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HHS/FDA RIN: 0910-AG98 Publication ID: Fall 2015 
Title: Sanitary Transportation of Human and Animal Food 
Abstract:

This rule would establish requirements for parties including shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 1   
Legal Authority: 21 U.S.C. 350e    21 U.S.C. 373    21 U.S.C. 331    21 U.S.C. 342    21 U.S.C. 371    ...   
Legal Deadline:
Action Source Description Date
Final  Judicial  To the Office of the Federal Register for publication.  03/31/2016 

Statement of Need:

There have been concerns over the past few decades about the need to ensure that food is transported in the United States in a sanitary manner. Congress responded to these concerns by passing the Sanitary Food Transportation Act of 1990 (1990 SFTA) which directed the Department of Transportation (DOT) to establish regulations to prevent food or food additives transported in certain types of bulk vehicles from being contaminated by nonfood products that were simultaneously or previously transported in those vehicles. Following the passage of the 1990 SFTA it became clear that potential sources of food contamination during transport were not just limited to nonfood products. Most notably, a 1994 outbreak of salmonellosis occurred in which ice cream mix became contaminated during transport in tanker trucks that had previously hauled raw liquid eggs. That outbreak affected an estimated 224,000 persons nationwide. In 2005, Congress reallocated authority for food transportation safety to the Food and Drug Administration, Department of Transportation and the United States Department of Agriculture by passing the 2005 Sanitary Food Transportation Act (2005 SFTA), a broader food transportation safety law than the 1990 SFTA in that its focus was not limited only to preventing food contamination from nonfood sources during transportation. The 2005 SFTA amended the Food, Drug, and Cosmetic Act (the FD&C Act), in part, by creating a new section, 416 of the FD&C Act (21 U.S.C. 350e). Section 416(b) of the FD&C Act directed us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. In addition, section 111(a) of Food Safety Modernization Act (FSMA), directed us to issue these sanitary transportation regulations not later than 18 months after the date of enactment of FSMA. This action is part of FDA’s larger effort to focus on prevention of food safety problems throughout the food chain.

Summary of the Legal Basis:

FDA's authority for issuing this rule is provided in the Sanitary Food Transportation Act (Pub. L. 109-59) which amended the FD&C Act by establishing section 416 which directed FDA to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. FDA is also issuing this rule under section 111(a) of the Food Safety Modernization Act (Pub. L. 111-353), which directed FDA to promulgate these sanitary transportation regulations.  In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act.

 

Alternatives:

FSMA requires FDA to promulgate regulations to establish sanitary transportation practices under the authority of the 2005 SFTA.

Anticipated Costs and Benefits:

Because no complete data exist to precisely quantify the likelihood of food becoming adulterated during its transport, we are unable to estimate the effectiveness of the requirements of the proposed rule to reduce potential adverse health effects in humans or animals. Furthermore, while we expect small changes in behavior (in the form of safer practices), we do not anticipate large scale changes in practices as a result of the requirements of this proposed rule. Nevertheless, improving food transportation systems could reduce the number of recalls, reduce the risk of adverse health effects related to such contaminated human and animal food and feed, and reduce the losses of contaminated human and animal food and feed ingredients and products.  The compliance costs of the proposed rule would result from the additional labor and capital required to carry out sanitary transportation practices during transportation operations and the costs to train personnel and keep the required records.

Risks:

FDA is proposing this rule to establish sanitary transportation practices to provide greater assurance that food will not become adulterated during transportation and will not cause illness or injury to humans or animals. The rule would apply to food transported in the United States by motor vehicle or rail vehicle.

Timetable:
Action Date FR Cite
ANPRM  04/30/2010  75 FR 22713   
ANPRM Comment Period End  08/30/2010 
NPRM  02/05/2014  79 FR 7005   
NPRM Comment Period Extended  05/23/2014  79 FR 29699   
NPRM Comment Period End  05/31/2014 
NPRM Comment Period Extended End  07/30/2014 
Final Rule  04/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Michael E. Kashtock
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-2022
Fax:301 346-2632
Email: michael.kashtock@fda.hhs.gov

 
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