:
- Regarding safety – Ms. Frye discussed imported foods and stated that the Center needs to give a high priority to reducing the risk to consumers from imported foods.
- Regarding priority programs -- Ms. Frye discussed the need for more educational programs for consumers and food handlers. She also stated that health-related product labeling should be given a higher priority, particularly updating standards of identity and review of health claim petitions.
- Ms. Frye stated that she agrees with the priority-setting criteria being used in the regulations program.
- In terms of research, Ms. Frye stated that research or modeling in the areas of infectious dose for pathogens should be considered. She stated her belief that the Center’s zero tolerance policy for pathogens in food does not always reflect the current scientific information.
- Ms. Frye noted support for the Center’s international programs and commented that additional resources are required to adequately participate in Codex and other international activities.
In Flight Food Service Association: Mr. Simpson was very complimentary of the Center’s cooperative food programs. He expressed concern regarding discussions to relocate the program and delegate more authority to the states. Mr. Simpson discussed the IFFSA-FDA HACCP pilot project and stated that its success is due to the fact that it is process-based, rather than product-based. Mr. Simpson supports HACCP as a voluntary program and he encouraged the Center to expand the pilot to other FDA regions and to use it as a model for HACCP retail.
One concern expressed by Mr. Simpson is the need for additional funding for the Center. A second concern is what he believes to be a lack of visibility for the retail food and interstate travel programs. Mr. Simpson stated that these programs need FDA oversight to be effective. In terms of program priorities, Mr. Simpson pushed for adoption by states of the 1997 Food Code.
International Sprout Growers: Ms. Snyder urged FDA to rapidly approve irradiation of sprouts to eradicate E. coli 0157:H7 and salmonella when the data is presented to the Agency for approval. Ms. Snyder also urged FDA to approve more antimicrobials to help ensure food safety. Ms. Snyder discussed research at MOD1 for use of hydrogen peroxide to sanitize seed and urged that such research be continued. Lastly, Ms. Snyder discussed the sprout industry’s voluntary HACCP plan.
Panel 7 - Nutrition/Dietary Supplements
Council for Responsible Nutrition: Dr. Dickinson stated that the industry is committed to be more proactive in terms of self-regulation in order to take some of the burden off FDA in dealing with dietary supplements. Dr. Dickinson recommended two actions in order for a self-regulatory system to thrive: (1) nutrition labeling and (2) GMP’s for dietary supplements.
Regarding statements of nutritional support, Dr. Dickinson criticized FDA’s proposed rule because it broadened the definition of disease and it embraced a medical model of disease rather than the fully emergent model of health promotion and disease prevention. Dr. Dickinson noted that industry and consumers need a strong regulatory presence and there needs to be swift enforcement when unanticipated questions arise regarding the safety of dietary supplements. She believes the recent issue involving plantains contaminated with digitalis was a good example of swift cooperative efforts. In contrast, Dr. Dickinson stated that the situation with ephedra is not being adequately addressed. Dr. Dickinson urged the Center to improve its handling of adverse event reports so the industry can be involved earlier when problems are identified. She also stressed the importance of the Center’s active involvement in risk assessment and international activities. Lastly, Dr. Dickinson encouraged the Center to establish a dietary supplement advisory committee.
Nutrition Network Inc.: Ms. Rainey encouraged the Center to give high priority to approval and review of nutrient databases in high priority and to convey the economic importance to the food industry of having nutrient databases. Ms. Rainey discussed nutrient databases submitted by the Dairy Board and the National Potato Board as illustrative examples of how dynamic information about the data (i.e., sample collection, lab analyses and math used to summarize the results) necessitates continual monitoring/updating of the databases.
National Nutritional Foods Association: Mr. Ford disputed allegations he has heard that FDA does not have adequate authority to regulate dietary supplements. He cited the various enforcement mechanisms authorized by the Dietary Supplement Health and Education Act (DSHEA). Mr. Ford stated that criteria for new and continuing membership in NNFA will be adherence to GMP’s.
In the area of international activities, Mr. Ford commended CFSAN on Codex activities for health claims and suggested that the U.S. Trade Representative Office be invited to Codex meetings. He also commented that he fully supports the Center’s plans to extend the FDAMA provision on health and nutrient content claims based on an authoritative statement to dietary supplements. Mr. Ford echoed Dr. Dickinson’s comments about improving the handling of adverse event reports and working more closely with the industry on postmarket surveillance and tracking of adverse reaction reports when problems arise. Lastly, Mr. Ford supported a recommendation in the President’s Commission on Dietary Supplement Labels that an option be made available for dietary supplements to make a more direct health claim through the OTC designation.
Panel 8 - Trade Associations
National Food Processors Association: With respect to FSI, Mr. Cady stated that high priority should be devoted to research, risk assessment, and education. Outside of FSI, Mr. Cady recommended several actions that should be a high priority for CFSAN:
- Mandate that fruit and vegetable juices be pasteurized, or otherwise processed, to ensure their safety.
- Implement HACCP regulations for foods with a demonstrated high risk (e.g., unpasteurized juice but not pasteurized juice).
- Reform the food additive review process.
- Improve international food safety standards through cooperation in Codex.
- Promote national uniformity and harmonization among federal and state agencies.
- Continue the food standards program.
- Prevent economic fraud.
Lastly, Mr. Cady urged the Administration and Department to make CFSAN funding a high priority.
The Society of Plastics Industries, Inc.: Mr. Heckman and Mr. Brown urged FDA to implement the notification system for food contact substances created by the Food and Drug Administration Modernization Act of 1997. They stated that, while the packaging industry is willing to pay reasonable fees to cover the cost of processing the notifications, they are still working with Congress to obtain necessary funding or approval of user fees for the program. Mr. Brown suggested that the Center initiate a pilot study by taking petitions or threshold of regulation requests from the current backlog and processing them through the review portions of the proposed food contact notification program.
Apple Processors Association: Mr. Weller recommended that the Center focus its priorities in three areas:
First, on identification of valid food safety problems. Mr. Weller stated that FDA should target the problem; find the most effective remedy; and act quickly to implement the remedy. Mr. Weller believes that the proposal for juice HACCP is an example of FDA’s failure to target the industry that poses the greatest risk, i.e., the fresh fruit juice processors that do not pasteurize their products. Mr. Weller recommended that FDA require all fresh juice processors to pasteurize, or otherwise process their products.
Second, FDA should target programs that ensure that consumers know what they are buying. Mr. Weller stated that FDA should maintain a strict interpretation of the law vis-à-vis food labels and that FDA should take necessary steps to enforce compliance with the law. If FDA acted quickly and decisively in cases of mislabeled products, both FDA and the industry would gain through increased consumer confidence.
Lastly, FDA should adopt a science-based policy on health claims and labeling. Moreover, Mr. Weller stated that health claims should be supported by statements made by federal agencies.
Panel 9 - Health Professional Organizations
American Heart Association: Ms. Johnson stated that CFSAN leadership plays a vital role on diet and health. Her comments focussed on implementation of the FDA Modernization Act of 1997, particularly the provision related to health and nutrient content claims. Ms. Johnson applauded the recently issued guidance on this issue. She urged the Center to place notifications for health claims in a public docket in order that interested parties like the AHA can review the submission and provide comments to the agency on the scientific validity of the claim. Ms. Johnson also spoke of the need for adequate resources to review the notifications.
American Dietetic Association: Ms. Fox urged the Center to continue and strengthen efforts surrounding dietary supplements. Areas needing specific attention include regulations addressing GMP’s and labeling issues. Ms. Fox spoke of the trend towards consumers seeking more health-related information from health care providers other than physicians. It is important that these health professionals -- e.g., registered dieticians -- have accurate information about the appropriate use of supplements. Accordingly, Ms. Fox encouraged the Center to optimize its resources by working with others, such as the ADA, the AHA, and NIH’s Office of Dietary Supplements, in developing effective communication strategies about dietary supplements for use by health professionals such as registered dieticians.
Regarding priority research areas, Ms. Fox stated a need for more research in the consumer arena. Specifically, more data regarding consumer perception of labeling information on foods and dietary supplements. Ms. Fox noted that the responsibility for conducting research should be a shared between FDA, the food and dietary supplement industry, and other organizations. Lastly, Ms. Fox suggested that the Center consider requiring consumer research as a component of substantiation files for dietary supplements.
Panel 10 - Companies
Viskase Corporation: Mr. Higgins was very complimentary of the openness and responsiveness of CFSAN staff. Mr. Higgins discussed two programs that he believes should have a high priority: threshold of regulation determinations for food packaging and certificates of free sale. In both programs, he spoke about the value of opinion letters, phone calls, small meetings and large meetings. All are important options that should remain available for industry to communicate with FDA.
Summary of Written Comments
Association of Food and Drug Officials: In addition to AFDO's oral presentation, written comments were submitted that addressed four additional points:
- Dietary Supplements: FDA should dedicate enough resources to the safety of dietary supplements to ensure that only safe products are manufactured and distributed for human consumption. To conserve resources, AFDO recommends that FDA consider partnerships with industry groups in the evaluation of dietary supplements.
- Codex: FDA should play an important role in ensuring that U.S. standards are not lowered due to pressure from the EU and other international bodies. AFDO further recommends that the U.S. delegation to Codex include state issues in their deliberations.
- Adverse Event Reports: CFSAN should continue to collect adverse event reports and utilize the reports to determine when/what products pose unreasonable risk to the public. CFSAN should also pursue means for expanding the methods of collection of such reports.
- Sample Analysis Data Collection: CFSAN should work with state programs and devise a system for collection and compilation of food product samples that involve food safety such as pathogen testing and HACCP verification sampling. Such a database would be critical for establishing a vertically integrated national food safety system.
National Association of Chewing Gum Manufacturers: The National Association of Chewing Gum Manufacturers (NACGM) notes the importance that FDA plays in ensuring food safety, both domestically and internationally through its influence in international standard setting activities and by financially supporting the Food Chemicals Codex. NACGM recommends that continued funding of the Food Chemicals Codex be a high priority.
The Society of Plastics Industry, Inc. The Society of Plastics Industry, Inc. supplemented their oral remarks with written comments urging FDA to implement the notification system for food contact substances created by FDAMA. They suggested that CFSAN conduct a pilot study to measure the impact of the notification program on resources. The written comments outline all the steps in the current process, noting those steps where resources could be saved through a notification process. For each petition in the pilot, it is estimated that approximately 15 hours would be saved by eliminating the filing notice; approximately 80 hours would be saved by eliminating development and clearance of a final rule; and review resources in the Office of Premarket Review would be considerably reduced. In summary, the Society believes that a pilot study would demonstrate that the food contact notification process would not require significant additional resources over and above the current review process and may eventually free some personnel to assist in high priority projects.
International Food Additives Council: The International Food Additives Council (IFAC) urges simplification and streamlining of the GRAS review process and prompt finalization of the GRAS notification proposal. IFAC also notes their support for a food additive petition user fee system, provided reasonable fees are earmarked for petition reviews and performance goals are specified. IFAC urges FDA to continue to support the Food Chemicals Codex and to increase efforts towards harmonization of international regulations.
Mary Waleski: Ms. Waleski urges the Center to reinvent the cosmetics program. Specifically, she believes the voluntary cosmetics registration program should be terminated; that FDA should establish a mandatory program for the regulation of cosmetics that is funded by user fees; and that a new Center for Cosmetics Research and Regulation be established in collaboration with academia.
International Association of Color Manufacturers: The International Association of Color Manufacturers (IACM) urges CFSAN to make resources available to assure the timely completion of the regulation to permanently list color lakes. They also encourage the Center to expeditiously act on petitions that have a major positive impact -- e.g., petitions for approval of D&C Red 28 for use in foods.
International Hydrolyzed Protein Council: While the International Hydrolyzed Protein Council (IHPC) agrees with the prioritization criteria used in the regulations program, they encourage the Center to include non-microbial food safety issues as one of its top priorities. They also encourage continued funding of the Food Chemicals Codex. With regard to labeling initiatives, they recommend that the Center focus resources on those initiatives that are supported by sound scientific data. They cited FDA's 1996 ANPRM on labeling for foods that are significant sources of free glutamate (e.g., MSG) as an example of a labeling initiative that is not based on sound science.
Institute of Food Technologists: The Institute of Food Technologists (IFT) agrees that FSI and associated activities should be the Center's highest priorities. IFT's comments address the questions in the FR notice.
- With respect to safety issues, IFT recommends that the Center enhance efforts to address the safety of dietary supplements and raw molluscan shellfish.
With respect to program areas outside of FSI, IFT recommends that high priority be given to GRAS determinations; timely review of petitions for new ingredients and new technologies; continued support for the Food Chemicals Codex; research; and consumer education on safety and nutrition regulations.
IFT believes the criteria for assigning work priorities in the regulations program are suitable. However, they recommend switching the order of the last two criteria -- i.e., additional regulations having a major positive impact should be more important than regulations improving efficiency of operations. IFT also recommends adding cost-benefit as a consideration.
Concerning research, CFSAN should focus on developing state-of-the-art analytical capabilities; developing improved testing methods; continuing consumer research; and conducting research to evaluate new technologies.
In the international arena, CFSAN should expand involvement in Codex activities; sustain the agency's international leadership in biotechnology regulations and involvement in food hygiene regulations; and bolster the agency's international inspection force.
IFT believes that economic fraud is important but a lower priority than the issues outlined above.
National Food Processors Association: The National Food Processors Association (NFPA) submitted written comments for the record that elaborate on Mr. Cady's oral presentation. The written comments also include an NFPA Report entitled, "Research Needs for the United States in Food Safety." The report, based on a member survey, addresses research needs in the following areas: risk communication to consumers; risk assessment; microbial ecology; improved animal production practices to reduce carriage and shedding of pathogens; pathogen control through HACCP; improved pathogen detection methods; improved food processing technologies; improved methods for food preservation; food biotechnology; environmental aspects of food processing and packaging; food-package interactions; the safety of food packaged in recycled materials; and education needs and sources of education that elicit the greatest change in consumer behavior.
State of Wisconsin; Department of Agriculture, Trade and Consumer Protection: Beyond FSI, the State of Wisconsin identified three program areas that should be a high priority for the Center:
- Development of science-based guidance concerning prevention and regulatory action associated with contamination of ready-to-eat foods. They note that science or documentation of cause and effect may not support a zero tolerance in every circumstance.
- Design, implementation, and evaluation of HACCP pilots in a continually broadening range of commodities and processes.
- Development of an interim process for modifying food standards and labeling requirements to facilitate the orderly movement from current standards to some future standard which will establish up-to-date boundaries of fair competition and consumer information.
To make resources available for international activities, they recommend that the Center work with other federal and state agencies to establish a vertically integrated national system. Lastly, regarding the issue of economic fraud, the comments note that FDA should more actively enforce food standards and labeling requirements.
Infant Formula Council: The Infant Formula Council (IFC) believes that timely review and approval of new ingredients for infant formulas should be a top FDA priority. They also urge FDA to more promptly review pending food additive and GRAS petitions. While the Council notes support for the concept of a simplified GRAS notification procedure, they oppose the proposal to eliminate the current GRAS affirmation process. They believe the GRAS affirmation process should remain in place for GRAS petitions currently pending should petitioners wish to receive affirmations. Lastly, IFC encourages FDA to improve leadership in those activities directly impacting harmonization.
Enteral Nutrition Council: The Enteral Nutrition Council (ENC) believes the timely approval of new constituents should be a top FDA priority, especially for the category of enteral formulas defined by law as medical foods. While such constituents may lack general recognition of safety for use in ordinary diets, the Council believes there may be adequate scientific support for declaring as GRAS their use in enteral formulas. The Council also urges FDA to more promptly review pending food additive and GRAS petitions. While ENC notes support for the concept of a simplified GRAS notification procedure, they oppose the proposal to eliminate the current GRAS affirmation process. They believe the GRAS affirmation process should remain in place for GRAS petitions currently pending should petitioners wish to receive affirmations. Lastly, ENC encourages FDA to improve leadership in those activities directly impacting harmonization.
International Jelly and Preserve Association: The International Jelly & Preserve Association (IJPA) agrees that implementation of FSI should be CFSAN's highest priority and that as part of FSI, coordination of foodborne disease outbreaks should be a priority. They also note the importance of the produce safety initiative. Beyond these initiatives, IJPA recommends that CFSAN provide necessary resources and assign a high priority to updating and modernizing food standards; preventing economic fraud; enforcing product labeling; and promoting international harmonization.
The Association for Dressings and Sauces: The Association for Dressings and Sauces (ADS) agrees that implementation of FSI should be CFSAN's top priority. Outside FSI, they believe the Center should focus efforts on the continued maintenance and administration of the food standards program, national uniformity and preventing economic fraud.
Processed Apples Institute, Inc.: The Processed Apples Institute (PAI) agrees that FSI should be the Center's highest priority. PAI criticized FDA's proposed juice HACCP regulation, noting that mandating HACCP for pasteurized juice is overly burdensome. Stating that pasteurization is an effective technology to ensure that juice does not contain pathogens, PAI recommended that the agency mandate pasteurization of juice.
Kraft Foods: Kraft encourages the Center to devote sufficient resources to modernizing food standards and to give a high priority to responding to temporary marketing permit applications and petitions to amend current standards. Kraft notes that the need to update food standards has become even more critical with the continuing efforts at the international level to amend and modernize the current Codex standards. Lastly, Kraft notes that, since the absence of a standard will generally not be regarded as inhibiting the continued development or improvement of a nonstandard product, a lower priority may appropriately be assigned to the creation of new standards of identity during this period of limited resources.
The American Dietetic Association: Written comments submitted by the ADA addressed three points not covered in their oral presentation:
Regarding adverse event reporting, ADA expressed concern that while health care professionals may understand the system, consumers generally have little if any knowledge about it. ADA offered to work with FDA on educating health care professionals and consumers on the adverse event reporting system and in discussing enhancements to improve current reporting mechanisms.
Regarding international issues, FDA urges the Center to uphold safety and nutrition standards first and foremost in any and all trade negotiations. They emphasize that trade concerns should not take precedent over health concerns.
Regarding economic fraud, ADA believes that if FDA places a high priority on the accuracy of dietary supplement and food labels, this will impact on and reduce economic fraud.
The American Society of Nutritional Science: The American Society of Nutritional Science (ASNS) notes endorsement of the Center's efforts at interagency coordination of research as mandated not only by FSI but also implementation of the Food Quality Protection Act. They agree with the priority-setting criteria outlined in the FR notice, adding that the Center's needs to use peer reviewed science as the primary basis for decision making. ASNS recommends that research efforts focus on data comparability and the identification of new, sensitive and specific biomarkers. They note that chemical toxicology will be increasingly important with the aging of the population as not enough is known about the ability of this vulnerable population to respond to chronic exposures. Other high priority areas identified by ASNS include evaluation of the safety of food additives, foods and food ingredients, and dietary supplements; involvement in international/Codex activities; and activities to deter economic fraud.
Safe Tables Our Priority (S.T.O.P.): STOP recommends that the Center's highest priorities be regulations that promote consumer safety and safety-related product labeling regulations. Specifically, they ask that FDA require warning labels similar to those for unpasteurized juices, for oysters, sprouts and lettuce that by their growing conditions, have health consequences.
S.T.O.P.'s comments note disappointment with the Center's current methods for informing consumers of outbreaks and investigations. Therefore, they ask that CFSAN give high priority to development of a system for notifying the public immediately under two circumstances: (1) when a recall is in effect; and (2) when an outbreak is under investigation. Noting that prevention of contamination is the focus of any food safety strategy, S.T.O.P. asks that FDA eliminate the use of unsterilized manure and compost as fertilizer on produce that is consumed uncooked or lightly cooked. S.T.O.P.'s last point on produce is endorsement of mandatory HACCP from farm-to-fork. In the absence of a mandatory program, S.T.O.P. recommends that FDA direct growers to begin voluntarily implementing HACCP programs.
In terms of new legislation, S.T.O.P. urges the Center to aggressively pursue authority to mandate recalls and assess civil penalties and fines as needed.
In the area of research, S.T.O.P. recommends that the Center establish an advisory group that would identify potential research areas critical to food safety and criteria for establishing their priority for research funding. As one priority research area, S.T.O.P. recommends that the Center begin to perform testing that addresses potential areas of contamination under realistic scenarios and the extent to which contamination is possible or probable -- e.g., microbial testing of produce at retail; survival of pathogens in compost and manure; and insect transfer of pathogens.
With respect to educational activities, S.T.O.P. encourages the Center to be more proactive in outreach efforts with major medical, patient, and at-risk consumer organizations. In particular, they encourage the Center to use such groups as venues for getting information to their constituents. In all educational activities, FDA is encouraged to involve consumer organizations in curriculum development and message content. S.T.O.P.'s comments also noted the absence of Center efforts to educate food processors and growers about safe food production and urged future programs in this area.
Lastly, regarding economic fraud, S.T.O.P. identifies three areas of potential concern: (1) produce labeled, "healthy," or "good for you," that is contaminated; (2) batching together foods that have different "go bad" dates; and (3) adding water weight to any product.