Senator Curtis S. Bramble proposes the following substitute bill:




Chief Sponsor: Curtis S. Bramble

House Sponsor: Steve Eliason


8     General Description:
9          This bill authorizes the Department of Agriculture and Food to issue good
10     manufacturing practices certificates to cosmetic manufacturers.
11     Highlighted Provisions:
12          This bill:
13          ▸     defines terms;
14          ▸     requires the Department of Agriculture and Food to create a process for issuing
15     good manufacturing practices certificates to cosmetics manufacturers; and
16          ▸     makes technical and conforming changes.
17     Money Appropriated in this Bill:
18          None
19     Other Special Clauses:
20          None
21     Utah Code Sections Affected:
22     ENACTS:
23          4-2-801, Utah Code Annotated 1953

25     Be it enacted by the Legislature of the state of Utah:

26          Section 1. Section 4-2-801 is enacted to read:
Part 8. Cosmetics

28          4-2-801. Good manufacturing practices for cosmetics.
29          (1) As used in this section:
30          (a) "Cosmetic" means the same as that term is defined in 21 U.S.C. Sec. 321.
31          (b) "Good manufacturing practices" means the current good manufacturing practices
32     described in the United States Food and Drug Administration's Guidance for Industry:
33     Cosmetic Good Manufacturing Practices.
34          (2) (a) In accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act,
35     and consistent with this section, the department shall make and enforce rules establishing a
36     voluntary certification program for good manufacturing practices for cosmetics, including:
37          (i) the criteria for receiving a good manufacturing practices certificate, including the
38     qualifications for registering with the department as required by Subsection (3)(a);
39          (ii) the process to apply for and receive a good manufacturing practices certificate
40     under this section; and
41          (iii) criteria by which the department will determine the term of a good manufacturing
42     practices certificate in accordance with Subsection (5).
43          (b) Rules made pursuant to this section may not be more stringent than:
44          (i) rules established by federal law; or
45          (ii) guidance published by the United States Food and Drug Administration.
46          (3) The department's good manufacturing practices certification program shall provide
47     for the issuance of a certificate to an applicant if:
48          (a) the applicant is registered with the department pursuant to registration requirements
49     established by the department under Subsection (2)(a);
50          (b) the applicant submits an application to the department requesting a certificate for
51     the applicant's manufacturing facility; and
52          (c) the department inspects the applicant's manufacturing facility and determines that
53     the applicant is in compliance with good manufacturing practices.
54          (4) (a) In accordance with Section 63J-1-504, the department shall adopt a schedule of
55     registration and certificate fees to cover the department's costs of administering the certification
56     program described in this section.

57          (b) Notwithstanding Section 63J-1-504, the department shall retain the fees as
58     dedicated credits.
59          (5) A good manufacturing practices certificate issued under this section shall:
60          (a) specify the certificate issuance date and expiration date; and
61          (b) be valid for a term of one to three years as determined by the department pursuant
62     to criteria established under Subsection (2)(a).