Docket #: 02N-0276

April 4, 2003

Lesley M. Fraser

Center for Food Safety and Applied Nutrition

Food and Drug Administration

5100 Paint Branch Pkwy.

College Park, MD 20740

Dear Ms. Fraser:

We would like to comment on the proposed "Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002" (FR 2/3/03). 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 addition to the
undersigned.

We understand the government's need to respond to the increased threat
of intentional contamination of the U.S. food supply, as we ourselves
have taken a closer look at how we operate in that light. 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.

# Effectiveness of Regulations

The Food and Drug Administration (FDA) lists several benefits from the
proposed registration of all food facilities that hold, pack, process
and/or manufacture foods. Registration certainly will assist FDA in
deploying, more efficiently, the agency's domestic compliance and
regulatory resources. It will also allow FDA to inform those facilities
that may be potentially affected by a threat. However, we are not
entirely sure what we would do if we were to receive an alert from FDA.

The proposal does not make it apparent how requiring registration will
deter persons who might intentionally contaminate the food supply from
entering the food production chain. Nor are we sure how the registration
requirement will enhance FDA's ability to respond quickly to detections
of intentional or unintentional contamination. In reviewing the
incidents FDA cites for the costs of intentional/unintentional food
contamination, it is not clear how facility registration in any of those
examples would have made a difference in FDA's ability to limit or
prevent the incidents. It seems to us that the record keeping
requirements will allow FDA to more rapidly trace back/forward.

-   We would like to see more specificity in how registering so many
    facilities, let alone keeping track of them, will truly enhance
    FDA's ability to improve food safety.

Furthermore, since several of the steps in the movement of food from
farm to table, such as domestic transport, are not covered by these
regulations, the supply chain is not being fully monitored by FDA. The
most costly unintentional food poisoning outbreak discussed in the
proposed rule (Salmonella in ice cream in 1994) was caused by problems
in the domestic transport system.

# Duplication

In California, since 1986, any person engaged in the manufacturing,
packing, labeling, or holding (warehousing) of processed food in the
State is required to register annually with the California Department of
Health Services (CDHS). Producers, packers, labelers or warehouses that
deal exclusively with agricultural products in the their raw or natural
state, as well as low acid food canneries, bottled water facilities,
cold storage or frozen food locker facilities, and pet food
manufacturing facilities, are exempt from this requirement. There is an
annual fee to register that depends on the size of the operation. Each
registered facility must be inspected by the CDHS annually.

We understand that FDA, in its effort to encompass nearly all food
facilities, is not relying on previously existing registration programs.
However, the duplication with the already existing California
registration program needs to be addressed.

-   We request that efforts to coordinate between the state and federal
    agencies be initiated in order to minimize duplication of efforts.

    -   Who will be responsible for inspections deemed necessary based
        on the proposed facility registration requirement?

    -   Will the States be assigned the responsibility on behalf of
        FDA's objectives?

    -   What role will be accorded the already-existing California
        regulations, where the majority of facilities are already being
        inspected regularly and there is a fee involved?

Clarification of the role of the States in food safety in light of
bioterrorism concerns needs to be undertaken.

# Enforcement

We are concerned about the potential costs of enforcement, which have
not been discussed in the proposal. Is the registration number to be
part of the record keeping requirements? Will domestic produce be held
if a registration number is lacking somewhere in the paperwork? All of
these possibilities entail costs that have not been addressed by the
current cost/benefit analysis.

-   The costs to the industry for the enforcement of the registration
    requirement need to be calculated.

FDA asks for feedback on the idea of revoking or withholding a
registration of a food facility under, as yet, unspecified
circumstances. Given that the law states that the lack of registration
could result in criminal or civil penalties, the loss of registration
effectively means a prohibition of that facility participating in the
U.S. food supply system. Therefore, revocation would be a significant
action and would require the development of a due process procedure.
Such a provision would create a new license for the fresh and processed
fruit and vegetable industries.

-   Revocation/withholding a registration needs substantially more
    thought before being discussed.

# Farm Exemption

FDA is proposing to exempt farms from registration even if they conduct
packing/ holding/processing on their premises, so long as they only
handle food grown on that farm or same ownership, or if they mix feed
from outside sources for exclusive use on that farm. However, most
farmers that pack or process their own production often sell or pay for
the discarded materials, such as sorted-out produce, hulls, etc., to be
used as feed.

-   Is it FDA's intent to include all incidental by-products from
    processing that go to feed as feed production, therefore triggering
    the registration requirement?

-   Would the by-products sold/disposed of as feed need to be listed
    among the items produced by a facility that is registering for other
    reasons?

We also request further clarification of the exemption for farms that
pack, hold or process food if they only process food grown on that farm.

-   Does this exemption extend to growers who pack fruit or vegetables
    grown only on their farm, if the packing includes washing, waxing,
    and/or post-harvest fungicide treatment?

-   Does it extend to growers who hold food grown on their farm that
    must be misted or otherwise treated with water/ice during storage?

In the definition for exempt farms, FDA uses the words "consumed on that
farm or another farm under the same ownership."

-   The definition "ownership" needs to encompass produce packed from
    land that is owned by the farmer as well as from land rented and
    managed by the farmer (or all from rented land).

The current wording would preclude the storage/packing/processing of
food produced by one farmer from land leased by that farmer.

Also, in the proposed Code of Federal Regulations language, FDA defines
a farm as "a facility in one general physical location...." Some farming
operations are spread out over several locations within California,
utilizing the variety of microclimates to provide nearly year round
production. All of these locations are under the same ownership and
management.

-   FDA needs to define "farm" in a way that is more relevant to current
    farming practices.

# Food Definition

The language FDA uses for food packaging as part of the definition of
"food" is very confusing. The language defines the food as "...food and
feed ingredients and additives, including substances that migrate into
food from food packaging and other articles that contact food...."

-   Does this definition include any packaging material that comes into
    immediate contact with the food such as plastic liners, boxes
    holding fresh fruit or vegetables, tin cans, etc.?

We request clarification so that we can determine if packaging suppliers
need to be registered. If that is the FDA's intent, it must be clarified
and also recognized that a substantially larger number of facilities
than currently assumed would be affected by this regulation.

# Schedule

The proposal only allows two months for all domestic and foreign
facilities to register. We believe this to be too short a time period
for all facilities to be given to comply with the regulation. Much of
the affected U.S. industry is not aware yet of the need to register with
FDA, let alone fully understanding the details of the registration
process. A few video broadcasts, while a useful attempt, will not even
begin to reach the majority of countries that export to the U.S.

-   We recommend that the registration requirement not be strictly
    enforced for at least 6 months, including for the prior notification
    at the border.

Not all food facilities, such as warehouses or packinghouses, are
represented by commodity or other organizations.

-   We recommend that the FDA reach out to State agencies and the
    relevant media to ensure that word is put out in all venues relevant
    to the affected industries.

While we understand FDA's desire to strongly encourage use of internet
registration, having the only other option be via the U.S. postal
service is punitive to those facilities that do not readily have access
to the internet.

-   FDA should consider a fax-in registration option as well.

# Foreign Facility Registration/ Prior Notification

There are still many issues to clarify as to who must register as a
foreign facility.

-   Do brokers, warehousers or traders who take possession of goods
    prior to shipment need to register, even though they do not
    transform the food in anyway?

-   How to distinguish between labelers and final processors?

-   Do the refrigerated / freezer spaces on ships qualify as
    "warehouses"?

Given the complexity of understanding exactly who needs to register, as
mentioned above, 2 months is insufficient time.

Furthermore, FDA has not clarified how the registration requirement and
the prior notification regulation will work with Customs' 24-hour prior
notification rule. At a minimum, the U.S. Customs Service and FDA should
work together to ensure that only one entry at one-point in time and
location need to occur for prior notification.

-   FDA must coordinate better with Customs.

Given the extra layers for foreign producers, in terms of needing a U.S.
agent, multiple prior notifications, the greater costs for registering,
this regulation is likely to be perceived as a non-tariff trade barrier.

-   As currently proposed, the regulations impose different standards or
    requirements on domestic and foreign producers, in violation of WTO.

In our experience, if the United States requires some kind of action,
the countries we export to will require a similar action. Therefore, FDA
needs to consider overall trade implications of any regulation they
promulgate.

# Cost assumptions

We believe the FDA's estimates of the cost of the initial registration
are too low, simply because they have not factored in enough time to
understand the regulation. It is a fairly complex regulation that
requires substantial time to digest. For example, simply reading the
proposed Code of Federal Regulations language would not be sufficient to
understand all the nuances of the exemptions. As mentioned above, we do
not believe that all of the costs that will be incurred to ensure
compliance with the registration requirement have been accounted for.

Also, we believe that the FDA underestimates the frequency with which
the registration information needs to be updated. Many processors and
packers pack under a variety of tradenames, partly because of the desire
of retailers to have food labeled under their own brand. However, trade
names applied to product can change more frequently than once per year.
In addition, personnel can change.

-   We believe that FDA's assumption that 20% of the facilities will
    require one change per year is low.

We thank the FDA for the opportunity to comment on the proposed food
facility registration requirements.

Sincerely,

Ed Beckman

California Tomato Commission

Number range CHAPTER1625 E. Shaw Avenue, Suite 122

Fresno, CA 93710

Gene Beach

Almond Hullers & Processor Association

Number range CHAPTER2350 Lecco Way

Merced, Calif. 95340

Patrick Kelly

Grimmway Farms

Number range CHAPTER6900 Mountain View Rd.

Bakersfield, CA 93307

Joel Nelsen

California Citrus Mutual

Number range CHAPTER512 N. Kaweah Ave.

Exeter, CA 93221-1200

Karen Reinecke

California Pistachio Commission

Number range CHAPTER1318 East Shaw Avenue, #420

Fresno, CA 93710

Cherie Watte

California Asparagus Commission

Number range CHAPTER4565 Quail Lakes Drive #A-1

Stockton, CA 95207