Food Additives Permitted in Feed and Drinking Water of Animals; Formaldehyde

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