[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Notices]
[Pages 58091-58092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00F-0812]


Bayer Co.; Filing of Food Additive Petition; Amendment; 
Withdrawal in Part

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Bayer Co. to clarify that 
the petitioner's request to amend the food additive regulations to 
provide for a more descriptive term in place of ``inhibitor of yeast,'' 
for the safe use of dimethyl dicarbonate (DMDC) will also involve 
adding related limitations to 21 CFR 172.133. The agency is also 
announcing the withdrawal of the petitioner's additional request to 
amend the food additive regulations to provide for the safe use of DMDC 
in noncarbonated juice beverages containing up to and including 100 
percent juice.

FOR FURTHER INFORMATION CONTACT: Martha D. Peiperl, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3077.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 7, 2000 (65 FR 12014), FDA announced that a food 
additive petition (FAP 0A4718) had been filed by Bayer Co., c/o McKenna 
& Cuneo LLP, 1900 K St. NW., Washington, DC 20006-1108. The petition 
proposed to amend the food additive regulations in Sec. 172.133 
Dimethyl dicarbonate (21 CFR 172.133) both to provide for the safe use 
of DMDC in noncarbonated juice beverages containing up to and including 
100 percent juice and to provide for a more descriptive term in place 
of ``inhibitor of yeast,'' for the safe use of DMDC.
    Upon further review of the petition, FDA determined that, if 
granted, the requested amendment of Sec. 172.133 to provide for a more 
descriptive term in place of ``inhibitor of yeast'' for the safe use of 
DMDC will also require adding related limitations to this regulation. 
Therefore, FDA is amending the filing notice of March 7, 2000, to 
indicate that this proposed amendment will involve adding related 
limitations to Sec. 172.133.
    The petitioner's additional request, to amend the food additive 
regulations to provide for the safe use of DMDC in noncarbonated juice 
beverages containing up to and including 100 percent juice, was 
converted to a food contact substance notice (FCN 0035), 21 U.S.C. 
348(h)(5). This request to amend the food additive regulations was 
withdrawn from the petition as of the effective date of FCN 0035 (June 
9, 2000).
    The agency has determined under 21 CFR 25.30(I) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore,

[[Page 58092]]

neither an environmental assessment nor an environmental impact 
statement is required.

    Dated: September 14, 2000.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 00-24843 Filed 9-26-00; 8:45 am]
BILLING CODE 4160-01-F