President Bill Clinton
Vice President Al Gore

January 1996

Table of Contents


"....I applaud your desire to get rid of
costly, unnecessary regulations. But
when we deregulate, let's remember what
national action in the national interest
has given us: Safer food for our families;....."
President Clinton
State of the Union Address; January 24, 1995


The American food system is justifiably admired around the globe for its ability to provide consumers with an abundant supply of convenient, economical, high quality and safe food products. This system is built on the enterprise and innovative capacities of those who produce and market food in the United States, and it is driven by the high expectations of American consumers for the foods they purchase for their families.

Protecting the safety and integrity of the food supply is one of the oldest functions of government, and it is one of the core functions the American people expect their government to perform. The Federal government's oversight of food safety, wholesomeness and labeling has contributed significantly to the success of the U.S. food system, especially where it has set and successfully enforced sound standards for sanitation and safety and fostered accurate and informative labeling consumers can use to exercise choice in the marketplace.

The Federal system of food regulation is, however, nearly a century old. Regulatory efforts successful in protecting the public over the past century must be reassessed as new food safety and other consumer concerns come increasingly into focus. Federal food regulations must be revised continually for a number of reasons: so that consumers are provided the safest possible foods and can make more informed choices in the marketplace, so that food companies have the flexibility to innovate and incentives to engage in vigorous competition for consumers' dollars, and so that taxpayers are assured that government resources are used in the most effective and efficient manner possible.

Today's food safety and consumer challenges demonstrate that current Federal regulations are in need of reform. Foodborne illness caused by harmful bacteria and other pathogenic microorganisms in meat, poultry, seafood, dairy products, and a host of other foods is a significant public health problem in the United States. Estimates range from 6 million to 33 million foodborne illnesses per year. The present system of food regulation has not adequately addressed this problem in large part because it depends heavily on detecting and correcting problems after they occur, rather than preventing them in the first place. The current system often relies on prescriptive "command and control" regulations that can deter beneficial innovation.

This is especially true of the current system of meat and poultry inspection. It relies primarily on extensive command and control oversight of the plants that slaughter animals and process meat and poultry products, and does not target control and reduction of harmful bacteria on raw meat and poultry products. The result is a system that provides inadequate incentives and flexibility for meat and poultry plants to address the most significant food safety hazards in innovative ways.

The Clinton Administration is committed to fundamental reform of food regulation to improve food safety. The Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) and the Food Safety and Inspection Service (FSIS) in the Department of Agriculture (USDA) intend to adopt a common framework and build a common approach to food safety by incorporating into their programs a science-based system of food safety controls, known as HACCP (Hazard Analysis and Critical Control Points), the specifics of which are designed and implemented by the food companies themselves.

HACCP is designed to reduce reliance on command and control regulations and increase reliance on science-based preventative measures and performance standards to improve food safety. Under a HACCP system, each company must meet the same, rigorous safety standards, yet each has the flexibility to devise and adopt food safety plans uniquely suited to its circumstances. As the common conceptual framework for the future of U.S. food safety programs, a primary strength of HACCP is that its principles can be applied to many food categories and can be tailored to the needs of individual food manufacturing and processing plants, thereby providing flexibility while also improving food safety.

In addition to improving the safety of the domestic food supply, HACCP will be a valuable tool in advancing the progress of food safety internationally and a critical element in expanding U.S. food trade. Many other countries, including the 15 member countries of the European Union, Canada, Australia, New Zealand, and Norway, are also committing to HACCP-based food safety programs.

FDA and FSIS are also reviewing and will revise their existing regulations to eliminate unnecessary burdens and requirements. Regulations being reviewed and revised include regulations directly affecting food safety and food labeling, and regulations regarding certain animal drug and feed applications that also may affect the food supply.

As President Clinton has said, regulatory reform must not roll back protections people expect from their government. Rather, it must meet people's expectations better by using modern tools of regulation that make better use of both public and private resources. These goals are shared by all Americans. The end result of the Clinton Administration's reform of food regulation will be safer food, more consumer choice in the marketplace, more effective use of taxpayers' dollars, and a food system that remains second to none.


FDA has had a mandate to protect Americans from unsafe foods and drugs since 1906. FDA is charged with ensuring foods are safe, wholesome, and properly labeled, that drugs, vaccines, and medical devices are safe and effective, and that cosmetics are safe. FDA also protects consumers from economic fraud and promotes sound nutrition.

FDA oversees a vast food industry that includes about 46,000 U.S. food processors and warehouses, and comprises a significant segment of the nation's economy. FDA regulated products account for about two-thirds of consumer spending on food, with an annual retail value of $430 billion. Every year, U.S. food processors spend $1.4 billion on research and development and introduce 15,000 new products. The following is just a partial list of matters of concern to the public that are addressed by FDA's food-related regulations:

In addition, FDA is responsible for setting standards for safe and sanitary production of food, resolving issues involving imported foods, and advising state and local governments on safety and sanitation standards for supermarkets, restaurants, and other retail food establishments.

FDA carries out its food mission with about 2,700 employees, 900 at headquarters and 1,800 people at 160 other sites around the U.S.

In most instances, FDA regulations permit foods to be marketed without prior approval by the agency. FDA enforces its regulations primarily through inspections of food processing facilities, examination of imports, collection and testing of food products on the market, and imposition of enforcement measures as required to protect consumers.

FDA also regulates animal drugs, medicated feeds, and animal food additives, all of which may affect the human food supply. FDA protects the public health from harmful veterinary products in several ways. FDA reviews new animal drug applications, investigational new animal drug applications, abbreviated new animal drug applications, medicated feed applications, and food additive petitions. FDA also regulates marketed products through review of drug experience reports and compliance programs. Finally, FDA assesses the environmental impact of product approvals. Through these efforts, FDA ensures that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat.


FSIS is a consumer protection agency of the U.S. Department of Agriculture that regulates meat and poultry products, primarily by means of inspection activities at the facilities producing those foods, to ensure they are safe, wholesome, and accurately labeled.

FSIS-regulated meat and poultry products account for close to a third of consumer spending for food, with an annual retail value of about $210 billion. FSIS regulated products include raw beef, pork, lamb, chicken, and turkey, as well as about 250,000 different processed meat and poultry products, including hams, sausage, soups, stews, pizzas, and frozen dinners (any product that contains 2% or more cooked poultry or 3% or more raw meat). Consumers purchase these products under 500,000 different USDA- approved labels.

Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS inspects all meat and poultry sold in interstate and foreign commerce, including imported products. About 7,400 Federal inspectors carry out inspection laws in some 6,200 plants.

Inspectors check animals before and after slaughter, visually examining over 6 billion poultry carcasses and 125 million livestock carcasses each year. They prevent diseased animals from entering the food supply and examine carcasses for visible defects that can affect safety and quality. FSIS also inspects products during processing, handling, and packaging to ensure that they are safe and truthfully labeled.

Unfortunately, these activities have been inadequate to prevent illnesses attributable to pathogenic microorganisms found in and on meat and poultry. The best available data indicate that foodborne microbial pathogens such as Salmonella, E. coli O157:H7, Campylobacter, and Listeria monocytogenes contaminating meat and poultry products are associated with as many as 5 million cases of illness and more than 4,000 deaths annually. There are many factors contributing to such illnesses, however it is clear that there are also many technologies and procedures available for keeping raw meat and poultry products from being contaminated with pathogenic bacteria during processing, and for minimizing the growth of bacteria that nonetheless may be present. The current system of meat and poultry inspection must be reformed to provide more incentive and flexibility for the use of these technologies and procedures.

FSIS is pursuing a broad and long-term science-based strategy to improve the safety of meat and poultry products and to better protect Americans from foodborne pathogens. FSIS has adopted a farm-to-table approach that includes steps to improve the safety of meat and poultry at each stage in food production, processing, distribution, and marketing. For example, safe handling labels are now required on all raw products, informing consumers of the crucial role proper handling and cooking play in preventing foodborne illness.


FDA and FSIS routinely work together to coordinate food regulatory policy and ensure the most efficient use of Federal resources in areas of mutual interest. Matters on which the agencies have coordinated closely include:


FSIS and FDA are proposing a number of reforms that will reinvent how the two agencies regulate. The reforms described in this report will result in more productive use of FSIS' and FDA's resources, reduce unnecessary burdens on industry, expand consumer choice in the marketplace, and, most importantly, improve food safety.


FDA INITIATIVES: The following are more detailed descriptions of these initiatives.


Many authorities, including the National Academy of Sciences (NAS), the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), the Codex Alimentarius Commission, and the Vice President's National Performance Review have recommended fundamental changes in the existing food safety system. Those recommendations urge adoption of a preventative system of quality control known as HACCP (Hazard Analysis and Critical Control Points).

HACCP consists of several internationally recognized principles, including the identification of safety hazards, the establishment of controls that focus on preventing those hazards at critical control points, and the monitoring of controls during operations, to provide immediate information to processors as to whether their operation is under control. Under a mandatory system, the results of the monitoring are documented in records to which government inspectors or investigators have access. In this way, the burden of operating a HACCP system is related to the nature of the hazards presented by a food. The burden on the processor of a low risk food may be as simple as monitoring and controlling the temperature or pH levels of the product and recording the results. If there is a deviation that poses a safety risk, the data collected would enable the processor to identify corrective action more easily. The end result is continual self-monitoring of the food's safety that will prevent problems and facilitate necessary government oversight.

1. Implementation of HACCP-Based Systems to Ensure Food Safety

Background: The Federal government is charged by law with protecting consumers from unsafe, unwholesome and mislabeled foods. The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) implements the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. Under those laws, FSIS regulates meat, poultry, and processed egg products. The Department of Health and Human Service's Food and Drug Administration (FDA) regulates all other food products primarily under the Federal Food, Drug, and Cosmetic Act.

Although the two agencies' laws are similar in many respects, each has its own kind of "inspection." FSIS inspects daily all meat, poultry, and processed egg products, and the establishments producing those products, to ensure the products comply with the law before they are sold in commerce. FDA, on the other hand, inspects processing establishments less frequently, generally targeting specific establishments. The relatively small number of FDA inspectors must give priority to products and establishments known to pose a risk of being in violation of the law. FDA's food program, faced with an increasing workload, is conducting fewer inspections of food establishments each year.

To carry out its statutory mandate to ensure a safe food supply, FDA operates a comprehensive regulatory program for the foods it regulates. This program includes: (1) mandatory, unannounced inspections of the domestic industry; (2) examinations of imports into the U.S.; (3) sample analysis; (4) administration of Federal-State cooperative programs for molluscan shellfish, milk, and retail food; (5) training and technical assistance to states to help them operate their own programs; (6) consumer education; and (7) research.

Although the nation's food supply overall is safe, outbreaks of foodborne illnesses (from sources such as E. coli, Listeria monocytogenes, and Salmonella) do occur. FDA tries to "catch" potential microbiological hazards and other food safety problems during its infrequent inspections. This system is neither as effective or efficient as it could be. FDA must have a better means to ensure that food processors are taking appropriate steps to protect consumers.

FSIS has authorities and programs for meat and poultry products under its jurisdiction similar to FDA's. However, FSIS historically has devoted most of its resources to in-plant inspection activities. Consequently, the present meat and poultry inspection program is based on intensive command-and-control oversight of plant operations and heavy reliance on detecting and correcting problems with plants and products after they occur, instead of preventing them in the first place. The current system does not effectively target control and reduction of the harmful bacteria on raw products that pose the most important food safety hazards for meat and poultry. The result is a resource-intensive system that provides inadequate incentives and flexibility for meat and poultry plants to address the most significant food safety hazards in innovative ways.

Proposals and Justification: FDA and FSIS intend to implement HACCP-type performance standards and flexible science-based systems of preventative controls for, at a minimum, the meat, poultry, and seafood industries. In addition, FSIS will eliminate obsolete or counterproductive command and control measures.

Seafood: Although NAS concluded that commercial seafood is generally safe, FDA is implementing HACCP in this industry first because of the wide array of hazards that can adversely affect seafood safety. Because seafood consists of hundreds of species from every part of the globe, is predominantly wild-caught, is the most perishable of all flesh foods, and is consumed raw more than other flesh foods, the regulation of seafood will always present special challenges. Thus, FDA's seafood program must remain flexible and dynamic and seek ways to maximize efficiencies and effectiveness. HACCP is the best way to achieve these goals.

Because over half of seafood consumed in the U.S. is imported, FDA's regulation requires that all seafood, both domestic and that which is imported into the U.S., be processed under HACCP controls. In this regard, the U.S. is conforming to a growing trend among our trading partners in requiring HACCP control of seafood.

At the same time, the Department of Commerce will privatize its voluntary fee-for-service seafood inspection program presently operated by the National Oceanic and Atmospheric Administration (NOAA). The voluntary program promotes domestic and foreign commerce in American seafood by inspecting for the safety, wholesomeness, and acceptability of products through contracts with processors that purchase their service.

Meat and Poultry: On February 3, 1995, FSIS announced sweeping new food safety proposals in the Federal Register that would "reinvent" federal meat and poultry inspection. These regulations represent a fundamental shift in the FSIS regulatory approach from heavy reliance on prescriptive command and control regulations and requirements to greater reliance on food safety performance standards that plants must meet to improve food safety. The proposed new system would focus on preventing problems before they occur, and provide greater flexibility than the current regulatory scheme, thereby making food inspection more effective and efficient.

Other Foods: For the rest of the food industry, which is under FDA's jurisdiction, the FDA has (1) issued an advanced notice of proposed rulemaking (ANPR) to gather input from interested parties on the expansion of the HACCP concept to "land food" and (2) has begun a voluntary pilot program to assess the feasibility of HACCP for products other than seafood.

Impact: The HACCP rulemaking would improve food safety by

Although there will be some initial costs to establishing and implementing a HACCP system, the benefits to public health and industry are many, including a reduction in foodborne illnesses and increased public confidence in the food supply. Additionally, the American food industry should benefit from harmonization with foreign countries' requirements for a HACCP-type system and from overall improvement in the safety of food. There also should be greater efficiencies in the conduct of Federal regulatory oversight, permitting more assurance of food safety despite shrinking Federal resources.

Implementation and Timeline: FDA published its final seafood HACCP regulations on December 18, 1995 (NOAA published a notice regarding the restructuring of its fee-for-service seafood inspection on September 22, 1995). FSIS is preparing the final HACCP regulations for meat and poultry. FSIS reopened the comment period for its proposal on August, 1995, to permit additional comments and dialogue with interested parties on issues raised during the initial comment period. The comment period remained open through November 13, 1995. FSIS is working to review all comments and complete the rule as quickly as possible. Timing and structure of a proposed HACCP rule applicable to other segments of the food industry depends on analysis of the comments received in response to FDA's ANPR and on the results from the on-going pilot program.

2 . Comprehensive Reform of Meat and Poultry Inspection System to be Consistent with HACCP

Background: FSIS's HACCP proposal reflects a fundamental shift in how it regulates to ensure the safety of meat and poultry products: a shift away from the agency's traditional approach of reliance on command and control regulations and requirements to greater use of performance standards. The current FSIS regulations, policy notices, and directives contain command and control requirements that are inconsistent with the new approach. FSIS acknowledges that it cannot simply layer HACCP on top of the current system.

Proposal and Justification: FSIS is committed to a comprehensive review and revision of all its existing regulations and related inspection requirements.

As part of the Administration's regulatory reform initiative to eliminate unneeded or unnecessarily burdensome regulations and make the regulations easier to use, FSIS conducted a page-by-page review of its regulations. It identified over 400 pages of specific regulations for possible revision or elimination, and a need to restructure all its regulations to make them simpler and more user friendly.

The agency has identified many specific regulations that will need revision to make them consistent with the proposed HACCP regulation before HACCP can be implemented. For example, FSIS will soon propose to amend current cooking regulations for meat and poultry products to incorporate performance standards, and allow processors the flexibility to develop their own innovative ways to achieve those standards. FSIS must thoughtfully reconsider all of its regulations that mandate specific actions, techniques, or processing parameters designed to achieve food safety objectives and determine whether they should be repealed or amended to provide the flexibility required to be consistent with HACCP. FSIS intends to have extensive dialogue with industry and other interested parties as it carries out these reforms.

Impact: In order for FSIS to operate an integrated HACCP-based food safety program, it must first revise existing regulations and inspection procedures that conflict with HACCP.

Implementation and Timeline: FSIS plans to publish an Advance Notice of Proposed Rulemaking soliciting public comment on its regulation review, and on its plans to revise its existing regulations to make them comport with HACCP prior to implementation of HACCP. Subsequent Notices of Proposed Rulemaking will address specific performance standards.

3. Reform of Meat and Poultry Inspection Prior Approval Systems to be Consistent with HACCP

Background: The current meat and poultry inspection program is based on intensive command-and-control oversight of plant operations, including prior approval systems for blueprints, facilities, equipment, in-plant chemicals, ingredients, process changes and labels. FSIS approves virtually everything used during slaughter and processing of meat and poultry that might affect the safety, quality, or wholesomeness of the food. FSIS also conducts a prior approval program for the labels of federally inspected meat and poultry products and imported products to ensure that they comply with the requirements of the Federal Meat Inspection Act and the Poultry Products Inspection Act.

These prior approval systems consume public and private sector resources that could be better used in reducing the public's risk of foodborne disease.

Proposal and Justification: Consistent with moving to a HACCP-based inspection system, the agency is reviewing its current policies and practices with the intent of simplifying them, while ensuring that important food safety and efficacy issues are considered.

FSIS will publish a proposed rule for a number of prior approval requirements: those concerning facility blueprints, equipment and utensils specifications, non-food chemicals used in facilities, and quality control plans. (The requirement for prior approval of substances added to meat and poultry products is a joint FSIS-FDA responsibility discussed elsewhere in this paper.)

FSIS will publish an ANPR initiating its review of all of remaining prior approval requirements and related command and control regulations, most notably the label-by-label review system, and seek public comment on how to eliminate, streamline, or simplify them.

At the same time, FSIS will proceed with an ongoing rulemaking to expand the categories of labels exempt from prior agency review.

Impact: Reform of the prior approval systems is part of the paradigm shift required for FSIS to implement HACCP successfully.

It will help foster innovation in food safety, reduce unnecessary burdens on industry, and make better use of agency resources.

Implementation and Timeline: Early in 1996, FSIS intends to publish Notices of Proposed Rulemaking and an ANPR on its prior approval systems. Also, FSIS plans to publish a final rule to expand categories of labels exempt from prior approval in the near future.


One of the missions of FDA and of FSIS is to ensure that foods do not become adulterated by added substances. FDA has primary jurisdiction over the additives themselves; it provides premarket review and regulations on the safety of substances for specific uses. FSIS further regulates the use of substances added to meat and poultry to prevent adulteration of products under its jurisdiction.

FDA scientists review data packages (petitions) submitted by manufacturers of GRAS (Generally Recognized As Safe) substances, as well as manufacturers of new food additives, which are by law considered unsafe until shown to be safe for the intended use. FDA's review process is often protracted; the food industry believes that review takes too long. FDA acknowledges that it needs to improve its review performance. FDA's reform proposal aims to achieve reform without jeopardizing food safety or the independence, integrity, and credibility of the review process.

FSIS has had an additional, largely redundant premarket approval process for ingredients used in meat and poultry products. FDA and FSIS jointly propose to reform premarket review of food additives for meat and poultry uses so that only one rulemaking is required.

1. Reform of FDA's Food-Additive Petition Review

Background: Congress charged the FDA with ensuring the safe use of direct (such as new sweeteners) and indirect (such as components of plastic bottles that can get into food) food additives when it passed the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960. These amendments to the Federal Food, Drug, and Cosmetic Act require that such additives undergo premarket evaluation to establish that their intended use will be safe.

Proposal and Justification: FDA's plan for comprehensive reform has the following elements:

In order to meet its petition-review deadlines, FDA must first reduce the petition backlog, improve the review process, and complete planned management reforms.

Performance Goals: FDA will establish timeframes and performance goals for the review of direct and indirect food additive petitions. The timeframes that will be established will ensure expeditious Agency reviews and decisions on petition approvals.

Reduce Pending Inventory: FDA intends to reduce the inventory of 290 pending petitions by (1) assigning additional staff to petition review, with an emphasis on reducing the pending-petition inventory; (2) establishing a mechanism for outside scientific review of a number of pending indirect additive petitions; and 3) establishing contracts for evaluation by third parties of data, such as toxicity studies, from a number of pending direct additive petitions. For both (2) and (3), FDA will render the final safety decision and notify the petitioner that either the petition is approvable or why the data do not support such a finding. The goal is to reduce the number of pending petitions so that new petitions may be evaluated more expeditiously.

New Approaches to Petition Review: (1) FDA has begun to implement a "Threshold of Regulation" approach for non-carcinogenic, indirect food additives. This approach allows FDA to determine that an indirect additive's migration into food is likely to be so trivial that the substance does not need to be listed in a food additive regulation. Under this approach, such indirect additives would receive expeditious, abbreviated review by FDA, thereby avoiding submission and review of food additive petitions. More than 100 such "Threshold of Regulation" letters have been issued to date. (2) FDA has implemented a policy in which firms developing food products through biotechnology consult early with FDA to identify potential safety and regulatory issues for their products. Such early consultation allows FDA to keep abreast of biotechnological developments, and to identify early the products raising safety issues that need to be resolved.

Management Reforms: Management reforms will include (1) increased use of in-house special review teams to expedite review of routine petitions, and for attention to and resolution of complex petitions; and (2) increased use of and consultation with experts from other FDA units, other agencies, and FDA's Food Advisory Committee to resolve complex scientific issues. In addition, FDA is working with the Federation of American Societies for Experimental Biology (FASEB) on criteria that the scientific community would agree justify the use of an alternative model to ensure the safety of non-traditional food ingredients, such as fat substitutes.

Impact: The proposed solutions will address several major complaints about food additive review procedures and response times. The food ingredient industry will benefit from increasingly shorter review times, will be able to market more new and innovative products faster, and will become more competitive in foreign markets. U.S. consumers will benefit from faster access to the new approved food products and ingredients. FDA will make better use of its limited resources.

Implementation and Timeline: The reforms have already begun to be implemented. Management reforms began in late 1992. New petition-review staff were re-assigned in August 1995 in an effort to reduce the petition inventory. Timeframes, resource, and process options will be set forth early in 1996 to ensure expeditious agency response to incoming petitions. Contracts to implement the third-party review components of the petition-review reform proposals will be established by June 1996. The final rule codifying the agency's new threshold of regulation policy was published in the Federal Register on July 17, 1995. The current consultation procedure for genetically engineered plant varieties was first used in 1994.

2. FDA's Premarket Notification for GRAS Substances

Background: Many substances that are added to foods, such as new sweeteners, are "food additives" under the law, and must be approved for safety by FDA prior to marketing. Other food ingredients, such as sugar, are not considered to be food additives under the law and need not be preapproved by FDA. Although food firms can market the latter by independently determining that they are "Generally Recognized As Safe (GRAS)," firms often request that FDA "affirm" that the ingredient is GRAS (thus gaining Federal agreement that the ingredient will be considered safe under the law if widely marketed).

In the early 1970s, FDA established a formal GRAS-affirmation petition process in response, in part, to industry requests. This system is now viewed by both industry and FDA as too inefficient and time-consuming. To illustrate: FDA receives an average of 4 to 8 GRAS affirmation petitions per year and acts on an average of 1 to 2 per year. In large part because of their low priority--these substances are nearly always affirmed as safe, and are being marketed while FDA reviews the petition--GRAS petitions can take between 6 and 10 years to review, which has led to a backlog of about 80 GRAS petitions.

Proposal and Justification: FDA proposes to establish a notification procedure by which companies would use a greatly simplified process to notify FDA of their independent GRAS determinations. FDA would have up to 90 days in which to review each notification submission and to inform the petitioner if a problem with the status of the substance is identified. After that period, companies could market the new food ingredient with the understanding that FDA is aware of the company's determination of the substance's GRAS status, that FDA does not take issue with that determination, and that FDA is aware of the company's marketing of that substance.

Impact: Industry would realize significant savings through elimination of the time and expense associated with assembling large and complex GRAS-petition packages and through elimination of significant administrative costs. These savings could range from thousands to hundreds of thousands of dollars, depending on the food ingredient involved. For the FDA, this reform would result in a net savings of 4 to 5 staff persons per year. These resources could be allocated to other, higher priority areas.

Implementation and Timeline: FDA intends to propose the necessary changes in its regulations by May 1996.

3. Premarket Approval of Substances Used in the Preparation of Meat and Poultry Products (FSIS and FDA)

Background: FDA has the responsibility for determining that substances used as food ingredients are safe. FDA implements this authority under the Federal Food, Drug, and Cosmetic Act, which requires premarket approval, by regulation, of all food and color additives. FSIS has separate authority under the meat and poultry inspection statutes to regulate those ingredients that are used in meat and poultry products. As a consequence, FSIS adopted a regulatory procedure that, like FDA's, requires petition and rulemaking on each substance before it may be used in a product under its jurisdiction. FSIS promulgates such regulations after determining (1) that FDA has already found the requested use of the substance to be safe and (2) use of the substance will not cause inspected products to be found adulterated or misbranded. This has resulted in a sequential, duplicative rulemaking process for substances used in meat and poultry that generates significant costs and delays over and above those attributable to FDA's premarket approval process.

Proposal and Justification: FDA and FSIS intend to amend their regulations and enter into a Memorandum of Understanding (MOU) under which the two agencies will work cooperatively so that only one rulemaking--FDA's--is required for substances to be used in meat and poultry products. FDA intends to change its regulations to require petitioners to state at the time of petitioning for additive approvals whether they are seeking approval of meat or poultry product uses. FSIS intends to change its regulations to specify that FDA regulations permitting meat or poultry product uses constitute prior approval by FSIS, as well as FDA. Under the MOU, FDA and FSIS would conduct their reviews concurrently when any petition to FDA includes a new meat and poultry use of a substance, and will consult to ensure the FDA regulation of the meat and poultry use is appropriate to ensure suitability under FSIS's inspection statutes.

Impact: This initiative should provide for a simpler, quicker, and more coherent Federal approval process for meat and poultry uses of food and color additives. It clarifies and harmonizes FDA and FSIS responsibilities, and results in more logical, comprehensive Federal regulation of food and color additives. It also will eliminate unnecessary, burdensome restrictions on the use of GRAS substances in meat and poultry products; encourage product/process innovations; and reduce costs to the government. It will result in no diminution of FSIS food safety oversight and consumer protection authority or activity under its inspection laws.

Implementation and Timeline: Notices of Proposed Rulemaking have been completed for both FDA and FSIS regulations and both proposals should be published in the same issue of the Federal Register in the near future. The MOU also has been drafted and will be published as an appendix to the FSIS proposed rule.


Background: Before current labeling laws, consumers had to base purchasing decisions primarily on the appearance of the product. Emerging food technology made it increasingly easy for some food manufacturers to produce cheaper traditional-looking products by substituting lower quality, less economically desirable ingredients for higher quality, more valuable ones. Consequently, Congress authorized FDA and FSIS to establish "standards of identity." These standards define a food's composition and prescribe minimum levels of valuable ingredients, such as milkfat in dairy products and meat in meat food products, or maximum levels for cheaper ingredients, such as fillers or water. Food standards are like "time-honored recipes" for hundreds of foods such as mayonnaise, cheeses, breads, fruit juices, corned beef, and hot dogs.

FDA has 285 specific food standards of identity that occupy about 270 pages in the Code of Federal Regulations. Most of these standards of identity were promulgated by formal rulemaking, which can involve often cumbersome evidentiary hearings. Because of a 1990 change in the law, however, most food standards now can be promulgated by notice and comment rulemaking, without the burden of evidentiary hearings. Formal rulemaking is still required for the amendment or revocation of existing standards for dairy products.

FSIS has about 74 standard of identity regulations. It has many more informal "standards," or labeling policies, that have evolved as a consequence of the reviews of product labels required for prior approval.

Although Congress' main concern when food standards were established was to protect consumers from economic deception, many food processors have come to view them as beneficial for commercial reasons, viz., as establishing a level playing field, providing certainty as to the identity of products, and preempting inconsistent State standards. They also continue to have strong support among consumer organizations.

The marketplace is and must be dynamic to meet changing consumer demands. For example, milkfat, once a desirable indicator of quality in dairy products, is no longer as desirable, and new lowfat and nonfat dairy products have become available to meet the demand. To keep pace with consumers' demands, FDA has recently established a new general standard of identity which would allow manufacturers to modify the composition of traditional standardized food, provided they meet minimum nutritional requirements and bear informative labeling. Thus, the processors are not prevented from reformulating products to meet such shifting consumer demand. FSIS will soon propose a similar rule for products under its jurisdiction. Nonetheless, many manufacturers continue to consider standards of identity to be overly prescriptive regulations that inhibit innovation, and result in less competition and fewer product choices in the marketplace.

Although standards of identity are intended for use primarily by manufacturers and not consumers, they do specify what a food contains and what the consumer is entitled to receive when a food is purchased by its common or usual name. In addition to specifying a name, the standards may require additional labeling to provide consumers with additional information about that product.

Proposal and Justification: FDA and FSIS propose to explore alternatives to the present food standards that will promote innovation and increase efficiency. The Agencies will seek comments on a broad range of options from eliminating food standards to simplifying many of the detailed requirements of the food standard regulations, including eliminating many of the procedural requirements and test methods that may hinder industry's ability to produce the food efficiently. Adoption of international standards, discussed elsewhere in this document, is a promising possibility.

Impact: The impact of this proposal will vary depending on the option chosen. Eliminating or simplifying food standards would benefit industry by permitting it flexibility to develop products using innovative ingredients to meet consumers' dietary preferences as well as allow the food industry to use more efficient procedures for producing their products. Complete elimination of all food standards, however, may place a greater burden on industry because, in the absence of Federal standards, states may decide to impose their own individual standards. Consumer groups may argue that eliminating food standards will invite the same economic deception that led to their creation more than a half century ago.

As part of FDA's recently promulgated nutrition labeling regulations, in order to give processors the flexibility to develop products with better nutritional profiles, FDA now allows the use of nutrient content claims in conjunction with the names of standardized foods (e.g., "low fat", "no fat", etc). As long as the product meets the requirements for the nutrient claim, it may, to the extent noted by the claim, deviate from the regulatory requirements for the standardized food. This change is a major break with the past approach to food standards of identity, when any product appearing to be the standardized product had to comply with the standard. FSIS soon will publish a notice of proposed rulemaking to permit the same use of nutrient content claims in conjunction with the standardized name of meat and poultry products.

Implementation and Timeline: Early in 1996, each of the two Agencies intends to publish an ANPR in the Federal Register seeking comment on how to simplify food standards. In addition, FSIS expects to publish in the near future a Notice of Proposed Rulemaking on the use of nutrient content claims in conjunction with standardized product names. In a related rulemaking, FDA proposed the direct elimination of a small number of specific food standards of identity on October 13, 1995.


The U.S. imports and exports tens of billions of dollars worth of food each year. International trade in the food arena is complex because nations often employ different systems of food safety. Nations have differing standards for the production of safe and wholesome food as well as varying regulatory procedures for inspecting and safeguarding product safety and quality. Companies seeking premarket approval of food additives and animal drugs, for example, must complete different applications for marketing approval in each country, entailing varying batteries of required tests. Similarly, most countries have laws like those in the United States that require imports of meat and poultry to have been subjected to inspection requirements equivalent to domestically produced products, and often require some form of certification to demonstrate that these products meet these requirements. FDA and FSIS try to facilitate international trade in the products they regulate in a manner consistent with their primary missions of food safety and consumer protection, with U.S. regulatory requirements, and, to the extent possible, with foreign requirements.

1. Harmonization of International Standards (FDA and FSIS)

Background: As noted above, nations often employ different regulatory standards relating to food safety. Because so much of our nation's food supply is either imported or exported, there is a substantial need to harmonize standards while retaining the U.S.'s high level of public health protection.

Proposal and Justification: FDA will seek common, science-based, international standards. The Agency will work with other countries, such as Canada, Mexico and the European Union and through international fora, especially the Codex Alimentarius Commission, to harmonize food and animal drug safety standards. In addition, FDA will encourage the harmonization of registration requirements for animal drugs.

FSIS will continue to ensure that equivalent inspection systems and standards for meat and poultry products exist in all countries exporting such products to the U.S., especially in light of the better U. S. safety standards expected under HACCP.

FDA also will evaluate the food safety systems of other countries, with the purpose of entering into agreements with those countries having food safety systems that offer equivalent levels of public health protection to those of the U.S. or that can provide assurance that their products will be in compliance with FDA requirements.

In addition, FDA and FSIS will work together to improve procedures for U. S. evaluation and, where appropriate, acceptance of Codex standards and to facilitate public participation in that process.

Impact: Increased harmonization offers clear benefits for U.S. public health. It increases the safety and quality of food imported into the U.S. It can also improve the safety and quality of foods produced and sold in foreign countries, as more countries participate in the international standard setting process.

Harmonization benefits industry by replacing many different standards with one international standard that must be met. In the long run, harmonization provides a level playing field, brings cost savings to industry, opens markets, enhances opportunities for export of U.S. goods and, in some cases, lessens the time needed to bring new products to market.

Harmonization permits FDA and FSIS to make more efficient use of their resources, as other countries share the workload of developing new standards. Investing now in harmonization may save future U.S. government resources by fostering cooperation with other countries in the assessment of new products.

Bilateral and multilateral agreements improve the safety of food imported into the U.S. from countries with which agencies have such agreements, allowing the agencies focus inspection and laboratory resources in other, more crucial areas, and provide predictable requirements for U.S. exports to such countries.

Implementation and Timeline: FDA and FSIS will build on and expand efforts to achieve international harmonization by:

2. Enhanced Use of the Private Sector in Monitoring Imported Foods (FDA)

Background: FDA oversees the importation each year of about 1.5 million food entries. While the Agency reviews paper or electronic documentation on almost all imports, it has the resources to examine physically only about 8 percent of the entries, and to perform laboratory analyses on about 2 percent. While the Agency targets its resources towards those products most likely to be in violation of the Federal Food, Drug, and Cosmetic Act, the relatively low inspection rate has been the subject of congressional hearings on the safety of imported foods.

FDA would like to make increased and better use of private, state and local laboratories to monitor food imports, both to reduce the length of time importers of foods must wait for results of laboratory analysis, and to increase the percentage of imported foods receiving sample analysis.

FDA already has several initiatives under way. For example, the Agency's New York District has just completed a pilot program in which importers of seafood, after receiving approval from FDA, were able to choose between having their products sampled and tested by FDA or by a private laboratory at their own expense. The private laboratories allowed FDA increased access to their facilities and submitted all of their results directly to the Agency. The Agency and the import and laboratory communities are now evaluating the program to see if it met the needs and expectations of all parties.

The Boston District of FDA is presently conducting a similar pilot program. Additionally, the Agency has entered into or is negotiating partnership agreements with several state governments in which state inspectors collect import food samples for FDA analysis, or for analysis by the states themselves.

Private laboratories already play a substantial role in testing imported foods that the Agency has detained without physical examination. (FDA may detain products without physical examination where there is prior evidence of a violation.) FDA expends substantial resources monitoring the laboratories and reviewing their analytical reports.

Proposal and Justification: FDA will work to develop pilot programs that make better use of private and state or local laboratories for analyzing food imports. The Agency will solicit input from the import, laboratory, and consumer communities by holding public meetings around the country, and by publishing in the Federal Register a notice requesting comments on how best to enhance Agency use of private, state and local laboratories for analyzing food imports.

Impact: The development of pilot programs will enable the Agency to learn how best to make further use of non-FDA laboratories for monitoring and analyzing imported foods. Ultimately, these programs should enable the Agency to institute programs that will make significantly increased and better use of the private sector and state and local governments for monitoring imported foods in order to ensure their safety. Such enhanced use of non-FDA resources should also reduce the time importers of foods have to wait for results of laboratory analysis, while at the same time increase the percentage of imported foods receiving sample analysis.

Implementation and Timeline: The Agency will hold a series of public meetings, and will publish a Federal Register notice, to solicit information on how best to make increased and better use of private, state and local laboratories to monitor imported foods. FDA will then begin to initiate pilot programs based on that information. Additionally, to help develop pilot programs making enhanced Agency use of private laboratories, FDA also will publish, by December 1996, either a guidance document and/or proposed rule to establish acceptable practices for laboratories.

3. Animal Drug Exports (FDA)

Background: Current law prohibits the export of U.S.- manufactured animal drug products unless the drug's substance, labeling, and use conform to an approved marketing application in the U.S. or FDA has approved an export application for the animal drug product. For FDA to approve such an export application, the drug must be subject to an investigational use exemption and the manufacturer must be actively pursuing U.S. marketing approval. In addition, current law permits export of unapproved products to only 21 developed countries. This means that, even if an animal drug is approved by the importing country, it often cannot be exported to that country from the U.S.

Proposal and Justification: FDA will work to allow the export of animal drugs, whether or not they have been approved for marketing in the U.S., to any country so long as the exported product has been approved for marketing in the receiving country. This change from current procedures would significantly relax restrictions on exports of animal drugs.

Impact: First, U.S. manufacturers of animal drugs will have the opportunity to expand their exports. Because use conditions for animal drugs in other countries can differ dramatically from use conditions in the U.S., foreign countries frequently approve products with different dosages, claims, strengths, animal species, etc. than are considered for use in the U.S. Legislative changes that permit the export of products in forms or with labeling that have not been approved in the U.S. will therefore expand the market available to U.S. exporters.

Second, companies may be more likely to locate animal drug manufacturing plants on U.S. territory. Industry believes that the current statutory language has contributed to animal drug manufacturers locating plants off-shore where domestic laws do not prohibit finished dosage form drugs from being labeled according to the specifications of the foreign purchaser and according to the laws of the country to which it is intended for export.

Implementation and Timeline: This action requires a statutory change. The Administration is engaged in discussions with Congress on new legislation.

4. Abbreviated Application for Veterinary Drug Residues in Imported Foods

Background: Currently, FDA establishes legally acceptable levels (tolerance levels) of veterinary drug residues in food only through its drug approval process. Thus, even for drugs that would not be used domestically (for example, because they are intended to treat diseases or pests that are not problems here), and for which the only domestic health concern would be that the residues in food be safe, the sponsor would submit, and the agency would review, data demonstrating that the drug is effective and safe for use in animals.

This requirement is burdensome both to the agency and industry, and adds nothing to public health or safety of American consumers. It also has the following undesirable effects:

Proposal and Justification: For animal drugs intended for use abroad, FDA will develop an administrative mechanism, or will seek specific legislative authority, to enable the agency to focus its reviews on the safety of the drug residue in the imported food product. FDA would rely on the provisions of its new animal drug regulations that spell out the residue studies and toxicological data required to determine whether such a drug residue is safe, such that a tolerance level would be appropriate for humans who consume the food. Such tolerances could be granted based on outside petitions or on the agency's own initiative, for example after reviewing a Codex decision to adopt a veterinary drug residue tolerance. The agency would eliminate or reduce the requirements for its review of whether the drug is safe and effective for use in animals in foreign countries.

Impact: This change would eliminate entirely, or make less burdensome, an unnecessary approval requirement and would be a step in the direction of international harmonization of regulatory requirements, as encouraged by the Uruguay Round Agreements.

Implementation and Timeline: FDA is pursuing administrative solutions and concurrently seeking this specific legislative authority.


1. Environmental Assessments for Animal Drugs, Animal Feed Additives, Food Additives, and Color Additives (FDA)

Background: The National Environmental Policy Act (NEPA) requires all federal agencies, including the FDA, to assess the environmental impact of actions that may significantly affect the human environment. Therefore, an animal drug, animal feed, food additive, or color additive, the approval of which may significantly affect the environment, cannot be approved unless the manufacturer has submitted an acceptable environmental assessment (EA). Preparation of an EA can be quite expensive. On the basis of FDA analysis of the EA, the Agency can either issue a "finding of no significant impact" (FONSI), or decide that a full environmental impact statement (EIS) must be prepared. In almost every case, FDA issues a FONSI.

The Center for Veterinary Medicine (CVM) is primarily responsible for the approval of animal drugs and animal feed additives. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the approval of packaging for human food and substances added to human food. Each of these Centers has developed categorical exclusions under which categories of industry submissions and Agency-initiated actions are excluded from the EA requirement. The Centers have determined that their actions concerning those submissions will not have a significant effect on the human environment.

However, there remain actions for which the food, food packaging, animal drug, and animal feed industries submit a hundred or more EAs to the Agency each year. Based on its experience to date, CVM and CFSAN have identified additional categories of actions that individually and cumulatively have been determined not to affect the environment significantly.

Proposal and Justification: FDA proposes to increase the number of categorical exclusions from the EA and EIS requirements.

FDA proposes to reduce the number of EAs required to be submitted by industry and, consequently, the number of FONSIs prepared by the Agency under NEPA, by increasing the number of categorical exclusions which are based upon little or no impact on the environment of the approval of the animal drug, animal feed, food additive, or color additive. Based upon its experience to date in reviewing EAs, FDA believes that many animal drug and animal feed applications and food additive and color additive petitions will qualify for categorical exclusion. For example, approvals of animal drugs for administration to companion animals would result in only minute releases of the animal drug into the environment as a result of use and such releases would not be environmentally significant. FDA procedures will provide for extraordinary circumstances in which a usually excluded action may have a significant environmental impact -- circumstances that would require at least an EA.

FDA will not categorically exclude from the EA requirement those approvals of products whose use may significantly affect the human environment. Examples include, but are not limited to, drugs and feed additives administered for extended periods of time to food animals (e.g, cattle, poultry, farmed fish); drugs and feed additives administered to a large number of animals; and food-packaging materials that may affect solid waste management.

Impact: These changes will benefit industry and will improve regulatory efficiency without having any adverse impact on public health or the environment. Industry and FDA could redirect thousands of dollars in development costs and human resources in preparing and reviewing EAs. Implementation and Timeline: These changes will be implemented by amending FDA regulations, in consultation with the President's Council on Environmental Quality (CEQ), to increase the number of categorically excluded actions for which an EA or EIS is not required. New regulations, proposed in consultation with CEQ, are expected to publish by June, 1996.

2. Elimination of Medicated Feed Applications (MFAs) (FDA)

Background: In order to manufacture a medicated feed containing a new animal drug that requires a withdrawal period (i.e., a period of time prior to slaughter during which an animal may not be fed the medicated feed), a manufacturer must submit a medicated feed application (MFA). Currently some 2,500 MFAs are submitted each year, and because of resource limitations, FDA contracts out the processing of these applications. Among other information, the Federal Food, Drug, and Cosmetic Act requires that MFAs contain a full statement of the composition of the feed, and a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of the animal feed. Under the Act, facilities manufacturing medicated feed must manufacture these products in compliance with FDA's current good manufacturing practice (CGMP) regulations. Inspections for compliance with CGMPs are conducted biennially.

Proposal and Justification: FDA has concluded that MFAs represent a sizable paperwork burden to industry, but provide no additional public protection to that provided by the Agency's product approval processes and by manufacturers' compliance with CGMP regulations. The Administration supports legislative change that would eliminate MFAs and institute a system to license medicated feed manufacturing facilities that comply with CGMP regulations. Any animal feed containing an approved new animal drug could be manufactured at a licensed facility; facilities would be subject to CGMP inspections biennially, as they are now; and licensing would be phased in over a 2-year period. Licenses could be suspended or revoked for CGMP violations, as well as for an imminent hazard to the health of animals for which the feed is intended or an imminent hazard to humans consuming edible products derived from animals that consume medicated feeds.

Impact: Elimination of MFAs would result in an estimated savings to industry in excess of $1 million per year, and a savings to FDA of $200,000 yearly that is currently allocated for the processing of MFAs by a contractor. Each of the almost 1,800 existing facilities would need to apply for a license, and new license applications are projected annually for some 50 new or renovated facilities. FDA would not charge fees for licenses.

Implementation and Timeline: This action requires a statutory change. The Administration intends soon to initiate discussions with Congress on new legislation.

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