Sanitary Transportation of Human and Animal Food

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 11

[Docket No. FDA-2013-N-0013]

RIN 0910-AG98

Sanitary Transportation of Human and Animal Food

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our 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 of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).

DATES:

This rule is effective June 6, 2016. See section V for the compliance dates.

FOR FURTHER INFORMATION CONTACT:

Michael Kashtock, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2022.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Rule

Summary of the Major Provisions of the Rule

Costs and Benefits

I. Background

A. FDA Food Safety Modernization Act

B. What risks to humans and animals have been associated with the transportation of food? How has this issue been addressed in the past?

C. What did the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 do with respect to food transportation? What other activities did we conduct for this rulemaking?

D. What did we propose to do?

II. What is the legal authority for this rule?

III. What general comments did we receive on the proposed rule?

A. Purpose of This Rule

B. What regulatory approach should we take?

C. How does this rule relate to other FSMA rules?

D. Effect of Other Statutes on the Applicability of This Rule and How This Rule Affects Food Regulated by Other Federal Agencies

E. Other Comments

IV. What comments did we receive on the specific provisions of the proposed rule?

A. Who is subject to this subpart? (§ 1.900)

B. How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act? (§ 1.902)

C. What definitions apply to this subpart? (§ 1.904)

D. What requirements apply to vehicles and transportation equipment? (§ 1.906)

E. What requirements apply to transportation operations? (§ 1.908)

F. What training requirements apply to carriers engaged in transportation operations? (§ 1.910)

G. What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations? (§ 1.912)

H. Waivers (§§ 1.914-1.934)

V. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 1, Subpart O

B. Effective Dates for Conforming Changes

VI. Executive Order 13175

VII. Economic Analysis of Impacts

VIII. How does the Paperwork Reduction Act of 1995 apply to this final rule?

IX. What is the environmental impact of this rule?

X. What are the federalism impacts of this rule?

XI. References

Executive Summary

Purpose and Coverage of the Rule

This rule is part of FDA's implementation of the 2005 SFTA and the FSMA. These statutes require us to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. This rule creates new requirements for the sanitary transportation of human and animal food by motor vehicle and rail vehicle to ensure that transportation practices do not create food safety risks. Practices that create such risk include failure to properly refrigerate food requiring temperature control for food safety, the inadequate cleaning of vehicles between loads, and the failure to otherwise properly protect food during transportation. This rule builds on current safe food transportation best practices and is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. The rule is flexible to allow the transportation industry to continue to use industry best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety.

Summary of the Major Provisions of the Rule

As required by the 2005 SFTA, this final rule addresses the sanitary transportation of food (human and animal food) by establishing criteria and definitions that apply in determining whether food is adulterated because it has been transported or offered for transport by a shipper, loader, carrier by motor vehicle or rail vehicle, or receiver engaged in the transportation of food under conditions that are not in compliance with the sanitary food transportation regulations. This rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle” and establishes requirements for sanitary transportation practices applicable to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations addressing:

• Vehicles and transportation equipment;

• Transportation operations;

• Training;

• Records; and

• Waivers.

This rule allows the transportation industry to continue to use best practices,

i.e.,

“commercial or professional procedures that are accepted or prescribed as being correct or most effective,” (Ref. 1), concerning cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety.

We made several revisions to this final rule, in response to comments that we received regarding the proposed rule, to affirm that the use of current sanitary food transportation best practices as described in these comments,

e.g.,

the “Rendering Industry Code of Practice” and “Model Tanker Wash Guidelines For the Fruit Juice Industry,” will allow industry to meet the requirements of this rule. Some of these best practices have been provided to the Agency as industry documents submitted with comments on the proposed rule, while others were described in the comments or the public meetings we held for the proposed rule.

As discussed in detail in later sections of the rule, we made several major revisions to the provisions of this rule mainly in response to comments that focus the rule more narrowly on food safety and are consistent with existing safe transportation best practices. These major revisions include the following:

• We have simplified the definitions for parties covered by the rule to make them all activity based and added a definition for “loader” as a new party covered by the rule, based on comments indicating that this was a relevant segment of the transportation industry that we had not previously identified.

• We have amended the definition of “transportation operations” such that additional transportation activities are not covered by the rule, including transport of food completely enclosed by a container, except food that requires temperature control for safety (broadens proposed exclusion for transport of shelf stable food completely enclosed by a container), food contact substances, and human food byproducts transported for use as animal food without further processing.

• We changed the provisions of the rule to focus on food safety concerns and not additionally adulteration as a result of spoilage or quality defects. Therefore, we have replaced language indicating that the goal of the rule is prevention of both food safety and non-safety concerns with language indicating that the goal is prevention of food becoming “unsafe,

i.e.,

adulterated within the meaning of section 402(a)(1), (2), and (4) of the FD&C Act” during transportation operations.

• We have removed prescriptive requirements for temperature monitoring devices and continuous monitoring of temperature during transport and replaced these provisions with a more flexible approach which allows the shipper and carrier to agree to a temperature monitoring mechanism for shipments of food that require temperature control for safety. We have also removed the provision requiring the carrier to demonstrate temperature control to the receiver for every shipment requiring temperature control. In this final rule, the demonstration must only be made if the shipper or receiver requests it, which is consistent with industry best practices and would likely only be done in situations in which it is suspected that there has been a material failure of temperature control.

• We have revised this rule to require that if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action, to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual, that the temperature deviation or other condition did not render the food unsafe.

• We have revised the requirements of this final rule to make it clear that its requirements account for the fact that the intended use of the vehicle or equipment with respect to the type of food that is being transported,

e.g.,

the transportation of animal feed versus food for humans, is relevant in establishing the applicable sanitary transportation requirements, as is the production stage of the food being transported,

e.g.,

raw materials, ingredients, or finished food products.

• Finally, we have revised the rule to primarily place the responsibility for determinations about appropriate transportation operations (

e.g.,

whether food needs temperature control for safety and the relevant operating temperature and mode of temperature monitoring, whether particular clean out procedures are needed, and whether previous cargo must be identified) on the shipper. The shipper may rely on contractual agreements to assign some of these responsibilities to other parties, such as a loader or carrier, if they agree to accept the responsibility. We believe the shipper is in the best position of the parties covered by this rule to know the appropriate specifications for transport of its food.

Costs and Benefits

This final rule implements requirements addressing the sanitary transportation of human and animal food. It establishes requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, loaders, and receivers. Specifically, these finalized requirements address design and maintenance of vehicles and transportation equipment; sanitary practices during transportation operations that apply to shippers, receivers, loaders, and carriers; training of carrier employees; and records related to, for example, training, and written procedures. As shown in table 1, the total annualized costs are estimated to be approximately $113 million per year, estimated with a 3 percent discount rate, and $117 million per year, estimated at 7 percent when discounted over 10 years. We do not have sufficient data to fully quantify the benefits of this regulation.

Table 1—Estimated Costs and Benefits

[In millions of $]

Initial costs

Annual

Benefits

$162.7

$93.5

Not quantified.

Costs Annualized over 10 Years

Costs

Benefits

3%

$113

Not quantified.

7%

117

I. Background

A. FDA Food Safety Modernization Act

FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages

partnerships with State, local, tribal, and territorial authorities and international collaborations with foreign regulatory counterparts. A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food. To that end, we proposed the seven foundational rules listed in table 2 and requested comments on all aspects of these proposed rules.

Table 2—Published Foundational Rules for Implementation of FSMA

Title

Abbreviation

Publication

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

2013 proposed human preventive controls regulation

78 FR 3646, January 16, 2013.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2013 proposed produce safety regulation

78 FR 3504, January 16, 2013.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2013 proposed animal preventive controls regulation

78 FR 64736, October 29, 2013.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2013 proposed FSVP regulation

78 FR 45730, July 29, 2013.

Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications

2013 proposed third-party certification regulation

78 FR 45782, July 29, 2013.

Focused Mitigation Strategies To Protect Food Against Intentional Adulteration

2013 proposed intentional adulteration regulation

78 FR 78014, December 24, 2013.

Sanitary Transportation of Human and Animal Food

2014 proposed sanitary transportation regulation

79 FR 7006, February 5, 2014.

We also issued a supplemental notice of proposed rulemaking for the rules listed in table 3 and requested comments on specific issues identified in each supplemental notice of proposed rulemaking.

Table 3—Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation of FSMA

Title

Abbreviation

Publication

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

2014 supplemental human preventive controls notice

79 FR 58524, September 29, 2014.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2014 supplemental produce safety notice

79 FR 58434, September 29, 2014.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2014 supplemental animal preventive controls notice

79 FR 58476, September 29, 2014.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2014 supplemental FSVP notice

79 FR 58574, September 29, 2014.

We finalized five of the foundational rulemakings listed in table 4 in September and November 2015.

Table 4—Published Foundational Rules for Implementation of FSMA

Title

Abbreviation

Publication

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Final human preventive controls regulation

80 FR 55908, September 17, 2015.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Final animal preventive controls regulation

80 FR 56170, September 17, 2015.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Final FSVP regulation

80 FR 74225, November 27, 2015.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Final produce safety regulation

80 FR 74353, November 27, 2015.

Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

N/A

80 FR 74569, November 27, 2015.

As FDA finalizes these seven foundational rulemakings, we are putting in place a modern, risk-based framework for food safety, based on the most recent science, that focuses efforts where the hazards are reasonably likely to occur, and that is flexible and practical given our current knowledge of food safety practices. To achieve this, FDA has engaged in a significant amount of outreach to the stakeholder community to find the right balance between flexibility and accountability in these regulations.

After FSMA was enacted in 2011, we have been involved in approximately 600 stakeholder engagements on FSMA and the proposed rules, including public meetings, Webinars, listening sessions, farm tours, and extensive presentations and meetings with various

stakeholder groups (Refs. 2 and 3). As a result of this stakeholder dialogue, FDA decided to issue the four supplemental notices of proposed rulemaking to share our current thinking on key issues and get additional stakeholder input on those issues. As we move forward into the next phase of FSMA implementation, we intend to continue this dialogue and collaboration with our stakeholders, through guidance, education, training, and assistance, to ensure that stakeholders understand and engage in their respective roles in food safety. FDA believes these seven foundational final rules, when implemented, will affect the paradigm shift toward prevention that was envisioned in FSMA and be a major step forward for food safety that will help protect consumers into the future.

B. What risks to humans and animals have been associated with the transportation of food? How has this issue been addressed in the past?

Due to illness outbreaks involving human food and animal food that became contaminated during transportation (Refs. 4 and 5), and incidents and reports of insanitary transportation practices (Refs. 6 to 11), 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 (Ref. 12). Press accounts in the late 1980s of trucks carrying food from the Midwest to both the East and West Coasts and returning with garbage for Midwest landfills caused concern that food products could become contaminated and unfit for human consumption if irresponsible vehicle operators failed to properly clean vehicles that had been previously used to haul waste or other nonfood materials (Refs. 13 to 15). Congress responded to these concerns by passing the Sanitary Food Transportation Act of 1990 (1990 SFTA) (Pub. L. 101-500), 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 (Ref. 4). In 2005, Congress reallocated authority for food transportation safety to FDA, DOT, and USDA by passing the 2005 SFTA, a broader food transportation safety law than the 1990 SFTA. The focus of the 2005 SFTA was not limited only to preventing food contamination from nonfood sources during transportation.

C. What did the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 do with respect to food transportation? What other activities did we conduct for this rulemaking?

The 2005 SFTA directed us to establish regulations prescribing sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food. Section 111(a) of FSMA also directed FDA to issue these sanitary transportation regulations. In April of 2010, we issued guidance to provide the industry with broadly applicable recommendations for controls to prevent food safety problems during transport while we worked toward implementing the 2005 SFTA (Ref. 16). We also published a

Federal Register

advance notice of proposed rulemaking in 2010 (the 2010 ANPRM; 75 FR 22713, April 30, 2010) to request data and information on the food transportation industry and its practices to prevent the contamination of transported foods and any associated outbreaks.

D. What did we propose to do?

We subsequently published a proposed rule in the

Federal Register

of February 5, 2014 (79 FR 7006), to establish sanitary transportation requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of both human and animal food to ensure the safety of the food they transport.

In brief, we proposed to address the sanitary transportation of food for humans and animals by establishing definitions and criteria that would apply to determine whether food is adulterated because it has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, or receiver under conditions that are not in compliance with the sanitary food transportation regulations. We proposed to define transportation as any movement of food in commerce by motor vehicle or rail vehicle. We proposed to establish requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations. Specifically, we proposed to establish requirements for:

• Vehicles and transportation equipment;

• Transportation operations;

• Training;

• Records; and

• Waivers.

The proposed rule would allow the transportation industry to continue to use best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent contamination and other safety hazards.

We received about 240 submissions in response to the proposed rule. We received comments from individuals, industry and trade associations, consumer and advocacy groups, academia, law firms, professional organizations, Federal and State, tribal and foreign government agencies and other organizations. In this document, we describe these comments, respond to them, and explain any revisions we made to the proposed rule in response to those comments. In addition, we held three public meetings to discuss the proposed rule. The meetings took place on February 27, 2014, in Chicago, IL; March 13, 2014, in Anaheim, CA; and March 20, 2014, in Washington, DC.

Some comments address issues that are outside the scope of this rule. For example, a comment suggests that we undertake a comprehensive examination of transportation that occurs by ship or barge within, into, or out of the United States to provide Congress with sufficient information to reevaluate our safe food transportation statutory authority (see responses to Comment 9 and Comment 30). Another comment states that this rule should identify the parties who are responsible for paying attorney's fees in cases where claims are made for damage that occurs during truck or rail transport of food. We do not discuss these types of comments in this document.

II. What is the legal authority for this rule?

We are issuing this rule under authority of the 2005 SFTA and as directed by section 111(a) of FSMA.

The 2005 SFTA amended the Federal 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 directs us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons

engaged in the transportation of food in the United States to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. Section 416(c) of the FD&C Act specifies that we shall prescribe those practices that we determine are appropriate relating to: (1) Sanitation; (2) packaging, isolation, and other protective measures; (3) limitations on the use of vehicles; (4) information to be disclosed to carriers and to manufacturers; and (5) recordkeeping. Section 416(c) of the FD&C Act also states that the regulations are to include a list of nonfood products that may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle, and a list of nonfood products that may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle. Section 111(a) of FSMA directed us to issue these sanitary transportation regulations not later than 18 months after the date of enactment of FSMA.

In addition, the 2005 SFTA created new section 402(i) in the FD&C Act (21 U.S.C. 342(i)) which provides that food that is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with the regulations issued under section 416 is adulterated. Also, new section 301(hh) in the FD&C Act (21 U.S.C. 331(hh)) prohibits the failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the regulations issued under section 416. The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C. 373) by adding section 703(b), which provides that a shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 416 shall, on request of an officer or employee designated by FDA, permit the officer or employee, at reasonable times, to have access to and to copy all records that are required to be kept under the regulations issued under section 416.

FDA's authority for this rule is also derived from sections 402(a)(1), (2), and (4) and 701(a) of the FD&C Act (21 U.S.C. 371(a)). Section 402(a)(1) of the FD&C Act provides, in part, that a food is adulterated if it bears or contains any added poisonous or deleterious substance, which may render it injurious to health. Section 402(a)(2) of the FD&C Act provides that a food is adulterated if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity (RAC) or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of 21 U.S.C. 346; if it bears or contains a pesticide chemical residue that is unsafe within the meaning of 21 U.S.C 346a(a); or if it is or if it bears or contains (1) any food additive that is unsafe within the meaning of 21 U.S.C. 348; or (2) a new animal drug (or conversion product thereof) that is unsafe within the meaning of 21 U.S.C. 360b. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. This rule includes requirements that are necessary to prevent food from becoming unsafe,

i.e.,

adulterated under the aforementioned provisions of section 402 of the FD&C Act, due to insanitary transportation practices. These requirements allow for the efficient enforcement of the FD&C Act.

III. What general comments did we receive on the proposed rule?

A. Purpose of This Rule

(Comment 1) We stated in the proposed rule that the goal of this rulemaking is to ensure that transportation practices do not create food safety risks and that this rule builds on current food transport industry best practices. The rule is focused on ensuring that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. This rule allows the food transportation industry to continue to use best practices concerning the cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent contamination and other safety hazards.

Several comments support our intent to provide shippers, loaders, carriers and receivers with the flexibility to continue to utilize appropriate sanitary transportation industry best practices. A comment states that this approach allows companies to tailor their practices, as appropriate and necessary, based on the nature of the food and the transportation conveyance used, and to adopt new practices when there are advances in technology. Other comments agree with many aspects of the proposed rule, but conclude that some aspects need further refinement to reflect current industry best practices.

On the other hand, one comment states that this rulemaking is not necessary and that the food transportation industry, instead, should be given the flexibility to meet the standards placed upon it by the shippers without undue interference, or rules and regulations, that hinder the safe and efficient movement of human and animal food. One comment states that there are no systemic food safety issues related to the sanitary transport of food and that, therefore, this rulemaking is unnecessary.

(Response 1) As stated in the proposed rule, the SFTA requires FDA to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. We have met this mandate, in part, by incorporating current best practices into this rule to the extent that we believe they are effective in achieving the goal of this rule. We disagree with the comments that stated this rule is unnecessary because Congress found that there was an adequate need to mandate that FDA issue these regulations in the 2005 SFTA and FSMA.

B. What regulatory approach should we take?

(Comment 2) Several comments express concern that the proposed rule applies the same requirements to human food and animal food. Many of these comments state that we should issue a separate rule for the sanitary transportation of animal food that is appropriately risk-based and specific to the types of ingredients and manufacturing processes used for animal food. Other comments state that we should distinguish between sanitary transportation requirements for animal food and human food in this rule to allow it to be reasonable and practical for the animal food industry.

(Response 2) We agree that this rule should more clearly recognize that sanitary transportation practices may differ for different types of food being transported to avoid confusion in its

interpretation and application. Accordingly, and as discussed in our responses to Comment 89, we have revised the requirements of this rule for vehicles and transportation equipment (§ 1.906), and for transportation operations (§ 1.908), to make it clear that these requirements take into account the intended use of the vehicle or equipment,

e.g.,

the transportation of animal feed. Also, as discussed in our response to Comment 130, we have also revised the requirements of this rule for transportation operations (§ 1.908) to state that the type of food being transported,

e.g.,

human food or animal feed, must be considered in establishing the applicable sanitary transportation practices.

(Comment 3) One comment states that there are two distinct animal food industries, the pet food industry, which employs standards and practices equivalent or close to those used for human food, and the animal feed industry, for which product is not normally handled with the same equipment used for human food transportation operations. This comment encourages us to recognize the significant difference between the purpose and function of these two “markets” for animal food, so that livestock feed transportation is not held to the same standards as pet food transportation. A related comment encourages us not to establish a pet food standard for all animal food and stated that the final rule should not require significant conversion of equipment used in animal feed sourcing and transport operations to pet food standards which necessitate the use of stainless steel equipment.

(Response 3) We agree that sanitary transportation practices for pet food differ from those for animal feed. The revisions we have made to this rule in § 1.906 and § 1.908, as explained in our response to Comment 2, will allow practices employed for the transport of pet food and animal feed to be appropriately tailored to the unique needs of those operations. This rule, therefore, will not necessitate the conversion of equipment used in animal feed operations to meet standards for pet food.

(Comment 4) Some comments suggest that produce safety could be improved by establishing general requirements under the FSMA produce safety rule for the transportation of produce after it leaves the farm, if the farm assumes the role of either the shipper or the carrier. These comments suggest that these FSMA produce safety requirements should be similar to the practices outlined in the proposed rule for the transport of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control. These comments also state that, by covering produce under a transportation provision in the FSMA produce safety rule, enforcement for sanitary transportation practices would be performed by Agencies already tasked with implementing the produce safety rule. One comment states that regulating the transportation of produce in this manner would provide a single source for compliance requirements and would likely reduce the possibility that any requirements might be overlooked.

(Response 4) The produce safety rule establishes science-based minimum standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death, focusing on the most important routes of on-farm contamination of produce with biological hazards. By contrast this rule requires persons engaged in the transportation of all foods, including fresh fruits and vegetables, to use sanitary transportation practices in their operations to ensure that food is transported under conditions that prevent it from becoming unsafe. The sanitary transportation practices required by this rule are not limited to those that address potential contamination of food with biological hazards, they also apply to other forms of contamination,

e.g.,

with chemical and physical hazards, that could cause food to become unsafe. We believe it is most appropriate to establish requirements related to transportation of produce after it leaves the farm in this rule.

(Comment 5) One comment expresses concern that this rule's requirements would apply uniformly across the entire U.S. food transportation sector, despite the fact that current railroad industry best practices have resulted in very few reported cases of foodborne illnesses directly attributable to rail carriers. Another comment asserts that we should defer issuing this rule as it applies to railroads. It states that, in view of the absence of reported incidents of insanitary food rail transportation and the existing rail industry practices to prevent such incidents, applying the rule to the rail industry is not necessary at this time.

(Response 5) The 2005 SFTA directs us to issue regulations that require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. We are issuing this rule as directed by Congress. It is unlikely carriers who have successfully employed best practices for food transportation, whether they be motor or rail carriers, will need to alter their transportation practices significantly to comply with this rule, although we acknowledge that there are new costs associated with training and recordkeeping.

(Comment 6) One comment identifies smaller box trucks making local deliveries as a particular sanitary food transport problem. The comment states that most of the instances where food transportation problems were found in the 2007 Interstate Food Transportation Assessment Project study (Ref. 6) involved smaller box trucks as discussed in the proposed rule (79 FR 7006 at 7008). The comment suggests that FDA develop an enforcement plan focused on smaller box trucks engaged in local food delivery operations.

(Response 6) As we implement this rule, we will work with our partners,

i.e.,

DOT, and State, local, territorial and tribal officials, to direct our efforts to address the areas of greatest need with respect to practices that create potential food safety risks for local deliveries. To the extent that smaller box trucks making local deliveries fall below the “Non-Covered Business” cutoff of $500,000, we note that these trucks remain subject to the provisions, including the adulteration provisions, of the FD&C Act with regard to their transport of food.

(Comment 7) One comment states that the provisions of this rule are not specific and so broad based that they should be viewed only as non-binding recommendations. It further asserts that the only way we can protect the food supply is by implementing enforceable laws like the Sanitary Food Transportation Act of 1990 and that DOT already has a system in place in which vehicles are inspected wherein they could use an F (signifying food vehicle) on the inspection sticker of the trucks and trailers that transport food.

(Response 7) We reject this interpretation of this rule. The provisions of this rule are not guidance nor are they recommendations. Many of the requirements established in this rule address broadly applicable procedures and practices intended to provide flexibility for shippers, loaders, carriers, and receivers to comply with the requirements in a way that is most suitable for their practices, as many are already implementing the industry best practices on which the rule is based. Furthermore, Congress enacted the 2005

SFTA to grant FDA, DOT, and USDA shared responsibility over regulating the sanitary transportation of food.

C. How does this rule relate to other FSMA rules?

(Comment 8) Several of the comments express a preference for the farm definition in the proposed transportation rule over the definitions in other FSMA proposed rules because it does not limit the facility's activities to the packing and holding of a farm's own food. These comments recommend that we apply the sanitary transportation rule's farm definition throughout all of the FSMA rules. Conversely, another comment suggests that we use different definitions for entities such as “farms” in the various FSMA rules, allowing us to take a customized approach to each specific rule.

(Response 8) We agree that using a definition of the term “farm” in this rule that, to the extent practicable, is aligned with this term as defined in other FDA regulations, including the regulations we have established under FSMA, would be functionally efficient for us and for stakeholders. We explained in the proposed rule that we tentatively defined the term “farm” differently than it was defined in 21 CFR 1.227(b)(3), which is used to establish which facilities are required to register under section 415 of the FD&C Act (21 U.S.C. 350d), because 21 CFR 1.227(b)(3) applies only to facilities that pack or hold food if the food used in such activities is grown, raised, or consumed on that farm or a farm under the same ownership. We had tentatively concluded that the sanitary transportation practices that would be required by our proposed rule would not be necessary to prevent RACs from becoming adulterated during transportation by farms, regardless of whether the farms are conducting transportation operations for RACs that were grown, raised, or consumed on the same farm or on another farm under different ownership. We therefore tentatively concluded to use a different definition of the term “farm” for purposes of this rulemaking.

In the FSMA preventive controls for human food final rule (80 FR 55908 at 55925), we revised our definition of the term “farm” in 21 CFR 1.227 to clarify the types of activities that are included as part of the definition of the term “facility” and to clarify the scope of the exemption from the registration requirement for “farms” established in section 415 of the FD&C Act. This revised definition no longer requires that farms that pack or hold food only carry out these activities for food that was grown, raised, or consumed on that farm or a farm under the same management. This revised definition now governs the applicability of the provision in this final rule that excludes transportation operations performed by farms from coverage under this rule. We, therefore, have aligned this rule with the revised definition of the term “farm” in 21 CFR 1.227 by revising 21 CFR 1.904 to state that this term has the new meaning contained in 21 CFR 1.227. This action also aligns the definition in this rule with this term as defined in other FSMA rules,

i.e.,

the preventive controls rule for animal food and the produce safety rule.

(Comment 9) One comment urges us to create a party with the same responsibilities as the “importer” in the FSMA Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule who would be responsible for verifying that the practices of foreign suppliers are in compliance with our regulations. The comment states that this person would be responsible for verifying the safe transportation of imported products before and after the products arrive in the United States. The comment explains that in the preamble to the FSVP proposed rule, we stated that the person responsible for verifying the safety of the foreign supplier “has a direct financial interest in the food and is most likely to have knowledge and control over the product's supply chain.” The comment asserts that for imported food, the safety of the food transport is inextricably linked with the safety of the supply chain, starting with the foreign supplier. The comment further states that the person with a direct financial interest in the food product is the party most likely to have the knowledge and control necessary to ensure not just the safety of the foreign supplier, but also the safety of the transportation after the food arrives in the United States. The comment argues that there should be consistency between these two rules for imported products.

(Response 9) The 2005 SFTA direct us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food in the United States to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. It does not direct us to establish requirements for the transport of food destined for the United States before it reaches the United States. Shipments of food destined for consumption in the United States remain subject to the provisions of the FD&C Act, including the adulteration provisions.

(Comment 10) One comment states that the treatment of small businesses in the FSMA rules is not consistent. The comment states that modified requirements, compliance dates, and exemptions have been based on annual sales throughout the FSMA proposed rules, but the annual sales metrics have not been consistent,

i.e.,

the rules have addressed business size alternatively on the basis of total annual sales, rolling averages of total annual sales, numbers of employees, total annual food sales, and total sales in combination with qualified end user sales. The comment recommends that we create a simpler, consistent approach so that businesses can clearly discern whether they must comply with the regulations.

(Response 10) The only provisions of this final rule that are related to the business size or business volume are the number of employees threshold for businesses, other than carriers by motor vehicle, in the definition of a “small business,” the annual receipts threshold for carriers by motor vehicle in the definition of a “small business,” and the annual revenue threshold in the definition of a “non-covered business.”

With respect to the number of employees threshold for businesses that are not carriers by motor vehicle, as explained in the proposed rule (79 FR 7006 at 7014) and the discussion of this definition in section IV.C. of this final rule, this provision is based upon the size based standard (expressed in terms of numbers of employees) that has been established by the U.S. Small Business Administration under 13 CFR 121.201 for most food manufacturers. This provision of the “small business” definition incorporates the same size based standard as we included in the preventive controls final rules for human and animal food.

With respect to the annual receipts threshold for small businesses that are motor carriers, as explained in the proposed rule (79 FR 7006 at 7014) and the discussion of this definition in section IV.C. of this final rule, this provision is based upon the size based standard of the U.S. Small Business Administration for truck transportation firms in 13 CFR 121.201. This provision of the “small business” definition is unique to this rule and has no relation to other FSMA rules, because only this rule establishes requirements for carriers.

With respect to the annual revenue threshold in the definition of a “non-covered business,” as we state in our response to Comment 62, we proposed

to establish this provision, in part, to treat firms subject to this rule comparably to those firms that are subject to FSMA preventive controls rules. As also explained in the discussion of this definition in section IV.C., we have revised this definition in this final rule to apply the same method for calculating a firm's annual revenue that we used in very small business definitions of the preventive controls rules.

(Comment 11) One comment states that we did not address the issue of routine security measures, such as the use of truck seals, in the proposed transportation rule and other proposed FSMA rules. The comment states that these measures provide a benefit in transportation similar to that of underlying prerequisite programs in the context of a food manufacturer's hazard analysis and critical control point (HACCP) system. The comment further states that these measures need to be addressed by the FSMA rules to ensure that potential contamination risks (that do not rise to the level of the massive, catastrophic threats that are the subject of the proposed FSMA intentional adulteration rule) are addressed.

(Response 11) This suggestion is outside the scope of this rulemaking. We agree that persons engaged in food transportation should consider the use of routine security measures. We have issued guidance on this subject: “FDA Guidance on Food Security Preventive Measures for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors;” and “FDA Guidance on Food Security Preventive Measures for Food Producers, Processors, and Transporters” (Refs. 17 and 18). However, the purpose of this rule is to establish sanitary transportation practices to be used by shippers, carriers by motor vehicle and rail vehicle, receivers, and other persons engaged in food transportation to ensure that food is not rendered adulterated during transportation, which is distinct from the issue of the security of food transportation. FDA will be addressing food defense concerns in its upcoming final rulemaking on Intentional Adulteration; however, to the extent that certain food defense issues are not covered in the FSMA rulemakings, and it becomes apparent as we implement the rules that there are food defense concerns that would benefit from additional regulation, we will consider initiating such rulemakings in the future.

D. Effect of Other Statutes on the Applicability of This Rule and How This Rule Affects Food Regulated by Other Federal Agencies

(Comment 12) Several comments note that FDA lacks jurisdiction over meat, poultry, and egg products within meat, poultry, and egg product establishments that are subject to USDA regulation and inspection by USDA's Food Safety and Inspection Service (FSIS) under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601

et seq.

), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451

et seq.

), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031

et seq.

). Some of these comments ask us to explicitly acknowledge in this rule that USDA has exclusive jurisdiction over meat, poultry, and egg products operations conducted in these establishments and over the meat, poultry, and egg products up until the time these food products leave these establishments. They also observed that the requirements of this rule would only apply to meat, poultry, and egg products after they have left the FSIS-inspected establishments and, therefore, that the requirements of this rule only apply to carriers as they transport meat, poultry, and egg products and receivers of those products, provided that the receiver is not exclusively inspected by FSIS.

In addition to the FDA-USDA jurisdictional issue, some comments state that a new layer of FDA sanitary food transportation regulation is unnecessarily duplicative with respect to the meat and poultry industries because meat and poultry establishments are already subject to FSIS regulations that address the transportation of meat and poultry products (see, 9 CFR part 325 and 9 CFR part 381, subpart S), as well as by guidance issued by USDA. These comments also state that FSIS's existing meat and poultry safety regulations and oversight activities are adequate and sufficiently robust, and are based on established industry best practices. Another comment suggests that we should dispense with any unnecessarily duplicative sanitary food transportation regulation of meat, poultry, and egg products by issuing a waiver, as provided for under this rule, or by establishing a Memorandum of Understanding (MOU) with FSIS that provides for FSIS to regulate transportation of these products from FSIS-regulated facilities.

(Response 12) We agree that FDA lacks jurisdiction for meat, poultry, and egg product activities that occur within meat, poultry, and egg product processing facilities regulated exclusively by USDA. We have consulted with USDA and modified § 1.900(b) in this rule by adding a third category of persons exempt from the requirements of this subpart. In this final rule, § 1.900(b)(3) excludes shippers, loaders, receivers, or carriers when they are engaged in transportation operations of food while the food is located in food facilities as defined in § 1.227, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the FMIA, the PPIA, or the EPIA. However, there are dual jurisdiction establishments that prepare, pack, hold, or otherwise handle both foods regulated by USDA and foods regulated by FDA. In the case of dual jurisdiction establishments, FDA would inspect in accordance with its existing MOU with USDA (Ref. 19).

In addition, we did not tentatively conclude in the proposed rule that USDA guidance on the safe transportation and distribution of meat, poultry, and egg products is not adequate to ensure their safety. Rather, we stated that FSIS does not have requirements that directly address transportation operations for these foods once they leave FSIS-inspected facilities. However, FSIS has regulations that require that FSIS-regulated establishments to address sanitation during transportation,

e.g.,

9 CFR 416.4(d) and 9 CFR 417.2(a)(1), and this rulemaking will complement FSIS's efforts to promote the application of sanitary food transportation practices for FSIS-regulated meat, poultry, and egg products.

(Comment 13) One comment opposes applying the sanitary food transportation rule to shell eggs on the grounds that the transportation of shell eggs is already regulated by FDA under 21 CFR part 118, and that the transportation of egg products is already regulated by USDA under requirements established under the EPIA. The comment further states that most shell egg producers also are subject to additional transportation safeguards either because of customers' proprietary specifications or customers' requests that the egg producers participate in voluntary quality-assurance programs, such as the Safe Quality Food (SQF-2000) standards or the United Egg Producer's 5-Star Egg Safety Program.

(Response 13) We disagree with this comment. The transportation requirements in 21 CFR part 118 address only the ambient temperature of vehicles used to transport shell eggs and do not include requirements for the design, condition, and sanitation of the vehicles or specific procedures to

ensure that the specified temperatures are consistently achieved. Similarly, USDA's requirements for the transportation and storage of eggs packed for the ultimate consumer (9 CFR 590.50) refer only to the ambient temperature at which shell eggs must be stored and transported. By contrast, this rule addresses the design, condition, and sanitation, as well as the temperature, of vehicles used to transport food.

With regard to customers' specifications and quality assurance programs, many types of foods are subject to customers' transportation specifications and quality assurance programs. However, we cannot rely on them, exclusively and under all circumstances, to keep food safe during transportation because they vary in effectiveness and are not uniformly administered. This rule establishes uniform, nationwide requirements for the sanitary transportation of food, including shell eggs. To the extent that transportation practices are covered under egg quality assurance programs, these egg producers should find it easier to comply with our requirements.

(Comment 14) A few comments ask us to amend this rule to clarify that under section 116(a) of the FSMA, a facility engaged in the manufacturing, processing, packing, or holding of beverage alcohol products is exempt from this rulemaking. The comments also suggest that we should exempt the transport of all bulk or packaged beverage alcohol products from this rule, including the transport of ingredients and the co-products or by-products of beverage alcohol manufacture. The comments state that the language of section 116 of FSMA specifies which sections of the statute apply to a facility engaged in the manufacturing, processing, packing, or holding of one or more beverage alcohol products, and note that unless a rule falls under sections 102, 206, 207, 302, 304, 402, 403 or 404 of FSMA, Congress does not intend for it to apply to a facility engaged in manufacturing, processing, packing, or holding beverage alcohol products. The comments further assert that because section 111(a) of the FSMA, which directs us to issue this rule, is not one of the listed sections, a facility that is exempt under section 116 should also be exempt from the sanitary food transportation rule. Some of the comments also state that we should exempt the transport of alcoholic beverage products, as well as any oversight of their production facilities, from this rule to avoid duplicative regulatory schemes implemented by both FDA and the U.S. Tax and Trade Bureau (TTB).

(Response 14) There is nothing in FSMA that indicates that transportation operations for beverage alcohol should be exempt from the requirements of this rule. Section 111(a) of the FSMA only creates a deadline for the implementation of the 2005 SFTA final rule, and nothing in the FSMA otherwise addresses the 2005 SFTA. Therefore, it seems that, based on a plain reading of the statute, transportation operations for beverage alcohol can be covered by this rule. In addition, we are not aware of TTB regulatory requirements that would duplicate the requirements of this rule. However, this final rule, as provided under the revised definition of “transportation operations” in § 1.904, does not apply to the transportation of food fully enclosed by a container that does not require temperature control to prevent it from becoming unsafe. This provision essentially excludes packaged beverage alcohol products from coverage under this rule.

(Comment 15) One comment asks that we consider issues regarding the rejection of produce shipments under this rule that are also subject to the Perishable Agricultural Commodities Act (PACA). The comment states that under the PACA, sellers and buyers must legally ship and accept the quantity and quality of produce specified in their contracts, and receivers must accept produce that is damaged and decayed, up to a certain percentage, depending on the product's grade standards. The comment contemplates a situation where a receiver would be required to accept shipments under the PACA, but, according to the comment, might be required to reject them under this rule for deviation from quality standards set by the shipper.

(Response 15) This rule does not require a receiver to reject a shipment that is transported under conditions that deviate from those specified by the shipper to the carrier and loader in accordance with § 1.908(b)(1). As explained in our response to Comment 129, the rule establishes requirements for shippers, loaders, carriers, and receivers in § 1.908(a)(6) that precludes the sale or distribution of any food subject to this rule where there is an indication of a material failure of temperature control or other conditions during transportation that may render the food unsafe, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Contrary to the comment's assertions, this rule does not address the disposition of any produce delivered to a receiver that might deviate from quality standards set by a shipper.

E. Other Comments

1. Contractual Reassignment

(Comment 16) Several comments asserted that, to reflect common industry practice, we should explicitly recognize that companies that bear legal responsibility for compliance with this rule may contractually assign specific tasks,

e.g.,

vehicle inspections or taking a temperature measurement, to an alternative or better suited entity. Several comments state that we acknowledged the potential for parties to contractually allocate tasks in the preamble discussion of the proposed rule (79 FR 7006 at 7014) and that we should explicitly recognize in the final rule that shippers, carriers, and receivers may enter into contracts that allocate tasks either between them or to another entity. For example, one comment states that a carrier should be able to rely exclusively on a receiver to take the temperature of a refrigerated food load upon delivery to assess the potential for temperature abuse during transport given that the receiver may already be engaging in this activity for its own purposes. Several comments state that firms that contractually reassign tasks should maintain records that FDA could review during inspections to document these contractual agreements. One comment states that there may be entities involved in food transportation other than those that would be subject to the proposed rule, such as warehouses, that might contractually assume some of the requirements described in the proposed rule.

(Response 16) We acknowledge that industry practice is to alter, by contract, the tasks assigned to shippers, loaders, carriers, and receivers in this rule. Therefore, we also explicitly recognize that companies that bear legal responsibility for compliance with this rule may contractually assign specific tasks,

e.g.,

cleaning a vehicle or communicating previous loads hauled, to an alternative entity. We also understand that industry best practice is to memorialize the assignment of duties in a transportation operation with a written contract.

The duty to comply with the provisions in this rule can be reassigned via contract among parties covered by this rule (

e.g.,

as described in § 1.908(b)(5) where the shipper assigns responsibilities such as monitoring temperature during transit via written

contract to a carrier). We have further clarified this point by adding language at § 1.908(a)(1) that states that an entity subject to this rule (shipper, loader, carrier, or receiver) may reassign, in a written agreement, its responsibilities under this rule to another party subject to this rule. This provision also states that the written agreement is subject to the records requirements of § 1.912. Further, parties may accomplish their duty to comply with provisions in this rule by assigning tasks to parties not covered by this rule, as long as such assignment is covered by a written contract (

e.g.,

a carrier may contract with a truck wash station to wash a bulk tanker, where the truck wash station is not an entity that is covered by this rule). If responsibility under this rule is assigned via contract to another party covered by this rule (first example, aforementioned), FDA would consider the terms of the contract in determining who is responsible for compliance. If a task under this rule is assigned via contract to a party who is not covered by the rule (second example, aforementioned), FDA would hold the party covered by the rule ultimately responsible for compliance with the provisions of the rule. Any written agreements assigning duties in compliance with this rule will be subject to the recordkeeping provisions in § 1.912.

2. Intrastate Transportation

(Comment 17) One comment states that the application of this rule to both intrastate and interstate shipments would create consistent expectations among parties engaged in food transportation. Furthermore, the comment suggests that we consider addressing in this rule a common practice among the parties engaged in food transportation whereby they engage in a separate contract for the transportation of food, as authorized by 49 U.S.C. 14101(b). The comment states that because there is currently no standard transportation contract, parties are free to agree to any and all terms that they choose, and the various State laws apply to those terms. Further, the comment asked whether parties can shift responsibilities, agree to terms more or less onerous, and change the meaning of this rule by contract. The comment states that we should clarify whether the rule cannot be modified by contract or specify what parts can be modified. The comment also states that leaving these questions unsettled in the final rule might result in numerous State contract claims related to this rule.

(Response 17) We agree that the application of this rule to both intrastate and interstate shipments would create consistent expectations among parties engaged in food transportation.

Further, we acknowledge that under the provisions of 49 U.S.C. 14101(b), carriers by motor vehicle may “expressly waive any and all rights and remedies under [that] part for transportation covered [by a contract between that carrier and a shipper].” However, the purpose of this rule is not to address the ability of parties to contract under that provision. The purpose of this rule is to ensure that shippers, loaders, carriers, and receivers use practices that ensure the sanitary transportation of human and animal food. Therefore, as discussed in the previous comment, the roles being played by the particular parties involved in the transportation of food can be shifted among the parties within the contractual relationship However, entities covered by this rule cannot, via contract or otherwise, either change the meaning of the rule or establish sanitary transportation requirements that are less onerous than those contained in this rule.

(Comment 18) One comment states that intrastate activities should be exempt from the requirements of this rule. It asserts that the paperwork burden required by this rule would be onerous for local bulk animal feed facilities and that complying with this rule would make it difficult for these types of facilities to remain in business. The comment further states that the intrastate transportation of commercial animal feed historically has presented little to no risk to humans and animals.

(Response 18) We disagree that intrastate transportation activities should be exempt from this rule. As we noted in the proposed rule, section 416(b) of the FD&C Act directs us to create regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated. The scope of section 416(b) is not limited to interstate commerce. We are sensitive to the concerns voiced by this comment about the burden this rule might impose upon small facilities. As we discuss in sections IV.E.2 and 5, we have revised the requirements regarding the exchange of information between shippers and carriers (§ 1.908(b) and (e)), which in many cases will reduce or eliminate paperwork burdens imposed on parties subject to this rule, including facilities engaged exclusively in the intrastate shipment of bulk animal feed. In addition, feed facilities engaged in intrastate transportation operations are not subject to this rule if they are a “non-covered business” as defined in this rule. This final rule establishes appropriate requirements for such facilities and will not impose undue cost or paperwork burdens. Since the rule has its basis in industry best practices, many persons should be in substantial compliance with its provisions and should not find compliance burdensome. Accordingly, this comment does not persuade us that it would be appropriate or in keeping with the purpose of this statute to exclude intrastate activities from the scope of this rule.

3. Enforcement Issues Related to This Rule

(Comment 19) We received many comments regarding the enforcement of this rule. The comments cover a broad range of topics, such as: The need for clarification of the roles of various Agencies including DOT and State and local regulatory authorities in enforcing the rule; FDA's need to establish enforcement partnerships with other Agencies; how variations in the applicability of this rule (

e.g.,

those entities that are subject to the rule and those that are not, and the effects of the varying size of the entities covered by the rule) will be addressed; whether enforcement during transportation, as opposed to at points of origin and destination, is practical and/or necessary to ensure food safety; how enforcement actions might vary depending on the severity of a violation and the potential threat posed to food safety resulting from a violation; the training that inspectors will likely need to properly enforce this rule; how inspections will be carried out without compromising the safety of the food shipment; and the need for enforcement guidance for industry. Some comments express concern about unequal enforcement of this rule directed toward trucking as compared to railroad operations, because regulators can more readily develop and execute truck surveillance and inspection programs. Comparable surveillance and inspection activities are more difficult for railroad operations,

e.g.,

access to rail yards may be more limited and trains cannot be stopped for inspection during transit. One comment addresses the importance of ensuring that enforcement has a minimal impact on international trade, especially in the case of rail carriers operating between the United States, Canada, and Mexico. Some comments express concern that we currently lack the resources to carry out inspections

and that we will face staffing and training challenges in operationalizing this rule to achieve consistent enforcement of the rule.

(Response 19) The Secretary of Transportation, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, is required by section 5701(a)(1) of the 2005 SFTA to establish procedures for transportation safety inspections to identify suspected incidents of contamination or adulteration of: Food in violation of regulations issued under section 416 of the FD&C Act; carcasses, parts of carcasses, meat, meat food products, or animals subject to detention under section 402 of the FMIA (21 U.S.C. 672) and the DOT's food transportation safety inspection requirements that appear at 49 U.S.C. 5701; and poultry products and poultry subject to detention under section 19 of the PPIA (21 U.S.C. 467a). The 2005 SFTA further states in section 5701(b) that the Secretary of Transportation shall promptly notify the Secretary of Health and Human Services or the Secretary of Agriculture, as applicable, of any instances of potential food contamination or adulteration of a food identified during DOT transportation safety inspections. We note that DOT and USDA have jointly produced a training video, entitled “Considerations for the Safe Transportation of Food Video,” that is available via the Department of Homeland Security at the University of Tennessee Knoxville's Web site:

http://www.vet.utk.edu/cafsp/online/ftsvideo.php.

DOT also has trained its enforcement officers to report any food safety violation they encounter to FDA or USDA, depending on the nature of the food being transported. We will work with DOT to support these inspection efforts. However, we note that while DOT has authority to conduct transportation safety inspections for the purpose of identifying suspected incidents of food shipments that are not in compliance with this rule and is authorized by section 416(f) of the FD&C Act to provide assistance upon request by FDA in the enforcement of this rule, FDA will generally be responsible for taking action when food or persons are found to be in violation of the statutes and regulations it administers.

We intend to allocate our resources for the enforcement of this rule by following up on information that DOT provides us or by initiating inspections and investigations. These comments raise issues that we will consider when developing enforcement strategies. The details of our prospective enforcement strategies, however, are beyond the scope of this rulemaking; however we believe that the impact of our enforcement activities upon international trade will be minimal since this rule allows the transportation industry to continue to use existing practices that have proven to be effective for the safe transportation of food. We know that we will need to address staffing and training needs, and we will seek to establish partnerships with other Federal Agencies and with State, local, and tribal governments to implement this rule. We also will communicate with the public, including with regulated industry, as appropriate, throughout the process of developing and implementing our enforcement efforts for this rule.

4. Intra-Corporate Operations

We received several comments asking us to include provisions in this final rule for food transportation operations that are conducted under the ownership or operational control of a single corporate/legal entity,

i.e.,

food shipments involving shippers, loaders, carriers, and/or receivers that are corporate subsidiaries or affiliates of a common corporate parent company/legal entity. The comments refer to these types of activities alternatively as “intra-corporate” or “intra-company” food transportation operations.

(Comment 20) Several comments state that intra-corporate transportation operations should be completely and expressly exempt from this final rule. Some of these comments suggest that we should define the term intra-corporate/intra-company in § 1.904 of the final rule and exempt these types of activities from the definition of “transportation operations” as that term is defined in § 1.904. Some of the comments ask us to exempt intra-corporate transportation operations by issuing a waiver as provided for under §§ 1.914 and 1.916 of this final rule. Most of these comments assert that intra-corporate shipments typically are conducted in accordance with integrated, intra-corporate Standard Operating Procedures (SOPs) and good sanitary food transportation practices and therefore should be exempt from the final rule. Some of the comments argue that food transportation operations that are predominantly, but not entirely intra-corporate, for example, in which a shipper and a receiver share a common corporate ownership, but in which the loader or carrier might be an independent, third-party entity operating under a contract with the shipper, also should be entirely and expressly exempt from this final rule.

Some of these comments assert that we should exempt intra-corporate food shipments from this rule because we contemplated exempting similarly situated entities under our FSMA FSVP proposed rule (78 FR 45730 at 45743). Two comments argue that exempting all intra-corporate food transportation operations from this rule is warranted because intra-corporate transfers would be addressed under the FSMA preventive controls rules for human and animal food. These comments assert that subjecting intra-corporate shipments to additional regulation and recordkeeping requirements under this sanitary food transportation rule therefore would be unnecessary and redundant.

One of the comments observes that the SFTA of 2005 and § 1.904 of the proposed rule define the term “transportation” to mean “any movement in commerce by motor vehicle or rail vehicle.” The comment asserts that intra-corporate food shipments therefore should be exempt from this rule because, for example, food shipped between facilities owned, leased, or operated by the same corporate entity “does not enter the stream of commerce.”

(Response 20) We decline to establish a blanket exemption from all of this rule's requirements for food transportation operations that are conducted between shippers, loaders, carriers, and/or receivers that are part of the same corporate/legal entity either by revising the definition of “transportation operations” in the final rule, by issuing a waiver for intra-corporate shipments, or by any other mechanism. We conclude that the fact that shippers, loaders, carriers, and/or receivers may be operating within a unified corporate/legal entity or sanitary food transportation system does not necessarily ensure that all of the involved parties are operating in compliance with the portions of section 402 of the FD&C Act that are relevant to this rulemaking. While we acknowledge that parties involved in intra-corporate food transportation operations can lessen their recordkeeping burden by adopting a unified, company-wide approach to sanitary food transportation operations,

e.g.,

by creating comprehensive SOPs that are to be followed by shippers, loaders, carriers, and/or receivers that operate under common corporate ownership or control, such unified, company-wide SOPs must ensure that the food is transported in compliance with the requirements of this final rule. We address the use of contracts to assign specific food transportation tasks to independent, third parties in our response to Comment 16.

In the FSVP final rule, we declined to establish “an exemption from the FSVP requirements for food that an importer obtains from a foreign supplier that is part of the same corporate structure as the importer,” and we further declined “to establish an exemption from the FSVP requirements where the foreign supplier and importer may otherwise be affiliated, and where the foreign supplier and importer are part of the same company-wide `approach' to food safety” (80 FR 74225 at 74255-56).

We also decline to exempt intra-corporate food transportation operations from this rule on the grounds that such activities will be covered by the requirements of the preventive controls rules for human and animal food. The primary purpose of the preventive controls rules is to establish modern science- and risk-based preventive controls requirements for the manufacturing, processing, packing, or holding of human and animal food. Although facilities under the preventive controls rules may identify refrigeration during transport as a preventive control, for example, the preventive controls rule, unlike this final rule, does not directly regulate carriers. We also note that SFTA was signed into law in 2005 and FSMA was signed into law in 2011. If Congress had intended for FSMA's preventive controls rules to supplant the sanitary food transportation statutory requirements set forth in SFTA under any circumstances, including but not limited to intra-corporate food shipments, Congress presumably would have stated so explicitly in FSMA's statutory language.

Finally, we also decline to completely exempt intra-corporate food transportation operations from this final rule on the commenter's theory that food shipments between shippers, loaders, carriers, and/or receivers that share a common corporate ownership do not fall within the rule's definition of “transportation” because such food shipments do not enter the stream of commerce. Although not explicitly stated in the comment that asserts this theory, the comment appears to suggest that the shipment of food between entities that operate under a common corporate ownership or control does not enter into the stream of “commerce” presumably because the food is not being offered for sale between the parties involved in the transportation operations. We conclude that this interpretation of the 2005 SFTA's statutory definition and the parallel definition of “transportation” in § 1.904 of this final rule is incorrect. The 2005 SFTA does not define the term “in commerce” and therefore does not explicitly limit the scope of the rule, for example, only to those transportation operations that involve the shipment of food that is offered for sale.

(Comment 21) We received several comments asking us to apply modified requirements regarding this rule's information sharing and recordkeeping provisions to shippers, loaders, carriers, and/or receivers engaged in intra-corporate food transportation operations. These comments state, for example, that to require a shipper under this rule that owns its own carrier fleet to provide to the carrier, in writing, all necessary sanitary requirements for the carrier's vehicles and transportation equipment would be redundant and serve no purpose because the information sharing required by this rule, under these circumstances, would presumably already be established by written intra-corporate food transportation SOPs.

Some of these comments assert that a precedent for exempting intra-corporate food shipments from the information sharing and recordkeeping provisions of this rule can be found in the recordkeeping final rule that we issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), at 21 CFR part 1, subpart J.

(Response 21) We agree with these comments and have revised the regulatory text accordingly. Section 1.908(a)(5) of this final rule stipulates that as an alternative to meeting this rule's applicable requirements, shippers, receivers, loaders, and carriers that are under the ownership or operational control of a single legal entity may conduct transportation operations in conformance with common, integrated, written procedures that ensure the sanitary transportation of food consistent with the rule. Section 1.908(a)(5) also states that these written procedures are subject to the records requirements of this rule in § 1.912, which are discussed in section IV.G of this document.

Finally, as we already mentioned earlier in this document, some of the comments invoked the Bioterrorism Act recordkeeping rule as a precedent for granting the revised information sharing and recordkeeping requirements of this rule for intra-corporate food transportation operations. As we explained in the preamble to the Bioterrorism Act recordkeeping rule, “intra-corporate” interactions, for purposes of the implementation of that rule, are limited to interactions between entities that are part of a “vertically integrated company,” for example, a food manufacturer that owns its own suppliers, carriers, distributors, and food retail outlets and, therefore, never releases the food to persons outside of its vertically controlled production path (69 FR 71562 at 71568-71569, December 9, 2004).

The definition of a vertically integrated company as used in the Bioterrorism Act recordkeeping rule is narrower in scope than the definition of “intra-corporate” in this rule. As we explain in our February 2012 guidance to industry entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)” (Ref. 20), two corporate entities that have the same controlling corporate parent are not always part of a vertically integrated company. They may be legally distinct persons, for example, and therefore would not be exempt from the Bioterrorism Act rule's recordkeeping requirements. Similarly, two corporate subsidiaries that are legally distinct persons, but that are managed operationally as a single entity, would not be exempt from the Bioterrorism Act recordkeeping rule. We conclude that the information exchange and recordkeeping provisions set forth in § 1.908(a)(5) of this final rule are appropriate because shippers, carriers, receivers, and loaders operating under the control of a single legal entity can effectively use common integrated written procedures that prescribe sanitary food transportation practices. Accordingly, the provisions set forth in § 1.908(a)(5) of this rule will not be strictly limited to vertically integrated companies, like the Bioterrorism Act's recordkeeping rule.

(Comment 22) One comment asks us to exempt from this final rule's information exchange and recordkeeping requirements food transportation operations that involve shipments of food from centralized charitable food distribution centers that act as shippers, and sometimes also carriers, to member food banks that are separate legal entities, but are closely affiliated with the shippers. The comment also asks us to exempt shipments between food banks. This comment asserts that these types of operations are similar to intra-corporate food transportation operations and, therefore, adherence to this rule's information exchange and recordkeeping requirements should not be required because internal written SOPs are sufficient for ensuring the sanitary transportation of food between these types of entities.

(Response 22) We decline to exempt food transportation operations that involve shipments from centralized charitable food distribution centers to food banks, as well, as food shipments between food banks, from this rule's information exchange and recordkeeping requirements. The commenter describes itself as being a national, domestic hunger relief charity that acts as a shipper to distribute food to and through a network of 200 member community food banks. The comment also states that the individual food banks that form the network “are separate legal entities,” but are “closely affiliated with the national organization.” We decline to exempt these types of transportation operations from this rule because we do not believe that they are comparable to intra-corporate food transportation operations in which shippers, loaders, carriers, and/or receivers operate under the ownership or operational control of a single corporate/legal entity. The commenter and its network of independent food banks are “affiliated” only in the sense that they cooperate closely to advance their shared mission of delivering food assistance to people in need.

However, we have made revisions in this final rule that may lessen the information sharing and corresponding records requirements for organizations such as the ones described by this comment. As we note in our response to Comment 124, we have revised the information sharing provisions in § 1.908(b)(1) to only require one-time notification to the carrier and when necessary, to the loader, by the shipper, unless the design requirements and cleaning procedures required for sanitary transport change because of the type of food being transported. In addition, as we note in our response to Comment 129 and Comment 134, we have revised § 1.908(b)(2) to recognize that the specification of pre-cooling and operating temperature parameters by the shipper to the carrier, and to the loader, may not be necessary for transportation operations conducted during winter in cold areas or for short distance transportation of food in appropriate circumstances.

5. Lists of Nonfood Cargo That May Adulterate Food

We requested comments in the preamble to the proposed rule in response to our tentative decision not to identify and include, in this rulemaking, specific nonfood products that, under all circumstances, may adulterate food subsequently hauled in bulk or non-bulk vehicles. We also requested comment on our tentative conclusion that issuing guidance instead, regarding how some transportation practices may affect the potential for nonfood products to adulterate food products, and would be helpful to the transportation industry.

(Comment 23) Many comments support our decision not to issue lists of nonfood items that may adulterate food if transported simultaneously with food in a non-bulk vehicle, or prior to the transport of food in a bulk vehicle. Several comments agree with our tentative conclusion that issuing guidance regarding how specific transportation practices may affect the potential for nonfood products to adulterate food products would be helpful to the transportation industry. One comment states that the oilseed industry already uses lists of acceptable and unacceptable previous cargos to prevent the adulteration of edible oils during transport and encourages us to incorporate these lists as reference documents in this rulemaking or to establish corresponding guidance documents.

(Response 23) Based upon these comments, we affirm our decision not to include lists of nonfood items that may adulterate food if transported simultaneously with food in a non-bulk vehicle, or prior to the transport of food in a bulk vehicle, as part of this rulemaking. However, we will consider the utility of using such lists as references in any guidance we may issue on this subject in the future.

6. Need for Guidance

(Comment 24) Several comments express the need for guidance documents related to this rule. These comments state that guidance will be important for explaining our expectations (

e.g.,

what measures are “effective” or “adequate”). Some comments state that, we should provide specific guidance for foreign individuals and entities to clarify who would be responsible for complying with the rule in complex transportation operations involving international shipments into the United States. In addition, a comment states that specific quantitative requirements should be included in guidance rather than in this rule to avoid implementation difficulties.

(Response 24) We agree that guidance are important for helping stakeholders to understand the application of this rule to their operations. As we note elsewhere in this document, we may issue future guidance, as resources allow, regarding issues such as the granting of waivers, transportation activities performed by farms, and how transportation practices may affect the potential for the adulteration of food products by nonfood products during transportation operations. We will consider whether guidance on these or other matters would be useful to clarify measures that entities engaged in the transportation of food may take to comply with this rule. We would not include requirements in any guidance because under our good guidance practices regulation (21 CFR 10.115), guidance documents do not establish legally enforceable rights or responsibilities.

(Comment 25) A comment addressing the transportation of RACs by farms agrees with our tentative conclusion in the proposed rule that the sanitary transportation practices that would be required by this rule are not necessary to prevent RACs from becoming adulterated during transportation by farms. However, to minimize the potential for adulteration, this commenter recommends that we develop a guidance document on good transportation practices, as well as user-friendly education materials. The comment suggests that such guidance should stress the importance of cleanout procedures in non-dedicated farm transportation conveyances and equipment used to haul RACs and other products, and provide sample clean-out procedures for such conveyances. The comment also suggests that the guidance could encourage farms that transport RACs to inform receivers about the previous load hauled in the conveyance.

(Response 25) We discussed the exemption of transportation activities for RACs performed by farms from this rule in the proposed rule (79 FR 7006 at 7016) and noted that the diversity of farms and their transportation operations pose challenges in developing mandatory requirements via rulemaking that would be broadly suitable and meaningful for this sector of the food transportation industry. As we discuss in Comment 79, we have revised this final rule to provide that all transportation activities performed by a farm are not subject to this rule. However, we agree that issuing a guidance document on farm transportation operations may be useful in setting forth good transportation practices, given the diverse practices that occur within this sector. We, therefore, intend to consider establishing such guidance and will consider the role that we might be able to play in promoting educational and training activities to address this issue.

7. Preemption

(Comment 26) Some comments expressed concern with the preemption provision of the 2005 SFTA and its potential impact on any State with existing transportation requirements. One comment stated that this rule should be flexible enough to permit State laws to stay in effect if the State law is stronger and its enforcement is superior to what is being achieved under this rule. Some of these comments asserted that the statutory exclusions in the coverage of the 2005 SFTA,

e.g.,

its non-coverage of barge transport, in combination with the preemption provision could weaken existing State activities and regulation of industry and prevent States from developing a unified sanitary transportation regulation.

(Response 26) As we stated in the proposed rule (79 FR 7006 at 7032), the 2005 SFTA includes an express preemption provision at section 416(e) of the FD&C Act, which provides that a requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if: (1) Complying with the requirement of the State or political subdivision and with a requirement of section 416, or with a regulation issued under section 416, is not possible; or (2) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out section 416 or a regulation issued under section 416. Section 416(e) of the FD&C Act further provides that the express preemption provision applies to transportation that occurs on or after the effective date of regulations issued under section 416. This express preemption provision applies to the requirements of this final rule upon their becoming effective. Nonetheless, a State law, including unified State laws, should States wish to adopt such laws, concerning the sanitary transportation of food by motor vehicle or rail vehicle, is not preempted if such laws do not fall under either section 416(e)(1) or (2) of the FD&C Act. Furthermore, it is highly unlikely that any State law addressing transportation operations not subject to the 2005 SFTA,

e.g.,

barge transport, would fall within the scope of the 2005 SFTA's preemption provision. In most cases, a more stringent provision in State law would not be preempted.

(Comment 27) Some comments urge us to affirm that this rule does not preempt related State laws when they are “in addition to” Federal regulation and do not present an obstacle to advancing the purposes of SFTA. The comments further state that we should construe the preemption clause in the SFTA of 2005 narrowly and that we should work in tandem with State authorities by treating this regulation as a floor, and not a ceiling, for State public health measures such that States wishing to enact sanitary food transportation requirements that are more rigorous than those imposed by this rule will be permitted to do so. These comments state that there are two ways that a Federal authority can block State regulation—either by “conflict (or obstacle) preemption” or by “field preemption”—and the comment stated that the language in the SFTA is an example of the former. Conflict preemption only applies when a person or entity cannot satisfy both Federal and State law, and where State law is an obstacle to Federal goals.

(Response 27) Under section 416(e) of the FD&C Act, this rule does not preempt State laws or laws of a political subdivision regarding sanitary transportation of human and animal food unless complying with those laws and this law is impossible, or the requirement of the State or political subdivision as applied or enforced is an obstacle to carrying out this law. Section 416(e) of the FD&C Act further provides that the express preemption provision applies to transportation that occurs on or after the effective date of regulations issued under section 416.

We agree with the commenters that conflict preemption could apply to any State laws governing sanitary food transportation that would make it impossible to simultaneously comply with this rule. In addition, another aspect of conflict preemption could apply under a “frustration of purpose” or “obstacle” theory, whereby a State law requiring sanitary transportation practices would be preempted to the extent the State law frustrates the purpose of, or presents an obstacle to accomplishing the purpose of, this rule. Whether a State requirement is preempted by Federal law depends on specific factual situations. Therefore, although some State requirements may be preempted by Federal law, this law does not prevent States from developing sanitary transportation regulations at the State or local level.

8. Issuance of Sanitary Transportation Supplemental Proposed Rule

(Comment 28) Some comments ask us to publish a revised proposed rule or an interim rule before proceeding to a final rule because of anticipated, significant changes resulting from comments that we received in response to the proposed rule, as well as potentially significant changes in the other, interrelated FSMA rules. One comment states that because the FSMA rules are dependent on one another, all proposed FSMA rules should be issued concurrently so that a concurrent evaluation and comment period may be conducted. Some comments state that re-proposal and a second opportunity for public comment also is warranted because implementation of the sanitary transportation rule will require the complex coordination of efforts among multiple Federal Agencies.

(Response 28) We considered these comments requesting that we issue a supplemental proposal. This final rule includes numerous revisions to the proposed rule. These revisions, however, better achieve our stated objective in the proposed rule to align the provisions of this rule with current safe food transportation practices and to allow industry to continue to use existing practices that have proven to be effective. The revisions we made to this rule are also a logical outgrowth from the proposed rule and are supported by comments that we received in response to the proposed rule. Therefore, we have determined that issuing a supplemental proposal of the rule is not necessary.

We also do not believe that we need to issue a supplemental proposal because implementation will require complex coordination among multiple Federal Agencies. We have sufficiently addressed in our responses to Comment 12 and Comment 13 the application of this rule to food that is subject to the regulatory authority of USDA. In addition, while section 5701 of the 2005 SFTA directs DOT to establish procedures for transportation safety inspections for the purpose of identifying suspected incidents of contamination or adulteration of food during transport in violation of this rule, we do not consider any coordination that we must do with DOT on enforcement to be particularly complex, such that it would have benefited from an additional opportunity for public comment. Therefore, we have determined that issuing a supplemental proposal to consider further aspects of this rule that are relevant to our interactions and relationships with other Federal Agencies is not necessary.

With regard to the suggestion that we should re-issue all seven of the FSMA foundational proposed rules simultaneously for comment, we agree that this might have been helpful to commenters. However, given our deadlines under a consent decree for the seven rules (Ref. 21), this was not possible. We also believe that stakeholders were given adequate opportunity to comment on the

proposed rules, particularly those that are interrelated and were issued simultaneously as supplemental proposed rules in September 2014.

9. Retrospective Review

(Comment 29) One comment states that in line with the requirements of Executive Order 13563, the Office of Management and Budget's (OMB's) implementation memo for that Executive order (Ref. 22), and OMB's 2013 Report to Congress (Ref. 23), it is clear that FDA should incorporate specific plans for retrospective review and ex post evaluation into the text of its final rule. The comment also suggests that given the uncertainty of the underlying data used to formulate the provisions of this rule, we commit to measuring the actual effects of the regulation and use the data we collect during the implementation of the rule to annually review whether the standards are having their desired effects.

(Response 29) We disagree. As discussed in the Final Regulatory Impact Analysis for this rule (Ref. 24), we have examined the impacts of the proposed rule under Executive Orders 13563 and 12866, in relevant part. Section 6 of Executive Order 13563 addresses retrospective analysis of existing rules by agencies, but the Executive order does not require that agencies include retrospective review plans in the codified text. FDA is committed to reviewing its rules to ensure their implementation is effective.

10. Transportation by Modes Other Than Motor Vehicle and Rail Vehicle

(Comment 30) One comment expresses concern about gaps in FDA's authority to regulate different types of food transport conveyances under the 2005 SFTA. The comment notes that the statute specifically limits our regulatory authority to the transportation of food by motor carriers and rail vehicles, excluding transportation by barge or ship and by air. The comment asserts that these omissions create critical weaknesses in the sanitary food transportation system because significant amounts of animal feed grain are transported by barge or ship within the United States and because highly perishable food products are frequently transported by aircraft. Another comment recommends that we explicitly state in this rulemaking that these additional conveyances are excluded and provide a rationale for their exclusion.

(Response 30) The 2005 SFTA, as passed by Congress and signed into law by the President of the United States, expressly mandates that FDA issue regulations to “require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices . . . to ensure that food is not transported under conditions that may render the food adulterated” (21 U.S.C. 350e(b)). We do not believe that we need to issue any confirmatory statements or rationales in response to these comments because the relevant 2005 SFTA statutory language is plain and clear on its face. The 2005 SFTA does not mandate that we issue regulations applicable to the sanitary transportation of food by any other conveyances, including barges or ships and aircraft. However, if we find that there is a public health need for us to regulate air and barge or ship transportation, we will consider whether we want to pursue covering these routes under a non-SFTA authority in the future.

11. Waivers

We stated in the proposed rule (79 FR 7006 at 7029-7030) that we had tentatively determined that it would be appropriate to waive the applicable requirements of this rule, if finalized as proposed, with respect to the following classes of persons:

• Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products; and

• Food establishments,

i.e.,

retail and food service operations, holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.

We stated our intent to separately publish in the

Federal Register,

at the time of publication of this final rule, waivers and the reasons for the waivers for these two classes of persons from the applicable requirements of this rule. We requested comment regarding whether these proposed waivers could result in the transportation of food under conditions that would be unsafe for human or animal health, or could be contrary to the public interest. We did not receive any such comments.

However, we did receive comments requesting that we modify or expand the scope of these waivers beyond that which we discussed in the proposed rule. While we intend to publish waivers in the

Federal Register

addressing the aforementioned classes of persons prior to the compliance date of this final rule, we are evaluating these comments to determine whether we should modify either of these two waivers as requested, and we intend to post a notice on our Web site of our reasoning regarding the scope of these prospective waivers at the soonest possible date. We will also discuss, in this subsequent notice, our thinking on comments we received asking us to consider publishing an additional waiver for transportation operations for molluscan shellfish for entities that hold valid State permits under the National Shellfish Sanitation Program.

(Comment 31) We received comments that we should acknowledge Tribal food codes in addition to state and local food codes in our discussion of waivers and that we should refer to Tribal governments in this final rule in every instance in which we mention State or foreign governments.

(Response 31) We acknowledge that tribal authorities, as well as state and local government agencies, can issue permits to food establishments under their relevant regulatory authority. In light of comments, throughout this final rule we explicitly recognize Tribal governments as partners we intend to work with in the implementation of this rule,

e.g.,

as regulatory authorities we may partner with in future efforts to train regulators (see Comment 6, Comment 19, Comment 159, and Comment 176).

IV. What comments did we receive on the specific provisions of the proposed rule?

A. Who is subject to this subpart? (§ 1.900)

In table 5 we outline the revisions we have made to § 1.900 in finalizing this rulemaking. Following the table we respond to comments about these provisions.

Table 5—§ 1.900  Who is Subject to This Subpart?

Proposed section (§ )

Description

Revision

1.900(a)

Specifies that, except for certain exclusions and exceptions, this rule applies to shipper, loaders, carriers, and receivers engaged in transportation operations

Added “loaders” to the list of covered entities.

1.900(b)(1)

Specifies that the provisions do not apply to food that is transshipped through the United States to another country

No revisions.

1.900(b)(2)

Specifies that the provisions do not apply to food that is imported for export in accordance with 801(d)(3) and that is neither consumed or distributed in the United States

Added “in accordance with section 801(d)(3) of the FD&C Act” to the regulatory text for clarity.

1.900(b)(3)

Specifies that the provisions do not apply to food in facilities regulated exclusively, throughout the entire facility, by USDA

New provision.

(Comment 32) One comment expresses concern about whether the responsibilities that apply to persons subject to this rule would apply to a specific, individual person rather than to an entity. The comment notes that we indicated in the proposed rule that the intent of the rule is to establish accountability at the individual level for ensuring that transportation operations comply with the rule's requirements. However, the commenter asserts that it is not appropriate to place all responsibility onto a single individual. The comment supports having a qualified individual supervise and provide general oversight, but requests confirmation that the term “person” used in this rule refers to legal persons—including corporations.

(Response 32) The statement that this comment references from the proposed rule (79 FR 7006 at 7018) addresses the proposed requirement in § 1.908(a)(2) that responsibility for ensuring that transportation operations are carried out in compliance with all requirements of this rule must be assigned to competent supervisory personnel. That specific requirement does designate an individual as being responsible for this requirement, but we did not state that the intent of the rule is to establish accountability at the individual level for compliance with all requirements of the rule. The term “person” as used in this rule will include “individuals, partnerships, corporations, and associations.”

(Comment 33) One comment asked us to affirm that, for cheese exported to the United States under “freight on board” (FOB) contracts, the shipper is not responsible under this rule once the goods are delivered to a warehouse in the United States. FOB contracts specify that, once the goods have been turned over to the transporting company, the purchaser assumes the risk of loss as defined by the Agreement on International Commercial Terms.

(Response 33) The responsibilities of a shipper under this rule are not affected by the type of shipping arrangement,

e.g.,

an FOB contract, and nothing in this rule specifies which party assumes the risk of loss.

(Comment 34) One comment asked whether the term “other persons” engaged in transportation might include governmental customs agencies that might withhold or load products during the agencies' custom processing operations for more time than considered to be usual in transport to their final destination. The commenter expresses concern that such a delay might potentially create food safety issues.

(Response 34) The 2005 SFTA authorizes us by regulation to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. Generally, governmental customs officials are not engaged in food transportation operations and typically would not be subject to this rulemaking. Their role in inspecting food does not bring them within the scope of what this rule is intended to cover.

(Comment 35) A few comments asked us to address responsibility under this rule in a few situations involving international shipments into the United States. One comment, for example, asked if a rail bulk container travels from Canada to a U.S. rail yard and then is transferred to a new train, is the person or entity that initiated the shipment in Canada the shipper, or is the shipper the person that transferred the bulk container at the U.S. rail yard for further transport in the United States? Another comment asks us to identify the carrier for a closed container that is shipped into the United States by ocean-going vessel and then is transferred, unopened, at the U.S. port of entry onto a truck. Finally, one comment asks us who would be held responsible under this rule if a refrigerated container is shipped from China to the United States via ocean-going vessel and then is transferred, unopened, at the U.S. port of entry onto a truck, and upon receipt, the U.S. receiver discovers evidence of temperature abuse.

(Response 35) In the first example, the shipper for any segment of transportation of the bulk container,

e.g.,

the Canada to U.S. rail segment and also the rail segment originating in the United States, is the person who arranges for that segment of the transportation of the food by a carrier. The shipper may be the same person throughout the transit of the container if a single person arranges for all segments of its transport. In the second instance, the carrier is the person who physically moves the food from the point it becomes subject to this rule,

i.e.,

at the origination of the truck segment in the United States. With respect to the third example, the matter of (legal) responsibility will depend on whether it can be established which actor(s) (

i.e.,

the shipper, loader, and/or carrier) failed to comply with the applicable requirements of § 1.908, and whether this non-compliance contributed to the food becoming unsafe as a result of the failure to provide temperature control. At any rate, whenever it is discovered that the food may have experienced a material failure of temperature control or other conditions that could render the food unsafe, the provision in § 1.908(a)(6) applies and the food shall not be sold or otherwise distributed until it is determined that the temperature deviation or other condition did not render the food unsafe, which may involve communication among the persons subject to this rule. The responsibilities

of persons subject to this rule are discussed in our response to Comment 129.

(Comment 36) One comment asks us to consider situations that include several different transportation legs in determining how parties are defined, or whether specific responsibilities assigned on the basis of the roles the persons involved in transportation operations play are even necessary. For example, corn grain is harvested and (1) taken in a semi-trailer by a farmer to the grain elevator, where it is (2) loaded in a rail car and transported to the Mississippi River, and (3) loaded in a barge for additional transport. Upon arrival, the grain is offloaded into a railcar and is then sent to a feed mill for mixing into hog feed. The comment seeks clarification on the applicability of the regulation if not all parties are subject to this rule,

e.g.,

the parties are performing a non-covered activity (

e.g.,

transport by barge or airplane) or are exempt by size.

(Response 36) In this example, the initial transportation operation would not be subject to this rule because it involves the transportation of food by a farm. In the example described in this comment, the grain elevator would be the receiver. The second segment of transit is subject to this rule because the transportation operation is by rail vehicle and the shipper, loader, carrier and receiver would be the persons who meet the definitions of these entities in this rule. These may not be separate persons,

i.e.,

the shipper and the loader may be the same person. The third segment of transit is not subject to this rule because it involves transportation by a river barge. The fourth segment of transit is subject to this rule in the same manner as the second segment.

We acknowledge that situations may occur where not all parties involved in a transportation operation are subject to this rule,

e.g.,

the shipper is a non-covered business, but the carrier is subject to this rule. In these situations, interactive requirements among covered entities established by this rule,

e.g.,

communication between shippers and carriers, would not be operative and the dialogue between the covered entities that will ensure that safe food transport requirements are understood and entities play their respective roles will not necessarily happen. This situation will disadvantage the entities that are covered businesses, especially if the shipper is not a covered entity. In situations where the shipper (or any entity) is not covered, we believe that the relevant information to ensure safe transport of food (such as appropriate temperatures for refrigeration for foods that require temperature control for safety) will be available in some form to those entities that are covered, though it may not be provided via written records which we consider ideal. Even if certain entities are not covered by this rule, all parties are subject to the general food safety requirements of the FD&C Act.

(Comment 37) A comment expressed concern with the shipper requirements because shipments originating abroad and destined for interior locations in the United States are arranged in the country of origin and the shippers in under-developed countries are not always accessible or easy to connect with, and may not be equipped to communicate with foreign companies and governments. There would be no U.S. shipper in this circumstance and it is unclear how the U.S. carrier and receiver would comply with reporting requirements related to the shipper.

(Response 37) International shipments such as those described in this comment can present difficulties for U.S. firms subject to this rule when it may be necessary to investigate the history of a shipment because, in addition to the circumstances described by the comment, a segment of the shipment,

i.e.,

ocean transport, is not subject to this rule. In circumstances where it would normally be necessary for a U.S. receiver or carrier to contact the foreign shipper under the requirements of this rule (

e.g.,

if a question arose concerning temperature control during shipment) if the shipper is not readily accessible for any reason, the carrier or receiver would have the responsibility under § 1.908(a)(6), which we discuss in Comment 129. We have added this provision to this final rule to ensure that any question relevant to whether the food may be adulterated is adequately addressed before the shipment is allowed to proceed in U.S. commerce. It is unlawful under section 301(a) of the FD&C Act (21 U.S.C. 331(a)) to introduce or deliver for introduction into interstate commerce any food that is adulterated. Further, even in cases where there is a foreign shipper, that shipper may be working in conjunction with a U.S. freight broker that could be contacted in its place to evaluate whether the food is unsafe. Moreover, if the freight broker has arranged the U.S. land-based transportation leg of the foreign shipment, the broker is the legally responsible “shipper” for purposes of the rule and therefore subject to the applicable requirements of § 1.908, including the requirement to specify to the carrier the conditions necessary to ensure the safe transport of the food. We also refer readers to our response to Comment 9.

(Comment 38) One comment states that this rule should also apply to entities that transfer a product from one mode of transportation to another (trans-loaders). It is common, particularly for feed ingredients, to have the cargo trans-loaded from a railcar to a truck. The comment recommends that FDA clarify the situations in which trans-loaders are to be considered shippers, carriers, or receivers because a trans-loader may be a separate (sub-contracted) entity.

(Response 38) An entity that only transfers food cargo from one mode of transportation to another,

e.g.,

from a railcar to a truck, would be subject to this rule as a receiver of food arriving by rail vehicle and as a loader of food onto trucks. The entity would not be considered to be a shipper if it simply holds the food pending truck transport and does not arrange for its transport by the trucking firm. The entity may also be subject to other FDA requirements that address the operation of its facility,

e.g.,

the preventive controls rules for human or animal food.

(Comment 39) One comment asks who acts as the shipper when a single container is shipped using multiple modes of transportation. A container, for example, may start its transit on a truck and then be transferred to a rail car and remain sealed until it reaches its final destination. The comment states that in such instances, the entity that initiated the shipment initially should be considered the “shipper” throughout the voyage and not an entity that transfers the container between conveyances. The comment states that if the second entity were considered to be the shipper, it might have to open the container to inspect it for cleanliness before the container continues in transit, which could impact the safety of the shipment because this would mean breaking the container's seal.

(Response 39) Under this rule, the shipper is the person who arranges for the transportation of food by the carrier. If, in the example given in this comment, a single person arranges for the shipment of the food via multiple modes of transportation, that person is the shipper throughout all stages of transport. The commenter's interpretation, that if another person becomes a subsequent shipper of a sealed container, that person would have to open the container and inspect it before shipment, is incorrect. Nothing in this rule would require the second shipper to open and inspect the sealed container.

1.900(b)

We are adding text for clarity to § 1.900(b)(2) to specify that “food that is

imported for future export” specifically refers to articles of food that are subject to the provisions of section 801(d)(3) of the FD&C Act (21 U.S.C. 381(d)(3)). The added text gives definitive clarity to inform regulated entities that, when we refer to “food” that lawfully can be “imported for export,” “food” means “a food additive, color additive, or dietary supplement” as specified by section 801(d)(3) of the FD&C Act.

(Comment 40) We received a comment asking us to clarify what actions food transporters must take to assure compliance when their food product is intended exclusively for export markets. Another comment states that many commodities intended for export are shipped in standard ocean containers (known in the industry as forty-foot equivalent units (FEUs) and twenty-foot equivalent units (TEUs)), which are owned or leased by steamship lines. This means that the shipper, carrier, and receiver, as identified in the proposed rule, do not own the ocean-going container, which often travels on a truck or rail chassis before reaching a U.S. port for export. The comment asserts that this complicates the relationships and documentation required in the proposed rule between the shipper and the container holder for exports.

(Response 40) The 2005 SFTA states that we must, by regulation, require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated. Further, the statute defines “transportation” as any movement in commerce by motor vehicle or rail vehicle. Thus, persons engaged in the transportation of food that is intended for export are subject to all applicable requirements of this rule when the food is in transit by motor vehicle or rail vehicle to the land-based U.S. border point of export or a port facility. For example, the loader for a truck transportation segment moving the food to a vessel port facility is subject to the rule because it is loading a motor vehicle. The loader for the trans-oceanic ship transport segment is not subject to the rule because the rule does not cover transportation operations for water borne transportation. However, the operations of the second loader are still subject to section 402(a)(4) of the FD&C Act, which prohibits the holding of food under insanitary conditions whereby it may be rendered injurious to health or may become contaminated with filth.

We recognize that under typical practices in the industry, ocean containers are likely to be inspected and otherwise prepared for transportation by the person who loads the container,

e.g.,

the shipper or loader, not by the owner or supplier of the container. As we discuss in our response to Comment 53, this rule does not place any requirements upon the owner or supplier of the container whether foreign or domestic, in circumstances where they are not a shipper, loader, or carrier, and thus we do not anticipate that there will be relational or documentation issues for shippers to address with such equipment owners as a result of this rule.

(Comment 41) Another comment asks us to include an exemption for human and animal food originating in the United States but bound for export from the requirements of this rule. The comment notes that the proposed rule would not apply to transportation operations for food that is imported but is not “consumed or distributed” in the United States because it is exclusively destined for subsequent export. The comment states that food that originates in the United States and is bound for export travels by vehicle or rail car to reach U.S. ports of exit and, like food that is transshipped through the United States to another country or food that is imported for export, it is neither consumed nor distributed until it reaches foreign soil. The comment therefore recommends that we exempt food that originates in the United States, but that is bound for export, from this rule by including under § 1.900(b) the provision: “Human and animal food that moves under Customs and Border Protection (CBP) export reporting procedures including Automated Export System (AES) and is therefore neither consumed nor distributed in the United States.” The comment asserts that requiring that the shipments of the food comply with CBP export reporting and documentation procedures ensures that cargo bound for export will not be diverted into the U.S. food supply for domestic consumption.

(Response 41) We decline to exempt persons engaged in the transportation of human and animal food originating in the United States and bound for export from the requirements of this rule, because food that originates in the United States and is bound for export is handled in a fundamentally different manner than food that is transshipped through the United States to another country, for example from Mexico for delivery to Canada, or food that is imported for future export in accordance with section 801(d)(3) of the FD&C Act, and that is neither consumed nor distributed in the United States. In the cases of import for export and transshipment, legally enforceable mechanisms exist that ensure that the food will not be diverted for consumption or distribution in the United States.

With respect to food that is transshipped through the United States to another country, CBP regulations in 19 CFR 18.10, “Kinds of Entry,” list the various entries and withdrawals that may be made for merchandise transported in bond. One kind of entry is the transportation and exportation (T&E) entry. A party that transships merchandise in bond through the United States must submit T&E documentation with the CBP and the CBP supervises the shipment of the merchandise through the United States, as well as the intact export of the goods to foreign destinations.

Similarly, under section 801(d)(3) of the FD&C Act, parties which import certain articles that are intended exclusively for further processing or incorporation into another product and for subsequent, mandatory export because the articles cannot be distributed or used in the United States must provide FDA with certain information at the time of initial importation. These articles include food subject to this rule, specifically, food additives, color additives and dietary supplements. These parties must provide, among other things, a statement that confirms their intent to further process such articles or incorporate such articles into a product for purposes of subsequent export, and must provide us with the identities of the entities in the chain of possession of the imported articles while the articles are in the United States. Importers also must provide us with certificates of analysis, as necessary, to identify the article of food. In addition, at the time of initial importation and before delivery to the importer, initial owner, or consignee, a bond must be executed providing for liquidated damages in the event of default, in accordance with CBP requirements. The initial owner or consignee of the article also must maintain records of the use and/or destruction of such imports and must submit the records or a report to FDA upon request. The initial owner or consignee also must destroy any article or portion thereof that is not used in an exported product.

The AES system, on the other hand, collects Electronic Export Information (EEI), formerly known as Shipper's Export Declaration (or any successor document) from persons exporting

goods from the United States, Puerto Rico, or the U.S. Virgin Islands; between Puerto Rico and the United States; and to the U.S. Virgin Islands from the United States or Puerto Rico. AES is the central point through which export shipment data required by multiple Federal Agencies is filed electronically with CBP and is operational at all ports and for all methods of transportation. It was designed to assure compliance with and enforcement of various export laws, improve trade statistics, reduce duplicate reporting to multiple agencies, and improve customer service.

However, AES is not specifically designed to function as a legally enforceable mechanism to ensure that food bound for export is not diverted into the domestic supply chain and consumed in the United States. The AES system does not become operative until food arrives at a point of export. Therefore, if a shipper states that any given food shipment that originates in the United States is destined for export and transports the food without complying with the requirements of this rule, but subsequently decides to divert the food for purposes of domestic consumption or distribution, neither we nor the CBP would have any way of knowing that the food had been diverted for domestic consumption, perhaps after being transported under insanitary conditions. In addition, unlike food transshipped through the United States and food imported exclusively for subsequent export, food that originates in the United States and is intended for export, whether it is diverted for domestic consumption or is actually exported, is not transported under a bond. Accordingly, we do not agree that a basis comparable to that for food transshipped through the U.S., or food imported for export, exists for exempting persons engaged in the transportation of human and animal food that originates in the United States but is bound for export from the requirements of this rule as suggested by this comment.

(Comment 42) One comment states that, when cargo is deemed to be adulterated, one of the primary salvage markets may be destinations outside of the United States. The comment observes that this rule appears not to apply to food outside of the United States and argues that, if that is the case, we should clarify that it should not apply to food that is shipped outside of the United States to a destination that was not the original, intended primary market.

(Response 42) If the product has already been offered for sale in the United States and is found to be adulterated, it cannot be legally exported for sale in markets outside the United States. (See

United States

v.

Kanasco, Ltd.,

123 F.3d 209 (4th Cir. 1997) (although this case involved drug products and not food, it stands for the principle that, if product is adulterated, it cannot be legally offered for sale outside the United States).) The owner of the product can pursue other lawful options, such as reconditioning the product or diverting the product to nonfood uses. If, however, the food has not been offered for sale in the United States and otherwise meets the requirements of section 801(e)(1) of the FD&C Act, it can be shipped abroad and would not be subject to the adulterated food provisions of the FD&C Act and therefore would not be subject to this rule.

(Comment 43) A comment requests that we address the safe disposal of contaminated foods from a rejected delivery and the sanitization of trailers carrying such cargo. The comment states that when a delivery is rejected, the responsibility for and costs associated with safely disposing of the shipment is often placed on truckers, in some cases with little or no instructions from the shipper. Consequently, according to the comment, drivers who need to dispose of contaminated cargo sometimes simply dump it, give it away to the public, or sell it. The comment states that FDA should explore, in this or a separate rulemaking, the development of rules governing such rejections. The comment further suggests that we should address when rule violations can serve as the basis for the rejection of a delivery and/or a cargo insurance claim, acceptable methods of disposing of contaminated food products after rejection, and the apportionment of disposal costs among parties involved in the transportation of rejected cargoes.

(Response 43) This rule addresses the sanitary transportation of human and animal food to prevent practices that may create food safety risks. We recognize the burdens and uncertainties that may arise when a load is rejected. However, the basis on which a load may be rejected, and the disposition of and costs associated with the disposal of rejected loads of food, are beyond the scope of this rule. We do not agree that we should explore the development of rules to govern rejections and/or cargo insurance claims, or rejected product disposal issues, because they often involve purely economic considerations about food shipments, which do not fall within our jurisdiction. Also, issues of liability are similarly subject to Federal laws that we do not have the authority to administer. We note, however, that if a food shipment is rejected because it is adulterated, the person responsible for that food cannot distribute or offer it for sale. Further, the carrier of a rejected food shipment must ensure that the motor or rail vehicle used to transport the rejected load complies with the vehicle and equipment provisions of § 1.906 before it is used again to transport food.

B. How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act? (§ 1.902)

The only change we made in the proposed provisions in § 1.902(a) and (b), which specify that the criteria and definitions in part 1, subpart O apply in determining whether food is adulterated within the meaning of section 402(i) of the FD&C Act and that failure to comply with the requirements of part 1, subpart O is a prohibited act, was to add “loaders” to the list of covered entities in both paragraphs.

(Comment 44) One comment asks us to replace the term “in compliance” throughout the final rule with the term “in conformance.”

(Response 44) We decline this request. We have used the phrase “in compliance” in § 1.902(a) of this rule consistent with the language of section 7202(a) of the 2005 SFTA, which amends the FD&C Act by adding section 416 to the FD&C Act to provide that a food shall be deemed to be adulterated “[i]f it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416.”

(Comment 45) Several comments express concern about food being considered adulterated under this rule simply because of the failure of a carrier to adhere to a shipper's specified conditions during transport, such as maintaining a specified temperature, regardless of whether the food is actually unsafe. In particular, these comments speak to concerns about the impact the rule, as proposed, would have on the cargo claims process governed by the “Carmack Amendment” found in 49 U.S.C. 14706. Under this provision of Federal law, a shipper or receiver seeking to recover money for cargo loss or damage from a carrier must show that the cargo is actually lost or damaged. The mere possibility of damage through “potential” exposure is not sufficient to prove an actual loss. One comment states that this rule is problematic because it directly links failure to

adhere to shipper-specified conditions for transportation with adulteration of, or damage to, food products during transport. According to this comment, the operation of this rule would mean that a claimant would no longer be required to prove that a shipment of food is actually damaged, but rather would only be required to prove the shipment was not maintained in accordance with a shipper's specified condition. One comment also states that this rule should clearly state in § 1.902 that “Variance from the requirements of this rule does not create a per se presumption of adulteration, and that the provisions of the Carmack Amendment, 49 U.S.C. 14706, still apply in determining liability of the parties regarding loss or damage to cargo.”

(Response 45) We decline to make the specific change requested, but we have made other revisions to this rule that address the commenter's concerns. We have revised the provisions of this rule, for example, that address instances in which a carrier might not meet a shipper's specifications for temperature control during transportation. An inconsequential failure by a carrier to meet the shipper's temperature control specifications will not necessarily create a per se presumption that the affected food has become adulterated. However, as we discuss in our response to Comment 129, under this rule, in § 1.908(a)(6), if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Failure to take such action may render the food adulterated.

We also have revised this rule in §§ 1.906 and 1.908, as we discuss in our response to Comment 89, to clearly state that the requirements for transportation equipment and transportation operations are intended to prevent food from becoming unsafe during transportation. This revision, in addition to others, makes it clear that under this rule we will apply section 402 of the FD&C Act, as it addresses food safety, to determine whether food has become adulterated during transport. Persons engaged in transportation operations should not expect that we will apply a different standard or different criteria for evaluating compliance with this rule. Therefore, we do not anticipate that this rule will have a significant impact on the cargo claims process.

(Comment 46) Some comments state that there are other common occurrences that they believe could unnecessarily result in a presumption of adulteration under the proposed rule. These commenters express concern that the proposed rule can be interpreted broadly enough to create potential issues if broken seals or evidence of tampering create a presumption of adulteration, absent any evidence of actual threats to the public health.

(Response 46) We have made revisions to this rule that address the concerns of these comments. As we stated in our response to the previous comment, when assessing transportation equipment and transportation operations, we will apply the food safety provisions of section 402 of the FD&C Act as the standard for determining whether food has become adulterated during transport. Persons engaged in transportation operations should not expect that we will apply a different standard or different criteria for evaluating compliance with this rule. A broken cargo seal or any evidence of food cargo tampering would not necessarily create a per se presumption of adulteration. However, we advise persons engaged in transportation operations that, if such situations should arise, they should carefully evaluate the facts and circumstances of each incident, on a case-by-case basis, to determine whether the safety of the food cargo may have been compromised.

(Comment 47) Some comments asked that we clarify, in certain particulars, the interpretation of “conditions not in compliance” in section 402(i) in the FD&C Act, the statutory adulteration provision added to the FD&C Act by the 2005 SFTA. Under that provision, a food is adulterated if it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations issued under section 416 of the FD&C Act,

i.e.,

this final rule. Some of these comments expressed concern that the application of this provision would lead to food being deemed adulterated by regulatory authorities in the absence of physical conditions indicating a food safety risk. One comment stated that non-compliance with the recordkeeping provisions of this final rule alone should not be a basis for deeming food to be adulterated, assuming the records and documentation of the firm do not indicate a systematic and continued failure of a firm to implement sanitary transportation practices. A comment also asked us to recognize that under this rule, an enforcement authority will retain the discretion to consider the specific circumstances in each situation,

e.g.,

if there are only minor deviations from the requirements of this rule, in determining whether food is adulterated.

(Response 47) Under section 402(i) of the FD&C Act, “a food shall be deemed adulterated if it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416.” Section 416(b) of the FD&C Act mandates that the Secretary create regulations requiring that food carriers use sanitary transportation practices. Section 416(c)(1)(E) of the FD&C Act states “the regulations under section (b) shall—(1) prescribe such practices as the Secretary determines to be appropriate relating to— . . . (E) recordkeeping . . .” The way that the statute is structured implies that lack of or incomplete records in section 416(c)(1)(E) of the FD&C Act would lead to the food being adulterated under section 402(i) of the FD&C Act. The establishment of records requirements under this rule is consistent with the statutory purpose of the 2005 SFTA. It is clear from the statute and the legislative history that Congress intended recordkeeping to be one of the requirements for maintaining sanitary food transportation practices (See section 416 of the FD&C Act and S. Rep. No. 109-120, at 46 (2005) (Ref. 25)).

Furthermore, the Senate report (S. Rep. No. 109-120, at 46 (2005)) (Ref 25) expresses Congress' intention to grant FDA authority to deem food adulterated on recordkeeping grounds. That report states that SFTA “would amend section 402 of the Federal Food, Drug, and Cosmetic Act . . . to provide that food is adulterated if transported in violation of safe transportation practices prescribed in the new section 416 of the FD&C Act.”

In the seafood HACCP final rule (60 FR 65096 at 65100) we noted that in

National Confectioners Association

v.

Califano,

569 F.2d 690 (D.C. Cir. 1978), the courts upheld FDA's authority to issue regulations under section 402(a)(4) of the FD&C Act that included recordkeeping requirements, when challenged on the grounds that they would permit prosecution where processing conditions were completely sanitary, but the records were deficient.

Such an outcome, it was argued, would be beyond the scope of section 402(a)(4) of the FD&C Act. Citing

Toilet Goods Association

v.

Gardner,

387 U.S. 158 (1967), the court rejected this argument and held that the primary consideration was whether the statutory scheme as a whole, not just section 402(a)(4) of the FD&C Act, justified the Agency's regulations. (See

Nat'l Confectioners Ass'n,

569 F.2d 690 at 693.) The court pointed out that this consideration involved an inquiry into practicalities as well as statutory purpose,

i.e.,

enforcement problems encountered by FDA and the need for various forms of supervision in order to accomplish the goals of the FD&C Act. (Id.)

Thus, the necessary conditions for compliance with these regulations encompass all of the requirements in this final rule, including those that may not appear to directly affect the safety of the food, such as training and records. The SFTA of 2005 does not differentiate between physical conditions indicating food safety risk and requirements, such as training and recordkeeping.

However, we recognize the concerns expressed by these comments and do not believe that the SFTA of 2005 changes the way we enforce our regulations. Before initiating enforcement action, we will consider all circumstances surrounding the deviation(s),

e.g.,

the nature of the deviation, from these regulations as we have in the application of other preventive control-type regulations, such as the seafood HACCP regulation and the Juice HACCP regulation.

(Comment 48) One comment states that the rule does not address the obligations of carriers if shelf stable food is compromised during transit or while on a dock or being loaded onto a trailer. The comment states that when a shipment is damaged in transit, or during loading or unloading, the carrier will frequently transport the shipment of damaged goods to a location of the shipper's choice. The commenter asks us, if the carrier is only qualified to handle shelf stable food, can the carrier continue to handle the shelf stable food with compromised packaging? The comment also asks whether the carrier would be required to hire another carrier who has chosen to comply with the record keeping and training requirements of the proposed rule to handle the return of such shipments.

(Response 48) We would have no concerns about the carrier transporting the damaged goods to a location specified by the shipper because, under § 1.908(a)(6), an evaluation must be performed before further distribution to determine whether the food has been rendered unsafe.

C. What definitions apply to this subpart? (§ 1.904)

We proposed to establish several definitions in § 1.904. In table 6, we describe revisions to the proposed definitions and following the table we respond to comments related to these provisions. We did not make changes to the definitions of adequate, animal food, bulk vehicle, cross-contact, food not completely enclosed by a container, pest, transportation, and vehicle.

Table 6—§ 1.904 What Definitions Apply to This Subpart?

Definition

Revision

Carrier

Revised definition to specify that carrier means a person who physically moves food by rail or motor vehicle in commerce within the United States.

Farm

Applied farm definition given in § 1.227 (21 CFR 1.227).

Food

Removed the term because it is already defined in section 201 of the FD&C Act.

Full-time equivalent employee

A new definition.

Full-time equivalent employee is a term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks). If the result is not a whole number, round down to the next lowest whole number.

Microorganisms

Removed the term because not needed with revised provisions in §§ 1.906 and 1.908.

Loader

A new definition.

Loader means a person that loads food onto a motor or rail vehicle during transportation operations.

Non-Covered Business

Specified the limit of $500,000 as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year. For the purpose of determining an entity's 3-year average revenue threshold as adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.

Added “loader” to list of potential non-covered businesses.

Person

Removed the term because it is already defined in section 201.

Receiver

Revised definition to specify that receiver means any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.

Shelf Stable Food

Removed the definition, not needed for revised definition of “transportation operations”.

Shipper

Revised to specify that shipper means a person who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.

Provided examples of shipper, such as the manufacturer or a freight broker.

Small Business

Specified the limit of $27,500,000 annual receipts.

Specified that employee limit is fewer than 500 full-time equivalent employees.

Time/Temperature Control for Safety (TCS) Food

Removed the definition, not relevant to revised temperature control provisions.

Transportation

Revised to specify that transportation means any movement of food by motor vehicle or rail vehicle in commerce within the United States.

Transportation Equipment

Removed “other than vehicles” for clarity.

Transportation Operation

Removed “solely” and “shelf stable” to specify that transportation operations do not include activities on a food completely enclosed by a container except a food that requires temperature control for safety.

Added that transportation operations do not include any activities associated with the transportation of “food contact substances as defined in section 409(h)(6) of the FD&C Act,” “human food byproducts transported for use as animal food without further processing,” or live food animals “except molluscan shellfish”.

Removed “for raw agricultural commodities” to specify that transportation operations do not include any transportation activities performed by a farm.

1. Adequate

We proposed to define the term “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public health practice. We are finalizing this definition as proposed.

(Comment 49) One comment states that the term “adequate” is not suitable for a rule intended to achieve compliance with best transportation practices focused on reducing the risks of the adulteration of food products. The comment suggests that instead we should use the term “to guarantee,” which the comment defines as meaning “to ensure and protect from any risk or need,” to avoid ambiguity that might cause confusion and result in public health hazards.

(Response 49) We decline this request. The term “adequate” is a long-standing term that we defined in its current form when we first established Current Good Manufacturing Practices (cGMP) requirements for manufacturing, packing and holding food in 1969 (see 34 FR 6977 at 6978, “ `Adequate' means that which is needed to accomplish the intended purpose in keeping with good public health practice.”). The requirements established in this rule address broadly applicable procedures and practices and our use of the term “adequate” is intended to provide flexibility for shippers, loaders, carriers, and receivers to comply with the requirements in a way that is most suitable for their practices. We are not aware that the term has caused confusion in its use with the cGMPs and the comment does not provide any examples of how our use of the term “adequate” may create confusion that might result in public health hazards.

2. Animal Food

We proposed to define the term “animal food” to mean food for animals other than man, including pet food, animal feed, and associated raw materials and ingredients. We are finalizing this definition as proposed.

(Comment 50) A few comments state that raw materials should not be included in this definition because processing these materials into feed ingredients and finished animal food products after they have been transported to processing facilities removes many, if not all, of the hazards that may be associated with the transportation of the raw materials. One of the comments also notes that the Association of American Feed Control Officials (AAFCO) Model Regulations exempt raw materials (such as meat scraps) from regulation because they are not suitable for use in animal feed without further processing.

(Response 50) We decline to change the definition of animal food. While the transportation of raw materials for animal feed manufacture may not require the same degree of sanitary control as the transport of finished animal feed, there may be circumstances in which processing the raw materials may not remove all health hazards,

e.g.,

fertilizer residue from a prior cargo hauled in a vehicle, that might be caused by the insanitary transportation of the raw materials. We have added provisions to § 1.908(a)(3) of this final rule to provide sufficient flexibility to allow persons engaged in the transport of raw materials, feed ingredients, or finished animal food to use sanitary transportation practices that are appropriate for their circumstances.

3. Bulk Vehicle

We proposed to define the term “bulk vehicle” to mean a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the interior surfaces of the vehicle. We are finalizing this definition as proposed.

(Comment 51) One comment asks us to add terms such as “gondola” to the examples included in this definition in the interests of clarity.

(Response 51) We decline to change the definition based on this request. We are using the definition of “bulk vehicle” in this rule exactly as it appears in the 2005 SFTA and as incorporated into section 416 of the FD&C Act. However, we note that the list of examples included in the definition is not intended to be comprehensive or all inclusive with respect to the types of vehicles that are bulk vehicles. We define the term to include “any other vehicles in which food is shipped in bulk, with the food coming into direct contact with the vehicle.”

(Comment 52) Some comments state that in several respects, our definition of bulk vehicle is overly broad in scope. According to one commenter, the term “hopper bin,” for example, can be inferred to mean a grain hopper bottom storage bin that is part of a storage facility, and not a piece of transportation equipment. The comment requests that we delete the term “hopper bin” from this definition. Another comment asks us to explicitly exclude vehicles used to transport fruit and vegetable RACs from the definition because many RACs are thermally processed with a kill step or are cooked by the consumer before being consumed.

(Response 52) We decline these requests. A hopper bin constructed as part of a facility and used for storage would not be considered transportation equipment and therefore would not be subject to this rule. A hopper bin on a truck or other conveyance subject to this rule, however, is a piece of transportation equipment and therefore is subject to this rule. We also note that while some RACs that are transported in a bulk vehicle may undergo a kill step process or cooking before being consumed, there may be circumstances in which controls,

e.g.,

the cleaning of a vehicle that was last used to haul a nonfood item, are necessary to ensure the sanitary transportation of certain types of RACs. We have added provisions to § 1.908(a)(3) of this rule to provide sufficient flexibility to allow persons engaged in the transport of food intended for further processing to employ sanitary transportation practices that are appropriate for their circumstances.

4. Carrier

We proposed to define the term “carrier” to mean a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. The definition also specified that the carrier is responsible for all functions assigned to a carrier in this subpart even if they are performed by other persons, such as a driver that is employed or contracted by a trucking firm, and that a carrier may also be a receiver or a shipper if the person also performs the functions of those respective persons as defined in this subpart. In the final rule, as explained in the discussion of § 1.908(a)(1), we have added a general provision to that section about the multiple roles that can be played by a single entity to replace the separate provisions we had included in the proposed definitions of “carrier,” “shipper” and “receiver”. We are finalizing the definition for “carrier” to mean a person who physically moves food in commerce and clarifying that a carrier does not include any person who transports food while operating as a parcel delivery service. We explain these changes in the responses to the next 3 comments.

(Comment 53) Some comments oppose defining the term “carrier” to mean a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. These commenters express concern that this definition would result in the inappropriate and unworkable application of this rule's requirements to railroad operators for the following reasons.

• Railroad operators in many cases do not own or lease the railcars they transport, are not responsible for their storage when they are stored in private facilities, and exercise no control over the cars other than to inspect them for mechanical soundness during the transportation process.

• The shipper or loader is generally responsible for inspecting a railcar to ensure that it is suitable for the particular food cargo, regardless of who owns the car.

• Railroad operators do not have the ability to ensure that the shipper's sanitary and temperature control requirements are met before or during transportation when, as is common in freight railroad transport, other parties,

e.g.,

the shipper, assume the responsibility for preparing the railcars for loading, maintain their operating conditions during transportation, and deliver the loaded car to the railroad operator for transport.

• Railroad operators generally do not clean the cars they provide and do not maintain documented cleaning procedures.

• The use of railcars in interchange service, in which railroads convey freight cars from other companies over their lines would likely mean that the railroad operator would not be able to provide information about the identity of a bulk vehicle's previous cargoes and its most recent cleaning if requested by the shipper.

The commenters note that for the stated reasons, railroad operators cannot meet requirements of this rule assigned to carriers under proposed §§ 1.906 and 1.908.

These comments also contrast rail carrier and motor carrier food transportation operations, noting that motor carriers generally own the vehicles they provide for transport and are directly involved in transportation operations, such as the loading and unloading of the trailers that they haul, and therefore can comply with requirements assigned to the carrier in §§ 1.906 and 1.908 of the proposed rule.

Finally, one comment asks us to establish separate definitions for motor and rail carriers which would assign appropriate responsibilities for each of the two distinct types of carriers. Another comment asks us to establish a definition specific

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