From: Gabriele Ludwig [gludwig@swaconsult.com] Sent: Thursday, July 10, 2003 4:48 PM To: fdadockets@oc.fda.gov Subject: Docket #: 02N-0277 Docket #: 02N-0277 July 10, 2003 Nega Beru Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Pkwy. College Park, MD 20740 Dear Mr. Beru: We would like to comment on the proposed “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (FR 5/9/03). These comments summarize issues raised in discussions with a number of specialty crop producers and processors in California. The discussions included companies and organizations that represent almond, asparagus, carrot, citrus, pistachio, tomato growers/processors. In general, processors of fresh produce are already keeping records in response to increased concerns about food safety. However, the regulations as proposed would expand on what is currently being noted and kept. Also, there are a number of areas where we are requesting clarification of the proposed regulation. Previous Source Information The undersigned typically represent both growers and the first processor such as a packinghouse for asparagus, citrus or tomatoes, dehullers and processors for almonds and pistachios, and processors for baby-cut carrots. It is not clear as the first “non-transporter” in the chain exactly what information needs to be collected and kept on produce received from the field. For example, there is typically no “identifier” that accompanies a truck of freshly harvested produce to a packing house or processor. Most of these facilities are only processing one type of food - carrots or almonds or pistachios, etc., thus the requirement to describe the food does not make sense. • How much information about the growers is required, especially since growers are to be exempt from the regulations? • How much information about the raw produce is required? • As proposed, it is unclear how much information about the transportation of produce from the field to the packing house/processor needs to be collected. Processors may use in-house drivers; contract it to trucking companies, where the company is known but not the individual drivers; may contract with independent truckers; in some cases outside drivers may drive the load to the plant, where the load is detached and then some time later moved by a in-house driver to the unloading location. Generally, speed is a high priority during harvest. Farm Exemption Most processors/packers/dehullers send their waste products (hulls, culls, etc.) to feed. It is not clear whether records need to be kept for such materials. • Do records need to be kept on by-products that go to feed? If yes, what kind of records? • Does a grower & processor that only processes (as in dehulling or packing) produce grown on his/her farm, but sells the debris/hulls/culls to feed need to keep records? Almond hulling has traditionally been considered part of the harvesting process and thus exempt from State of California's food facility registration requirements. Most almond hullers dehull nuts grown from their own and other farms. It seems that FDA considers dehulling to be processing in the proposed regulations. • FDA should clarify whether dehulling nuts is considered "processing" and therefore subject to these regulations. Subsequent Recipient Information Through sales records, bill of lading etc. the buyer of produce is typically known and recorded by processors. However, the produce business runs on an amazing web of company purchasing agents and “brokers”, which buy and resell the produce. While, technically the buyer takes ownership of the product once it leaves the loading dock of the processing plant, in many cases the brokers never actually take possession of the product. Instead, they arrange for the sale and transportation of the product to the end of the supply chain or for export. The regulations need to clarify that a broker, even one that never physically controls the product, is the next “non-transporter” for recordkeeping purposes. In most cases the producer does not know the final destination of product sold to a broker and does not know all the transporters involved. • Clarify that records for the broker suffice to meet the “immediate subsequent non-transporter” definition. Transporter Records It is not clear who is meant by “responsible individual” for records of transporters. Does this mean the actual driver of each truck, train, ship, or plane or does this mean someone who is responsible for managing the movement of the trucks, etc.? As mentioned above, details of exactly who is driving the truck are not typically known. Especially during intense harvest periods, keeping records of drivers would be difficult. More commonly there are some records on the company contracted with to supply trucks or knowledge whether the drivers were from in-house. • The recordkeeping should include a contact for the shipping company that knows the drivers, but not be required to know the name and contact information for each individual driver that delivers or picks up food. On the shipping side, it will be difficult for the suppliers to know exactly all the transporters used between their loading dock and the next non-transporters. This knowledge will reside with whomever arranges for the movement of the goods. It would make more sense to require the non-transporter that makes the transportation arrangements be the record keeper, rather than just the shipping non-transporter. • Require the non-transporter that arranges for transportation to keep the detailed records on all the transporters between two non-transporters. Economic Analysis In general, the costs will be greater than FDA assumes. However, the additional costs will be extremely variable, even to the undersigned, as some currently keep few records, while others already have an extensive record keeping program. Some assumptions need to be revised. • In the almond industry there are about 360 hullers and processors of which all are also growers. With about 6000 almond growers that means 6% of the growers would be mixed facilities. Phase-In We appreciate the differential time frames for requiring compliance by size of company. We believe it would be useful for FDA to educate their officials around the country and their state liaisons, to ensure that outreach to especially the smaller entities is ensured. For example, we highly doubt that a farmer’s market seller or an urban cornerstore owner, who picks up a couple of cartons of produce at a wholesale market is keeping records on the sources of his/her produce. In addition, there are innumerable independent truckers involved in the transport of food. FDA will need to make a special effort to reach out to these smaller, generally unorganized entities in the food supply chain. Commingling In the case of nuts, after arrival at the processing facility the nuts are commingled. They are typically stored in a silo mixed together until further processing. During processing the nuts are sorted by size and quality. For example, to provide a sufficient quantity of the largest size pistachios for an order may take several days of sorting of nuts that were stored after drying in a silo. Or in the case of almonds the broken nuts are used to produce blanched, slivered, sliced nuts or ground almond paste. The pieces are collected during the sorting and then further processed. Thus, while nut processors can keep records on the sources of their nuts as well as to the next “non-transporter”, tracing the output to a source is nearly impossible. In the case of fresh-cut produce, the processors typically know what shipments were processed in a given day or time period, but during processing a certain amount of commingling occurs as product is sorted by size and quality. In some cases, such as fresh tomatoes, the buyers sometimes choose to mix lots from different suppliers. We understand the government’s need to respond to the increased threat of intentional contamination of the U.S. food supply. However, we do hope that any measures finally put in place will provide meaningful improvements in security and take into account the inherent impossibility to control all aspects of food production in the U.S. We note, for example, that the record keeping regulations as currently proposed, would not have made much difference in the cited cases of intentional contamination of a salad bar with Salmonella or of muffins with Shigella. Both incidents occurred after the retailer/restaurant received the shipments. We thank the FDA for the opportunity to comment on the proposed food facility registration requirements. Sincerely, Ed Beckman California Tomato Commission 1625 E. Shaw Avenue, Suite 122 Fresno, CA 93710 Gene Beach Almond Hullers & Processor Association 2350 Lecco Way Merced, Calif. 95340 Patrick Kelly Grimmway Farms 6900 Mountain View Rd. Bakersfield, CA 93307 Joel Nelsen California Citrus Mutual 512 N. Kaweah Ave. Exeter, CA 93221-1200 Robert Klein California Pistachio Commission 1318 East Shaw Avenue, #420 Fresno, CA 93710 Cherie Watte California Asparagus Commission 4565 Quail Lakes Drive #A-1 Stockton, CA 95207