Section 345 IAC 8-2-2.2 - Modified requirements that apply to a qualified facilityAuthority: IC 15-17-3-21
Affected: IC 15-18-1-9
Sec. 2.2.
(a) Except as provided in subsection (h), a manufacturing grade milk plant that is a qualified facility as defined in 21 CFR 117.3 is exempt from the requirements set forth in Subpart C and Subpart G of 21 CFR 117, which are incorporated by reference as a rule of the board.(b) In order to operate under the exemption authorized in subsection (a), a manufacturing grade milk plant must submit attestations to the state veterinarian that meet the requirements set forth at 21 CFR 117.201.(c) A manufacturing grade milk plant must determine and document its status as a qualified facility on an annual basis no later than July 1 of each calendar year.(d) The attestations required in subsection (b) must be submitted to the state veterinarian at least every two (2) years during the period beginning on October 1 and ending on December 31. However, when the status of a manufacturing grade milk plant changes from "not a qualified facility" to "qualified facility" based on the annual determination required by subsection (c), the attestations must be submitted by July 31 of the applicable calendar year.(e) When the status of a manufacturing grade milk plant changes from "qualified facility" to "not a qualified facility" based on the annual determination required by subsection (c), the facility must: (1) notify the state veterinarian of the change in status by July 31 of the applicable calendar year; and(2) comply with 21 CFR 117 Subparts C and G, which are incorporated by reference as a rule of the board, no later than December 31 of the applicable calendar year unless otherwise agreed to by the state veterinarian and the facility.(f) A qualified facility that does not submit an attestation under 21 CFR 117.201(a)(2)(i) must provide notification to consumers in accordance with 21 CFR 117.201(e).(g) A qualified facility must maintain the records relied upon to support the attestations that are required by subsection (b). The records that a qualified facility must maintain are subject to the requirements of 21 CFR 117 Subpart F, which is incorporated by reference as a rule of the board.(h) The state veterinarian may withdraw the exemption granted to a qualified facility under 21 CFR 117.5, which is incorporated by reference as a rule of the board, upon either of the following conditions: (1) In the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility.(2) Upon a determination that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conditions or conduct associated with the qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility.Indiana State Board of Animal Health; 345 IAC 8-2-2.2; filed 12/7/2016, 9:26 a.m.: 20170104-IR-345160222FRAReadopted filed 7/12/2022, 2:33 p.m.: 20220810-IR-345220146RFA