August 14, 2000 |
Re: Egg Safety: Current Thinking Papers on the National Standards for
Egg Safety Attn: Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
From: United Poultry Concerns, Inc.
Contact: Karen Davis, PhD President
PO Box 150 Machipongo, VA 23405-0150
Web Site: www.upc-online.org
| Docket No. 00N-0504 |
Comments Re: Docket No. 00N-0504.
On behalf of our 10,000 members
nationwide, we take this opportunity to express our disappointment in
and objection to the approach to reducing Salmonella enteritidis (SE)
summarized in the FDA's "On-Farm Thinking Paper" presented at the
Public Meeting on Eggs, July 31, 2000. This "Thinking Paper" does
not incorporate or even so much as acknowledge the information and
recommendations that have been submitted to the Food and Drug
Administration and the Food Safety and Inspection Service regarding
the cause and effect relationship between animal welfare and
foodborne pathogens in eggs. With citizens' tax dollars the U.S.
Department of Agriculture has generated studies and conclusions that
are omitted from the "Current On-Farm Thinking Paper on the National
Standards for Egg Safety." This omission represents an accommodation
of the egg industry at the expense of public health and animal
welfare. Therefore, United Poultry Concerns requests that prior to
finalization of Egg Safety National Standards, the FDA and FSIS hold
a closed door public interest- animal welfare meeting analogous to
the closed door meetings that these agencies have been holding with
the egg industry. In addition, we renew our request that the Food and
Drug Administration prohibit forced molting. FDA can do this, because
the agency has regulatory authority for shell eggs throughout the
farm-to-table process and "sole federal authority for regulating food
safety on egg farms" (GAO, July 1999, p. 31).
Together, animal welfare organizations and consumer advocacy
organizations have presented extensive oral and written testimony
during the past two years, including a Citizen Petition (Docket No.
98P-0203/CP1), documenting the cause and effect relationship between
the welfare abuse known as forced molting and Salmonella enteritidis
(SE) in eggs We have asked the FDA to prohibit the inhumane stress-
inducing sustenance withholding practice of forced molting, which has
been shown to induce cellular immune dysfunction in force-molted
hens. Forced molting predisposes the hens and their eggs to
Salmonella enteritidis infection. A USDA Risk Assessment predicted
that human SE infections could be "reduced by 2.1 percent if forced
molting were eliminated (USDA Farm Animal Well-Being Task Group
Meeting document, July 21, 1998). This would be approximately 6300
cases per year in the United States (Transcript, April 6, 2000,
Sacramento, CA, p. 19).USDA's Farm Animal Well-Being Task Group has
acknowledged "serious concerns regarding the practice of forced
molting of poultry" with respect to "the humaneness of this practice
as well as the food safety issue" (USDA-APHIS, Letter, August 21,
1998). USDA's Food Safety and Inspection Service wrote: "FSIS
recognizes that public health concerns are raised by highly stressful
forced molting practices. For example, extended starvation and water
deprivation practices lead to increased shedding of Salmonella
enteritidis by laying hens subjected to these practices" (USDA-FSIS,
Letter, August 21, 1998).
Despite these government acknowledgements, the "On-Farm Thinking
Paper" of July 31 mentions forced molting only to the extent of
suggesting that "environmental testing" may be done 25 weeks after
each molting period. This is 5 months and 25 days after the 6-8 week
molting period. This is the time when the laying cycle is concluding
and the flock is either going to be (a) disposed of or (b) restarved
in preparation for the next cycle in which the dwindling survivor
population of force-molted hens will be put back into production.
These are the "older hens" that, together with "heavy rodent
populations," have been linked with forced molting to increased SE
bacterial levels and chicken contamination (GAO, July 1999; Holt,
1993; FDA Docket No. 98P-0203/CP1).
The "On-Farm Thinking Paper" ignores the fact that the USDA, in
collaboration with the Pennsylvania Department of Agriculture,
conducted field studies of 31 flocks over a two- year period, from
May 1, 1992 to May 1, 1994, which showed that "molted flocks produced
SE-positive eggs twice as frequently as non-molted flocks for a
period up to 140 days [4 1/2 months] following molt (Salmonella
Enteritidis Risk Assessment-Shell Eggs and Egg Products, 1998,
We wish to point out that the USDA Food Safety and Inspection Service
publicly acknowledged the link between stress in farmed animals and
human disease. In the February 3, 1995 Federal Register notice of its
proposed HAACP rule, FSIS states: "There are major aspects in the
production phase that can influence incidence, control, and
prevention of potential human pathogens. . . . Management systems
addressing increased animal welfare and better husbandry decrease
levels of stress, and would be expected to decrease the incidence of
pathogens [by reducing] stress-related immune suppression."
USDA immunologist Peter Holt and his colleagues published a series of
Agricultural Research Service studies between 1992 and 1996 in which
they are found that depriving hens of sustenance causes immune
suppression, thereby predisposing the birds to SE invasion,
colonization and migration. As summarized by USDA's Food Safety and
There is epidemiologic evidence which associates [forced] molting
with higher prevalence of SE in flocks. Molted SE-positive flocks
also seem to produce SE- positive eggs more frequently than their
non-molted counterparts. Experimentally, Holt et al. (1996, 1995,
1994, 1993, 1992) have demonstrated that molting is associated with
increased numbers of SE in hens' intestinal tracts, and higher rates
of SE-positive eggs are produced following [the forced] molt.
(Salmonella Enteritidis Risk Assessment-Shell Eggs and Egg Products,
In study after study, what Holt and his colleagues referred to in
1994 (p. 1268) as the "traumatic physiological impact" of total feed
removal resulted in a significant increase in systemic and infectious
diseases. Their studies showed that: Molted birds shed significantly
higher numbers of SE during the feed removal period than the unmolted
group. Histological examination of cecum and colon from molted
infected hens revealed inflammation compared with minimal changes in
the intestines of unmolted infected hens. Molting, in combination
with an SE infection, created an actual disease state in the
alimentary tract of affected hens, whereas, under normal conditions,
little SE-induced morbidity occurred in adult birds. (Holt & Porter,
Holt and his colleagues found that "induced molting has a profound
effect on both intestinal and extraintestinal infection by S.
enteritidis, and these effects occur 24 hr post infection in the
intestine and within 48 hr postinfection in the livers and spleens"
(Holt et al., 1995:55). In a paper published during the same year of
1995, they observed that "The stress of molting thus appears to
result in an increase in intestinal numbers of S. enteritidis and
the transmission to uninfected hens. . . . Stress has also been shown
to cause the reactivation and transmission of infectious
laryngotracheitis virus in hens" (Holt, 1995:248).
Holt summarized the causality between the withholding of food,
immunosuppression, and diseases in hens including, but not confined
to, Salmonella enteritidis in a review paper obtained by United
Poultry Concerns through a Freedom of Information Act request to the
USDA, June 3, 1999.This undated 17-page paper, "Impact of Induced
Molting on Immunity and Salmonella enteritidis infection in Laying
Hens,"cites studies showing that deficient diets diminished
cell-mediated immunity in mammals and birds (p. 3). Likewise, a
concurrency of systemic and infectious disease conditions occurs in
force- molted hens: According to Holt, to cite key points:
- "An altered immune response was also observed in birds
subjected to induced molting through feed withdrawal" (p. 3).
- Total peripheral blood lymphocyte numbers were significantly
decreased in molted birds" (p. 3).
- "Elevated levels of serum corticosterone were detected during
times of stress [in birds and mammals in other studies]. . . . A
similar elevation in this stress hormone was noted in hens subjected
to feed removal . . . which may be responsible for observed effects
on immunity during an induced molt" (pp. 3-4).
- "Protection [of internal organs from pathogens] is mediated
by effector T cells and by a battery of hormone messages called
lymphokines which regulate the intensity of the immune response and
define what effector cells will play a role in the protection.
Breaching this immunity can dramatically alter its ability to protect
the host against infection" (p. 4).
- "The discovery [was] that the immune system in molted hens
was compromised" (p. 4).
- "The potential problems associated with the presence of S.
enteritidis in the flock environment therefore becomes [sic]
exacerbated when birds are exposed to a stress situation such as feed
removal" p. 5).
- "Stress situations can reactivate a previous infection. . . .
and feed withdrawal to induce a molt can also cause the recurrence of
a previous S. enteritidis infection" (p. 5).
- "[R]ecrudescence of infection was observed significantly more
often in molted birds. These birds shed significantly more S.
enteritidis and more readily transmitted the organism to previously
uninfected, but contact-exposed hens" (p. 5).
- "The molted hens also produced more eggs contaminated with
the organism" (p. 5).
Dismissal of the scientific data and public input implies that the
government's purported concern for public health in the case of
eggborne contamination is a pretense. Transcripts of Proceedings of
the Egg Safety Public Meeting in Columbus, Ohio, March 30, 2000, and
the Egg Safety Public Meeting in Sacramento, California, April 6,
2000 reveal the many substantive arguments raised by representatives
from both animal protection and consumer advocacy organizations
concerning the need for the FDA to prohibit forced molting in keeping
with the agency's authority to regulate, including if need be to
prohibit, farming practices that post a significant risk to human
health. FDA representative Robert Brackett referred as a matter of
course to "forced molting and other stress factors that would lead to
enhanced SE in eggs" (Transcript, April 6, 2000, Public Meeting,
Sacramento, CA, p. 73).
FDA and FSIS claim they are soliciting public views on whether the
agencies are implementing the Egg Safety Plan "in a way that will
best achieve its public health goals" (Federal Register, July 11,
2000: 42708). United Poultry Concerns and other public interest
organizations have responded to this solicitation in good faith, with
relevant facts, and the answer is no, you are not. We have presented
to the government its own evidence, which is being ignored in
deference to the egg industry. The "On-Farm Thinking Paper"
distributed at the July 31 Public Meeting is a nonresponsive paper.
An article in the Journal of the American Veterinary Medical
Association (JAVMA) says that Salmonella is a "major public health
problem" in the United States. According to the article, "Eggs are
the predominant source of Salmonella Enteritidis infection in
humans," and many of the egg-associated Salmonella outbreaks in the
United States "were traced back to the farm of origin and have
documentation that infected hens were the source of the outbreak"
(Angulo and Swerdlow, 1998, p.1731). The authors concluded that
"control of Salmonella will require preventing infections in
egg-laying and broiler chickens" (p. 1731).
One way to do this is to eliminate forced molting. As Gary D.
Butcher, DVM, a poultry veterinarian, and Richard Miles, PhD, a
poultry nutritionist at the University of Florida, conclude: "No
matter what specific or combination of factors are involved in
causing increased susceptibility of laying hens to SE infection, the
fact remains that laying hens undergoing a forced molt by feed
removal are under stress and are more likely to become salmonella
shedders as compared to non-molted hens" (Salmonella Control and
Molting of Egg-Laying Flocks Are They Compatible, July 1994).
The bottom line is that Salmonella control and forced molting are not
compatible. Why is this elementary fact being ignored by the agencies
that are claiming to be concerned about, and are charged with
protecting, the public's health from "farm to table"?
Mary Evans of the Centers for Disease Control reported at the March
30, 2000 Egg Safety Public Meeting in Columbus, Ohio, that while in
terms of outbreaks there have been major declines in SE in certain
regions of the United States, "the number of outbreaks have remained
relatively unchanged in the most recent years, like, '97, '98, and
'99," and that "with outbreaks with a known source, we know that the
predominant vehicle remains raw or undercooked eggs" (p. 5). Evans
noted, moreover, that every culture-confirmed case actually
represents 38 cases in the general population (p. 4). This
information corresponds with the acknowledgement in Foodborne
Pathogens: Risks and Consequences, published by the Council for
Agricultural Science and Technology (CAST) in September 1994 that
"[T]he outbreak cases reported to the CDC constitute a small fraction
of the actual numbers" (p. 51). In other words, Salmonella
enteritidis has been and continues to be a significant disease
problem in the United States. To suggest that this infectious disease
can be meaningfully addressed while ignoring the biological condition
and responses of the birds to the treatment they receive and must
cope with is nonsense. To call forced molting a Best Management
Practice is, as a speaker at the Columbus, Ohio Public Meeting said,
absurd (Transcript, March 30, 2000, p. 12).
It is significant that an intestinal microorganism like Salmonella
has evolved a serotype Salmonella enteritidis that thrives in the
ovaries and oviducts of hens where their eggs are formed, thereby
precontaminating the interiors of intact eggs. According to the
Centers for Disease Control, "The specific serotype Salmonella
enteritidis can live in the intestinal tract, but it also can infect
the ovaries and oviducts of egg-laying hens. It is not known why this
is an increasing problem. It is possible that this bacterial strain
has become more invasive, or that hens have less resistance, or that
some change in poultry husbandry permitted this strain to become more
widespread" (CDC Record, June 8, 1990, .p. 2; see also p. 12 of the
Transcript of the April 6 Public Meeting in Sacramento, California).
This is significant because hens' eggs, which are intended to hatch
healthy chicks in nature, have virtually full-proof, many-layered
barriers, from the inside out, against pathogens. In nature, hens'
eggs are formed in a clean protective ovarian environment and they
incorporate that environment as they develop from a bundle of cells
to shelled egg. Modern farming practices have somehow managed to make
the hen's reproductive system a disease-ridden place. To take the
chicken houses themselves, they are so filthy and pathogenic that,
according to Rich Dutton of Michael Foods, to wash a typical house
holding 70,000 plus caged hens, "takes at least two weeks, eight to
ten people, and nearly 24 hours a day washing per day to get it
clean" (Transcript, March 30, 2000 Public Meeting, Columbus, Ohio, p.
19). And as Meryl Sosa of Food Animal Concerns Trust (FACT) said at
the same meeting, "[R]esearch and studies have shown that even after
you've cleaned and disinfected, sometimes SE persists in the house
and you need to clean and disinfect again" (Transcript, March 30,
2000, Columbus, Ohio, p. 18).
As for the ubiquitous rodents in these filthy houses, according to
Ken Klippen of United Egg producers, "One rodent can deposit 100
pellets in the course of one night and each pellet can contain 25,000
different salmonella organisms" (Transcript, March 30, 2000,
Columbus, Ohio, p. 19). Many of these Salmonella-contaminated rodent
pellets are deposited in the food troughs and are therefore
unavoidably consumed by the hens. Charles Beard and Richard Gast
reported this in Egg Industry magazine, citing the work of Drs. Opitz
and Henzler: "At night the mice come out of hiding, eat from the feed
trough and deposit an average of a hundred pellets per mouse in the
feed trough in a 24-hr. period. Those pellets are the first things
that the chickens consume when the lights turn on" (July/August 1992,
p. 35). Amplification of the rodent population in the layer buildings
has been linked to the practice of forced molting, suggesting that
the elimination of forced molting would reduce the pathogen load in
the buildings, complexes, hens, and their eggs. Reporting research by
Michael Opitz at the University of Maine, Holt concluded in a 1993
study of forced molting and SE, "Because induced molting has been
shown to exacerbate concurrent S. enteritidis infection, resulting in
the shedding of large numbers of the organisms, molted hens could
serve as a second amplifier of S. enteritidis infection, spreading
the organism to other molting hens (and to mice) within a layer
operation" (Holt, 1993:416-417).
We find the FDA and FSIS's silence on all this information to be a
breach of public trust. The American public wants not only safe food
but humanely treated animals, or at least not grossly inhumanely
treated animals. As Mary Jo Brooks said at the April 6th Public
Meeting in Sacramento, "I'm here to represent a growing number of
people like myself that are just members of the public who are
increasingly concerned about the quality of [the] food supply, and
also about the growing amount of cruelty in much of the factory
farming industry. . . . The public doesn't want more hormones and
antibiotics and drugs in the food they buy. . . . [T]hey're also very
concerned about cruelty in the industry. So practices such as forced
molting, which seems to be scientifically proven . . . if it were
alleviated [sic], would up front cut down on the amount of Salmonella
and a lot of the other diseases that the birds, and therefore the
eggs, develop"(Transcript, p. 97).
United Poultry Concerns perceives that FDA and FSIS show no
intention, if the "Thinking Papers" are a reflection of agency
intention, of addressing such public concerns except to record them
and use them to reinvent the wheel with more chicken starvation
studies at taxpayers' expense. We urge the agencies not to do this.
We request that prior to finalization of the Egg Safety Plan and Egg
Safety Standards, the FDA and FSIS hold a closed door public interest
meeting with public interest and animal welfare organizations. In
addition, we request that the Food and Drug Administration prohibit
the disease-producing inhumane practice of forced molting. The
cruelty and the contamination are linked. It doesn't take a highly
trained person to see this, but the fact is that highly trained
scientists have documented it and the informed public is requesting
that forced molting be banned. The next step should be government
action. In summarizing the "substantial damage" to both the large and
the small intestine of molted hens compared to unmolted hens,
Nicholas, Porter, and Holt conclude: "These results are important to
the layer industry since they show that a prevalent industry
procedure has a substantial effect on the severity of an SE infection
and these effects are observed early in the disease process. Also,
many organisms infect poultry and if [forced] molting has such rapid
effects on an infection by SE, it is very possible that it could have
similar effects on infection by other poultry disease agents" (July
- Angulo, F.J. and D.L. Swerdlow. Food safety symposium Post Harvest.
JAVMA. Dec. 15, 1998: 1729-1731.
- Beard, C. and R. Gast. Where are we with S.e.? Egg Industry.
July/Aug. 1992: 32, 34-37.
- Butcher, G.D. and R. Miles. July 1994. Salmonella Control And Molting
Of Egg-Laying Flocks Are They Compatible. University of Florida
Cooperative Extension Service Fact Sheet VM 92.
- CAST. Sept. 1994. Foodborne Pathogens. Task Force Report No. 122.
- CDC. June 8, 1990. Questions and Answers About Salmonella enteritidis
and Eggs. Memorandum to the Record: 1-7.
- Federal Register. Vol. 65, No. 133. July 11, 2000. Egg Safety;
Current Thinking Papers on Egg Safety National Standards: Notice of
Availability; Public Meeting: 42707-42709.
- FDA, USDA. Public Meeting on Eggs: "Current Thinking Papers on the
National Standards for Egg Safety." July 31, 2000.
- GAO. Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to
Egg Safety. GAO/RCED-99-184. July 1999.
- Holt, P.S. n.d. Impact of Induced Molting on Immunity and Salmonella
enteritidis infection in Laying Hens. USDA/ARS Southeast Poultry
Research Laboratory. Athens, GA (email firstname.lastname@example.org).
- Holt, P.S. and R.E. Porter. 1992. Effect of induced molting on the
course of infection and transmission of Salmonella enteritidis in
white leghorn hens of different ages. Poultry Science 71:1842-1848.
- Holt, P.S. 1993. Effect of induced molting on the susceptibility of
white leghorn hens to a Salmonella enteritidis infection. Avian
- Holt, P.S. et al. 1994. Effect of Two Different Molting Procedures on
a Salmonella enteritidis infection. Poultry Science 73:1267-1275.
- Holt, P.S. et al. 1995. Microbiological analysis of the earliest
Salmonella enteritidis infection in molted and unmolted hens. Avian
- Holt, P.S. 1995. Horizontal transmission of Salmonella enteritidis in
molted and unmolted laying chickens. Avian Diseases 39:239-249.
- Nicholas, M.P. et al. July 2, 1998.The Effects Of Induced Molting On
The Severity Of Acute Intestinal Infection Caused By Salmonella
- Reed, C.A. USDA-APHIS. Aug. 21, 1998. Letter to Karen Davis, United
- Stolfa, P. USDA-FSIS. Aug. 21, 1998. Letter to Karen Davis, United
Poultry Concerns. Transcript of Proceedings. Egg Safety Public
Meeting. Columbus, Ohio. March 30, 2000. Transcript of Proceedings.
Egg Safety Public Meeting, Sacramento, CA. April 6, 2000. United
Poultry Concerns and the Association of Veterinarians for Animal
Rights. April 14, 1998. Advance Notice of Proposed Rulemaking: Egg
Safety From Farm to Table. Citizen Petition to the Food and Drug
Administration. Docket No. 98P-0203/CP1. USDA Farm Animal Well-Being
Task Group Meeting. Washington, DC. July 21, 1998. USDA-FSIS.
Salmonella Enteritidis Risk Assessment-Shell Eggs and Egg Products.
Final Report. June 12, 1998; Aug. 10, 1998: 40.
End. of Comments Presented by United Poultry Concerns re: Egg Safety;
Current Thinking Papers. FDA Docket No. 00N-0504. (And FSIS Docket
United Poultry Concerns, Inc.
PO Box 150
Machipongo, VA 23405-0150
(Action Alert - UPC Egg Safety Comments to FDA)