Attachment_8.pdf

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FSMA Facts cer fica ons of foreign facili es and the foods they produce for humans and animals, and (6) and focused mi ga on strategies to prevent inten onal adultera-on aimed at causing large-scale public health harm.

The goal of the proposed rule on the sanitary trans-porta on of human and animal food is to prevent prac ces that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly pro-tect food during transporta on. The proposed rule addresses the sanitary transporta on of both human and animal food traveling via motor or rail vehicle by establishing criteria for the safe transporta on of food. Specifically, the proposed rule would establish requirements for: vehicles and transporta on equip-ment, transporta on opera ons, informa on ex-change, training, records, and waivers.

Who is Covered?

With some excep ons, this proposed rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It would also apply to a person outside of the United States, such as an ex-porter, who ships food to the United States in an interna onal freight container by oceangoing vessel or in an air freight container, and arranges for the transfer of the intact container in the United States onto a motor vehicle or rail vehicle for transporta on in U.S. commerce, if that food will be consumed or distributed in the United States. The FDA would con-sider this person to be a shipper under this proposed rule because the person would be ini a ng a ship-ment of food by motor vehicle or rail vehicle, even if doing so from abroad, that would be entering U.S.

commerce.

Summary The FDA’s proposed rule would require those who transport food to use sanitary transporta on prac c-es to ensure the safety of food.

The proposed rule, which is required by the FDA Food Safety Moderniza on Act (FSMA), would help main-tain the safety of both human and animal food during transporta on by establishing criteria, e.g., condi ons and prac ces, training and record keeping, for the sanitary transporta on of food.

The FDA is proposing that the requirements be effec-ve 60 days a er the final rule is published in the Fed-eral Register. Recognizing that small businesses may need more me to comply with the requirements, the FDA is proposing ered compliance dates based on business size. The proposed rule displayed on Jan. 31, 2014, and comments are due by May 31, 2014.

Background FSMA was signed into law on Jan. 4, 2011, to be er protect human and animal health by helping to en-sure the safety and security of the food and feed sup-ply. FSMA embraces preven ng food safety problems as the founda on of a modern food safety system and recognizes the need for a global approach to food and feed safety. The FDA has proposed six addi onal rules that are founda onal to this preven ve approach en-compassed by FSMA. In addi on to the rule on sani-tary transporta on, the FDA has proposed: (1) pre-ven ve controls requirements for human food, (2) preven ve controls requirements for animal food, (3) standards for produce safety, (4) a Foreign Supplier Verifica on Program for importers, which requires importers to take steps to help ensure that imported human and animal food is as safe as that which is pro-duced domes cally, (5) a program for the accredita-on of third-party auditors, also known as cer fica-on bodies, to conduct food safety audits and issue

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 1

Proposed Rule on Sanitary Transporta on of Human and Animal Food businesses may need more me to comply with the requirements, the compliance dates are adjusted accordingly.

Compliance Dates:

Small Businesses—businesses other than motor carriers who are not also shippers and/or receiv-ers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts would have to comply two years a er the publica on of the final rule.

Other Businesses—a business that is not small and is not otherwise excluded from coverage would have to comply one year a er the publica-on of the final rule.

Economic Impact of the Proposed Rule Improving food transporta on systems could reduce the likelihood of condi ons during transporta on that can lead to human or animal illness or injury or prod-uct recalls and reduce the losses of contaminated hu-man and animal food and feed ingredients and prod-ucts. This proposed rule is es mated to cover 83,609 businesses. This number includes carriers engaged in food transporta on and facili es that ship food sub-ject to this proposed rule. The total first-year cost is es mated to be $149.1 million (with an average of $1,784 per business), and the total annual cost is es -mated to be $30.08 million (with an average of $360 per business).

Rulemaking Process and How to Submit Comments The proposed rule, “Sanitary Transporta on of Hu-man and Animal Food,” is published in the Federal Register so that the public can review it and submit comments. The FDA considers comments received during the comment period on the proposed rule and then considers revising the rule, based on its review of the comments, before issuing a final rule. The pro-posed rule and suppor ng documents are filed in the

Highlights of the Proposed Rule Specifically, the proposed rule would establish require-ments for:

Vehicles and transporta on equipment: The de-sign and maintenance of vehicles and transporta on equipment to ensure that it does not cause the food that it transports to become contaminated.

Transporta on opera ons: The measures taken during transporta on to ensure food is not con-taminated, such as adequate temperature con-trols and separa on of food from non-food items in the same load.

Informa on exchange: Procedures for exchange of informa on about prior cargos, cleaning of transporta on equipment, and temperature con-trol between the shipper, carrier, and receiver, as appropriate to the situa on. For example, a carri-er transpor ng bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.

Training: Training of carrier personnel in sanitary transporta on prac ces and documenta on of the training.

Records: Maintenance of wri en procedures and records by carriers and shippers related to trans-porta on equipment cleaning, prior cargos, and temperature control.

Waivers: Procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transporta on of food under condi ons that would be unsafe for human or animal health and that it is in the public interest.

Effec ve and Compliance Dates and Defini ons for Small Businesses The FDA is proposing the effec ve date for businesses subject to the new requirements to be 60 days a er the final rule is published. Recognizing that small

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 2

Proposed Rule on Sanitary Transporta on of Human and Animal Food

FDA’s official docket on h p://www.regula ons.gov and also can be accessed at www.fda.gov/fsma.

The FDA will hold public mee ngs on this proposed rule and will conduct addi onal outreach during the comment period.

For Addi onal Informa on FDA Food Safety Moderniza on Act website The Food Safety Law and the Rulemaking Process:

Pu ng FSMA to Work Video: The Rulemaking Process: A Primer by FDA Video: FDA Food Safety Moderniza on Act: A

Primer by FDA

Updated: 1/31/14

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 3

Proposed Rule on Sanitary Transporta on of Human and Animal Food http://www.regulations.gov� http://www.fda.gov/fsma� http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm� http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM277713.pdf� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#rulemaking� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer�

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 4

Proposed Rule on Sanitary Transporta on of Human and Animal Food

Exemp ons and Modified Requirements for Sanitary Transporta on of Human and Animal Food*

Excluded or exempted from coverage

Shippers, receivers, or carriers engaged in food transporta on opera ons that have less than $500,000 in total annual sales

Transporta on ac vi es for raw agricultural commodi es performed by a farm

Food that is transshipped through the United States to another country

Food that is imported for future export and that is neither consumed or distributed in the United States

Transporta on of shelf stable food that is completely enclosed by a container

Transporta on of compressed food gases

Transporta on of live food animals

*This chart does not contain all of the informa on necessary to determine the proposed requirements for compliance in a par cular circumstance. Consult the proposed rule for specific requirements.

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/HRV (Za stvaranje Adobe PDF dokumenata najpogodnijih za visokokvalitetni ispis prije tiskanja koristite ove postavke. Stvoreni PDF dokumenti mogu se otvoriti Acrobat i Adobe Reader 5.0 i kasnijim verzijama.)

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<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> /ENU (Use these settings to create Adobe PDF documents best suited for high-quality prepress printing. Created PDF documents can be opened with Acrobat and Adobe Reader 5.0 and later.)

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