Proposed Rule for Sanitary Transportation of Human and Animal Food http://www.fda.gov/fsma Welcome everyone. FDA recently announced the proposed rule for the sanitary transportation of human and animal food.

Proposed Regulations for Sanitary Transportation The Sanitary Food Transportation regulations would implement section 111(a) of FSMA and would also implement the Sanitary Food Transportation Act of 2005.

Summary of Requirements Shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, and food subject to USDA/FSIS requirements must use sanitary transportation practices to ensure the safety of the food they transport Under the proposed regulations for sanitary food transportation, food shippers, receivers, and carriers by motor vehicle and rail, would for the first time, be required to use sanitary transportation practices as specified in these proposed regulations, to ensure the safety of the food they transport.

Significance of Proposal Part of FDA’s larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act (SFTA) of 2005 and the FDA Food Safety Modernization Act of 2011 This rule is the seventh and last major rule implementing preventive measures across the food system under the landmark FDA Food Safety Modernization Act (FSMA).

History of Sanitary Food Transportation Regulation 1990 SFTA – Transport of food in bulk FDA/USDA ANPRM – 1996, Transport of potentially hazardous foods 2005 SFTA – Sanitary transportation practices for all food transportation FDA ANPRM – 2010, SFTA rulemaking FSMA – 2011, Timeframe for SFTA regs The issues of this rulemaking have a history that goes back to another law called the Sanitary Food Transportation Act (SFTA) of 1990, with actions by FDA, the United States Department of Agriculture (USDA) and the Department of Transportation (DOT) along the way to the present. Interested readers can find this information in detail in FDA’s 2010 Advance Notice of Proposed Rulemaking (ANPRM) which is cited in the preamble. The cite is Volume 75 of the Federal Register, page 22713.

2005 SFTA Food deemed adulterated if transported by motor vehicle or rail contrary to conditions (sanitary transportation practices) to be prescribed in new regulations Other transportation modes, e.g., ship, air, not addressed in SFTA Here are some key provisions of the 2005 SFTA: The SFTA requires FDA to promulgate regulations establishing sanitary transportation practices Once these regulations become effective, food that is transported under conditions that are not in compliance with the regulations is deemed adulterated “Transportation,” as defined by the law only encompasses the movement of food in the U.S. by motor vehicle or rail Thus food transportation by any other mode of transport, for example a barge hauling grain, is not covered by this proposal

2005 SFTA Provisions Applicable to shippers, carriers, receivers, other persons engaged in food transport FDA to establish regulations for sanitary transportation practices addressing: sanitation vehicle use limitations packaging isolation and other protective measures Continuing with key provisions of the law: The requirements of the law and the implementing regulations apply to shippers, receivers and carriers by motor vehicle or rail The law provides the authority to apply these requirements to “other persons engaged in the transportation of food,” but we have not proposed to do so, and have requested comment on whether other persons should be subjected to the proposed regulations The law specifically authorizes FDA to include in the new regulations provisions addressing: Sanitation Vehicle use limitations Packaging, isolation and other protective measures

2005 SFTA Provisions cont. Waivers Preemption Information disclosure, e.g., between carriers and shippers Records Waivers Preemption The law specifically authorizes FDA to include in the new regulations provisions addressing (cont.): Information disclosure between persons engaged in food transportation Recordkeeping The SFTA authorizes FDA to waive the requirements of these regulations under circumstances where we have determined that the waiver would not result in the transport of food under unsafe conditions or be contrary to the public interest. The law explicitly provides that these regulations would preempt any conflicting State (or other political subdivision) requirement.

Key Elements of FDA’s Proposal Activities/entities covered/not covered Definitions Good transportation practices Vehicles/equipm’t /operations/info exchange Training Records Waiver procedures This is in outline form the key elements of the proposed regulation that would be established in 21 CFR Parts 1.900 to 1.934.

Covered by Proposal Transportation* operations of shippers, receivers and carriers Transportation of food in intrastate commerce * Transportation means any movement of food in commerce by motor vehicle or rail vehicle Here is some more detail on what is covered by the proposed rule. Again the requirements only apply to shippers, receivers and carriers. Furthermore, the law itself defines transportation as shown at bottom of the slide, i.e., movement by motor vehicle or rail vehicle, so a river barge operator would not be engaged in “transportation” as defined by SFTA, and is not covered by these regulations. The proposed regulations would apply to transportation solely in intrastate commerce.

Not Covered by Proposal Trans-shipments of food through the U.S. Food not consumed in the U.S. (import for export) Transportation of raw agricultural commodities (RACs) by a farm Shippers, receivers and carriers with transportation operations with less than $500,000 in total annual sales Here is some detail on what is not covered by the proposed rule: Food that is trans-shipped would be a food that travels by truck from Canada to Mexico passing through the U.S. Some food may be imported and processed in the U.S. for the purpose of subsequent export Any type of transportation activity for raw agricultural commodities (RACs) performed by a farm is not covered, whether it involves shipping, receiving or carrying There is an annual sales threshold of $500,000 below which a shipper, receiver or carrier is not subject to the proposed rule

Not Covered by Proposal Transportation of: Shelf stable food fully enclosed by a container Live food animals Compressed food gases Here are some categories of food transport that are not subject to the proposed rule because we have determined that the food is at little risk of becoming adulterated during transportation: Shelf stable food fully enclosed by a container, e.g., canned vegetables, bottled water, a sealed bag of sugar, packaged spices Live food animals Compressed food gasses, e.g., cylinders of carbon dioxide that would be used to carbonate soft drinks

Examples of Types of Food Subject to Proposal Foods transported in bulk, e.g., juice, animal feed Packaged foods not fully enclosed by a container, e.g., fresh produce Foods that require temperature control for safety (TCS food) or to prevent spoilage These food types represent significant categories of food that is covered: Food that is transported in bulk, meaning that the food is in contact with the walls of the cargo bay of the vehicle during transportation, e.g., juice, corn syrup, animal feed Packaged foods not fully enclosed by a container, e.g., fresh fruits and vegetables in vented boxes Foods that require temperature control to ensure that they do not spoil or become unsafe (TCS foods). Pasteurized non-shelf stable juice would be an example of the former. Fresh-cut vegetables and unpasteurized shell eggs would be examples of the latter

Provisions of Proposal Good transportation practices: Provisions for vehicle and equipment design, storage and maintenance Ensure temperature control where necessary to ensure safety and prevent spoilage Ensure that transportation operations are conducted in a way that prevents contamination and cross contact The proposed rule includes several baseline sanitary transportation practices that would be required of all shippers, receivers and carriers subject to the proposed rule. These are found in Section 1.906 and 1.908(a): Provisions for vehicle and equipment design, storage and maintenance Ensure temperature control where necessary to ensure safety and prevent spoilage Ensure that transportation operations are conducted in a way that prevents contamination and cross contact Cross contact is a term that refers to the unintentional incorporation of a food allergen as defined in section 201(qq) of the FD&C Act into food, except animal food Cross-contamination is the transfer of harmful bacteria to food from other foods when food is improperly handled

Provisions of Proposal Good transportation practices: Shipper specifies all necessary sanitary requirements for vehicle, including conditions necessary for a temperature-controlled food Carrier must supply a vehicle that meets the shipper’s specifications, including precooling Shipper verifies vehicle precooling and sanitary condition, as appropriate Sections 1.908 (b) and (d) of the proposed rule contain provisions that are specific to shippers and carriers respectively: Shipper specifies all necessary sanitary requirements for the vehicle, including conditions necessary for a temperature-controlled food Carrier must supply a vehicle that meets the shipper’s specifications, including precooling Shipper verifies vehicle precooling and sanitary condition, as appropriate

Provisions of Proposal Good transportation practices Carriers must be able to demonstrate to shippers (and upon request, receivers) that appropriate temperature conditions were maintained during transport, as appropriate Flexible and consistent with current practices Here is a provision of proposed 1.908(d) that is based upon the authority in the SFTA for FDA to include information disclosure provisions in the sanitary transportation practices requirements. The “as appropriate” tag is in recognition that this demonstration may be very different for a cross-country transportation operation than it would be for one between two neighboring towns.

Provisions of Proposal Good transportation practices (bulk transport) For bulk vehicles, carriers must provide to shippers information that: Identifies of up to 3 previous cargoes for the vehicle Describes the most recent cleaning of the vehicle Flexible and consistent with current practices Here is a another provision of proposed 1.908(d) that is based upon the authority in the SFTA for FDA to include information disclosure provisions in the sanitary transportation practices requirements. The disclosure of information from carriers to shippers about prior cargoes and recent cleaning for a bulk food transport vehicle is a routine practice for much of the bulk food transportation industry, e.g., for the bulk transport of juice and animal feed.

Provisions of Proposal Required records for shippers Records that demonstrate that the shipper provides information to carriers about the necessary sanitary requirements for a vehicle, and the necessary temperature conditions for a temperature-controlled food as appropriate We have established record keeping requirements in Section 1.912 that require shippers and carriers to be able demonstrate to FDA through retained records, that they do as required by Sections 1.908(b) and (d), disclose specified types of information to each other. The requirement for shippers relates to the providing information to carriers concerning the necessary sanitary requirements for a vehicle and the necessary temperature conditions for a temperature-controlled food.

Provisions of Proposal Required records for carriers Carriers must develop written procedures (SOPs) for cleaning and inspection of vehicles, and that describe how it will meet requirements to provide information to shippers about temperature conditions and bulk cargo protection, as appropriate Training records We have established record keeping requirements in Section 1.912 that require shippers and carriers to be able demonstrate to FDA through retained records, that they do as required by Sections 1.908(b) and (d), disclose specified types of information to each other. The requirement for carriers relates to the providing information to shippers concerning the temperature conditions and bulk cargo protection. Carriers have additional record keeping requirements for procedures they must develop for the cleaning and inspection of their vehicles and for records documenting that they have met the training requirements of Section 1.911.

Provisions of Proposal Required training for carriers Carrier personnel engaged in transportation operations must have training that provides an awareness of the food safety problems that may occur during transport, proper sanitary practices, and their responsibilities under the rule Here is some detail on the training requirement for carriers noted in the previous slide.

Waiver Procedures Proposed rule includes process for FDA to grant waivers either on its initiative or via petition Preamble discusses tentative conclusions on potential waivers Sections 1.914 through 1.934 of the proposed rule lay out the process by which FDA will grant waivers to classes of persons, vehicles, food or non-food products either on its initiative or by petition. As previously noted, the SFTA provides authority for FDA to grant waivers in circumstances where we have determined that the waiver would not result in the transport of food under unsafe conditions or be contrary to the public interest. The preamble of the proposed rule presents FDA’s tentative conclusions concerning potential waivers it would grant for two circumstances, if the proposed rule is finalized.

Potential Waivers Shippers, carriers and receivers holding valid permits under the NCIMS Grade A Milk program, when transporting Grade A milk and products Food establishments, e.g., retail stores and restaurants, holding valid permits, when acting as a receiver or as a carrier delivering food to consumers The NCIMS refers to the National Conference on Interstate Milk Shipments. The NCIMS Grade "A" Milk Safety Program, is a program participated in by all 50 States, the District of Columbia, and Puerto Rico. The program uses as its basic standard a model milk regulation, the Grade "A" Pasteurized Milk Ordinance published by the FDA. “Food Establishments” are defined in the Food Code as an establishment that: Stores, prepares, packages, serves, vends food directly to the consumer, or otherwise provides food for human consumption such as a restaurant; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and Relinquishes possession of food to a consumer directly or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers. FDA publishes the Food Code to assist food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal model for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). Local, State, tribal, and Federal regulators use the Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy. State codes patterned after the current or previous versions of the Food Code have been adopted in all 50 States.

Effective and Compliance Dates Effective date: 60 days after the final rule is published Compliance dates 2 years after publication of the final rule for small businesses 1 year after the date of publication of the final rule for businesses other than small businesses Compliance dates for the sanitary transportation rule are staggered depending on facility size.

Proposed Small Business Definition A business subject to this rule employing fewer than 500 persons except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to this rule having less than $25,500,000 in annual receipts. The small business definition depends upon whether or not the entity is a motor vehicle carrier.

How to Comment on the Proposed Rules http://www.regulations.gov Link to rules on http://www.fda.gov/fsma Comment period closes on May 31, 2014 Comment periods on major FSMA proposals will be coordinated to enable comment on how the rules can best work together We encourage comments on the proposed rule from a wide variety of stakeholders. The proposed and final rules and supporting documents will be filed in FDA’s official docket on http://www.regulations.gov and also can be accessed at www.fda.gov/fsma. The comment period will close on May 31, 2014. However, we plan to coordinate the comment periods on the major FSMA proposals as fully as possible to enable public comment on how the rules can best work together to create an integrated and effective food safety system.

Outreach and Technical Assistance Will Continue Public meetings Presentations Listening sessions Guidance documents Outreach: We will hold public meetings across the country, give presentations and hold listening sessions to explain the proposed rules and get comments. We will continue to work closely with our government partners at the state and federal levels and with stakeholders. Technical assistance: Will help facilities comply with the sanitary food transportation requirements once the final rule is issued. FDA has numerous food transportation guidance documents and plans to update those as necessary and issue additional guidance to accompany this final rule to help industry comply with requirements. As with all FSMA rules, partnerships will be essential.

More Information Available Web site: http://www.fda.gov/fsma Subscription feature available Send questions to FSMA@fda.hhs.gov The FSMA web site, at fda.gov/fsma, has a number of materials on the proposed rules that you can download. They also are available in several languages. We have a subscription feature to get the latest news. Stakeholders can send questions to FSMA@fda.hhs.gov. We will continue to update the frequently-asked-questions on our web site. I hope this overview has been helpful and we look forward to continuing our discussions on the rules during the comment period.