I. INTRODUCTION Field tests of plants engineered to produce pharmaceutical and industrial compounds will increase significantly in number and scale over the next few years. These applications of plant biotechnology, which are now in their infancy, hold substantial therapeutic and economic promise. However, the same technology should be stringently controlled to minimize risk to the safety and integrity of the U.S. food supply. The new permit conditions proposed by the Animal and Plant Health Inspection Service (APHIS) for 2003 are a swift and responsive move to address this risk.

The undersigned U.S. trade associations, including the Grocery Manufacturers of America (“GMA”), American Bakers Association (“ABA”), Biscuit & Cracker Manufacturers Association (“B&CMA”), Food Marketing Institute (“FMI”), Institute of Shortening & Edible Oils (“ISEO”), International Dairy Foods Association (“IDFA”), National Confectioners Association (“NCA”), National Council of Chain Restaurants (“NCCR”), National Restaurant Association (“NRA”), National Soft Drink Association (“NSDA”) and the Snack Food Association (SFA) appreciate the opportunity to provide these comments to APHIS, in response to the Federal Register notice describing the more stringent permit conditions that APHIS intends to implement for field tests taking place in 2003 (68 Federal Register 11337, March 10, 2003). We applaud this prompt action by APHIS in the wake of the several incidents within the last two years involving the mishandling of genetically engineered crops and one involving transgenic animals. That said, conditions mandated by one agency, for one year, focused predominantly on one crop are not what is needed to minimize or eliminate the risk posed by this rapidly evolving technology. What is necessary is a stringent and comprehensive framework that is firmly grounded in scientific risk assessment and tightly coordinated among the agencies responsible for crops and for human food and feed.

GMA is the world’s largest association of food, beverage and consumer products companies. With U.S. sales of more than $500 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry, including the critical issue of biotechnology. Led by a board of 42 Chief Executive Officers, GMA speaks for the food and consumer product manufacturers and sales agencies at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry.

ABA is the national trade association representing the wholesale baking industry. The Association’s membership consists of approximately 300 bakers and bakery suppliers who together are responsible for the manufacture of approximately 80 percent of the baked goods sold in the United States.

B&CMA represents more than 70 national and international biscuit and cracker manufacturers and over 150 bakery suppliers. Cookies and crackers include a wide variety of distinctive products with retail sales in the United States of more than $10 billion.

FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 2,300 member companies — food retailers and wholesalers — in the United States and around the world. FMI’s U.S. members operate approximately 26,000 retail food stores with a combined annual sales volume of $340 billion — three-quarters of all food retail store sales in the United States. FMI’s retail membership is composed of large multi-store chains, regional firms and independent supermarkets. Its international membership includes 200 companies from 60 countries.

IDFA is the dairy foods industry's collective voice in Washington, D.C., throughout the country and in the international arena. IDFA has become a leading player in the formation of positive domestic and international dairy policies. Today, IDFA represents more than 500 dairy food manufacturers, marketers, distributors and industry suppliers across the United States and Canada, and in 20 other countries. IDFA is the umbrella organization for three constituent organizations: The Milk Industry Foundation (MIF), National Cheese Institute (NCI), and International Ice Cream Association (IICA). Members range from large multinational corporations to single plant operations, and represent more than 85% of the total volume of milk, cultured products, cheese, and ice cream and frozen desserts produced in the United States - an estimated $70 billion a year industry.

ISEO represents the refiners of edible fats and oils in the United States. Our members represent approximately 90-95% of the edible fats and oils produced domestically (20 billion pounds) that are used in baking and frying fats (shortening), cooking and salad oils, margarines, spreads, confections and toppings, and ingredients in a wide variety of foods.

NCA represents more than 700 companies that manufacture and market the vast majority of chocolate and non-chocolate confectionary in the United States.

NCCR, a division of the National Retail Federation (“NRF”), is a national trade association representing forty of the nation’s largest multi-unit, multi-state chain restaurant companies. These forty companies own and operate in excess of 50,000 restaurant facilities. Additionally, through franchise and licensing agreements, another 70,000 facilities are operated under their trademarks. In the aggregate, NCCR’s member companies and their franchisees employ in excess of 2.8 million individuals.

NRA is the leading business association for the restaurant industry. Together with the National Restaurant Association Educational Foundation, the Association's mission is to represent, educate and promote a rapidly growing industry that is comprised of 870,000 restaurant and foodservice outlets employing 11.7 million people. Founded in 1919, the National Restaurant Association's 60,000 member companies represent more than 300,000 restaurant establishments. NRA’s membership base consists of many different facets of the industry.

NSDA is the trade association representing the broad spectrum of companies that manufacture and distribute non-alcoholic beverages in the United States.

SFA is an international trade association representing approximately 700 snack food manufacturers and suppliers to the industry. Retail sales of snack foods in the U.S. alone total more than $32 billion annually.

II. DISCUSSION The undersigned trade associations and their members support development of plant biotechnology techniques and products that might afford therapeutic and economic advances to citizens of the United States and other countries. That said, the food industry will not benefit from these new applications of plant biotechnology, but could be saddled with substantial losses and liabilities if the number and size of the failures of containment systems multiply.

A. The U.S. Government Needs a Comprehensive, Coordinated, Science-Based Framework to Regulate Plant Biotechnology.

The APHIS permit conditions for 2003 follow close on the heels of the several incidents during the last two years that involved the mishandling of genetically engineered crops and one involving transgenic animals.

In September 2001, traces of StarLink, a corn that had been engineered to produce its own pesticides, were found in in a large number of food products made with corn. Because StarLink had never been approved for human consumption, this discovery triggered massive food recalls and efforts to contain the corn commingled with the StarLink corn. In March 2002, Environmental Protection Agency (EPA) inspections showed that two companies testing genetically engineered corn in Hawaii had violated the conditions of their experimental use permits (EUPs) that are required to contain the genetically engineered corn. Both companies paid fines to resolve EPA’s complaints. However, in April 2003, EPA levied a second fine on one of the companies for failing to notify EPA that the test results showed that the experimental gene had been detected in the seed corn grown on a neighboring plot. This triggered a USDA investigation because the plot was below the ten-acre threshold for EPA regulation. That company contended that it followed all applicable containment regulations, which implicitly suggests that the applicable regulations are insufficient to prevent cross-pollination.

In April 2002, The Wall Street Journal reported that USDA had received a letter stating that canola seed sold in the United States might contain “low, adventitious levels” of a genetically engineered canola known as GT200 that was not approved in the United States. Although it did not intend to commercialize that seed, the company initiated a voluntary premarket consultation with FDA after which FDA determined that it had “no further questions about further questions concerning canola seeds and canola based-products derived from canola line GT200.”

In November 2002 APHIS announced that a pharmaceutical protein from corn grown at test sites in Nebraska and Iowa had been found in conventional soybeans intended for food or feed use that were delivered to a Nebraska grain elevator. APHIS fined ProdiGene, Inc. for violating the terms of its experimental use permits. (In connection with this incident, we should note that, during 2002, only 20 of the 1000 field tests authorized by APHIS involved pharmaceutical plants, yet, even in that small sample, there already has been a failure of containment.)

In February 2003, the FDA announced that over a period of almost two years nearly 400 genetically engineered pigs may have become part of the food supply because researchers did not dispose of them properly, as required by applicable FDA regulations. All these incidents have taken place at a time when the use of agricultural biotechnology -- whether to produce food, pharmaceutical, or industrial products -- has not yet become widespread. It is commendable that APHIS responded to the Prodigene plant pharmaceutical incident by re-examining and strengthening its permitting and supervision processes. But, commendable as it is, APHIS’s effort to strengthen permit conditions on bioengineered crops for the 2003 growing season should not obscure the bigger picture by focusing attention solely on the role of APHIS, on the 2003 growing season, or on corn crops alone. The APHIS notice is not a substitute for a comprehensive, coordinated, science-based framework. Significant risk exists to the U.S. food supply and to the success of the technology broadly if such an approach is not adopted.

To regulate this technology effectively, two things should happen: First, there needs to be a stringent, comprehensive, and seamless regulatory framework that covers these crops at every stage of development and use. For example, before granting a permit for the use of a food crop for nonfood purposes, USDA will need to consult with FDA concerning the relevant food safety issues. USDA should not grant a permit for such field testing unless FDA has concluded that any release of the nonfood product into the food supply will be safe -- that is, it will have no adverse effect on human health. Similarly, enforcement decisions will require a high level of coordination between the agencies. USDA will need to keep FDA apprised of compliance (or lack thereof) with permit conditions so FDA can determine whether the pharmaceutical product complies with good manufacturing procedures (GMPs). Permit violations documented by USDA could require FDA to impose a clinical hold or to withhold approval of a marketing application for a product containing an active ingredient produced in a food crop.

Second, although FDA and USDA are making efforts to impose appropriate controls on this new technology, both the USDA notice and the FDA proposed guidance indicate that the necessary regulatory structure is still in the formative stages. Until the U.S. Government has promulgated mandatory, science-based regulations that effectively isolate these products and prevent the inadvertent or intentional contamination of the U.S. food supply, it should not permit the use of food crops or crops that are sexually compatible with food crops in the manufacture of pharmaceutical (or industrial) compounds. B. Comprehensive and Effective Regulation Must be Based on Scientific Risk Assessment

Both USDA and FDA are science-based regulatory agencies. Their regulations must be grounded in a rigorous scientific risk assessment and a scientific determination that the proposed regulatory measures -- in this case, permit conditions -- will control the underlying risks -- including in this case, food safety. Using this measurement, USDA’s effort to strengthen the permit conditions, although commendable, falls short.

Among the additional measures that USDA should adopt is a presumption against the use of food or feed crops for drug or industrial compound manufacturing. This would materially alleviate the potential risk to the food and feed supply more than any current permit conditions requiring biological or physical containment. To overcome this presumption to obtain a permit from USDA, a pharmaceutical (or industrial) product developer who wishes to use such crops should be required to demonstrate that it has tested the suitability of non-food crops and has determined that the use of such crops is not feasible from either an economic or a technological standpoint. We also question some of the proposed actions announced by APHIS that provide the appearance of increased stringency without identifying the degree of stringency necessary to eliminate the risk or to reduce it in a material way. For example, APHIS will require that the perimeter fallow zone around the field test site be 50 (rather than 25) feet and will prohibit the growing of any corn within one mile of a field test of open pollinated corn for the duration of the field test. These measures clearly are an improvement on prior safeguards but there is nothing in the notice that indicates how these distances were selected or why the APHIS believes that these distances will prevent gene flow or other forms of cross contamination.

C. APHIS Should Continue to Consider Other Measures to Control the Risk to Food Safety When Food Crops are Used for Drug or Industrial Compound Manufacture.

The APHIS notice is an improvement on existing permitting conditions; Increased recordkeeping, auditing, APHIS inspections, and operator training are all critical to the conduct and oversight of such field tests. Some of these permit conditions should be strengthened still further. For example, APHIS requires that some equipment -- harvesters and planters -- and all storage facilities be dedicated, but other equipment need only be cleaned pursuant to APHIS-approved protocols. We believe that all such equipment should be dedicated – as should all related land.

APHIS also needs to confirm expressly that pharmaceutical and industrial crops are and will remain ineligible for the notification procedures provided by 7 CFR Part 340. We understand that such a statement is expected shortly from the Agency, and we applaud this action. Such action is integral to the meticulous oversight of pharmaceutical and (industrial field tests.

The APHIS notice also should establish guidelines for the handling of contamination incidents. In other words, the notice should make provisions for the possibility that the Agency’s proposed containment measures will not be 100% effective. Both APHIS and the regulated community need to be prepared for such incidents. This would entail requiring a readily available, qualified, and rapid test that can be used on agricultural commodities to detect trace amounts of (or markers for) the active drug (or industrial chemical) ingredient. In addition to the current requirement that individuals involved in the handling of pharmaceutical crops provide prompt notice to appropriate authorities regarding of any releases of such material into the environment, we recommend that they develop an appropriate communications plan in advance in conjunction with those authorities to communicate promptly and clearly with the public about an incident, if and when one occurs.

We urge APHIS to address these issues promptly.

III. CONCLUSION

Biotechnology has tremendous potential for many positive applications but these applications are not without risk. Within the last two years, several failures to contain genetically engineered crops and transgenic animals have highlighted this risk. U.S. regulators as well as biotechnology developers must address these risks responsibly before we proceed to a large scale, commercial production of that technology. The only way to address the risk to the safety and integrity of the U.S. food supply is for the U.S. Government as a whole -- including but not limited to APHIS -- to develop a comprehensive, coordinated and science-based regulatory framework for this technology before this technology is pursued on a larger commercial scale, and before there are more and larger contamination incidents. Sincerely,

C. Manly Molpus President & Chief Executive Officer Grocery Manufacturers of America 1010 Wisconsin Avenue, N.W. - #900 Washington, DC 20007 202/337-9400

American Bakers Association 1350 I Street, N.W. Washington, D.C. 20005 202/789-0300

Biscuit & Cracker Manufacturers Association 8484 Georgia Avenue - #700 Silver Spring, MD 20910 301/608-1552

Food Marketing Institute 655 15th Street, N.W. Washington, D.C. 20005 202/452-8444

Institute of Shortening & Edible Oils 1750 New York Avenue, N.W. - #120 Washington, DC 20006 202/783-7960

International Dairy Foods Association 1250 H Street, N.W. - #900 Washington, D.C. 20005 202/737-4332

National Confectioners Association 8320 Old Courthouse Road - #300 Vienna, Virginia 22182 703/790-5750 National Council of Chain Restaurants 325 Seventh Street, N.W. - #100 Washington, D.C. 20004 202/626.8183

National Restaurant Association 1200 17th Street, N.W. Washington, D.C. 20036 202/331-5900

National Soft Drink Association 1101 16th Street, N.W. Washington, D.C. 20036 202/463.6732 Snack Food Association 1711 King Street, Suite One Alexandria, VA 22314 703/836.4500

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