[Federal Register Volume 60, Number 125 (Thursday, June 29, 1995)]
[Rules and Regulations]
[Pages 33710-33711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15924]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 94F-0222]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Calcium Disodium EDTA

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 to provide for the safe use of calcium disodium 
EDTA (ethylenediaminetetraacetate) to promote color retention for 
canned, cooked fava beans. This action is in response to a petition 
filed by Ramico Foods, Inc.

DATES: Effective June 29, 1995; written objections and requests for a 
hearing by July 31, 1995.

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

FOR FURTHER INFORMATION CONTACT: Mary E. LaVecchia, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3072.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 14, 1994 (59 FR 35933), FDA announced that a food 
additive petition (FAP 3A4404) had been filed by Ramico Foods, Inc., 
8245 Le Creusot, St-Leonard, Quebec, CANADA H1P 2A2. The petition 
proposed to amend the food additive regulations in Sec. 172.120 Calcium 
disodium EDTA (21 CFR 172.120) to provide for the safe use of calcium 
disodium EDTA to promote color retention for canned, cooked fava beans.
    FDA has evaluated data in the petition and other relevant material 
and concludes that the proposed food additive use of calcium disodium 
EDTA is safe, and that Sec. 172.120 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 21 CFR 
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 carefully considered the potential environmental 
effects of this action. 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 an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 31, 1995, file with the Dockets Management 
Branch (address above) written objections thereto. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 172

     Food additives, Reporting and recordkeeping requirements.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

 PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

     1. The authority citation for 21 CFR part 172 continues to read as 
follows:

     Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).
     2. Section 172.120 is amended in the table in paragraph (b)(1) by 
alphabetically adding a new entry to read as follows:


Sec. 172.120  Calcium disodium EDTA.

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    (b) * * *

[[Page 33711]]

    (1) * * *

                                                                        
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                          Limitation (parts per                         
          Food                   million)                   Use         
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                      *      *      *      *      *                     
Fava beans (cooked       365....................  Promote color         
 canned).                                          retention.           
                      *      *      *      *      *                     
------------------------------------------------------------------------

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    Dated: June 15, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-15924 Filed 6-28-95; 8:45 am]
BILLING CODE 4160-01-F