**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**