[Federal Register Volume 61, Number 151 (Monday, August 5, 1996)]
[Notices]
[Pages 40648-40649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19743]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 84G-0257]


Enzyme Technical Association; Filing of Petition for Affirmation 
of GRAS Status; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a petition (GRASP 3G0016) filed by the Enzyme Technical 
Association (formerly the Ad Hoc Enzyme Technical Committee). The 
document proposed to affirm that certain enzyme preparations from 
animal, plant, and microbial sources are generally recognized as safe 
(GRAS) as direct human food ingredients. This amendment proposes to 
affirm that carbohydrase and protease enzyme preparations from Bacillus 
amyloliquefaciens are GRAS as direct human food ingredients.

DATES: Comments by October 21, 1996.

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

FOR FURTHER INFORMATION CONTACT:  Linda S. Kahl, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3101.

SUPPLEMENTARY INFORMATION:  In accordance with the procedures described 
in Sec. 170.35 (21 CFR 170.35), the Ad Hoc Enzyme Technical Committee 
(now the Enzyme Technical Association), c/o Miles Laboratories, Inc., 
1127 Myrtle St., Elkhart, IN 46514, submitted a petition (GRASP 3G0016) 
requesting that the following enzyme preparations be affirmed as GRAS 
for use in food: ---
    -1. Animal-derived enzyme preparations: Catalase (bovine liver); 
lipase, animal; pepsin; rennet; rennet, bovine; and trypsin.
    -2. Plant-derived enzyme preparations: Bromelain; malt; and papain.
    -3. Microbially-derived enzyme preparations: Aspergillus niger, 
var. (lipase, catalase, glucose oxidase, and carbohydrase); B. 
subtilis, var. (carbohydrase and protease mixtures); Rhizopus oryzae 
(carbohydrase); and Saccharomyces species (carbohydrase).
     -In the Federal Register of April 12, 1973 (38 FR 9256), FDA 
published a notice of filing of this petition and gave interested 
persons an opportunity to submit comments to the Dockets Management 
Branch (address above). The petition was amended by notices published 
in the Federal Register of: (1) June 12, 1973 (38 FR 15471), proposing 
affirmation that microbially derived enzyme preparations (carbohydrase, 
lipase, and protease) from A. oryzae are GRAS for use in food; (2) 
August 29, 1984 (49 FR 34305), proposing affirmation that the enzyme 
preparations ficin, obtained from species of the genus Ficus (fig 
tree), and pancreatin, obtained from bovine and porcine pancreas, are 
GRAS for use in food; and (3) June 23, 1987 (52 FR 23607), proposing 
affirmation that the enzyme preparation protease from A. niger is GRAS 
for use in food. In the June 23, 1987, notice, FDA also noted the 
petitioner's assertion that pectinase enzyme preparation from A. niger 
and lactase enzyme preparation from A. niger are included under 
carbohydrase enzyme preparation from A. niger, and that invertase 
enzyme preparation from Saccharomyces cerevisiae and lactase enzyme 
preparation from Kluyveromyces marxianus are both included under 
carbohydrase enzyme preparation from species of the genus 
Saccharomyces. The agency further noted that, therefore, pectinase 
enzyme preparation from A. niger, lactase enzyme preparation from A. 
niger, invertase enzyme preparation from S. cerevisiae, and lactase 
enzyme preparation from K. marxianus were to be considered part of the 
petition. Interested persons were given an opportunity to submit 
comments to the Dockets Management Branch (address above) on each 
amendment.
    -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, notice is given that the Enzyme Technical Association 
has submitted a further amendment to its petition (GRASP 3G0016). The 
amendment proposes that carbohydrase and protease enzyme preparations 
from B. amyloliquefaciens be affirmed as GRAS for use as direct human 
food ingredients based on the taxonomic separation of B. subtilis and 
B. amyloliquefaciens in

[[Page 40649]]

1987. The amendment has been placed on display at the Dockets 
Management Branch (address above).
    -Any petition that meets the requirements outlined in 21 CFR 170.30 
and Sec. 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 agency has determined under 21 CFR 25.24(b)(7) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    -Interested persons may, on or before October 21, 1996, review the 
amendment and file comments with the Dockets Management Branch (address 
above). Two copies of any comments 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 substance is, or is not, 
GRAS for the proposed use. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 2, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 96-19743 Filed 8-2-96; 8:45 am]
BILLING CODE 4160-01-F