California Regulatory Notice Register — Register 2020, No. 6-Z (February 07, 2020)

Cal. Reg. Notice Reg. 2020, No. 6

California Z Register

GAVIN NEWSOM, GOVERNOR OFFICE OF ADMINISTRATIVE LAW REGISTER 2020, NUMBER 6−Z PUBLISHED WEEKLY BY THE OFFICE OF ADMINISTRATIVE LAW FEBRUARY 7, 2020 PROPOSED ACTION ON REGULATIONS TITLE 2. SECRETARY OF STATE Statewide Voter Registration System — Notice File Number Z2020−0128−11 ............................... 169 TITLE 10. DEPARTMENT OF INSURANCE Notice of Proposed Action and Notice of Public Hearing for the California Automobile Assigned Risk Plan Simplified Manual of Rule and Rates — Notice File Number Z2020−0128−09 ............................................... 172 TITLE 10.

DEPARTMENT OF INSURANCE Notice of Proposed Action and Notice of Public Hearing Regarding the California Automobile Assigned Risk Plan — Plan of Operations — Notice File Number Z2020−0128−08 ....... 174 TITLE 10. DEPARTMENT OF INSURANCE Notice of Proposed Action and Notice of Public Hearing Revisions to California Low Cost Automobile Plan of Operations — Notice File Number Z2020−0128−07 ................. 178 TITLE 13. CALIFORNIA HIGHWAY PATROL Federal Consistency — Notice File Number Z2020−0123−01 ........................................... 181 TITLE 16.

BOARD OF BEHA VIORAL SCIENCES Supervision−Related Requirements — Notice File Number Z2020−0124−01 ................................ 183 TITLE 16. BOARD OF PHARMACY Off−Site Storage Waiver — Notice File Number Z2020−0128−02 ........................................ 186 TITLE 16. BOARD OF PHARMACY Renewal Requirements — Notice File Number Z2020−0128−01 ......................................... 188 TITLE 17. DEPARTMENT OF PUBLIC HEALTH Clinical Lab Personnel Standards:

Definitions — Notice File Number Z2020−0128−10 ...................... 192 (Continued on next page) Time- Dated Material

GENERAL PUBLIC INTEREST DEPARTMENT OF FISH AND WILDLIFE California Endangered Species Act Consistency Determination Number 2080−2019−010−05, 5665 Campbell Road, Lompoc, CA 93436, Santa Barbara County ............... 199 DEPARTMENT OF FISH AND WILDLIFE California Endangered Species Act Consistency Determination Number 2080−2019−011−03, Phase 4 and 5 of the 2017 Storm Damage Department of Water Resources Rehabilitation Project (SDDR), Butte, Colusa, Glenn, Sutter, Sacramento, San Joaquin, Tehama, and Yolo Counties .............................. 205 DEPARTMENT OF FISH AND WILDLIFE Habitat Restoration and Enhancement Act Consistency Determination Number 1653−2019−051−001−R1, North Fork Battle Creek Barrier Modification and Fish Passage Improvement Project — Upper Barrier Site, Shasta and Tehama Counties ....... 215 DEPARTMENT OF TOXIC SUBSTANCES CONTROL South Fresno PCE Groundwater Plume Site Proposed Administrative Settlement ........................... 218 OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT Public Health Goals for Trihalomethanes ........................................................... 219 ACCEPTANCE OF PETITION TO REVIEW ALLEGED UNDERGROUND REGULATIONS OFFICE OF ADMINISTRATIVE LAW Non−Designated Programming Facility ............................................................ 219

SUMMARY OF REGULATORY ACTIONS Regulations filed with the Secretary of State ......................................................... 220 The California Regulatory Notice Register is an official state publication of the Office of Administrative Law containing notices of proposed regulatory actions by state regulatory agencies to adopt, amend or repeal regulations contained in the California Code of Regulations. The effective period of a notice of proposed regulatory action by a state agency in the California Regulatory Notice Register shall not exceed one year [Government Code § 11346.4(b)].

It is suggested, therefore, that issues of the California Regulatory Notice Register be retained for a minimum of 18 months. CALIFORNIA REGULA TORY NOTICE REGISTER is published weekly by the Office of Administrative Law, 300 Capitol Mall, Suite 1250, Sacramento, CA 95814-4339. The Register is printed by Barclays, a subsidiary of West, a Thomson Reuters Business, and is offered by subscription for $205.00 (annual price). To order or make changes to current subscriptions, please call (800) 328−4880. The Register can also be accessed at http://www.oal.ca.gov.

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z PROPOSED ACTION ON REGULATIONS Information contained in this document is published as received from agencies and is not edited by Thomson Reuters. TITLE 2. SECRETARY OF STATE Statewide Voter Registration System NOTICE IS HEREBY GIVEN that the Secretary of State (SOS) is proposing to take the action described in the Informative Digest. Any person interested may present statements or arguments in writing relevant to the action proposed.

Written comments, including those sent by mail, facsimile, or e−mail to the address listed under Contact Persons in this Notice, must be re- ceived by the SOS at its office not later than 5:00 p.m. on March 24, 2020. A public hearing is not scheduled. A public hearing will be held if any interested person, or his or her duly authorized representative, submits a written request for a public hearing to the contact persons listed below no later than 15 days prior to the close of the written com- ment period.

Following the public hearing, if one is re- quested, or following the written comment period if no public hearing is requested, the SOS, upon its own mo- tion or at the instance of any interested party, may there- after adopt the proposals substantially as described be- low or may modify such proposals if such modifica- tions are sufficiently related to the original text.

With the exception of technical or grammatical changes, the full text of any modified proposal will be available for 15 days prior to its adoption from the person designated in this Notice as contact persons and will be mailed to those persons who submit written or oral testimony re- lated to this proposal or who have requested notification of any changes to the proposal. Public Comment Period: February 7, 2020, through March 24, 2020. AUTHORITY AND REFERENCE Authority cited:

Section 12172.5, Government Code and Sections 10 and 2168, Elections Code. Reference cited: National V oter Registration Act of 1993, 52 U.S.C.

Section 20507; Help America V ote Act of 2002, 52 U.S.C. Sections 20102, 20505, 21083, Pub.L. No. 107−252,

Section 303(a) (October 29, 2002) 116 Stat. 1666, 42 U.S.C

Section 15483; Uniformed and Overseas Citizens Absentee V oting Act, 52 U.S.C. Sections 20302, et seq.; V oting Accessibility for the El- derly and Handicapped Act, 52 U.S.C.

Section 20102(1)(b)(2)(B)(ii); California Elections Code Sec- tions 323, 338.5 2000, 2100, 2101, 2102, 2150, 2153, 2154, 2155, 2166, 2166.5, 2166.7, 2168, 2170, 2187, 2189, 2193, 2201, 2205, 2206, 2212, 2220, 2221, 2223, 2224, 2225, 2226, 2227, 2263, 2500, 2501, 3000−3026, 3400, 3402, 3500 12223, 12241, 12260, 12281, 12286, 14310, 14311; Civil Code Sections 1798, et seq.; Cali- fornia Code of Regulations Title 2, Division 7,

Chapter 1,

Article 3.5

Section 20025, 20026; State Administra- tion Manual Sections 5320, 5320.1, 5320.2, 5321.1; National Institute of Standards and Technology Special Publication 800−175B; Federal Information Process- ing Standards Publication 140−2. INFORMATIVE DIGEST A. Informative Digest The Help America V ote Act of 2002 (HA V A) (52 U.S.C. 21083, et seq.), which was signed into law on October 29, 2002, provides federal funding to states conditioned upon the planned implementation of cer- tain requirements, including the establishment of a statewide voter registration system database.

Section 21083 of HA V A requires that each state having voter registration requirements shall, through the chief state elections official, establish a single, uniform, official, centralized, interactive computerized statewide voter registration list. In accordance with HA V A require- ments, a new statewide voter registration database has been developed by the SOS and implemented in all 58 counties. These proposed new regulations will replace the current established standards and procedures used by counties for processing, transmitting, and maintain- ing voter registration records. These new regulations comply with the requirements of HA V A

Section 21083 and assure the uniform application and administration of state election laws. The purpose of repealing Title 2, Division 7,

Chapter 2, Statewide V oter Registration Database, of the Cali- fornia Code of Regulations, and replacing it with Title 2, Division 7,

Chapter 1,

Article 2.5 of the California Code of Regulations is as follows: 1. To provide guidance to county elections officials on the procedures for processing voter registrations for all registrants including pre−registrants and confidential voters. 2. To eliminate outdated requirements that are no longer relevant to the processing of voter registrations. 169

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z 3. To establish Election Management System (EMS) standards for certification. 4. To establish voter registration security requirements. 5. To ensure that EMS vendors adhere to any applicable federal and state laws, the statewide voter registration system EMS Integration Specifications, and the Data Standards, and participate in ongoing verification of compliance with these standards. 6. To require regular synchronization checks that identify and resolve data differences between the statewide voter registration system and county systems. 7.

To clarify list maintenance activities such as matching voter records, processing Department of Motor Vehicle change of address records, felon and death records, and inactivating and cancelling voter registrations. 8. To ensure that the Report of Registration and Official List contain the most current list of voters that appears in their correct districts and precincts and accurately reflect the voters in each county. 9. To provide transparency for the public on voter registration and voter participation. B.

Policy Statement Overview/Anticipated Benefits of Proposal The proposed regulations were drafted for the pur- pose of addressing the new statewide voter registration system processes and to give guidance that will ensure data accuracy and consistency across the state. These changes amend

definitions, define processes and add new procedures to conform to requirements needed for processing data in the new statewide voter registration system. These proposed regulations also eliminate out- dated requirements that are no longer relevant to the processing of voter registrations. In addition, these reg- ulations will provide transparency for voters to view their voter participation history and to determine if their vote by mail or provisional ballots were processed. C.

Consistency/Compatibility with Existing State Regulations After conducting an evaluation of regulations in this area, the SOS has determined that these are the only reg- ulations dealing with statewide voter registration sys- tem. This regulatory proposal updates existing regula- tions relating to the statewide voter registration data- base. Therefore, the proposed regulations are neither in- consistent nor incompatible with existing state regulations. D.

Documents Incorporated by Reference: V oteCal System EMS Integration and Data Exchange Specifications Document, revised June 29, 2016 VoteCal Data Standards, revised January 27, 2020 California Application for Certification of an Election Management System, version 1.0 National Institute of Standards and Technology Special Publication 800−175B, published August, 2016 Readily available online at: https://csrc.nist. gov/publications/detail/sp/800−175b/final Federal Information Processing Standards Publication 140−2, published May 25, 2001 Readily available online at: https://csrc.nist. gov/publications/detail/fips/140/2/final E.

Documents Relied Upon in Preparing the Regulations: Sections 20250 through 20253 of Division 7 of Title 2 of California Code of Regulations Brennan Center for Justice report titled “Preparing for Cyberattacks and Technical Failures: A Guide for Elections Officials” (https://www. brennancenter.org/sites/default/files/2019−12/ 2019_12_ContingencyPlanning.pdf) Election Security Advance Planning Checklist prepared by Brennan Center for Justice (https://www.brennancenter.org/sites/default/ files/2019−12/2019_12_ContingencyPlanning Checklist_Final.pdf) Election Security Recourse Library developed by the Department of Homeland Security. (https:// www.dhs.gov/publication/election−security− resource−library?topic=election−security) CIS Critical Security Controls, 41st Edition (dated Winter, 2016) (https://www.cisecurity.org/white− papers/cis−controls−2016−poster/) DISCLOSURES REGARDING THE PROPOSED REGULATIONS The SOS has made the following initial determinations: Fiscal Impact on Public Agencies Including Costs or Savings to State Agencies or Costs/Savings in Federal Funding to the State: None.

Nondiscretionary Costs/Savings to Local Agencies: None. Mandate on Local Agencies and School Districts: None. Cost to Any Local Agency or School District for Which Government Code Sections 17500−17630 Re- quire Reimbursement: None. 170

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z Business Impact: The SOS has made an initial deter- mination that the proposed regulatory action will have no significant statewide adverse economic impact di- rectly affecting business, including the ability of Cali- fornia businesses to compete with businesses in other states. Cost Impact on Representative Private Person or Business: The SOS is not aware of any cost impacts that a representative private person or business would nec- essarily incur in reasonable compliance with the pro- posed action. Significant Effect on Housing Costs: None.

Effect on Small Business: The SOS has determined that the proposed regulations would not affect small businesses. The proposed regulations are updating the regulations to conform to current business practices. The proposed regulations affect counties and individu- als, neither of whom are small businesses.

RESULTS OF THE ECONOMIC IMPACT ASSESSMENT The SOS has determined that the proposed regula- tions are (1) unlikely to create or eliminate any jobs in California, (2) unlikely to create or eliminate any Cali- fornia businesses, and (3) unlikely to result in the ex- pansion of businesses currently doing business within California. The proposed regulations reflect updated business practices for the new statewide voter registra- tion system. These regulations do not significantly change existing business practices such that jobs or businesses would be created or eliminated.

Benefits of the Proposed Regulations: The benefits of the regulation to the health and welfare of California residents lies in the fact that these regulations will elimi- nate outdated requirements, define processes, add new procedures and give guidance to ensure data accuracy and data constancy statewide.

These regulations will ul- timately benefit California residents as they will expand the opportunities for them to participate in the demo- cratic process by providing voters, via the SOS website, the ability to determine if they are registered to vote, their political party and language preference, if their participation history was recorded and the status of their vote by mail or provision ballot.

CONSIDERATION OF ALTERNATIVES The SOS must determine that no reasonable alterna- tive it considered or that has otherwise been identified and brought to its attention would either be more effec- tive in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons or would be more cost− effective to affected private persons and equally effec- tive in implementing the statutory policy or other provi- sion of law. Any interested person may present statements or ar- guments relevant to the above determinations.

INITIAL STATEMENT OF REASONS, THE TEXT OF PROPOSAL AND THE RULEMAKING FILE The SOS has prepared an Initial Statement of the rea- sons for the proposed action and has available all the in- formation upon which the proposal is based. The Initial Statement of Reasons is available on the SOS’s website. Copies of the express language of the proposed regu- lations, any document incorporated by reference, the initial statement of reasons, and all of the information upon which the proposal is based, may be obtained throughout the rulemaking process upon request from the SOS contact or on the website listed below.

A V AILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE A Final Statement of Reasons will be created after the closing of the public comment period. A copy of the fi- nal statement of reasons can be obtained once it has been prepared from the contact persons named below or by accessing the website listed below.

CONTACT PERSONS Inquiries or comments concerning the proposed rule- making action may be addressed to: Raj Bathla Secretary of State 1500 11 th St., 5th Floor Sacramento, CA 95814 (916) 695−1597 rbathla@sos.ca.gov The backup contact person is: Taylor Kayatta Secretary of State 1500 11 th St., 4th Floor Sacramento, CA 95814 (916) 695−1530 tkayatta@sos.ca.gov Website Access: Materials regarding this proposal can be found at: https://www.sos.ca.gov/ administration/regulations/proposed−regulations/. 171

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z TITLE 10. DEPARTMENT OF INSURANCE REG−2020−00001 CALIFORNIA AUTOMOBILE ASSIGNED RISK PLAN SIMPLIFIED MANUAL OF RULES AND RATES SUBJECT OF HEARING California’s Insurance Commissioner will hold a public hearing to consider the application of the Cali- fornia Automobile Assigned Risk Plan (“CAARP” or “Plan”) for changes to the Simplified Manual of Rules and Rates. AUTHORITY AND REFERENCE TO ADOPT RATES The Commissioner will consider the application pur- suant to the authority vested in him by

Section 11620 of the California Insurance Code. The Commissioner’s decision on the application will implement, interpret, or make specific the requirements of Insurance Code Sec- tion 11624(e). Government Code

Section 11340.9(

g) applies to this proceeding. HEARING DATE AND LOCATION Notice is hereby given that a public hearing will be held to permit all interested persons the opportunity to present statements or arguments, orally or in writing, with respect to the application at the following date, time, and place: Date: March 25, 2020 Time: 1:00 p.m. Place: Department of Insurance Hearing Room 300 South Spring Street Los Angeles, CA 90013 The hearing will continue on the date noted above until all testimony has been submitted or until 5:00 p.m., whichever is earlier.

ACCESS TO HEARING ROOM The facilities to be used for the public hearing are ac- cessible to persons with mobility impairments. Persons with sight or hearing impairments are requested to noti- fy the contact person (listed below) for this hearing in order to make special arrangements, if necessary. WRITTEN AND/OR ORAL COMMENTS: AGENCY CONTACT PERSON All persons are invited to submit written comments to the Insurance Commissioner on the application prior to the public comment deadline.

Comments should be ad- dressed to the contact person for this proceeding: Contact Person: Michael Riordan, Attorney California Department of Insurance Rate Enforcement Bureau 45 Fremont Street, 21 st Floor San Francisco, CA 94105 riordanm@insurance.ca.gov Telephone: (415) 538−4226 Facsimile: (415) 904−5490 The backup agency contact person for this proceed- ing will be: Emily Gallagher, Attorney California Department of Insurance Rate Enforcement Bureau 45 Fremont Street 21 st Floor San Francisco, CA 94105 gallaghere@insurance.ca.gov Telephone: (415) 538−4108 All persons are invited to present oral and/or written testimony at the scheduled public hearing.

DEADLINE FOR WRITTEN COMMENTS All written materials, unless submitted at the hearing, must be received by the Insurance Commissioner at the address listed above no later than 5:00 p.m. on March 25, 2020. Any written materials received after that time will not be considered. Written comments may also be submitted to the contact person by e−mail or facsimile transmission. Please select only one method to submit written comments.

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z tions, Title 10, Sections 2662.1−2662.6 in connection with their participation in this matter. Interested persons must submit a Petition to Participate, as specified in California Code of Regulations, Title 10,

Section 2661.4. The Petition to Participate must be submitted to the Commissioner at the Office of the Public Advisor at the following address: California Department of Insurance Office of the Public Advisor 300 Spring Street 12 th Floor Los Angeles, CA 90013 Telephone: (213) 346−6635 A copy of the Petition to Participate must also be sub- mitted to the contact person for this hearing (listed above). For further information, please contact the Of- fice of the Public Advisor.

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW CA 20−04−A Currently, the definition of married does not include a classification as a person is/or becomes widowed. This causes confusion and can lead to policy being mis− rated. The change is necessary to ensure that the insured will not receive a change in classification or premium in the event he/she becomes widowed. COMPARABLE FEDERAL LAW There are no comparable existing federal regulations or statutes.

LOCAL MANDATE DETERMINATION The Insurance Commissioner has initially deter- mined that the application will not result in any new program mandates on local agencies or school districts. MANDATES ON LOCAL AGENCIES OR SCHOOL DISTRICTS OR COSTS WHICH MUST BE REIMBURSED PURSUANT TO GOVERNMENT CODE SECTIONS 17500 THROUGH 17630 The Insurance Commissioner has initially deter- mined that the application will not result in any cost or significant savings to any local agency or school district for which

Part 7 (commencing with

Section 17500) of Division 4 of the Government Code would require re- imbursement, or in other nondiscretionary costs or sav- ings to local agencies. COST OR SA VINGS TO ANY STATE AGENCY; FEDERAL FUNDING The Commissioner has determined that the applica- tion will result in no cost or savings to any state agency and no cost or savings in federal funding to the state.

SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT ON BUSINESSES AND THE ABILITY OF CALIFORNIA BUSINESSES TO COMPETE The Commissioner has initially determined that the proposal will not have a significant statewide adverse economic impact directly affecting businesses, includ- ing the ability of California businesses to compete with businesses in other states. This proposal will have no ef- fect on the creation or elimination of jobs in California, the creation of new businesses, the elimination of exist- ing businesses in California, or the expansion of busi- nesses in California.

COST IMPACT ON PRIV ATE PERSONS OR ENTITIES The Insurance Commissioner has initially deter- mined that the proposal will not affect private persons or entities. IMPACT ON HOUSING COSTS The Insurance Commissioner has initially deter- mined that the application will not affect housing costs. IMPACT ON SMALL BUSINESS The proposed rate changes will not affect small businesses. SPECIFIC TECHNOLOGIES OR EQUIPMENT The application would not mandate the use of specif- ic technologies or equipment.

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons than the proposed action. PLAIN ENGLISH The application describing the proposal is in plain English. However, the application itself is based on technical actuarial principles. TEXT AND INITIAL STATEMENT OF REASONS The Department has prepared an Initial Statement of Reasons addressing the proposed rate application in ad- dition to the Informative Digest included in this notice.

The Initial Statement of Reasons, Notice of Proposed Action and Regulation Text are available for inspection or copying, and will be provided at no charge upon re- quest to the contact person listed above. Further details on CAARP’s proposal are on file with the Commission- er and available for review as set forth below. FINAL STATEMENT OF REASONS A Final Statement of Reasons will be prepared at the conclusion of this proceeding. Upon written or e−mail request to the contact person listed above, the Final Statement of Reasons will be made available for inspec- tion and copying once it has been prepared.

A copy of the Final Statement of Reasons will also be posted on the Department’s website. ACCESS TO RULEMAKING FILE Any interested person may inspect a copy of or direct questions about CAARP’s application, the statement of reasons, and any supplemental information contained in the rulemaking file by contacting the contact person listed above. By prior appointment, the rulemaking file is available for inspection at 45 Fremont Street, 21 st Floor, San Francisco, California 94105, between the hours of 9:00 a.m. and 4:30 p.m. Monday through Friday.

AUTOMATIC MAILING A copy of this Notice, including the Informative Di- gest, is being sent to all persons on the Insurance Com- missioner’s mailing list. A V AILABILITY OF DOCUMENTS ON THE INTERNET The Initial Statement of Reasons, proposed text, and this Notice of Proposed Action will be published online and may be accessed through the Department’s website at www.insurance.ca.gov.

A V AILABILITY OF MODIFIED TEXT OF REGULATIONS If the Department amends the application with changes that are sufficiently related to the original ap- plication, the Department will make the full text of the amended rates, with the changes clearly indicated, available to the public for at least 15 days before the date the Department adopts the amended rates. TITLE 10.

DEPARTMENT OF INSURANCE REG−2020−00003 CALIFORNIA AUTOMOBILE ASSIGNED RISK PLAN PLAN OF OPERATIONS SUBJECT OF HEARING California Insurance Commissioner Ricardo Lara will hold a public hearing to address the proposed amendments to the California Automobile Assigned Risk Plan (CAARP) Plan of Operations. AUTHORITY TO ADOPT RULES AND PROCEDURES AND REFERENCE The Commissioner will consider the proposed changes pursuant to the authority vested in him by Sec- tion 11620 of the California Insurance Code.

The Com- missioner’s decision on the proposed changes will im- plement, interpret, or make specific the requirements of Insurance Code

Section 11624(e). Insurance Code Sec- tion 11620(

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z Date: March 25, 2020 Time: 1:00 p.m. Place: Department of Insurance Hearing Room 300 South Spring Street Los Angeles, CA 90013 The hearing will continue on the date noted above until all testimony has been submitted or until 5:00 p.m., whichever is earlier. ACCESS TO HEARING ROOM The facilities to be used for the public hearing are ac- cessible to persons with mobility impairments. Persons with sight or hearing impairments are requested to noti- fy the contact person (listed below) for this hearing in order to make special arrangements, if necessary.

WRITTEN AND/OR ORAL COMMENTS: AGENCY CONTACT PERSON All persons are invited to submit written comments to the Insurance Commissioner on the application prior to the public comment deadline.

ADVOCACY OR WITNESS FEES Persons or groups representing the interest of con- sumers may be entitled to reasonable advocacy fees, witness fees, and other reasonable expenses, in accor- dance with the provisions of California Code of Regula- tions, Title 10, Sections 2662.1−2662.6 in connection with their participation in this matter. Interested persons must submit a Petition to Participate, as specified in California Code of Regulations, Title 10,

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW CA 20−01 Currently CAARP mails assignment notices for CAARP applications to the producer and applicant when they are submitted electronically. The producer has the option to print an electronic assignment notice. Since producers have electronic access to assignment notices, the Plan’s mailing of these documents to the producer is no longer necessary. CAARP proposes eliminating mailing the assign- ment notice to producers for applications submitted electronically.

Producers will have real time notifica- tion when an assignment is made, insureds will still have assignment notices mailed to them, and assign- ment notices for CAARP applications submitted through the alternate application submission procedure will continue to be mailed to the insured, company and the producer. Finally elimination of the mailing of the 175

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z assignment notice to the producer will reduce the CAARP’s mailing budget. CA 20−02 Plan rules currently do not address how unreported or inaccurate voluntary base data should be handled for in- surers who are not affiliated with a statistical agent. In addition, current Plan rules do not provide a consistent method to estimate a company’s unreported or inaccu- rate data when statistical agent efforts to obtain the data are ongoing or when the insurer reports directly.

To address this CAARP proposed new provisions clarifying how estimation of voluntary data for compa- nies who do not report data or provide inaccurate data will be handled. This will help resolve any matters relat- ed to unreported or inaccurate voluntary data. Allowing CAARP to estimate a company’s data, when it is not re- ceived, by accessing statistical data found in the compa- ny’s NAIC Annual Statement Automobile Written pre- mium. Finally a standard procedure for estimation of an insurer’s unreported or inaccurate data is introduced.

CA 20−03 CAARP is the insurer of last resort for drivers who cannot get insurance anywhere else. Companies that are licensed to sell auto insurance in California must also participate in the CAARP. Companies are assigned risk based on their percentage of policies it writes in the vol- untary market. It has come to CAARP’s attention that some companies do not address their assignment obli- gation until they develop a quota and receive an assign- ment(s).

Although the Plan monitors and contacts com- panies who develop a quota for the first time, a tempo- rary assignment restriction must be placed until the company decides how to address its quota obligation. CAARP proposes expanding the CAARP Plan of Op- erations to clarify how the Plan handles these compa- nies and to introduce a fee for applications returned to the Plan. CA 20−04 Currently, the definition of married does not include a classification as a person is/or becomes widowed. This causes confusion and can lead to policy being mis− rated.

The change is necessary to ensure that the insured will not receive a change in classification or premium in the event he/she becomes widowed. CA 20−05 Currently CAARP rules do not allow CAARP to re- ject passenger auto or commercial auto applications when misleading information is provided or the appli- cant and/or producer have failed to disclose requested information pertinent to the underwriting and rating of the policy. CAARP proposes expanding the criteria review of applications prior to assignment.

This will include pro- visions that will allow the Plan to reject applications when the application provides misleading information appears on the application or when the applicant and/or producer fail to disclose information pertinent to the un- derwriting and rating of the policy. The Plan will be allowed to reject a commercial appli- cation for an applicant requesting federal filings or en- dorsement when a completed CAIP Inspected Units Form either is not provided with the application or has not been thoroughly completed. COMPARABLE FEDERAL LAW There are no comparable existing federal regulations or statutes.

Part 7 (commencing with

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z the creation of new businesses, the elimination of exist- ing businesses in California, or the expansion of busi- nesses in California. COST IMPACTS ON PRIV ATE PERSONS OR ENTITIES The Insurance Commissioner has initially deter- mined that the proposal will not affect private persons or entities. IMPACT ON HOUSING COSTS The Insurance Commissioner has initially deter- mined that the application will not affect housing costs. IMPACT ON SMALL BUSINESS The proposed rate changes could affect small businesses.

SPECIFIC TECHNOLOGIES OR EQUIPMENT The application would not mandate the use of specif- ic technologies or equipment. ALTERNATIVES The Insurance Commissioner must determine that no reasonable alternative considered by the agency, or that has otherwise been identified and brought to the atten- tion of the agency, would be more effective in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons than the proposed action. PLAIN ENGLISH The application describing the proposal is in plain English.

However, the application itself is based on technical actuarial principles. TEXT AND INITIAL STATEMENT OF REASONS The Department has prepared an Initial Statement of Reasons addressing the proposed rate application in ad- dition to the Informative Digest included in this notice. The Initial Statement of Reasons, Notice of Proposed Action and Regulation Text are available for inspection or copying, and will be provided at no charge upon re- quest to the contact person listed above. Further details on CAARP’s proposal are on file with the Commission- er and available for review as set forth below.

FINAL STATEMENT OF REASONS A Final Statement of Reasons will be prepared at the conclusion of this proceeding. Upon written or e−mail request to the contact person listed above, the Final Statement of Reasons will be made available for inspec- tion and copying once it has been prepared. A copy of the Final Statement of Reasons will also be posted on the Department’s website.

ACCESS TO RULEMAKING FILE Any interested person may inspect a copy of or direct questions about CAARP’s application, the statement of reasons, and any supplemental information contained in the rulemaking file by contacting the contact person listed above. By prior appointment, the rulemaking file is available for inspection at 45 Fremont Street, 21 st Floor, San Francisco, California 94105, between the hours of 9:00 a.m. and 4:30 p.m. Monday through Friday. AUTOMATIC MAILING A copy of this Notice, including the Informative Di- gest, is being sent to all persons on the Insurance Com- missioner’s mailing list.

A V AILABILITY OF DOCUMENTS ON THE INTERNET The Initial Statement of Reasons, proposed text, and this Notice of Proposed Action will be published online and may be accessed through the Department’s website at www.insurance.ca.gov. A V AILABILITY OF MODIFIED TEXT OF REGULATIONS If the Department amends the application with changes that are sufficiently related to the original ap- plication, the Department will make the full text of the amended rates, with the changes clearly indicated, available to the public for at least 15 days before the date the Department adopts the amended rates. 177

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z TITLE 10. DEPARTMENT OF INSURANCE REG−2020−00002 REVISIONS TO CALIFORNIA LOW COST AUTOMOBILE PLAN OF OPERATIONS SUBJECT OF HEARING California Insurance Commissioner Ricardo Lara will hold a public hearing to address the proposed amendments to the California Low Cost Automobile (“CLCA”) Plan of Operations. AUTHORITY TO ADOPT RULES AND PROCEDURES AND REFERENCE The Commissioner will consider the proposed changes pursuant to the authority vested in him by Sec- tion 11620 of the California Insurance Code.

The Com- missioner’s decision on the proposed changes will im- plement, interpret, or make specific the requirements of Insurance Code

Section 11624(e). Insurance Code Sec- tion 11620(

c) applies to this proceeding. HEARING DATE AND LOCATION Notice is hereby given that a public hearing will be held to permit all interested persons the opportunity to present statements or arguments, orally or in writing, with respect to the proposed changes at the following date, time, and place: Date: March 25, 2020 Time: 1:00 p.m. Place: Department of Insurance Hearing Room 300 South Spring Street Los Angeles, CA 90013 The hearing will continue on the date noted above until all testimony has been submitted or until 5:00 p.m., whichever is earlier.

Section 178

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z 2661.4. The Petition to Participate must be submitted to the Commissioner at the Office of the Public Advisor at the following address: California Department of Insurance Office of the Public Advisor 300 Spring Street 12 th Floor Los Angeles, CA 90013 Telephone: (213) 346−6635 A copy of the Petition to Participate must also be sub- mitted to the contact person for this hearing (listed above). For further information, please contact the Of- fice of the Public Advisor.

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW LC 20−01 Currently CAARP mails assignment notices for Low Cost applications to the producer and applicant when they are submitted electronically. The producer has the option to print an electronic assignment notice. Since producers have electronic access to assignment notices, the Plan’s mailing of these documents to the producer is no longer necessary. CAARP proposes eliminating mailing the assign- ment notice to producers for applications submitted electronically.

Producers will have real time notifica- tion when an assignment is made, insureds will still have assignment notices mailed to them, and assign- ment notices for Low Cost applications submitted through the alternate application submission procedure will continue to be mailed to the insured, company and the producer. Finally, elimination of the mailing of the assignment notice to the producer will reduce CAARP’s mailing budget. LC 20−02 Plan rules currently do not address how unreported or inaccurate voluntary base data should be handled for in- surers who are not affiliated with a statistical agent.

In addition, current Plan rules do not provide a consistent method to estimate a company’s unreported or inaccu- rate data when statistical agent efforts to obtain the data are ongoing or when the insurer reports directly. To address this CAARP proposed new provisions clarifying how estimation of voluntary data for compa- nies who do not report data or provide inaccurate data will be handled. This will help resolve any matters relat- ed to unreported or inaccurate voluntary data.

Allow CAARP to estimate a company’s data, when it is not re- ceived, by accessing statistical data found in the compa- ny’s NAIC Annual Statement Automobile Written pre- mium. Finally, a standard procedure for estimation of an insurer’s unreported or inaccurate data is introduced. LC 20−03 The CLCA is a program that offers eligible applicants insurance at a discounted rate. Companies that are li- censed to sell auto insurance in California must also participate in the CLCA. Companies are assigned risk based on their percentage of policies it writes in the vol- untary market.

It has come to CAARP’s attention that some companies do not address their assignment obli- gation until they develop a quota and receive an assign- ment(s). Although the Plan monitors and contacts com- panies who develop a quota for the first time, a tempo- rary assignment restriction must be placed until the company decides how to address its quota obligation. CAARP proposes expanding the LCA Plan of Opera- tions to clarify how the Plan handles these companies and to introduce a fee for applications returned to the Plan.

LC 20−04 Currently, the definition of married does not include a classification as a person is/or becomes widowed. This causes confusion and can lead to policy being mis− rated. The change is necessary to ensure that the insured will not receive a change in classification or premium in the event he/she becomes widowed. LC 20−05 The current definition of an eligible vehicle for Low Cost Program purposes does not extend to an otherwise eligible private passenger vehicle that is furnished to the applicant by another individual for personal use.

Be- cause the nonowned vehicle is not registered to the ap- plicant or their spouse, the applicant is not eligible for a CA Low Cost Auto Policy. CAARP proposes expansion of eligible vehicles to include a private passenger vehicle that is not registered to the applicant, insured, or their spouse that is fur- nished to the applicant or insured by another individual for personal use. COMPARABLE FEDERAL LAW There are no comparable existing federal regulations or statutes.

LOCAL MANDATE DETERMINATION The Insurance Commissioner has initially deter- mined that the proposal will not result in any new pro- gram mandates on local agencies or school districts. 179

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z MANDATES ON LOCAL AGENCIES OR SCHOOL DISTRICTS OR COSTS WHICH MUST BE REIMBURSED PURSUANT TO GOVERNMENT CODE SECTIONS 17500 THROUGH 17630 The Insurance Commissioner has initially deter- mined that the proposal will not result in any cost or sig- nificant savings to any local agency or school district for which

Part 7 (commencing with

Section 17500) of Division 4 of the Government Code would require re- imbursement, or in other nondiscretionary costs or sav- ings to local agencies. COST OR SA VINGS TO ANY STATE AGENCY; FEDERAL FUNDING The Commissioner has determined that the proposed regulation will result in no cost or savings to any state agency and no cost or savings in federal funding to the state.

COST IMPACT ON PRIV ATE PERSONS OR ENTITIES The Insurance Commissioner has initially deter- mined that the proposal will not affect private persons or entities. IMPACT ON HOUSING COSTS The Insurance Commissioner has initially deter- mined that the proposal will not affect housing costs. IMPACT ON SMALL BUSINESS The Insurance Commissioner has initially deter- mined that the proposal will not affect small business. SPECIFIC TECHNOLOGIES OR EQUIPMENT The Insurance Commissioner has initially deter- mined that specific technologies or equipment will be needed.

ALTERNATIVES The Insurance Commissioner must determine that no reasonable alternative considered by the agency, or that has otherwise been identified and brought to the atten- tion of the agency, would be more effective in carrying out the purpose for which the action is proposed or would be as effective as and less burdensome to affect- ed private persons than the proposed action. PLAIN ENGLISH The proposed changes describing CAARP’s propos- als are in plain English.

TEXT AND INITIAL STATEMENT OF REASONS The Department has prepared an Initial Statement of Reasons addressing the proposed amendments in addi- tion to the Informative Digest included in this notice. The Initial Statement of Reasons, Notice of Proposed Action and Text of Regulations are available for inspec- tion or copying, and will be provided at no charge upon request to the contact person listed above. Further de- tails on CAARP’s proposal are on file with the Commis- sioner and available for review as set forth below.

ACCESS TO RULEMAKING FILE Any interested person may inspect a copy of or direct questions about CAARP’s proposed amendments, the statement of reasons, and any supplemental informa- tion contained in the rulemaking file by contacting the contact person listed above. By prior appointment, the rulemaking file is available for inspection at 45 Fre- mont Street, 21 st Floor, San Francisco, California 94105, between the hours of 9:00 a.m. and 4:30 p.m. Monday through Friday. 180

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z AUTOMATIC MAILING A copy of this Notice, including the Informative Di- gest, is being sent to all persons on the Insurance Com- missioner’s mailing list. A V AILABILITY OF DOCUMENTS ON THE INTERNET The Initial Statement of Reasons, proposed text, and this Notice of Proposed Action will be published online and may be accessed through the Department’s website at www.insurance.ca.gov.

A V AILABILITY OF MODIFIED TEXT OF REGULATIONS If the Department amends the proposed regulations with changes that are sufficiently related to the original text, the Department will make the full text of the amended regulations, with the changes clearly indicat- ed, available to the public for at least 15 days before the date the Department adopts the amended regulations. TITLE 13. CALIFORNIA HIGHWAY PATROL TITLE 13, CALIFORNIA CODE OF REGULATIONS, DIVISION 2,

CHAPTER 6.5, AMEND

ARTICLE 1,

SECTION 1200 AND

ARTICLE 6,

SECTION 1234 FEDERAL CONSISTENCY (CHP−R−2018−01) The California Highway Patrol (CHP) proposes to amend Sections 1200 and 1234 contained in Title 13, California Code of Regulations (CCR), to reflect changes to statutes in 2016 and 1989, respectively, re- lated to consistency with Federal Motor Carrier Safety Regulations (FMCSR). INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW Title 13, CCR, Division 2,

Chapter 6.5, contains the CHP motor carrier safety regulations;

Article 1,

Section 1200, contains

definitions and general provisions; and

Article 6,

Section 1234, contains carrier requirements. This rulemaking action proposes to amend Title 13, CCR, sections in order to align with current California Vehicle Code (CVC) sections and increase the competi- tiveness of California carriers by eliminating or modi- fying, to the extent possible, regulations which conflict with updated federal regulations, reducing negative im- pacts on businesses. This rulemaking will also allow the CHP to remain consistent with FMCSR adopted by the United States Department of Transportation, and ad- dresses inconsistencies and incompatibilities between state and federal regulations.

Anticipated Benefits of the Proposed Regulation: The proposed regulations will continue to provide nonmonetary benefits by protecting the health, safety, and welfare of the public, transportation industry work- ers, and the environment. The proposed regulations provide the regulatory authority for enforcement efforts as they relate to requirements of the CVC, and current adopted federal regulations and hazardous materials regulations found in Title 49, Code of Federal Regula- tions (CFR), which directly improves the safety of the motoring public.

Evaluation of Inconsistency/Incompatibility with Existing State Regulations: The CHP has determined this proposed regulation is neither inconsistent, nor incompatible, with existing regulations. After conducting a review for any regula- tions that would relate to or affect this area, the CHP has concluded that these are the only regulations that con- cern the Federal Consistency. PUBLIC COMMENTS Any interested person may submit written comments on this proposed action via facsimile at (916) 322−3154, by e−mail to cvsregulations@chp.ca.gov, or by writing to: California Highway Patrol Commercial Vehicle

Section Attention: Officer David Kelly P.O. Box 942898 Sacramento, CA 94298−0001 Written comments will be accepted until March 23, 2020. No public hearing has been scheduled. If any person desires a public hearing, a written request must be re- ceived by the CHP, Commercial Vehicle

Section (CVS), no later than 15 days prior to the close of the written comment period. A V AILABILITY OF INFORMATION The CHP has available for public review an initial statement of reasons for the proposed regulatory action, the information upon which this action is based (the rulemaking file), and the proposed regulation text. Re- 181

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z quests to review or receive copies of this information should be directed to the CHP at the above address, by facsimile at (916) 322−3154, or by calling the CHP, CVS, at (916) 843−3400. All requests for information should include the following information: the title of the rulemaking package, the requester’s name, proper mailing address (including city, state, and zip code), and a daytime telephone number (in case information is in- complete or illegible). The rulemaking file is available for inspection.

Inter- ested parties are advised to call the CHP, CVS, for an ap- pointment. All documents regarding the proposed action are available through the CHP’s website at www.chp.ca. gov/news−alerts/regulatory−actions. Any person desiring to obtain a copy of the adopted text and a final statement of reasons may request them at the above−noted address. Copies will be posted on the CHP’s website.

CONTACT PERSON Any inquiries concerning the written materials per- taining to the proposed regulations, or questions regard- ing the substance of the proposed regulations, should be directed to Officer David Kelly or Sergeant Jaime Nunez, CHP , CVS, at (916) 843−3400. ADOPTION OF PROPOSED REGULATIONS After consideration of public comments, the CHP may adopt the proposal substantially as set forth with- out further notice.

If the proposal is modified prior to adoption and the change is not solely grammatical or nonsubstantive in nature, the full text of the resulting regulation, with the changes clearly indicated, will be made available to the public for at least 15 days prior to the date of adoption.

FISCAL IMPACT AND RESULTS OF THE ECONOMIC IMPACT ANALYSIS The CHP has made an initial determination that this proposed regulatory action: (1) will have no effect on housing costs; (2) will impose no new mandate upon lo- cal agencies or school districts; (3) will involve no nondiscretionary costs or savings to any local agency; no cost to any local agency or school district for which Government Code (GC), Sections 17500−17630, re- quire reimbursement; no cost or savings to any state agency; nor costs or savings in federal funding to the state; (4) will neither create or eliminate jobs in the state of California, nor result in the elimination of existing businesses, nor create or expand businesses in the state of California; (5) will continue to provide a nonmone- tary benefit to the protection and safety of public health, employees, and safety to the environment by providing a regulatory basis for enforcement efforts as they relate to the CFR; and (6) will have no significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to com- pete with businesses in other states.

COST IMPACTS ON REPRESENTATIVE PRIV ATE PERSONS OR BUSINESSES The CHP is not aware of any cost impacts that a repre- sentative private person or business would necessarily incur in reasonable compliance with the proposed action. EFFECT ON SMALL BUSINESSES The CHP has determined that the proposed regulation will not affect small businesses as the proposed amend- ments are either already required by federal regulation or are editorial in nature and are without regulatory ef- fect.

However, the regulated community is encouraged to respond during the public comment period of this regulatory process if significant impacts are identified. ALTERNATIVES In accordance with GC,

Section 11346.5(a)(13), the CHP must determine that no reasonable alternative it considered or that has otherwise been identified and brought to the attention of the agency would be more ef- fective in carrying out the purpose for which the action is proposed or would be as effective and less burden- some to affected private persons than the proposed ac- tion or would be more cost−effective to affected private persons and equally effective in implementing the statutory policy or other provision of law.

The CHP invites interested persons to present state- ments or arguments with respect to alternatives to the proposed regulations during the written comment period. AUTHORITY This regulatory action is being taken pursuant to Sec- tions 2402 and 34501 CVC. REFERENCE This action implements, interprets, or makes specific Sections 2402 and 34501 CVC. 182

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z TITLE 16. BOARD OF INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW BEHA VIORAL SCIENCES Supervision−Related Requirements NOTICE IS HEREBY GIVEN that the Board of Be- havioral Sciences (Board) is proposing to take the ac- tion described in the Informative Digest. Any person in- terested may present statements or arguments orally or in writing relevant to the action proposed at a hearing to be held at: Board of Behavioral Sciences 1625 N. Market Blvd.

El Dorado Room, Suite 220 Sacramento, CA 95834 March 23, 2020 Written comments, including those sent by mail, fac- simile, or e−mail to the addresses listed under Contact Person in this Notice, must be received by the Board at its office not later than March 23, 2020, or must be re- ceived by the Board at the hearing. The Board, upon its own motion or at the insistence of any interested party, may thereafter adopt the proposals substantially as described below or may modify such proposals if such modifications are sufficiently related to the original text.

With the exception of technical or grammatical changes, the full text of any modified pro- posal will be available for 15 days prior to its adoption from the person designated in this Notice as contact per- son and will be mailed to those persons who submit written or oral testimony related to this proposal or who have requested notification of any changes to the proposal. Authority and Reference: Pursuant to the authority vested by

section 4990.20 of the Business and Profes- sions Code (BPC), and to implement, interpret or make specific sections 4980.03, 4980.35, 4980.40, 4980.42, 4980.43, 4980.43.1, 4980.43.3, 4980.43.4, 4980.43.5, 4980.44, 4980.45, 4980.60, 4980.72, 4980.74, 4996.17, 4996.18, 4996.20, 4996.23, 4996.23.1, 4996.23.2, 4996.23.3, 4999.12, 4999.20, 4999.32, 4999.33, 4999.46, 4999.46.1, 4999.46.2, 4999.46.3, 4999.46.4, 4999.46.5, 4999.48, 4999.50, 4999.60, and 4999.61 of the BPC, the Board is considering changes to Division 18 of Title 16 of the California Code of Reg- ulations as described in this Notice.

The Board of Behavioral Sciences (Board) licenses and regulates Licensed Marriage and Family Therapists (LMFTs), Licensed Clinical Social Workers (LCSWs), and Licensed Professional Clinical Counselors (LPCCs). The Board also registers and regulates individuals gaining supervised experience toward meeting the re- quirements for licensure. This includes registered As- sociate Marriage and Family Therapists (AMFTs), As- sociate Professional Clinical Counselors (APCCs) and Associate Clinical Social Workers (ASWs) and appli- cants pending registration.

The Board also sets forth certain requirements for Marriage and Family Thera- pist Trainees and Professional Clinical Counselor Trainees. Existing law: Specifies the number and types of supervised experience hours required for licensure and sets forth parameters regarding those hours (BPC sections 4980.43, 4996.23 and 4999.46, and Title 16, California Code of Regulations (16CCR) sections 1820 and 1833). Specifies the requirements pertaining to supervision of individuals gaining hours of experience toward licensure, including: Supervisor qualifications (BPC sections 4980.03(g), 4996.20(

a) and 4999.12(h), and 16CCR sections 1821, 1833.1, 1870 and 1874). Supervisor responsibilities and acceptable supervision practices (BPC sections 4980.43.1, 4980.43.3, 4980.43.5, 4996.20(b), 4996.21, 4996.23.2, 4999.46.1, 4999.46.3 and 4999.46.5, and 16CCR sections 1821, 1833.1 and 1870). Direct supervisor contact (BPC sections 4980.43.2, 4996.23.1 and 4999.46.2). Required documentation pertaining to supervision (BPC sections 4980.43.4, 4996.23.3 and 4999.46.4, and 16CCR sections 1820(e)(4), 1821(b), 1822, 1833(e), 1833.1(

a) and 1870(a)). This proposal would do the following: Make technical, nonsubstantive and clarifying changes. 183

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z Create consistency in supervisor requirements and responsibilities among the three substantially equivalent license types. Set standards for documentation when a supervisor is deceased or becomes incapacitated prior to signing off on an applicant’s supervised experience. Require supervisors to notify the Board that they are supervising and that they meet the qualifications to supervise. Require supervisors and supervisees to complete and sign a supervision agreement. Codify how completed experience hours shall be verified to the Board. Require supervisors to monitor for and address dynamics that could lead to ineffective supervision. Address requirements pertaining to temporary substitute supervisors. Provide for flexibility in supervisor ongoing training requirements by allowing for certain continuing professional development activities to count. Set forth parameters for situations where an individual gaining supervised experience has been placed in an agency by a temporary staffing agency. Allow licensees who hold an approved supervisor certification from one of several specified entities to be exempt from certain supervisor qualifications. Clarify requirements pertaining to supervision of experience gained outside of California and allow for flexibility in the supervisor’s license title. Clarify who can supervise the experience required with couples, families or children that is necessary for an LPCC to obtain the “couples and families” specialty designation.

There is not an existing federal regulation or statute comparable to this proposal, as the Board’s license types are regulated at the state level.

ANTICIPATED BENEFITS OF PROPOSAL This proposal is expected to result in the following benefits: Provide clarity and consistency in the Board’s regulations, and promote consistency in the laws between three substantially equivalent professions. Help protect consumers by strengthening requirements that help to ensure competent and effective supervision and facilitate supervisee development and competency. Help protect the safety of the supervisee and protect supervisees from losing experience hours. Address supervisor shortages, expand job prospects for out−of−state licensees upon licensure in California and improve portability of experience hours from another state to California. Allow the Board to target communications with supervisors, and simplify and streamline a substitute supervisor’s responsibilities.

CONSISTENCY OR COMPATIBILITY WITH EXISTING STATE REGULATIONS During the process of developing these regulations and amendments, the Board of Behavioral Sciences has conducted a search of any similar regulations on this topic and has concluded that these regulations are nei- ther inconsistent or incompatible with existing state regulations. FORMS INCORPORATED BY REFERENCE No forms have been incorporated by reference.

FISCAL IMPACT ESTIMATES Fiscal Impact on Public Agencies Including Costs or Savings to State Agencies or Costs/Savings in Federal Funding to the State: The fiscal effect associated with this proposal was ad- dressed through a legislative Budget Change Proposal (BCP), which was approved for Fiscal Year (FY) 2019−2020.

The BCP was based on costs and workload identified in the fiscal analysis for Assembly Bill (AB) 93 (Chapter 743, Statutes of 2018), which included the following estimates: $82,000 in FY 2019−2020 and $74,000 annually thereafter to fund a 1.0 management services technician (MST) to handle the new workload for data entry to document compliance with the proposed supervisor self−assessment.

It was estimated that the regulations would be approved around January 2020, at which time the MST position would need to be established. Minor and absorbable enforcement workload increase related to ensuring the new supervision requirements are being met. Minor and absorbable costs for the Department of Consumer Affairs’ Office of Information Services for executing technical functions related to these changes. 184

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z Nondiscretionary Costs/Savings to Local Agencies: None. Local Mandate: None. Cost to Any Local Agency or School District for Which Government Code Sections 17500−17630 Re- quire Reimbursement: None. Business Impact: The Board has made an initial de- termination that the proposed regulatory action would have no significant statewide adverse economic impact directly affecting business, including the ability of Cali- fornia businesses to compete with businesses in other states.

Cost Impact on Representative Private Person or Business: The cost impacts that a representative private person or business would necessarily incur in reason- able compliance with the proposed action would result from the following: This proposal increases the initial supervisor training required from 6 hours to 15 hours (a 9−hour increase) for LMFTs and LPCCs. A survey of three supervisor training course providers found an average cost of $76.05 for 9 hours of continuing education (CE). There are no new costs for LCSWs as current regulations al- ready require a 15−hour initial supervisor training.

The proposal also newly implements 6 hours of con- tinuing professional development (CPD) for supervi- sors, for all three license types, every two years while supervising. However, there will be no additional costs for LMFTs and LPCCs, as these professions already have a 6−hour ongoing supervisor training requirement, and the new options for CPD do not typically have asso- ciated costs. LCSW supervisors currently do not have an ongoing training requirement. However, there would also be no cost to LCSWs. The new 6−hour CPD requirement would allow for CE courses to fulfill the requirement.

CE courses for supervisors would count toward the 36 hours of CE that is currently required for all LCSWs ev- ery two years per BPC

section 4996.22(a)(1). In addi- tion, the other options for CPD do not typically have as- sociated costs. Impact on Jobs/New Businesses: The Board has de- termined that this regulatory proposal will not have a significant impact on the creation of jobs or new busi- nesses or the elimination of jobs or existing businesses or the expansion of businesses in the State of California. Effect on Housing Costs: None. EFFECT ON SMALL BUSINESS The Board has determined that the proposed regula- tions would affect small businesses.

Many of the Board’s licensees either own or work for a small busi- ness, and would need to ensure that the business, as well as their supervisors and supervisees, comply with the new requirements. The proposal would benefit small businesses by providing clarity, consistency and flexi- bility in the Board’s laws. Small businesses would also benefit from consistency in supervision requirements among substantially equivalent professions, as well as flexibility in supervisor qualifications and training requirements.

RESULTS OF ECONOMIC IMPACT ASSESSMENT/ANALYSIS The Board has made an initial determination that the proposed regulatory action would not have a significant statewide adverse economic impact directly affecting businesses, including the ability of California business- es to compete with businesses in other states. This ini- tial determination is based on the following facts: Analysis of creation/elimination of jobs: This proposal will not create or eliminate any jobs within California.

The vast majority of the proposed amendments are for the purpose of clarifying, streamlining, or creating consistency or flexibility.

The proposed amendments that are more substantial in nature simply impose new minor training requirements for supervisors every two years, new one−time paperwork requirements, and new yearly supervisee evaluations. Analysis of creation/elimination of businesses: This proposal will not create or eliminate any businesses in California for the reasons described above. Analysis of expansion of business: This proposal will not expand any businesses in California for the reasons described above. Benefits of the Regulation to the Health and Welfare of California Residents, Worker Safety, and the State’s Environment: This regulatory proposal will help protect consumers who are receiving mental health treatment from an individual who is not yet licensed by setting standards that lead to proper and effective supervision of the unlicensed individual.

Requiring supervisors to create written procedures to assist in handling crises and emergencies will help protect the safety of both the supervisee and consumers. The proposal will have no effect on the State’s environment. As part of its Economic Impact Analysis, the Board has determined that its proposal will not affect the abili- ty of California businesses to compete with other states by making it more costly to produce goods or services, and will not eliminate any jobs or occupations. This proposal does not impact multiple industries. 185

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z CONSIDERATION OF ALTERNATIVES The Board must determine that no reasonable alterna- tive it considered to the regulation or that has otherwise been identified and brought to its attention would either be more effective in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons than the pro- posed action, or would be more cost−effective to affect- ed private persons and equally effective in implement- ing the statutory policy or other provision of law.

INITIAL STATEMENT OF REASONS AND INFORMATION The Board has prepared an initial statement of the reasons for the proposed action and has available all the information upon which the proposal is based. TEXT OF PROPOSAL Copies of the exact language of the proposed regula- tions and of the initial statement of reasons, and all of the information upon which the proposal is based, may be obtained at the hearing or prior to the hearing upon request from the person designated in the Notice under Contact Person or by accessing the Board’s website at www.bbs.ca.gov.

A V AILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE All the information upon which the proposed regula- tions are based is contained in the rulemaking file which is available for public inspection by contacting the per- son named below. You may obtain a copy of the final statement of reasons once it has been prepared, by mak- ing a written request to the contact person named below or by accessing the website listed below. CONTACT PERSON Inquiries or comments concerning the proposed rule- making action may be addressed to: Name: Christy Berger Address: 1625 N.

Market Blvd., Suite S−200 Sacramento, CA 95834 Telephone Number: (916) 574−7817 Fax Number: (916) 574−8625 E−Mail Address: Christy.Berger@dca.ca.gov The backup contact person is: Name: Rosanne Helms Address: 1625 N. Market Blvd., Suite S−200 Sacramento, CA 95834 Telephone Number: (916) 574−7897 Fax Number: (916) 574−8625 E−Mail Address: Rosanne.Helms@dca.ca.gov Website Access: Materials regarding this proposal can be found on the Board’s website at https://www. bbs.ca.gov/about/law_reg.html. TITLE 16.

BOARD OF PHARMACY NOTICE IS HEREBY GIVEN that the Board of Pharmacy (Board) is proposing to take the action de- scribed in the Informative Digest. Any person interest- ed may present statements or arguments relevant to the action proposed in writing. Written comments, includ- ing those sent by mail, facsimile, or e−mail to the ad- dresses listed under Contact Person in this Notice, must be received by the Board at its office on March 23, 2020. The Board does not intend to conduct a Regulation Hearing on the matter, unless requested.

Any interested person may submit a written request for a public hearing no later than 15 days prior to the close of the written comment period. The Board, upon its own motion or at the request of any interested party, may thereafter adopt the proposals substantially as described below or may modify such proposals if such modifications are sufficiently related to the original text.

Section 4005 of the Business and Professions Code (B and

P) to implement, interpret, and make spe- cific Sections 4081, 4105, and 4333 of the Business and Professions Code, the Board is proposing to amend Sec- tion 1707 of

Article 2 of Division 17 of Title 16 of the California Code of Regulations as follows: 186

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW The Board proposes to amend

Section 1707 of

Article 2 of Division 17 of Title 16 of the California Code of Regulations (CCR) for the purpose of amending the Board’s regulation specific to waiver requirements for the off−site storage of records. Existing pharmacy law specifies that protection of the public is the highest priority for the Board in exer- cising its licensing, regulatory, and disciplinary func- tions and generally authorizes the Board to adopt and amend rules and regulations necessary for the protec- tion of the public pertaining to the practice of pharmacy. Additionally, existing law authorizes the Board to issue a license to a pharmacy.

Existing law specifies the record keeping require- ments for the manufacture, sale, acquisition, receipt, shipment, and disposition of dangerous drugs or dan- gerous devices (B and P

section 4081). Additionally, current law requires that records of acquisition and dis- position of dangerous drugs or dangerous devices be stored in a readily retrievable form (B and P

section 4105). Lastly, existing statute requires that pharmacies keep a record of any prescriptions filled on the licensed premises of the pharmacy and allows for the Board to grant a waiver of that requirement (B and P

section 4333 (

a) and (c)(1)). Some pharmacies struggle to find space to store these paper records and still maintain a safe working environ- ment for their employees. This proposal will allow the Board more discretion when approving a waiver and clarify that a waiver will allow storage of these records outside of the licensed area of the pharmacy. ANTICIPATED BENEFITS OF PROPOSAL This proposal will benefit a pharmacy that lacks suffi- cient space to store records within the licensed area of the pharmacy by allowing the records to be stored out- side the licensed premises while maintaining public protection.

Smaller pharmacies as well as high−volume pharmacies do not have the physical space on the li- censed premises to store the amount of records required by licensing regulations. This proposal will help to cre- ate a safer work environment by allowing the Board dis- cretion to grant a waiver of the storage requirement so that a pharmacy can avoid the fire hazard as well as the health and safety hazard of storing boxes of files in a pharmacy with inadequate space.

CONSISTENCY AND COMPATIBILITY WITH EXISTING STATE REGULATIONS During the process of developing these regulations and amendments, the Board conducted a search of any similar regulations on this topic and has concluded that these regulations are neither inconsistent nor incompat- ible with existing state regulations. FISCAL IMPACT ESTIMATES Fiscal Impact on Public Agencies Including Costs/ Savings to State Agencies or Costs/Savings in Federal Funding to the State: None. Nondiscretionary Costs/Savings to Local Agencies: None. Local Mandate: None.

Cost to Any Local Agency or School District for Which Government Code Sections 17500−17630 Re- quire Reimbursement: None. Business Impact: The Board has made an initial determination that the proposed regulatory action would have no significant statewide adverse economic impact directly affecting businesses and/or employees. This includes the ability of California businesses to compete with businesses in other states.

Cost Impact on Representative Private Person or Business: The Board is not aware of any cost impacts that a rep- resentative private person or business would necessari- ly incur in reasonable compliance with the proposed action. Effect on Housing Costs: None.

Effect on Small Business: While the Board does not have nor does it maintain data to define if any of its licensees (pharmacies) are a “small business” as defined in Government Code sec- tion 11342.610, the Board has made an initial determi- nation that the proposed regulatory action would not have a significant adverse economic impact directly af- fecting small businesses. The proposed regulation does not require the use of specific computer software.

RESULTS OF ECONOMIC IMPACT ASSESSMENT/ANALYSIS Impact on Jobs/New Businesses: The Board has determined that this regulatory pro- posal will not have a significant impact on the creation of jobs or new businesses or the elimination of jobs or existing businesses or the expansion of businesses in the 187

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z State of California because this regulation is related to the storage of records and not jobs. Benefits of Regulation: The Board has determined that this regulatory pro- posal will benefit worker safety because the proposed regulation will allow pharmacies to minimize health and safety hazards within the pharmacy by allowing the storage of records outside of the licensed area of the pharmacy.

CONSIDERATION OF ALTERNATIVES The Board must determine that no reasonable alterna- tive it considered to the regulation or that has otherwise been identified and brought to its attention would either be more effective in carrying out the purpose for which the action is proposed, would be as effective and less burdensome to affected private persons than the pro- posal described in this Notice, or would be more cost ef- fective to affected private persons and equally effective in implementing the statutory policy or other provision of law.

Any interested person may present statements or ar- guments in writing relevant to the above determinations at the address listed for theContact Person. INITIAL STATEMENT OF REASONS AND INFORMATION The Board of Pharmacy has prepared an initial state- ment of the reasons for the proposed action and has available all the information upon which the proposal is based.

TEXT OF PROPOSAL Copies of the exact language of the proposed regula- tion, and any document incorporated by reference, and of the initial statement of reasons, and all of the infor- mation upon which the proposal is based, may be ob- tained upon request from the Board of Pharmacy at 2720 Gateway Oaks Drive, Ste. 100, Sacramento, Cali- fornia 95833, or from the Board of Pharmacy’s website http://www.pharmacy.ca.gov.

A V AILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE All the information upon which the proposed regula- tions are based is contained in the rulemaking file which is available for public inspection by contacting the per- son named below. You may obtain a copy of the final statement of rea- sons once it has been prepared, by making a written re- quest to the contact person named below or by access- ing the website listed below.

CONTACT PERSON Inquiries or comments concerning the proposed rule- making action may be addressed to: Name: Lori Martinez Address: 2720 Gateway Oaks Drive, Ste. 100 Sacramento, CA 95833 Phone Number: (916) 518−3078 Fax Number: (916) 574−8618 E−Mail Address: Lori.Martinez@dca.ca.gov The backup contact person is: Name: Debbie Damoth Address: 2720 Gateway Oaks Drive, Ste. 100 Sacramento, CA 95833 Phone Number: (916) 518−3090 Fax Number: (916) 574−8618 E−Mail Address: Debbie.Damoth@dca.ca.gov WEBSITE ACCESS Materials regarding this proposal can be found at the Board of Pharmacy’s website: www.pharmacy.ca.gov.

TITLE 16. BOARD OF PHARMACY NOTICE IS HEREBY GIVEN that the California State Board of Pharmacy (board) is proposing to take the rulemaking action described below under the head- ing Informative Digest/Policy Statement Overview. Any person interested may present statements or argu- ments relevant to the action proposed in writing. Writ- ten comments, including those sent by mail, facsimile, or e−mail to the addresses listed under Contact Person in this Notice, must be received by the board at its office on March 23, 2020. The board has not scheduled a public hearing on this proposed action.

The board will, however, hold a hear- 188

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z ing if it receives a written request for a public hearing from any interested person, or his or her authorized rep- resentative, no later than 15 days prior to the close of the written comment period. The board may, after considering all timely and rele- vant comments, adopt the proposed regulations sub- stantially as described in this notice, or may modify the proposed regulations if such modifications are suffi- ciently related to the original text.

With the exception of technical or grammatical changes, the full text of any modified proposal will be available for 15 days prior to its adoption from the person designated in this Notice as the contact person and will be mailed to those persons who submit written or oral testimony related to this pro- posal or who have requested notification of any changes to the proposal. Authority and Reference: Sections 4001.1 and 4005 of the Business and Professions Code authorize the board to adopt these regulations.

The proposed regula- tions implement, interpret, and make specific sections 141, 490, 4022.5, 4022.6, 4022.7, 4036, 4038, 4053, 4112, 4115, 4161, 4200.5, 4202, 4207, 4231, 4300, 4301, 4301.5, 4302, 4303, 4303.1, 4311, 4316, and 4400 of the Business and Professions Code and

section 11105 of the Penal Code. INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW The California State Board of Pharmacy (board) pro- poses to amend or repeal the regulatory language of 16 CCR sections 1702, 1702.1, 1702.2, and 1702.5 to con- solidate all board license types to ensure that the board’s regulations remain efficient and consistently applied to all license types, even those that may be created in the future.

Existing pharmacy law specifies that protection of the public is the highest priority for the board in exercis- ing its licensing, regulatory, and disciplinary functions and generally authorizes the board to adopt and amend rules and regulations necessary for the protection of the public pertaining to the practice of pharmacy. Addition- ally, existing pharmacy law at 16 CCR sections 1702, 1702.1, 1702.2, and 1702.5 establish the license renew- al requirements for board licensees.

These regulatory sections are necessary to provide clarity to the regulated public with respect to the requirements and criteria used by the board to deem an application for renewal complete. As currently written, the regulation sections require frequent amendments to incorporate each new licens- ing program as they are established. Amending regula- tions is a time intensive process and the board has not been able to update the regulation as frequently as nec- essary. Since 2014, the board’s regulatory jurisdiction has increased in size. In 2018 alone, the board’s licens- ing types grew from 25 to 39.

This proposal will simpli- fy the regulatory language and consolidate the license types into two categories: (1) a premises or facility li- cense and (2) an individual license, with an exception for the pharmacist and advanced practice pharmacist li- censee, as these licensing programs have specialized continuing education requirements. Consolidating the regulations text to only two categories will provide clar- ity to the regulated public by increasing the readability of the regulations and ensure consistent application of the renewal requirements.

Additionally, as currently written, the regulations do not require all premises or facility license types to report disciplinary action taken by other government agencies to the board; this is only required of nonresident phar- macies and nonresident wholesalers. The proposed reg- ulations would allow the board a mechanism to identify such discipline for all premises or facility license types.

If a licensee has been disciplined by another agency, the board must be made aware of this discipline in order to investigate and ensure that the licensee does not pose a risk to the safety of California residents by continuing to operate. ANTICIPATED BENEFITS OF PROPOSAL This regulatory proposal benefits California resi- dents because the proposed regulation will simplify the regulatory language which will provide clarity to the regulated public. A premises/facility cannot operate with an expired license and an individual cannot work with an expired license.

These regulations will ensure that the requirements for a complete renewal applica- tion are clearly specified based on the license type (premises/facility or individual). This will help to en- sure that licensees are submitting complete applica- tions, which will allow for the timely renewal of licens- es. Renewing licenses timely ensures that individuals can continue to work and premises/facilities can contin- ue to distribute and/or furnish prescription medication to California residents.

Additionally, the disclosure of discipline by all premises or facility licensees will allow the board to investigate the disciplinary action and en- sure that the licensees are operating in accordance with pharmacy law, which will ensure the health and welfare of California residents. Lastly, the proposed action will increase the board’s efficiency by eliminating the need to prepare a regular rulemaking action each time a new license type is created. 189

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z CONSISTENCY AND COMPATIBILITY WITH EXISTING STATE REGULATIONS During the process of developing these regulations and amendments, the board has conducted a search of any similar regulations on this topic and has concluded that these regulations are neither inconsistent nor in- compatible with existing state regulations.

FISCAL IMPACT ESTIMATES Fiscal Impact on Public Agencies Including Costs/ Savings to State Agencies or Costs/Savings in Federal Funding to the State: There will be minor workload costs to the board, which are absorbable with the board’s budget. Nondiscretionary Costs/Savings to Local Agencies: None. Local Mandate: None. Cost to Any Local Agency or School District for Which Government Code Sections 17500−17630 Re- quire Reimbursement: None.

Business Impact: The board has made an initial determination that the proposed regulatory action would have no significant statewide adverse economic impact directly affecting businesses and/or employees including the ability of California businesses to compete with businesses in other states. This determination is based on the absence of testimony to that effect during the development of the proposed regulation, which occurred over several months.

Additionally, the proposed regulation will sim- plify the regulatory language, thereby providing clarity and consistency to the regulated public with respect to the requirements and criteria used by the board to deem an application of renewal complete. The proposed regu- lations require all premises or facility licensees to report discipline by another government agency at the time of the license renewal; however, this is done by marking an indicator on the application for renewal and will not impose an economic or fiscal impact on the licensee.

EFFECT ON SMALL BUSINESS While the board does not have nor does it maintain data to define if any of its licensees (pharmacies) are a “small business” as defined in Government Code sec- tion 11342.610, the board has made an initial determi- nation that the proposed regulatory action would not have a significant adverse economic impact directly af- fecting small businesses. This determination is based on the absence of testimony to that effect during the de- velopment of the proposed regulation, which occurred over several months.

Additionally, the proposed regula- tion will simplify the regulatory language, thereby pro- viding clarity and consistency to the regulated public with respect to the requirements and criteria used by the board to deem an application of renewal complete. The proposal requires all premises or facility licensees to re- port discipline by another government agency at the time of the license renewal; however, this is done by marking an indicator on the application for renewal and will not impose an economic or fiscal impact on the licensee.

RESULTS OF ECONOMIC IMPACT ASSESSMENT/ANALYSIS The board concludes that this regulatory proposal will have the following effects:

(1) It will not create or eliminate any jobs within California;

(2) It will not create new, or eliminate existing, businesses in California; and

(3) It will not expand businesses currently doing business within the state. As the board’s licensing program authority has in- creased, the board has not been able to update these reg- ulations at the same pace. The proposed regulations provide clarity to all licensees with respect to the re- quirements necessary for a renewal to be deemed com- plete by the board and will ensure consistent application of the renewal requirements. While this may allow a business or individual to renew their license timely, the regulatory proposal does not actually create the busi- ness or the job.

Benefits of Regulation: This regulatory proposal benefits the health and wel- fare of California residents because the proposed regu- lation will simplify the regulatory language which will provide clarity to the regulated public. A premises/fa- cility cannot operate with an expired license and an in- dividual cannot work with an expired license. These regulations will ensure that the requirements for a com- plete renewal application are clearly specified based on the license type (premises/facility or individual).

This will help to ensure that licensees are submitting com- plete applications, which will allow for the timely re- newal of licenses. Renewing licenses timely ensures that individuals can continue to work and premises/fa- 190

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z cilities can continue to distribute and/or furnish pre- scription medication to California residents. If a busi- ness is able to continue services, it benefits the health and welfare of California residents by providing contin- ued access to pharmacy related care. Additionally, it will ensure that the board is aware of any disciplinary action taken by other government agencies against a board licensee.

This disclosure will allow the board to investigate the disciplinary action and ensure that the li- censees are operating in accordance with pharmacy law, which will ensure the health and welfare of California residents. Lastly, the proposed action will increase the board’s efficiency. The proposed regulation does not af- fect worker safety or the state’s environment because it does not involve these matters.

CONSIDERATION OF ALTERNATIVES The board must determine that no reasonable alterna- tive it considered to the regulation or that has otherwise been identified and brought to its attention would either be more effective in carrying out the purpose for which the action is proposed, would be as effective and less burdensome to affected private persons than the pro- posal described in this Notice, or would be more cost ef- fective to affected private persons and equally effective in implementing the statutory policy or other provision of law.

Any interested person may present statements or ar- guments in writing relevant to the above determinations during the written comment period at the address listed for the Contact Person. INITIAL STATEMENT OF REASONS AND INFORMATION The Board of Pharmacy has prepared an initial state- ment of the reasons for the proposed action and has made available all the information upon which the pro- posal is based.

TEXT OF PROPOSAL Copies of the exact language of the proposed regula- tions, and any document incorporated by reference, and of the initial statement of reasons, and all of the infor- mation upon which the proposal is based, may be ob- tained upon request from the Board of Pharmacy at 1625 N. Market Blvd., N219, Sacramento, California 95834, or from the Board of Pharmacy’s website http://www.pharmacy.ca.gov.

A V AILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE All the information upon which the proposed regula- tions are based is contained in the rulemaking file which is available for public inspection by contacting the per- son named below. You may obtain a copy of the final statement of rea- sons, once it has been prepared, by making a written re- quest to the contact person named below or by access- ing the website listed below.

CONTACT PERSON Inquiries or comments concerning the proposed rule- making action may be addressed to: Name: Lori Martinez Address: 2720 Gateway Oaks Dr., Ste. 100 Sacramento, CA 95833 Phone Number: (916) 518−3078 Fax Number: (916) 574−8618 E−Mail Address: Lori.Martinez@dca.ca.gov The backup contact person is: Name: Debbie Damoth Address: 2720 Gateway Oaks Dr., Ste. 100 Sacramento, CA 95833 Phone Number: (916) 518−3090 Fax Number: (916) 574−8618 E−Mail Address: Debbie.Damoth@dca.ca.gov WEBSITE ACCESS Materials regarding this proposal can be found at the Board of Pharmacy’s website: www.pharmacy.ca.gov. 191

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z TITLE 17. DEPARTMENT OF PUBLIC HEALTH DPH−11−012 Clinical Laboratory Personnel Standards:

Definitions Notice is hereby given that the California Department of Public Health (Department) is proposing the regula- tion described below. This notice of proposed rulemak- ing commences a rulemaking to make the regulations permanent after considering all comments, objections, and recommendations regarding the regulation. PUBLIC PROCEEDINGS The Department is conducting a 45−day written pub- lic proceeding during which time any interested person or such person’s duly authorized representative may present statements, arguments or contentions (all of which are hereinafter referred to as comments) relevant to the action described in the Informative Digest/Policy Statement Overview

section of this notice. To request copies of the regulatory proposal in an al- ternate format, please write or call: V eronica Rollin, Of- fice of Regulations, 1415 L Street, Suite 500, Sacra- mento, CA 95814, at (916) 558−1710, email to veronica.rollin@CDPH.ca.gov or use the California Relay Service by dialing 711. WRITTEN COMMENT PERIOD Written comments pertaining to this proposal, re- gardless of the method of transmittal, must be received by Office of Regulations by March 23, 2020, which is hereby designated as the close of the written comment period.

Comments received after this date will not be considered timely. Written comments may be submitted as follows: 1. By email to: regulations@cdph.ca.gov. It is requested that email transmission of comments, particularly those with attachments, contain the regulation package identifier “DPH−1 1−012 Clinical Laboratory Personnel Standards:

Definitions” in the subject line to facilitate timely identification and review of the comment; 2. By fax transmission to: (916) 636−6220; 3. By postal service or hand delivered to: California Department of Public Health, Office of Regulations, 1415 L Street, Suite 500, Sacramento, CA 95814. All submitted comments should include the regula- tion package identifier “DPH−11−012 Clinical Labo- ratory Personnel Standards:

Definitions” with the comment author’s name and email or mailing address. PUBLIC HEARING A public hearing has not been scheduled for this rule- making. However, the Department will conduct a hear- ing if a written request for a public hearing is received from any interested person, or his or her duly authorized representative, no later than 15 days prior to the close of the written comment period, pursuant to Government Code

Section 11346.8. ASSISTIVE SERVICES For individuals with disabilities, the Department will provide assistive services such as the conversion of written materials into Braille, large print, audiocassette, and computer disk. For public hearings, assistive ser- vices can include sign−language

interpretation, real− time captioning, note taking, reading or writing assis- tance. To request these assistive services, please call (916) 558−1710 or California Relay at 711 or 1−800−735−2929, email Regulations@cdph.ca.gov or write to the Office of Regulations at the address noted above. Note: The range of assistive services available may be limited if requests are made less than 10 busi- ness days prior to a public hearing.

AUTHORITY AND REFERENCE The Department is proposing to adopt, repeal, and amend portions of the regulations in the CCR, title 17, sections 1029 through 1067.15, Clinical Laboratory Regulations, under the authority provided in sections 1208, 1222, 1222.5, 1224, 1262, 1263, 1264, and 1320 of the Business and Professions Code (BPC),

section 131200 of the Health and Safety Code (HSC), and sec- tion 14105 of the Welfare and Institutions Code (WIC). General authority: Under HSC

section 131200, the Department has authority to adopt and enforce regulations for the execution of its duties. Under BPC

section 1224, the Department has authority to adopt, amend, or repeal any regulations necessary for the administration or enforcement of

Chapter 3, Clinical Laboratory Technology. Specific Authority: Under BPC

section 1208, the Department has authority to create new categories of laboratory personnel licenses and to modify education, 192

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z training, examination, and licensing standards for existing license categories. Under BPC

section 1262, the Department has authority to approve the evaluation of national or state accrediting boards for licensure. Under

article 4, Licensing, sections 1262, 1263, and 1264 of the BPC, the Department has authority to issue licenses for clinical laboratory bioanalysts (Bus. and Prof. Code,

section 1260), clinical laboratory scientists (Bus. and Prof. Code,

section 1261), and clinical laboratory scientists limited to a specialty (Bus. and Prof. Code,

section 1261.5), clinical laboratory scientist trainees and clinical laboratory scientist trainees limited to a specialty (Bus. and Prof. Code,

section 1263), clinical chemists, clinical microbiologists, clinical toxicologists, clinical genetic molecular biologists, clinical cytogeneticists, and oral and maxillofacial pathologists (Bus. and Prof. Code,

section 1264). Under BPC

section 1222, the Department has authority to approve schools that are accredited by the National Accrediting Agency for Clinical Laboratory Sciences. Under BPC

section 1246, the Department has authority to approve national accrediting agencies for phlebotomy (Bus. and Prof. Code,

section 1246(b)(4)). INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW

Summary of Proposal The California Department of Public Health (Depart- ment) intends to adopt, amend, and repeal sections of the license and certification standards for clinical labo- ratory personnel as specified in the Clinical Laboratory Regulations in the California Code of Regulations (CCR), title 17, sections 1029 through 1067.15. These changes specify requirements for education, training, experience, and examinations leading to licensure and certification.

Advancements in technology and the need for new avenues for training create new requirements for educa- tion and training of qualified persons seeking licensure or certification.

The purpose of these regulations is to: Facilitate licensure and certification of qualified laboratory personnel for employment in California. Standardize licensing and certification regulations for high−school graduate, associate−level, baccalaureate−level, masters−level, and doctorate−level license categories. Set requirements for academic coursework and degrees, practical training and experience, and examinations for each licensure and certification category. Repeal redundant or outdated standards and replace them with more relevant standards, and create new

definitions as necessary. Modernize existing regulations to match the most updated technology and current demand of the industry. Clarify and adopt terms used in the industry, terms mandated through statutory language, and terms defined under federal law. This proposal consists of

Article 1, sections 1029 through 1029.197 (Definitions) and

Article 5.3, sec- tions 1054.1 and 1054.2 (Blood Electrolyte Analysis by Respiratory Care Practitioners). Future proposals will pertain to portions of

Article 1 (Definitions),

Article 1.5 (Licensure and Certification of Clinical Laboratory Personnel),

Article 1.6 (Unlicensed Laboratory Person- nel),

Article 1.7 (Application and Renewal, Continuing Education), and

Article 2 (Training Schools and Pro- grams). Background The Department (through its Laboratory Field Ser- vices branch) is charged with ensuring the qualifica- tions of personnel working in clinical laboratories by administering a licensure and certification program. California has one of the most extensive personnel li- censure and certification programs in the nation.

The Department monitors education, training, and experi- ence of applicants, administers examinations, and over- sees continuing education compliance in an effort to en- sure that persons performing or assisting with clinical laboratory testing are well qualified. The Department also has authority to deny, suspend, and revoke licenses and certificates for failure to comply with California li- censure and certification standards for quality assurance. All clinical laboratory personnel who perform or as- sist with clinical laboratory tests or examinations must be qualified pursuant to

chapter 3 of the BPC. The va- lidity of a person’s qualifications is demonstrated by meeting licensing and certification standards specified in departmental regulations. These standards include requirements for education, training, experience, and examination that must be met to qualify for licensure or certification. Maintenance of current and valid licen- sure and certification requires completion of continuing education and payment of a renewal fee. Testing per- sonnel must be licensed or otherwise authorized to do testing. The work scope of a licensed or certified person is limited to that defined by the person’s license or cer- tificate category. Failure to comply with personnel li- 193

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z censing and certification standards may result in sanc- tions such as revocation or suspension of licensure or certification. The Department is responsible for administering ini- tial issuance and renewal of licenses or certificates for 32 categories. The Department currently administers over 62,000 active clinical laboratory personnel licens- es and certificates in California. Out of the estimated 62,000 total, 35 percent are licensed and the remaining 65 percent are certified.

The Department also has over- sight of about 202 training programs and schools as well as accrediting agencies that provide continuing educa- tion offered to clinical laboratory personnel. In 2010, the Department submitted a proposal to adopt, amend, or repeal sections of the license and certi- fication standards for clinical laboratory personnel.

That regulatory proposal (DPH−08−001) was with- drawn due to the high volume of public inquiries and comments received during the 45−day comment period, and the inability of the Department to respond to the volume of comments within the time constraints of the rulemaking process. As a result of that experience, the Department will submit proposed Clinical Laboratory Personnel regulations in eight separate regulatory pro- posals. This is the first of the eight proposals. This will allow adequate time for public review, submission of comments, and departmental response required by the rulemaking process.

Problem Statement Existing licensing and certification standards are out- dated and require revision to reflect advances in labora- tory science and technology and consequent changes in industry procedures, tests, techniques, standards, and requirements for education and training. In addition, the standards need updating to account for changes to statutory law. The regulated community has also re- quested regulations to clarify the requirements of Cali- fornia laboratory law.

Objectives (Goals) of the Regulation The goal of the proposed regulations is to ensure con- sistency and clarity in the Department regulations, specifically: To ensure California laboratories satisfy federal Clinical Laboratory Improvement Amendments (CLIA) standards. To ensure consistency and quality in clinical laboratories throughout the state. To address the regulatory challenges posed by new technological advances in the industry. To update the list of organizations that are accepted by the Department for licensure and certification purposes. To clarify the law and answer questions frequently received by the Department. To create a system of

definitions in alphabetical order for ease of reference. To implement recommendations and proposals from the program’s Clinical Laboratory Technology Advisory Committee (CLTAC) and stakeholders. Anticipated Benefits Implementation of these standards will enhance the efficiency of the licensing and certification program and help ensure compliance with related federal regula- tions.

Other benefits of the proposed regulations include: Protecting the health and safety of the public by helping ensure high quality training schools produce qualified clinical laboratory personnel. Increasing worker safety through ensuring proper education, training, and experience of those working in laboratories. Promoting fairness of the licensing and certification process through more objective, consistent, and equitable standards for applying and qualifying for licensure and certification. Protecting the integrity and quality of test results produced by clinical laboratories. Implementing proper and safe use of new technologies.

Renumbering of all

definitions and making non− substantive changes in existing regulations will benefit the industry and California residents by providing clari- fication and ease of reference, and clearer regulations will increase adherence to the regulations. This change may also reduce calls to the Department from individu- als requesting clarification of the regulations, which will increase efficient use of departmental time.

EV ALUATION AS TO WHETHER THE PROPOSED REGULATIONS ARE INCONSISTENT OR INCOMPATIBLE WITH EXISTING STATE AND FEDERAL REGULATIONS The Department evaluated this proposal and deter- mined that it, if adopted, will not be inconsistent or in- compatible with existing state regulations. This evalua- tion included a review of the Department’s existing general regulations and those regulations specific to personnel in clinical laboratory science. An internet search of other state agency regulations was also per- formed. It was determined that no other state regula- tions address the same subject matter. 194

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z FORMS INCORPORATED BY REFERENCE Not applicable. MANDATED BY FEDERAL LAW OR REGULATIONS Not applicable. OTHER STATUTORY REQUIREMENTS Not applicable. LOCAL MANDATE The Department has determined that the proposed regulations would not impose a mandate on local agen- cies or school districts, and not impose any costs for which reimbursement is required by

part 7 (commenc- ing with

section 17500) of division 4 of the Government Code. DISCLOSURES REGARDING THE PROPOSED ACTION FISCAL IMPACT ESTIMATES

A) Cost to any local agencies or school districts that must be reimbursed pursuant to

Section 17561 of Government Code: None.

B) The cost or savings to any state agency: None.

C) Impact on any cost or savings in federal funding of the program: None.

D) Other nondiscretionary costs or savings imposed on local agencies: None. HOUSING COSTS The Department has determined that the proposed regulations will have no impact on housing costs. The regulations affect standards only for clinical laboratory personnel in licensed, certified, or registered clinical laboratories, accredited schools and training programs, military specialist programs, and U.S. government laboratories.

SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE The Department has made an initial determination that these regulations would not have a significant statewide adverse economic impact directly affecting businesses and individuals, including the ability of Cal- ifornia businesses to compete with businesses in other states.

STATEMENT OF THE RESULTS OF THE ECONOMIC IMPACT ASSESSMENT The Department has made the initial determination that the proposed regulations would not have a signifi- cant statewide adverse economic impact directly affect- ing businesses, including the ability of California busi- nesses to compete with businesses in other states. Most of the proposed changes to the regulations are clarifica- tions and updates to

definitions, and repeals of outdated and unused regulations for clarification and ease of reference. Creation or elimination of jobs within California : There would likely be no significant creation or elimi- nation of jobs within the state. There may be a slight possible increase in the creation of jobs in California. An applicant for licensure who submits a transcript from an educational institution located outside the U. S. and not accredited by a Department−approved accredi- tation association must submit an evaluation of the tran- script by a Department−approved transcript evaluation service.

This ensures that the education obtained in a non−U.S. educational institution is equivalent to an ed- ucation obtained from an accredited college or universi- ty in the US, and that the applicant meets the Depart- ment’s educational requirements. The existing regulatory law requires foreign tran- script evaluations provided by an organization that no longer performs that service. The proposed regulations will allow the Department to accept transcripts evaluat- ed by other transcript evaluation services.

Since the pro- posed regulations will allow applicants to use other transcript evaluation services, applicants who obtained education at non−U.S. colleges and universities will have a choice of approved evaluation services to show, via their transcript evaluation, that they satisfy the De- partment’s educational requirement. More applicants who obtained education in a foreign country may apply for licensure. California laboratories have been unable to fill vacant positions because of the shortage of quali- fied personnel.

The proposed regulations may enable them to fill the vacant positions or create new positions if a larger number of qualified individuals apply for and receive California licensure, expanding the number of 195

CALIFORNIA REGULATORY NOTICE REGISTER 2020, VOLUME NUMBER 6-Z employees in their businesses in California. Since ap- plicants with non−U.S. education are a small percent- age of license applicants, this expansion of the number of acceptable evaluation services will not likely have a significant effect. Creation or elimination of new businesses within California: There would likely be no significant cre- ation or elimination of businesses within the state. The clarification of the types of clinical laboratory techniques and procedures (in the proposed

section 1029 definition of “Clinical Laboratory Practice”) is not likely to eliminate existing laboratories or create new laboratories. Instead, it will likely enable existing clinical laboratories to standardize their business prac- tices. Clinical laboratories are not regionalized in the United States; therefore, the effect, if any, will affect the state as a whole. Clarification regarding the acceptance of transcript evaluations is not likely to have a significant impact on the creation or elimination of business in California.

AACRAO, the one organization specified under cur- rent regulations to review transcripts from a foreign ed- ucational institution, no longer reviews transcripts. The proposed regulations will allow applicants to submit a transcript evaluation from two specified organizations or another organization approved by the Department. Since there is no significant difference in the cost of ser- vices charged by these proposed transcript evaluation services versus the costs previously charged by AACRAO, there is no significant change in cost to individuals.

Clarification regarding the accreditation of U.S. edu- cational institutions is also not likely to have a signifi- cant impact on the creation or elimination of businesses in California. Colleges and universities that provide ed- ucation and training to clinical laboratory personnel will not be significantly impacted by changing the list of accreditation associations that accredit these education- al institutions. (See the proposed

section 1029 defini- tion of “Accredited College or University”.) For over a decade the Department has been using authorized statu- tory discretion to accept education obtained at colleges or universities accredited not only by the Western Asso- ciation of Schools and Colleges, which is the accredita- tion association listed in the existing regulations, but those with “equivalent standards.” These other associa- tions include the associations listed by name in the pro- posed regulations.

Few, if any, colleges and universities will need to ap- ply for new accreditation from an association listed in the proposed regulations and the Department will con- tinue to accept education obtained at accredited educa- tional institutions as usual. The proposed change to the list of acceptable accrediting associations is unlikely to increase or decrease the number of accredited educa- tional institutions considered acceptable by the Depart- ment, and is thus not likely to affect the instructors or the graduates of those institutions.

Impact on California Businesses to compete with businesses in other states: There is no foreseeable neg- ative impact on the ability of California businesses to compete with businesses in other states. The potential positive impact is not significant.

The regulations may create a slight increase in the number of out−of−state laboratory personnel who apply and receive a license because (1) the proposed definition of official school transcript will now include optional electronic tran- script submission in place of the paper submission cur- rently required, (2) applicants will be able to have their transcripts evaluated by one of the newly approved transcript evaluation services, and (3) specifying the national accreditation associations acceptable by the Department creates clarity and reassurance to training programs and licensure applicants as to which educa- tional institutions offer credentials that will qualify them.

These changes may slightly increase the pool of qualified job candidates. This increase may provide a slight increase in the number of jobs created and/or in- crease the ability of California businesses to hire quali- fied clinical laboratory personnel. This will likely re- duce the current industry shortage of licensed clinical personnel in California. However, there will be no sig- nificant economic or fiscal impact on businesses in California.

Expansion of businesses currently doing business within the state: There is not likely to be significant ex- pansion of businesses currently doing business within the state. The proposed regulations are unlikely to affect educational institutions accredited by associations pre- viously considered acceptable by the Department based on statutory departmental authority. (See the discussion under

Document details

Collection	California Z Register
Citation	Cal. Reg. Notice Reg. 2020, No. 6
Type	gazette
Language	en
Format	pdf
Source	CA_ZREG
Identifier	e3c4d720c0197674c74a5490a729a43504044990

Source file is stored in the law ingest library (pdf).