[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
