Code of Massachusetts Regulations
330 CMR - DEPARTMENT OF AGRICULTURAL RESOURCES
Title 330 CMR 14.00 - Manufacture, Sale, And Distribution Of Commercial Feed
Section 14.09 - Drug and Feed Additives
Universal Citation: 330 MA Code of Regs 330.14
Current through Register 1531, September 27, 2024
(1) Prior to approval of a application and/or approval of a label for commercial feed which contains additives, including drugs, other special purpose additives, or non-nutritive additives, the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.
(2) Satisfactory evidence of safety and efficacy of a commercial feed may be:
(a) When
the commercial feed contains such additives, the use of which conforms to the
requirements of the applicable regulation in the Code of Federal Regulations,
Title 21, or other applicable regulation adopted by the United States Food and
Drug Administration, or which are "prior sanctioned" or "informal review
sanctioned" or "generally recognized as safe" for such use, or
(b) When the commercial feed is itself a drug
as defined in Section 3(g) of the Food, Drug and Cosmetic Act and is generally
recognized as safe and effective for the labeled use or is marketed subject to
an application approved by the Food and Drug Administration under Title
21
U.S.C.360(b), or
(c) When one of the purposes for feeding a
commercial feed is to impart immunity (that is to act through some
immunological process) the constituents imparting immunity have been approved
for the purpose through the Federal Virus, Serum and Toxins Act of 1913, as
amended, or
(d) When the commercial
feed is a direct fed microbial product and:
1.
The product meets the particular fermentation product definition; and
2. The microbial content statement, as
expressed in the labeling, is limited to the following: "Contains a source of
live (viable) naturally occurring microorganisms." This statement shall appear
on the label; and
3. The source is
stated with a corresponding guarantee.
(e) When the commercial feed is an enzyme
product and:
1. The product meets the
particular enzyme definition by the Association of American Feed Control
Officials; and
2. The enzyme is
stated with a corresponding guarantee.
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