• If you are having problems logging in please use the Contact Us in the lower right hand corner of the forum page for assistance.

FOOD SAFETY VS. PROMOTION OF INDUSTRY VS BSE BERLOWITZ ET AL

flounder

Well-known member
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
 

flounder

Well-known member
Genesis Bioventures Announces United States Patent Granted For Mad Cow Disease Rapid Test

2006-05-24 09:30 ET - News Release

NEW YORK, May 24 /PRNewswire-FirstCall/ - Genesis Bioventures, Inc. (GBI) today announced that the US Patent and Trademark Office has granted a patent for the Rapid Prion Detection Assay technology developed by Prion Developmental Laboratories (PDL), a portfolio company of GBI.

"This is a very positive development for our portfolio company and for the industry. The speed of this rapid assay provides a strategic testing alternative for beef producers throughout the world that can enable a broader spectrum of food safety testing while containing costs to consumers and processors," said Douglas C. Lane, CEO and President of GBI. "Grant of this patent to PDL, combined with the recent developments in the BSE and Scrapie assays, will accelerate our commercialization efforts to bring these products to market throughout the world."

"We are very pleased that the United States Patent Office granted this patent to us," said Dr. Robert B. Petersen, CEO of PDL. "We improved the BSE and Scrapie Rapid Assay performance and achieved 100% sensitivity and 100% specificity in a recent trial on confirmed positive and negative samples at the Veterinary Laboratory Agency in Weybridge, UK. The data gathered were used in our application submitted to the USDA on April 14, 2006 for product approval."

"Genesis Bioventures is very pleased to have Dr. Petersen and Dr. Rubenstein leading the scientific and product development for PDL. These are two gifted, accomplished and dedicated scientists who are to be recognized for their outstanding scientific and technical accomplishments to bring these assays to the international community," said Mr. Lane. "The 100% sensitivity and 100% specificity accomplishment they recently achieved ranks these tests with the top performing approved assays globally. The speed of producing positive or negative results with the Rapid Assay creates a test performance benefit that other testing products cannot claim."

Further to a Notice of Allowance issued by the US Patent and Trademark Office in January of this year, PDL was granted Patent number 7,045,297 "Rapid Prion Detection Assay" on May 16, 2006. The PDL assays are easy-to-use strip tests that provide accurate results in less than an hour. The assays are intended for use at the slaughterhouse level, feasibly testing every animal before it enters the food chain.

The patent for the Rapid Prion-Detection Assay protects this method of testing for all transmissible spongiform encephalopathies (TSEs) in animals and humans. TSEs are fatal neurological diseases, including Mad Cow disease (BSE), Scrapie in sheep, and Chronic Wasting disease (CWD) in deer and elk.

About Prion Developmental Laboratories

Prion Developmental Laboratories, Inc. (PDL) produces tests for Transmissible Spongiform Encephalopathies (TSE's) such as Bovine Spongiform Encephalopathy (BSE or 'Mad Cow") in cattle, Scrapie in sheep and goats, and Chronic Wasting disease (CWD) in deer. Formed in 2001, PDL has developed a number of rapid tests which are manufactured on-site. PDL received USDA approval for its CWD assay in 2004 and recently submitted applications for its BSE and scrapie assays for USDA approval. Approval of the original CWD Rapid test demonstrated the suitability of this platform for all TSE testing. Genesis Bioventures, Inc. has a significant investment in PDL.

About Genesis Bioventures, Inc.

Genesis Bioventures, Inc. is a biomedical development corporation focusing on the development and marketing of novel diagnostics and therapeutics in oncology and neurodegenerative diseases.

This press release may contain statements that constitute "forward- looking statements" as defined under U.S. federal securities laws. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "establish," "project" and similar expressions identify forward-looking statements, which generally are not historical in nature. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from Genesis' historical experience and its present expectations or projections. These risks include, but are not limited to: actual use of the Rapid Prion Detection assays in slaughterhouses; actual commercialization of assays for transmissible spongiform encephalopathies in animals and humans; GBI's ability to transition its corporate restructuring; to generate revenues and net income; ability to obtain personnel and directors familiar with investment, biotechnology, and pharmaceutical industries; commercialization of products through Prion Developmental Laboratories; our ability to become an industry leader; changes in economic conditions; the competitive environment within the biomedical industry; GBI's ability to capture market share; the effectiveness of GBI's advertising and marketing programs; ability to raise additional capital; ability to achieve earnings goals; regulatory and legal changes; ability to penetrate developing and emerging markets; litigation uncertainties; and other risks discussed in GBI's filings with the SEC, including the Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB, and Current Reports on Form 8-K, which reports are available from the SEC. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise any forward- looking statements to reflect current events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT:
GBI Investor Relations: (604) 542-0820, [email protected],
www.gnsbio.com
Experigen: (310) 443-4100, [email protected], www.experigen.com

Genesis Bioventures Inc.

CONTACT: GBI Investor Relations: (604) 542-0820, [email protected],
www.gnsbio.com; Experigen: (310) 443-4100, [email protected],
www.experigen.com
 

rkaiser

Well-known member
Thanks for that Terry - Hardly a fear mongering word in either article. I can read that kind of stuff, and as you know support testing for reasons that differ just a little :roll: from yours.

USDA is obviously overstepping their bounds when it comes to testing and we all know where the pressure on the USDA comes from don't we.
 
Top