[Federal Register: November 21, 2003 (Volume 68, Number 225)]
[Rules and Regulations]
[Page 65632-65633]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no03-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. 1998F-0522]
Food Additives Permitted in Feed and Drinking Water of Animals;
Formaldehyde
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for food additives permitted in feed to provide for the
safe use of formaldehyde to improve the handling characteristics of
canola and soybean oilseeds and/or meals in feed for beef and dairy
cattle, and to provide a description of the food additive. This action
is in response to a food additive petition filed by Rumentek Industries
Pty Ltd.
DATES: This rule is effective November 21, 2003. Submit written
objections and request for hearing by January 20, 2004. The Director of
the Office of the Federal Register approves the incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR 51 of certain
publications in 21 CFR 573.460 as of November 21, 2003.
ADDRESSES: Submit written objections and request for hearing to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit objections
electronically to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Karen Ekelman, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6653, e-mail: kekelman@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of August 11, 1998
(63 FR 42856), FDA announced that a food additive petition (animal use)
(FAP 2241) had been filed by Rumentek Industries Pty Ltd., 63-69 Market
St., South Melbourne, Vic 3205 Australia. The petition proposed to
amend the food additive regulations in part 573 (21 CFR part 573) to
provide for the safe use of formaldehyde to improve the handling
characteristics of soybean and canola oilseeds and/or meals in feeds
for beef and dairy cattle. The notice of filing provided for a 60-day
comment period on the petitioner's environmental assessment. No
substantive comments have been received.
In the regulation in Sec. 571.1(c) (21 CFR 571.1(c)), paragraph E
of the form for petitions requires full reports of investigations of
the safety of a food additive. The Center for Veterinary Medicine (CVM)
evaluated information in the petition and in the scientific literature
and has determined that the use of formaldehyde to improve the handling
characteristics of soybean and canola oilseeds and/or meals in feeds
for beef and dairy cattle is safe under the conditions of use
prescribed in the amended regulation (Sec. 573.460).
II. Conclusion
FDA concludes that the data establish the safety and utility of
formaldehyde 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), 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 CVM by appointment
with the information contact person listed previously. As provided in
Sec. 571.1(h), the agency will delete from the documents any materials
that are not available for public disclosure before making the
documents available for inspection.
IV. Environmental Impact
The agency has determined under 21 CFR 25.32(r) 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.
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) written
objections (see DATES). Each objection must be separately numbered, and
each numbered objection must 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 must
state that a hearing is requested. Failure to request a hearing for any
particular objection will constitute a waiver of the right to a hearing
on that objection. Each numbered objection for which a hearing is
requested must 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 will constitute
a waiver of the right to a hearing on the objection. Three copies of
all documents must be submitted and must 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives, Incorporation by reference.
0
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:
[[Page 65633]]
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. Section 573.460 is amended by revising paragraph (a) to read as
follows:
Sec. 573.460 Formaldehyde.
* * * * *
(a) The additive is used, or intended for use, to improve the
handling characteristics of fat by producing a dry, free-flowing
product, as follows:
(1) For animal fat in combination with certain oilseed meals, as a
component of dry, nonpelletted feeds for beef and nonlactating dairy
cattle.
(i) An aqueous blend of soybean and sunflower meals in a ratio of
3:1, respectively, is mixed with animal fat such that the oilseed meals
and animal fat are in a ratio of 3:2. The feed ingredients are those
defined by the ``Official Publication'' of the Association of American
Feed Control Officials, Inc., 2003 ed., pp. 303, 308, and 309, which is
incorporated by reference. The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
Assistant Secretary-Treasurer, Association of American Feed Control
Officials Inc., P.O. Box 478, Oxford, IN 47971, or you may examine a
copy at the Division of Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or at
the Office of the Federal Register, 800 North Capitol St. NW., suite
700, Washington, DC.
(ii) Formaldehyde (37 percent solution) is added to the mixture at
a level of 4 percent of the dry matter weight of the oilseed meals and
animal fat. This mixture, upon drying, contains not more than 1 percent
formaldehyde and not more than 12 percent moisture.
(iii) To assure the safe use of the additive, in addition to the
other information required by the Federal Food, Drug, and Cosmetic Act
(the act), the label and labeling of the dried mixture shall bear:
(A) The name of the additive.
(B) Adequate directions for use providing that the feed as consumed
does not contain more than 25 percent of the mixture.
(2) For soybean and canola seeds and/or meals to which there may be
added vegetable oil as a component of dry, nonpelleted feeds for beef
and dairy cattle, including lactating dairy cattle.
(i) An aqueous blend of oilseed and/or meals, with or without added
vegetable oil, in a ratio such that, on a dry matter basis, the final
protein level will be 25 to 35 percent and the fat content will be 20
to 45 percent. The feed ingredients are those defined by the ``Official
Publication'' of the Association of American Feed Control Officials,
Inc., 2003 ed., pp. 301, 307, 308, and 309, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies from the Assistant Secretary-
Treasurer, Association of American Feed Control Officials Inc., P.O.
Box 478, Oxford, IN 47971, or you may examine a copy at the Division of
Dockets Management, Food and Drug Administration, 5630 Fishers lane,
rm. 1061, Rockville, MD 20852, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(ii) Formaldehyde (37 percent solution) is added to the mixture at
a level of 2.7 percent of the dry matter weight basis of the oilseeds
and/or meals and the vegetable oil. This mixture, upon drying, contains
not more than 0.5 percent formaldehyde and not more than 12 percent
moisture.
(iii) To assure the safe use of the additive, in addition to the
other information required by the act, the label and labeling of the
dried mixture shall bear:
(A) The name of the additive.
(B) The statement, ``This supplement is not to exceed 12.5% of the
total ration. Dietary calcium and magnesium levels should be considered
when supplementing the diet with fat.''
(C) The minimum and maximum levels of crude fat must be guaranteed
and must be between -5 percent and +5 percent of the analyzed fat
content for each batch.
* * * * *
Dated: November 7, 2003.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-29069 Filed 11-20-03; 8:45 am]
BILLING CODE 4160-01-S