[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67186-67187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0574]


Interim Safety and Risk Assessment of Melamine and Its Analogues 
in Food for Humans; 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 Safety and Risk 
Assessment of Melamine and Its Analogues in Food for Humans.'' The 
interim safety/risk assessment evaluated exposure to melamine and its 
analogues (cyanuric acid, ammelide and ammeline) in infant formula and 
other foods to identify, where possible, a level of exposure that would 
not raise public health concerns. FDA is seeking public comment on the 
interim safety/risk assessment.

DATES: Comments on the interim safety/risk assessment must be submitted 
by January 12, 2009.

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 electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1057, FAX: 
301-436-2973, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the interim safety/risk assessment is to identify 
the level of melamine and melamine-related compounds in food which 
would not raise public health concerns. On September 11, 2008, FDA 
learned that melamine may be contained in an infant formula 
manufactured by a firm in China. As of September 21, 2008, FDA learned 
that a total of 52,857 cases of nephrolithiasis (and, in some 
instances, renal failure) had been reported in China linked to 
consumption of this contaminated powdered formula. There have been 
approximately 13,000 hospitalizations, and at least 3 deaths have been 
confirmed to date. The results of an investigation conducted in China 
indicated that Chinese-produced powdered infant formula was linked to 
these illnesses; no cases were associated with liquid infant formula. 
Test results conducted in China on samples of the powdered infant 
formula showed that they contained a wide range of concentrations (0.1 
parts per million (ppm) to greater than 2,500 ppm melamine). In 
addition, other countries have reported detection of melamine in other 
product categories, such as confections and beverages.
    The interim safety/risk assessment concludes that, based on 
currently available data and information, there is too much uncertainty 
for FDA to establish a level of melamine and its analogues in infant 
formula that does not raise public health concerns. In foods other than 
infant formula, FDA concludes that levels of melamine and

[[Page 67187]]

melamine-related compounds below 2.5 ppm do not raise public health 
concerns. This interim safety/risk assessment was developed rapidly due 
to the extremely time-sensitive need to understand the nature of the 
potential risk. We are seeking public comment on this interim safety/
risk assessment. 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 safety/
risk assessment of melamine and its analogues builds upon the 2007 
Melamine Safety/Risk Assessment and considers the toxicological profile 
of melamine and its analogues, including the observed results from 
controlled animal studies conducted with melamine.
    For infant formula, there are gaps in our scientific knowledge 
about the toxicity of melamine and its analogues in infants, including:
    1. The consequences of the continuous use of infant formulas as the 
sole source of nutrition;
    2. The uncertainties associated with the possible presence and co-
ingestion of more than one melamine analogue; and
    3. For premature infants with immature kidney function, the 
possibility that they may be fed these formulas as the sole source of 
nutrition and thus on a body weight basis experience greater levels of 
intake for a longer time than is experienced by term infants. For these 
reasons, there is too much uncertainty for FDA to establish a level of 
melamine and its analogues in infant formula that does not raise public 
health concerns. However, it is important to understand that this does 
not mean that any exposure to any detectable level of melamine and 
melamine-related compounds in formula will result in harm to infants.
    In food products other than infant formula, to estimate the level 
of melamine that does not raise public health concerns, FDA used a 
worst case exposure scenario in which one-half of a person's total 
daily dietary intake (Tolerable Daily Intake (TDI), an estimate of the 
maximum amount of an agent to which an individual could be exposed on a 
daily basis over the course of a lifetime without appreciable health 
risk) is contaminated with melamine and its analogues. The TDI used, 
0.63 milligrams/kilogram (mg/kg) body weight/day (bw/d), was developed 
in 2007 in collaboration with the Food Safety and Inspection Service of 
the Department of Agriculture and in consultation with the Centers for 
Disease Control and Prevention, the Environmental Protection Agency, 
and the Department of Homeland Security.\1\ In the present interim 
safety/risk assessment, we estimated that if 50 percent of the diet 
were contaminated at a level of 2.5 ppm of melamine and its analogues, 
a person's daily intake would equal 0.063 mg/kg bw/d --a level 10-fold 
below the TDI. Therefore, FDA concludes that levels of melamine and 
melamine-related compounds below 2.5 ppm do not raise public health 
concerns in food other than infant formula.
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    \1\Interim Melamine and Analogues Safety/Risk Assessment, May 
25, 2007 (http://www.cfsan.fda.gov/~dms/melamra.html).
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    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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    The interim safety/risk assessment is available electronically at 
http://www.cfsan.fda.gov/~dms/melamra3.html.

    Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26869 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S