Regulatory Primer 101

1. Regulatory Primer 101 Patrick Kennelly, Chief Food Safety Section California Department of Public Health March 11, 2014

2. 1906

3. 1927

4. 1938

5. Statute A formal written law enacted by the legislative branch of government. Typically, statutes command or prohibit something.

6. Legislative Branch Executive Branch Judicial Branch

7. Bill A bill is a proposed law under consideration by a legislature. A bill does not become law until it is passed by the legislature and, in most cases, is approved by the Executive Branch. Once a bill has been enacted into law, it is called an Act or a statute.

8. Introducing a Bill Committees Standing Select Joint Conference House Rules

9. Floor Action • Calendar • Debate • Vote

10. Passing a bill Approval of a bill

11. The Bill Becomes Law

12. Regulation A process of the promulgation, monitoring and enforcement of rules A written instrument containing rules having the force of law

13. FD&C Section 701 (21 U.S.C. 371) (a) The authority to promulgate regulations for the efficient enforcement of this Act, except as otherwise provided in this section is hereby vested with the Secretary.

14. FD&C Section 418 (21 U.S.C. 350g) (n) Regulations. (1) In general. Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations: • to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and • to define, for purposes of this section, the terms `small business' and `very small business', taking into consideration the study described in subsection (l)(5)……..

15. Rule-making

16. Process In the United States, the governing law for rulemaking is the Administrative Procedures Act of 1946. States often have parallel systems.

18. FSMA Rules • Sanitary Transportation of Human & Animal Food • Protecting Food Against Intentional Adulteration • Risk Based Preventative Controls / GMPs for Animal Feed • Foreign Supplier Verification • Accreditation of Third Party Auditor/Certification Bodies • Produce Safety • Preventative Controls / GMPs for Human Food

19. State Authority How do States Gain the Authority to Enforce Federal Statutes and Regulations?

20. State Authority • Work through the State Legislature to Establish Equivalent Language in State Law. • Go through the State’s Rulemaking Process to Adopt Equivalent Language in State Regulations.

21. State Authority • Adopt by reference, including automatic adoption provisions for future amendments to the federal rules.

22. California H&S 110105. All good manufacturing practices regulations for any food, drug, device, or cosmetic and any amendments to the regulations adopted pursuant to the federal act in effect on November 23, 1970, or adopted on or after such date, are the good manufacturing practices regulations of this state. If the department finds that it is necessary for the protection of consumers, it may adopt interpretative regulations as necessary to define “current good manufacturing practice” as used in this part.

23. Contact Information Patrick Kennelly, Chief Food Safety Section California Department of Public Health March 11, 2014