[Federal Register Volume 61, Number 220 (Wednesday, November 13, 1996)]
[Proposed Rules]
[Pages 58151-58152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 96N-0244]


Food Labeling: Declaration of Free Glutamate in Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to March 
12, 1997, the comment period for the advance notice of proposed 
rulemaking (ANPRM) on the declaration of free glutamate in food. The 
ANPRM appeared in the Federal Register of September 12, 1996. The 
agency is taking this action in response to requests for an extension 
of the comment period. This extension is intended to allow interested 
persons additional time to submit comments to FDA on the declaration of 
free glutamate in foods.

DATES: Written comments by March 12, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Felicia B. Satchell, Center for Food 
Safety and Applied Nutrition (HFS-158), 200 C St. SW., Washington, DC 
20204, 202-205-5099.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 12, 
1996 (61 FR 48102), FDA issued an ANPRM announcing that it is: (1) 
Considering establishing labeling requirements to alert MSG-intolerant 
consumers to the presence of free glutamate in a food when the amount 
of free glutamate in a serving of the food may contribute to the 
occurrence of adverse reactions, and (2) intending to establish formal 
criteria for the use of claims about the absence of MSG to ensure that 
labels bearing such claims are not misleading. The agency asked a 
series of questions on both issues. In particular, the agency requested 
data on the levels of glutamate in foods to determine how many and what 
kinds of foods would be affected by various regulatory approaches and 
the associated costs of requiring free glutamate labeling. Interested 
persons were given until November 12, 1996, to comment on the ANPRM.
    FDA received two requests for a 120-day extension of the comment 
period on its ANPRM on declaration of free glutamate. The requests were 
from trade associations that collectively represent more than 90 
percent of the food industry. Both requests indicated that industry 
representatives would need to collect and analyze relevant data before 
comments could be compiled. One request further explained that the data 
requested by the agency in the ANPRM are not readily available, and 
that the food industry began collecting this data only after the 
September 12, 1996, publication of the ANPRM. Furthermore, because of 
the unanticipated demand for the test kits necessary to measure the 
glutamate content in foods and the limited number of suppliers of the 
test kits, the delivery of the kits has been delayed. As further 
discussed in the second request for an extension, it is expected that 
the collection and analysis of the preliminary data to identify foods 
that would be affected by a labeling policy would require an additional 
45 days. Once such data have been analyzed it is expected that an 
additional 60 days will be required to collect and analyze cost 
estimate data to address analytical costs, administrative costs, 
potential reformulation costs, label redesign costs, printing costs, 
and the value of any discarded label and package inventory. Following 
analysis of the data, a few additional days will be needed to prepare 
final comments.
    After careful consideration, FDA has decided to extend the comment 
period to March 12, 1997, to allow additional time for the submission 
of comments on whether the agency should establish labeling 
requirements to alert MSG-intolerant consumers to the presence of free 
glutamate in food and whether the agency should establish formal 
criteria for the use of claims about the absence of MSG. In the ANPRM, 
the agency asked a series of questions and requested data, as discussed 
above, because the agency did not have sufficient information on which 
to base a labeling policy for free glutamate or establish criteria for 
a ``No MSG'' claim. Consequently, the agency believes that extending 
the comment period to allow the requested data to be collected is 
prudent and in the consumer's best interest, because any labeling 
policy that the agency develops should be based on data that are sound, 
valid, and that accurately reflects the free glutamate content of 
foods.
    Interested persons may, on or before March 12, 1997, submit to the 
Dockets

[[Page 58152]]

Management Branch (address above) written comments regarding this 
proposal. Two copies of any comments are to be submitted, except that 
individuals may submit one 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 office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: November 8, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29237 Filed 11-8-96; 2:56 pm]
BILLING CODE 4160-01-F