[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30014-30015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0208]


Interim Melamine and Melamine Analogues Safety/Risk Assessment; 
Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled, ``Interim Melamine and Melamine 
Analogues Safety/Risk Assessment.'' The interim safety/risk assessment 
describes the risk to human health associated with eating pork, 
chicken, fish, and eggs from animals that were inadvertently fed animal 
feed that contained melamine and its analogues (cyanuric acid, ammelide 
and ammeline). FDA is seeking public comment on the interim safety/risk 
assessment to assist the agency and the Food Safety and Inspection 
Service (FSIS) at the U. S. Department of Agriculture (USDA) in the 
ongoing investigation of contaminated vegetable protein products 
imported from China that were mislabeled as ``wheat gluten'' and ``rice 
protein concentrate,'' and ensuring the safety of the U.S. food supply.

DATES: Comments on the interim safety/risk assessment must be submitted 
by June 29, 2007.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit

[[Page 30015]]

electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: P. Michael Bolger, Chief, Risk 
Assessment Staff, Center for Food Safety and Applied Nutrition (HFS-
308), 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-
1941, FAX 301-436-2632, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The interim safety/risk assessment was prepared by FDA in 
collaboration with FSIS and in consultation with the Centers for 
Disease Control and Prevention, the Environmental Protection Agency, 
and the Department of Homeland Security. The purpose of the safety/risk 
assessment is to assist FDA and FSIS in the ongoing investigation of 
contaminated vegetable protein products imported from China that were 
mislabeled as ``wheat gluten'' and ``rice protein concentrate,'' and 
ensuring the safety of the U.S. food supply. The interim safety/risk 
assessment concludes that, based on currently available data and 
information, the consumption of even large amounts of pork, chicken, 
fish, and/or eggs from animals that had been inadvertently fed animal 
feed contaminated with melamine and its analogues is very unlikely to 
pose a human health risk. This safety/risk assessment was developed 
rapidly due to the extremely time-sensitive need to understand the 
nature of the potential risk. However, we are seeking public comment on 
this interim safety/risk assessment, and in addition it will undergo 
expert peer review.

II. Safety/Risk Assessment

    A human health safety/risk assessment is a scientifically-based 
methodology used to estimate risk to human health from exposure to 
specific compounds such as contaminant(s) in food. The interim melamine 
and its analogues safety/risk assessment addresses:
    (1) The chemical characteristics of melamine and its analogues;
    (2) The toxicological profile of melamine and its analogues, 
including the observed results from controlled animal studies conducted 
with melamine; and
    (3) The likelihood that consumption of pork, chicken, fish and eggs 
from animals fed feed contaminated with melamine and its analogues 
poses a health risk to humans.
    FDA used the following methodology to develop the safety/risk 
assessment. The safety/risk assessment was based on the currently 
available scientific data and information. FDA estimated human exposure 
to melamine and its analogues based on the estimated levels in specific 
foods and the estimated consumption of those foods. The agency compared 
the exposure estimate to a ``Tolerable Daily Intake'' level, which was 
derived using available toxicity data on the level of melamine that did 
not cause adverse renal effects in a laboratory-animal (13-week rat) 
bioassay study. FDA adjusted this level, ``the No Observed Adverse 
Effect Level'' for uncertainty in the data by dividing by a safety/
uncertainty factor of 100 to account for differences in sensitivity 
within and across species.
    Recognizing the time-sensitive need for the safety/risk assessment, 
FDA invites comments concerning:
    (1) The assessment approach used;
    (2) The assumptions made;
    (3) The data used; and
    (4) The transparency and clarity of the report.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    The interim safety/risk assessment is available electronically at 
http://www.cfsan.fda.gov/~dms/melamra.html.

    Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-2679 Filed 5-25-07; 8:45 am]
BILLING CODE 4160-01-S