HERE is an excellent review of what has been really going on inside the USDA et al with bse testing, and or the lack of. I wish to thank Berlowitz et al for this. ...TSS
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
625
FOOD SAFETY VS. PROMOTION OF INDUSTRY: CAN THE
USDA PROTECT AMERICANS FROM BOVINE
SPONGIFORM ENCEPHALOPATHY?†
GREGORY L. BERLOWITZ*
When bovine spongiform encephalopathy (BSE), or mad cow
disease, first struck the United States in December 2003, a debate
raged over whether the tragedy that decimated Great Britain’s beef
industry had finally reached U.S. shores, or whether the infected cow
was an anomaly which had somehow broken through a BSE “firewall.”
After major importers halted importation of U.S. beef, the
United States Department of Agriculture (USDA) announced longawaited
new regulations, including increased testing for BSE. Shortly
thereafter, two private producers petitioned the USDA for permission
to test their own cattle for BSE, and were turned down on the authority
of the 1913 Virus, Serum, and Toxin Act (VSTA).
† Author’s Note. At the time this note was written, Japan had refused to open its markets to
U.S. beef, although, as indicated within, Japan appeared to be succumbing to U.S. lobbying efforts.
The American pressure paid off, and on December 11, 2005, Japan reopened its market to American
beef products from cattle 20 months and younger. See Statement, Agric. Sec’y Mike Johanns Regarding
the Opening of the Japanese Market to U.S. Beef, Dec. 11, 2005, http://www.usda.gov/ (follow
“Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then search by date) (last visited
Jan. 20, 2006).
Hong Kong and Singapore followed suit shortly after. See Statement, Agric. Sec’y Mike Johanns
Regarding Resumption of U.S. Beef Trade with Hong Kong, Dec. 29, 2005, http://www.usda.gov/ (follow
“Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then search by date) (last visited
Jan. 20, 2006); News Release, Singapore Reopens Market to U.S. Beef, Jan. 19, 2006,
http://www.usda.gov/ (follow “Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then
search by date) (last visited Jan. 20, 2006). Japan didn’t last long. On January 20, 2006, it reimposed a
complete ban on American cattle after receiving an American shipment containing beef with vertebral
column. See New U.S. Beef Import in Japan, BBC NEWS ONLINE, January 20, 2006,
http://news.bbc.co.uk/go/pr/fr//2/hi/business/4631580.stm. The USDA claimed the vertebral column
wasn’t specified risk material, but conceded it was a violation of the agreement between the United
States and Japan. See Statement, Agric. Sec’y Mike Johanns Regarding U.S. Beef Exports to Japan,
January 20, 2006, http://www.usda.gov/ (follow “Newsroom” hyperlink; then follow “Latest Releases”
hyperlink; then search by date) (last visited Jan. 20, 2006).
To be sure, while the $1.4 billion Japanese market may eventually reopen to American beef, until
the BSE problem is addressed more satisfactorily, similar intractable issues will remain.
* J.D. Candidate, University of Illinois College of Law; B.A., Hampshire College (1993). I
want to thank the Institute for Agriculture and Trade Policy, especially Kristin Dawkins, Steve Suppan,
and Mark Ritchie, and the Farmers Legal Action Group, especially Carl Flink, Jess Anna Speier
and David Moeller, for their inestimable assistance and support at the birth of this project. Additionally,
many thanks to Amy Dickerson, Ashley Burden and Bryan Endres for their helpful insight, critiques,
and fine tuning of this note. Finally, my deepest appreciation goes to Laura for supporting me
not only throughout the writing of this note, but through three years of law school in Champaign, Illinois.
And to Miles APB—thank you for you.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
626 UNIVERSITY OF ILLINOIS LAW REVIEW [Vol. 2006
snip...
In sum, the USDA cannot regulate the BSE test through the VSTA
because the BSE test is not worthless, contaminated, dangerous or harmful.
The BSE test is not a virus, serum, toxin or analogous product, nor a
biological product. Considering the BSE test as intended for use in the
treatment of animals when it is designed for postmortem use is an overexpansion
of the VSTA. It is likewise a stretch to manipulate the BSE
test and force it into the definition of a diagnostic component (especially
since the diagnostic component is necessarily a biological product) simply
to allow VSTA inclusion. Finally, preventing testing for a disease is
manifestly contrary to a statute whose purpose is to prevent disease. The
USDA, by denying Creekstone and Gateway through application of the
VSTA, sought not to regulate the procedures or substance in each individual
element of the test, but the test itself. In its ninety-two years of
existence, the VSTA has never before been used or interpreted to regulate
testing of any kind. Manipulating the VSTA to include the BSE test
in the age of BSE perverts the statute’s purpose.
The USDA is responsible for the safety of American beef. When it
uses the VSTA to prevent BSE testing, it is limiting its ability to impact
food safety. The use of the VSTA implies a false assumption of authority
that undermines the USDA’s status as a regulator and protector of
American health. Implementing a more comprehensive BSE policy will
serve to strengthen the public’s view of the USDA and food safety and
more importantly, lead to actual protection for Americans from BSE.
217. 9 C.F.R. § 101.2 (2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
No. 3] PROTECTING AMERICANS FROM MAD COW DISEASE 655
IV. RESOLUTION
A comprehensive BSE testing strategy would ideally create a topdown
approach, beginning with a philosophy of disease prevention and
expanding outward to envelope all of the factors, issues, and circumstances
to achieve the single goal of BSE prevention. The purpose of
BSE testing would be multifold, and include surveillance and food safety
concerns based on accepted scientific methods. All animals scientifically
capable of testing positive for BSE would be tested. Decisions on
whether to open borders would include a thoroughly reviewed plan to
prohibit the entrance—or exit—of BSE. Ideally, private testing would be
a non-issue as well, as USDA testing would be adequate.
In June 2004, a coalition of consumer safety and public interest organizations
compiled a list of recommendations for a comprehensive
BSE testing strategy incorporating many of these concerns.218 If the
USDA were to incorporate these rules into a comprehensive BSE testing
strategy, not only would food safety in the United States be greatly increased,
but a more consistent application of law and policy would be
applied to the BSE problem, allowing producers and consumers accurately
to assess the BSE costs within a balanced and predictable set of
objectives. The following is a list of recommendations, adapted in part
from the coalition noted above. Each of these recommendations would
encourage foreign markets, especially Japan, to reopen their borders to
American beef, satisfying the goals of the beef industry.
1. Test all slaughtered cattle for BSE at 30 months. It is inexcusable
that more than 98% of the cattle slaughtered annually in
the United States never get tested for BSE. Japan tests every
single cow it slaughters—most EU countries test all slaughtered
cattle over thirty months; Germany tests all slaughtered cattle
at twenty-four months.219 The cost to consumers? Six to ten
cents per pound.220 And the current policy of testing downers
doesn’t work either: 2142 (or 0.025%) of 8.5 million symptomless
thirty-month-old cattle in Europe tested for BSE in 2001
were positive.221
218. The coalition of consumer safety and public interest organizations included the Center for
Food Safety, Consumers Union, The Creutzfeldt-Jakob Disease Foundation, Friends of the Earth,
Government Accountability Project, Institute for Agriculture and Trade Policy—Action, and Public
Citizen. See Bush Administration Mad Cow Disease Prevention Report Card, June 22, 2004, available
at http://www.agobservatory.org/library.cfm?refid=31808.
219. Thomas M. Burton & Martin Fackler, Should U.S. Start to Screen Every Last Cow as in Japan?
‘A Negligible Cost Increase’, WALL ST. J., Jan. 2, 2004, at B1.
220. Id.
221. Id.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
656 UNIVERSITY OF ILLINOIS LAW REVIEW [Vol. 2006
2. Randomly administer BSE tests to slaughtered cattle starting at
20 months.222 Both England and Japan have discovered animals
younger than thirty months with BSE.223 This would align
USDA policy with Japanese BSE-testing policy and hasten the
reopening of the Japanese market.
3. Test cattle randomly on unannounced visits to slaughterhouses,
feedlots, and anywhere else cattle is raised. The USDA calls
their policy random, but in actuality, BSE tests are announced,
and producers are permitted to select the animals to be
tested.224 While this may save time, it also allows an unacceptable
level of discretion to the producers, who have a strong
economic motive not to have BSE in their herd. Random testing
would be far more representative of the incidence of BSE in
the United States.
4. Congress should require the USDA to license the BSE test. The
USDA should then license the test to private companies that
choose to test their own cattle. The USDA should create standards
for testing conditions and requirements, and promulgate
an application process with objective criteria for private producers.
A standard testing regime would enable private producers
such as Creekstone and Gateway to market their beef as
“tested for BSE.”
5. Ensure feed restrictions are enforced. The FDA has the authority
to enforce the feed ban which prevents rendered cattle from
being fed to cattle. But a February 25, 2005, Government Accountability
Office memo notes that the FDA is far behind on
inspecting feed businesses subject to the feed ban, has no uniform
plan to identify feed businesses, has no routine procedure
for testing of cattle feed, does not require a notice about the
ban to be placed on feed, and has repeatedly failed to notify the
USDA when it discovered that cattle may have been fed
banned feed.225 The need to improve these deficiencies to
lessen the possibility of BSE infection cannot be overstated.
222. See Letter from Jean Halloran, Dir., Food Policy Initiatives, and Michael K. Hansen, Senior
Research Assoc., Consumers Union, to Mike Johanns, Sec’y of Agric., USDA (June 20, 2005) (on file
with author), available at http://www.consumersunion.org/pub/foodmad_cow/002417.html.
223. Safer Beef, supra note 9.
224. See Letter from Jean Halloran, Dir. Food Policy Initiatives, and Michael K. Hansen, Senior
Research Assoc., Consumers Union, to Mike Johanns, Sec’y of Agric., USDA (July 25, 2005) (on file
with author).
225. See generally UNITED STATES GOVERNMENT ACCOUNTABILITY OFFICE, REPORT TO
CONGRESSIONAL REQUESTERS, MAD COW DISEASE: FDA’S MANAGEMENT OF THE FEED BAN HAS
IMPROVED, BUT OVERSIGHT WEAKNESSES CONTINUE TO LIMIT PROGRAM EFFECTIVENESS (Feb.
2005), http://www.gao.gov/new.items/d05101.pdf [hereinafter United States Government Accountability
Office].
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
No. 3] PROTECTING AMERICANS FROM MAD COW DISEASE 657
6. Implement a national animal identification and tracking system.
226 Every automobile sold in the United States has a unique
identification number to prevent fraud and insure protection in
the case of a recall. The USDA has acknowledged the need for
a similar system for cattle in the past and held public meetings
to evaluate costs and benefits; as outbreaks of E. coli have
shown,227 the ability to quickly recall infected beef will save
lives. In addition, an identification and tracking system would
not only help to remove tainted meat from store shelves and
storage, but also present an opportunity to fix conditions at the
source which fostered BSE initially.228
7. Give the USDA authority for mandatory recall.229 Most Americans
assume the USDA has the authority to recall infected
meat. In fact, the USDA has never exercised this authority and
regularly withholds information about the sources of infected
meat on the basis that the information is proprietary.230 But the
national animal identification and tracking system will have no
teeth if the USDA cannot exercise the authority to recall meat.
The USDA must confirm with Congress its authority for mandatory
recall.231 This, too, is a food safety measure whose benefits
vastly outweigh its costs.
8. Implement Country of Origin Labeling (COOL). Although required
under the 2002 Farm Bill, COOL remains unenforced
and mired under unnecessary appropriations delays since its
passage.232 Why not give consumers the ability to know the national
origin of their meat and the choice to buy American
products?
9. Increase surveillance for, and implement mandatory reporting
of, Creutzfeldt-Jakob Disease. The objective of BSE testing is
to prevent infected beef from infecting humans, resulting in
CJD, or vCJD, the incurable neurological disease already re-
226. See generally, Michael T. Roberts & Harrison M. Pittman, Legal Issues in Developing a National
Plan for Animal Identification, NAT’L AGRIC. L. CENTER Feb. 2004, http://www.
nationalaglawcenter.org/assets/articles/roberts_animalid.pdf (last visited Oct. 2, 2005).
227. See Sabin Russell, Beef recall process draws criticism; USDA lacks power to inform public,
mandate returns, S.F. CHRON., Jan. 6, 2004, at A15, available at http://www.sfgate.com/cgi-bin/article.
cgi?file=/c/a/2004/01/06/BAGJO443IA1.DTL&type=printable.
228. See Editorial, Round 2 for Mad Cow Disease, N.Y. TIMES, July 1, 2005, at A16.
229. See generally, Michael T. Roberts, Anatomy of the Government’s Role in the Recall of Unsafe
Food Products, NAT’L AGRIC. L. CENTER May 2004, http://www.nationalaglawcenter.org/assets/articles/
roberts_recall.pdf (last visited Oct. 2, 2005).
230. Russell, supra note 227.
231. See Letter from Michael F. Jacobson & Caroline Smith DeWaal, Dir. Food Safety Program,
Center for Science in the Public Interest, to Ann Veneman, Sec’y, USDA (Jan. 7, 2004) (on file with
author), available at http://cspinet.org/new/pdf/uenemanbsesafeguards.pdf.
232. See Jane Kay, The Fish You Buy to Carry a Label This Fall: You’ll Know its Origin and
Whether it’s Wild or Farmed, Feb. 4, 2004, at A1, available at http://www.sfgate.com/cgi-bin/article.cgi?
f=16/a/2004/02/04/MNG744OER81.DTL.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
658 UNIVERSITY OF ILLINOIS LAW REVIEW [Vol. 2006
sponsible for the death of more than 160 people in England.233
Tracking the disease would aid BSE prevention from another
angle; mandatory reporting of the disease would enable scientists
to establish the routes of transmission and translate into
better policy for the prevention of the disease.
Each of these recommendations come with costs attached, as do all
regulations. But because beef is ultimately a consumer product, the costs
of improving its safety can, and should, be shared between the USDA,
producers and consumers. More significant are its benefits; the USDA’s
current BSE prevention policy is based on many sound principles, but
has considerable weaknesses which must be resolved. The USDA’s Office
of Inspector General, in August 2004, released a report detailing
many of these shortcomings.234 The Government Accountability Office’s
February 2005 report on the FDA offers another set of sensible recommendations
to improve the BSE policy.235 An inclusive process in which
these government recommendations, the consumer food safety concerns
addressed in part in the above recommendations, and industry concerns
were incorporated into a comprehensive BSE policy would translate into
a successful open foreign market for American beef, and a safer beef
product for all Americans.
V. CONCLUSION
BSE is a problem far from under control. A political economy that
prevents the USDA from adequately considering legitimate food safety
concerns must be curtailed; a comprehensive BSE prevention policy incorporating
the recommendations of government agencies, consumer
food safety concerns, and industry interests must be implemented. The
consideration of rational, peer-reviewed science-based research is a
strong foundation for the new comprehensive policy, as are public interest
and industry concerns gathered during a public comment period.
Only after these safeguards ensuring a fair balance between public and
private concerns are in place can the USDA stand confidently behind a
sound BSE policy which is wise, forward-thinking, and substantial.
233. See supra note 8.
234. See USDA AUDIT REPORT, ANIMAL AND PLANT HEALTH INSPECTION SERVICE AND FOOD
SAFETY AND INSPECTION SERVICE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) SURVEILLANCE
PROGRAM-PHASE I (Aug. 18, 2004), available at http://www.usda.gov/oig/ webdocs/50601-9-final.pdf.
235. United States Government Accountability Office, supra note 225. ...TSS
SEE FULL TEXT 34 PAGES HERE, worth reading ;
http://vegsource.com/talk/madcow/messages/1000709.html
TSS