[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
