July 30, 2014

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852
Federal Docket: FDA-2013-N-0013

Dear Sir or Madam:

Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the proposed rule Food and Drug Administration (FDA) rule, “Sanitary Transportation of Human and Animal Food.”

PFB is a general farm organization, made up of more than 58,000 members, providing legislative support, information, and services to Pennsylvania's farmers and rural families since 1950. Our organization includes 54 local organizations (county Farm Bureaus) that actively operate in 64 of Pennsylvania’s 67 counties. PFB is the state affiliate of the American Farm Bureau Federation (AFBF), an organization representing more than six million member families throughout the United States. In addition to the comments we are offering today, we want to affirm our support of any comments to be filed by AFBF on this topic, and would request that such comments be treated as part of the comments contained herein.

General Comments
The safe and sanitary transportation of the food they grow is critically important to Pennsylvania’s farmers. PFB members believe that for the most part, as FDA recognizes in the preamble to the proposed sanitary transportation rule, that current transportation safety practices are working well and that large-scale regulatory changes are not needed. This is especially true given that FDA also acknowledges in the preamble that it “lack(s) sufficient data to quantify the potential benefits of the proposed rule” and that it is “unable to estimate the effectiveness of the requirements of the proposed rule to reduce potential adverse health effects in humans or animals.” In that context, PFB wishes to offer the following general comments on the proposed rule:

1. PFB supports the exemptions included in the proposed rule for the transportation of live food animals, shelf stable food that is completely enclosed by a container, compressed food gases, and raw agricultural commodities (RACs) that are performed by a farm. Any transportation requirements that might be contemplated for produce RACs would be better addressed under the proposed produce safety and preventive controls rules.

2. PFB continues to have concerns about the definition of “farm” in the proposed rule, as it has regarding that definition in comments previously submitted on the other proposed Food Safety Management Act (FSMA) rules. The definition continues to use the word "facility" to describe a farm. A farm is not a facility. Facilities have to register with FDA; farms do not. Facilities are subject to certain inspection and regulatory requirements; farms are subject to other requirements. The word "facility" must be removed from the definition of “farm.” FDA did, however, address a significant issue in the definition of “farm” in the proposed sanitary transportation rule, in that it does not limit it to the packing and holding of a farm's own food. This change should replicated throughout the FSMA rules.

3. The proposed rule suggests that wood is not a properly sanitary surface for food transportation, but if food does not come into direct contact with a wooden surface, the opportunity for contamination is limited. Rather than prohibiting the use of wood in transportation operations, FDA should seek to more clearly define when the use of wooden equipment or wooden lined trailers may be a concern for the sanitary transportation of food.

4. Certain food packing facilities may meet the definition of “shipper” under the proposed rule, but at certain times of the shipping season, product may be shipped as less than truckload (LTL) freight. In cases where these types of shipments take place, it is important to take into account that while the first shipper may take every precaution necessary to remain in conformance with the rule, subsequent additions to the trailer by other shippers could compromise the integrity of the load. The maintenance of the appropriate sanitation standards of an LTL load would fall to the carrier (as would prevention of contamination, adulteration, etc.), as the shipper ceases to have control of the shipment once it leaves his dock. This should also be true of full or straight loads, as the shipper does not accompany or control the load after it leaves the dock.

5. The proposed rule would require a shipper or receiver to provide access to an adequate hand-washing facility if the driver is expected to handle the food being transported in order to ensure that the operator’s hands are not a source of contamination to the food. This condition should only apply if the vehicle operator will have physical contact with the food, as a great deal of product is moved by forklift and is palletized, making the requirement superfluous in many cases.

6. PFB notes that not all entities affected by the proposed rule are registered with FDA, and that the rule’s breadth encompasses multiple government agencies (e.g. DOT, USDA, EPA, state and local authorities) and at times crosses international borders. Given this situation, it is not clear how enforcement of the rule will be coordinated. As we have noted in our comments on the other FSMA proposed rules, it is important that any FSMA rules that are ultimately adopted be implemented in a way that is transparent and even-handed. FDA’s inspection and enforcement program must be applied consistently throughout the United States and in a way that improves public health.

7. FDA’s implementation and enforcement of this regulation, as with the preventive controls rules, import rules and intentional adulteration rules, will require the development of guidance and extensive training. Key areas of focus include building capability of inspectors, consistency of inspections, management of findings and appeals, the writing of guidance documents, transparency, and timing of implementation.

8. PFB would request that FDA provide additional clarification of the following items:

a. The definition of what FDA considers to be “appropriate sanitary conditions.” The term “sanitary” is very broad and subjective as to the level of cleanliness that must be attained in order to achieve compliance with the rule.
b. Whether or not a not-ready-to-eat RAC, packed in a vented carton where the edible portion of the product is not exposed, is subject to the rule.
c. Whether or not the use of the term “independent carrier” was intended to imply that the carrier is not under contract.
d. Whether or not fruit transported to a processing facility is covered under the farm exemption.

PFB is committed to improving food safety in a targeted, scientific, and risk-based manner, and its members look forward to continuing our working partnership with FDA to promote food safety.

Grant Gulibon
Director, Regulatory Affairs