[Federal Register Volume 68, Number 225 (Friday, November 21, 2003)]
[Rules and Regulations]
[Pages 65632-65633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29069]


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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://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: [email protected].

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

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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