[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Rules and Regulations]
[Pages 35568-35570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15220]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2010-F-0537]
Food Additives Permitted in Feed and Drinking Water of Animals;
Gamma-Linolenic Acid Safflower Meal
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of seed meal from
a variety of bioengineered safflower in cattle and poultry feeds. This
action is in response to a food additive petition filed by Arcadia
Biosciences, Inc.
DATES: This rule is effective June 22, 2015. Submit either written or
electronic objections and requests for a hearing by July 22, 2015. See
section V of this document for information on the filing of objections.
ADDRESSES: You may submit either electronic or written objections and a
request for a hearing, identified by
[[Page 35569]]
Docket No. FDA-2010-F-0537, by any of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All objections received will be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
objections, see the ``Objections'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5877,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of October 20, 2010
(75 FR 64733), FDA announced that a food additive petition (animal use)
(FAP 2267) had been filed by Arcadia Biosciences, Inc., 202 Cousteau
Pl., suite 105, Davis, CA 95618. The petition proposed to amend the
food additive regulations to provide for the safe use of seed meal from
a variety of bioengineered safflower (Carthamus tinctorius L.) in
cattle and poultry feeds. The safflower variety has been bioengineered
to contain a gene from the water mold Saprolegnia diclina responsible
for production of gamma-linolenic acid in the seed oil. Seed meals are
the ground residues obtained after processing seeds to extract their
oil and are a common ingredient in livestock feed. The notice of filing
provided for a 30-day comment period on the petitioner's environmental
assessment.
II. Conclusion
FDA concludes that the data establish the safety and utility of
gamma-linolenic acid safflower meal for use as proposed and that the
food additive regulations should be amended as set forth in this
document.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec. 571.1(h), we
will delete from the documents any materials that are not available for
public disclosure.
IV. Environmental Impact
The Agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (address above) between 9 a.m. and 4 p.m., Monday through
Friday.
V. Objections and Hearing Requests
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision 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.
It is only necessary to send one set of documents. Identify
documents 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 Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for 21 CFR part 573 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Add Sec. 573.490 to read as follows:
Sec. 573.490 Gamma-linolenic acid safflower meal.
The food additive consists of the meal obtained after the removal
of most of the oil from whole seeds or partially dehulled seeds or both
obtained from a Carthamus tinctorius L. safflower Centennial variety
genetically engineered to express the delta-6-desaturase gene from
Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase
enzyme converts the fatty acid linoleic acid to gamma-linolenic acid
during seed development. The resulting additive may be safely used in
cattle and poultry feeds in accordance with the following prescribed
conditions:
(a) The additive shall contain not less than 20 percent crude
protein, not more than 40 percent crude fiber, not more than 10 percent
moisture, and not more than 2 percent crude fat.
(b) The crude fat in the additive meets the following
specifications:
(1) Gamma-linolenic acid content not to exceed 55 percent.
(2) Total content of stearidonic acid and cis, cis-6, 9-
octadecadienoic acid not to exceed a total of 0.5 percent.
(3) Total content of palmitic, stearic, oleic, linoleic, and other
associated fatty acids to exceed a total of 40 percent.
(c) The additive is used or intended for use in cattle and poultry
feeds as a source of protein in accordance with good manufacturing and
feeding practices.
(d) To assure safe use of the additive, in addition to the other
information required by the Food, Drug, and Cosmetic Act, the label and
labeling of
[[Page 35570]]
the additive, any feed premix, or complete feed shall bear the
following:
(1) The name of the additive or the common name, safflower meal.
(2) Adequate directions for use in cattle and poultry feeds.
(e) The additive may be identified by the common or usual name,
safflower meal.
Dated: June 16, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-15220 Filed 6-19-15; 8:45 am]
BILLING CODE 4164-01-P