**PASTEURIZED EGGS, L.P.**

**The Davidson Group Shell Egg Corporation, General Partner**

**South Down Shores • 1921 Parade Road**

**Laconia, New Hampshire 03246-1517**

# *Telephone: (603) 528-3042 • Facsimile: (603) 524-5235 • e-mail: pelp@worldpath.net*

April 20, 2000

FDA/Dockets Management Branch (HFA-305)

5630 Fishers Lane -- Room 1061

Rockville, MD 20852

Re: FDA Docket No. 00N-0504

Dear Sirs/Madams:

This communication is to provide comments on the above-referenced
matter.

**Introduction:**

Pasteurized Eggs, L.P. d/b/a Davidson's Pasteurized Eggs attended the
Meeting held in Sacramento, California on April 6, 2000 on the above
referenced subject matter, and provided oral comments for the record. At
the Meeting comments were made into the record by L. John Davidson. This
communication will supplement those comments.

Because of the nature of the Company's business, the comments will be
limited to those areas of pertinency to the Company's business and the
impact on the general subject matter of the Meeting.

**Background:** Davidson's Pasteurized Eggs will be introduced to the
retail market prior to May 10, 2000 by four major retail chains located
between New Jersey and Georgia. They are: Giant Eagle, Harris-Teeter,
Giant Foods, and ShopRite Supermarkets. Immediately following that
entrance product will be supplied to Foodservice through SYSCO Food
Systems and other wholesale providers. Commitments from some 4,000
additional supermarkets have been received to not only carry the product
but to feature it as soon as it is available. Multiple units of
pasteurization equipment are currently under construction for June
delivery to satisfy the initial market described. The licensed machinery
manufacturer, Heat and Control, Inc., home based in Hayward, California,
has the capacity to produce enough pasteurization equipment to satisfy a
total shell egg market conversion to pasteurized product in twenty-four
(24) months.

Three (3) production models of the equipment are being offered to egg
producers who will act as licensees of the technology. The purpose of
offering the three models incorporating different production capacities
and varying cost is to provide an opportunity for all but the very
smallest of producers to be able to join in and to provide the public
with the benefits of pasteurization consistent with FDA requirements at
low cost to the public and, at the same time, provide a reasonable
profit center to a distressed industry.

**Machine Features:** The Davidson pasteurization process receives
pre-graded eggs which include a specification to exclude cracked,
sub-standard shells or dirty eggs. The eggs are required to be washed
and sanitized prior to receipt. The pasteurization process includes
their immersion in ultra-clean water heated to a level and held for the
required time to destroy all strains of Salmonella, including Phage
types, commonly found in shell eggs to the FDA requirement of a 5-log
reduction. After pasteurization, eggs are transferred to a chilling bath
to reduce their internal temperature to approximately 45ºF internal yolk
temperature. As in the warm water bath, the chilling bath is maintained
free of bacteria. Upon exit from the chilling bath, the eggs are
recandled to eliminate those that are damaged, provided with a
protective sealant to avoid recontamination, stamped with an emblem to
distinguish them from raw unpasteurized eggs, packaged and refrigerated
at 45ºF. All of the equipment employed is food grade. Monitoring of
water quality is constantly performed with records maintained. Each
batch of eggs is identified and carries with it evidence of exposure to
the time and temperature applied. Permanent records are maintained.

**Public Cost:** General agreement seems to exist that the public cost
of illness and death caused by salmonella found in shell eggs is
unknown. The FDA has reported that the cost of each illness averages
\$1,300. The current frequency of illness is estimated between 300,000
cases per year to over one million. That statistic is limited to the
most common strain, Salmonella enteritidis (Se).

The statistics offered by various government agencies vary
significantly. It is unknown as to whether the resiliency and adaptation
of this particular bacteria will prosper in the changing environment
being provided. That prospect has been evidenced by the introduction of
Phage types which, wherever they occur, increase the frequency of
illnesses four-fold.

The average consumer eats approximately 15.5 dozen shell eggs per annum.
Davidson's Pasteurized Eggs are programmed to cost an extra 38¢ per
dozen at retail.

The collective cost of the husbandry programs under consideration i.e.
sterilization of feed, elimination of rodents, elimination of
contaminated flocks, vaccines, sterilization of hen houses, etc., is
unknown.

What is known is that liquid egg product utilizes the worst of all shell
eggs as its dominant source of supply. Those eggs include eggs derived
from flocks which are salmonella contaminated, flocks infected by avian
influenza, old eggs, damaged eggs and the like. Since mandating
pasteurization at an effective 4.2-log reduction requirement, according
to the CDC, no trace back of an outbreak has been attributed to a liquid
egg source.

Davidson's Pasteurized Eggs employ a 5-log reduction for the most heat
resistant strain of all salmonella species commonly found in shell eggs.

**Comments:**

1\. If the public and the foodservice industry are provided with full
information concerning the threat of salmonella by the government and
are provided with product reasonably priced, the public and the
foodservice industry, on its own will make up its mind as to what safety
is worth. Under those conditions, public mandating will occur on its own
without government involvement.

Recommendations:

A.  When reporting on salmonella illnesses involving shell eggs, the
    government should not use "outbreaks" as the category. The number of
    outbreaks is small. The recitation of percentile change is
    misleading. Illustration: All statistics indicate that a minimum of
    300 illnesses occur daily. Some statistics indicate 3,000 per day. A
    published statement by egg producers or by the government indicating
    that outbreaks have been reduced by some 40% does not reflect the
    scope of the residual problem to the average consumer.

B.  Statistics should include all strains of salmonella and not be
    limited to Se as is presently being done. Although reductions in
    strains of salmonella other than Se has occurred, those strains that
    dominated the industry prior to the discovery of Se in 1985 have not
    been eliminated. Their elimination furthers the misconception
    provided to the public.

C.  When discussing proper preparation of eggs, terms like "raw" or
    "under-cooked" should not be used because they too are misleading.
    People do not associate a soft-boiled egg, an over-easy egg,
    sunny-side egg or several other methods of preparation as being
    "under-cooked". The language should be simply: "unless hard-cooked
    .....".

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2.  Currently, USDA Grade A and AA eggs are allowed to include up to 7%
    cracked and dented egg shells. It is commonly understood that
    damaged egg shells are a higher risk source for salmonella
    contamination. That practice should be eliminated.

3.  The Model Food Code has been adopted by 18 States with some 23
    additional States nearing adoption. The Code requires all health
    care facilities to use pasteurized product including pasteurized
    shell eggs. It also requires restaurants serving groups including
    those at high risk to place warning labels on the menus that unless
    the yolks are cooked firmly, an egg may be harmful to one's health.
    Unfortunately, the program does not include requirements that the
    State's enforce the provisions of the Code. A block grant to the
    States for enforcement purposes or some other vehicle to ensure
    enforcement would be a major step forward in eliminating salmonella
    in shell eggs as a public health risk. The merits of this are that
    only a modification to the existing program, providing it with the
    ability to be successful, would create the impetus towards a total
    solution.

4.  The President has recommended that warning labels be placed on raw
    shell egg cartons. A movement against the language for being too
    harsh or too inflammatory has publicly surfaced. Instead of making
    the language innocuous and destroying its intent, it is recommended
    that a phrase, incorporating some other considerations referred to
    earlier be used: "Unless hard cooked, eggs may be harmful to one's
    health". At the least, the public deserves a clear statement that
    cannot be misunderstood. The use of words like "under-cooked",
    "raw", etc., are misleading to the average person. It is our
    government's obligation to be painfully clear on how to avoid the
    risk of illness even if the reference proposed in the President's
    language to "harmful bacteria" is eliminated.

5.  The FDA labeling section has denied Davidson's Pasteurized Eggs the
    ability to use any word in its marketing that is a derivative of the
    word "safe" i.e. Pasteurized for your Safety, Safer, Pasteurization
    provides improved food safety, etc. The written reason offered was
    that the Department felt that the use of such language unfairly
    portrayed raw eggs as being less safe. We find that argument
    outrageous. The diversion of all problematic eggs to pasteurization
    has been government sanctioned for decades. We urgently request a
    review of the FDA's position so that the key issue concerning
    pasteurized product i.e. safety will not be denied to the public by
    its own government.

Respectfully submitted,

L. John Davidson

President

The Davidson Group Shell Egg Corporation

General Partner: Pasteurized Eggs, L.P.

LJD:pb