July 22, Dockets Management Branch Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD CITIZEN PETITION

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1 Dockets Management Branch 5630 Fishers Lane, Room 1061 Rockville, MD CITIZEN PETITION Dear Sir/Madam: The American Bakers Association ( ABA ) and the undersigned petitioners (collectively, Petitioners ) hereby submit this Citizen Petition under 21 C.F.R to request that the Commissioner of Food and Drugs take the action requested below. ABA is joined in this petition by the American Frozen Food Institute, the Grocery Manufacturers Association, the International Bottled Water Association, the International Dairy Foods Association, the International Warehouse Logistics Association, the Peanut & Tree Nut Processors Association, and the Snack Food Association. I. Action Requested Petitioners request that the ( FDA ) promulgate regulations, pursuant to section 418(m) of the Federal Food, Drug and Cosmetic Act ( FDCA ), to exempt from compliance or modify the requirements for compliance under section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment, by allowing such facilities to satisfy the requirements of that section through compliance with the good manufacturing practices ( GMPs ) mandated for such facilities by 21 C.F.R The food safety issues presented by facilities used only to store packaged foods that are not exposed to the environment are essentially the same, regardless of the type of food. As such, trade associations representing a variety of product sectors are signatories to this petition and are supportive of the request to exempt such facilities from the provisions of section 418, as provided for in section 418(m) of the FDCA.

2 Page 2 II. Statement of Grounds A. Background Storage facilities for packaged foods are crucial to the industries represented by the Petitioners. Although practices vary slightly, Petitioners have identified the following commonalities among their members regarding use of such storage facilities: Facilities are registered under FDCA 415. Whether owned by the manufacturer or by an independent third party, the storage facility will be registered as a food facility under section 415 of the FDCA. Access to facilities is restricted. Facilities are locked, and access to the facilities is limited to authorized persons. Facilities do not engage in further packing, labeling, processing, or manufacturing activities that expose product to the environment. These facilities simply store only packaged foods that are ready to be purchased by consumers, restaurants, or retail stores, including ready-to-eat ( RTE ) and ready-to-cook ( RTC ) foods. Any facilities that engage in repack operations (e.g., repacking packed products for sale in club stores or stickering products for export) do not remove products from their primary packaging. Transported from the facility to the purchaser. These facilities are intermediaries between the manufacturer and a purchaser, which may include grocery stores, restaurants, and institutions. Sales to such a purchaser may be made by the manufacturer or by an independent wholesale distributor. These types of storage facilities are crucial to a number of product sectors. They have the common purpose of allowing efficient movement of food products from the manufacturer to purchaser. For example: In the baking industry, commercial bakeries of all sizes utilize storage facilities as an intermediary between the bakery and retailers and other purchasers, to facilitate expedient distribution of freshly-prepared products that generally have a relatively short shelf life. Typically, a regional bakery will transport packaged foods to upwards of storage facilities, which may include facilities owned by the bakery or smaller distribution facilities maintained by independent wholesale distributors. These foods, which may be stored at ambient temperature, refrigerated, or frozen, will remain in the facility on a temporary basis, often for less than hours and rarely for more than three or four days. The food is then transported and sold to grocery stores, restaurants, schools, and other purchasers. The result is that a single bakery can have its products quickly and efficiently transported to hundreds (or thousands) of retailers and consumers.

3 Page 3 A medium to large snack food manufacturer may utilize hundreds, if not thousands of storage facilities. As with the baking industry, this network of warehouse facilities allows for the continual flow of packaged products from the manufacturer to consumers and retailers. Bottled water manufacturers also use warehouses for efficient and quick distribution of their products. Products typically stay at the warehouse for a relatively short period of time generally less than a week even if the products themselves have longer shelf lives. A small amount of bottled water product may stay at a warehouse for a longer period of time. In addition to bottled water, many manufacturers also store allied products at their warehouses, such as coffee, sugar, creamer, and other beverages. Although many bottled water manufacturers use dozens of warehouses, some smaller companies may only use one or two warehouses. In all cases, the products are packaged and are not subject to any further manufacturing or processing. Warehouses are commonly used in the dairy industry for inventory and distribution purposes for fluid milk, yogurt, ice cream, cheese, butter, powdered and canned dairy products. In some cases the storage facilities are owned and operated by the manufacturing facility and in other cases they are third party warehouses under direct or indirect control by the manufacturing facility. Packaged product may be in storage for relatively brief periods of time or even as long as three to six months or longer. Most dairy products are stored under refrigerated conditions. The volume of dairy products in storage facilities can be at any particular point in time quite significant, for example, according to the United States Department of Agriculture s Cold Storage Report, on April 30, 2011, there were 141 million pounds of butter and over 1 billion pounds of natural cheese in public and private warehouses. As a final note, the food industry produces an incredible variety of foods that move through warehouses and eventually become available at retail. In addition to the above, these include processed and packaged fruits and vegetables, meat and poultry, seafood, cereals, processed dairy products, drinks, juices, seasonings, spices, frozen foods, and other specialty items in packaged form where the food is not exposed to the environment.

4 Page 4 B. Full Application of the Food Safety Modernization Act s Hazard Analysis and Preventive Controls Provisions to Storage Facilities Would Be Redundant and Impose an Unnecessary Cost with No Public Health Benefit Section 418 of the FSMA, which requires food facilities to conduct a hazard analysis and implement risk-based preventive controls to address food-safety hazards, represents Congress desire to implement a flexible food-safety system that can be adjusted to meet realworld risks. Rejecting a one-size-fits-all approach, Congress specified that FDA implement section 418 in a manner that acknowledges the difference in risk posed by various types of operations. Under section 418, owners and operators of a facility as defined by section 415 of the FDCA must conduct a hazard evaluation to identify hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, and unapproved food or color additives. 1 In addition, the facility must identify and evaluate hazards that occur naturally and hazards that may be intentionally introduced. 2 The facility must also identify and implement preventive controls to provide assurances that the identified hazards would be significantly minimized and that food would not be adulterated. 3 Section 418 provides an illustrative list of activities that constitute preventive controls, which primarily are directed toward minimizing the risks that occur in food production and packaging: sanitation for food-contact surfaces and utensils, hygiene training, environmental controls where a food is exposed to a potential contaminant, allergen controls, a recall contingency plan, GMPs under part 110 of 21 C.F.R., and supplier verification activities. 4 FDA is required to promulgate regulations that establish science-based minimum standards for conducting a hazard analysis and implementing preventive controls. 5 These 1 FDCA 418(b), (o). 2 Id. 418(b). 3 Id. 418(c). 4 Id. 418(o)(3). 5 Id. 418(n)(1)(A).

5 Page 5 regulations must provide sufficient flexibility to be practicable for all sizes and types of facilities and acknowledge differences in risk associated with different types of operations. 6 Section 418 also specifies categories of facilities that may be exempted from its requirements. FDA may, by regulation, exempt or modify the requirements of section 418 for facilities that are solely engaged in... the storage of packaged foods that are not exposed to the environment. 7 The statute also exempts from the requirements of section 418 other facilities for which the safety of their food products are assured through existing requirements, such as facilities meeting FDA s seafood, or juice standards, and facilities in compliance with the dietary supplement GMP and adverse-event-reporting requirements. These exemptions from the full requirements of section 418 demonstrate Congress intent to rely on existing safety standards, where possible, and avoid duplicative layers of regulation. Most of the potential hazards and preventive controls discussed in section 418 are not relevant to facilities solely engaged in the storage of packaged foods not exposed to the environment. Whether in RTE or RTC form, 8 these foods have already been subjected to hazard analyses and preventive controls (including GMPs) throughout the process of their manufacture and packaging, and they are ready to be delivered to retailers and end-users. Sanitation of foodcontact surfaces and utensils, for example, offers no benefit for a facility storing packaged foods. Supplier verification and recall plans will be addressed by the manufacturing facility from which the foods originated. The few hazards that may arise in such storage facilities, including those relating to environmental, climate, and pest controls, are already addressed under FDA s existing GMPs governing warehousing and distribution at 21 C.F.R , as detailed below. The storage facilities themselves pose a very limited, if any, food-safety risk. Most notably, we are not aware of any significant food-borne illness outbreaks attributable to storage at such facilities. Importantly, many packaged food product warehouses contain a variety of food products that can come from many different manufacturing facilities or even different companies. The warehouse operators work closely with the food manufacturers to understand the conditions and controls that need to be utilized to ensure the quality of the food products they 6 Id. 418(n)(3)(A),(C). 7 Id. 418(m). 8 RTC foods may include packaged foods, such as pasta or pizza dough, that are further cooked or prepared by a consumer, or that retailers or restaurants use in food preparation. Although such foods will be further prepared, they have completed their journey through the manufacturing process at facilities registered with FDA under section 415 of the FDCA, and will have been subject to the full scope of hazard analysis and preventive controls applicable to such manufacturing facilities.

6 Page 6 store and distribute. In many cases those conditions and controls are formally memorialized in written contracts. The warehouse operators themselves do not have access to product formulations and other relevant information that would be necessary for them to conduct a hazard analysis, develop preventive controls and monitor them. In essence, they lack the information and expertise needed to perform the requirements laid out in Section 418. The food manufacturer, on the other hand, does understand the details and idiosyncrasies of the products they produce and they factor in the storage and distribution parameters and considerations into their hazard analysis and appropriately instruct the warehouses to ensure packaged products are being properly stored. The responsibility for Section 418 is properly and best shouldered by the food manufacturer. Further, a key aspect of the FSMA s risk-based regulatory approach is that the public health benefit must justify the cost of compliance. For example, in the baking industry, each bakery feeds into upwards of storage facilities, and in the snack food industry, manufacturers may utilize hundreds or even thousands of such facilities. Petitioners estimate that the per-facility cost of compliance with the full requirements of section 418 could amount to several thousand dollars. 9 As a result, the aggregate cost of performing a full hazard analysis and designing preventive controls for each facility would be significant. Additionally, Petitioners note that some companies have agreements with relatively small distributors who run the storage facilities. Often family businesses, these distributors typically employ between one and five workers. Because of their limited resources, these distributors generally would be unable to absorb the cost of implementing the full requirements of section 418. The anticipated costs to industry and to consumers are simply not justified by any risks that might be presented at facilities solely engaged in the storage of packaged foods that are not exposed to the environment. Moreover, the application of section 418 to thousands of warehouses and storage facilities would undoubtedly dilute the focus and effort of both FDA and the affected industries, consuming resources that could be directed to higher-risk sources and facilities. Certainly, these resources would be put to better use in controlling the risks that arise before the product leaves the manufacturing facility. Accordingly, imposing extensive hazard analysis and preventive controls requirements on facilities solely engaged in the storage of packaged foods not exposed to the environment would create significant costs and administrative burdens without a corresponding benefit to public health. These factors present a compelling need for FDA to exercise its authority under section 418(m) to modify the application of section 418 to storage facilities. 9 This estimate generally is consistent with the cost estimates FDA produced for various activities required by the juice HACCP regulations. See 66 Fed. Reg. 6137, (Jan. 19, 2001).

7 Page 7 C. FDA Should Modify the Application of Section 418 to Exempt Packaged Product Storage Facilities that Comply with Existing GMP Requirements Consistent with Congressional intent to utilize existing, effective food safety standards, FDA should modify the application of section 418 to require only compliance with 21 C.F.R a regulation that broadly addresses the food safety risks of packaged foods. That regulation provides that [s]torage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. This standard fully captures the limited risks posed by storage facilities and mandates proper preventive measures. For both cold-storage and ambient-storage products, facilities compliant with section use appropriate environmental and climate controls to prevent deterioration of the food and its packaging. Additionally, they take measures to control pests that could result in physical, chemical, and microbial contamination or deterioration of the food or packaging. These controls fully address the limited risks that may arise while packaged foods are held at storage facilities, awaiting distribution to retailers and other purchasers. In addition to addressing food safety risks, facilities need to address hazards that may be intentionally introduced. As an initial matter, the risk of intentional adulteration at facilities solely engaged in the storage of packaged foods not exposed to the environment is quite remote. The food in these facilities is stored in unit packaging, meaning any effort to adulterate the food would be laborious and likely ineffective. To the extent intentional adulteration risks exist, however, facilities have food defense plans consistent with agency guidelines. Members of the food industry have implemented a number of precautions against intentional adulteration. Most importantly, these facilities are locked and secured against unauthorized entry. Access is restricted to the employees of the manufacturer dropping off food, any staff employed at the facility, and the persons who deliver food to retailers and other customers. Food is often held in such facilities for a short period of time, which would not be conducive to attempts at intentional adulteration. Further, we note that the continual activity in these facilities during pickup and drop-off hours serves as a deterrent for anyone attempting to gain unauthorized access. Finally, as part of the recordkeeping requirements mandated by section 414 of the FDCA and FDA s implementing regulations, as well as for other business reasons, detailed records are kept regarding the movement of the goods to and from the storage facilities in a manner that fosters accountability for the security of these foods. D. Suggested Text for Implementing Regulation Petitioners propose that FDA use the following language as part of its regulations implementing section 418 to modify the application of that section to facilities that hold packaged foods:

8 Page 8 A facility that is engaged solely in the storage, holding, warehousing, or distribution of packaged foods that are not exposed to the environment shall be exempt from the requirements of section 418 of the Federal Food, Drug, and Cosmetic Act if the facility complies with the requirements set forth at 21 C.F.R E. Conclusion Pursuant to section 418(m) of the FDCA, FDA should promulgate regulations exempting facilities solely engaged in the storage of packaged foods not exposed to the environment from the requirements of section 418. Given the limited risk posed by these facilities, FDA should allow facilities to satisfy the requirements of section 418 by complying with 21 C.F.R III. Environmental Impact This petition is categorically exempt from the requirement for an environmental assessment or an environmental impact statement pursuant to 21 C.F.R (j). IV. Economic Impact V. Certification Information on the economic impact of the petition will be provided upon request. The undersigned, on behalf of ABA and the additional undersigned associations, certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition. Lee Sanders, CAE Senior Vice President Government Relations & Public Affairs American Bakers Association 1300 I Street, N.W., Suite 700 West Washington, DC

9 Page 9 Petitioners Membership and Interests The American Bakers Association ( ABA ) is the Washington D.C.-based voice of the wholesale baking industry. Since 1897, ABA has represented the interests of bakers before the U.S. Congress, federal agencies, and international regulatory authorities. ABA advocates on behalf of more than 700 baking facilities and baking company suppliers. ABA members produce bread, rolls, crackers, bagels, sweet goods, tortillas and many other wholesome, nutritious, baked products for America s families. The baking industry generates more than $70 billion in economic activity annually and employs close to half a million highlyskilled people. Because of the extensive use by the baking industry of facilities solely engaged in the storage of packaged foods that are not exposed to the environment, ABA and its members have a strong interest in ensuring that the regulatory obligations imposed upon such facilities are appropriate. The American Frozen Food Institute ( AFFI ) is the sole national trade association that promotes and represents the interests of all segments of the frozen food industry. AFFI members manufacture and distribute frozen foods throughout the United States and globally. Although AFFI s membership comprises many of the largest food companies in the world, the institute prides itself on also representing the interests of small and mid-sized frozen food companies, as well. Founded in 1908, the Grocery Manufacturers Association ( GMA ) and its member companies are committed to meeting the needs of consumers through product innovation, responsible business practices, and effective public policy solutions developed through a genuine partnership with policymakers and other stakeholders. In keeping with our founding principles, GMA helps its members produce safe products through a strong and ongoing commitment to scientific research, testing, and evaluation. We ensure that our members have the very best and latest scientific knowledge available so they can provide consumers with the products, tools, and information they need to achieve a healthy diet and an active lifestyle. The $2.1 trillion food, beverage, and consumer packaged goods industry employs 14 million U.S. workers, and contributes over $1 trillion in added value to the nation's economy. The International Bottled Water Association ( IBWA ) is the trade association representing all segments of the bottled water industry, including spring, artesian, mineral, sparkling, well, groundwater and purified bottled waters. Founded in 1958, IBWA member companies include United States and international bottlers, distributors and suppliers. Bottled water companies produce a packaged food product that is comprehensively and stringently regulated by FDA. As a condition of membership, IBWA bottlers must submit to an annual plant inspection by an independent third party to determine compliance with the IBWA s Code of Practice and all applicable FDA regulations. The International Dairy Foods Association ( IDFA ), located in Washington, D.C., represents the nation s dairy manufacturing and marketing industries and their suppliers,

10 Page 10 with a membership of 550 companies representing a $110-billion a year industry. IDFA is composed of three constituent organizations: the Milk Industry Foundation ( MIF ), the National Cheese Institute ( NCI ), and the International Ice Cream Association ( IICA ). IDFA s 220 dairy processing members and their 175 divisions, subsidiaries, and joint ventures run nearly 575 plant operations, and range from large multi-national organizations to single-plant companies. Together they represent more than 85% of the milk, cultured products, cheese and frozen desserts produced and marketed in the United States. In addition, 320 member companies provide processing equipment and supplies, packaging equipment and materials, ingredients and a wide variety of products and services to the dairy processing industry. More than 15 state and regional trade associations are also members of IDFA. The International Warehouse Logistics Association ( IWLA ) is the association for warehouse-based third party logistics ( 3PL ) providers. IWLA s 450 member companies range in size from the 10,000 square-foot, single-city warehouse to international companies with more than 25 million square feet of warehouse space in cities throughout North America and the world. IWLA members employ nearly 100,000 people in North America and are a vital and growing component of the overall logistics industry. IWLA members provide warehousing; fulfillment; reverse logistics; transportation, freight forwarding and brokerage services; inventory and supply chain management capabilities; and a broad range of value-added services. Members who store and handle food products, comply with FDA regulations and meet independent quality standards, such as those of AIB International; and develop collaborative relationships with food shippers to create leaner, more efficient logistics practices within their supply chains. The Peanut and Tree Nut Processors Association ( PTNPA ) was established in 1939 and for decades has served as the Voice of America s Nut Industry. With several hundred members strong the PTNPA includes members (companies large, mid-sized and small) that shell, grade, blanch, sort, dice, roast or package tree nut and peanut products, along with companies who provide equipment, packaging and services to the tree nut and peanut industries. The PTNPA works to fulfill the mission of proactively advancing the nut industry through professional networks, advocacy and education. The Snack Food Association ( SFA ) is the international trade association of the snack food industry representing snack manufacturers and suppliers. SFA represents over 400 companies worldwide. SFA business membership includes, but is not limited to, manufacturers of potato chips, tortilla chips, cereal snacks, pretzels, popcorn, cheese snacks, snack crackers, meat snacks, pork rinds, snack nuts, party mix, corn snacks, pellet snacks, fruit snacks, snack bars, granola, snack cakes, cookies and various other snacks.