WORKSHOP SUMMARY

Opinions vary on the historical success of the U.S. Food and Drug Administration (FDA) in protecting the American public from harmful food ingredients. Industry and academic representatives credit the agency with prevention of public health emergencies associated with consumption of food substances. Consumer groups are reluctant to praise FDA, and are not convinced that the public has been adequately served by the food additive petition process. The cases of violet dye #1 and sulfites are cited as historical examples of once-approved ingredients that may have adversely affected the public's health.

In the absence of timely approval, industry is likely to rely more heavily on the statutory exception for Generally Recognized as Safe (GRAS) substances to facilitate the marketing of new ingredients. A recent FDA proposed rule (see section on "Extramural Reviews" in Appendix A), if finalized, would eliminate the FDA GRAS affirmation process and establish a FDA GRAS notification procedure in its place.

However, not all potential ingredients can detour food additive review. Reform of the formal food additive review process may significantly affect the willingness of manufacturers to invest substantial sums of money in the research and development of new technologies. Congressional intent in enacting the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act was to create a process that would encourage technological development, not hinder it. This statute may need updating to serve this purpose. At the same time, it must continue to protect the food supply for the consuming public.

Three major themes emerged during the workshop. First, communication is a key to enhancing the regulatory review process. Well-developed food additive petitions that include all of the necessary data can only serve to enhance scarce agency resources. However, the determination of the appropriate level of communication needs further exploration. What some may consider to be a consultative process may appear to be collaborative to others.

Second, solving complex food ingredient issues requires the involvement of many scientific disciplines that are often not available within the FDA staff. Often, outside experts residing in academia, professional scientific associations, and public interest groups may need to be involved in the evaluation process, but barriers, such as the Federal Advisory Committee Act and the confidential nature of the data submitted, limit the involvement of outside experts.



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WORKSHOP SUMMARY Opinions vary on the historical success of the U.S. Food and Drug Administration (FDA) in protecting the American public from harmful food ingredients. Industry and academic representatives credit the agency with prevention of public health emergencies associated with consumption of food substances. Consumer groups are reluctant to praise FDA, and are not convinced that the public has been adequately served by the food additive petition process. The cases of violet dye #1 and sulfites are cited as historical examples of once-approved ingredients that may have adversely affected the public's health. In the absence of timely approval, industry is likely to rely more heavily on the statutory exception for Generally Recognized as Safe (GRAS) substances to facilitate the marketing of new ingredients. A recent FDA proposed rule (see section on "Extramural Reviews" in Appendix A), if finalized, would eliminate the FDA GRAS affirmation process and establish a FDA GRAS notification procedure in its place. However, not all potential ingredients can detour food additive review. Reform of the formal food additive review process may significantly affect the willingness of manufacturers to invest substantial sums of money in the research and development of new technologies. Congressional intent in enacting the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act was to create a process that would encourage technological development, not hinder it. This statute may need updating to serve this purpose. At the same time, it must continue to protect the food supply for the consuming public. Three major themes emerged during the workshop. First, communication is a key to enhancing the regulatory review process. Well-developed food additive petitions that include all of the necessary data can only serve to enhance scarce agency resources. However, the determination of the appropriate level of communication needs further exploration. What some may consider to be a consultative process may appear to be collaborative to others. Second, solving complex food ingredient issues requires the involvement of many scientific disciplines that are often not available within the FDA staff. Often, outside experts residing in academia, professional scientific associations, and public interest groups may need to be involved in the evaluation process, but barriers, such as the Federal Advisory Committee Act and the confidential nature of the data submitted, limit the involvement of outside experts.

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Finally, the possibility of congressional authorization of user fees to enhance FDA's diminishing resources needs further discussion. Many participants agreed with the user fee concept, but representatives of the public interest groups were opposed to the idea of manufacturers paying for FDA contractor-approved petition reviews. Manufacturers are reluctant to pay a user fee without some assurance of benefit, such as market exclusivity. Continued exploration of the fundamental public policy issues raised by user fees is critical to mutual understanding among all parties. Introduction and Background The purpose of the workshop was to allow experts in food science and policy to discuss the capacity of the current food ingredient regulatory review process to facilitate and/or impede the application of new food science and technologies into the marketplace. Prior to the workshop, Lars Noah, Assistant Professor of Law at the University of Florida, was commissioned to draft a background document, Legal Aspects of the Food Additive Approval Process (Appendix A). In addition, a series of case studies of the food additive review process were developed by members of the Food Forum and distributed to participants (Appendix B). This summary is based on those papers and dialogue among participants during the workshop. The views presented in this summary represent the diverse backgrounds and interests of the participants, including representatives from the FDA, academia, consumer groups, and the food industry. Since the passage of the 1958 Food Additives Amendment to the FD&C Act of 1938, significant technological advances have tested the effectiveness of the FDA's primary tool for ensuring the safety of new food ingredients. Manufacturers of controversial new food ingredients have sought FDA approval, and the agency has experienced a rise in the number of applications seeking approval for novel food technologies, such as bioengineered foods, macronutrient substitutes, or genetically produced or modified foods or ingredients, placing additional burdens on an agency already constrained by resource limitations. As a result, the average time to approve a new direct food additive is estimated to exceed six years. Yet the formal statutory deadline for action on a food additive petition remains just 180 days (see section on "Food Additives Petitions" in Appendix A). Overview of the Approval Process for Food Use Substances Food substances include food and color additives, ingredients generally recognized as safe (GRAS), new food-animal drugs, dietary supplements, and bioengineered or genetically produced or modified foods or ingredients. These substances can extend shelf life and provide taste, texture, color, and nutritional value, among other vital functions, in foods. Food Additives By legal definition, a food additive is "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . , if such substance is not generally recognized . . . to be safe under the conditions of its intended use . . . " (see the section on "Components of Food" in Appendix A). A food additive may be a direct (intentional) or an indirect (incidental) food additive. The definition specifically excludes GRAS substances, substances approved by the FDA and USDA during 1938 to 1958 (so called "prior sanctioned"),

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as well as color additives, pesticide chemicals, new animal drugs, and dietary supplements (see the section on ''Components of Food'' in Appendix A). Some substances, such as dietary supplements, were potentially eligible for food additive status, but a subsequent amendment to the FD&C Act narrowed the legal definition to exclude them. GRAS Substances Substances determined to be generally recognized as safe (GRAS) are excluded from the food additive definition. GRAS status requires consensus, but not unanimity, among experts qualified by scientific training and experience. Under the FD&C Act, GRAS determination must be made "among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use" (see the section on "Generally Recognized as Safe" in Appendix A). The phrase "scientific procedures" is defined under FDA regulations as data based upon "published studies which may be corroborated by unpublished studies or other data and information" (see the section on "Generally Recognized as Safe in Appendix A). Nevertheless, interpretation of the GRAS definition leaves room for judgment. The statute provides few details about the requirements of scientific substantiation, which has raised questions in GRAS determinations over the years. GRAS determinations can be made either by FDA upon petition, or by self-determination, in which case the sponsor may rely on a third party's review. Following the enactment of the 1958 Food Additives Amendment, FDA affirmed that a number of food ingredients met the GRAS standard. After questions were raised about the safety of some GRAS ingredients, the agency initiated a review of these ingredients in 1972. The agency utilized the scientific expertise of an independent organization, the Federation of American Societies for Experimental Biology (FASEB), to assist in the evaluation, which spanned a decade. During that time, FASEB's Select Committee on GRAS Substances (SCOGS) evaluated over 450 food use ingredients, and recommended that only one percent of the ingredients on the original GRAS list be re-categorized as food additives. To date, nearly 200 substances appear on FDA's affirmed GRAS list for direct use in foods. The agency's review of the SCOGS reports has never been completed, and FDA has never intended that the GRAS lists be comprehensive. As mentioned, a food substance does not need to be affirmed GRAS by the FDA to be eligible for GRAS status (and thus excluded from food additive requirements). An ingredient manufacturer, or a third party, may apply the scientific requirements and determine with or without notifying FDA that a substance is GRAS. In most cases, the ingredient manufacturer contracts with an independent organization to make such a determination. For example, both Proctor & Gamble and Nabisco sought FASEB review for ingredients they later marketed as GRAS. FDA has rarely challenged GRAS self-determinations, but there is some regulatory risk involved. GRAS determinations are never absolute. The agency retains the right to pursue enforcement proceedings, if it disagrees with a manufacturer's own GRAS determination. GRAS self-determinations raise the legal question of who bears the burden of proof for a GRAS determination to be considered scientifically substantiated. There is disagreement on whether this burden lies with the agency or the ingredient manufacturer. A GRAS affirmation process whereby manufacturers submit a petition to FDA requesting the affirmation of a GRAS self-determination has been a primary mechanism for manufacturers to protect themselves from

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FDA enforcement actions. A recent FDA proposed rule (see section on "Extramural Reviews" in Appendix A), if finalized, would eliminate the FDA GRAS affirmation process and establish an FDA GRAS notification procedure in its place (see the section on "Extramural Reviews" in Appendix A). Interim Additives Interim food additives are previously approved or long used ingredients placed in this transitional category pending further safety review. This regulatory category emerged when FDA initiated its review of food additives in 1972 after the safety of some food additives was questioned. Interim food additives may remain on the market indefinitely, pending a lack of immediate public health concern from their continued use. Interim food additives are intended either to be reconfirmed as safe or removed from the market following additional safety review. There has been significant delay, both from the agency and manufacturers, in reevaluating these substances. As a result, several food ingredients have remained in interim food additive status for many years. Legal Framework of the Ingredient Approval Process Evaluation of the legal framework of the ingredient approval process demands a comprehensive understanding of the events and legal history from which current food laws emerged. Equally important are understanding the FDA's interpretation and application of the law, and recognizing that the agency is not merely an implementer of law, but an architect of the law as well, as noted by one workshop participant. Flaws of the Current Review Process The length of time taken by the agency to review a petition was a primary concern of workshop participants. The background paper by Lars Noah estimated that it took first-time food additive petitions more than six years, on average, from date of filing to publication of an approval order in the Federal Register (see section on "Track Records Compared" in Appendix A). However, it was noted that FDA is not responsible for all of the time it takes from the filing date to notification. The agency must often wait months for companies to respond to its requests for additional data. Further, decisions made at FDA must also be approved at the Office of Management and Budget (OMB) prior to public notification. Time is only one criterion by which the regulatory process is evaluated. Although time may be over-emphasized, it is a critical issue to the food industry when awaiting approval to market a new ingredient or technology. For industry, there is a financial incentive to expedite the time taken for any new product to reach the marketplace. New food ingredients can and often do have wide appeal once available to consumers. However, one consumer representative observed that a lengthy review process concerns industry much more than it does the public. One industry spokesperson and an FDA representative also expressed the view that the quality of incoming petitions needs to be improved and that the agency and industry must work together to improve new food additive petitions.

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Proposed Changes in the Approval Process Representatives from industry, consumer groups, and FDA agreed that changes are needed to improve the regulatory review process and they suggested ways in which the system might be improved. Some changes would require statutory modifications through congressional action, while others could be initiated by FDA. The background paper by Lars Noah outlined several possible solutions (see section on "A Catalogue of Proposed Solutions" in Appendix A), and other workshop participants raised additional suggestions for change during the workshop. Change or Enforce Deadlines for Petition Reviews As mentioned, statutory deadlines for reviewing food additive petitions are rarely, if ever, met by the agency. FDA representatives informed workshop participants that the statutory clock is reset when the agency requests additional information for the review of a petition, but such timekeeping does not explain the gross delay in petition approval. According to the background paper by Lars Noah, some critics suggested the use of a statutory "hammer" to enforce FDA deadlines, but this suggestion has also met criticism from both within and outside the agency (see section on "Statutory Hammers" in Appendix A). Although a hammer mechanism would force the agency to make its determination within the mandated time frame, it could compromise the quality of its decisions. Most observers agree that the statutory deadlines that currently exist are too short and should be changed. Implement User Fees The payment of user fees was suggested by several participants as a method to supplement FDA Center for Food Science and Applied Nutrition's (CFSAN) resource base. The agency is familiar with user fees because its Center for Drug Evaluation and Review (CDER) has been collecting these fees since the passage of the Prescription Drug User Fee Act of 1992. The collection of user fees for food products would require authorization by Congress. Grant a Period of Market Exclusivity Congress could provide a period of market exclusivity to manufacturers of approved food additives, similar to the licensing system for new drugs. When a new drug application is approved, the manufacturer is granted an exclusive marketing period (separate from any patent protection) for a limited time. One participant suggested that industry has not yet realized the potential benefits of user fees in expediting review times. The participant added that, if user fees were authorized, the industry should also urge Congress to provide a period of market exclusivity for approved ingredients or technologies. Without a period of market exclusivity, user fees could be problematic because food additive petitions, once approved, benefit both the petitioner and competitors. Support for willingness to pay a fee for a product's review, in addition to the financial investment already made in the development of the ingredient or technology, would be substantially reduced. Currently, patents are the only mechanism of protection extended to manufacturers of a new food additive. However, patent terms often expire by the time the agency approves a new food additive.

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Re-evaluate GRAS Affirmation Process FDA regulations have long allowed the manufacturer of a food ingredient to seek the agency's concurrence that the ingredient is GRAS. This process is similar to the process for nonexclusive over-the-counter drug monographs which has certain conditions of use written into the regulations. However, FDA recently published a proposal to change this procedure from a petition for GRAS affirmation to a notification of self-determination of GRAS status (see section on "Extramural Reviews" in Appendix A). This proposal, if finalized, would eliminate the GRAS affirmation process and replace it with a notification procedure. Public interest representatives voiced concern that the current process does not require agency notification prior to the marketing of a substance determined by a manufacturer to be GRAS. They suggested that a letter should be filed with FDA when a GRAS self-determination is made. It was noted that the notification process was designed to bring together the information needed to have a determination that is supported by the evidence. An FDA representative commented that GRAS determination is not a subjective decision by any party, but is a legal status. A substance either is or is not GRAS. Eliminate Notice-and-Comment Procedures Notice-and-comment procedures are not mandated by law for food additive approvals, but FDA's procedures do provide an opportunity for third party comment within 30 days after FDA publishes a final order on a petition. In addition, FDA's recent practice has been to allow, and in some cases such as the olestra petition, even solicit, external input. Consumer groups believe that this opportunity for public comment should continue to play a role in the food additive approval process, but industry representatives pointed to the delay resulting from this practice. Abbreviate Review for Supplemental Uses The estimated average review time to approve a supplemental use of a direct food additive is 38 months (see section on "Track Records Compared" in Appendix A). It was suggested that FDA might develop an abbreviated protocol for approving petitions for supplemental uses of previously approved food additives. In theory, it should take less time to approve supplemental uses since toxicity data and other determinants of safety have already been evaluated. However, in some cases, such as polydextrose, the agency has taken more time to approve supplemental uses than the original use (see section on "Track Records Compared" in Appendix A). The agency reports that supplemental approvals are not always simple and straightforward. FDA often must consider new exposure patterns and mediums for use because there are unique differences in how the same ingredient might be regulated and used in different types of food. Evaluate Use of Extramural Petition Review According to several participants, the agency needs to make greater use of scientific experts from academia or professional societies to help reach final determinations on food ingredient petitions. FDA has, in some cases, deferred completely to qualified outside review boards to conduct food ingredient reviews. As mentioned earlier, from 1972 to 1982 FDA commissioned FASEB to re-evaluate over 450 GRAS substances following concerns raised about the GRAS ingredient cyclamate. Industry associations have also set up independent review boards to

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evaluate ingredients. The most notable is the Flavor and Extracts Manufacturers Association (FEMA), which has evaluated over 2,000 substances. Representatives from government, academia, and industry recognize that there can be several benefits to consultation with outside experts. Some people believe that FASEB and FEMA reviews of GRAS materials demonstrate that some topics are better handled independently. By using external resources, reviews are sometimes conducted more efficiently and economically, with little or no controversy. External bodies can operate within their own time frames, and do not have to contend with competing demands encountered within the agency. Consumer representatives, however, expressed less confidence in external reviews and raised concern that such reviews involve potential conflicts of interest. One consumer representative suggested that FDA should do all reviews internally with additional funding, either from government revenues or from small registration fees from all food manufacturing operations in the United States. However, another consumer representative commented that contracting out reviews may be an acceptable practice provided there is clearly demonstrated independence in the process. Even though the use of outside experts could enhance the speed and breadth of expertise, workshop participants noted that they must be carefully managed by FDA. The cyclamate case study was given as an illustration that the proper use of outside experts requires their understanding of the regulatory legal framework (see case study on "Cyclamate" in Appendix B). When a panel of outside experts is convened, the agency must provide adequate guidance to those experts to ensure that the decision-making criteria are clearly understood. Prioritize Reviews Currently FDA reviews food additive petitions in the order in which they are received. In light of the serious resource constraints on CFSAN, prioritizing reviews based on benefit could allow some petitions to move through the review process faster. This suggestion raised concerns from both representatives of consumer interest groups and the agency. Agreement on the criteria for determining which applications should get priority could become controversial. Prioritizing reviews raises the potential for petitions deemed of lesser importance by the agency to be delayed indefinitely. The background paper by Lars Noah suggested prioritizing reviews based on an initial assessment of likely public health risk and potential health benefits (see section on "Prioritizing Reviews" in Appendix A). Consideration of an ingredient's potential impact on public health is a factor used to prioritize applications in the drug review process. However, CFSAN currently does not prioritize its reviews. Implement Safeguards to Prevent Sham Petitioning Industry representatives raised concern about the potential for sham petitioning. Sham petitioning occurs when competitors point to what they contend is new information about a pending food additive petition in an attempt to delay or prevent approval. Virtually all aspects of a petition become available for public disclosure once it is filed with FDA. The agency has acknowledged the potential for sham petitioning. In the case of a food additive petition for the sweetener sucralose, an anonymous party, through a law firm, filed comments raising safety concerns late in the review process and submitted information to a consumer group. Imposing strict deadlines for the submission of comments used by FDA has been suggested to help combat the disruption of the review process. A consumer lawyer suggested that FDA simply refuse to accept or consider anonymous comments, unless the commentator can make a case for anonymity.

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Establish a Sunset Period for Interim Additives Establishing a moderate sunset period for current interim food additives may help eliminate food additives from this regulatory status and perhaps expedite their completion of review. Despite the intent that prompt action be taken by petitioners to provide additional substantiation for the safety of such additives, many interim food additives have remained in a semi-permanent regulatory limbo for years. Foster Improved Communication between Industry and FDA Several suggestions were made for improving communications between petitioners and FDA, without compromising the maintenance of a clear administrative process and record. Both the agency and industry recognize that the current level of formality of the communication can dramatically slow the review process, as each dialogue between FDA and petitioner must be adequately recorded in writing both for historical purposes and to ensure the substantiation of the agency's position. Improve Quality of Petitions Submitted to FDA Representatives of FDA, consumer groups, academia, and industry all concurred that improving the quality of petitions submitted to the agency would help decrease review time. The submission of incomplete petitions or those with inadequate scientific information can substantially increase the burden on FDA and the time spent on review. Historically, the agency has worked with the industry to complete missing data, but many participants suggested that the FDA should deny review of these petitions. A suggestion was offered that the agency provide better defined data requirements or guidelines to help petitioners decide what information to submit in a petition. Due to the heterogeneity of the substances reviewed by the agency, FDA representatives commented that it would be impossible to create a single document to provide guidance for petitioners. However, it was suggested that prefiling consultations could help industry improve the quality of petitions. Scientific Interpretation and the Approval Process Scientific aspects of the food additive approval process were explored through discussion of generic issues and problems affecting the process as a whole. The petition process has evolved extensively since the Food Additives Amendment was enacted in 1958. Several background factors have contributed to the workload and complexity of the current food additive petition process. This discussion of the scientific and regulatory aspects of food ingredient review included key lessons learned about food safety, science and compliance infrastructure, ways in which the process has improved over recent years, and, finally, suggestions for change. Several speakers observed that scientific advances have led to more detailed studies, more data, and increased complexity in the development of information to support food additive petitions. Several changes in technology and society identified during the discussion are found in Box 1.

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BOX 1. Changes in Technology and Society Affecting Decision-Making in the Current Food Additive Petition Process Developments in analytical chemistry Developments in toxicology Changes in the understanding of mechanisms Changes in risk and safety assessment Changes in agriculture Changes in environmental concerns Increased consumer activity Changes in food marketing and consumption trends Increased FDA tasks with fewer resources Criteria to Evaluate Food Additive Safety Consensus exists that technical assessments of modern food additive petitions have become more complex. Analytical chemistry has magnified the understanding of food composition. Limits of detection and measurement have dropped from parts per million to parts per trillion. Often, questions of chemistry and biochemistry now can be raised and resolved more quickly than can questions related to toxicology. The criteria for each evaluation are unique, as are the properties and uses of each individual substance. As mentioned previously, for a food additive the statute demands neither confirmation of safety under all conditions of use, nor an absolute assurance of safety for every intended use. In the current food additive regulations, "safe" is defined as a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. Evaluation of safety currently requires data and professional knowledge from many more disciplines than were required in the past. FDA representatives indicated that the agency must seek counsel from a wide range of scientific disciplines to adequately review the diverse nature of the petitions submitted. Scientists from a range of disciplines participate in the food additive review process, which often includes chemists, toxicologists, nutritionists, and microbiologists. In the case of the olestra petition, CFSAN tapped the resources of six other intra-agency centers and federal agencies, numerous outside consultants, and an FDA Food Advisory Committee special working group to assist in its review and decision-making process. FDA has attempted to specify acceptable study designs for generating the data necessary to support the approval of a food additive without imposing unduly rigid guidelines. These guidelines assist industry to assure that appropriate data are submitted to the agency. According to FDA, the agency will soon make available "Redbook II" (a revised edition of its 1982 Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, which is referred to as the Redbook). The revised document is intended to provide updated guidance to petitioners regarding suggestions for toxicological safety data to assess direct food and color additives and GRAS ingredients. The Redbook does not mandate the submission of any specific scientific data, though in practice petitioners are reluctant to deviate far from FDA guidelines.

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Current Efforts Workshop participants agreed that all parties with an interest in the quality of the food additive review process should work together to make sure that the process is efficient and effective. Industry and consumer interest groups can provide input into this process, but ultimately only Congress and FDA can initiate reform. FDA representatives highlighted current efforts to improve the process within the current statutory limits. These efforts include a series of management and infrastructure initiatives designed to improve the efficiency of the approval process for direct food and color additives. The agency has implemented several missives to help foster better lines of communication and interact with petitioners throughout the process. For example, agency representatives have expressed willingness to engage in pre-filing consultations so that petitioners have a better understanding of the types of data that are needed or that should be included in a petition submitted for review. Advance letters are a new tool of the agency to notify petitioners of a petition status, or explain why a submission may not be approved in its current form. FDA has also sponsored workshops for industry that address the food additive process and provide suggestions for petitioners. The GRAS notification proposal is another recent initiative. It is designed to simplify the process of GRAS determination. Elimination of the lengthy GRAS affirmation procedure should help alleviate some agency resources. FDA has organized focus teams to assist in making decisions on difficult issues that may arise during a petition review. These teams assist in moving the review process forward at times when the agency might otherwise have stalled. Finally, FDA has entered into contractual agreements with several independent consulting organizations. One contractor assists the agency by assessing review times and analyzing the costs and resources needed to perform petition reviews most effectively. Another contractual agreement was made to assist in reducing the backlog of FDA's workload. These independent experts are assisting the agency in the scientific evaluation of more complex petitions and in the review of indirect additive petitions. Although these efforts offer initial steps in improving the food additive review process, participants recognized that long-term solutions may require statutory change. International Efforts While the food industry is interested in protecting the approval of new direct food additives, it is equally concerned with protecting the use of existing approvals in the global marketplace. The importance of international trade has tremendous implications for industry growth in the future. FDA may want to take a leadership role to ensure that the science-based approvals in the United States are recognized by international Codex standards. The Codex Alimentarius sets international regulatory standards useful in the case of trade disputes between countries. Currently, the Codex Commission is in the process of developing a general standard for food additives worldwide.

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Improving the Regulatory Review Process Government Perspective FDA representatives acknowledge that the current direct food additive review process has several shortcomings; the inability to process petitions within the statutory time frame is perhaps the greatest problem. Recently, the agency implemented a number of managerial and procedural changes designed to improve the system, but additional solutions are still needed. FDA seeks the suggestions of those with an interest in the process to help identify needs and propose changes. Food additive petitions are growing more complex, and the agency cannot maintain internally the range of expertise needed for sound scientific assessments. FDA will increasingly need to call upon the expertise of outside consultants to assist in decision-making. One consumer representative maintained that outside advisory committees or consultants should include consumer representatives with an understanding of the regulatory review process. Industry Perspective The substantial delay in the petition approval severely hinders food manufacturers from the timely introduction of new products into the marketplace. Several workshop participants suggested that the FDA needs additional resources to increase efficiency. These resources could come from congressional appropriations, petitioners, or both. Establishing a third-party review process to support FDA's activities may improve the current system. Industry and the agency could work together to determine criteria for accrediting reviewers and for the financing of these reviews. User fees for the review of direct and indirect additives may also be a viable mechanism, but would require statutory change. If user fees are imposed, a period of market exclusivity may be desirable for food ingredients that receive approval. The quality of petitions can be improved; pre-filing consultations are useful opportunities for petitioners to better understand filing requirements. The proposed GRAS notification procedure may be useful to industry, but manufacturers who voluntarily file GRAS self-determinations are likely to seek some level of FDA recognition for these determinations. Industry will seek some incentive, such as a no objection letter, to make the filing of GRAS self-determinations worthwhile. Industry representatives would like the Delaney clause to be replaced with a broader "reasonable certainty of no harm" standard for all additives. Finally, industry representatives emphasized the importance of protecting the integrity of the review process so that food additive approvals are upheld in the international marketplace. Consumer Perspective The length of the direct food additive review process is not a serious consumer concern. The imposition of user fees may also be largely inconsequential, but consumer representatives prefer user fees to an alternative that would make petitioners more directly responsible for funding the review. Consumer representatives varied in their opposition to the use of third-party reviews. Some were strictly opposed, claiming that such reviews create conflicts of interest and bias and diminish public confidence in the review process. Others were less opposed if careful guidelines are developed to ensure the independence of the process. Consumers or their representatives would like to play an active role in providing comment to FDA on food additive petitions. The agency does provide opportunity for consumer comments in

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the notice-and-comment procedure and the FDA-sponsored Food Advisory Committee. Also, consumer representatives suggested that food additive approvals should never be final; rather, the agency should create a cyclical review process whereby approved ingredients are reevaluated over time. However, if authorized, a cyclical review process would add an additional cost burden to the FDA. Most consumer representatives approve of the proposed GRAS notification procedure, but believe FDA should be notified of all GRAS self-determinations. Summary Three major themes emerged during the workshop. First, communication is the key to enhancing the regulatory review process as better communication results in better decision-making. Food additive petitions that include all of the necessary data can only serve to enhance scarce agency resources. However, what constitutes appropriate communication needs further exploration to delineate whether a consultative or collaborative process is occurring. Second, solving complex scientific problems requires the involvement of many scientific disciplines that are often not available within the FDA staff. Accredited outside experts residing in academia, professional scientific associations, and public interest groups may need to be involved in the evaluation process, but barriers, such as the Federal Advisory Committee Act, the confidential nature of the data submitted, and concerns about potential conflict of interest, limit the involvement of outside experts. However, because the resources of FDA have remained almost level in constant dollars in recent years and the overwhelming competing pressures on the federal budget suggest that the future will be no brighter, the FDA will need to continue to rely on outside experts to resolve complex issues. Finally, allowing user fees to enhance FDA's diminishing resources needs further discussion. Most participants agreed with the user fee concept, but public interest groups were opposed to the idea of manufacturers paying for FDA-contractor-approved petition reviews. Manufacturers are opposed to paying a user fee without a benefit such as market exclusivity. Continued discussion to further explore the public policy implications of the concept of user fees is critical to maximizing mutual understanding among all parties.