[Federal Register: May 30, 2007 (Volume 72, Number 103)]
[Notices]               
[Page 29945-29948]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my07-32]                         

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS 2007-0018]

 
Disposition of Hogs and Chickens From Farms Identified as Having 
Received Pet Food Scraps Contaminated With Melamine and Melamine-
Related Compounds and Offered for Slaughter

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this notice to articulate its position on the slaughter for human food 
of hogs and chickens from farms identified as having purchased or 
otherwise received pet food scraps that contain melamine and melamine-
related compounds. The contaminated pet food scraps were used to 
supplement animal feed on farms in several States. The results of an 
interim safety/risk assessment indicate that, based on currently 
available data and information, the consumption of pork, poultry, eggs, 
and domestic fish products from animals inadvertently fed animal feed 
contaminated with melamine and melamine-related compounds is very 
unlikely to pose a human health risk.
    Based on the findings of the interim safety/risk assessment, as 
well as the results of validated testing for melamine concentration 
that has been conducted on tissue samples of hogs and chickens exposed 
to the adulterated feed, FSIS has determined that pork and poultry 
products from all animals identified as having been fed animal feed 
containing contaminated pet food scraps are ``not adulterated'' and are 
thus eligible to receive the mark of inspection. All such animals that 
were being held on farms have been released and may be offered for 
slaughter for human food.

DATES: Comments on this Federal Register notice must be received by 
August 28, 2007.

ADDRESSES: FSIS invites interested persons to submit comments on the 
findings in this notice. Comments may be submitted by any of the 
following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov
 and, in the ``Search for Open Regulations'' box, 

select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select FDMS 
Docket Number FSIS-2007-0018 to submit or view public comments and to 
view supporting and related materials available electronically.
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
     Electronic mail: fsis.regulationscomments@fsis.usda.gov.
    Individuals who do not wish FSIS to post their personal contact 
information -- mailing address, e-mail address, telephone number -- on 
the Internet may leave the information off their comments. All 
submissions received by mail or electronic mail must include the Agency 
name and docket number FSIS-2007-0018. All comments submitted in 
response to this notice, as well as research and background information 
used by FSIS in developing this document, will be available for public 
inspection in the FSIS Docket Room at the address listed above between 
8:30 a.m. and 4:30 p.m., Monday through Friday. Comments will also be 
posted on the Agency's Web site at http://www.fsis.usda.gov/.


FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Deputy Assistant

[[Page 29946]]

Administrator, Office of Policy, Program, and Employee Development 
(OPPED), (202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is responsible for ensuring that meat and poultry products are 
safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat 
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products 
Inspection Act (PPIA) (21 U.S.C. 451 et seq.). These two statutes 
require Federal inspection and provide for Federal regulation of meat 
and poultry products prepared for distribution in commerce for use as 
human food.
    Under the Acts, FSIS inspection personnel apply the mark of 
inspection to meat and poultry products if they find upon inspection 
that these articles are not adulterated (21 U.S.C. 455, 457; 21 U.S.C. 
604, 606, 607). The Acts prohibit the sale or transportation in 
commerce of meat and poultry products capable of use as human food that 
are adulterated or misbranded or that have not been inspected and 
passed (21 U.S.C. 458 (a)(2); 21 U.S.C. 610(c)). The Acts also 
authorize FSIS to take certain actions to remove from commerce meat or 
poultry products that the Agency has reason to believe are adulterated 
or misbranded, or that have not been inspected (21 U.S.C. 
467(a),467(b); 21 U.S.C. 672,673). Under the Acts, a meat or poultry 
product is adulterated if, among other circumstances, it bears or 
contains any poisonous or deleterious substance that may render it 
injurious to health (21 U.S.C. 453(g)(1), 601(m)(1)); it bears or 
contains (by reason of administration of any substance to the live 
animal or poultry, or otherwise) any added poisonous or added 
deleterious substance which may in the judgment of the Secretary render 
it unfit for human food (21 U.S.C. 453(g)(2), 601(m)(2)); if it is for 
any reason unsound, unhealthful, unwholesome, or unfit for human food 
(21 U.S.C. 453(g)(3), 601(m)(3)); or if it has been prepared, packaged, 
or held under insanitary conditions whereby it may have been rendered 
injurious to health (21 U.S.C. 453(g)(4), 601(m)(4)).
    On April 26, 2007, FSIS and the U.S. Food and Drug Administration 
(FDA) announced that hogs on farms in certain States had consumed 
animal feed supplemented with pet food scraps contaminated with 
melamine and melamine-related compounds. On April 30, 2007, the 
agencies announced that chickens on certain farms in Indiana had also 
been fed poultry feed supplemented with melamine-contaminated pet food 
scraps. FSIS learned of the adulterated feed during the course of an 
ongoing FDA investigation of pet food associated with illnesses and 
deaths in cats and dogs. The pet food was found to contain melamine or 
melamine-related compounds (cyanuric acid, ammelide, and ammeline).
    Based on the available science and information, FDA investigators 
believed that the combination of melamine and melamine-related 
compounds, particularly cyanuric acid, caused the formation of crystals 
in the kidneys that led to kidney failure in some of the pets that had 
consumed the adulterated pet food. The investigation found that the 
source of the melamine and melamine-related compounds in the pet food 
was products, labeled as rice protein concentrate and as wheat gluten, 
which had been imported from China. The investigation also revealed 
that scraps from the adulterated pet food had been sold to hog and 
chicken producers and feed mills, where they were used to supplement 
animal feed. FDA then notified FSIS of its findings regarding animal 
feed.
    When FSIS and FDA announced that they had learned that hog and 
chicken farms in various States had purchased or otherwise received pet 
food scraps contaminated with melamine and melamine-related compounds, 
the agencies noted that some of the hogs and chickens that had consumed 
feed supplemented with the contaminated pet food scraps may have been 
slaughtered and their products distributed in commerce. At that time, 
the agencies also explained that they would work with States and 
industry to take the appropriate action with regard to the disposition 
of these products.

Actions Taken Based on Data Concerning the Consumption of Feed 
Supplemented With Adulterated Pet Food

    When FSIS learned that hogs and chickens had consumed feed that had 
been supplemented with pet food scraps contaminated with melamine and 
melamine-related compounds, the Agency concluded that risk to human 
health from consuming pork or poultry products from these animals was 
likely to be very low. This conclusion was based on information that 
indicated that the concentration of melamine and melamine-related 
compounds in the adulterated feed was likely very low due to dilution. 
However, because the animal feed in question was adulterated, and given 
the information that was available at the time, FSIS could not rule out 
the possibility that pork and poultry products produced from hogs and 
chickens that consumed the adulterated feed could also be adulterated. 
Therefore, all animals that had been identified as having consumed feed 
supplemented with pet food scraps contaminated with melamine and 
melamine-related compounds and that were not yet offered for slaughter 
were placed under State quarantine or voluntarily held by the 
producers.
    In a press release issued on May 7, 2007, FDA and FSIS announced 
the results of a human health risk assessment estimating the risk to 
human health from melamine and melamine-related compounds through the 
consumption of edible animal products derived from poultry, pork, and 
fish. This human health risk assessment has since been updated with new 
information and is hereafter referred to as the interim safety/risk 
assessment. The interim safety/risk assessment concludes that, based on 
currently available data and information, the consumption of pork, 
poultry, eggs, and domestic fish products from animals inadvertently 
fed animal feed contaminated with melamine and melamine-related 
compounds is very unlikely to pose a human health risk. In a Notice of 
Availability published in this issue of the Federal Register, FDA is 
announcing the availability of this ``Interim Melamine and Analogues 
Safety/Risk Assessment.''
    In the May 7, 2007, press release, FDA and FSIS also announced that 
several samples of feed from farms identified as having received 
contaminated pet food scraps had been tested by Federal laboratories or 
state laboratories using approved methods and the tests did not detect 
the presence of melamine and melamine-related compounds. The negative 
tests most likely reflected the fact that, because of dilution, the 
amount of melamine and melamine-related compounds present in the feed 
was so small that the compounds were no longer detectable by the 
approved testing method.
    After considering the new information presented in the interim 
safety/risk assessment, together with the recent test results that 
found that melamine concentrations in some of the adulterated feed was 
below the level of detection, FSIS determined that it would be 
appropriate at that time for the Agency to permit, under certain 
conditions, hogs and chickens that had been identified as having 
consumed adulterated feed to be offered for slaughter. Therefore, at 
that time, FSIS decided to allow hogs and chickens identified as having 
consumed adulterated feed to be offered for slaughter for human food if 
the feed had

[[Page 29947]]

been tested by a Federal laboratory or state laboratory using approved 
methods and the test did not detect the presence of melamine and 
melamine-related compounds. FSIS concluded that under these conditions, 
FSIS would be able to find that pork and poultry products from animals 
that had consumed adulterated feed were ``not adulterated'' and thus 
eligible to receive the mark of inspection.
    At that time, hogs and chickens that had been identified as having 
consumed feed that had tested positive for melamine and melamine-
related compounds, as well as animals that had been identified as 
having consumed feed supplemented with contaminated pet food scraps but 
none of the adulterated feed was available for testing, continued to be 
held under State quarantine or voluntarily by the producers. The 
disposition of these animals was to be determined on the basis of 
information from on-going investigations of hogs and chickens 
identified as having consumed adulterated feed. As part of these 
investigations, samples of animal feed, urine, and tissues were 
collected and analyzed for melamine concentration.
    In addition, based on the information that was available at the 
time, including information in the interim safety/risk assessment, FSIS 
concluded that it did not have sufficient evidence to demonstrate that 
the pork or poultry products that had already been distributed in 
commerce were injurious to health, unfit for human food, or otherwise 
adulterated under the FMIA or PPIA. Therefore, FSIS decided that it 
would not take action to remove from commerce any pork or poultry 
products that were produced from hogs and chickens that had consumed 
feed supplemented with pet food scraps contaminated with melamine and 
melamine-related compounds, but that had been slaughtered and processed 
prior to May 7, 2007. Thus, FSIS did not request that companies 
voluntarily recall the affected products from commerce. Information on 
the safety of pork and poultry from animals inadvertently fed 
adulterated feed that has become available since that time and is now 
reported in the interim safety/risk assessment further affirms this 
decision.

Actions Taken in Response to Tissue Test Results

    As discussed above, as part of the on-going investigations of hogs 
and chickens identified as having consumed feed supplemented with pet 
food scraps contaminated with melamine and melamine-related compounds, 
samples of animal feed, urine, and tissues were collected and analyzed 
for melamine concentration. Information from these ongoing 
investigations is being used to examine the relationship between 
melamine levels in feed and the levels in animal tissues, assess the 
changes in melamine level in the animals over time, and compare the 
level found in animals and feed with concentrations that could pose a 
risk to humans.
    On May 12, 2007, FSIS completed its validation of the methodology 
used to detect melamine concentration in pork tissues. The current 
analytical method for measuring melamine concentrations in pork can 
screen for melamine concentrations in pork tissue at 50 ppb and above. 
It should be noted that 50 ppb represents a conservative estimate for 
the method employed. All pork samples analyzed to date have had 
melamine concentrations below the validated 50 ppb screening level 
(ranges measured were estimated to be from 9 to 12 ppb), including 
samples from hogs identified as having consumed the highest percentage 
of pet food scraps, as to which the hog feed was composed primarily, if 
not exclusively, of the contaminated pet food scraps.
    On May 15, 2007, USDA issued a press release that announced that 
results of testing conducted on tissue samples from hogs confirm that 
meat from hogs fed animal feed supplemented with pet food scraps 
containing melamine and melamine-related compounds is safe for human 
consumption. The press release also announced that hogs being held on 
farms because they had consumed adulterated feed would be released and 
approved for slaughter and processing into human food. The press 
release explained that the interim safety/risk assessment had been 
updated to reflect the melamine concentration for pork of 50 ppb 
screening level. The conclusion of the interim safety/risk assessment 
did not change.
    Subsequent to the development of the validated testing method for 
hog tissue, FSIS validated the test methodology used to screen for 
melamine concentration levels in poultry tissue at the 50 ppb level. 
All poultry tissue samples analyzed to date have had melamine 
concentrations below 50 ppb. On May 18, 2007, a USDA press release 
announced that the validated test for poultry confirms the safety of 
eating meat from chickens fed poultry feed supplemented with pet food 
scraps containing melamine and melamine-related compounds. The press 
release also announced that, based on the results of the tests, 
approximately 80,000 birds that were being held on farms in Indiana 
were to be released and approved for slaughter and processing into 
human food.
    Thus, as announced on May 15, 2007, regarding hogs, and on May 18, 
2007, regarding chickens, FSIS has decided to allow all animals 
identified as having consumed pet food scraps contaminated with 
melamine and melamine-related compounds to be offered for slaughter. 
Based on the results of the measured melamine concentration in pork and 
poultry tissue samples from animals exposed to adulterated feed, 
together with the findings of the interim safety/risk assessment, FSIS 
had determined that it is able to find that pork and poultry products 
from animals that have consumed feed that contains pet food scraps 
contaminated with melamine and melamine-related compounds are ``not 
adulterated'' and thus eligible to receive the mark of inspection as 
required under the FMIA and PPIA.
    At the time of publication of this Federal Register notice, all 
hogs and chickens that were previously under State quarantine or being 
held voluntarily by the producers because they had been identified as 
having consumed adulterated feed have been released.

Request for Comments

    FSIS requests comments on the findings articulated by FSIS in this 
Federal Register notice, and specifically on whether the FSIS findings 
are appropriate to protect public health. Comments on the interim 
safety/risk assessment should be submitted to FDA as instructed 
elsewhere in this issue of the Federal Register.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
document, FSIS will announce it on-line through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/2007_Notices_Index/index.asp.
 FSIS will also make copies of this Federal 

Register publication available through the FSIS Constituent Update, 
which is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, recalls, and other types of information that could affect or 
would be of interest to constituents and stakeholders. The update is 
communicated via Listserv, a free electronic mail subscription service 
for industry, trade and farm groups, consumer interest groups, allied 
health professionals, and other individuals

[[Page 29948]]

who have asked to be included. The update is available on the FSIS Web 
page. Through the Listserv and Web page, FSIS is able to provide 
information to a much broader and more diverse audience. In addition, 
FSIS offers an e-mail subscription service which provides automatic and 
customized access to selected food safety news and information. This 
service is available at http://www.fsis.usda.gov/news_&_events/email_subscription/
.

    Options range from recalls to export information to regulations, 
directives and notices. Customers can add or delete subscriptions 
themselves and have the option to password-protect their account.

    Done at Washington, DC, on May 23, 2007.
David Goldman,
Acting Administrator.
[FR Doc. 07-2649 Filed 5-25-07; 8:45 am]

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