Requirements Applicable to Facilities That Manufacture Food for Human Consumption
NY-ADR
3/29/17 N.Y. St. Reg. AAM-13-17-00002-P
NEW YORK STATE REGISTER
VOLUME XXXIX, ISSUE 13
March 29, 2017
RULE MAKING ACTIVITIES
DEPARTMENT OF AGRICULTURE AND MARKETS
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
I.D No. AAM-13-17-00002-P
Requirements Applicable to Facilities That Manufacture Food for Human Consumption
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
This is a consensus rule making to add Part 260, sections 261.1(d) and 261.12 to Title 1 NYCRR.
Statutory authority:
Agriculture and Markets Law, sections 16, 18 and 214-b
Subject:
Requirements applicable to facilities that manufacture food for human consumption.
Purpose:
To incorporate by reference 21 CFR part 117, containing such requirements.
Text of proposed rule:
Subchapter C of Chapter VI of 1 NYCRR is amended by adding thereto a new Part 260, to read as follows:
PART 260
CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
260.1 Standards
(a) For the purpose of the enforcement of Article 17 of the Agriculture and Markets Law, the Commissioner of the Department of Agriculture and Markets hereby adopts Part 117 of Title 21 of the Code of Federal Regulations (revised as of April 1, 2016; U.S. Government Printing Office, Washington, D.C. 20402), except that each reference therein to the terms:
(1) “FDA” shall be deemed to be a reference to the Department of Agriculture and Markets;
(2) “FDA District Director and to Director” and to “Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition” shall be deemed to be a reference to the Director of the Division of Food Safety and Inspection of the Department of Agriculture and Markets;
(3) “Secretary” and to “Commissioner of Food and Drugs” shall be deemed to be a reference to the Commissioner of the Department of Agriculture and Markets unless the context clearly indicates that each such term should have the meaning ascribed to it in Title 21 of the Code of Federal Regulations section 117.3.
(b) Notwithstanding the provisions of subdivisions (a) of this section:
(1) The Commissioner of the Department of Agriculture and Markets does not adopt section 117.201 of Subpart D, and does not adopt Subpart E, of Part 117 of Title 21 of the Code of Federal Regulations; and
(2) Part 117 of Title 21 of the Code of Federal Regulations does not apply to a milk plant or transfer station that is an interstate milk shipper listed in the document entitled Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers, published by the U.S. Department of Health and Human Services, unless such listing has been properly withdrawn.
(c) Every term used in this section that is defined or given meaning in Title 21 of the Code of Federal Regulations Part 117 shall be construed as set forth therein.
(d) A copy of Title 21 of the Code of Federal Regulations containing Part 117 is maintained in a file at the Department of Agriculture and Markets, Division of Food Safety and Inspection, 10B Airline Drive, Albany, New York 12235, and at the Department of State, 99 Washington Avenue, Suite 650, Albany, New York 12231, and is available for public inspection and copying during regular business hours.
(e) This section shall take effect on September 1, 2017, except that “small businesses” are not required to comply with Part 117 of Title 21 of the Code of Federal Regulations, as adopted pursuant to and consistent with subdivisions (a) and (b) of this section, until September 18, 2017, and very small businesses and qualified facilities are not required to comply therewith until September 18, 2018.
Section 261.1 of Title One of the Official Compilation of Codes, Rules and Regulations of the State of New York (“1 NYCRR”) is amended by adding thereto a new subdivision (d) to read as follows:
(d) “Small business”, “very small business”, and “qualified facility” each mean the entities so defined in section 117.3 of Title 21 of the Code of Federal Regulations (revised as of April 1, 2016; U.S. Government Printing Office, Washington, D.C. 20402); a copy of that Title containing that section is maintained in a file at the Department of Agriculture and Markets, Division of Food Safety and Inspection, 10B Airline Drive, Albany, New York 12235, and at the Department of State, 99 Washington Avenue, Suite 650, Albany, New York 12231, and is available for public inspection and copying during regular business hours.
Part 261 of 1 NYCRR is amended by adding thereto a new section 261.12, to read as follows:
§ 261.12 Applicability.
The requirements of this Part are applicable only to:
(a) small businesses, until September 18, 2017; and
(b) very small businesses and qualified facilities, until September 18, 2018.
Text of proposed rule and any required statements and analyses may be obtained from:
Stephen D. Stich, Director, Food Safety and Inspection, NYS Dept. of Agriculture and Markets, 10B Airline Drive, Albany, NY 12235, (518) 457-4492, email: [email protected]
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Consensus Rule Making Determination
The proposed rule will amend Subchapter C of Chapter VI of 1 NYCRR to add a new Part 260, to be headed “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”. The proposed rule will incorporate by reference all of the substantive subparts of 21 CFR Part 117 which, generally, require food plants to adhere to requirements designed to ensure that food is safe for human consumption; the proposed rule will not, however, incorporate by reference the procedural requirements set forth in section 117.201 of Subpart D, and in Subpart E, of 21 CFR Part 117.
Upon adoption of the proposed rule, the Department of Agriculture and Markets (“Department”) will have the power to regulate only those facilities that are required to comply with the substantive subparts of 21 CFR Part 117, as enforced by the United States Food and Drug Administration (“FDA”). Pursuant to 21 CFR section 117.5, FDA will not require certain facilities to comply with certain substantive subparts of 21 CFR Part 117 (i.e., Subpart C, headed “Hazard Analysis and Risk-Based Preventive Controls”, and Subpart G, headed “Supply-Chain Program”) and the proposed rule maintains that “exemption”; as such, the proposed rule authorizes the Department to require facilities to comply only with those requirements with which they are currently required to comply.
Based upon the preceding, the Department believes that the proposed rule will not be controversial and will, itself, have no adverse impact upon regulated parties.
Job Impact Statement
The proposed rule will not have an adverse impact upon employment opportunities.
The proposed rule will amend Subchapter C of Chapter VI of 1 NYCRR to add a new Part 260, to be headed “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”. The proposed rule will incorporate by reference all of the substantive subparts of 21 CFR Part 117 which, generally, require food plants to adhere to requirements designed to ensure that food is safe for human consumption; the proposed rule will not, however, incorporate by reference the procedural requirements set forth in section 117.201 of Subpart D, and in Subpart E, of 21 CFR Part 117.
Upon adoption of the proposed rule, the Department of Agriculture and Markets (“Department”) will have the power to regulate only those facilities that are required to comply with the substantive subparts of 21 CFR Part 117, as enforced by the United States Food and Drug Administration (“FDA”). Pursuant to 21 CFR section 117.5, FDA will not require certain facilities to comply with certain substantive subparts of 21 CFR Part 117 (i.e., Subpart C, headed “Hazard Analysis and Risk-Based Preventive Controls”, and Subpart G, headed “Supply-Chain Program”) and the proposed rule maintains that “exemption”; as such, the proposed rule, when adopted, will authorize the Department to require facilities to comply only with those requirements with which they are currently required to comply.
Based upon the preceding, the Department believes that the proposed rule will have no adverse impact upon jobs.
| End of Document |