October 10, 2000

FDA/Dockets Management Branch (HFA-305)

Docket No. 00N-1460

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

**Re: Salmonella Enteritidis Research Public Meeting**

**Docket No. 00N-1460**

**65 [Fed.Reg.]{.underline} 51324 (August 23, 2000)**

The Center for Science in the Public Interest (CSPI) appreciates this
opportunity to provide comments on the current status of scientific
research on *Salmonella* enteritidis (SE) in eggs. CSPI is a nonprofit
consumer group that focuses primarily on nutrition and food-safety
issues and has more than 850,000 member-subscribers to its *Nutrition
Action Healthletter*.

The Centers for Disease Control and Prevention first identified SE in
eggs as a public-health threat in 1988.[^1] In 1992, the Government
Accounting Office recommended that the Food and Drug Administration
(FDA) and the U.S. Department of Agriculture (USDA) develop a
comprehensive farm-to-table program to control SE in eggs.[^2] But not
until 1998 did the federal government begin to develop such a plan.

Since 1990, eggs and multi-ingredient dishes containing eggs have been
linked to nearly 200 foodborne illness outbreaks\--mostly from SE.[^3]
Each year, SE-contaminated eggs are estimated to cause more than 660,000
illnesses and 330 deaths.[^4] For this reason, the President's Council
on Food Safety stated that "egg safety is a food safety issue that
warrants immediate federal agency attention" and committed to a 50
percent reduction in egg-associated SE illnesses by 2005.[^5] It is
imperative that the FDA remains fully committed to this goal as it
proceeds with its research agenda on *Salmonella enteritidis* (SE)
contamination in eggs.

**FDA Should Fill Research Gaps on Forced Molting and Deep Litter
Systems.**

In earlier comments, CSPI asked the agency to ban forced molting
practices because of studies demonstrating that the stress of induced
molting results in increased shedding of *Salmonella* and encourages
horizontal transmission of *Salmonella* to other hens in the confinement
environment.[^6] We also have informed the FDA of a draft Food Safety
and Inspection Service report estimating that eliminating molting
practices would reduce SE-related illnesses by 2.1 percent.[^7] We
believe that these studies are sufficient to support an immediate ban on
forced molting practices. However, if the FDA has determined that
additional studies on forced molting are necessary, it should make such
studies one of its top research priorities. In addition, CSPI suggests
that the FDA fund research to compare SE prevalence in layer houses
using deep litter systems against those using cage systems.

**FDA Should Develop On-Farm Controls Based on the PEQAP and NEST EGGS®
Models, While the SE Research Is Ongoing.**

Due to the significant public health threat posed by SE-contaminated
eggs, CSPI has long advocated on-farm monitoring and control programs to
help prevent eggs from being infected with SE in the first place. In
particular CSPI has supported the measures adopted by the Pennsylvania
Egg Quality Assurance Program (PEQAP) and the Food Animal Concerns
Trust's NEST EGGS® Program, which have proven themselves by achieving
significant reductions in SE prevalence. As one FDA official testified
before Congress:

> We have learned a great deal about control of SE during production by
> research activities during the past decade, including programs like
> the Pennsylvania Egg Quality Program. The Pennsylvania program began
> as a pilot in 1992, and demonstrated key risk factors for the
> introduction and persistence of SE in the production environment.[^8]

CSPI strongly urges the FDA to proceed with issuing on-farm SE control
requirements, with the PEQAP and NEST EGGS® programs as templates, even
as the SE studies are being conducted.[^9]

The Government Accounting Office (GAO) also has encouraged the agency to
press on:

> We agree with FDA that the scientific issues involved in designing and
> establishing the effectiveness of control measures for *Salmonella*
> Enteritidis are complex. However, we believe FDA can take immediate
> action to develop a model program that contains controls that are
> based on currently available scientific information and the experience
> of existing state programs. . . . We recognize that USDA and FDA have
> worked together . . . \[h\]owever, we continue to believe that
> progress on developing a comprehensive egg safety strategy has been
> slow.[^10]

Given the known public-health threat of deaths and illnesses from
SE-contaminated eggs, it is time for the FDA to finally offer consumers
the protection they deserve.

Sincerely,

Charlotte Christin

Food Safety Attorney

[^1]: Morris Potter, D.V.M., Director, Food Safety Initiatives, Center
    for Food Safety and Applied Nutrition, Food and Drug Administration,
    Testimony Before the Subcommittee on Oversight of Government,
    Management, Restructuring and the District of Columbia, Committee on
    Governmental Affairs, U.S. Senate, (July 1, 1999) \[hereinafter
    cited as *FDA Testimony*\].

[^2]: Government Accounting Office, *Food Safety and Quality:*
    Salmonella *Control Efforts Show Need for More Coordination*,
    (Washington, DC: Government Accounting Office, April 1992).

[^3]: C. Smith DeWaal et al., *Outbreak Alert! Closing the Gaps in Our
    Federal Food-Safety Net*, (Washington, DC: Center for Science in the
    Public Interest (CSPI), rev'd. Aug. 2000). There were 170 outbreaks
    associated with eggs and egg dishes and another 28 *Salmonella
    enteritidis* (SE) outbreaks associated with multi-ingredient dishes
    that contain raw or often-undercooked eggs. *Id.*

[^4]: U.S. Department of Agriculture, *Salmonella* Risk Assessment Team,
    Salmonella *Enteritidis Risk Assessment*, Final Report (June, 1998),
    p. 1 The U.S. Department of Agriculture calculated the costs
    associated with all SE-related illnesses as \$150 million to \$870
    million annually. *Id.*

[^5]: President's Council on Food Safety, *Egg Safety From Production To
    Consumption: An Action Plan To Eliminate* Salmonella *Enteritidis
    Illness Due to Eggs,* (Washington, DC: President's Council on Food
    Safety, December 10, 1999).

[^6]: U.S. Department of Agriculture, Agricultural Research Service,
    Southeast Poultry Research Laboratory, "Impact of Induced Molting on
    Immunity and *Salmonella enteritidis* infection in Laying Hens," (on
    file). Center for Science in the Public Interest, Comments on the
    Current Thinking Papers on Egg Safety National Standards (Docket
    00N-0504), (Aug. 14, 2000) and Comments on the Egg Safety Action
    Plan (Docket 00N-0504), (April 20, 2000).

[^7]: U.S. Department of Agriculture, Food Safety and Inspection
    Service, Draft Recommendations, (on file).

[^8]: *FDA Testimony.*

[^9]: Indeed, the FDA may have committed to this course of action when
    it told the Government Accounting Office last year: "The first step
    will be to develop prevention controls for egg production. Then as
    the science progresses, FDA will develop criteria for a \[Hazard
    Analysis and Critical Control Point\] HACCP-type program."
    Government Accounting Office, *Food Safety: U.S. Lacks a Consistent
    Farm-to-Table Approach to Egg Safety*, (Washington, DC: Government
    Accounting Office, July 1999), p. 46 (comments from the FDA).

[^10]: *Id.* at 19-20.