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, 29945-29948 [07-2649]
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• The determination of cooking
parameters for safe seafood for
consumers,
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importance of Mycobacterium avium
subspecies paratuberculosis, and
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rulemaking and policy development is
important. Consequently, in an effort to
ensure that minorities, women, and
persons with disabilities are aware of
this notice, FSIS will announce it online through the FSIS Web page located
at https://www.fsis.usda.gov/regulations/
2007_Notices_Index/. 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
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
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
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 https://
www.fsis.usda.gov/news_and_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 24, 2007.
David P. Goldman,
Acting Administrator.
[FR Doc. E7–10321 Filed 5–29–07; 8:45 am]
BILLING CODE 3410–DM–P
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
Food Safety and Inspection
Service (FSIS), USDA.
ACTION: Notice and request for
comments.
AGENCY:
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.
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29945
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 https://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 https://
www.fsis.usda.gov/.
FOR FURTHER INFORMATION CONTACT: Dr.
Daniel Engeljohn, Deputy Assistant
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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 melaminecontaminated pet food scraps. FSIS
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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 melaminerelated 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
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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 melaminerelated 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 melaminerelated 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
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
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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 ongoing investigations of hogs and
chickens identified as having consumed
feed supplemented with pet food scraps
contaminated with melamine and
melamine-related compounds, samples
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19:13 May 29, 2007
Jkt 211001
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 melaminerelated 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
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29947
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 https://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
E:\FR\FM\30MYN1.SGM
30MYN1
29948
Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
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 https://
www.fsis.usda.gov/news_and_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]
BILLING CODE 3410–DM–P
DEPARTMENT OF AGRICULTURE
Forest Service
Caribou-Targhee National Forest,
Idaho; Big Bend Ridge Vegetation
Management Project and Timber Sale
Supplement Environmental Impact
Statement and Proposed Targhee
Revised Forest Plan Amendment
Forest Service, USDA.
Notice of intent to prepare a
supplemental environmental impact
statement.
AGENCY:
sroberts on PROD1PC70 with NOTICES
ACTION:
SUMMARY: The Caribou-Targhee National
Forest proposes to supplement the Big
Bend Ridge Vegetation Management
Project and Timber Sale analysis and to
consider amending the Targhee Revised
Forest Plan with regard to old growth
and aspen. The supplement will provide
additional analysis and disclosure of
environmental effects.
DATES: Comments concerning the scope
of the analysis must be received within
45 days from the date of this
publication. The draft supplemental
environmental impact statement is
expected in September 2007. The
comment period on the draft
supplemental environmental impact
statement will be 45 days from the date
the Environmental Protection Agency
publishes the notice of availability in
the Federal Register. The final
supplemental environmental impact
statement is expected in early 2008.
ADDRESSES: Send written comments to
Robbin Redman, Forest Planner,
Caribou-Targhee National Forest, 1405
Hollipark Drive, Idaho Falls, Idaho
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19:13 May 29, 2007
Jkt 211001
83401. Electronic comments can be
submitted in rich text format (.rtf), or
Word (.doc) to comments-intermtncaribou-targhee@fs.fed.us.
For further information, mail
correspondence to Robbin Redman,
Forest Planner, Caribou-Targhee
National Forest, 1405 Hollipark Drive,
Idaho Falls, Idaho 83401 or call (208)
557–5821.
FOR FURTHER INFORMATION CONTACT:
Robbin Redman, Forest Planner,
Caribou-Targhee National Forest, USDA,
(see address above).
SUPPLEMENTARY INFORMATION: The Forest
Service, working with the public,
developed the Big Bend Ridge
Vegetation Management Project and
Timber Sale over numerous years
beginning in 1998. The process
included publishing a Notice of Intent
(NOI), seeking comments (scoping) on
the proposed project and also seeking
comments on the Draft EIS that
included various alternatives for the
project. On December 12, 2003 a Record
of Decision selecting Alternative C was
signed by the Forest Supervisor. This
decision was appealed and upheld by
the Intermountain Regional Forester.
After the ROD was upheld on appeal,
a Complaint was filed in Idaho District
Court. In the Complaint the Plaintiffs
sought to enjoin the Big Bend
Vegetation Management Project and
Timber Sale project. The Court did not
enjoin the Big Bend Vegetation
Management Project and Timber Sale in
its November 2004 ruling stating the
logging was not imminent. The Court
did enjoin the Big Bend Ridge
Vegetation Project and Timber Sale on
September 28, 2005 in its Memorandum
Decision and Order when it determined
the logging was imminent.
To address the Court’s decision on the
Big Bend Ridge Vegetation Project and
Timber Sale, the Forest has completed
a draft vegetation assessment of old
growth and aspen for the Targhee
National Forest. This preliminary
information revealed that more
clarification and guidance in the
Targhee Revised Forest Plan (TRFP) is
needed to assess, monitor, and manage
old growth and aspen forests, and the
proposed Targhee amendment is a result
of this assessment.
Project and Timber Sale analysis and to
consider updating the Targhee Revised
Forest Plan (TRFP) with regard to
managing old growth, and aspen forests.
This draft assessment will be used in
the Forest’s review of the Big Bend
Ridge Vegetation Management Project
and Timber Sale and incorporated into
the DSEIS and FSEIS for the project. In
the SEIS process for the Big Bend Ridge
Vegetation Management Project and
Timber Sale, the Forest will consider
amending the TRFP as needed to
address clarification of old growth forest
and aspen.
The purpose and need for the Big
Bend Ridge Vegetation Management
Project and Timber Sale is: (1) Need for
ecosystems and their components to be
resilient to disturbances to structure,
composition and processes at
appropriate landscape scales. (2) Need
to improve overall representation of
forested age classes across the landscape
over the long-term. (3) Need to maintain
and regenerate declining species (at
risk). (4) Need to provide for a sustained
yield of forest products.
Purpose and Need for Action
New information and a court ruling
on the Big Bend Ridge Vegetation
Management Project has shown that
more clarification and guidance to
assess, monitor, and manage old growth
forest is needed. The Forest has
determined a need to supplement the
Big Bend Ridge Vegetation Management
Possible Alternatives
The Forest has developed the
Proposed Action for the TRFP
amendment as discussed above and the
no-action alternative.
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Proposed Action
The Forest will supplement the
analysis for the Big Bend Ridge
Vegetation Management Project and
Timber Sale with regard to old growth,
and aspen. The Forest also proposes to
amend the TRFP to make it consistent
regarding old growth, and aspen.
The Forest proposes to develop
Desired Future Conditions for old
growth, and aspen that would be
incorporated into the Targhee Revised
Forest Plan. The Forest also proposes to
remove the current guidance for old
growth/late seral management found on
page III–12–13 #6 of the Targhee
Revised Forest Plan.
The Big Bend Ridge Vegetation
Management Project includes the
following: harvesting by thinning from
below and also some limited sanitation
improvement harvest, planting a limited
amount of trees (approximately 200
acres), closing some non-system roads
before and after harvest, relocating a
specific road, some maintenance of
roads used in the harvest activities,
fencing some aspen units if needed, and
some temporary road construction with
rehabilitation after harvest.
Responsible Official
The responsible official is: Lawrence
Timchak, Forest Supervisor, Caribou-
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]]>Agencies
[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 29945-29948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2649]
-----------------------------------------------------------------------
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 https://
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 https://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 https://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
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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 https://www.fsis.usda.gov/news_and_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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