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From: Terry S. Singeltary Sr. (wt-d6-170.wt.net)
Subject: R-Calf: Files Third Set of Supplemental Comments with USDA [FULL TEXT]
Date: December 29, 2004 at 8:35 am PST
-------- Original Message --------
Subject: R-Calf: Files Third Set of Supplemental Comments with USDA [FULL TEXT]
Date: Wed, 29 Dec 2004 10:20:58 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
December 27, 2004
The Honorable Ann Veneman
Secretary
United States Department of Agriculture
1400 Independence Ave., SW
Washington, DC 20250
Docket No. 03-080-1
Regulatory Analysis and Development
PPD, APHIS, Station 3C71
4700 River Road, Unit 118
Riverdale, MD 20737-1238
Via E-mail and Overnight Delivery
Re: R-CALF USAs Third Submission of Supplemental Comments for
Docket No. 03-080-1: Bovine Spongiform Encephalopathy; Minimal
Risk Regions and Importation of Commodities
Dear Secretary Veneman and Administrator DeHaven:
R-CALF USA is disappointed to learn through unofficial channels that the
United
States Department of Agricultures Animal and Plant Health Inspection
Service
(USDA-APHIS) has chosen not to consider R-CALF USAs Second Submission
of Supplemental Comments for Docket No. 03-080-1: Bovine Spongiform
Encephalopathy; Minimal Risk Regions and Importation of Commodities (Second
Submission of Supplemental Comments) prior to publishing the agencys final
rule in the Federal Register. Notwithstanding this decision, R-CALF USA
hereby
submits its Third Submission of Supplemental Comments for Docket No. 03-080-
1: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation
of Commodities (Third Submission of Supplemental Comments).
R-CALF USA offered its constructive, Second Submission of Supplemental
Comments in recognition of the evolving BSE-related scientific research that
continually challenges the now outdated assumptions underpinning the
USDAAPHIS
proposed rule issued over one year ago. In the context of BSE research,
which began only around 1986, the agencys refusal to consider the
scientific
developments over the past eight months effectively blocks from the agencys
2
view some of the most important scientific discoveries regarding the
epidemiology of BSE. This
despite the fact that R-CALF USA provided the agency with complete
copies of nine recent
scientific reports within its Second Submission of Supplemental
Comments, which affords the
agency with immediate and ready access to this critical information. The
agencys rejection of
this critical information is a serious oversight that could well imperil
the health and safety of
U.S. and international consumers and the U.S. cattle industry.
R-CALF USA is committed to ensuring the health and safety of U.S. and
international beef
consumers and the welfare of the U.S. cattle industry. Toward this end,
R-CALF USA submits
the following supplemental comments so USDA-APHIS will have the most
recent and relevant
scientific and factual information with which to base its final decision
regarding Docket No. 03-
080-1:
1. A study published in December 2004 shows how prions cross the human
intestinal
epithelial cell barrier, a finding that undercuts several key
assumptions that were
the basis for the USDA-APHIS proposed rule.
An article published December 15, 2004, in the Journal of Neuroscience
adds another piece of
information to the Bovine Spongiform Encephalopathy (BSE) puzzle that
has evaded scientific
explanation since BSE was first discovered in European cattle in the
mid-1980s. This new
research supports the theory that BSE resulted from the transmission of
sheep scrapie to cattle as
BSE and is subsequently transmitted to humans as variant Creutzfeldt
Jakob disease (vCJD).1
But more importantly, the article describes the process by which prions
cross the generally
impermeable and highly selective epithelial barrier of the human
intestinal tract.
Scientists at Case Western Reserve University, a leading research center
for transmissible
spongiform encephalopathies (TSEs) and prions, have identified ferritin,
which is present in
meat, particularly beef, as the likely carrier protein that
co-transports prions across the intestinal
epithelial cell barrier.2 The researchers suggest ferritin may be only
one such carrier protein.3
More research is needed to identify other potential carrier proteins to
prevent a carrier state
across species, either by transport . . . to sites where it may undergo
conformational adaptation
with time . . . ; or in the case of livestock, lie dormant until
ingested by a susceptible host. 4 The
implication is that apparently healthy livestock could be carriers,
which disseminate prions
through a variety of means. This, the researchers found, could pose a
potential threat to the
population.5
The implications of this finding should be carefully considered by
USDA-APHIS before relaxing
regulatory restrictions on importing cattle and beef from countries
known to have BSE present in
their cattle herds. Other research previously submitted by R-CALF USA to
USDA-APHIS, as
1 R. Mishra, S. Basu, Y. Gu, X. Luo, W. Zou, R. Mishra, R. Li, S. Chen,
P. Gambetti, H. Fujioka, N. Singh,
Protease-Resistant Human Pion Protein and Ferritin Are Cotransported
Across Caco-2 Epithelial Cells: Implications
for Species Barrier in Prion Uptake from the Intestine, The Journal of
Neuroscience, 24(50): 11280-11290 (Dec 15,
2004), attached hereto as Attachment A.
2 Id. at 11289.
3 Id. at 11290.
4 Id.
5 Id.
3
well as an article regarding prions in tongue that is attached to these
comments, has shown that
prions accumulate in muscle tissue, i.e. meat.6 USDA must address the
very real possibility that
consumption of meat containing BSE prions will result in a significant
risk of exposure to
humans. Removal of Specified Risk Materials (SRMs) does not address this
problem, as the
meat itself is the source of infectious prions.
The proposed USDA-APHIS rule does not address the potential that other
proteins residing in
cattle could be carriers of BSE, and by extension, the host cattle as
well. The proposed rule does
not provide for any measures that would prevent consumers from being
exposed to BSE prions
from asymptomatic, BSE-infected cattle. Testing all Canadian cattle at
slaughter for BSE would
identify infected animals within the sensitivity of testing technology;
however, given the limits
of current tests, only animals over 20 months of age could be adequately
screened. Somewhat
ironically, if USDA-APHIS adopted a requirement that all Canadian cattle
be tested, older
animals, which could be screened with more confidence, could well pose a
lower risk to
consumers than younger animals that USDA-APHIS proposes to allow to be
imported into the
United States. Therefore, until testing technology allows for detection
of prions in younger
animals, the safest course would be to maintain the current regulations,
which ban the
importation of cattle and beef from countries where BSE exists.
2. Recently published research shows prion infection of the tongue, a
finding that
further undercuts several key assumptions that were the basis for the
USDA-APHIS
proposed rule.
Another piece of the BSE puzzle was revealed in July 2004 when
scientists published research
findings in the Journal of Virology that indicate prion infection of
skeletal muscle cells and the
epithelial layer in the tongue can be established following the spread
of the prion agent from
nerve terminals and/or axons that innervate the tongue. The researchers
stated:
Our data suggest that ingestion of meat products containing
prion-infected tongue
could result in human exposure to the prion agent, while sloughing of
prioninfected
epithelial cells at the mucosal surface of the tongue could be a
mechanism for prion agent shedding and subsequent prion transmission in
animals.7
The researchers acknowledge they have not identified prion infectivity
in bovine tongues, but
they qualify this condition as likely resulting from a lack of
sensitivity in the infectivity
bioassays used in previous investigations, which may not detect low
levels of the prion agent.
The researchers believe their findings have implications for
intraspecies transmission of animal
prion diseases.8
6 See E. Mulcahy, J. Bartz, A. Kincaid, R. Bessen, Prion Infection of
Skeletal Muscle Cells and Papillae in the
Tongue, J. Journal of Virology, Vol. 78 No. 13, 6792 -6798 (July 2004)
attached hereto as Attachment B.
7 Ellyn R. Mulcahy, Jason C. Bartz, Anthony E. Kincaid, Richard A.
Bessen, Prion Infection of Skeletal Muscle
Cells and Papillae in the Tongue, Journal of Virology, Vol. 78, No. 13:
6792-6798 (July 2004), attached hereto as
Attachment B.
8 Id. at 6797.
4
This new research undercuts several key assumptions that were the basis
for the proposed rule.
First, it is apparent that USDA-APHIS' assumption that beef tongue is
unlikely to be infected
even in an animal with BSE, and therefore tongue should be imported
freely, is incorrect.
Second, the agencys assumption that the misformed prions thought to
cause BSE are limited to
parts of cattle designated as SRMs is inaccurate or overly simplistic.
Clearly these prions can
migrate out of nervous system material and into muscle tissue in the
tongue. Third, the
researchers suggest there is a plausible route of migration of BSE from
one live animal to
another, through sloughing of the epithelial layer of the tongue into
saliva.9 This points to a
potential risk that USDA-APHIS has assumed does not exist the risk
that Canadian cattle
infected with BSE could infect U.S. cattle when imported and co-mingled
with the U.S. herd,
regardless of how effective the U.S. and Canadian feed bans are.
3. December 2004 news reports originating in Canada collaborate pre-existing
evidence that demonstrates Canada has not adequately enforced its
meat-and-bone
meal (MBM) feed ban, up to and including 2004.
In mid-December 2004, a Canadian journalist for The Vancouver Sun (The
Sun) reported that the
Canadian government had conducted secret tests that revealed Canadian
cattle feed labeled as
vegetable-only was contaminated by animal parts.10 The tests
reportedly showed that a
majority of Canadian feed labeled as containing vegetable matter only in
fact contained animal
parts as well. The article identified the source of the test results as
. . . internal Canadian Food
Inspection Agency documents obtained by The Sun through the Access to
Information Act. . .
11 The article named Sergio Tolusso, feed program coordinator for the
Canadian Food
Inspection Agency (CFIA) as the author of a government memo who
described the test results as
worrisome, 12 and who reportedly said . . . the agency [CFIA] doesnt
have a clear idea of how
much cattle remains have been fed to other cattle. 13 The findings of
the study reported by The
Sun include, Of the 28 domestic feed samples tested by the agency, 20
had undeclared animal
protein in them 71 percent of all the samples. 14
Alarmingly, the article suggests that United States authorities knew at
least as early as the
summer of 2003 that Canada was negligent in its MBM feed ban
enforcement. The article stated
that in the summer of 2003, U.S. authorities turned-back seven separate
shipments of vegetable
feed from Canada because they were contaminated with animal parts. 15 If
this allegation is
correct, then many decision-makers in the United States, including
USDA-APHIS officials
who believed that Canada has been in full compliance and should be
designated a minimal risk
9 Ellyn R. Mulcahy, Jason C. Bartz, Anthony E. Kincaid, Richard A.
Bessen, Prion Infection of Skeletal Muscle
Cells and Papillae in the Tongue, Journal of Virology, Vol. 78, No. 13:
6792-6798 (July 2004), at 6797, attached
hereto as Attachment B.
10 Chad Skelton, Secret Tests Reveal Cattle Feed Contaminated by Animal
Parts Mad Cow Fears Spark Review of
Vegetable-only livestock feeds, The Vancouver Sun, December 16, 2004,
available at:
http://www.canada.com/vancouver/vancouversun/news/story.html?id=892f5a65-1b99-4b84-8359-6629bbd1f419,
attached hereto as Attachment C.
11 Id.
12 Id.
13 Id.
14 Id.
15 Id.
5
region, as well as members of the consuming public, may have been
seriously misled. Not only
was USDA-APHIS silent regarding any known violations by Canada of the
Canadian MBM feed
ban in its October 2003 risk analysis concerning the risk of importing
ruminant and ruminant
products from Canada into the United States, but USDA-APHIS made
repeated claims within its
risk analysis that no known violations had occurred:16 USDA-APHIS stated
in its October 2003
risk analysis:
(c) The region [Canada] has a ban on the feeding of ruminant protein to
ruminants
that appears to be an effective barrier to the dissemination of the BSE
infectious
agent in place, and compliance with the ban appears to be good.17
(c) The region [Canada] has implemented a ban on the feeding of ruminant
protein to ruminants that appears to be an effective barrier to the
dissemination of
the BSE infectious agent. There is no evidence of significant
non-compliance with
the feed ban.18
Canadian government authorities inspect rendering facilities, feed
manufacturers
and feed retailers to ensure compliance with the feed ban (CFIA 2003a).
Rendering facilities are regulated under an annual permit system, and
compliance
with the regulations is verified through at least one inspection each
year. Feed
manufacturers or mills, feed retailers, and farms have been inspected on
a routine
basis. These inspections have revealed that the level of compliance is
good, and
there is no evidence of significant noncompliance with the feed ban (CFIA
2003a).19
As noted previously, Canada has maintained an effective
mammalian-to-ruminant
feed ban, with requirements similar to the feed ban in place in the
United States
(DHHS), since 1997. Since compliance with the feed ban appears to have been
good (CFIA 2003a), it is unlikely that the animal recently confirmed
with BSE
ingested contaminated feed during the period covered by the ban. This
suggests
that the ban has been effective. All of these actions will further
reduce the already
minimal risk of the spread of BSE.20
The Sun article links the United States discovery of the summer 2003
Canadian feed ban
violation to the secret, nationwide testing program Canada initiated
for both domestic and
imported animal feed in 2004.21
16 Risk Analysis: BSE Risk from Inportation of Designated Ruminants and
Ruminant Products from Canada into
the United States, United States Department of Agriculture Animal and
Plant Health Inspection Service Veterinary
Services, October 2003, attached hereto as Attachment D.
17 Id. at 11.
18 Id. at 13.
19 Id.
20 Id. at 15
21 Chad Skelton, Secret Tests Reveal Cattle Feed Contaminated by Animal
Parts Mad Cow Fears Spark Review of
Vegetable-only livestock feeds, The Vancouver Sun, December 16, 2004,
available at:
http://www.canada.com/vancouver/vancouversun/news/story.html?id=892f5a65-1b99-4b84-8359-6629bbd1f419,
attached hereto as Attachment C.
6
The Sun article further reveals the results of the CFIAs investigation
of Canadas commercial
feed meals. It indicates that Canada has approximately 550 commercial
feed mills, and several
hundred of those mills were inspected with the following results:
However, the report notes that seven mills had major non-compliance issues
involving things like proper labeling and record-keeping.22
And three mills were failing to prevent the contamination of ruminant
feeds with
non-ruminant feeds containing ruminant meat and bone meal the exact
type of
contamination that can spread BSE.23
Two of those three mills successfully recalled their contaminated
product, but the
report notes that in one case, some of the feed was sent out and consumed by
cattle.24
USDA-APHIS fully understands why Canadas compliance with its feed ban
is critically
important in protecting against the spread of BSE: The primary source
of BSE infection is
commercial feed contaminated with the infectious agent,25 USDA-APHIS
stated in its October
2003 risk analysis. And, USDA-APHIS acknowledged the results of the
Harvard Center for Risk
Analysis when it referenced the Harvard studys conclusion:
The study concluded that the most effective U.S. measure preventing BSE
spread
is the feed ban instituted by the Food and Drug Administration (FDA) in 1997
(DHHS) to prevent recycling of potentially infectious cattle tissues.26
This information indicates that a key assumption of USDA-APHIS
assessment of the risks of
resuming trade in Canadian cattle and beefthat Canadas food ban will
prevent isolated cases
of BSE in the Canadian herd from being spread to other Canadian
cattleis not supported by the
facts. Obviously, the agency will want to consider this critical
information because, again, it
indicates the agencys assumptions formulated over a year ago no longer
may be valid.
Given the tremendous importance associated with Canadas compliance with
its MBM feed ban
to the question of whether USDA-APHIS can allow the importation of
Canadian cattle and beef
into the United States from Canada without endangering the U.S. cattle
industry, the validity of
the aforementioned claims raised by The Sun must definitively be
determined before USDAAPHIS
proceeds with its rulemaking proposal.
22 Chad Skelton, Secret Tests Reveal Cattle Feed Contaminated by Animal
Parts Mad Cow Fears Spark Review of
Vegetable-only livestock feeds, The Vancouver Sun, December 16, 2004,
available at:
http://www.canada.com/vancouver/vancouversun/news/story.html?id=892f5a65-1b99-4b84-8359-6629bbd1f419,
attached hereto as Attachment C.
23 Id.
24 Id.
25 Risk Analysis: BSE Risk from Inportation of Designated Ruminants and
Ruminant Products from Canada into
the United States, United States Department of Agriculture Animal and
Plant Health Inspection Service Veterinary
Services, October 2003, at 16, attached hereto as Attachment D.
26 Id. at 32.
7
4. In December 2004, The National Joint Council of Food Inspection
Locals lodged a
complaint against USDA alleging failure to implement adequate controls and
delegate the critical authorization necessary to properly enforce BSE
risk mitigation
measures and export requirements failures that could compromise U.S. and
international consumer confidence in U.S. beef, thereby harming the U.S.
cattle
industry.
In R-CALF USAs first submission of comments regarding the instant
USDA-APHIS rule,
Docket No. 03-080-1, dated January 5, 2004, R-CALF USA provided evidence
that USDAAPHIS
existing rules are not sufficiently robust to protect the U.S. cattle
industry and United
States consumers from the introduction of BSE.27 R-CALF USA further
provided evidence in
those comments that USDA-APHIS has not adequately enforced its existing
BSE regulations,
thereby subjecting the United States cattle industry and United States
consumers to unnecessary
risk.28 In R-CALF USAs Second Submission of Supplemental Comments on
this USDAAPHIS
rule dated December 9, 2004, R-CALF USA provided evidence showing that
Canada has
already demonstrated it cannot adequately ensure that products exported
to the United States are
compliant with U.S. BSE-related regulations.29 At the very least, the
foregoing submissions
provide evidence demonstrating that the USDA-APHIS rule fails to
consider known compliance
complications with both its current BSE regulations and its proposed
regulations.
We presume USDA-APHIS is also aware of the letter this month from the
chairman of the
National Joint Council of Food Inspection Locals (NJC), the union which
represents federal
government meat inspectors. The NJC letter detailed reports by
inspectors that they have limited
ability to enforce current BSE-related regulations and that they have
observed many instances
where export requirements of Mexico were not being met for products
originating from cattle
over 30 months of age. The letter included the following complaints:
1. plant employees are not correctly identifying and marking all heads
and carcasses
of animals over 30 months old. Therefore, plant employees and government
personnel further down the line are unaware that numerous parts should be
removed as SRMs and these high risk materials are entering the food supply.
2. on line Inspectors are not authorized to take actions when they see plant
employees sending products that do not meet export requirements past the
point
on the line where they can be identified and removed.30
Additionally, the NJC argues that USDAs Food Safety Inspection Service
(FSIS) has not
established any qualifications or training requirements for plant
employees charged with meeting
27 R-CALF USA comments in Docket No. 03-080-1: Bovine Spongiform
Encephalopathy; Minimal Risk Regions
and Importation of Commodities, January 5, 2004, at 10-11.
28 Id. at 11-13.
29 R-CALF USAs Second Submission of Supplemental Comments for Docket
No. 03-080-1: Bovine Spongiform
Encephalopathy; Minimal Risk Regions and Importation of Commodities,
December 9, 2004, at 15-16.
30 Charles S. Painter, Chairman, National Joint Council of Food
Inspection Locals, American Federation of
Government Employees, Letter to Mr. William Smith, Assistant
Administrator for Field Operations, USDA-Food
Safety Inspection Service, December 8, 2004, attached hereto as
Attachment E.
8
certain BSE risk mitigation requirements and that frontline inspectors
have been told . . . not to
intervene when they see that the export requirements of Mexico are not
being met. 31
Taken together, the previous and immediate evidence described above that
demonstrates USDAAPHIS
and USDA-FSIS have not or are not properly discharging their obligations
under current
BSE regulations and are intentionally avoiding opportunities to mitigate
the risk of BSE
transmission and exposure strongly suggests that APHIS, FSIS and other
inspection agencies
cannot be expected to properly implement the more complicated and risky
provisions contained
in the agencys proposed rule. For this reason alone, USDA-APHIS should
immediately
withdraw its proposed rule. Moreover, this calls into question the key
APHIS assumption that
regulations requiring SRM removal would be sufficient to ensure that
consumers are not exposed
to BSE infectivity potentially found in Canadian cattle.
Sincerely,
Bill Bullard
CEO
31 Charles S. Painter, Chairman, National Joint Council of Food
Inspection Locals, American Federation of
Government Employees, Letter to Mr. William Smith, Assistant
Administrator for Field Operations, USDA-Food
Safety Inspection Service, December 8, 2004, attached hereto as
Attachment E.
http://www.r-calfusa.com/BSE/12-27-04%20R-CALF%20USA's%20Third%20Submission,%20Final.pdf
Attachment A
http://www.r-calfusa.com/BSE/Attachment%20A,%20Prion%20Transport.pdf Attachment B
http://www.r-calfusa.com/BSE/Attachment%20B,%20Prions%20in%20tounge.pdf Attachment C
http://www.r-calfusa.com/BSE/Attachment%20C,%2012-16-04,%20The%20Vancouver%20Sun,%20animal%20parts%20in%20feed.pdf
Attachment D
http://www.r-calfusa.com/BSE/Attachment%20D,%20APHIS%20Risk%20Analysis,%20October.pdf
Attachment E
http://www.r-calfusa.com/BSE/Attachment%20E,%2012-08-04,%20Joint%20Council%20of%20Food%20Inspection%20Locals.pdf USDA's 5th Status Report
December 9, 2004 (Adobe Acrobat Reader PDF File 42K) PETER D. KEISLER
Assistant Attorney General
WILLIAM MERCER
United States Attorney
VICTORIA FRANCIS
Assistant United States Attorney
JAMES J. GILLIGAN
LISA A. OLSON
U.S. Department of Justice
20 Mass. Ave., N.W., Room 6118
Washington, D.C. 20530
(202) 514-5633
Fax: (202) 616-8460
Email: lisa.olson@usdoj.gov
Counsel for Defendants IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MONTANA
BILLINGS DIVISION RANCHERS CATTLEMEN ACTION LEGAL FUND )
UNITED STOCKGROWERS OF AMERICA, )
)
Plaintiff, ) CV-04-BLG-RFC
)
vs. ) DEFENDANTS' FIFTH
) STATUS REPORT
UNITED STATES DEPARTMENT OF AGRICULTURE, )
ANIMAL AND PLANT HEALTH INSPECTION )
SERVICE, and ANN M. VENEMAN, IN HER )
CAPACITY AS THE SECRETARY OF AGRICULTURE, )
)
Defendants. )
________________________________________________) Defendants are submitting this pursuant to paragraph 3 of the Court?s
May 5, 2004 Order
requiring a status report on the rulemaking proposed on November 4,
2003, 68 Fed. Reg. 62,386,
and reopened for further public input on March 8, 2004, 69 Fed. Reg.
10,633. The draft final
rule has been submitted by the Department of Agriculture to the Office
of Management and
Budget pursuant to Executive Order 12,866 and is currently undergoing
review. The rule under
review is a final rule and provides that the rule will not become
effective until sixty days after 2
publication in the Federal Register. This period coincides with the
sixty day statutory review
period provided for in the Small Business Regulatory Enforcement
Fairness Act of 1996 (5
U.S.C 801-808). Respectfully submitted, PETER D. KEISLER
Assistant Attorney General WILLIAM MERCER
United States Attorney VICTORIA FRANCIS
Assistant United States Attorney ___________________________
JAMES J. GILLIGAN
LISA A. OLSON
U.S. Department of Justice
20 Mass. Ave., N.W., Room 6118
Washington, D.C. 20530
(202) 514-5633
Fax: (202) 616-8460
Email: lisa.olson@usdoj.gov
Dated: Dec. 9, 2004 Counsel for Defendants 3
CERTIFICATE OF SERVICE I certify that on December 9, 2004, a copy of the Defendants' Fifth
Status Report was
served upon plaintiff's counsel by telefax and first-class mail, postage
prepaid, as follows: A. Clifford Edwards
Edwards, Frickle, Anner-Hughes & Cook
1601 Lewis Avenue, Suite 206
P.O. Box 20039
Billings, MT 59104
fax: (406) 256-8159 William Miller
Russell S. Frye
Willie L. Hudgins
Collier Shannon Scott, PLLC
3050 K Street, N.W.
Suite 400
Washington, D.C. 20007
fax: (202) 342-8451 ___________________________
Lisa A. Olson http://www.r-calfusa.com/BSE/12-09-04%20--%20USDA's%20Final%20Status%20Report%20(not%20due%20til%2012-19).pdf TSS ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
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