#### October 9, 2000

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

##### Re: FDA Docket No. 00N-1460

People for the Ethical Treatment of Animals (PETA) is an international
nonprofit organization with more than 700,000 members dedicated to
ending animal suffering. Please accept the following comments on behalf
of our members regarding the federal register notice (65 FR 51324)
entitled "Salmonella Enteritidis Research Public Meeting."

#### We urge the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) to direct their "scientific research required to make decisions about *Salmonella enteritidis* (*Se*) in egg preventative controls, surveillance, and education based on the Egg Safety Action Plan.," towards developing mechanisms to prohibit the widespread practice of forced molting, which has been scientifically shown to increase the frequency and severity of *Se* in both hens and humans. By not strictly prohibiting this practice, the hazards of *Se* can never be effectively reduced. It is absolutely critical to eliminate vectors of transmission that cause eggs to become infected in the first place. We therefore ask that your agency include a ban on forced molting when the egg safety regulations are finally written and enacted. 

#### Despite the overwhelming evidence that eliminating forced molting would significantly reduce human *Se* infections across the country, the issue continues to be inadequately addressed by various governmental agencies working on egg safety standards. Government scientists have shown that forced molting leads to higher rates of *Salmonella enteritidis (Se)*, causing serious human illness, and sometimes death. For example, the U.S. Department of Agriculture (USDA) recently reported that the number of human *Se* infections would be significantly reduced if forced molting were eliminated.[^1] Even the USDA's Food Safety and Inspection Service (FSIS) advises that "in an effort to reduce human illnesses caused by *Se*, FSIS is encouraging poultry and egg producers to eliminate forced molting practices."[^2] 

Another USDA study concludes that forced molting increases the frequency
and severity of *Se* infections of a flock regardless of an individual
hen's age[^3] and "could conceivably alter the *Se* situation in a flock
from a minor problem involving a small number of birds to one where a
large number of birds \[are\] affected."[^4] Similarly, a study out of
the University of Florida finds that stress caused by a forced molt
significantly compromises the immune system of laying hens, resulting in
higher levels of *Se* infections.[^5] Furthermore, the study concludes
that forced molting is detrimental to the *Se* rate of the entire flock:
"Molted birds shed significantly higher numbers of *Se* during a forced
molt as compared to unmolted birds ... and \[forced molting\] causes an
increase in the transmission of *Se* to uninfected hens housed in
adjacent cages."[^6] These studies are only a sample of the many in
existence pointing toward the dangerous implications forced molting has
on both animal and human health.[^7]

The Food Animal Concerns Trust in the United States also reports that by
using systems that preclude forced molting for layers, *Se* was reduced
by up to by 70%. And the top consumer groups in the U.S. have taken a
strong stance against the practice due to the serious health risks it
creates for consumers, including the Center for Science in the Public
Interest, Consumers Union (publisher of *Consumer Reports*), and Public
Citizen. Even the United Egg Producers Animal Welfare Committee recently
wrote that "we do not believe that feed restriction or withdrawal to
induce a molt should be continued."

These findings have serious implications for the health of our nation.
This is apparent by applying the USDA's conservative estimate that human
salmonella infections from eggs would be reduced by 2.1 percent if
forced molting were eliminated[^8] to the 5900 reported cases of *Se* in
the U.S. in 1998[^9]. According to the Centers for Disease Control and
Prevention, the actual number of cases is at least 38 times greater than
those reported[^10] which means that in 1998, there were at least
224,200 cases of *Se*. Of these, 183,844 of them can be attributed to
contaminated eggs.[^11] [Thus, by eliminating forced molting,
approximately 3860 cases of *Se* poisoning can be avoided in the U.S.
every year]{.underline}.[^12] Furthermore, applying the case fatality
rate provided in a recent article in *Emerging Infectious Diseases* to
the number of reported *Se* cases in 1998, we can see that [eliminating
forced molting would save at least one life every year and could
potentially save up to 46 annually]{.underline}.[^13]

Monetary health-care costs to the nation and its citizens due to forced
molting must also be considered. There have been many studies reporting
the expensive consequences of *Se.*[^14] One such study, published in
*The New England Journal of Medicine,* found that when adjusted for
inflation,[^15] each nonreported case of Salmonella had a mean cost of
\$314, and each reported case a cost of \$1961.[^16] For the former,
costs were in terms of loss of salary or output, and for the latter,
they were in terms of medical care or hospitalization. [As a result, by
eliminating forced molting, the country and its citizens will save, at
the very least, \$1,378,387 each year,]{.underline}[^17] [and with newer
and stronger phages of *Se* developing, the increasing potential for
unreported cases to worsen means that medical costs of more than
\$7,569,460 could be avoided.]{.underline}[^18] If pain, suffering, and
chronic disease costs were also included, these estimates would be
significantly higher.

Perhaps the greatest hardships caused by forced molting, however, are to
the hens themselves. This inhumane practice inflicts intense and
unjustifiable suffering for more than 234 million hens each year by
starving them for up to two weeks, often in complete darkness.[^19]
Hundreds of thousands die, while those who survive shed their feathers,
lose up to 35 percent of their body weight, and grow weak. The stressful
conditions weaken the birds' immune systems so badly to the point that
they become prone to disease, especially *Se* infections. The result is
sick birds and contaminated eggs.

Any one of the nearly 4 million infected eggs produced every year in the
U.S. can cause a dangerous *Se* outbreak.[^20] It is therefore
imperative that the *Se* infection be prevented and addressed in the
hen, at the source of the problem, by explicitly prohibiting the
practice of forced molting. The serious risks to human health and animal
welfare caused by forced molting can no longer be ignored; the
occurrence of fatal *Se* poisonings and severe animal suffering caused
by the practice are all too real. Given the substantial evidence linking
forced molting to *Se*, it would be both irresponsible and inadvisable
for the agency to ignore the effectiveness of a ban on forced molting
and implement future regulations that fail to address this significant
cause of *Se.* Such action by the agency could only be viewed as
arbitrary. [Once again, on behalf of our members, we urge the relevant
agencies to direct their research towards developing methods to
effectively prohibit forced molting and to include a strict prohibition
on the practice in the egg safety regulations once they are released
and, as a result, help reduce animal suffering, human illness, and
taxpayer medical costs.]{.underline}

Thank you for the opportunity to comment.

Sincerely,

Cem Akin

Research Associate

Research & Investigations Department

###### References

[^1]: USDA Farm Animal Well-Being Task Group, "Meeting Summary,"
    Washington, D.C., 21 Jul., 1998.

[^2]: In a letter dated Aug. 21, 1998, from Patricia Stolfa, Acting
    Director, Regulations Development and Analysis

    Division, Office of Policy, Program Development and Evaluation, U.S.
    Food Safety and Inspection Service

[^3]: U.S. Department of Agriculture, Agricultural Research Service,
    Peter S. Holt & Robert E. Porter, Jr., "Effect of

    Induced Molting on the Course of Infection and Transmission of
    *Salmonella enteritidis* in White Leghorn Hens

    of Different Ages," *Poultry Science*, 71 (1992), pp. 1842-1848.

[^4]: *Ibid,* p. 1847.

[^5]: Gary D. Butcher, D.V.M., Ph.D. and Richard Miles, Ph.D.,.
    "Salmonella Control and Molting of Egg-Laying

    Flocks---Are they Compatible?" Fact Sheet VM 92 (University of
    Floida, Jul. 1994).

[^6]: *Ibid,* p. 2.

[^7]: For other studies, please see:

    Gary D. Butcher, D.V.M., Ph.D., and Richard Miles, Ph.D., Institute
    of Food and Agricultural

    Sciences Fact Sheet VM 92, "Salmonella Control and Molting of
    Egg-Laying Flocks -- Are They

    Compatible?" (University of Florida, Jul. 1994).

    J. Durant, D.E. Corrier, J.A. Byrd, L.H. Stanker, and S.C. Ricke,
    "Feed Deprivation Affects Crop Environment

    and Modulates Salmonella Enteritidis Colonization and Invasion of
    Leghorn Hens," *Applied and*

    *Environmental Microbiology,* 65, No. 5, May, 1999, p. 1919-1923.

    P.S. Holt, "Effects of Induced Moulting on Immune Responses of
    Hens," *Br. Poultry Sci*, 33 (1992), pp. 165-

    175\.

    P.S. Holt, "Effect of Induced Molting on B Cell and CT4 and CT8 T
    Cell Numbers in Spleens and Peripheral

    Blood of White Leghorn Hens," *Poultry Sci*, 71 (1992), pp.
    2027-2034.

    P.S. Holt, "Effect of Induced Molting on the Susceptibility of White
    Leghorn Hens to a Salmonella Enteritidis

    Infection," *Avian Dis,* 37 (1993), pp. 412-417.

    P.S. Holt, "Horizontal Transmission of Salmonella Enteritidis in
    Molted and Unmolted Laying Chickens," *Avian*

    *Dis*, 39 (1995), pp. 239-249.

    P.S. Holt, R.J. Buhr, D.L. Cunningham, and R.E. Porter Jr., "Effect
    of Two Different Molting Procedures on a Salmonella Enteritidis
    Infection," *Poultry Sci*, 73 (1994), pp. 1267-1275.

    P.S. Holt, N.P. Macri, and R.E. Porter Jr., "Microbiological
    Analysis of the Early Salmonella Enteritidis

    Infection in Molted and Unmolted Hens," *Avian Dis,* 39 (1995), pp.
    55-63.

    P.S. Holt, N.P. Macri, and R.E. Porter, "The Effects of Induced
    Molting on the Severity of Acute Intestinal

    Infection Caused by Salmonella Enteritidis," Agricultural Research
    Service Report No. 0000070701 (1996).

    P.S. Holt and R.E. Porter, "Effect of Induced Molting on the Course
    of Infection and Transmission of Salmonella

    Enteritidis in White Leghorn Hens of Different Ages," *Poultry
    Science*, 71 (1992), pp. 1842-1848.

    M. Nakamura, N. Nagamine, T. Takahashi, S. Suzuki, M. Kijima, Y.
    Tamura, and S. Sato, "Horizontal

    Transmission of Salmonella Enteritidis and Effect of Stress on
    Shedding in Laying Hens," *Avian Dis*, 38

    (1994), pp. 282-288.

[^8]: USDA Farm Animal Well-Being Task Group, "Meeting Summary,"
    Washington, D.C., 21 Jul., 1998.

[^9]: Centers for Disease Control and Prevention, "1998 Annual
    Salmonella," Table 1.

[^10]: P. Mead, L. Slutsker, V. Dietz, L. McCaig, J. Bresee, C. Shapiro,
    P. Griffin, and R. Tauxe, "Food-Related Illness

    and Death in the United States," *Emerging Infectious Diseases*, 5,
    No. 5 (1999).

[^11]: According to B. Mishu, J. Koehler, L. Lee, D. Rodrigue, F.H.
    Brenner, P. Blake, and R.V. Tauxe, "Outbreaks of

    Salmonella Enteritidis Infections in the United States, 1985-1991,"
    *J Infect Dis*, 169, No. 3, pp. 547-52, 82

    percent of infections were due to shell eggs. Thus, 224,200
    multiplied by .82 yields 183,844. Furthermore,

    reported cases due to contaminated shell eggs numbered 4838 (5900 x
    .82 ) while unreported cases

    numbered 179,006 (218,300 x .82).

[^12]: 2.1 percent of 183,844 is 3860.

[^13]: According to P. Mead, L. Slutsker, V. Dietz, L. McCaig, J.
    Bresee, C. Shapiro, P. Griffin, and R. Tauxe, "Food-

    Related Illness and Death in the United States," *Emerging
    Infectious Diseases*, 5, No. 5 (1999), the case fatality

    rate for nontyphoidal Salmonella is .0078. So, 5900 x .0078 is
    46.02. The 2.1 percent reduction if forced

    molting were eliminated yields .966 lives saved every year (46.02 x
    2.1% = .966).

[^14]: For other studies, please see:

    "Salmonellosis Shown to Cost \$487 and \$535 Per Case," *Can Med
    Assoc J*, 120, No. 4, 17 Feb., 1979, p. 497.

    P.N. Sockett and J.A. Roberts, "The Social and Economic Impact of
    Salmonellosis," *Epidemiol Infect,* 107

    (1991), pp. 335-347.

    J.A. Roberts and P.N. Sockett, "The Socio-Economic Impact of Human
    Salmonella Enteritidis Infection," *Int J*

    *Food Microbiol*, 21, Jan. 1994, pp. 117-29.

    P.N. Sockett, "The Economic Implications of Human Salmonella
    Infection," *J Appl Bacteriol,* 71, No. 4, Oct.

    991, pp. 289-95.

    J.C. Buzby and T. Roberts, "Economic Costs and Trade Impacts of
    Microbial Foodborne Illness," *World Health*

    *Stat Q,* 50, No. 1-2 (1997), pp. 57-66.

[^15]: Original monetary figures adjusted to 1998 dollar values using
    the *Columbia Journalism Review* conversion

    equation.

[^16]: Mitchell Cohen, M.D., Robert Fontaine, M.D., Robert Pollard,
    M.A., Stephen VonAllmen, M.A.,Thomas

    Vernon, M.D., and Eugene Gangarosa M.D., "An Assessment of
    Patient-Related Economic Costs in an Outbreak

    of Salmonellosis," *N Engl J Med*, 299, No. 9, 31 Aug. 1978, pp.
    459-60.

[^17]: Using the 2.1 percent reduction in *Se* cases if forced molting
    were eliminated, we find that there would be 101

    fewer reported cases (2.1% x 4838) and 3759 fewer nonreported cases
    (2.1% x 179,006) due to contaminated

    eggs (see footnote 15). Thus, (101) (\$1961) + (3759) (\$314) =
    \$1,378,387.

[^18]: Again, using the 2.1 pecent reduction in *Se* cases if forced
    molting were eliminated (a reduction of 3860 cases),

    we find that if all cases were to be reported, the figure would be
    (3860) (\$1961) = \$7,569,460.

[^19]: The number of laying hens in the U.S. in 1998, according to
    USDA-NASS Document POU 2-4/99, "Layers

    and Egg Production: 1998 Summary," is 312,058,000 and according to
    Donald Bell, "Moulting Technologies --

    Welfare Issues," University of California, 75 percent of the
    nation's flock is force-molted. Thus, 312,058,000 x

    .75 = 234,043,500.

[^20]: According to GAO report #GAO/RCED-99-184, one in every 20,000
    eggs is infected with *Se.* Thus, of the

    79,717,000,000 eggs produced every year in the U.S. (figure from
    USDA-NASS Document POU 2-4/99,

    "Layers and Egg Production: 1998 Summary"), at least 3,985,850 will
    be infected.