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From: TSS ()
Subject: [Docket No. 2004N-0257] RIN 0910-AF48 Recordkeeping Requirements for Human Food and Cosmetics material from cattle i.e. BSE
Date: October 11, 2006 at 8:31 am PST

[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Rules and Regulations]
[Page 59653-59669]
From the Federal Register Online via GPO Access []



Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0257]
RIN 0910-AF48

Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


SUMMARY: The Food and Drug Administration (FDA) is requiring that
manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle establish and maintain records sufficient to demonstrate that
the human food or cosmetic is not manufactured from, processed with, or
does not otherwise contain, prohibited cattle materials. These
recordkeeping requirements provide documentation for the provisions in
FDA's interim final rule entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping
because manufacturers and processors of human food and cosmetics need
records to ensure that their products do not contain prohibited cattle
materials, and records are necessary to help FDA ensure compliance with
the requirements of the interim final rule.

DATES: This rule is effective on January 9, 2007.

FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.


[[Page 59654]]

I. Background

On July 14, 2004, FDA proposed a rule entitled ``Recordkeeping
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing, Material From Cattle'' (the proposed
rule) (69 FR 42275) to require that manufacturers and processors of
human food and cosmetics that are manufactured from, processed with, or
otherwise contain, material from cattle 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. The proposed rule was a companion rulemaking to FDA's
interim final rule (IFR) entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics'' (the IFR) (69 FR 42256). We
believe that records sufficient to demonstrate the absence of
prohibited cattle materials in human food and cosmetics are critical
for manufacturers, processors, and FDA to ensure compliance with the
ban on prohibited cattle materials. Therefore, we are finalizing the
proposed rule to require that manufacturers and processors of human
food and cosmetics that are manufactured from, processed with, or
otherwise contain, material from cattle establish and maintain records
sufficient to demonstrate that human food and cosmetics are not
manufactured from, processed with, or do not otherwise contain,
prohibited cattle materials. We also are finalizing the provision in
the proposed rule that these records must be made available to FDA for
inspection and copying. FDA notes that the requirement in the IFR that
existing records relevant to compliance be made available to FDA
remains and has been incorporated into the final record provisions.
In response to the December 2003 finding of an adult cow--imported
from Canada--that tested positive for bovine spongiform encephalopathy
(BSE) in the State of Washington, FDA published the IFR requiring that
specified risk materials (SRMs), small intestine of all cattle, tissue
from nonambulatory disabled cattle, tissue from cattle not inspected
and passed for human consumption, and mechanically separated beef (MS
beef) not be used for FDA-regulated human food and cosmetics.\1\ SRMs
include the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse
process of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older, as well
as the tonsils and distal ileum of the small intestine of all cattle.

\1\ In June 2005, USDA confirmed the second case of BSE in the
United States in a cow born in Texas.

The U.S. Department of Agriculture (USDA) also published an IFR (69
FR 1862, January 12, 2004) to prohibit certain cattle material from use
in human food. FDA's IFR extended the protection from BSE provided
under USDA's BSE IFR to FDA-regulated human food and cosmetics. On
September 7, 2005, both FDA (70 FR 53063) and USDA (70 FR 53043)
published amendments to their respective IFRs to allow the use of small
intestine in human food and cosmetics provided the distal ileum has
been removed. This final rule on recordkeeping will help ensure
compliance with the provisions of FDA's IFR and, thereby, will serve as
an additional safeguard to reduce human exposure to the agent that
causes BSE that may be present in human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
FDA believes that these recordkeeping requirements are necessary
for manufacturers and processors to ensure that all cattle material
they use is free from prohibited cattle materials. Furthermore, these
requirements are necessary for FDA to ensure compliance with the
provisions of the IFR. There is currently no validated premortem test
to reliably detect the presence of the BSE agent or the presence of
prohibited cattle material in human food and cosmetics. Once cattle
material such as brain or spinal cord is separated from the source
animal, it may not be possible to determine the age of the animal from
which the material came without records and, therefore, whether the
material is an SRM. In addition, without records, it may not be
possible to determine whether a product contains material from cattle
that were not inspected and passed for human consumption. Also, a
product might contain MS beef without its presence being evident from
the appearance of the product.
FDA received 32 responses, each containing one or more comments,
from industry, consumers, and other stakeholder groups in response to
the proposed rule. We have responded in this document to the comments
that were within the scope of this rulemaking. We received several
comments that pertained to the prohibitions on the cattle materials
themselves, as opposed to the recordkeeping requirements, and other
issues that are covered in the IFR. We will be responding to those
comments when we finalize the IFR.

II. Response to Comments

snip...full text ;


No blood from placenta shot recipients from fear of CJD

Thu Aug 31, 2006 06:5368.238.107.14

No blood from placenta shot recipients

The Yomiuri Shimbun

To prevent the spread of variant Creutzfeldt-Jakob disease the Health, Labor and Welfare Ministry decided Wednesday to ban blood donations by people who have received injections of human placenta extract, the ministry said. Variant Creutzfeldt-Jakob disease is believed to be caused when humans are infected with bovine spongiform encephalopathy. The extract is often injected in beauty treatment because it is believed to have a whitening effect on skin tone and boosts the metabolism. "Although the risk of infection is said to be low, we made the decision because the risk can't be completely ruled out," a ministry official said. The policy was endorsed by the research panel of a subcommittee on blood administration under the ministry's Pharmaceutical Affairs and Food Sanitation Council and comes into effect in October at the earliest. The policy will prompt the Japanese Red Cross Society to ask prospective blood donors whether they have been injected with placenta extract and raise awareness by displaying a poster. It is unclear whether placenta contains abnormal prions, which is said to be the variant CJD agent, and there has been no report of any variant CJD infection in humans through placenta extract injection.
(Aug. 25, 2006)

Part No : 1227Description : Hask Placenta Treat.Vial 24/unit

This product is in stock, and will ships in one to two business day.If the order is received before 1:00 pm Pacific Time, usually ships onsame business day.

HASK PLACENTA products are leaders in the Deep Conditioner segment ofHair Care.Henna-n-Placenta Pacs are #13 in Unit Sales of ALL conditioners and #1of all DEEP conditioners inthe Drug Class*. Hask Placenta Instant Hair Repair, with No-Rinsetreatment, is a top-10 unit seller*.National Media Support drives the brand and Hasks strong professionalheritage has consumer recognition.

Use of Bovine offal in Cosmetics;

***(Third paragraph: The wording of this paragraphwill raise NEW concerns which cannot bescientifically answered. We would ask thatthe third paragraph be OMITTED.)

(there may still be some strange products administered by injection that are trying to_evade_ the Medicines Act by calling themselvescosmetics. If _any_ of those involve bovineingredients, they need to _comply_ with theCSM guidelines)...


The Department of Health wishes to reinforce the advice given to theCosmetics Industry in February 1990 (ref.)It is possible that some ruminant-derivedmaterials are being incorporated intocosmetics or beauty treatments which arethen marketed as 'naturalproducts.The particular materials that should notunder _ANY_ circumstances be used in themanufacturer of cosmetics or beauty treatmentsare:1. bovine (cattle)-derived offals, or proteinsderived from these offals. These offals are:brain, spinal cord, spleen, thymus, tonsils,intestines of Bovine offal (prohibition)regulations2. ovine (sheep)-derived offals and ovine placenta.In view of the current uncertainty about theincidence of infection with spongiformencephalopathy agents it is probably advisablethat these recommendations apply to the aboveruminant-derived materials of ANY COUNTRY OF ORIGIN...31 October 199191/10.31/9.1It also emerged from the 16- volumereport of Lord Phillips, released onThursday, that people who bought anti-agingcream may have exposed themselves to BSE unwittingly.The report describes their use as a potentialpathway to infection because some creams may haveincluded cattle brain placenta.





Monday, Jan. 26, 2004

FDA Press Office

Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission

HHS Secretary Tommy G. Thompson today announced several new public healthmeasures, to be implemented by the Food and Drug Administration (FDA), tostrengthen significantly the multiple existing firewalls that protectAmericans from exposure to the agent thought to cause bovine spongiformencephalopathy (BSE, also known as mad cow disease) and that help preventthe spread of BSE in U.S. cattle.The existing multiple firewalls, developed by both the U.S. Department ofAgriculture (USDA) and HHS, have been extremely effective in protecting theAmerican consumer from exposure to BSE. The first firewall is based onimport controls started in 1989. A second firewall is surveillance of theU.S. cattle population for the presence of BSE, a USDA firewall that led tothe finding of the BSE cow in December. The third firewall is FDA's 1997animal feed ban, which is the critical safeguard to help prevent the spreadof BSE through cattle herds by prohibiting the feeding of most mammalianprotein to ruminant animals, including cattle. The fourth firewall, recentlyannounced by USDA, makes sure that no bovine tissues known to be at highrisk for carrying the agent of BSE enter the human food supply regulated byUSDA. The fifth firewall is effective response planning to contain thepotential for any damage from a BSE positive animal, if one is discovered.This contingency response plan, which had been developed over the pastseveral years, was initiated immediately upon the discovery of a BSEpositive cow in Washington State December 23.The new safeguards being announced today are science-based and furtherbolster these already effective safeguards.Specifically, HHS intends to ban from human food (including dietarysupplements), and cosmetics a wide range of bovine-derived material so thatthe same safeguards that protect Americans from exposure to the agent of BSEthrough meat products regulated by USDA also apply to food products that FDAregulates.FDA will also prohibit certain currently allowed feeding and manufacturingpractices involving feed for cattle and other ruminant animals. Theseadditional measures will further strengthen FDA's 1997 "animal feed" rule."Today's actions will make strong public health protections against BSE evenstronger," Secretary Thompson said. "Although the current animal feed ruleprovides a strong barrier against the further spread of BSE, we must neverbe satisfied with the status quo where the health and safety of our animalsand our population is at stake. The science and our own experience andknowledge in this area are constantly evolving. Small as the risk mayalready be, this is the time to make sure the public is protected to thegreatest extent possible.""Today we are bolstering our BSE firewalls to protect the public," said FDACommissioner Mark B. McClellan, M.D., Ph.D. "We are further strengtheningour animal feed rule, and we are taking additional steps to further protectthe public from being exposed to any potentially risky materials fromcattle. FDA's vigorous inspection and enforcement program has helped usachieve a compliance rate of more than 99 percent with the feed ban rule,and we intend to increase our enforcement efforts to assure compliance withour enhanced regulations. Finally, we are continuing to assist in thedevelopment of new technologies that will help us in the future improve evenfurther these BSE protections. With today's actions, FDA will be doing morethan ever before to protect the public against BSE by eliminating additionalpotential sources of BSE exposure."To implement these new protections, FDA will publish two interim final rulesthat will take effect immediately upon publication, although there will bean opportunity for public comment after publication.The first interim final rule will ban the following materials fromFDA-regulated human food, (including dietary supplements) and cosmetics:* Any material from "downer" cattle. ("Downer" cattle are animals thatcannot walk.)* Any material from "dead" cattle. ("Dead" cattle are cattle that die on thefarm (i.e. before reaching the slaughter plant);* Specified Risk Materials (SRMs) that are known to harbor the highestconcentrations of the infectious agent for BSE, such as the brain, skull,eyes, and spinal cord of cattle 30 months or older, and a portion of thesmall intestine and tonsils from all cattle, regardless of their age orhealth; and* The product known as mechanically separated beef, a product which maycontain SRMs. Meat obtained by Advanced Meat Recovery (an automated systemfor cutting meat from bones), may be used since USDA regulations do notallow the presence of SRMs in this product.The second interim final rule is designed to lower even further the riskthat cattle will be purposefully or inadvertently fed prohibited protein. Itwas the feeding of such protein to cattle that was the route of diseasetransmission that led to the BSE epidemic in United Kingdom cattle in the1980's and 1990's.This interim final rule will implement four specific changes in FDA'spresent animal feed rule. First, the rule will eliminate the presentexemption in the feed rule that allows mammalian blood and blood products tobe fed to other ruminants as a protein source. Recent scientific evidencesuggests that blood can carry some infectivity for BSE.Second, the rule will also ban the use of "poultry litter" as a feedingredient for ruminant animals. Poultry litter consists of bedding, spilledfeed, feathers, and fecal matter that are collected from living quarterswhere poultry is raised. This material is then used in cattle feed in someareas of the country where cattle and large poultry raising operations arelocated near each other. Poultry feed may legally contain protein that isprohibited in ruminant feed, such as bovine meat and bone meal. The concernis that spillage of poultry feed in the chicken house occurs and thatpoultry feed (which may contain protein prohibited in ruminant feed) is thencollected as part of the "poultry litter" and added to ruminant feed.Third, the rule will ban the use of "plate waste" as a feed ingredient forruminants. Plate waste consists of uneaten meat and other meat scraps thatare currently collected from some large restaurant operations and renderedinto meat and bone meal for animal feed. The use of "plate waste" confoundsFDA's ability to analyze ruminant feeds for the presence of prohibitedproteins, compromising the Agency's ability to fully enforce the animal feedrule.Fourth, the rule will further minimize the possibility ofcross-contamination of ruminant and non-ruminant animal feed by requiringequipment, facilities or production lines to be dedicated to non-ruminantanimal feeds if they use protein that is prohibited in ruminant feed.Currently, some equipment, facilities and production lines process or handleprohibited and non-prohibited materials and make both ruminant andnon-ruminant feed -- a practice which could lead to cross-contamination.To accompany these new measures designed to provide a further layer ofprotection against BSE, FDA will in 2004 step up its inspections of feedmills and renderers. FDA will itself conduct 2,800 inspections and will makeits resources go even further by continuing to work with state agencies tofund 3,100 contract inspections of feed mill and renderers and other firmsthat handle animal feed and feed ingredients. Through partnerships withstates, FDA will also receive data on 700 additional inspections, for atotal of 3,800 state contract and partnership inspections in 2004 alone,including annual inspections of 100 percent of all known renderers and feedmills that process products containing materials prohibited in ruminantfeed."We have worked hard with the rendering and animal feed productionindustries to try and achieve full compliance with the animal feed rule,"said Dr. McClellan, "and through strong education and a vigorous enforcementcampaign, backed by additional inspections and resources, we intend tomaintain a high level of compliance."Dr. McClellan also noted that, in response to finding a BSE positive cow inWashington state December 23, FDA inspected and traced products at 22facilities related to that positive cow or products from the cow, includingfeed mills, farms, dairy farms, calf feeder lots, slaughter houses, meatprocessors, transfer stations, and shipping terminals. Moreover, FDA hasconducted inspections at the rendering facilities that handled materialsfrom the positive cow, and they were found to be fully in compliance withFDA's feed rule.To further strengthen protections for Americans, FDA/HHS intends to workwith Congress to consider proposals to assure that these importantprotective measures will be implemented as effectively as possible.FDA is also continuing its efforts to assist in the development of betterBSE science, to achieve the same or greater confidence in BSE protection ata lower cost. For example, to enhance the ability of our public healthsystem to detect prohibited materials in animal feed, FDA will continue tosupport the development and evaluation of diagnostic tests to identifyprohibited materials. These tests would offer a quick and reliable method oftesting animal feeds for prohibited materials and for testing other productsfor contamination with the agent thought to cause BSE.FDA has publicly discussed many of the measures being announced today withstakeholders in workshops, videoconferences, and public meetings.

Inaddition, FDA published an Advance Notice of Proposed Rulemaking in November2002 (available online at

concerning possible changes to the animal feed rule.Comprehensive information about FDA's work on BSE and links to other relatedwebsites are available at



Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IFA 03-025IFA-2

Terry S. Singeltary 9/13/2005

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

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