Title 21

SECTION 573.480

573.480 Formic acid.

§ 573.480 Formic acid.

The food additive, formic acid, may be safely used in accordance with the following conditions:

(a) The additive is used as a preservative in hay crop silage in an amount not to exceed 2.25 percent of the silage on a dry weight basis or 0.45 percent when direct cut, as follows:

(1) The top foot of silage stored should not contain formic acid and

(2) Silage should not be fed to livestock within 4 weeks of treatment.

(b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete feed for swine and poultry at levels not to exceed 1.2 percent of the complete feed.

(1) The additive consists of not less than 85 percent formic acid (CAS 64-18-6).

(2) The additive meets the following specifications:

(i) Free methyl alcohol not to exceed 1,000 parts per million (ppm);

(ii) Methyl formate not to exceed 1,000 ppm; and

(iii) Moisture not to exceed 15 percent.

(3) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.

(4) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug and Cosmetic Act, the label and labeling shall contain:

(i) The name of the additive.

(ii) Adequate directions for use including a statement that formic acid must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing formic acid.

(iii) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.

(5) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act and paragraph (b)(4) of this section, the label and labeling shall contain:

(i) Appropriate warnings and safety precautions concerning formic acid (85 percent formic acid).

(ii) Statements identifying formic acid (85 percent formic acid) as a corrosive and possible severe irritant.

(iii) Information about emergency aid in case of accidental exposure.

(A) 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.

(B) Contact address and telephone number for reporting adverse reactions or to request a copy of the Safety Data Sheet (SDS).

[76 FR 7106, Feb. 9, 2011, as amended at 82 FR 52209, Nov. 13, 2017; 83 FR 20, Jan. 2, 2018; 83 FR 66618, Dec. 27, 2018]