1. Summary of Rulemaking in California for the Forensic Alcohol Laboratories Regulation Review Committee Cathy L. Ruebusch, RN, MSN Office of Regulations August 25, 2005

2. Administrative Procedure Act  Government Code, Title 2, Division 3, Part 1, Chapter 3.5 Administrative Regulations and Rulemaking  California Code of Regulations, Title 1, Division 1 Review of Proposed Regulations; Procedures for Regulatory Determinations

3. Purpose of Regulations “Regulation” means every rule, regulation, order, or standard of general application … adopted by state agency to implement, interpret, or make specific the law enforced or administered by it, or to govern its procedure. (Government Code Section 11342.600)

4. Standards of the APA  Authority  Reference  Clarity  Necessity  Consistency  Nonduplication

5. Critical Points  A regulation must have statutory authority to exist.  A regulation must implement, interpret, or make specific a statute, regulation, or court order.  A regulation must be written so it is interpreted in only one way by the affected parties.  A regulation must have an evidence-based reason to exist.

6. Non-Emergency Regulations b  Must complete the processes of rulemaking before the regulations become effective b  The Department must file a Filing Order for OAL review to complete the rulemaking process b  The Department has one year after public notice to complete the rulemaking process b  Regulations become effective one month after Office of Administrative Law approval

7. REGULATION PACKAGE COMPONENTS b  Transmittal Memo b  Informative Digest/Policy Statement Overview b  Statement of Reasons Including Documents Relied Upon b  Statement of Determinations b  Regulation Text Including any documents Incorporated by Reference b  Fiscal Impact Statement

8. Reviews to Complete  DHS Office of Regulation  DHS Office of Legal Services  Budget Office  Health and Human Services Agency  Department of Finance (Required if proposal results in cost or savings to the state)  Other State Departments (possibly CHP)

9. Time Lines  Concept determination to completed Regulation Package, indeterminate Depends on process used to write, resources dedicated to process, and complexity of concepts  Complete Package to Reviews completed, usually 9 months  Reviews completed to Public Notice, one month

10. Public Notice  The Public Notice is a notice issued by the department announcing a proposed rulemaking.  The Public Notice is published (through OAL) in the California Regulatory Notice Register also called the CRNR or the Z-register.  Once the public notice has been published in the Z-register it signifies the official beginning of the APA rulemaking process The department has 1 year (from the date of Z-register publication) to complete the rulemaking process. The public comment period begins and shall be no less than 45 days.

11. 45 Day Public Comment Period  Per the APA, departments shall provide the public an opportunity to comment on the regulatory proposal.  This comment period shall be a minimum of 45 days.  Comments are accepted in writing, by fax or by e-mail until 5:00 p.m. the last day of the comment period.

12. Public Hearing  The program may opt to hold a public hearing on a regulatory proposal.  Additionally any interested person may submit a written request for a public hearing prior to 15 days before the close of the written comment period.  At the hearing interested persons may present their concerns to a Hearing Officer. A court reporter is also present to record public testimonies.  This is not a forum for a public debate.

13. Post Comment/Hearing Process  At the close of the comment period, any comments received by OOR and a transcript of any public hearing held are forwarded to the program for review and response.  Program decides not to propose post comment/hearing changes OR  Program proposes post comment/hearing changes

14. 15 Day Comment Period  If the modifications to the regulation proposal are sufficiently related to the text of the original proposal and within the scope of the original public notice, the department shall make these changes available for public comment for a minimum of 15 days.  Post comment/hearing changes are required to be sent only to people who commented on the original proposal or who have specifically requested to receive changes.  Generally, only those areas which were changed are open for comment.

15. Final Rulemaking Documents  Transmittal Memo  Updated Informative Digest/ Policy Statement Overview  Updated Regulation Text  Final Statement of Reasons Each “relevant” comment received shall be separately identified and addressed by including –a summary of the comment AND –an explanation of how the regulations were changed to accommodate the comment OR –an explanation as to why no changes were made based on the comment.

16. Filing Order  Review Summary of Comments and Responses  Individual Comments Not In Review Package  May Be (Not Always) Supplement to Statement of Reasons

17. OAL Review and Determination  OAL has 30 days to review and make determination on approval  OAL transmits legal opinion to DHS explaining basis for disapproval  DHS has 120 days to correct problems  Usually involves additional 15 day public notice