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Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391



May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm




AHH, with all the bad news about FDA et al on there lack of enforcement, I would have expected a token mad cow feed ban warning letter or two to pop up now. what would really be interesting would be to see all violations of the mad cow feed ban, large and small, from all states. ...tss


Top Democrat Finds F.D.A.'s Efforts Have Plunged


By GARDINER HARRIS
Published: June 27, 2006
WASHINGTON, June 26 — A 15-month inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

For instance, the investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Representative Henry A. Waxman of California, the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the F.D.A. continued to uncover about the same number of problems at drug and device companies as before, Mr. Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations.

The biggest decline in enforcement actions was found at the agency's device center, where they decreased 65 percent in the five-year period despite a wave of problems with devices including implantable defibrillators and pacemakers.

"Americans have relied on F.D.A. to ensure the safety of their food and drugs for 100 years," Mr. Waxman said. "But under the Bush administration, enforcement efforts have plummeted and serious violations are ignored."

David K. Elder, the director of the agency's Office of Enforcement, explained that the F.D.A. had increasingly focused on the most serious violations.

"As a result of F.D.A.'s focus on those firms and those violations that present the highest risk to consumers and public health," Mr. Elder said in a statement, "the agency has taken prompt, targeted and aggressive action against firms that are in violation of law."

Jack Calfee, a resident scholar at the conservative American Enterprise Institute, said the decline in the statistics was meaningless because most of the violations involved paperwork problems.

"I doubt that it makes a significant difference in the safety of drugs or other products," Mr. Calfee said.

Mr. Waxman began his inquiry after Congressional hearings in 2004 suggested that the agency was partly to blame for a shortage of flu vaccines. His staff requested thousands of documents from the F.D.A.

The investigation found that by almost every measure, enforcement actions had significantly declined from 2000 to 2005. The lone exception was in the number of products that had to be recalled from the market: that increased 44 percent.

"Since one of the goals of an enforcement system is to deter violations and keep dangerous products off of the market," the report said, "the increase in recalls is not a hallmark of effective enforcement."

In one prominent case, in December 2000, a worker at a nursing home in Xenia, Ohio, mistakenly hooked up a tank of nitrogen gas to the home's oxygen delivery system. Four residents died.

In the months that followed, investigators for the agency concluded that the company that delivered the tanks, BOC Gases, was partly to blame for the mix-up, given what they deemed inadequacy of the company's own controls and employee training. Indeed, BOC had a "corporate-wide problem," F.D.A. documents at the time said. The investigators recommended prosecution, but the agency took no enforcement action.

Kristina Schurr, a spokeswoman for BOC, said that the company's controls had not been to blame but that in any case it had improved its procedures since then.

Several former top officials of the agency attributed the decline in enforcement actions to budget problems.

"This is a tragedy," said Peter Barton Hutt, a former general counsel of the F.D.A. who now represents drug companies and teaches food and drug law at Harvard. "Congress has failed to realize that our single most important government agency is being systematically dismantled."

Dr. Sidney M. Wolfe, director of the Health Research Group at the watchdog organization Public Citizen, noted that the agency now received about $380 million a year in fees from drug makers.

"The public," Dr. Wolfe said, "is getting the kind of F.D.A. that the industry is paying for them to get."


http://www.nytimes.com/2006/06/27/health/policy/27fda.html?hp&ex=1151467200&en=0e25a48e6978b523&ei=5094&partner=homepage


June 26, 2006, 11:10PM
Study shows drop in enforcement of FDA laws


New York Times

WASHINGTON - An inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

For instance, the 15-month investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Rep. Henry Waxman, D-Calif., the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the FDA continued to uncover about the same number of problems at drug and device companies as before, Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations. .......... chron.com/


>> >>Date: Wed, 2 Oct 2002 09:04:42 -0700

>>Reply-To: Bovine Spongiform Encephalopathy

>>Sender: Bovine Spongiform Encephalopathy

>>From: Terry S. Singeltary Sr.

>>Subject: MAD COW FEED BAN WARNING LETTERS USA 'update'


>>where, oh where, did all Terry's mad cow feed ban warning letters go$


>> >>FDA Cuts Back on Warnings

>> >>10/01/02

>> >>WASHINGTON -- The Food and Drug Administration has substantially cut

>>back on warnings sent to companies that run afoul of its rules, a move

>>the agency contends will result in more-effective enforcement but that

>>critics say lets violators off the hook.


>> >>The drop results from a policy change in late February that requires the


>>FDA chief counsel's office to clear all warning letters to ensure they

>>are legally sound. Before the change, division and district offices

>>around the country issued such letters unilaterally. In the six months

>>since, the agency issued 279 warning letters, a drop of 64% from the

>>same period last year, a review of agency records shows. The FDA says

>>the chief counsel's office rejected only 6% of the 699 warning letters

>>and other citations it reviewed. At the same time, division and district

>>enforcers may be holding back letters they once would have sent.


>> >>SEE FULL STORY >> >>


http://online.wsj.com/


>> >>snip...


>> >>Date: Wed, 9 Oct 2002 13:21:00 -0700

>>Reply-To: Bovine Spongiform Encephalopathy

>>Sender: Bovine Spongiform Encephalopathy

>>From: Terry S. Singeltary Sr.

>>Subject: 'TONNAGE' OF TAINTED FEED $ what's up with the mad cow warning >> letters >>

>>Greetings, >>

>>since the FDA has apparently stopped issuing some warning letters; >> >>10/7/02 >>

>>Senate Questions FDA Commissioner Nominee

>> >>In testimony today before the U.S. Senate, Dr. Mark McClellan, the Bush

>>administration nominee for Commissioner of Food and Drugs, said that

>>under his leadership, the FDA would uphold its enforcement authority to

>>ensure the safety and effectiveness of the products it regulates and to

>>ensure that accurate and truthful information is conveyed to the public.


>> >>Sen. Edward Kennedy (D-Mass.), chairman of the Senate Health, Education,

>>Labor and Pensions (HELP) Committee, expressed concern at the start of

>>the hearing that the FDA may be backing away from its regulatory

>>authority, noting a drop in the number of Warning Letters issued by the ...


snip... full text


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html


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