[Federal Register Volume 65, Number 153 (Tuesday, August 8, 2000)]
[Rules and Regulations]
[Pages 48377-48379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 00F-0119]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Calcium Disodium EDTA and 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) or disodium EDTA to promote color 
retention for all edible types of cooked, canned legumes. This action 
is in response to a petition filed by the National Food Processors 
Association.

DATES: This rule is effective August 8, 2000. Submit written objections 
and requests for a hearing by September 7, 2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary E. LaVecchia, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3042.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of January 20, 2000 
(65 FR

[[Page 48378]]

3242), FDA announced that a food additive petition (FAP 0A4709) had 
been filed by the National Food Processors Association, 1350 I St. NW., 
suite 300, Washington, DC 20005. The petition proposed to amend the 
food additive regulations in Secs. 172.120 Calcium Disodium EDTA (21 
CFR 172.120) and 172.135 Disodium EDTA (21 CFR 172.135) to provide for 
the safe use of calcium disodium EDTA or disodium EDTA to promote color 
retention for all edible types of cooked, canned legumes.
    A review of the petition establishes that the petition proposes the 
use of 365 parts per million (ppm) of calcium disodium EDTA or 165 ppm 
disodium EDTA in all cooked, canned legumes, other than those cooked, 
canned legumes currently listed in Sec. 172.120 or Sec. 172.135. FDA 
has determined that consumer exposure to calcium disodium EDTA and 
disodium EDTA will not increase from the proposed use (Ref. 1). The 
agency notes that consumption of cooked, canned legumes is 
substitutional,  i.e., the consumer will generally eat one type of 
cooked, canned legume or another at any given time and not increase the 
overall consumption of cooked, canned legumes. Additionally, the agency 
expects that no more of the additive will be used than necessary, up to 
a maximum of 365 ppm for calcium disodium EDTA and up to a maximum of 
165 ppm disodium EDTA, to achieve the intended technical effect of 
promoting color retention in cooked, canned legumes.

II. Conclusions

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of the additives is safe, that the additives will achieve 
their intended technical effect, and therefore, that the regulations in 
Secs. 172.120 and 172.135 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.

III. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this rule as announced in the notice of filing for FAP 
0A4709. No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by September 7, 2000. 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 are to be 
submitted and are to 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.

VI. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from M. DiNovi, Division of Product Manufacture and 
Use, FDA, to M. LaVecchia, Division of Petition Control, FDA, February 
8, 2000.

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: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

    2. Section 172.120 is amended in the table in paragraph (b)(1) by 
removing the entry for ``Fava beans (cooked canned)'', and by 
alphabetically adding an entry for ``Legumes (all cooked canned, other 
than dried lima beans, pink beans, and red beans)'' to read as follows:


Sec. 172.120  Calcium disodium EDTA.

* * * * *
    (b) * * *
    (1) * * *

[[Page 48379]]



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                        Food                                        Limitation (parts per million)                                 Use
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                    *                  *                  *                  *                  *                  *                  *
Legumes (all cooked canned, other than dried lima                                                          365   Promote color retention.
 beans, pink beans, and red beans).
                    *                  *                  *                  *                  *                  *                  *
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* * * * *
    3. Section 172.135 is amended in the table in paragraph (b)(1) by 
removing the entry for ``Canned cooked chickpeas'' and by 
alphabetically adding an entry for ``Legumes (all cooked canned, other 
than black-eyed peas)'' to read as follows:


Sec. 172.135  Disodium EDTA.

* * * * *
    (b) * * *
    (1) * * *

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                        Food                                        Limitation (parts per million)                                 Use
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                    *                  *                  *                  *                  *                  *                  *
Legumes (all cooked canned, other than black-eyed                                                          165   Promote color retention.
 peas).
                    *                  *                  *                  *                  *                  *                  *
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* * * * *

    Dated: July 19, 2000.
L. Robert Lake,
Director for Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-19990 Filed 8-7-00; 8:45 am]
BILLING CODE 4160-01-F