Sanitary Transportation of Human and Animal Food; Proposed Rule (Docket No. FDA-2013-N-0013; RIN 0910 AG98)

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1 July 30, 2014 Submitted Electronically via Regulations.gov Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD Re: Sanitary Transportation of Human and Animal Food; Proposed Rule (Docket No. FDA-2013-N-0013; RIN 0910 AG98) Dear Sir or Madam: The Grocery Manufacturers Association (GMA) appreciates the opportunity to provide comments on the Food and Drug Administration s (FDA s) proposed rule regarding Sanitary Transportation of Human and Animal Food (79 Fed. Reg (Feb. 5, 2014)). Founded in 1908, GMA and its member companies are committed to meeting the needs of consumers through product innovation, responsible business practices, and effective public policy solutions developed through a genuine partnership with policymakers and other stakeholders. In keeping with our founding principles, GMA helps its members produce safe products through a strong and ongoing commitment to scientific research, testing, and evaluation. We ensure that our members have the very best and latest scientific knowledge available, so they can provide consumers with the products, tools, and information they need to achieve a healthy diet and an active lifestyle. The $2.1 trillion food, beverage, and consumer packaged goods industry employs 14 million U.S. workers, and contributes over $1 trillion in added value to the nation's economy. GMA strongly supported the FDA Food Safety Modernization Act (FSMA) and looks forward to working with FDA for successful implementation of this groundbreaking law. GMA applauds FDA for the considerable efforts to reach out to stakeholders during the pre-rulemaking stage of the proceedings and for the Agency s willingness to continue that dialogue during the public comment period. We appreciate the Agency s desire to develop a regulatory framework that is protective of public health, risk-based, and practical. We all share a common goal of providing safe food to American consumers. Executive Summary of Comments GMA appreciates the opportunity to comment on the sanitary transportation of food proposed rule. We commend FDA on its consideration of the comments submitted in response to the 2010 advance notice of proposed rulemaking. We also appreciate the Agency s intent to develop a regulation based on current industry practices, as a reflection that the transportation systems used today already are accomplishing what s needed to transport food safely. It is a positive reflection on

2 the success of industry s voluntary efforts in this area that FDA does not anticipate large scale changes in practices as a result of the requirements of this proposed rule. 1 Transporting food safely is fundamental to our members success, as significant time and resources are lost if food safety is not maintained between production and consumer purchase. GMA supports FDA s generally flexible approach in the proposed rule that sets broad expectations without prescribing exactly what companies need to do to achieve those requirements. This approach allows companies to tailor their practices, as appropriate and necessary, based on the nature of the food and the transportation conveyance and to adapt new practices when there are new advances in technology. We also appreciate the recognition that industry can diverge from certain proposed requirements, such as those for bulk shipments, by contractual agreement. This reflects a practical understanding of the way business is conducted and how flexibility is essential because of the highly complex nature of the transportation chain. We agree that the rule itself should be risk-based, focusing only on transportation circumstances that pose the greatest food safety risk to public health. Similarly, when enforcing the regulation, FDA should take a risk-based approach. However, as our members considered the proposed rule, they concluded that some aspects of the proposal need further refinement to achieve this goal. That is, the rule needs to be revised so that it reflects current practices, as is the Agency s intent. For example, the proposed temperature control requirements suggest a need for continuous monitoring that is routinely communicated to the shipper by the carrier. The proposed approach would add considerable cost in an area where there is no demonstrated food safety problem that needs to be rectified. We also conclude that there are some aspects of the proposal that take a simplified view of current transportation operations. For example, the regulation focuses on shippers, carriers, and receivers, but there often are many other important intermediaries in the chain that play an integral role (e.g., brokers, traders, third-party warehouses). Moreover, the receiver often fills responsibilities that FDA assigns to carriers under the regulation. Therefore, our comments focus in part on educating the Agency about how food transportation works today. Given the Agency s intent to align the regulation with current leading practices, we think it is important that further consideration is given to aspects of the proposal that would require industry to change the current approach to food transportation. Our comments focus on the following issues and recommendations: FDA should revise the temperature monitoring requirements to align with current effective industry transportation practices that ensure food safety. FDA should tailor the scope of the proposed rule so it is more risk-based. FDA should finalize the proposed waivers and issue other important waivers recommended herein. The proposed rule should allow flexibility in allocation of responsibilities between shippers, carriers, and receivers by contractual agreements Fed. Reg. at 7007 Page 2 of 38

3 The proposed rule should provide modified requirements for intra-company shipments and short-haul shipments. GMA commends FDA s practical approach to the recordkeeping aspects of the proposal. FDA should provide stakeholders with information about implementation and enforcement plans. Implementation In addition, we want to emphasize the following essential points that should inform the Agency s efforts for FSMA implementation: The Final Rule Should Be Cost Neutral for Food Companies with Advanced Food Safety Programs: We agree with FDA s stated goal of issuing regulations that would be essentially cost neutral for food companies that already have advanced food safety systems. GMA understands that the task of quantifying the economic impact of the new food safety regulations is difficult. However, the implementation cost estimates should accurately reflect the true costs the food industry will incur. GMA encourages FDA to adopt the approach outlined in our comments based on our analysis that our recommended approach will prevent the diversion of resources from important food safety activities, while still providing the same food safety protections as FDA s approach in the proposal. Effective Implementation Will Require Comprehensive Inspector Training: Even after the Agency issues final regulations and publishes guidance, FSMA can only be successful if it is enforced effectively, uniformly, and fairly by the Agency s inspectorate on both the federal and state levels. FDA should start now with stakeholder input to develop and implement a comprehensive program to train investigators about a wide range of issues, including what the regulations require, how the regulatory requirements can be met through contractual agreements, how and by whom inspections will be conducted, and what types of observations are appropriate to include on FDA Form 483s. Investigator calibration also will be essential so that the law is enforced consistently from one region to another, by both federal and state officials. FSMA Inspections Should Take a Systems-Based Approach: Inspections should focus on whether the facility has designed and implemented effective management systems to maximize food safety, including management systems for sanitary food transportation. Inspections should also reinforce incentives for behavior that promotes food safety, such as implementing effective employee training programs. Given the wide diversity of approaches that can be followed to make and safely transport food, FDA also should establish a mechanism for investigators to consult with experts from the Agency s Center for Food Safety and Applied Nutrition (CFSAN) if they have questions about technical issues regarding a facility s operations. We also strongly support development of a timely appeals mechanism so companies that disagree with an investigator s conclusion can readily bring the issue to the attention of FDA experts. We believe it is in everyone s interest that the inspection process be transparent in its planning, decision-making, and appeals process. Guidance Should Not Be Treated as Binding: GMA strongly supports the use of guidance to assist with implementing the FSMA regulations, provided that guidance is appropriately Page 3 of 38

4 treated as illustrative but non-binding. The Agency s good guidance practices regulation, 21 CFR , very clearly explains that guidance does not legally bind the public or FDA and companies may choose to use an approach other than one set forth in a guidance document. FDA s investigators need to understand this limit so that they do not seek to enforce guidance as imposing regulatory requirements, as has occurred at times in the past. Rather, investigators should treat guidance as a safe harbor that represents an acceptable compliance approach but not the only one. The Agency should take particular precautions to educate its inspectors about this limitation. * * * We appreciate the opportunity to submit these comments and look forward to continuing to work with the Agency to ensure FSMA implementation is a success. Keeping food safe for consumers is our top priority. Sincerely, Leon Bruner, DVM, Ph.D. Executive Vice President for Scientific and Regulatory Affairs & Chief Science Officer Page 4 of 38

5 GMA Feedback and Recommendations on Proposed Rule: Sanitary Transportation of Human and Animal Food; 21 CFR Part 1 TABLE OF CONTENTS COMMENTS ON PROPOSED REGULATORY FRAMEWORK... 6 APPENDIX: GMA COMMENTS ON THE PRELIMINARY REGULATORY IMPACT ANALYSIS Page 5 of 38

6 GMA Feedback and Recommendations on Proposed Rule: Sanitary Transportation of Human and Animal Food; 21 CFR Part 1 I. Background and Introduction Comments on Proposed Regulatory Framework GMA appreciates the opportunity to comment on the sanitary transportation of food (STF) proposed rule. We commend FDA on its consideration of the comments submitted in response to the 2010 advance notice of proposed rulemaking. We also appreciate the Agency s intent to develop a regulation that reflects current industry practices, as a reflection that the transportation systems used today are already accomplishing what is needed to transport food safely. It is a positive reflection on the success of industry s voluntary efforts in this area that FDA does not anticipate large scale changes in practices as a result of the requirements of this proposed rule. 2 Transporting food safely is fundamental to our members success, as significant time and resources are lost if food safety is not maintained between production and consumer purchase. GMA supports FDA s generally flexible approach in the proposed rule that sets broad expectations without prescribing exactly what companies need to do to achieve those requirements. This approach allows companies to tailor their practices as appropriate based on the nature of the food and the transportation conveyance. We also appreciate the recognition that industry can diverge from certain proposed requirements, such as those for bulk shipments, by contractual agreement. This reflects a practical understanding of the way business is conducted and how flexibility is essential because of the complex nature of the transportation chain. We agree that the rule itself should be risk-based, focusing only on transportation circumstances that pose the greatest food safety risk to public health. Similarly, when applying the regulation, FDA should take a risk-based approach. For example, the conditions necessary for sanitary transportation of heads of lettuce destined for retail sale may be quite different than the conditions necessary to transport produce redirected to a farm for animal consumption. As our members considered the proposed rule, they concluded that some aspects of the proposal could be further tailored to be even more risk-based and better reflect the Agency s intent to match current practices. For example, the proposed temperature control requirements suggest a need for continuous monitoring that is routinely communicated to the shipper by the carrier, but this would add considerable cost in an area where there is no demonstrated food safety problem that needs to be rectified. We also concluded that there are some aspects of the proposal that take a simplified view of how food transportation operates today. For example, the regulation focuses on shippers, carriers, and receivers, but there often are many other important intermediaries in the chain that play an integral role (e.g., brokers, traders, third-party warehouses). Moreover, the receiver often fills responsibilities that FDA assigns to carriers under the regulation (e.g., confirming temperature requirements were met upon arrival). In our comments, we focus in part on educating the Agency about how food is safely transported today. Given the Agency s intent to align the regulation with current leading effective practices, we think it is important that further consideration is given to aspects of the proposal that would require industry to change the current approach to food transportation without providing a 2 79 Fed. Reg. at Page 6 of 38

7 corresponding increase in food safety. Specifically, our comments focus on the following issues and recommendations: FDA should revise the temperature monitoring requirements to align with current effective industry transportation practices that ensure food safety. FDA should tailor the scope of the proposed rule so it is more risk-based. FDA should finalize the proposed waivers and issue other important waivers recommended herein. The proposed rule should allow flexibility in allocation of responsibilities between shippers, carriers, and receivers by contractual agreements. The proposed rule should provide modified requirements for intra-company shipments and short-haul shipments. GMA commends FDA s practical approach to the recordkeeping aspects of the proposal. FDA should provide stakeholders with information about implementation and enforcement plans. II. FDA Should Revise the Temperature Monitoring Requirements to Align with Current Effective Industry Transportation Practices that Ensure Food Safety Under the proposed rule, special temperature control requirements apply to food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, whether or not the food requires time/temperature control for safety (TCS). The shipper must specify the necessary temperature conditions to the carrier in writing and verify precooling, if required. The carrier must, once the transportation operation is complete, demonstrate to the shipper (and the receiver too, if requested) that it has maintained temperature conditions during the transportation operation consistent with those specified by the shipper. FDA provides that this demonstration can be accomplished by any appropriate means agreeable to the carrier and shipper. However, the two examples provided in the regulation both suggest a need for communication of the results of continuous temperature monitoring (i.e., printouts of a time/temperature recording device, a log of temperature measurements taken at various times during shipment). The temperature control aspects of the proposal relating to shippers are aligned with our members current practices, as our members routinely communicate their temperature control requirements to carriers and also confirm pre-cooling, if required. However, there are two significant aspects of this proposal that we are concerned about: (1) FDA s expectations for when and how the carrier would be expected to demonstrate that it maintained temperature conditions as specified by the shipper, and (2) actions required in the event of a deviation from the temperature requirements specified by the shipper. We also provide comments on the pre-cooling provision of the proposed rule and recommend changes to the codified language. Page 7 of 38

8 A. Continuous Temperature Monitoring and Demonstration of Temperature Maintenance Are Not Always Necessary for Food Safety FDA should revise the regulatory language in the final rule to avoid implying that continuous temperature monitoring is uniformly expected and that carriers must provide such data to shippers for every load. We support the broad, flexible language proposed that says the carrier s demonstration can be accomplished by any appropriate means agreeable to the carrier and shipper. However, we are concerned that the examples provided in the proposed codified language imply a need to communicate the results of continuous temperature monitoring. 3 While carriers can and often do engage in continuous temperature monitoring, there are some parts of the industry where demonstration of the continuous temperature monitoring is not the norm because there are other methods available to ensure safe transportation of food. For example, sometimes the temperature of the product and/or cargo area is checked upon departure and arrival; this is sufficient to demonstrate that the food remained safe. When continuous temperature monitoring is used, it typically involves a refrigerator unit that records either the set temperature or air temperature. Although there are other technologies available, such as time/temperature recording devices (TTRs), their use is not the norm. GMA recommends that the need to use such devices should be risk-based, as determined by the shipper. The current typical industry practice does not involve the use of stand-alone continuous TTRs for most temperature controlled shipments. In the instances when they are used, it typically is because the product s manufacturer determined that a TTR is needed for safety reasons. In addition, it is not the norm today for the carrier to routinely demonstrate to the shipper that they have met the shipper s temperature requirements. Typically the shipper communicates temperature requirements to the carrier and confirms pre-cooling, when needed. When appropriate and necessary, the receiver or carrier checks the trailer or product temperature upon arrival. 4 Further, the readings from continuous monitoring devices are only provided if: (1) a TTR was used, or (2) if there is an indication of a problem with temperature maintenance and the shipper or receiver requires additional information from the carrier to assess food safety. This practice is appropriate for food safety because, as explained below, visual inspections are adequate to demonstrate any material temperature deviations that affect the safety of the load. When the receiver or carrier conducts a visual inspection upon arrival they can easily find evidence of temperature variations, such as sweating, ice crystals, signs of moisture, leaking product, moisture damage to packaging, or loss of the structural integrity of packaging. Visual evidence will be apparent if the deviation is material (i.e., if the deviation will affect the safety of the load), as refrigerated trailers do not function to lower product temperature they simply maintain temperature during transit. 5 If the cooler is turned off during transit and the temperature in the refrigerated trailer 3 We also support FDA s recognition that there are some foods transported under temperature control that are not at risk of becoming adulterated without temperature control and, therefore, fall outside of the scope of the temperature-related requirements in the regulation. 79 Fed. Reg. at 7020 (discussing transportation of fruit, such as bananas, that occurs under temperature control for marketability purposes). 4 Checking the trailer temperature is more common than checking the product temperature. Based on discussions with our members, product temperature is more likely to be checked for TCS foods. 5 The cooling capacity of a trailer refrigeration unit (TRU) is limited based on the amount of heat it can remove from the product (in BTUs). Protecting Perishable Food in Transport by Truck Handbook (hereinafter USDA Handbook ), at 2; see also id. at 14, Figure 8 (showing a classification label used to rate the cooling capacity of refrigerated trucks), Page 8 of 38

9 rises significantly, the food product temperature will also rise. Once the cooler is turned back on, it will not be able to adequately bring the temperature of the food back down. Therefore, there will be visual evidence of the temperature deviation. When there is evidence of a temperature deviation, the shipper will ask the carrier for temperature data. Further, although many refrigeration units have the capability to capture and print out temperature recordings during shipment (e.g., through the unit s return air monitoring system), it is not easy to download the information from these units. Often, they need to be taken out of service and delivered to a third-party center where the information can be downloaded. There also is time and cost required to analyze hours of data to determine whether a deviation occurred and, if so, whether it is material. This provides an unnecessary layer of complexity beyond current effective industry practices without a commensurate food safety benefit. The proposed regulatory language regarding the obligation for the carrier to demonstrate its maintenance of temperature control to the shipper ( 1.908(d)(2)(i)) could be interpreted to require continuous temperature monitoring and demonstration through provision of a TTR or print outs of the temperature during shipment. This is because the examples provided in the regulation itself both involve demonstration of the continuous temperature monitoring: (1) printouts of a time/temperature recording device, and (2) a log of temperature measurements taken at various times during shipment. These examples provide much more specificity than the preceding language any appropriate means agreeable and we are concerned they could establish the norm that documentation of continuous monitoring is required on every shipment. Moreover, in the preamble FDA provides an example of temperature monitoring conducted upon departure and arrival, but this example specifically is limited to short-distance transportation. 6 accessible at: The refrigeration capacity needed to safely transport a particular load depends on several factors, including, but not limited to, the desired product temperature, the amount of vehicle insulation, ambient temperatures, product temperatures at loading, degree of precooling of the cargo area, and the extra cooling capacity required (as a reserve). To maintain the desired temperature of the food in transit, the TRU must be capable of removing sufficient heat from inside the trailer. USDA Handbook at 2 (discussing various sources of heat); see also Heat and Mass Transfer: A Practical Approach 3 rd Ed., Chapter 17, Section 8. Yunus A. Engel, Heat and Mass Transfer: A Practical Approach rd ed. 2008) (stating that the interior of refrigerated trucks should be pre-cooled to the desired temperature before loading because the refrigerated cars or trucks do not have the additional refrigeration capacity to cool the products fast enough). If the TRU lacks the capacity to remove enough heat or if the TRU malfunctions or is improperly used, then the air temperature of the trailer will rise. However, this temperature change is not immediate; it is a function of time. In fact, most TRUs are designed to cycle on and off in order to maintain the desired temperature of the food product. See Catherine Ka Po Hui, Air Circulation Inside Refrigerated Semi-trailers Transporting Fresh Produce (2001) at 12-13, accessible at: Just because the TRU is off does not mean that the temperature of the food will rise. See Wenting Zeng et. al (2014), Air Circulation Inside Refrigerated Semi-Trailers Transporting Fresh Produce, J. Food Protection, Number 2 pp (stating that at low temperatures during transport and retail sale, rapid and slight temperature changes caused by normal refrigeration cycles may have little effect on the growth of E. coli O157:H7). If the average temperature of the trailer rises to a significant degree and for a significant time, only then can the temperature of the food product rise. See also World Food Logistics Organization: Commodity Storage Manual, Frozen Foods Handling and Storage (2008), accessible at (stating that Refrigeration equipment used to transport frozen foods is designed to remove heat that may leak into the load compartment of the railcar, truck, or container. It should be noted that the refrigeration capacity does not provide for removal of much heat from the load. Therefore, if products are loaded with the temperature warmer than 0 F (-18 C), there is little or no opportunity for the product temperature to be reduced to the desired level during transit. ) Fed. Reg. at Page 9 of 38

10 If carriers were required to routinely demonstrate their compliance with the shipper s temperature expectations through communication of continuous temperature monitoring data, this would consume limited resources and would require a major change to the safe practices already in place today. Given FDA s goal of aligning the proposed rule with current industry practices and not increasing costs without providing value for food safety, the Agency should revise this aspect of the proposed rule to provide flexibility to the shipper and/or receiver. The demonstration should only be required when requested by the shipper and/or receiver and continuous temperature recording results are only needed if this is the appropriate means agreeable to them as defined by contractual agreement. FDA should also modify the regulation by either eliminating the examples of continuous temperature monitoring or adding examples involving temperature verification upon departure and arrival, such as the visual inspection described above. These revisions would align the regulation with current industry practices that have proven to be effective. Suggested changes to the codified language are provided below. B. Temperature Deviations Do Not Necessarily Mean that the Food Is Adulterated GMA recommends FDA recognize that a deviation from the shipper s specified temperature requirement does not necessarily mean the food is adulterated. The temperature the shipper communicates to the carrier, typically on the Bill of Lading, is not usually a critical limit for food safety. Rather, for a variety of reasons, it is often set lower than the food safety threshold, such as to provide a margin-of-error in case of a potential temperature increase or to protect product quality. In many cases the temperature limit for food safety may be higher than necessary to maintain the desired product color, appearance, flavor, and/or shelf-life. For example, a manufacturer may specify that TCS frozen food products need to be transported at zero o F to maintain optimum product quality. If the product is transported at temperatures up to 31 o F, microbial growth for food safety or spoilage is typically not a concern. However, at temperatures between 10 o F and 31 o F, the quality degrades and shelf life is shortened. The product will lose quality attributes such as color, flavor and texture, and become much less desirable for consumer use, but the food will not be microbially spoiled or potentially hazardous due to microbial growth. Another reason that refrigerator temperatures may be set lower than necessary is to account for seasonality (e.g., the set temperature for a truck driven through a hot area during the summer may be lowered somewhat to account for the impact of the high external temperatures to which it will be exposed). We strongly oppose any requirement for shippers to communicate more than one temperature per shipment to carriers. Asking carriers to manage multiple set points in a given shipment could create confusion amongst drivers and other carrier personnel with negative product effects. In order to prevent such confusion, our members only communicate to carriers one temperature at which the refrigeration unit should be set rather than communicating one temperature to prevent adulteration and another temperature to protect quality. GMA encourages FDA not to suggest that simply because a temperature deviation occurs in transit that the food is adulterated and therefore unsuitable for any purpose. In the event the carrier is not able to demonstrate that it met the shipper s transportation requirements, the shipper and/or receiver should have the discretion to thoroughly assess whether the deviation rendered the food adulterated. In many cases, the food may still be fit for its originally intended use. Further, in the case where a food may no longer be fit for its original intended use, this does not mean that it is entirely unfit for any food use (i.e., adulterated). For example, a food may need to be downgraded or reconditioned, but could be entirely safe for use in a manner other than initially intended, such as for animal food. Deeming food adulterated simply because there was a temperature deviation during Page 10 of 38

11 transit, without allowing for an evaluation of whether that deviation affected the safety of that food, would result in significant amounts of food waste, an increase in disposal costs, and an increase in cargo insurance claims, without providing any corresponding food safety benefit. 7 We recommend this point be clarified in the preamble to the final rule. C. FDA Should Clarify that Pre-Cooling is Only Required when Determined Necessary by the Shipper We interpret the language of the proposed rule and preamble to say that pre-cooling only is required when necessary to maintain the temperature conditions during transport. Thus, a shipper should not be required to direct the carrier to engage in pre-cooling if they determine the food can be transported safely without it. For example, pre-cooling may not required for transportation during the winter in cold areas or for trips that cover only short distances. The language in the regulation should be clearer on this point, and we request that FDA clarify this issue in the final rule. D. Recommended Revisions to the Regulation To capture the revisions to the codified language supported by these comments, modifications should be made to sections 1.08(b) and (d) of the proposed rule as follows: 8 (b)(3) A shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, whether a TCS food or a non-tcs food, must specify in writing to the carrier, except a carrier who transports the food in a thermally insulated tank, the temperature conditions necessary during the transportation operation, including the pre-cooling phase if necessary, to ensure that the operation will maintain the temperature conditions and meet the requirements of paragraph (a)(3) of this section.... (b)(6) If the carrier is unable to maintain temperature conditions during the transportation operation that are consistent with those specified by the shipper in accordance with 1.908(b)(3), or if the carrier s demonstration under 1.908(d)(2) demonstrates a deviation from the temperature specified by the shipper in accordance with 1.908(b)(3), the shipper must evaluate whether the temperature deviation renders the food adulterated for its intended use. Adulterated food may be reconditioned or diverted to another use, such as animal consumption, so long as the food is not adulterated for that use. (d)(2) A carrier: (i) Must, once the transportation operation is complete and if requested by the shipper or receiver, demonstrate to the shipper and if requested, to the receiver, that it has maintained temperature conditions during the transportation operation consistent with those specified 7 With respect to cargo insurance claims, we urge FDA to consider the interaction between the proposed rule and the Carmack Amendment, codified at 49 U.S.C The Carmack Amendment, provides that carriers are liable for any actual loss or injury to the property that are caused by the carrier. If food is considered adulterated based on the failure of a carrier to conform to requirements of the STF regulation, regardless of whether the food is actually unsafe, this could trigger liability under the Carmack Amendment and would significantly increase cargo insurance claims. These cost impacts should be considered in the economic analysis for the final rule. 8 Deletions are indicated by strikethrough and additions are underlined. Page 11 of 38

12 by the shipper in accordance with 1.908(b)(3). Such demonstration may be accomplished by any appropriate means agreeable to the carrier and shipper. III. FDA Should Tailor the Scope of the Proposed Rule so it is More Risk-Based There are several areas where we encourage FDA to reconsider its proposal with respect to the scope of the regulation to ensure that the final rule is as risk-based as possible. Given the preamble discussion that there is no epidemiological case that drives the need for major changes to food transportation, we believe the practices already in place today work well to ensure food remains safe while it is transported. The regulation does not need to take a heavy-handed approach that brings all food within its scope. Rather, FDA should tailor the regulation so that it only affects the key areas of public health concern safety of shipments subject to temperature-control to prevent adulteration, bulk shipment where the food comes into direct contact with the vehicle, and food not fully enclosed by a container. Our comments that follow urge FDA to take the following actions to refine and clarify the scope of the final rule: Exempt shipments of all shelf stable foods, regardless of whether they are the only food being transported; Narrow the scope of the regulation to only food for consumption, exempting articles like pesticides, food packaging, and food additives; Reframe the farm exemption so that it applies for any transportation of raw agricultural commodities to or from a farm regardless of who initiates the shipment; and Issue guidance regarding the applicability of the regulation to cross-border shipments. A. Transportation Solely of Shelf Stable Food We support the proposed exemption for transportation of shelf stable food that is completely enclosed by a container. We are concerned, however, by the proposed restriction that such food only is exempt if the transportation solely involves shelf stable foods. Shelf stable foods often are transported together with non-foods (e.g., consumer goods destined for the same retail store) or covered foods (e.g., boxes of produce). If FDA maintains the solely restriction, industry may be inclined to separate the transportation of packaged shelf stable foods into different loads in order to fit within the exemption. Stopping the practice of co-loading will dramatically increase cost. FDA should modify the regulation to provide that any transportation of shelf stable foods is exempt, regardless of whether they are transported with a regulated food. For example, if a shelf stable food is transported together with boxes of vented produce, the load would be subject to the regulation only with respect to the produce. If a shelf stable food is transported with boxes of nonfood consumer goods, the load would be exempt from the regulation. In both situations, the statutory obligation to prevent adulteration would apply, providing assurance that shelf stable foods cannot be transported in a way that could make them unsafe. Accordingly, we recommend the following revision to section of the regulation: Transportation Operations means all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment. Transportation operations Page 12 of 38

13 do not include any activities associated with the transportation solely of shelf stable food that is completely enclosed by a container.... Relatedly, when packaged shelf stable food is transported along with foods that are covered by the regulation, we strongly urge FDA to take a practical approach to enforcement. If the STF regulation is not followed and a portion of the load is deemed adulterated (e.g., due to a temperature control failure), this does not necessarily mean that all of the food on the load is adulterated. For example, if a temperature deviation renders temperature controlled food adulterated, this does not necessarily mean the safety of shelf stable food in the same load is affected. The impact of a regulatory violation needs to be assessed on a food-specific basis, rather than on a load-specific basis, considering the nature of the violation. Simply because a problem occurs that affects the safety of some food in the load (e.g., vented boxes of produce, temperature controlled foods), this does not mean that other foods in the same load (e.g., packaged shelf stable foods) necessarily are not safe. B. Food Additives and Other Foods Not For Consumption FDA proposes defining food in the same way it is defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This broad definition encompasses not only the edible food and food ingredients but also materials such as food additives. The STF regulation is not necessary for public health when applied for direct and indirect food additives and similar substances. While we view many of these materials, such as packaging, as exempt under the shelf stable food exemption, FDA should clarify this interpretation in the final rule. Another approach would be to list examples of these materials under the definition of shelf stable food in section Furthermore, it would be inconsistent for FDA to exempt fully-packaged shelf stable food and not exempt transportation of the packaging that food will be transported in before food is packaged. Given that there are no known instances of food safety concern relating to transportation of food additives, FDA should clarify that they fall outside of the regulation s scope. We also encourage FDA to exempt the transportation of food that will not be commercialized or consumed, such as samples, research and development products, and test products. This would be consistent with the approach we encouraged in our comments regarding the preventive controls proposed rule, where we asked the Agency to reconsider the need for pilot plants and similar establishments to register and, therefore, be subject to the food safety plan requirements. This approach will be risk-based because the transportation of such products does not present a risk to public health. C. Farm Exemption The proposed farm exemption should be expanded to apply to any shipments of a raw agricultural commodity (RAC) to or from a farm, regardless of whether the shipment was initiated by the farm itself. FDA proposes exempting transportation activities for RACs performed by a farm as the shipper. For purposes of the STF regulation, a farm includes facilities that pack or hold food, regardless of whether all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership. If RACs are safe enough to exempt from the regulation when a shipment from a farm is performed by a farmer, the products are just as safe when transportation from the farm is performed by a non-farmer. As proposed, however, the regulation would result in arbitrary distinctions based Page 13 of 38

14 on who performs the transportation. For example, if a farmer hires a third-party to transport a RAC from their farm to a food processor, this would be exempt because the third-party is performing the transportation on behalf of the farmer. But, if the food processor hires the same third-party to transport the same RAC to the food processor s facility from the farm, this would not be exempt. Transportation to the farm also should be exempt, regardless of who initiates the shipment, so that transportation of diverted food production materials that will be consumed by animals is not covered by the regulation. We recommend revising the final rule to provide that all transportation activities for RACs to or from a farm are exempt from the regulation regardless of who initiates the shipment. We are not requesting any modifications with respect to the shipment of RACs in any point of the supply chain other than from or to a farm. D. Cross-Border Shipments There is considerable confusion in the industry regarding the scope of the proposed rule internationally. As we interpret the proposal, an international individual or entity is considered the shipper for purposes of the regulation if they initiate the shipment of a container from another country that will continue moving in U.S. commerce by motor or rail transport after the time of entry. That is, FDA is not directly regulating the air/sea segment of the transportation but simply is designating responsibility for the shipper responsibilities to the person overseas that initiates the shipment that will be moving in the U.S. The carrier would be the person transporting the food by motor or rail once the shipment arrives in the U.S. We request that FDA confirm our understanding in the preamble to the final rule. Given the many complex situations involving international imports, and considerable potential for confusion by foreign individuals or entities subject to the regulation, we believe that guidance would be particularly helpful on this issue. For example: If a bulk container goes 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 initiated the cross-border shipment in the U.S.? We believe that the original entity that initiated the shipment and arranged for the cross-border shipment should bear responsibility. Who would be responsible as the carrier for a closed container that is shipped into the U.S. by boat and then transferred, unopened, at the U.S. port of entry onto a truck? We believe that only the trucking operation in the U.S. should be responsible as the carrier because the regulation does not apply to water transportation. If a refrigerated container is shipped from China to the U.S. via sea and then is transferred, unopened, at the U.S. port of entry onto a truck, and upon receipt at the U.S. receiver s warehouse evidence of temperature abuse is found, who would be held responsible? Under the regulation, only the trucking operation must provide temperature information, but the boat operator would not have any such responsibility. The trucking operation should not be responsible for any temperature deviations that occurred while the container was in the boat operator s possession. The trucking operation should only be responsible from the time that the container was transferred to the truck operator until the time of delivery to the receiver. Page 14 of 38

15 There are many other complex situations like that guidance would be helpful to address. This guidance should be consistent with other international-oriented guidance, such as that on foreign supplier verification. IV. FDA Should Finalize the Proposed Waivers and Issue Other Necessary Waivers. GMA urges FDA to finalize the waivers for Grade A milk and food establishments as proposed. Additionally, we request that the Agency exempt foods regulated by the U.S. Department of Agriculture s Food Safety and Inspection Service (FSIS) from coverage by this regulation through issuance of a waiver. A. Proposed Waivers FDA proposes establishing two waivers from the regulation, involving (1) transportation of Grade A milk and milk products under the National Conference on Interstate Milk Shipments (NCIMS) Grade A Milk Safety Program and (2) appropriately permitted food establishments, as defined in the Food Code, when food is relinquished to consumers after transportation. We encourage FDA to finalize both of these waivers because the safe transportation of these products already is adequately regulated by the state authorities involved. We support comments filed to this docket regarding this issue from the International Dairy Foods Association (IDFA) and the Food Marketing Institute (FMI). In particular, regarding the milk waiver, FDA should revise the proposal so that it covers outbound finished product shipments. In addition, shipping Grade A milk alongside non-grade A products (e.g., orange juice) on the same vehicle should not affect the applicability of the waiver. Regarding the food code waiver, FDA should consider the applicability of the regulation to home grocery delivery services that originate from locations other than food establishments, such as distribution centers and warehouses. B. FSIS-Regulated Products We encourage FDA to reconsider its decision to include products produced under FSIS jurisdiction under the scope of this regulation (i.e., meat, poultry, and egg products), simply because they fall within the definition of food. In particular, we disagree with FDA s conclusion that FSIS guidance on the safe transportation of foods is not adequate to ensure their safety. 9 FDA s regulation is duplicative and unnecessary given that FSIS has jurisdiction over the transportation of these foods. 10 The adequacy of FSIS s existing guidance for public health protection has been proven by the absence of any food safety problems in this area in recent years. Further, FSIS has determined that its existing approach is adequate to ensure foods under its jurisdiction are transported safely. FDA should defer to this determination. If FSIS considered there to be a problem in this area, it could issue its own regulations that would be tailored to the products under its jurisdiction. However, FSIS has not done so and there is no need for duplicative FDA effort in that area Fed. Reg at 7013 (stating that FSIS does not have requirements that directly address the transportation of USDAregulated products). 10 FSIS has stated: Under provisions of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), FSIS has authority to regulate the production, sale, transportation, and storage of meat and poultry products. 64 Fed. Reg 3678 (Jan. 25, 1999) (emphasis added). Page 15 of 38

16 Accordingly, FDA should issue a waiver for products regulated by FSIS. Such a waiver will not result in the transportation of food under conditions that would be unsafe for human health and would not be contrary to the public interest because FSIS already has guidance and jurisdiction in this area. Alternatively, we encourage FDA to establish a Memorandum of Understanding with FSIS that provides for FSIS to regulate transportation from facilities under its jurisdiction. GMA agrees with comments made by the American Meat Institute (AMI) that this new layer of regulation is unnecessary for the meat and poultry industry for several reasons. First, federally inspected meat and poultry establishments are already subject to regulations developed and administered by FSIS. FSIS regulations, 9 CFR Part 325 and 9 CFR Part 381, Subpart S, address many transportation issues unique to meat and poultry products. In addition, FSIS has a regulation that is directly on point for purposes of the STF proposal. Furthermore, the FSIS Hazard Analysis and Critical Control Point (HACCP) regulations impose a duty on federally inspected establishments to conduct a hazard analysis and that hazard analysis:... shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls (emphasis added). 11 Through this provision, FSIS already requires inspected establishments to consider and address the hazards that could present themselves even after the inspected product leaves the facility including hazards presented during loading, transport, and unloading of the product. 12 V. The Regulation Should Allow Flexibility in Allocation of Responsibilities Between Shippers, Carriers, and Receivers by Contractual Agreements FDA s proposal imposes obligations on the shipper, carrier, and receiver. In a simple situation, the shipper is the manufacturer, the carrier is a third-party transportation company, and the receiver is a retailer. However, the shipping supply chain involves many intermediaries that also should be considered when assessing responsibilities under the regulation. That is, there are some entities in the transportation chain that play an important role in transportation operations, and may be considered responsible under the proposal, but do not appear to have been considered by FDA. Our comments highlight a few of these entities and explain why FDA should allow shippers, carriers, and receivers to enter into contracts that allocate responsibilities either between them or to another entity. A. FDA Should Permit Contractual Allocations of Shipper, Carrier, and Receiver Responsibilities FDA should permit flexibility to allow businesses to enter into contractual agreements that allocate the responsibilities for shippers, carriers, and receivers to other parties. The records documenting these agreements should be subject to proposed section regarding recordkeeping CFR 417.2(a)(1). 12 For example, in September 2005 FSIS published the Meat and Poultry Hazards and Controls Guide, which identifies hazards along the production and distribution chain. See page fcff-4809-a f3cd711a9/meat_and_poultry_hazards_controls_guide_ pdf?mod=ajperes Page 16 of 38