[Federal Register Volume 66, Number 63 (Monday, April 2, 2001)]
[Rules and Regulations]
[Pages 17508-17509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8060]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 99F-2082]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Food Starch-Modified by Amylolytic Enzymes

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of food starch-
modified by amylolytic enzymes. This action is in response to a 
petition filed by the National Starch and Chemical Co.

DATES: This rule is effective April 2, 2001. Submit written objections 
and requests for a hearing by May 2, 2001.

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, 202-418-3072.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register on July 2, 1999 (64 
FR 36021), FDA announced that a food additive petition (FAP 9A4674) had 
been filed by the National Starch and Chemical Co., 10 Finderne Ave., 
Bridgewater, NJ 08807-0500. The petition proposed to amend the food 
additive regulations in Sec. 172.892(i) Food starch-modified (21 CFR 
172.892(i)) to provide for the safe use of food starch-modified by 
amylolytic enzymes. These amylolytic enzymes include beta-amylase, 
glucoamylase, isoamylase, and pullulanase. This petitioner proposes to 
use these amylolytic enzymes as a method of starch hydrolysis in 
addition to the use of alpha-amylase which is currently approved under 
Sec. 172.892(i). The petitioner also requested that the limitation on 
dextrose equivalent (DE) as a measure of starch hydrolysis not be 
applied to starches hydrolyzed with beta-amylase, glucoamylase, 
isoamylase, or pullulanase. The petitioner states that standard 
practice is to measure starch hydrolysis by viscosity and other 
physiochemical properties rather than by dextrose equivalence which 
measures the ratio of reducing sugars to total sugars.

II. Conclusion

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of beta-amylase, glucoamylase, isoamylase, and pullulanase 
enzymes to modify food starch is safe and that the enzymes will achieve 
their intended technical effect. Additionally, the agency is not

[[Page 17509]]

imposing the limitation that food starch hydrolyzed by beta-amylase, 
glucoamylase, isoamylase, or pullulanase enzymes have a DE of less than 
20.
    Under current Sec. 172.892(i), food starch can only be modified by 
treatment with alpha-amylase (E.C. 3.2.1.1) to produce a nonsweet 
nutritive saccharide polymer with a DE of less than 20. However, the 
agency has concluded that this limitation is not necessary for food 
starch-modified by the petitioned enzymes, beta-amylase, glucoamylase, 
isoamylase, and pullulanase, that the agency is now adding to 
Sec. 172.892(i). Therefore, the agency concludes that the regulations 
in Sec. 172.892(i) 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 previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 9A4674 (64 FR 
36021). 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 May 2, 2001. 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.

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 172.892 is amended by revising the introductory text of 
paragraph (i) and in the table in paragraph (i) by alphabetically 
adding the following entries to read as follows:


Sec. 172.892  Food starch-modified.

* * * * *
    (i) Food starch may be modified by treatment with the following 
enzymes:

----------------------------------------------------------------------------------------------------------------
                         Enzyme                                                Limitations
----------------------------------------------------------------------------------------------------------------
 
 *                  *                  *              *                  *                  *                  *
Beta-amylase (E.C. 3.2.1.2)
Glucoamylase (E.C. 3.2.1.3)
Isoamylase (E.C. 3.2.1.68)
Pullulanase (E.C. 3.2.1.41)
----------------------------------------------------------------------------------------------------------------


    Dated: March 26, 2001.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 01-8060 Filed 3-30-01; 8:45 am]
BILLING CODE 4160-01-S