Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration 

          - [Docket No. 00F-0812] 

# AGENCY:

Food and Drug Administration, HHS. 

# ACTION:

Notice. 

# 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 § 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 § 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 § 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,                           ( print 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