37.110.315    CERTIFICATE OF FREE SALE

(1) Requirements for issuance of a Certificate of Free Sale (CFS) by the department or local regulatory authority are:

(a) all certificate applicants must possess a valid wholesale food license;

(b) a CFS will be issued only for license subtypes listed on the issued license;

(c) a CFS will only be issued for compliance with general good food manufacturing practices regulated in this subchapter, and not for the specific food manufacturing regulations stated in ARM 37.110.101;

(d) products for certification must not be under or pending any known embargo, detainment, or litigation by the regulatory authority, U.S. Food and Drug Administration (USFDA), or other enforcement action by health or safety authorities recognized by the department, including local, state, or federal judicial orders;

(e) prior to issuing a CFS, the certificate applicant will provide to the department or local regulatory authority a signed statement that certifies to the best of their knowledge the products are not pending any known embargo, detainment, or litigation by a local regulatory authority, the department, or USFDA, or local, state, or federal judicial orders;

(f) certificate applicants that request a CFS must have been inspected by the regulatory authority within the inspection frequency stated in ARM 37.110.307;

(g) certificate applicants must be in substantial compliance, and not have any uncorrected critical or priority violations of applicable food safety laws and rules;

(h) a CFS will be issued in a format approved by the department that specifies:

(i) plant location where the products were processed;

(ii) date the plant was inspected, and found in substantial compliance, without any uncorrected critical or priority violations of applicable food safety laws and rules;

(iii) only known facts about the products, and conditions found during the inspection;

(iv) the inspection was not conducted to assess compliance with federal good manufacturing practices, only for compliance with Montana wholesale food rules;

(v) the issued document is clearly titled ″Certificate of Free Sale″; and

(vi) the certificate does not imply or express any testimonials regarding product warranty;

(i) the applicant must provide the department or local regulatory authority with information for a CFS on a form provided and approved by the department;

(j) certificate applicant must currently be registered with USFDA, if products are shipped out of state, or outside the United States;

(k) the CFS will be issued in the order the requests are received, and provided in accordance with department or local regulatory authority resources in the timeliest manner possible; and

(l) the department or local regulatory authority will deliver CFSs by the U.S. Postal Service.

(2) The department or local regulatory authority will not charge a fee for the CFS, unless allowed by law.

(3) The decision by the department or local regulatory authority to deny a CFS may be appealed by the applicant by filing a written notice of appeal to the department or local regulatory authority within 30 days of the date on the written denial. Upon the filing of the notice of appeal, the applicant is entitled to a hearing before the department or local regulatory authority held pursuant to the contested case procedure detailed in the Montana Administrative Procedure Act. If the department or local regulatory authority finds the applicant is entitled to a CFS, the presiding officer of the department will issue written directions about how and when the certificate will be issued.

 

History: 50-57-103, MCA; IMP, 50-57-103, MCA; NEW, 2019 MAR p. 2126, Eff. 1/1/20.