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Secondary Direct Food Additives Permitted in Food for Human Consumption; Monester of alpha-Hydro-omega-Hydroxy-Poly(Oxyethylene) Poly(Oxypropylene) Poly(Oxyethylene) (15 Mole Minimum) Blocked Copolymer
Federal Register, Volume: 63 , Issue: 102 , Page: 29133 (63 FR 29133) , Thursday, May 28, 1998

Agency: Department of Health and Human Services--(HHS); Public Health Service--(PHS); Food and Drug Administration--(FDA); Center for Food Safety and Applied Nutrition--(CFSAN)
Document Type: Rules and Regulations
Code of Federal Regulations (CFR): 21 CFR Part 173
Numbers: Docket No. 97F-0283
Dates: Effective: 19980528 ; Request for hearing: 19980629; Protests: 19980629
Contact Information: Vivian M. Gilliam, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3167.
Action: Final rule.
Internal Data: (FR Doc. 98-14105 Filed 5-27-98; 8:45 am)

SUMMARY: The Food and Drug Administration (FDA) is amending the food additiv regulations for safe use of monoester of alpha-hydro-omega-hydroxy- poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil as a component of defoaming agents used in the washing of sugar beets for processing into sugar. This action responds to a petition filed by Akzo Nobel Chemical, Inc.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
21 CFR Part 173
(Docket No. 97F-0283)
Secondary Direct Food Additives Permitted in Food for Human Consumption; Monester of alpha-Hydro-omega-Hydroxy-Poly(Oxyethylene) Poly(Oxypropylene) Poly(Oxyethylene) (15 Mole Minimum) Blocked Copolymer

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations for safe use of monoester of alpha-hydro-omega-hydroxy- poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil as a component of defoaming agents used in the washing of sugar beets for processing into sugar. This action responds to a petition filed by Akzo Nobel Chemical, Inc.

DATES: The regulation is effective May 28, 1998; written objections and requests for a hearing by June 29, 1998.

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

FOR FURTHER INFORMATION CONTACT: Vivian M. Gilliam, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3167.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of July 11, 1997 (62 FR 37266), FDA announced that a food additive petition (FAP 6A4494) had been filed by Akzo Nobel Chemical, Inc., 5 Livingstone Ave., Dobbs Ferry, NY 10522-3407. The petition proposed to amend the food additive regulations in Sec. 173.340 Defoaming agents (21 CFR 173.340) to provide for the safe use of monoester of a
-hydro-v
-hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene)(15 mole minimum) blocked copolymer derived from low erucic acid rapeseed (LEAR) oil as a component of defoaming agents used in the washing of sugar beets for processing into sugar. (Although the additive was named in the filing notice using the Greek symbols for alpha and omega, the agency has chosen to spell out the words in the listing of the additive to facilitate electronic searches.)

FDA has evaluated data in the petition and other relevant material. Based on this information the agency concludes that the proposed use of monoester of alpha-hydro-omega-hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer is safe, that the additive will achieve its intended technical effect, and therefore, that the regulations should be amended as set forth below.

In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in Sec. 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has previously considered the potential environmental effects of this action, as announced in the notice of filing for FAP 6A4494 (62 FR 37266). FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in a environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. No comments were received during the 30-day comment period specified in the filing notice for comments on the environmental assessment submitted with the petition.

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