[Federal Register Volume 63, Number 193 (Tuesday, October 6, 1998)]
[Rules and Regulations]
[Pages 53579-53580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26646]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. 97F-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 and drinking water of
animals to provide for the safe use of formaldehyde (CAS No. 50-00-0;
37 percent aqueous solution), at a rate of 5.4 pounds (2.5 kilograms)
per ton, as an antimicrobial food additive for maintaining animal feeds
and feed ingredients Salmonella negative for up to 21 days. This action
is in response to a food additive petition filed by Anitox Corp. of
Buford, GA.
DATES: Effective October 6, 1998; written objections and request for
hearing should be submitted by November 5, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Henry E. Ekperigin, Center for
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0174.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of February 11, 1998
(63 FR 6945), FDA announced that a food additive petition (animal use)
(FAP 2237) had been filed by Anitox Corp., P. O. Box 1929, Buford, GA
30519. The petition proposed that the food additive regulations in
Sec. 573.460 Formaldehyde (21 CFR 573.460) be amended to provide for
the safe use of formaldehyde (37 percent aqueous solution) at a rate of
5.4 pounds per ton of animal feeds and feed ingredients to maintain the
animal feeds and feed ingredients free of Salmonella. The notice of
filing provided for a 30-day comment period on the petitioner's
environmental assessment. No comments have been received.
The sponsor has amended the petition three times since it was
originally filed, on March 2, 1998, providing additional data to
establish utility of formaldehyde for the intended use; July 14, 1998,
providing the proposed wording to be included on the product labeling
that indicated formaldehyde treatment maintains complete feed and feed
ingredients Salmonella negative up to 21 days from date of application;
and July 20, 1998, providing information requested by CVM on the Good
Laboratory Practice Statement, clarifying the chemical description of
the product on the labeling and in the proposed regulation, and
modifying the references to environmental authorities on the labeling
and in the proposed regulation. The amended petition proposes that
Sec. 573.460 be amended to provide for the safe use of formaldehyde
(CAS No. 50-00-0; 37 percent aqueous solution), at a rate of 5.4 pounds
(2.5 kilograms) per ton, as an antimicrobial food additive for
maintaining animal feeds and feed ingredients Salmonella negative for
up to 21 days.
Data submitted by the sponsor in support of the petition permitted
the agency to make an independent evaluation of whether formaldehyde
could be safely used to achieve the intended purpose. When included in
complete feed or feed ingredients as proposed, formaldehyde will
constitute 0.1 percent of the feed or feed ingredient. The sponsor
submitted data showing that this level of formaldehyde should not
present a human food safety concern. Formaldehyde occurs in animals as
a normal metabolite and is rapidly oxidized to formic acid which
further metabolizes into carbon dioxide and water. Formaldehyde is
currently approved for use in poultry feed at the inclusion level
requested by the petitioner.
Also, formaldehyde has been approved for use in feeds for beef and
non-lactating dairy cattle (Sec. 573.460(a)(2)). The level of
formaldehyde in feeds manufactured according to the approval under
Sec. 573.460(a)(2) can be as high as 0.25 percent. Formaldehyde is
exempted from tolerance requirements under 40 CFR 180.1032 when used as
a pesticide/fungicide in cereal grains and forages. Furthermore,
although formaldehyde has been found in chronic rat studies to be
carcinogenic when inhaled continuously at high doses (> 2 ppm), it has
not been found to be carcinogenic in rodents when orally ingested at
high doses (5 percent) for a lifetime (Ref. 1).
Formalin (formaldehyde 37 percent aqueous solution) can be life
threatening if improperly handled. The proposed label for formaldehyde
(CAS No. 50-00-0; 37 percent aqueous solution) acknowledges this fact.
To further minimize concerns for worker safety, the label contains
adequate directions for use, strong cautionary statements about
potential carcinogenic and adverse respiratory effects; information
about emergency aid in case of inhalation, ingestion or skin or eye
contact, and a contact address and telephone number for reporting
adverse reactions experienced by users or to request a copy of the
material safety data sheet (MSDS). The label also contains a statement
that ``Formaldehyde is subject to SARA Title III, Section 313
reporting'' (Superfund Amendments and Reauthorization Act (SARA), and
the Occupational Safety and Health Administration's (OSHA) human safety
guidance regulations). The petition contains assurances by the sponsor
that the proposed label will be placed on all containers of the
product. However, because formaldehyde is nonproprietary, FDA will
include these requirements in the amended formaldehyde food additive
regulation. That will enable others marketing formaldehyde to be
informed of the requirements and to comply with them.
The petition also includes satisfactory information about the
chemical identity of formaldehyde and indicates that formaldehyde will
achieve its intended effect in a manner that is safe to the animals
consuming the treated products.
[[Page 53580]]
II. Conclusion
FDA concludes that the data establish the safety and functionality
of formaldehyde (CAS No. 50-00-0; 37 percent aqueous solution), for use
as proposed and that the food additive regulations should be amended as
set forth below.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 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
Center for Veterinary Medicine by appointment with the information
contact person listed above. 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 carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (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 at
any time on or before November 5, 1998, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall 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 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. Three copies of all documents shall be
submitted and shall 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 Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
VI. References
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA Talk Paper ``Formaldehyde,'' T80-27, May 21, 1980, and
T82-40, June 17, 1982.
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
1. The authority citation for 21 CFR part 573 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
2. Section 573.460 is amended by revising paragraphs (b)(1),
(b)(2)(ii), (b)(2)(iii), and (b)(3)(iv), and by adding paragraph
(b)(2)(iv) to read as follows:
Sec. 573.460 Formaldehyde.
* * * * *
(b)(1) The food additive is formaldehyde (CAS No. 50-00-0; 37
percent aqueous solution). It is used at a rate of 5.4 pounds (2.5
kilograms) per ton of animal feed or feed ingredient. It is an
antimicrobial agent used to maintain complete animal feeds or feed
ingredients Salmonella negative for up to 21 days.
(2) * * *
(ii) A statement that formaldehyde solution which has been stored
below 40 deg.F or allowed to freeze should not be applied to complete
animal feeds or feed ingredients.
(iii) Adequate directions for use including a statement that
formaldehyde should be uniformly sprayed on and thoroughly mixed into
the complete animal feeds or feed ingredients and that the complete
animal feeds or feed ingredients so treated shall be labeled as
containing formaldehyde. The label must prominently display the
statement: ``Treated with formaldehyde to maintain feed Salmonella
negative. Use within 21 days.''
(iv) The labeling for feed or feed ingredients to which
formaldehyde has been added under the provisions of paragraph (b)(1) of
this section is required to carry the following statement: ``Treated
with formaldehyde to maintain feed Salmonella negative. Use within 21
days.''
(3) * * *
(iv) Statements reflecting requirements of applicable sections of
the Superfund Amendments and Reauthorization Act (SARA), and the
Occupational Safety and Health Administration's (OSHA) human safety
guidance regulations.
* * * * *
Dated: September 28, 1998.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 98-26646 Filed 10-5-98; 8:45 am]
BILLING CODE 4160-01-F