345 IAC 8-3-1 - Incorporation by reference; standards
Authority: IC 15-17-3-19; IC 15-17-3-21; IC 15-18-1-14
Affected: IC 15-17-2; IC 15-18-1
Sec. 1.
(a) The
board incorporates by reference as a rule of the board the Grade A Pasteurized
Milk Ordinance, United States Department of Health and Human Services, Public
Health Service, Food and Drug Administration (2019 revision), referred to as
the PMO for regulation of the production, transportation, processing, handling,
sampling, examination, grading, labeling, and sale of all Grade A milk and milk
products in the state. Except where specifically excluded, the board intends to
incorporate all parts of the PMO to include all of the administrative
procedures and the appendixes. However, the following parts of the PMO are not
incorporated by reference as a rule of the board:
(1) Section 16 on penalties.
(2) Section 17 on repeal and date of
effect.
(3) Appendix P.
The board intends to incorporate the footnoted language in the PMO regarding cottage cheese that will apply to any person producing Grade A cottage cheese and Grade A dry curd cottage cheese. However, a person may produce cottage cheese and dry curd cottage cheese as a manufacturing grade milk product (not Grade A) by complying with the manufacturing grade milk products requirements under this article. References in the PMO to the regulatory agency shall mean and refer to the board.
(b) The board will utilize the
latest edition of the following documents when interpreting and implementing
the provisions of the PMO, this article, and IC 15-18:
(1) The following National Conference on
Interstate Milk Shipments model documents:
(A) Procedures Governing the Cooperative
State-Public Health Service / Food and Drug Administration Program of the
National Conference on Interstate Shipments.
(B) Methods of Making Sanitation Ratings of
Milk Shippers.
(C) Evaluation of
Milk Laboratories.
(2)
The following sets of documents issued by the United States Food and Drug
Administration, Milk Safety Branch:
(A)
Memoranda of Interpretation (M-a series documents).
(B) Memoranda of Milk Ordinance Equipment
Compliance (M-b series documents).
(C) Memoranda of Information (M-I series
documents).
(c) The board adopts by reference the general
provisions relating to food standards set forth by the United States Food and
Drug Administration in
21 CFR
130.8, 21 CFR 130.9,
21
CFR 130.10, and 21 CFR 130.11, in effect on
April 1, 2020.
(d) The board adopts
by reference the definitions and standards of identity for milk and milk
products set forth by the United States Food and Drug Administration in
21
CFR 131.3 et seq., titled "Part 131-Milk and
Cream", in effect on April 1, 2020. Milk and milk products must conform to
these standards.
(e) The board
adopts by reference the definitions and standards of identity for cheeses and
related cheese products set forth by the United States Food and Drug
Administration in
21
CFR 133.3 et seq., titled "Part 133-Cheeses
and Related Cheese Products", in effect on April 1, 2020. Cheese and cheese
products must conform to these standards.
(f) The board adopts by reference the
definitions and standards of identity for frozen desserts set forth by the
United States Food and Drug Administration in
21
CFR 135.3 et seq., titled "Part 135-Frozen
Desserts", in effect on April 1, 2020. Frozen desserts must conform to these
standards.
(g) The board adopts by
reference the current good manufacturing practices for manufacturing, packing,
or holding human food set forth by the United States Food and Drug
Administration in 21 CFR 113, in effect on April 1, 2020. The criteria and
definitions in 21 CFR 113 and this rule shall apply in determining whether a
food is adulterated under IC 15-18-1 in that the food has been manufactured
under such conditions that it is unfit for human food or the food has been
prepared, packed, or held under unsanitary conditions under which the product
may:
(1) become contaminated with filth;
or
(2) have been made injurious to
health.
(h) The board
adopts by reference as a rule of the board the food labeling requirements set
forth by the United States Food and Drug Administration in 21 CFR 101, but not
including Subpart C, in effect on April 1, 2020.
(i) The board incorporates by reference into
this rule the definitions set forth in IC 15-17-2 and the matters set forth in
IC 15-18-1.
(j) Where the matters
incorporated by reference in this section conflict with provisions of this
article, IC 15-17-2, or IC 15-18-1, the express provisions of this article and
the Indiana Code shall control.
(k)
Incorporated documents are available for public inspection at the board. Copies
of incorporated documents and interpreting and implementing documents may be
obtained from the Food and Drug Administration, Milk Safety Branch website, the
U.S. Government Publishing Office website, or by sending a written request to
the board.
Notes
NOTE: Transferred from the Indiana State Department of Health (410 IAC 8-14-8.1) to the Indiana State Board of Animal Health (345 IAC 8-3-1) by P.L. 137-1996, SECTION 76, effective July 1, 1996.
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