Petition to Declare Poultry Litter as a Food Additive and to Ban Its Use as Cattle Feed August 12, 2009

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Petition to Declare Poultry Litter) as a Food Additive and to) Ban Its Use as Cattle Feed)

Docket No. ______________

submitted by

FOOD ANIMAL CONCERNS TRUST

August 12, 2009

Richard Wood Executive Director PO Box 14599 Chicago, IL 60614 Phone: (773) 525-4952

Table of Contents

I. Preliminary Statement II. Action Requested III. Factual Background

A. Poultry manure and other litter

B. In 1958 Congress enacted legislation that bars the use of an ingredient in human or animal food unless the FDA has either issued a regulation governing its safe use or declared that it is generally recognized as safe.

C. In 1967 FDA banned the use of poultry litter as animal feed because of its concerns about the effects of such use on human health.

D. In 1977 the FDA asked for public comment on its 1967 policy which could help it determine whether poultry litter was either a food additive or generally recognized as safe.

E. In 1980 the FDA, while reaffirming its concerns about the public health risks of using poultry litter as animal feed, revoked its 1967 policy statement and gave jurisdiction for the regulation of such use to the state Departments of Agriculture.

F. In 2008 the FDA, while acknowledging that the use of poultry litter as cattle feed may contribute to Variant Creutzfeldt-Jakob Disease (“vCJD”) in people, refused to ban such use.

G. The states are not adequately regulating the use of poultry litter as animal feed.

H. Numerous countries have banned the use of poultry litter as ruminant feed.

IV. Health Effects

A. Neurological diseases

1. Prion resistance to degradation 2. Distribution of infectivity in feed 3. The impact of soil particles on prion infectivity 4. Potential risk associated with new BSE strains 5. Harvard BSE Risk Assessment

B. Pathogenic organisms and inadequate litter processing

C. Drugs, residues and antibiotic resistant bacteria

V. Legal Argument

A. The FDA has the legal authority to regulate poultry litter used as cattle feed even if some of the poultry litter is not sold.

B. There is no convincing evidence that poultry litter used as cattle feed is is “Generally Recognized As Safe” by scientists, and so it is a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act.

C. The FDA can legally ban the use of poultry litter as cattle feed because such use is unsafe.

D. D. Summary of legal argument

VI. Conclusion

VII. Environmental Impact

VIII. Economic Impact

IX. Certification

List of endorsing organizations

References

snip...

August 12, 2009

Division of Dockets Management Food and Drug Administration Department of Health and Human Services Room 1061 5630 Fishers Lane Rockville, MD 20852

CITIZEN PETITION

I. Preliminary Statement

For more than 40 years the U.S. Food and Drug Administration (“FDA”) has acknowledged the public health risks of using poultry manure and other poultry litter as feed for cattle. Yet in 1980 the FDA abdicated its responsibility to protect the public health by giving to the states the sole responsibility of regulating such use. The states, however, are either unwilling or unable to perform this task.

II. Action Requested

Pursuant to section 4(e) of the Administrative Procedure Act, 5 U.S.C. 553(e), and 21 C.F.R. 10.25 and 10.30, Food Animal Concerns Trust (“FACT”)i requests that the FDA declare poultry litter to be a food additive and to ban its use as feed for cattle. More specifically, a new section should be added at the end of 21 C.F.R. Subpart B: “section 589._____. Poultry litter

(a) Definitions. (1) Poultry litter is a heterogeneous mixture consisting of raw manure, feathers, spilled feed and bedding material that accumulate on the floors of the buildings that house broiler chickens, laying hens and turkeys. (2) The terms renderer, blender, feed manufacturer, distributor, and establishment and/or individual that is responsible for feeding ruminant animals have the same meaning as in section 589.2000(a).

(b) Food additive status. The Food and Drug Administration has determined that chicken litter for use in ruminant feed is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act (the act). The use or intended use in ruminant feed of any material derived from chicken litter causes the feed to be adulterated and in violation of the act, unless it is the subject of an effective notice of claimed investigational exemption for a food additive under section i Founded in 1982, FACT is a Chicago-based non-profit organization that promotes better methods of raising livestock and poultry by improving the welfare of food animals, broadening opportunities for humane farmers, and addressing public health problems that come from the production of meat, milk and eggs.

2

570.17 of this chapter.

(c) Requirements for renderers, blenders, feed manufacturers, distributors, and establishments and individuals that are responsible for feeding ruminant animals. Renderers, blenders, feed manufacturers, distributors, and establishments and individuals that are responsible for feeding ruminant animals shall comply with sections 589.2000(c)(i) and (ii), 589.2000(f), and 589.2000(h).

(d) Adulteration and misbranding. (1) Animal protein products, and feeds containing such products, that are not in compliance with paragraphs (b) and (c) of this section, excluding labeling requirements, will be deemed adulterated under section 402(a)((2)(C) or 402(a)(4) of the act. (2) Animal protein products, and feeds containing such products, that are not in compliance with the labeling requirements of paragraphs (b) and (c) of this section will be deemed misbranded under section 403(a)(1) or 403(f) of the act.”

III. Factual Background

snip...

VI. Conclusion For the reasons stated above, the FDA should, pursuant to 21 C.F.R. 570.38(b)(1), immediately “issue a notice in the FEDERAL REGISTER proposing to determine that [poultry litter] ... is not GRAS and is a food additive subject to section 409 of the” FFDCA. VII. Environmental Impact The action requested is subject to a categorical exclusion under 21 C.F.R. 25.30 and 25.32 and therefore does not require the preparation of an environmental assessment. VIII. Economic Impact No statement of the economic impact of the requested action is presented because none has been requested by the Commissioner. 21 C.F.R. 10.30(b). IX. Certification The undersigned certify that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and it includes representative data and information known to the petitioner which are unfavorable to the petition. Respectfully submitted, Richard Wood Steven Roach Lisa Isenhart Larissa McKenna Executive Director Program Director Program Associate Associate Director Of counsel: Benjamin Cohen 18 Endorsing organizations The following organizations have endorsed FACT’s citizen petition to the FDA requesting that the Agency declare poultry litter a food additive and subsequently ban its use as feed for cattle: Center for Food Safety Center for Science in the Public Interest Consumer Federation of America Consumers Union Food & Water Watch Humane Society of the United States Institute for Agriculture and Trade Policy National Catholic Rural Life Conference National Consumers League National Sustainable Agriculture Coalition Safe Tables Our Priority Union of Concerned Scientists

snip...FULL TEXT ;

http://www.foodanimalconcerns.org/PDF/FDA%20Chicken%20Litter%20Petition_final.pdf



Thursday, April 9, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Thursday, April 09, 2009

Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed

mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000056/!x-usc:mailto:burt.pritchett@fda.hhs.gov

Greetings FDA et al,

I kindly wish to comment on the following ;

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46

Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed delay of effective date.

http://edocket.access.gpo.gov/2009/E9-8127.htm



MY COMMENT AS FOLLOWS ;

I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.

ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !

I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.

I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.

I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.

I strenuously urge President Obama to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.

LET's take a look back at past promises and discussions on this issue, and then for a breath of fresh air, let's look at some sound science, and why no further discussion is warranted, and why action is needed ASAP ;

snip...please see full text ;

http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html



MAD COW USA...THE FACTS


Monday, October 19, 2009

Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009

http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html




2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006

http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html



Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html



Saturday, June 13, 2009

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html



Sunday, May 17, 2009

WHO WILL WATCH THE CHILDREN ? SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE

http://downercattle.blogspot.com/2009/05/who-will-watch-children.html



http://downercattle.blogspot.com/



Sunday, September 6, 2009

MAD COW USA 1997 SECRET VIDEO

http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html



U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? see video at bottom

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html



DAMNING TESTIMONY FROM STANLEY PRUSINER THE NOBEL PEACE PRIZE WINNER ON PRIONS SPEAKING ABOUT ANN VENEMAN see video

http://maddeer.org/video/embedded/prusinerclip.html



Saturday, August 22, 2009

FREE Kim Min-sun, she is correct about mad cow fears from USDA BEEF

http://usdavskorea.blogspot.com/2009/08/free-kim-min-sun-she-is-correct-about.html



Office of Inspector General Semiannual Report to Congress FY 2007 - 2nd Half

Two Texas Companies Sentenced and Fined for Misbranding Meat Products In April 2007, two closely held and related Texas companies pled guilty in Federal court and were sentenced to 12 months of probation and ordered to pay $10,250 in fines for misbranding meat products. One of the companies sold adulterated meat products to a retail store in New Mexico. Additionally, portions of the invoices failed to properly and consistently identify the meat products as being from cattle more than 30 months old at time of slaughter. This information is required to be disclosed because of bovine spongiform encephalopathy (BSE, or "mad cow disease") concerns. No adulterated meat reached consumers.

http://www.usda.gov/oig/webdocs/sarc071212.pdf



Saturday, August 29, 2009

FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009

http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.html



Friday, September 4, 2009

FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009

http://madcowfeed.blogspot.com/2009/09/foia-request-on-feed-recall-product.html



THIS recall is not confusing ;

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II

___________________________________

PRODUCT

Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007

CODE

Cattle feed delivered between 01/12/2007 and 01/26/2007

RECALLING FIRM/MANUFACTURER

Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.

Firm initiated recall is ongoing.

REASON

Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE

42,090 lbs.

DISTRIBUTION

WI

___________________________________

PRODUCT

Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007

CODE

The firm does not utilize a code - only shipping documentation with commodity and weights identified.

RECALLING FIRM/MANUFACTURER

Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.

REASON

Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE

9,997,976 lbs.

DISTRIBUTION

ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html


NEW URL

http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm



Thursday, March 19, 2009

MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL

http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html



Sunday, October 18, 2009

Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, October 17, 2009

http://madcowfeed.blogspot.com/2009/10/wisconsin-firm-recalls-beef-tongues.html



Thursday, October 15, 2009

Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, Oct 15, 2009

http://madcowfeed.blogspot.com/2009/10/nebraska-firm-recalls-beef-tongues-that.html



Friday, September 4, 2009


FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009

http://madcowfeed.blogspot.com/2009/09/foia-request-on-feed-recall-product.html



Saturday, August 29, 2009

FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009


http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.html




Tuesday, July 14, 2009

U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST

WHERE did we go wrong $$$

http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html



Sunday, December 28, 2008

MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy

http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html



Wednesday, August 20, 2008

Bovine Spongiform Encephalopathy Mad Cow Disease typical and atypical strains, was there a cover-up ? August 20, 2008

http://bse-atypical.blogspot.com/2008/08/bovine-spongiform-encephalopathy-mad.html



Monday, May 11, 2009

Rare BSE mutation raises concerns over risks to public health

http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html



Monday, October 19, 2009

Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009

http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html



Monday, October 26, 2009

Similarities between Forms of Sheep Scrapie and Creutzfeldt-Jakob Disease Are Encoded by Distinct Prion Types

Published online before print October 22, 2009

http://nor-98.blogspot.com/2009/10/similarities-between-forms-of-sheep.html



Monday, October 26, 2009

MAD COW DISEASE, AND U.S. BEEF TRADE

MAD COW DISEASE, CJD, TSE, SOUND SCIENCE, COMMERCE, AND SELLING YOUR SOUL TO THE DEVIL

http://usdameatexport.blogspot.com/2009/10/mad-cow-disease-and-us-beef-trade.html



Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518