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H.F. No. 1926,  as introduced - 87th Legislative Session (2011-2012)   Posted on Jan 26, 2012

1.1A bill for an act
1.2relating to agriculture; providing for voluntary certification of good
1.3manufacturing practices for commercial feed and feed ingredients; authorizing
1.4fees for voluntary certification; modifying rule provisions relating to animal
1.5feed; appropriating money;amending Minnesota Statutes 2010, section 25.40,
1.6subdivisions 1, 2, by adding a subdivision; proposing coding for new law in
1.7Minnesota Statutes, chapter 25; repealing Minnesota Rules, parts 1510.2220;
1.81510.2230.
1.9BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.10    Section 1. [25.371] GOOD MANUFACTURING PRACTICES CERTIFICATE
1.11FOR COMMERCIAL FEED AND FEED INGREDIENTS.
1.12    Subdivision 1. Definition of words and terms. In addition to the definitions in
1.13section 25.33, for the purpose of this section, the terms defined in this subdivision have
1.14the meaning given them.
1.15(a) "Adulteration" means the presence of any poisonous or deleterious substance at
1.16a level that may render feed or feed ingredients injurious to human or animal health, as
1.17provided in section 25.37, paragraph (a).
1.18(b) "Establishment" includes, but is not limited to, buildings, structures, facilities,
1.19equipment, and conveyances that receive, store, manufacture, process, package, label,
1.20transport, or distribute feed or feed ingredients.
1.21(c) "Pest" means any objectionable animal, including, but not limited to, bats, birds,
1.22rodents, insects, and insect larvae.
1.23    Subd. 2. Certificate application. (a) A person may apply to the commissioner for
1.24a good manufacturing practices certificate for commercial feed and feed ingredients.
1.25Application for good manufacturing practices certificates must be made on forms provided
1.26or approved by the commissioner. The commissioner shall conduct inspections of
2.1facilities for persons that have applied for or intend to apply for a good manufacturing
2.2practices certificate for commercial feed and feed ingredients from the commissioner. The
2.3commissioner shall not conduct an inspection under this section if the applicant has not
2.4paid in full the inspection fee for previous inspections. Certificate issuance shall be based
2.5on compliance with subdivisions 3 to 14, or United States Food and Drug Administration
2.6rules regarding preventive controls for animal feed.
2.7(b) The commissioner may assess a fee for the inspection, service, and work
2.8performed in carrying out the issuance of a good manufacturing practices certificate for
2.9commercial feed and feed ingredients. The inspection fee must be based on mileage
2.10and the cost of inspection.
2.11    Subd. 3. Personnel. (a) Persons working in direct contact with feed and feed
2.12ingredients must conform to good hygienic practices to minimize the risk of adulteration.
2.13(b) Persons who receive, store, manufacture, process, package, label, sample,
2.14transport, or distribute feed or feed ingredients must be trained for the persons' areas of
2.15responsibility.
2.16    Subd. 4. Establishments. (a) Establishments must be of a size, construction, and
2.17design to facilitate routine maintenance and cleaning.
2.18(b) The grounds of establishments must be maintained in a condition that minimizes
2.19pest infestation of feed or feed ingredients.
2.20    Subd. 5. Maintenance and housekeeping. (a) Establishments must be kept in
2.21sufficient repair and condition to minimize the risk of adulteration.
2.22(b) Establishments must be cleaned in a manner and at a frequency that minimizes
2.23the risk of adulteration.
2.24(c) Establishments must implement procedures that are effective in minimizing
2.25pest infestation of feed or feed ingredients.
2.26(d) Substances not approved for use in feed or feed ingredients must be received,
2.27stored, and used in a manner that minimizes the risk of adulteration, and in accordance
2.28with applicable laws and regulations. These substances must be physically separated from
2.29work areas and equipment used for the production or storage of feed and feed ingredients.
2.30    Subd. 6. Equipment. (a) All equipment, including scales, metering devices, and
2.31mixers must be of a suitable size, design, construction, precision, and accuracy for the
2.32equipment's intended purpose, and to minimize the risk of adulteration.
2.33(b) All equipment, including scales, metering devices, and mixers must be designed
2.34to facilitate inspection and cleaning, and must be properly maintained and operated to
2.35minimize the risk of adulteration.
3.1(c) All equipment must be constructed and maintained so as to minimize the risk of
3.2lubricants and coolants becoming adulterants in feed or feed ingredients.
3.3(d) All scales and metering devices must be tested for accuracy upon installation
3.4and at least annually thereafter.
3.5(e) All mixers must be tested to demonstrate the capability of the equipment to
3.6produce a homogeneous mix upon installation and periodically thereafter to ensure proper
3.7function. Mixers must be operated utilizing procedures that provide for proper mixing and
3.8proper mixing times as demonstrated by testing.
3.9(f) Records sufficient to document the testing of equipment identified in paragraphs
3.10(d) and (e) must be maintained until a subsequent test is conducted or for one year from
3.11the date of the test, whichever is longer.
3.12    Subd. 7. Receiving and storage for further manufacture. Specifications and
3.13procedures effective in minimizing the risk of adulteration must be established and
3.14implemented to govern the acceptance, rejection, and storage of inbound feed or feed
3.15ingredients intended for further manufacturing of feed or feed ingredients. The procedures
3.16must include the following:
3.17(1) feed or feed ingredients must be visually inspected during receiving to confirm
3.18identity and check required labeling;
3.19(2) feed or feed ingredients to be used in the further manufacture of feed or feed
3.20ingredients must be stored in a manner that maintains the identity and minimizes the
3.21risk of adulteration;
3.22(3) cleanout procedures must be established and implemented for equipment,
3.23conveyances, and storage structures or containers that are effective in minimizing the risk
3.24of adulteration of feed or feed ingredients;
3.25(4) inventory practices, including inventory rotation, must be established and
3.26implemented for feed or feed ingredients to minimize the risk of adulteration; and
3.27(5) records must be maintained identifying the immediate previous source, quantity,
3.28type or name, and date received for each feed or feed ingredient for at least one year
3.29from the date of disposition.
3.30    Subd. 8. Manufacturing. (a) A feed or feed ingredient that is considered
3.31adulterated must not be used in the manufacture of feed or feed ingredients unless made
3.32safe for the feed or feed ingredient's intended use.
3.33(b) Procedures effective in minimizing the risk of adulteration and ensuring safety
3.34and identity must be established and implemented for the manufacture of feed or feed
3.35ingredients. The procedures must include the following:
4.1(1) a description of the manufacturing operation, which may include, but is not
4.2limited to, feed or feed ingredient formulation, mixing, and production practices;
4.3(2) measures effective in minimizing manufacturing errors that may result in
4.4adulteration of feed or feed ingredients. The measures must include, but are not limited to:
4.5(i) cleanout practices, which may include sequencing, flushing, or other methods; and
4.6(ii) measures to minimize the inclusion of physical adulterants, including metal, in
4.7feed or feed ingredients.
4.8(c) Records sufficient to document the production history of the feed or feed
4.9ingredient manufactured in the establishment must be maintained for at least one year
4.10from the date of disposition.
4.11    Subd. 9. Packaging. (a) Packaged feed or feed ingredients must be packaged in a
4.12manner that maintains identity and minimizes the risk of adulteration.
4.13(b) Bags and totes used as packaging for feed or feed ingredients must not be reused
4.14unless cleaned using effective and documented cleanout procedures.
4.15(c) Records sufficient to document these cleanout procedures must be maintained for
4.16at least one year from the date of disposition.
4.17    Subd. 10. Labeling. (a) A label or other unique identifier must be affixed to, or
4.18accompany feed or feed ingredients to maintain identity and facilitate safe and effective
4.19use.
4.20(b) Labels must be stored, handled, and used in a manner that minimizes errors.
4.21(c) Obsolete labels must be discarded promptly.
4.22    Subd. 11. Storage of finished feed or feed ingredients. (a) Finished feed or feed
4.23ingredients must be stored in a manner that minimizes the risk of adulteration. The bin,
4.24bulk tank, or other location where feed or feed ingredients are stored must be clearly
4.25identified.
4.26(b) Inventory practices, including inventory rotation, must be established and
4.27implemented for feed or feed ingredients to minimize the risk of adulteration.
4.28    Subd. 12. Inspection, sampling, and testing of incoming and finished feed or
4.29feed ingredients for adulterants. (a) Finished feed or feed ingredients must be visually
4.30inspected for the presence of visible adulterants and verification of identity.
4.31(b) When sampling and testing of feed or feed ingredients is performed by the
4.32establishment to monitor for adulteration, test results must be reviewed by trained
4.33personnel. Test results that indicate feed or feed ingredients are adulterated must be
4.34investigated by the establishment. Investigations may include, but are not limited to,
4.35review of:
4.36(1) ingredient specifications used in the development of the formula;
5.1(2) formula;
5.2(3) production records; and
5.3(4) sampling and testing methods.
5.4(c) Records must be kept for at least one year after the investigation and review of
5.5test results for adulterants, and of any corrective action or actions taken when adulterants
5.6are detected. Records must not be used as the sole basis for official enforcement actions or
5.7penalties by the commissioner.
5.8    Subd. 13. Transportation of feed or feed ingredients. Feed or feed ingredients
5.9must be transported utilizing methods that minimize the risk of adulterations, including,
5.10but not limited to, the following:
5.11(1) conveyances used to transport feed or feed ingredients must be inspected for
5.12cleanliness and structural integrity prior to loading;
5.13(2) feed, feed ingredients, or other materials or substances that may pose a risk of
5.14adulterating feed or feed ingredients must not be loaded onto the same conveyance unless
5.15measures are taken to minimize risk; and
5.16(3) records must be maintained for each feed or feed ingredient identifying the
5.17immediate subsequent recipient, quantity, type or name, unique identifier if available, and
5.18date shipped for at least one year from the date of disposition.
5.19    Subd. 14. Voluntary recall; withdrawal. (a) Sufficient records and other
5.20information concerning the identity and disposition of feed or feed ingredients must
5.21be maintained for at least one year from the date of disposition to permit the rapid
5.22and effective recall from the marketplace or withdrawal from feeding if a feed or feed
5.23ingredient is found to be adulterated.
5.24(b) Voluntary recalls of feed or feed ingredients should be guided by procedures
5.25outlined by the United States Food and Drug Administration in the Code of Federal
5.26Regulations, title 21, section 7.
5.27    Subd. 15. Expiration. Subdivisions 1 and 3 to 14 expire upon the United States
5.28Food and Drug Administration's adoption of rules regarding preventative controls for
5.29animal feed.

5.30    Sec. 2. Minnesota Statutes 2010, section 25.40, subdivision 1, is amended to read:
5.31    Subdivision 1. Adoption. The commissioner may adopt rules for commercial feeds,
5.32pet foods, and specialty pet foods as are authorized in sections 25.31 to 25.43 and such
5.33other reasonable rules as may be necessary for the efficient enforcement of sections 25.31
5.34to 25.43. In the interest of uniformity the commissioner shall by rule adopt, unless the
6.1commissioner determines that they are inconsistent with the provisions of sections 25.31
6.2to 25.43 or are not appropriate to conditions which exist in this state, the following:
6.3(a) the official definitions of feed ingredients and official feed terms adopted by the
6.4Association of American Feed Control Officials and published in the official publication
6.5of that organization; and.
6.6(b) any rule promulgated pursuant to the authority of the Federal Food, Drug, and
6.7Cosmetic Act, provided, that the commissioner would have the authority under sections
6.825.31 to 25.43 to adopt the rules.

6.9    Sec. 3. Minnesota Statutes 2010, section 25.40, subdivision 2, is amended to read:
6.10    Subd. 2. Notice; public comment. Before the issuance, amendment, or repeal
6.11of any rule authorized by sections 25.31 to 25.43, the commissioner shall publish the
6.12proposed rule, amendment, or notice to repeal an existing rule in a manner reasonably
6.13calculated to give interested parties, including all current license holders, adequate notice
6.14and shall afford all interested persons an opportunity to present their views orally or in
6.15writing, within a reasonable period of time. After consideration of all views presented
6.16by interested persons, the commissioner shall take appropriate action to issue the
6.17proposed rule or to amend or repeal an existing rule. The provisions of this subdivision
6.18notwithstanding, if the commissioner, pursuant to the authority of sections 25.31 to
6.1925.43 , adopts the official definitions of feed ingredients or official feed terms as adopted
6.20by the Association of American Feed Control Officials, or regulations promulgated
6.21pursuant to the authority of the Federal Food, Drug, and Cosmetic Act, any amendment or
6.22modification adopted by said the association or by the secretary of health, education and
6.23welfare in the case of regulations promulgated pursuant to the Federal Food, Drug, and
6.24Cosmetic Act, shall be adopted automatically under sections 25.31 to 25.43 without regard
6.25to the publication of the notice required by this subdivision unless the commissioner, by
6.26order specifically determines that said the amendment or modification shall not be adopted.

6.27    Sec. 4. Minnesota Statutes 2010, section 25.40, is amended by adding a subdivision to
6.28read:
6.29    Subd. 3. Food and drug rules. Applicable federal regulations including
6.30recodification contained in Code of Federal Regulations, title 21, parts 1 to 1299, not
6.31otherwise adopted herein, also are adopted as feed rules of this state.

6.32    Sec. 5. REPEALER.
6.33Minnesota Rules, parts 1510.2220; and 1510.2230, are repealed.

7.1    Sec. 6. EFFECTIVE DATE.
7.2Sections 1 to 5 are effective the day following final enactment.