[Federal Register Volume 61, Number 69 (Tuesday, April 9, 1996)]
[Rules and Regulations]
[Pages 15703-15704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8760]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 573

[Docket No. 90F-0297]


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 food 
additive regulations to provide for the safe use of formaldehyde (37 
percent aqueous solution), at the rate of 5.4 pounds per ton (2.5 
kilograms per ton) (lb/t) (kg/t) as an antimicrobial food additive for 
maintaining complete poultry feeds salmonella negative for up to 14 
days. This action is in response to a food additive petition filed by 
Anitox Corp.

DATES: Effective April 9, 1996; written objections and requests for 
hearing by May 9, 1996.

ADDRESSES: Submit written objections and requests for hearing to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Daniel G. McChesney, Center for 
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1728.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 18, 1990 (55 FR 42272), FDA announced that a food 
additive petition (FAP 2215) had been filed by Anitox Corp., P.O. Box 
1929, Buford, GA 30518. The petition proposed to amend the food 
additive regulations in Sec. 573.460 Formaldehyde (21 CFR 573.460) to 
provide for the safe use of formaldehyde as an antimicrobial agent 
against bacteria, mold, and yeast in feed, at a level of 1.65 to 2.65 
pounds per ton for fishmeal and animal byproduct meals, and at a level 
of 0.66 to 1.32 pounds per ton for complete feeds or feed ingredients. 
The notice of filing of FAP 2215 provided for a 60-day comment period. 
No comments have been received.
    The sponsor amended the petition since it was originally filed. The 
amended petition proposed that Sec. 573.460 be amended to provide for 
the safe use of formaldehyde (37 percent aqueous solution), at the rate 
of 5.4   lb/t (2.5 kg/t), as an antimicrobial food additive for 
maintaining complete poultry feeds salmonella negative for up to 14 
days.
    FDA has evaluated data in the petition and other relevant material. 
FDA concludes that the proposed food additive use of formaldehyde (37 
percent aqueous solution) as an antimicrobial for maintaining complete 
poultry feeds salmonella negative for up to 14 days is safe. Therefore, 
the food additive regulations in Sec. 573.460 is amended.
    Formaldehyde can be life threatening if improperly handled. The 
proposed label for formaldehyde (37 percent aqueous solution) 
acknowledges this fact and identifies the product as a poison. The 
label provides for worker safety and further minimizes safety concerns 
for persons handling formaldehyde by containing adequate directions for 
use, strong cautionary statements about potential adverse respiratory 
effects, information about emergency aid in case of inhalation,

[[Page 15704]]
ingestion or skin or eye contact, statements reflecting requirements of 
applicable sections of the National Environmental Protection Act 
(NEPA), the Superfund Amendments and Reauthorization Act (SARA), the 
Occupational Safety and Health Administration's (OSHA) human safety 
guidance regulations, 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). These worker safety concerns 
are required by other regulations.
    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 21 CFR 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.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before May 9, 1996, 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.

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: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

    2. Section 573.460 is amended by redesignating paragraphs (a) 
introductory text, (a)(1), (a)(2), (b), (c) introductory text, (c)(1), 
and (c)(2) as paragraphs (a)(1), (a)(1)(i), (a)(1)(ii), (a)(2), (a)(3), 
(a)(3)(i), and (a)(3)(ii) respectively; and by adding new paragraph (b) 
to read as follows:


Sec. 573.460  Formaldehyde.

 * * * * *
    (b)(1) The food additive is formaldehyde (37 percent aqueous 
solution). It is used at the rate of 5.4 pounds (2.5 kilograms) per ton 
of poultry feed. At this level, it is an antimicrobial agent used to 
maintain complete poultry feeds salmonella negative for up to 14 days.
    (2) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling shall contain:
    (i) The name of the additive.
    (ii) A statement that formaldehyde solution which has been stored 
below 40  deg.F or allowed to freeze should not be applied to complete 
poultry feeds.
    (iii) Adequate directions for use including a statement that 
formaldehyde should be thoroughly mixed into complete poultry feed and 
that the finished poultry feed shall be labeled as containing 
formaldehyde.
    (3) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling shall 
contain:(i) Appropriate warnings and safety precautions concerning 
formaldehyde.
    (ii) Statements identifying formaldehyde as a poison with 
potentials for adverse respiratory effects.
    (iii) Information about emergency aid in case of accidental 
inhalation, ingestion or skin or eye contact.
    (iv) Statements reflecting requirements of applicable sections of 
the National Environmental Protection Act (NEPA), the Superfund 
Amendments and Reauthorization Act (SARA), and the Occupational Safety 
and Health Administration's (OSHA) human safety guidance regulations.
    (v) Contact address and phone number for reporting adverse 
reactions or to request a copy of the Materials Safety Data Sheet 
(MSDS).

    Dated: March 11, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-8760 Filed 4-8-96; 8:45 am]
BILLING CODE 4160-01-F