[Federal Register Volume 59, Number 199 (Monday, October 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25635]


[[Page Unknown]]

[Federal Register: October 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94G-0313]

 

Hercules Food and Functional Products Co.; Filing of Petition to 
Change Process Description and Food Grade Specifications for Pectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Hercules Food and Functional Products Co. has filed a petition (GRASP 
4G0411) proposing to change the current process description and food 
grade specifications for pectins.

DATES: Written comments by December 16, 1994.

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

FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food 
Safety and Applied Nutrition (HFS-207), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3106.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))) and the regulations for 
affirmation of GRAS status in Sec. 170.35 (21 CFR 170.35), notice is 
given that Hercules Food and Functional Products Co., 1313 North Market 
St., Wilmington, DE 19899-8740, has filed a petition (GRASP 4G0411) 
proposing to amend the current process description and food grade 
specifications for pectin under 21 CFR 184.1588(a) and (b). The present 
regulation incorporates by reference, Food Chemicals Codex, 3d Ed., 
1981, p. 215. The petition requests a revision of the description of 
pectins to harmonize it with the current Codex Alimentarius and a 
Council Directive of the European Union. The petition also requests a 
revision of specifications consistent with the Food Chemicals Codex, 3d 
Supp. to the 3d Ed. A similar proposal has been submitted to the Food 
Chemicals Codex for consideration. The description and the 
specification would affirm the GRAS status of three additional types of 
pectin, namely, amidated high-methoxyl pectins; very low methoxyl 
pectins; and calcium salt of pectins. The petition has been placed on 
display at the Dockets Management Branch (address above) and it may be 
seen between 9 a.m. and 4 p.m., Monday through Friday.
    Any petition that meets the requirements outlined in Secs. 170.30 
(21 CFR 170.30) and 170.35 is filed by the agency. There is no 
prefiling review of the adequacy of data to support a GRAS conclusion. 
Thus, the filing of a petition for GRAS affirmation should not be 
interpreted as a preliminary indication of suitability for GRAS 
affirmation.
    The potential environmental impact of this action is being 
reviewed. If the agency finds that an environmental impact statement is 
not required and this petition results in a regulation, the notice of 
availability of the agency's finding of no significant impact and the 
evidence supporting that finding will be published with the regulation 
in the Federal Register in accordance with 21 CFR 25.40(c).
    Interested persons may, on or before December 16, 1994, review the 
petition and/or file comments with the Dockets Management Branch 
(address above). Two copies of any comment should be filed and should 
be identified with the docket number found in brackets in the heading 
of this document. Comments should include any available information 
that would be helpful in determining whether the proposed description 
and specification should be adopted for food grade pectin. In addition, 
consistent with the regulations promulgated under the National 
Environmental Policy Act (40 CFR 1501.4(b)), the agency encourages 
public participation by review of and comment on the environmental 
assessment submitted with the petition that is the subject of this 
notice. A copy of the petition (including the environmental assessment) 
and received comments may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 4, 1994.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 94-25635 Filed 10-14-94; 8:45 am]
BILLING CODE 4160-01-F