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From: TSS ()
Subject: COW SENSE: THE BUSH ADMINISTRATION’S BROKEN RECORD ON MAD COW DISEASE
Date: May 2, 2006 at 6:50 pm PST

1

COW SENSE:

THE BUSH ADMINISTRATION’S BROKEN RECORD ON

MAD COW DISEASE

A WHITE PAPER OF THE

CENTER FOR SCIENCE IN THE PUBLIC INTEREST,

OMB WATCH AND CONSUMER FEDERATION OF AMERICA

The country’s third confirmed case of Bovine Spongiform Encephalopathy, better known

as “Mad Cow Disease,”1 was discovered on March 10, 2006, in a cow located on a farm

in Alabama. When discussing this latest case of mad cow disease with a concerned

public, the U.S. Department of Agriculture’s (USDA) John Clifford announced in the

same breath that the agency intends to scale back testing for the brain-wasting disorder

from 1000 to about 110 daily. The lower testing levels haven't been finalized, “but the

department’s budget proposal calls for 40,000 tests annually,” about one-tenth of the

current testing level.2

Because of the gravity of the potential problem—mad cow disease infected millions of

cattle in Britain and resulted in 160 fatal human illnesses as well3—details about the case

are particularly troubling. The veterinarian who examined the cow estimated that it was

around 10 years old—estimated, that is, because the lack of an animal identification

program of the sort already in place in Europe, Canada, and Japan means that the

government cannot know with certainty the animal’s age. Moreover, there is much more

we do not know: we cannot know with any certainty how many calves it had, or even the

farm where it was born and probably ate the feed containing the agent that causes mad

cow disease. Without this information, it becomes nearly impossible to trace animals that

may have consumed the same infected feed and to ensure that they don’t make it into the

human or animal food supply.

The country’s first confirmed case of mad cow disease was discovered on December 23,

2003. Three years later why is the public still in the dark when it comes to mad cow

disease? Why can’t we trace animals back to the source herd to discover the related cows

that may also present the same risk to the food chain? Why are there still loopholes in the

safety net that weaken our ability to prevent the spread of BSE in the nation’s cattle herd

or even to monitor the incidence of the disease? The answer is a string of broken

promises that trace back to the special influence of special interests in the Bush

administration.

1 “USDA/Alabama BSE Epidemiological Update: News Release.” United States Department of

Agriculture. .

2 Quaid, Libby. “Update 12: Government to Scale Back Mad Cow Testing.” The Associate Press on the

web March 14, 2006. .

3 “Creutzfeld-Jakob Disease in the UK: Press release.” UK Department of Health. March 8, 2005.

.

2

Surveillance and Industry Testing

Enhanced Surveillance

In response to the discovery of the first BSE-infected cow in the U.S. in December of

2003, USDA’s Animal and Plant Health Inspection Service (APHIS) instituted an

intensive animal health testing program for BSE. According to APHIS, the program was

designed as a one-time effort to provide a snapshot of the prevalence of BSE in the

domestic cattle population. The program was designed to test as many cattle from the

high-risk population as possible in a 12- to 18-month period. 4

Since 1994, APHIS has tested over 650,000 samples with two confirmed positives from

cattle that could have been born before the implementation of 1997 feed ban. But because

of a lack of paperwork and an animal identification system, we may never know the exact

age or origin of the cattle in question.

When the recent BSE case in Alabama was announced, USDA also proposed scaling

back the surveillance program to test just 40,000 animals a year. However, Secretary

Johanns has since retreated, saying the agency is not in a hurry to reduce testing.5

Private Firms

In February of 2004, Creekstone Farms Premium Beef LLC, a privately owned producer

and processor, petitioned USDA to allow them to conduct private testing for mad cow

disease. The company wanted to regain entry into the Japanese beef market after Japan

closed its borders to American beef in 2003, citing BSE concerns. Of the roughly $3.9

billion in global sales of American beef in 2003, Japan accounted for $1.4 billion.6

Creekstone Farms was willing to address this concern by complying with Japan’s request

that every carcass exported to Japan be tested for BSE. But USDA refused the license

request. It is USDA’s contention that testing every animal or animals younger than 30

months is not scientifically justified or necessary.

While testing every animal for BSE is not necessary to assure food safety, private firms

like Creekstone should be able to voluntarily test for BSE, especially since they were

willing to do this at its own expense. USDA should not prohibit private companies from

testing their product. The Japanese government and consumers wanted all cattle tested for

mad cow disease and Creekstone was willing to comply with this request. By prohibiting

companies from giving their customers what they want, USDA is not only is restricting

free enterprise but also preventing companies from regaining the full value of their export

market. USDA’s action is in effect a disincentive for companies who are willing to go the

extra mile to address their customers concerns. It’s been over two years since Creekstone

4 Animal and Plant Health Inspection Service.

.

5 The Associated Press. “USDA in no hurry to scale back mad cow tests.” MSNBC.com on the web March

27, 2006. .

6 “Renewed Japan Beef ban prompts U.S. probe” USA Today on the web January 20, 2006.

.

3

petitioned USDA to allow testing for BSE and U.S. companies still have not fully

regained access to Japanese markets.

Bush Administration’s Broken Promises

After the first BSE case was found in the U.S, the Bush administration made a string of

promises to ensure that the United States would not experience the kind of crisis in

consumer confidence that happened in Britain. As the policy decisions moved from the

press secretary’s lectern to the pages of the Federal Register, however, the Bush

administration began to break promise after promise. Two stand out: the failure to

implement a national animal identification and tracking system; and the failure to

produce a strong feed rule to prevent the nation’s cattle herd from consuming materials

that pose the risk of transmitting BSE.

Failure to Follow Through on Animal ID

On December 30, 2003, just seven days after the first mad cow was discovered in the

United States, Secretary Ann Veneman announced that the U.S. would expedite the

adoption of a “verifiable nationwide animal identification system to help enhance the

speed and accuracy of our response to disease outbreaks across many different animal

species.”7 This important announcement was followed by multi-million dollar

investments, including $18.8 million in 2004, and Congressional appropriations of $33

million in both 2005 and 2006.8 USDA, in a 2004 statement of Undersecretary Bill

Hawkes, said that the Animal Health Protection Act gave the agency “authority to

address the animal ID system in a mandatory fashion if we so choose.”

Animal identification programs are already used in many parts of the world, including

Europe, Canada, Japan and New Zealand, to track animals and safeguard animal health.

Such systems are implemented to protect against the spread of animal diseases, some of

which also affect human health. Foot and mouth disease and bovine tuberculosis

outbreaks have historically been kept in check by controlling the movement of livestock.

When it comes to BSE, cattle identification provides critical information that helps to

identify animals from the same farm that years before may have eaten infected feed. (See

Table I.)

USDA began the implementation of the National Animal Identification System (NAIS)

on a voluntary basis in 2004. The long-term goal of the NAIS was to provide animal

health officials with the capability to identify all livestock and premises that have had

direct contact with a disease of concern within 48 hours after discovery.

7 “Veneman Announces Additional Protection Measures To Guard Against BSE: News Release No.

0449.03.” United States Department of Agriculture. December 3, 2003. < http://www.usda.

gov/Newsroom/0449.03.html>.

8 “Veneman Announces Framework and Funding for National Animal Identification System: News Release

No. 0170.04.” United States Department of Agriculture. April 27, 2004. Newsroom/0170.04.html>.

4

While Veneman expressed urgency, in May 2005, Secretary Michael Johanns announced

that full recording of animal movements would be delayed until 2009.9 This extended

timeline reversed the expedited implementation promised by Secretary Veneman.

In a February 2006 meeting of a cattleman’s association called R-CALF, the NAIS

coordinator Neil Hammerschmidt said that the 2009 timeline would not be met, as the

agency had “no one working on rules to implement a mandatory program.”10 In a letter

to the Center for Science in the Public Interest in March 2006, USDA “clarified”

Hammerschmidt’s remarks by saying that “broad support for the NAIS will motivate a

majority of stakeholders to voluntarily participate. . . . Such market incentives could

obviate the need for our Agency to take regulatory action to make participation

mandatory.” Thus, Hammerschmidt was right – USDA had already decided that animal

identification and tracking programs would not be mandatory.

Failure to Follow Through on Cattle Feed Standards

Although cattle are ruminants that by nature eat grasses, the agribusiness practice today is

to fatten them up quickly with grains, animal proteins and other materials not typically in

a ruminant diet. Until 1997, when the practice was banned, feed manufacturers would

feed rendered cattle proteins back to cattle. This practice increased the risk of spreading

mad cow disease, as cattle were exposed to the infectious proteins (or “prions”) when

parts from infected cattle were allowed in cattle feed. This is the likely cause of the large

outbreak of BSE in cattle in Great Britain.

The Bush Administration announced plans to strengthen the feed ban in January 2004,

when the U.S. Food and Drug Administration (FDA) announced it would ban the use of

mammalian blood, poultry litter, and plate waste as feed ingredients for cattle and other

ruminants.11 Feeding plate waste and chicken litter back to cattle can recycle bovine

proteins into cattle feed.

These actions would have strengthened the feed ban and reduced the loopholes where

cattle materials could inadvertently enter cattle feed. A panel of international experts also

supported strengthening the U.S. feed ban, and urged that all animal feed should be free

of high risk cattle parts.12

9 “USDA Unveils Multi-Year Draft Strategic Plan the National Animal Identification System,” News

Release No. 0149.05.” United States Department of Agriculture. May 5, 2005.

10 “USDA abandons plan for mandatory animal ID by 2009.” Food Chemical News February 6, 2006.

47:52.

11 “Expanded "Mad Cow" Safeguards Announced To Strengthen Existing Firewalls Against BSE

Transmission: News Release.” United States Department of Health and Human Services. January 26, 2004.

.

12 International Review Team, Report on Measures Related to Bovine Spongiform Encephalopathy (BSE) in

the United States (Feb. 2, 2004)..

5

Instead of adopting these safeguards, in July 2004, FDA delayed action by announcing

another study of feed ban issues.13 Over a year later, in October 2005, the FDA proposed

minimal new restrictions on the animal feed industry – restrictions that live up to neither

their own promises nor the recommendations of the international experts.14

Special Access for Special Interests

So, why at the same time the third case of BSE was confirmed, did USDA even suggest

reducing its surveillance testing? And how did common sense protections – like the

animal identification system and safer animal feed – get scuttled or weakened beyond

recognition?

The reason? Former industry players are embedded throughout the Bush administration

and often play key roles in the agencies that are supposed to regulate those same

industries. More importantly, any time the USDA or FDA makes a promise to protect the

public, industry can use its own special hotline straight to the White House to promote its

cause.

Going Straight to the Top

Industry interests have aggressively lobbied the White House itself to distort the entire

continuum of mad cow-related policy. Although Congress delegates authority to regulate

food safety issues directly to the agencies, the White House has granted itself authority to

review agency rulemakings with a series of executive orders.15 The White House has

asserted a role in the earliest stages of policymaking by convening agencies to coordinate

regulatory priorities and by reviewing agency rulemaking agendas.16 It demands the right

to review proposed and final significant rules before they can be published in the Federal

Register.17 The White House receives—and, in fact, welcomes—ex parte

communications from industry in the course of its reviews. In accordance with the

executive order,18 the White House maintains a log of those meetings on the website for

the Office of Management and Budget’s (OMB) Office of Information and Regulatory

Affairs (OIRA).19

These White House logs reveal that the feed and rendering industries brought their top

officials into numerous meetings both before and after BSE was found in the U.S. in

order to push back on BSE policy. The logs show six meetings regarding FDA’s

13 “USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy: Press Release.

United States Department of Health and Human Services. July 9, 2004.

14 Substances Prohibited from Use in Animal Food or Feed, 70 Fed. Reg. 58569 (October 6, 2005)..

15 See Exec. Order No. 12,866, 58 Fed. Reg. 51735 (Sept. 30, 1993).

16 See id. § 4.

17 See id. § 6.

18 See id. § 6(b)(4).

19 See Office of Info. & Reg. Affs., OMB, Meetings and Outside Communication. whitehouse.gov/omb/oira/>.

6

consideration of the feed ban and three more regarding USDA policies on specified risk

materials and downer cattle, featuring a Who’s Who of the rendering and related

industries. (See Table II.)

The rendering industry in particular has much at stake, because that sector takes cow

parts — not just those that are left over after material for beef products are removed, but

also any useable parts from cattle excluded from the food chain, including downer cows

— to produce protein feeds, tallow, meat and bone meal, and a wide array of other

products. Many such products are used in animal feeds that can be fed to hogs and

poultry, and thus can be indirectly fed back to cows because of the loophole in the FDA

feed ban rules.

In fact, some of the companies that sent executives to meet with the White House had

direct experience with mad cow disease. For example, Baker Commodities, Inc., which

sent executive vice president Ray Kelly to speak with the White House on both the FDA

feed ban and USDA policy on downer cattle and dead stock, owns two of the rendering

plants that received portions of the 6-year-old Holstein that tested positive as the

country’s first confirmed case of mad cow. Likewise, another company represented in

White House meetings, Valley Proteins, generates products—which president Gerald

Smith cannot “guarantee . . . are free of cattle products”—that are “used to make feed for

East Coast poultry and turkey farmers.”20 The renderers’ industry group National

Renderers Association ensured that its sector was well represented in White House

meetings, but one representative in particular — Don Franco, president of the Animal

Protein Producers Industry and vice president of scientific services for the National

Renderers Association, stands out from the rest because he also has a role in influencing

policy at the USDA directly. Franco was appointed in 2002 to serve a two-year term on

the USDA National Foreign Animal and Poultry Disease Advisory Committee, which is

described approvingly by the rendering industry magazine as providing “valuable

information on methods, techniques, and policies directed at preventing the introduction

of foreign diseases without imposing impractical restrictions.”21

Not surprisingly, with all the industry pressure documented publicly in the meeting logs

(and possibly complemented by yet more meetings not logged because they were held

before any policy was officially under OMB review), the White House ordered changes

in the rules that were ultimately published in the Federal Register.

Foxes in the Henhouse

It is currently unknown whether the National Cattlemen’s Beef Association (NCBA) held

any meetings with the White House, because OIRA logs only meetings about regulations

being reviewed under the executive order and USDA has made it clear that no one in the

agency was attempting to draft a rule on animal identification. Of course, NCBA did not

20 Gay, Lance. “Rendering Scrutinized Because of Mad Cow” Cincinnati (Ky.) Post Oct. 1, 2004, : at A17,

available on Westlaw at 2004 WLNR 1340543.

21 “Franco Named to Committee.” Render Magazine, Feb. 2002.

.

7

need to petition the White House to influence the agency’s priorities, because NCBA’s

interests are already deeply embedded in the USDA itself.

The USDA has a number of former executives from NCBA and other allied industry

concerns at both high levels and important staff positions:

Dale Moore, Chief of Staff at USDA since 2001, was formerly the Director of

Legislative Affairs for the National Cattlemen’s Beef Association from 1997 until his

appointment in 2001. Before that, he worked on the industry dominated House

Agriculture Committee in various positions.

Alisa Harrison served as Press Secretary and Deputy Director of Communications under

both Secretaries Veneman and Johanns. She came over to USDA directly from the

National Cattlemen’s Beef Association, where she was Executive Director of Public

Relations. Who better to handle the publicity following the first U.S. case of mad cow

disease. Clearly USDA was planning their public relations strategy long before their

public health response. Alisa Harrison is no longer at USDA.

Charles Lambert, Under Secretary for Marketing and Regulatory Programs, served 15

years in various positions at the National Cattlemen’s Beef Association in Denver and

Washington. Up to 1979, he also ran a cow-calf operation in West-Central Kansas.

Floyd D. Gaibler, Deputy Under Secretary for Farm & Foreign Ag. Services, was most

recently a consultant at Lesher & Russel, Inc., an agricultural consulting firm whose

clients include Altria, Monsanto, and the Meat Promotion Coalition, a group of

agribusiness companied that includes the National Meat Association, the American

Meat Institute, and the National Cattlemen’s Beef Association.

8

Conclusion

“Cronyism” is more than just a rhetorical bludgeon: it is a very real problem in the Bush

administration, with very serious consequences for the American public. The Bush

administration has a consistent history of putting the cattlemen’s and other special

interests above the public interest, in a “special interest takeover” of government.22 It is a

recurring problem that weakens public protections in all areas, from mine safety to the

environment. As the background of mad cow policy reveals, it is a problem that reaches

even the very food we eat.

Both to improve domestic BSE protections and to increase the Bush Administration’s

chances of getting U.S. beef into global markets, it should reverse course and institute

real reforms on mad cow disease:

• Close the loopholes in the feed ban. FDA needs to further reduce the risk of

BSE from infected animals that are not caught by its limited surveillance program

from being recycled into the cattle feed supply. Eliminating the use of bovine

blood products, chicken litter, and plate waste from animal feed is the first step.

Eliminating the use of high-risk cattle parts in all animal feed would be the most

protective. Without an animal identification and tracking system to find exposed

cattle, the risk that some of these cattle parts are getting into the food and feed

supplies is certainly elevated.

• Implement the mandatory animal ID system. The USDA should implement

the animal tracking system that is already thoroughly planned, has a multi-million

dollar investment of taxpayer funds, and has many key pieces in place. Canada

implemented its mandatory program within a single year. The United States has

been working on the animal ID plan since before 2003. It has the legal authority

but lacks the political will to implement a world class system, like those relied on

in many other countries. With nearly $100 million invested in the program,

USDA should make good on its promises and implement a mandatory system by

January 2007.

• Until USDA has a program in place to identify cattle that were exposed to

infected feed, USDA should (1) test all cattle of any age showing signs of central

nervous system disease; (2) continue a high-intensity testing system of all cattle

30 months or older; and (3) test a random sampling of healthy animals 20 to 30

months old. Companies that want to test their own cattle should not be prohibited

from doing so by the government.

• Cut off the special interest hotline to the White House. When it comes to mad

cow disease, the White House Office of Management and Budget has seen a

22 See generally Center for Amer. Prog. & OMB Watch. “Special Interest Takeover: The Bush

Administration and the Dismantling of Public Safeguards (2004).”

.

9

parade of special interest lobbyists who have had an impact on reducing the level

of protection that the Bush Administration promised, but never delivered.

Centralizing regulatory review in the White House gives industry a one-stop shop:

what they can’t achieve by having industry insiders staffing the agencies, they can

get by sitting down with the Bush administration’s top officials. Congress should

shut down this special access for special interests.

With these simple remedies, the Bush administration and Congress would ensure that the

next time someone claims to be sickened by the culture of corruption in the Bush

administration and its cozy ties with industry, the claim is merely rhetorical — not literal.

10

Table I

Does Animal ID Work?

Comparing Canada’s mandatory tracking system

with the U.S. system

CANADA Confirmed BSE Cases1

Proportion of Birth Cohort

Identified

Percentage

May 20, 2003; Alberta, Canada

undetermined

undetermined

Dec 23, 2003; Washington State*

Birth herd in Alberta, Canada

55 out of 57

96%

Jan 2, 2005; Alberta, Canada

135 out of 135

100%

Jan 11, 2005; Alberta, Canada

349 out of 349

100%

Jan 22, 2006; Alberta, Canada

156 out of 156

100%

U.S. Confirmed BSE Cases

Proportion of Birth Cohort

Identified

Percentage

Dec 23, 2003; Washington State1*

Herd imported to United States in 2001

Animals imported & also from birth herd

29 out of 81

14 out of 25

36%

56%

June 24, 2005; Texas2

146 out of 200

73%

March 15, 2006; Alabama3

Pending

Pending

*The U.S. cow originated from Alberta, Canada.

1 CFIA, BSE in North America, Completed Investigations, available at:

2 USDA APHIS, Texas BSE Investigation, Final Epidemiology Report, August 2005, available at:

http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf

3 USDA/Alabama BSE Epidemiological Update, aavailable at:

11

Table II

Meatings

An Overview of White House Meetings

With Special Interests on Mad Cow Policy

Office of Management and Budget Meetings on USDA Policies

Regarding Specified Risk Materials and Downer Cattle

2005 July 5 Australian Embassy

July 12 North American Casing Association

August 11 North American Casings Association – oral

contact

October 18 Darling International

Baker Commodities

National By-Products

National Renderers Association

Office of Management and Budget Meetings on FDA Policies Regarding

Ruminant Feed

2002 August 12 American Feed Industry Association

August 21 Darling International

Baker Commodities

National By-Products

September 26 National Renderers Association

2005 August 23 Darling International

Valley Proteins

Kaluzny Bros.

Griffin Industries

Anamax Group

National By-Products

National Renderers Association

August 24 American Feed Industry Association

August 26 Pet Food Industry

Canadian Cattlemen’s Association

American Meat Institute

National Grain & Feed Association

Canadian Meat Council

http://www.ombwatch.org/regs/2006/cowsense.pdf

913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 589.2001

Legal Deadline:

None

Abstract:

On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to help strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE which resulted in this rulemaking.

Timetable: Action Date FR Cite
ANPRM 07/14/04 69 FR 42288
ANPRM Comment Period End 08/13/04
NPRM 10/06/05 70 FR 58569
NPRM Comment Period End 12/20/05
Final Action 07/00/06

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855

Phone: 240 453-6860

Fax: 240 453-6882

Email: burt.pritchett@fda.hhs.gov

RIN:

0910-AF46

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=913

914. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 342; 21 USC 361; 21 USC 371

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 189.5; 21 CFR 700.27

Legal Deadline:

None

Abstract:

On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) (Beef). Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. After reviewing comments received to the interim final rule, FDA intends to issue a final rule.

On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics.

Timetable: Action Date FR Cite
Interim Final Rule 07/14/04 69 FR 42256
Interim Final Rule Comment Period End 10/12/04
Interim Final Rule (Ammendments) 09/07/05 70 FR 53063
Final Action 07/00/06

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

None

Agency Contact:

Morris E. Potter, Lead Scientist for Epidemiology, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., NE, Atlanta, GA 30309

Phone: 404 253-1225

Fax: 404-253-1218

Email: morris.potter@fda.hhs.gov

RIN:

0910-AF47

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=914

915. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 189.5; 21 CFR 700.27

Legal Deadline:

None

Abstract:

On July 14, 2004, FDA proposed to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics." FDA intends to finalize this proposal after reviewing any comments received.

Timetable: Action Date FR Cite
NPRM 07/14/04 69 FR 42275
NPRM Comment Period End 08/13/04
Final Action 09/00/06

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740

Phone: 301 436-1486

Fax: 301 436-2632

Email: rebecca.buckner@fda.hhs.gov

RIN:

0910-AF48

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=915


TSS



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