Minnesota Session Laws - 2012, Regular Session

CHAPTER 124--H.F.No. 1926

An act

relating to agriculture; providing for voluntary certification of good manufacturing practices for commercial feed and feed ingredients; authorizing fees for voluntary certification; modifying rule provisions relating to animal feed; appropriating money;

amending Minnesota Statutes 2010, section 25.40, subdivisions 1, 2, by adding a subdivision; proposing coding for new law in Minnesota Statutes, chapter 25; repealing Minnesota Rules, parts 1510.2220; 1510.2230.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [25.371] GOOD MANUFACTURING PRACTICES CERTIFICATE FOR COMMERCIAL FEED AND FEED INGREDIENTS. new text end

new text begin Subdivision 1. new text end

new text begin Definition of words and terms. new text end

new text begin In addition to the definitions in section 25.33, for the purpose of this section, the terms defined in this subdivision have the meaning given them. new text end

new text begin (a) "Adulteration" means the presence of any poisonous or deleterious substance at a level that may render feed or feed ingredients injurious to human or animal health, as provided in section 25.37, paragraph (a). new text end

new text begin (b) "Establishment" includes, but is not limited to, buildings, structures, facilities, equipment, and conveyances that receive, store, manufacture, process, package, label, transport, or distribute feed or feed ingredients. new text end

new text begin (c) "Pest" means any objectionable animal, including, but not limited to, bats, birds, rodents, insects, and insect larvae. new text end

new text begin Subd. 2. new text end

new text begin Certificate application. new text end

new text begin (a) A person may apply to the commissioner for a good manufacturing practices certificate for commercial feed and feed ingredients. Application for good manufacturing practices certificates must be made on forms provided or approved by the commissioner. The commissioner shall conduct inspections of facilities for persons that have applied for or intend to apply for a good manufacturing practices certificate for commercial feed and feed ingredients from the commissioner. The commissioner shall not conduct an inspection under this section if the applicant has not paid in full the inspection fee for previous inspections. Certificate issuance shall be based on compliance with subdivisions 3 to 14, or United States Food and Drug Administration rules regarding preventive controls for animal feed. new text end

new text begin (b) The commissioner may assess a fee for the inspection, service, and work performed in carrying out the issuance of a good manufacturing practices certificate for commercial feed and feed ingredients. The inspection fee must be based on mileage and the cost of inspection. new text end

new text begin Subd. 3. new text end

new text begin Personnel. new text end

new text begin (a) Persons working in direct contact with feed and feed ingredients must conform to good hygienic practices to minimize the risk of adulteration. new text end

new text begin (b) Persons who receive, store, manufacture, process, package, label, sample, transport, or distribute feed or feed ingredients must be trained for the persons' areas of responsibility. new text end

new text begin Subd. 4. new text end

new text begin Establishments. new text end

new text begin (a) Establishments must be of a size, construction, and design to facilitate routine maintenance and cleaning. new text end

new text begin (b) The grounds of establishments must be maintained in a condition that minimizes pest infestation of feed or feed ingredients. new text end

new text begin Subd. 5. new text end

new text begin Maintenance and housekeeping. new text end

new text begin (a) Establishments must be kept in sufficient repair and condition to minimize the risk of adulteration. new text end

new text begin (b) Establishments must be cleaned in a manner and at a frequency that minimizes the risk of adulteration. new text end

new text begin (c) Establishments must implement procedures that are effective in minimizing pest infestation of feed or feed ingredients. new text end

new text begin (d) Substances not approved for use in feed or feed ingredients must be received, stored, and used in a manner that minimizes the risk of adulteration, and in accordance with applicable laws and regulations. These substances must be physically separated from work areas and equipment used for the production or storage of feed and feed ingredients. new text end

new text begin Subd. 6. new text end

new text begin Equipment. new text end

new text begin (a) All equipment, including scales, metering devices, and mixers must be of a suitable size, design, construction, precision, and accuracy for the equipment's intended purpose, and to minimize the risk of adulteration. new text end

new text begin (b) All equipment, including scales, metering devices, and mixers must be designed to facilitate inspection and cleaning, and must be properly maintained and operated to minimize the risk of adulteration. new text end

new text begin (c) All equipment must be constructed and maintained so as to minimize the risk of lubricants and coolants becoming adulterants in feed or feed ingredients. new text end

new text begin (d) All scales and metering devices must be tested for accuracy upon installation and at least annually thereafter. new text end

new text begin (e) All mixers must be tested to demonstrate the capability of the equipment to produce a homogeneous mix upon installation and periodically thereafter to ensure proper function. Mixers must be operated utilizing procedures that provide for proper mixing and proper mixing times as demonstrated by testing. new text end

new text begin (f) Records sufficient to document the testing of equipment identified in paragraphs (d) and (e) must be maintained until a subsequent test is conducted or for one year from the date of the test, whichever is longer. new text end

new text begin Subd. 7. new text end

new text begin Receiving and storage for further manufacture. new text end

new text begin Specifications and procedures effective in minimizing the risk of adulteration must be established and implemented to govern the acceptance, rejection, and storage of inbound feed or feed ingredients intended for further manufacturing of feed or feed ingredients. The procedures must include the following: new text end

new text begin (1) feed or feed ingredients must be visually inspected during receiving to confirm identity and check required labeling; new text end

new text begin (2) feed or feed ingredients to be used in the further manufacture of feed or feed ingredients must be stored in a manner that maintains the identity and minimizes the risk of adulteration; new text end

new text begin (3) cleanout procedures must be established and implemented for equipment, conveyances, and storage structures or containers that are effective in minimizing the risk of adulteration of feed or feed ingredients; new text end

new text begin (4) inventory practices, including inventory rotation, must be established and implemented for feed or feed ingredients to minimize the risk of adulteration; and new text end

new text begin (5) records must be maintained identifying the immediate previous source, quantity, type or name, and date received for each feed or feed ingredient for at least one year from the date of disposition. new text end

new text begin Subd. 8. new text end

new text begin Manufacturing. new text end

new text begin (a) A feed or feed ingredient that is considered adulterated must not be used in the manufacture of feed or feed ingredients unless made safe for the feed or feed ingredient's intended use. new text end

new text begin (b) Procedures effective in minimizing the risk of adulteration and ensuring safety and identity must be established and implemented for the manufacture of feed or feed ingredients. The procedures must include the following: new text end

new text begin (1) a description of the manufacturing operation, which may include, but is not limited to, feed or feed ingredient formulation, mixing, and production practices; new text end

new text begin (2) measures effective in minimizing manufacturing errors that may result in adulteration of feed or feed ingredients. The measures must include, but are not limited to: new text end

new text begin (i) cleanout practices, which may include sequencing, flushing, or other methods; and new text end

new text begin (ii) measures to minimize the inclusion of physical adulterants, including metal, in feed or feed ingredients. new text end

new text begin (c) Records sufficient to document the production history of the feed or feed ingredient manufactured in the establishment must be maintained for at least one year from the date of disposition. new text end

new text begin Subd. 9. new text end

new text begin Packaging. new text end

new text begin (a) Packaged feed or feed ingredients must be packaged in a manner that maintains identity and minimizes the risk of adulteration. new text end

new text begin (b) Bags and totes used as packaging for feed or feed ingredients must not be reused unless cleaned using effective and documented cleanout procedures. new text end

new text begin (c) Records sufficient to document these cleanout procedures must be maintained for at least one year from the date of disposition. new text end

new text begin Subd. 10. new text end

new text begin Labeling. new text end

new text begin (a) A label or other unique identifier must be affixed to, or accompany feed or feed ingredients to maintain identity and facilitate safe and effective use. new text end

new text begin (b) Labels must be stored, handled, and used in a manner that minimizes errors. new text end

new text begin (c) Obsolete labels must be discarded promptly. new text end

new text begin Subd. 11. new text end

new text begin Storage of finished feed or feed ingredients. new text end

new text begin (a) Finished feed or feed ingredients must be stored in a manner that minimizes the risk of adulteration. The bin, bulk tank, or other location where feed or feed ingredients are stored must be clearly identified. new text end

new text begin (b) Inventory practices, including inventory rotation, must be established and implemented for feed or feed ingredients to minimize the risk of adulteration. new text end

new text begin Subd. 12. new text end

new text begin Inspection, sampling, and testing of incoming and finished feed or feed ingredients for adulterants. new text end

new text begin (a) Finished feed or feed ingredients must be visually inspected for the presence of visible adulterants and verification of identity. new text end

new text begin (b) When sampling and testing of feed or feed ingredients is performed by the establishment to monitor for adulteration, test results must be reviewed by trained personnel. Test results that indicate feed or feed ingredients are adulterated must be investigated by the establishment. Investigations may include, but are not limited to, review of: new text end

new text begin (1) ingredient specifications used in the development of the formula; new text end

new text begin (2) formula; new text end

new text begin (3) production records; and new text end

new text begin (4) sampling and testing methods. new text end

new text begin (c) Records must be kept for at least one year after the investigation and review of test results for adulterants, and of any corrective action or actions taken when adulterants are detected. Records must not be used as the sole basis for official enforcement actions or penalties by the commissioner. new text end

new text begin Subd. 13. new text end

new text begin Transportation of feed or feed ingredients. new text end

new text begin Feed or feed ingredients must be transported utilizing methods that minimize the risk of adulterations, including, but not limited to, the following: new text end

new text begin (1) conveyances used to transport feed or feed ingredients must be inspected for cleanliness and structural integrity prior to loading; new text end

new text begin (2) feed, feed ingredients, or other materials or substances that may pose a risk of adulterating feed or feed ingredients must not be loaded onto the same conveyance unless measures are taken to minimize risk; and new text end

new text begin (3) records must be maintained for each feed or feed ingredient identifying the immediate subsequent recipient, quantity, type or name, unique identifier if available, and date shipped for at least one year from the date of disposition. new text end

new text begin Subd. 14. new text end

new text begin Voluntary recall; withdrawal. new text end

new text begin (a) Sufficient records and other information concerning the identity and disposition of feed or feed ingredients must be maintained for at least one year from the date of disposition to permit the rapid and effective recall from the marketplace or withdrawal from feeding if a feed or feed ingredient is found to be adulterated. new text end

new text begin (b) Voluntary recalls of feed or feed ingredients should be guided by procedures outlined by the United States Food and Drug Administration in the Code of Federal Regulations, title 21, section 7. new text end

new text begin Subd. 15. new text end

new text begin Expiration. new text end

new text begin Subdivisions 1 and 3 to 14 expire upon the United States Food and Drug Administration's adoption of rules regarding preventative controls for animal feed. new text end

Sec. 2.

Minnesota Statutes 2010, section 25.40, subdivision 1, is amended to read:

Subdivision 1.

Adoption.

The commissioner may adopt rules for commercial feeds, pet foods, and specialty pet foods as are authorized in sections 25.31 to 25.43 and deleted text begin such deleted text end other reasonable rules as may be necessary for the efficient enforcement of sections 25.31 to 25.43. In the interest of uniformity the commissioner shall by rule adopt, unless the commissioner determines that they are inconsistent with the provisions of sections 25.31 to 25.43 or are not appropriate to conditions which exist in this state, the deleted text begin following: deleted text end

deleted text begin (a) the deleted text end official definitions of feed ingredients and official feed terms adopted by the Association of American Feed Control Officials and published in the official publication of that organization deleted text begin ; and deleted text end new text begin . new text end

deleted text begin (b) any rule promulgated pursuant to the authority of the Federal Food, Drug, and Cosmetic Act, provided, that the commissioner would have the authority under sections 25.31 to 25.43 to adopt the rules. deleted text end

Sec. 3.

Minnesota Statutes 2010, section 25.40, subdivision 2, is amended to read:

Subd. 2.

Notice; public comment.

Before the issuance, amendment, or repeal of any rule authorized by sections 25.31 to 25.43, the commissioner shall publish the proposed rule, amendment, or notice to repeal an existing rule in a manner reasonably calculated to give interested parties, including all current license holders, adequate notice and shall afford all interested persons an opportunity to present their views orally or in writing, within a reasonable period of time. After consideration of all views presented by interested persons, the commissioner shall take appropriate action to issue the proposed rule or to amend or repeal an existing rule. The provisions of this subdivision notwithstanding, if the commissioner, pursuant to the authority of sections 25.31 to 25.43, adopts the official definitions of feed ingredients or official feed terms as adopted by the Association of American Feed Control Officials, deleted text begin or regulations promulgated pursuant to the authority of the Federal Food, Drug, and Cosmetic Act, deleted text end any amendment or modification adopted by deleted text begin said deleted text end new text begin the new text end association deleted text begin or by the secretary of health, education and welfare in the case of regulations promulgated pursuant to the Federal Food, Drug, and Cosmetic Act, deleted text end shall be adopted automatically under sections 25.31 to 25.43 without regard to the publication of the notice required by this subdivision unless the commissioner, by order specifically determines that deleted text begin said deleted text end new text begin the new text end amendment or modification shall not be adopted.

Sec. 4.

Minnesota Statutes 2010, section 25.40, is amended by adding a subdivision to read:

new text begin Subd. 3. new text end

new text begin Food and drug rules. new text end

new text begin Applicable federal regulations including recodification contained in Code of Federal Regulations, title 21, parts 1 to 1299, not otherwise adopted herein, also are adopted as feed rules of this state. new text end

Sec. 5.

new text begin REPEALER. new text end

new text begin Minnesota Rules, parts 1510.2220; and 1510.2230, new text end new text begin are repealed. new text end

Sec. 6.

new text begin EFFECTIVE DATE. new text end

new text begin Sections 1 to 5 are effective the day following final enactment. new text end

Presented to the governor February 28, 2012

Signed by the governor March 1, 2012, 12:24 p.m.