[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR573.460]

[Page 503-504]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS--Table of Contents
 
                    Subpart B--Food Additive Listing
 
Sec.  573.460  Formaldehyde.

    The food additive formaldehyde may be safely used in the manufacture 
of animal feeds in accordance with the following conditions:
    (a)(1) The additive is used, or intended for use, to improve the 
handling

[[Page 504]]

characteristics of animal fat in combination with certain oilseed meals 
by producing therefrom a dry, free-flowing product as follows:
    (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., 1976 ed., pages 86, 103, and 109. \1\
---------------------------------------------------------------------------

    \1\ Copies of the current edition may be obtained from the 
Treasurer, Donald H. James, West Virginia Department of Agriculture, 
Capital Complex/Guthrie Center, Charleston, WV 25305.
---------------------------------------------------------------------------

    (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.
    (2) The dried mixture described in paragraph (a) of this section is 
used, or intended for use, as a component of dry, nonpelleted feeds for 
beef and nonlactating dairy cattle.
    (3) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling of the dried 
mixture described in paragraph (a) of this section shall bear:
    (i) The name of the additive.
    (ii) Adequate directions for use providing that feed as consumed is 
not to contain more than 25 percent of the mixture.
    (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) 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 
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) 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.
    (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.
    (v) Contact address and phone number for reporting adverse reactions 
or to request a copy of the Materials Safety Data Sheet (MSDS).

[41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 
61 FR 15704, Apr. 9, 1996; 63 FR 53580, Oct. 6, 1998]