TITLE 345 INDIANA STATE BOARD OF ANIMAL HEALTH

Under IC 4-22-2-23, the Indiana State Board of Animal Health intends to adopt a rule concerning the following:

OVERVIEW: Amends 345 IAC 8-2-1.1 to align certain definitions with the Grade A Pasteurized Milk Ordinance (PMO). Amends 345 IAC 8-2-2 to phase out the effective date for the manufacturing grade milk products plant standards in accordance with the compliance dates of 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food. Adds 345 IAC 8-2-2.1 to establish the requirements in 21 CFR 117 as the required standards for manufacturing grade milk product plants. Amends 345 IAC 8-2-2.5 to phase out the effective date for the manufacturing grade milk plant extended operation standards in accordance with the compliance dates of 21 CFR 117. Amends 345 IAC 8-3-1 to update the incorporation by reference of the PMO from the 2013 revision to the 2015 revision, and to update the incorporation by reference of certain Food and Drug Administration (FDA) regulations from April 1, 2014, to April 1, 2016. Amends 345 IAC 8-3-2 to establish a process for a Grade A dairy farm to convert a milk house bulk tank into a raw milk storage vessel holding commingled milk for pasteurization. Makes other updates and amendments to rules governing milk and milk products. Questions and comments concerning the proposed rule may be sent to the Small Business Regulatory Coordinator for this rule. Statutory authority: IC 15-18.

For purposes of IC 4-22-2-28.1, the Small Business Regulatory Coordinator for this rule is:

Sarah Simpson

Director of Legal Affairs, Licensing, and Enforcement

Indiana State Board of Animal Health

Discovery Hall, Suite 100

1202 East 38th Street

Indianapolis, IN 46205

(317) 544-2410

sasimpson@boah.in.gov

For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 4-4-35-8 is:

Robert Warner

Office of Small Business and Entrepreneurship

One North Capitol, Suite 600

Indianapolis, IN 46204

(317) 232-5679

ombudsman@osbe.in.gov

Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 4-4-35-8, specifically IC 4-4-35-8(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator.

DIN: 20160601-IR-345160222NIA

Composed: May 02,2024 2:52:31PM EDT

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