Summary of Rulemaking in California for the Forensic Alcohol Laboratories Regulation Review...
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Transcript of Summary of Rulemaking in California for the Forensic Alcohol Laboratories Regulation Review...
Summary of Rulemaking in California for the Forensic Alcohol Laboratories Regulation Review Committee
Cathy L. Ruebusch, RN, MSN
Office of Regulations
August 25, 2005
Administrative Procedure Administrative Procedure ActAct
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
Purpose of RegulationsPurpose 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)
Standards of the APAStandards of the APA
Authority
Reference
Clarity
Necessity
Consistency
Nonduplication
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.
Non-Emergency RegulationsNon-Emergency Regulations Must complete the processes of rulemaking before the regulations become effective
The Department must file a Filing Order for OAL review to complete the rulemaking process
The Department has one year after public notice to complete the rulemaking process
Regulations become effective one month after Office of Administrative Law approval
REGULATION PACKAGE COMPONENTSREGULATION PACKAGE COMPONENTS
Transmittal Memo
Informative Digest/Policy Statement Overview
Statement of Reasons
• Including Documents Relied Upon
Statement of Determinations
Regulation Text
• Including any documents Incorporated by Reference
Fiscal Impact Statement
Reviews to Complete 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)
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
Public NoticePublic 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.
45 Day Public Comment Period45 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.
Public HearingPublic 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.
Post Comment/Hearing ProcessPost 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
15 Day Comment Period15 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.
Final Rulemaking DocumentsFinal 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.
Filing OrderFiling Order
Review Summary of Comments and Responses
Individual Comments Not In Review Package
May Be (Not Always) Supplement to Statement of Reasons
OAL Review and DeterminationOAL 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