California Regulatory Notice Register — Register 2021, No. 30-Z (JULY 23, 2021)
Cal. Reg. Notice Reg. 2021, No. 30
California Z Register
GAVIN NEWSOM, GOVERNOR OFFICE OF ADMINISTRATIVE LAW California Regulatory Notice Register REGISTER 2021, NUMBER 30-Z P UBLISHED WEEKLY BY THE OFFICE OF ADMINISTRATIVE LAW J ULY 23, 2021 PROPOSED ACTION ON REGULATIONS TITLE 2. F AIR POLITICAL PRACTICES COMMISSION Conflict–of–Interest Code — Notice File Number Z2021–0713–05 ......................................... 925 AMENDMENT MULTI–COUNTY: Coachella V alley Water District Las V irgenes Unified School District South Sutter W ater District W inters Joint Unified School District ADOPTION MULTI–COUNTY: W estside Water Authority TITLE 3.
DEP ARTMENT OF PESTICIDE REGULATION Carbon Monoxide Pest Control Devices — Notice File Number Z2021–0713–04 ............................. 926 TITLE 10. DEP ARTMENT OF REAL ESTATE AB 2884
(2018) Terminology Update — Notice File Number Z2021–0712–02 ................................ 929 TITLE 12. DEP ARTMENT OF VETERANS AFFAIRS Veterans Homes Eligibility Determinations — Notice File Number Z2021–0713–07 ........................... 932 TITLE 16. BOARD OF PHARMACY Trust Ownership — Notice File Number Z2021–0707–04 ................................................ 936 TITLE 27. OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT Proposition 65 Glyphosate Warnings — Notice File Number Z2021–0713–02 ................................ 939 TITLE 28. DEP ARTMENT OF MANAGED HEALTH CARE
Summary of Dental Benefits Disclosure Matrix — Notice File Number Z2021–0713–01 ........................ 942 (Continued on next page) Time- Dated Material
GENERAL PUBLIC INTEREST DEPARTMENT OF FISH AND WILDLIFE Paynes Creek Bend Water Users Fish Passage Restoration Project, Consistency Determination Number 2080R–2021–006–01 ............................................... 948 DEPARTMENT OF TOXIC SUBSTANCES CONTROL Variance for Hazardous Treated Wood Waste Week of June 7 ............................................. 951 DEPARTMENT OF TOXIC SUBSTANCES CONTROL Variance for Hazardous Treated Wood Waste Week of May 17 ............................................ 951 DEPARTMENT OF TOXIC SUBSTANCES CONTROL Variance for Hazardous Treated Wood Waste Week of May 24 ............................................ 952 OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT Notice of Modification to Proposed Text Concerning Naturally Occurring Lead in Candy ...................... 953
SUMMARY OF REGULATORY ACTIONS Regulations filed with Secretary of State .............................................................. 954 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 REGULATORY 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 2021, VOLUME NUMBER 30-Z 925 PROPOSED ACTION ON REGULATIONS Information contained in this document is published as received from agencies and is not edited by Thomson Reuters. TITLE 2.
FAIR POLITICAL PRACTICES COMMISSION NOTICE IS HEREBY GIVEN that the Fair Political Practices Commission, pursuant to the authority vested in it by Sections 82011, 87303, and 87304 of the Government Code to review proposed conflict– of–interest codes, will review the proposed/amended conflict–of–interest codes of the following: CONFLICT–OF–INTEREST CODES AMENDMENT Multi–County: Coachella Valley Water District Las Virgenes Unified School District South Sutter Water District Winters Joint Unified School District ADOPTION Multi–County: Westside Water Authority A written comment period has been established commencing on July 23, 2021 and closing on September 6, 2021.
Written comments should be directed to the Fair Political Practices Commission, Attention Daniel Vo, 1102 Q Street, Suite 3000, Sacramento, California 95811. At the end of the 45–day comment period, the proposed conflict–of–interest code(
s) will be submitted to the Commission’s Executive Director for his review, unless any interested person or his or her duly authorized representative requests, no later than 15 days prior to the close of the written comment period, a public hearing before the full Commission. If a public hearing is requested, the proposed code(
s) will be submitted to the Commission for review. The Executive Director of the Commission will review the above–referenced conflict–of–interest code(s), proposed pursuant to Government Code
Section 87300, which designate, pursuant to Government Code
Section 87302, employees who must disclose certain investments, interests in real property and income. The Executive Director of the Commission, upon his or its own motion or at the request of any interested person, will approve, or revise and approve, or return the proposed code(
s) to the agency for revision and re– submission within 60 days without further notice. Any interested person may present statements, arguments or comments, in writing to the Executive Director of the Commission, relative to review of the proposed conflict–of–interest code(s). Any written comments must be received no later than September 6, 2021. If a public hearing is to be held, oral comments may be presented to the Commission at the hearing.
COST TO LOCAL AGENCIES There shall be no reimbursement for any new or increased costs to local government which may re - sult from compliance with these codes because these are not new programs mandated on local agencies by the codes since the requirements described herein were mandated by the Political Reform Act of 1974. Therefore, they are not “costs mandated by the state” as defined in Government Code
Section 17514. EFFECT ON HOUSING COSTS AND BUSINESSES Compliance with the codes has no potential effect on housing costs or on private persons, businesses or small businesses. AUTHORITY Government Code Sections 82011, 87303 and 87304 provide that the Fair Political Practices Commission as the code–reviewing body for the above conflict–of– interest codes shall approve codes as submitted, revise the proposed code and approve it as revised, or return the proposed code for revision and re–submission.
REFERENCE Government Code Sections 87300 and 87306 pro - vide that agencies shall adopt and promulgate conflict– of–interest codes pursuant to the Political Reform Act and amend their codes when change is necessitated by changed circumstances. CONTACT Any inquiries concerning the proposed conflict– of–interest code(
s) should be made to Daniel Vo, Fair Political Practices Commission, 1102 Q Street, Suite 3000, Sacramento, California 95811, telephone (916) 322–5660.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 926 AVAILABILITY OF PROPOSED CONFLICT–OF–INTEREST CODES Copies of the proposed conflict–of–interest codes may be obtained from the Commission offices or the respective agency. Requests for copies from the Commission should be made to Daniel Vo, Fair Political Practices Commission, 1102 Q Street, Suite 3000, Sacramento, California 95811, telephone (916) 322–5660. TITLE 3. D EPARTMENT OF PESTICIDE REGULATION CARBON MONOXIDE PEST CONTROL DEVICES DPR REGULATION NO. 21–00 2 The Department of Pesticide Regulation (DPR) proposes to adopt Title 3, California Code of Regulations (3 CCR)
section 6695. The pesticide regulatory program activities affected by the proposal are those pertaining to enforcement of pest control general standards of care. In
summary, the proposed action will ensure that each person using a carbon monoxide pest control device to perform pest control uses a device bearing the U.S. Environmental Protection Agency (U.S. EPA) establishment number; does not use the device inside any structure; uses the device at specified distances away from structures; does not use the device on a burrow known or believed to contain non–target vertebrate animals; and does not use the device for purposes other than to control for burrowing rodent pests.
It will also require employers of employees performing pest control for hire or for a local government to ensure protective eyewear is worn by employees, keep records of use, and report any adverse effect that occurs from use of the devices. SUBMITTAL OF COMMENTS Any interested person may present comments in writing about the proposed action to the agency contact person named below. Written comments must be received no later than 5:00 p.m. on September 8, 2021. Comments regarding this proposed action may also be transmitted via e–mail to dpr21002@cdpr. ca.gov or by facsimile at 916–324–1491.
A public hearing is not scheduled. However, one will be scheduled if any interested person submits a written request to DPR no later than 15 days prior to the close of the written comment period .1 1 I f you have special accommodation or language needs, please in - clude this in your request for a public hearing. TTY/TDD speech– to–speech users may dial 7–1–1 for the California Relay Service. EFFECT ON SMALL BUSINESS DPR has determined that the proposed regulatory action does affect small businesses.
INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW DPR protects human health and the environment through the regulation of pesticide sales and use, and by fostering reduced–risk pest management. DPR’s strict oversight begins with product evaluation and registration; and continues through statewide licensing of commercial and private applicators and pest control businesses; environmental monitoring; and residue testing of fresh produce. This statutory scheme is set forth primarily in Food and Agricultural Code (FAC) Divisions 6 and 7. In 2011, Assembly Bill 634 (Huber,
Chapter 407, Statutes of 2011) legalized the use of carbon monoxide pest control devices (CO pest control devices) to control burrowing rodents in California. (FAC
section 6025.4) This legislation requires CO pest control devices to be labeled with a warning about the toxicity of carbon monoxide; a statement prohibiting the use of a CO pest control device in inhabited structures; and a statement that the devices must be used in accordance with certain provisions of the California Fish and Game Code. Three years later, Senate Bill (SB) 1332 (Wolk,
Chapter 257, Statutes of 2014) directed DPR to regulate the proper, safe, and efficient use of CO pest control devices to control burrowing rodent pests. Under FAC
section 14160, CO pest control devices are defined as any method or instrument using carbon monoxide to prevent, eliminate, destroy, or mitigate burrowing rodents. These CO pest control devices are regulated as “pest control” in California. According to FAC
section 11403, “pest control” includes the use of any device to control pests, or to prevent, destroy, repel, mitigate, or correct any pest infestation or dis - order of plants. As a result, individuals using these devices must follow all laws and regulations specific to pest control. Even without specific regulations for the safe and effective use of CO pest control devices, there are existing laws and regulations that pertain to the use of these devices.
Anyone performing pest con- trol for hire, including individuals using CO pest con- trol devices to control burrowing rodents, must be li - censed by DPR and registered with the county agricul- tural commissioner (CAC) in any county where they perform pest control. Additionally, this use of carbon monoxide is subject to the requirements of Division 6 (commencing with FAC
section 11401) and Division 7 (commencing with FAC
section 12500). Other applica- ble laws and regulations include: FAC sections 11701 through 11701.5 and 11732; and 3 CCR
section 6600.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 927 DPR proposes to adopt
section 6695, as directed by FAC
section 14161, to ensure that the devices will be used safely and efficiently, in an enforceable manner that is more protective than existing laws and practice.
Section 6695(a)(1–5) applies to each person using a CO pest control device to perform pest control. Sec - tion 6695(a)(1) establishes that CO pest control devic- es used to control burrowing rodent pests must be fed- erally registered and bear a U.S. EPA Establishment Number of the establishment in which it was manufac- tured.
Section 6695(a)(2–3) prohibits the use of carbon monoxide pest control devices inside any structure inhabited by people or livestock, whether occupied or not. It will also prohibit use on burrow openings with- in 50 feet of a structure inhabited by people or live - stock, whether occupied or not, when used for control of ground squirrels and field mice, within 100 feet of a structure inhabited by people or livestock, whether occupied or not, when used for control of gophers, or within 65 feet of a structure inhabited by people or livestock, whether occupied or not, when controlling all other burrowing rodent pests. Additionally,
section 6695(a)(4) will prohibit use of a CO pest control de - vice on a burrow opening known or believed to con - tain non–target vertebrate animals, and subsection (a) (5) will prohibit use of a CO pest control device for purposes other than to control for burrowing rodent pests.
Section 6695(b)(1–3) outlines the responsibili - ties of the employer of an employee operating a car - bon monoxide pest control device to perform pest control for hire or for a local government, including a city, county, city and county, school district, park district, authority, or any other political subdivision of the state.
Section 6695(b)(1) requires the employer to ensure that the employee operating a carbon monox - ide pest control device to perform pest control wears protective eyewear that complies with the American National Standards Institute’s (ANSI) Standard for Occupational and Educational Personal Eye and Face Protection Devices ANSI Z87.1–2020 while the device is in use.
Section 6695(b)(2) requires the employer of the employee using a carbon monoxide pest control device to retain records of use of the carbon monoxide pest control device and requires the records to include the date the device was used, name of the operator of the property treated, address of where the device was used, site at which the device was used, and length of time the device was operated for every treatment. Lastly,
section 6695(b)(3) requires the employer to im- mediately submit to the Director any adverse effect to human health or safety, property, or the environment, from the use of the carbon monoxide pest control device. Carbon monoxide (CO) is a poisonous, colorless, odorless, and tasteless gas that can be deadly, espe - cially when confined in enclosed spaces. CO pest con- trol devices use gasoline–powered engines to generate CO, which is compressed and stored until released into the rodent burrow under pressure.
The pressur - ized system allows the CO to move farther through the burrow system than it would with a more passive application such as using a cartridge. By establishing additional requirements that will minimize the risks associated with exposure to CO, DPR can ensure that employees operating the devices and the public are protected from the risks of CO. Additionally, aside from the laws and regulations referenced in this sec - tion, there are currently no enforceable requirements pertaining to the use of CO pest control devices.
The intent of these proposed regulations is to ensure that the devices will be used safely and efficiently, in an en- forceable manner that is more protective than existing laws and practice.
Additionally, adoption of these regulations will benefit the health and welfare of California residents, worker safety, and the State’s environment by creating enforceable requirements that are protective of human health, such as prohibiting use near inhabited struc - tures, thus reducing the potential for accidental human carbon monoxide exposure, and benefit worker safety by requiring protective eyewear for users, reducing the risk of pesticide poisonings and injuries among device users.
During the process of developing these proposed regulations, DPR conducted a search of any similar regulations on this topic and has concluded that these proposed regulations are neither inconsistent nor in - compatible with existing state regulations. California law directs DPR to develop regulations for the proper, safe, and efficient use of carbon monoxide pest control devices, and is the only agency with the authority to do so. IMPACT ON LOCAL AGENCIES OR SCHOOL DISTRICTS DPR determined that the proposed regulatory action does not impose a mandate on local agencies or school districts.
DPR also determined that there are no costs to any local agency or school district requiring reimbursement pursuant to Government Code
section 17500 et seq. There are no other nondiscretionary costs or savings imposed upon local agencies that are expected to result from the proposed regulation action. COSTS OR SA VINGS TO STATE AGENCIES DPR determined that no savings or increased costs to any state agency will result from the proposed regulatory action.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 928 EFFECT ON FEDERAL FUNDING TO THE STATE DPR determined that no costs or savings in federal funding to the state will result from the proposed action. EFFECT ON HOUSING COSTS DPR made an initial determination that the proposed action will have no effect on housing costs.
SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS DPR made an initial determination that adoption of this regulation will not have a significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states. COST IMPACTS ON REPRESENTATIVE PRIVATE PERSONS OR BUSINESSES DPR is not aware of any significant cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action.
Pest control businesses and local governments who operate carbon monoxide pest control devices will be required to comply with the proposed regulations. Protective eyewear, recordkeeping and reporting of adverse effects will be new requirements that may incur additional costs. DPR estimates that these requirements will result in an initial cost of $100 per business, with annual costs of $100 per business.
RESULTS OF THE ECONOMIC IMPACT ANALYSIS Impact on the Creation, Elimination, or Expansion of Jobs/Businesses: DPR determined it is not likely the proposed regulatory action will impact the creation or elimination of jobs, the creation of new businesses or the elimination of existing businesses, or the expansion of businesses currently doing business within the State of California because carbon monoxide pest control devices are currently being used to control burrowing rodent pests.
This action is consistent with current law and will not significantly restrict or increase the use of carbon monoxide pest control devices. It will clarify and add limits for how CO pest control devices must be used. The proposed regulations do not prohibit the use.
The proposed regulations will benefit the health and welfare of California residents, worker safety, and the State’s environment by creating enforceable requirements that are protective of human health, such as prohibiting use near inhabited structures, thus reducing the potential for accidental human carbon monoxide exposure, and benefit worker safety by requiring protective eyewear for users, reducing the risk of pesticide poisonings and injuries among device users.
CONSIDERATION OF ALTERNATIVES DPR must determine that no reasonable alternative considered by the agency, or that has otherwise been identified and brought to the attention of the agency, would 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 proposed regulatory action, or would be more cost–effective to affected private persons and equally effective in implementing the statutory policy or other provision of the law.
AUTHORITY This regulatory action is taken pursuant to the authority vested by FAC sections 11456, 11502, and 14161. REFERENCE This regulatory action is to implement, interpret, or make specific FAC sections 11708, 11733, 12757, 14160, 14161, and 15316. A VAILABILITY OF STATEMENT OF REASONS AND TEXT OF PROPOSED REGULATIONS DPR prepared an Initial Statement of Reasons and is making available the express terms of the proposed action, all of the information upon which the proposal is based, and a rulemaking file.
A copy of the Initial Statement of Reasons and the proposed text of the regulation may be obtained from the agency contact person named in this notice. The information upon which DPR relied in preparing this proposal and the rulemaking file are available for review at the address specified below. AVAILABILITY OF CHANGED OR MODIFIED TEXT After the close of the comment period, DPR may make the regulation permanent if it remains substantially the same as described in the Informative
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 929 Digest. If DPR does make substantial changes to the regulation, the modified text will be made available for at least 15 days prior to adoption. Requests for the modified text should be addressed to the agency contact person named in this notice. DPR will accept written comments on any changes for 15 days after the modified text is made available.
AGENCY CONTACT Written comments about the proposed regulatory action; requests for a copy of the Initial Statement of Reasons, and the proposed text of the regulation; and inquiries regarding the rulemaking file may be directed to: Lauren Otani, Senior Environmental Scientist (Specialist) Department of Pesticide Regulation 1001 I Street, P.O.
Box 4015 Sacramento, California 95812–4015 916– 445–5781 Note: In the event the contact person is unavailable, questions on the substance of the proposed regulatory action may be directed to the following back–up person at the same address as noted below: Eryn Shimizu, Senior Environmental Scientist (Specialist) Office of Laws and Regulations 916– 445–7230 This Notice of Proposed Action, the Initial Statement of Reasons, and the proposed text of the regulation are also available on DPR’s Internet Home Page http:// www.cdpr.ca.gov.
Upon request, the documents can be made available in another language, or an alternate form as a disability–related accommodation. A VAILABILITY OF FINAL STATEMENT OF REASONS Following its preparation, a copy of the Final Statement of Reasons mandated by Government Code
section 11346.9(
a) may be obtained from the contact person named above. In addition, the Final Statement of Reasons will be posted on DPR’s Internet Home Page and accessed at http://www.cdpr.ca.gov. TITLE 10. DEPARTMENT OF REAL ESTATE AB 2884 TERMINOLOGY UPDATE — SECTIONS 2705, 2724, 2725, 2725.5, 2729, 2752, 2753, 2756, 2758.5, 2903, 2905, 2970, 3007.3, and 3102 The Commissioner (“Commissioner”) of the Department of Real Estate (“DRE”) proposes to amend Sections 2705, 2724, 2725, 2725.5, 2729, 2752, 2756, 2758.5, 2903, 2905, 2970, 3007.3, and 3102, and to re- peal
Section 2753, of the Regulations of the Real Estate Commissioner (Title 10,
Chapter 6 of the California Code of Regulations) (“the Regulations”) after consid- ering all comments, objections, and recommendations regarding the proposed action. Publication of this no - tice commences a 45–day public comment period. PUBLIC HEARING A public hearing is not scheduled. A public hearing will be held if any interested person, or that person’s duly authorized representative, submits a written re - quest for a public hearing to DRE at the contact listed below no later than 15 days prior to the close of the written comment period.
WRITTEN COMMENT PERIOD Any interested person, or that person’s authorized representative, may submit written comments relevant to the proposed regulatory action to the Commissioner addressed as follows: Regular Mail Department of Real Estate Attn: Daniel E. Kehew, Sacramento Legal Office P.O. Box 137007 Sacramento, CA 95813–7007 Electronic Mail DRE.RegComments@dre.ca.gov Facsimile (916) 263–8767 Comments may be submitted until 5:00 p.m., Wednesday, September 8, 2021.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 930 AUTHORITY AND REFERENCE
Section 10080 of the Business and Professions Code (“the Code”) authorizes the Commissioner to adopt regulations that are reasonably necessary for the en - forcement of the provisions of the Real Estate Law (Code Sections 10000 et seq.). Several other sections of the Code—Sections 10131.01, 10131.6, 10166.17, 10170.4, 10471.2, and 11001—also provide more lim- ited rulemaking authority to the Commissioner.
The proposed regulations implement, interpret, and make specific Sections 10015.1, 10018.1, 10026, 10085, 10087, 10131.01, 10132, 10148, 10150, 10151, 10159.2, 10161.8, 10166.01, 10166.02, 10166.07, 10166.11, 10166.12, 10170.4, 10177, 10177.6, 10471.2, and 11000 of the Code. The proposed regulations also repeal
Section 2753 in conjunction with the legislative repeal of that section’s corresponding statutory requirement, the former
Section 10160 of the Code. INFORMATIVE DIGEST/PLAIN ENGLISH OVERVIEW —
SUMMARY OF PROPOSED REGULATION AB 2884 (Irwin,
Chapter 285, Statutes of 2018) affected a large number of code sections within the Code. The bill amended Sections 10001, 10016, 10027, 10050, 10131, 10133.1, 10133.2, 10137, 10140.6, 10142, 10143.5, 10144, 10158, 10159, 10159.6, 10159.7, 10164, 10176, 10177, 10178, 10179, 10186.2, 10232.3, 10238, 10243, 10509, 10561, 11212, and 11267. The bill added Sections 10010.5, 10015.1, 10015.2, 10015.3, 10015.4, 10015.5, 10018.01, 10018.02, 10018.03, 10018.04, 10018.05, 10018.06, 10018.07, 10018.08, 10018.09, 10018.10, 10018.11, 10018.13, 10018.14, 10018.15, 10018.16, and 10018.17,
definitions that now apply to the Real Estate Law and to specified Articles in the Civil Code. Finally, AB 2884 repealed Sections 10132 and 10160 of the Code, and repealed and added
Section 10161.8. A core goal of these actions, according to the spon - sor of the legislation, was to update language in the Real Estate Law to match present industry terminol - ogy. Most frequently, the bill’s amendments changed uses of the word “employ” into forms of “retain” wherever the word (or a version of the word) appeared. Forms and uses of the words “transferor” and “trans - feree” were converted to “seller” and “buyer.” Most of the changes appearing in this proposal harmonize the terminology appearing in the Regulations with the terminology appearing in the newly revised Code sections. This proposal also: ■ Adds
definitions for “responsible broker” and “ ‘retain’ or ‘retention’ ” to the Regulations to harmonize with new
definitions that AB 2884 added to the Code. ■ Eliminates certain instances of gendered language. ■ Adds subdivision lettering to
Section 2752 for consistency and clarity with other regulatory subdivision usage. ■ Repeals
Section 2753 of the Regulations, based upon AB 2884’s repeal of that section’s archaic statutory basis,
Section 10160 of the Code. ■ Corrects or adds phrasing for clarity where such phrasing will not change legal meaning or impact of existing regulations. ■ For consistency, amends existing references to “Bureau” or “department” to “Department” in the Regulations sections impacted by AB 2884. Anticipated Benefits of the Proposed Regulation The proposed language brings the existing DRE regulations into consistency with the updated statutory terminology, as well as making other conforming changes for consistency with statute.
These amendments will benefit the real estate industry (real estate licensees and their support professionals) as well as the public generally (persons who retain the services of real estate licensees) by ensuring greater clarity of both the statutes and regulations when these laws are consulted separately or together. Evaluation of Inconsistency/Incompatibility with Existing State Regulations The Commissioner has determined that these pro - posed regulations are not inconsistent or incompatible with existing regulations.
After conducting a review for any regulations that would relate to the sections affected by this proposal, the Commissioner has con - cluded that these are the only State of California regu- lations relating to these subjects. DISCLOSURES REGARDING THE PROPOSED ACTION The Commissioner has made the following determinations: Mandate on local agencies and school districts: None. Cost or savings to any state agency: None. Cost to any local agency or school district that must be reimbursed in accordance with Government Code sections 17500 through 17630: None.
Other nondiscretionary cost or savings imposed on local agencies: None. Cost or savings in federal funding to the state: None. Cost impacts on a representative private person or business: DRE is not aware of any cost impacts that a representative private person or business would nec -
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 931 essarily incur in reasonable compliance with the pro - posed action. Significant, statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states: None. Significant effect on housing costs: None.
RESULTS OF THE ECONOMIC IMPACT ANALYSIS/ASSESSMENT The Commissioner concludes that it is (1) unlikely that the proposal will eliminate any jobs for real estate licensees or associated professions, (2) unlikely that the proposal will create jobs, (3) unlikely the propos - al will create new businesses of any sort, (4) unlikely that the proposal will eliminate any existing business- es, and (5) unlikely that the proposed regulations will result in the expansion of businesses currently doing business in the state.
BENEFITS OF THE PROPOSED ACTION This proposal will harmonize the terminology of DRE’s Regulations with the new AB 2884 terminol - ogy as used throughout the Real Estate Law and re - lated Civil Code sections, ensuring greater clarity of both the statutes and regulations when these laws are consulted separately or together. The proposed regula- tory amendments will not benefit worker safety or the states environment. SMALL BUSINESS DETERMINATION The Commissioner has determined that there is no fiscal impact to small businesses resulting from this proposed regulatory amendment.
The amendments serve only to implement the statutory standard, rather than impose a substantial change in that standard. CONSIDERATION OF ALTERNATIVES In accordance with Government Code
section 11346.5, subdivision (a)(13), the Commissioner must determine that no reasonable alternative he consid - ered, or that has otherwise been identified and brought to the attention of DRE, would be more effective in carrying out the purpose for which the action is pro - posed, would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost–effective to affected private per - sons and equally effective in implementing the statu - tory policy or other provision of law.
DRE invites interested persons to present state - ments or arguments with respect to alternatives to the proposed regulation at during the written comment period. CONTACT PERSON Inquiries concerning this action may be directed to Daniel Kehew at (916) 576–7842, or via email at DRE. RegComments@dre.ca.gov. The backup contact per - son is Stephen Lerner at (916) 576–8100.
A VAILABILITY OF STATEMENT OF REASONS, TEXT OF PROPOSED REGULATIONS, AND RULEMAKING FILE DRE will have the entire rulemaking file available for inspection and copying throughout the rulemak - ing process at its headquarters office, located at 1651 Exposition Boulevard in Sacramento.
As of the date this notice is published in the Notice Register, the rulemaking file consists of this notice, the proposed text of the regulations, the initial statement of rea - sons, the form STD. 399 Economic and Fiscal Impact Statement, and the form STD. 400 under which the package was submitted to the Office of Administrative Law for publication. Copies may be obtained by con - tacting Daniel Kehew at the mailing address and email address listed on the first page of this notice.
AVAILABILITY OF CHANGED OR MODIFIED TEXT After considering all timely and relevant comments received, the Commissioner may adopt the proposed regulation substantially as described in this notice. If the Commissioner makes modifications that are suf - ficiently related to the originally proposed text, DRE will make the modified text (with the changes clearly indicated) available to the public for at least 15 days before the Commissioner adopts the regulation as re - vised. A request for a copy of any modified regula - tion(
s) should be addressed to the contact person des - ignated above. The Commissioner will accept written comments on the modified regulation for 15 days after the date on which they are made available. A VAILABILITY OF THE FINAL STATEMENT OF REASONS Upon its completion, the Final Statement of Reasons will be available and copies may be requested from the contact person named in this notice or may be ac - cessed on the website listed below. A V AILABILITY OF DOCUMENTS ON THE INTERNET Copies of the notice, the initial statement of reasons, and the text of the regulations in underline and strike -
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 932 out can be accessed through DRE’s website at www. dre.ca.gov. TITLE 12. DEPARTMENT OF VETERANS AFFAIRS NOTICE IS HEREBY GIVEN that the California Department of Veterans Affairs (CalVet) is proposing to take the action described in the Informative Digest after considering all comments, objections, and rec - ommendations regarding the proposed action. PUBLIC HEARING CalVet will not hold a public hearing. The Department has not scheduled a public hearing.
However, any interested person or his or her authorized representative may request a hearing no later than fifteen (15) calendar days prior the end of the written comment period. Submit a request to Phil McAllister at the address below. WRITTEN COMMENT PERIOD Any interested person, or his or her authorized representative, may submit written comments relevant to the proposed regulatory action to CalVet. Comments may also be submitted by facsimile (FAX) at (916) 653–2456 or by e–mail to phil.mcallister@ calvet.ca.gov. The written comment period closes on September 8, 2021 .
CalVet will consider only comments received at CalVet offices by that time. Submit comments to: Phil McAllister, Regulatory Actions Coordinator California Department of Veterans Affairs 1227 O Street, Suite 500 Sacramento, California 95814 AUTHORITY AND REFERENCE Authority: Sections 79.3 and 1044, Military and Veterans Code (MVC). Reference: Sections 1012 and 1043, MVC. INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW A. Policy Statement Overview CalVet proposes this rulemaking action to make permanent CCR, title 12,
Section 505.2. This rulemaking action makes specific how CalVet determines eligibility for admission to California Veterans Homes and to clarify the criteria for admission in accordance with the MVC. Under the direction of its Secretary, CalVet currently operates eight Veterans Homes that are located in Yountville, Barstow, Chula Vista, Lancaster, Ventura, West Los Angeles, Fresno and Redding.
Beginning in 1884 with the opening of the Yountville Veterans Home, one of the nation’s first long–term care Veterans Homes for Civil War and Mexican–American War veterans, California has maintained a commitment to caring for veterans and their families. The Veterans Homes, which provide long–term health care services for more than two thousand aged and/or disabled veterans and their spouses and domestic partners, are certified by the United States Department of Veterans Affairs (USDVA) and licensed by the California Department of Public Health and/or the California Department of Social Services.
The specific problem being addressed in this regulatory action is codifying in regulation how CalVet determines eligibility for admission to California Veterans Homes and clarifying the criteria for admission in accordance with the MVC. This regulation is necessary because CalVet has determined that not enough space will be available for all eligible veterans, but MVC
Section 1012 does not define with sufficient specificity how the Veterans Homes will apply eligibility determination and admission criteria for qualified applicants. CalVet has the responsibility to proactively define eligibility and admissions criteria with more detail than the statute provides. The current regulation was written when one Veterans Home existed and was adopted prior to the development of all eight sites in the California Veterans Home system.
California Veterans Homes are limited by statute, licensing, and budget as to how many individuals may be admitted as members and what levels of care are provided. The eight Veterans Homes offer admission to between one and four levels of care: domiciliary, residential care facility for the elderly, intermediate facility care, and skilled nursing facility care (to include skilled nursing memory care). B. Informative Digest The MVC was revised by Senate Bill 96,
an act of the 2017 California State Legislature. The revised MVC permits investigation of the applicant’s personal background and the regulation proposal clarifies that criminal background checks may be conducted. The purpose of the check is to help ensure that a safe and secure environment is provided at each Veterans Home. For the safety and security of Veterans Home members, the regulation provides language to exclude applicants whose background indicates incompatibility with a safe and secure community environment such as applicants with a history of elder abuse, assault, or theft.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 933 Residency and health care at the Veterans Homes are taxpayer–supported public benefits, not unlike those of the USDVA which provides various medical services for veterans. Eligibility for such benefits must be determined by specific criteria. The Veterans Homes’ mission is providing long– term care for veterans that are aged and/or disabled. CalVet determines eligibility for admission to the Veterans Homes and applies admission criteria in a fair and equitable manner in accordance with
section 1012 of the MVC. The rationale for this regulation is to provide clarity to applicants and the general public on the admission criteria and how eligibility is determined. Proposed 12 CCR 505.2 would provide as follows:
Section 505.2(a)(1), (a)(2), (a)(3), (a)(4), (a)(5), and (a)(6) defines terms used in the regulations. This is necessary for the reader to be able to easily understand the meaning of the defined term or phrase as used in the regulations.
Section 505.2(e)(6) this revision is made in accordance with the revisions to MVC
Section 1033.1(c). Previously, the MVC did not specify that a Veterans Home member was required to maintain medical insurance.
Section 505.2(
f) MVC
Section 1012 states that certain nonveterans may be eligible for admission to a Veterans Home, including spouses or domestic partners of veteran applicants, widows or widowers of Medal of Honor recipients, and widows or widowers of former prisoners of war. The proposed regulations were adjusted to provide clarity.
Section 505.2(f)(3) in accordance with MVC 1012 in order for a nonveteran spouse or registered domestic partner to be eligible for admission to a veterans home, the veteran must be eligible for admission first and appropriate for admission to the home. This
section provides clear guidance that makes the distinction that the spouse or domestic partner is only eligible for admission if the veteran is first found to be eligible. In addition, this
section clarifies that a denial of a nonveteran spouse or domestic partner does not preclude the veteran applicant from continuing the application process as an individual.
Section 505.2(f)(5)(
A) emphasis in this subsection defines the rule that a couple must be able to be admitted to the same room, meaning the room that has been selected for the couple must have sufficient space to safely accommodate two individuals, as determined by the Veterans Home or as required by state fire marshal or other control agencies or authorities. Because there is a limited number of rooms that are configured to meet this requirement, couples may be delayed until a room becomes available.
If the veteran requires a different level of care than the spouse or domestic partner and they agree, they may be admitted to separate rooms in different levels of care. In the absence of this language, it is unclear that the Veterans Homes may limit the admission of couples to appropriate rooms, or that the Veterans Homes can deny a couple from joint admission to an inappropriate room.
Section 505.2(f)(5)(
B) clearly supports (
A) and provides a clause that specifies that a veteran and nonveteran spouse or domestic partner may be admitted at a different date to a different level of care and stresses that they must maintain their eligibility.
Section 505.2(f)(5)(
C) this clarifies that under no circumstances shall a nonveteran spouse or domestic partner be allowed to be admitted to the veterans home prior to the veteran applicant.
Section 505.2(f)(7) clarifies that there may be two eligible veterans that are married or domestic partners that may apply at the same time or at later times depending on their individual needs. In this instance, each veteran may submit individual applications, and neither veteran would be subject to the additional requirements or limitations that apply to nonveteran spouses or domestic partners.
Section 505.2(
g) in accordance with the MVC
Section 1012, CalVet may investigate an applicant’s or member’s personal background for suitability of becoming or continuing residency as a member. The purpose of the regulation is to provide a safe and secure environment for Veterans Home members. Safety and security are critical to the mission of the Veterans Homes as a matter of human rights and to comply with state and federal licensing requirements.
Section 505.2(g)(1) this
section requires the documentation necessary to provide the home sufficient information to review records related to criminal history. It also explains that this information is not discretionary but is a requirement of the admission process. Without this section, the Veterans Homes would potentially be unable to deny admission to applicants who fail to comply with requirements to produce necessary documentation, potentially creating an unsafe environment for members, staff, and property.
Section 505.2(g)(2) the application process requires applicants to be honest and forthright about the information provided on their application and all requests for information. This information is needed to accurately assess the appropriateness of the admission to a communal environment that houses predominately elderly frail seniors. Excluding critical information about prior criminal history that is found to have occurred prior to admission are considered legitimate grounds for denial of admission to, or discharge from, a Veterans Home. Without this section, the Veterans Homes would potentially be unable to deny admission to applicants who misrepresent dangerous criminal
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 934 histories, potentially creating an unsafe environment for members, staff, visitors and property.
Section 505.2(
h) when an applicant or member is actively on parole or probation, or is a registered sex offender, he or she may be visited by local law enforcement at any moment. This may constitute an infringement of other residents’ rights to privacy since many residents live in shared rooms and all share communal space. Many members of the Veterans Homes have physical or cognitive limitations that may place them at greater risk for victimization. Because of this, the Department believes it would be unsafe and inappropriate to allow any sex offenders or individuals actively on parole, or probation, to reside at a Veterans Home. Failure to adopt this
section may result in greater civil liability for the state as well as enforcement action against the Veterans Homes by licensing or control agencies for infringing residents’ rights.
Section 505.2(
i) this
section provides the exception for admission to ensure that the state is fully made whole (all delinquent fees are paid) prior to the admission of a previously discharged resident. Further, this
section is necessary as it clarifies that readmission is subject to all other admission criteria, including eligibility requirements and applicant prioritization.
Section 505.2(
j) this
section provides the legal rights of appeal to an applicant that has been denied acceptance for admission to the Veterans Home. Admission denials that are appealed provide the final step of the process for an applicant. Upon denial of the appeal the applicant’s file will be documented as denied. An overturned denial for admission starts the admission process again, including medical or psychological assessments and placement on waiting list or admission to the Veterans Home. This
section is necessary as it allows the Veterans Home to deny an applicant as soon as it obtains information suggesting that an applicant is inappropriate for admission. Evaluation of Inconsistency/Incompatibility with Existing State Regulations: After conducting an evaluation for any regulations related to this area, CalVet has found that this proposed regulation is not inconsistent or incompatible with existing regulations. Benefits of the Proposed Regulation: The proposed changes to CCR
Section 505.2 Eligibility Determination will clarify eligibility determination and admissions criteria for applicants to the California Veterans Homes, and add necessary clarity to the existing regulations. This regulation helps ensure a fair and equitable admissions process by defining in greater detail the eligibility requirements and admission criteria of the eight California Veterans Homes. This action removes ambiguity and clarifies eligibility determination and admission criteria that are missing from MVC 1012.
The proposal offers an explanation of CalVet’s eligibility determination and admission criteria to achieve an application process that is unambiguous and uniformly interpreted. To carry out the admissions process, CalVet classifies applicants on the basis of their initial level of self–sufficiency, a process that is rationally related to the goal of providing life–long care to as large a group as possible, given limited resources and a huge population of potentially eligible California veterans.
Each Veterans Home must provide for the health and safety of members as required by applicable state and federal licensing agencies that regulate facilities by levels of care including, but not limited to USDVA, the United States Centers for Medicare and Medicaid Services, the California Department of Public Health, and / or the California Department of Social Services. Services and programs may be available at one Veterans Home, but not at another.
These may include speech therapy, respiratory therapy, occupational therapy, physical therapy, in–house audiology services, medication assistance, memory care, skilled nursing care, fully independent living, or other programs. Additionally, each Veterans Home has unique buildings, room accommodations and storage space, electrical systems, therapeutic services, recreational amenities, and grounds.
There may be space at one Veterans Home for a member’s vehicle, mobility device, or furniture which may not be available at another site due to differences in the layout, electrical outlets, walkway and hallway widths, and fire marshal allowances. Some sites have private bedrooms or baths; other sites may have semi–private bedrooms and bathrooms or shared bathrooms.
The regulation seeks to ensure that Veterans Home members continue to reside in a safe and secure environment by providing for the exclusion of prospective members whose history indicates they may not be adaptable to the Veterans Home environment or might jeopardize the safety and security of members. DISCLOSURES REGARDING THE PROPOSED ACTION CalVet has made the following initial determinations: Mandate on local agencies and school districts: None. Cost or savings to any state agency: None.
Cost to any local agency or school district which must be reimbursed in accordance with Government Code Sections 17500 through 17630: None. Other nondiscretionary cost or savings imposed on local agencies: None. Cost or savings in federal funding to the state: None.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 935 Cost impacts on a representative private person or businesses: CalVet is not aware of any cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action. Significant, statewide adverse economic impact directly affecting business, including the ability of California businesses to compete with businesses in other states: None. Significant effect on housing costs: None.
RESULTS OF ECONOMIC IMPACT ASSESSMENT/ANALYSIS CalVet does not anticipate that there will be significant impacts on the public, private persons, or business due to the proposed regulation. CalVet does not anticipate that there will be an expansion of existing business in California. No jobs will be created; none will be eliminated. No new businesses will be created; no existing businesses will be eliminated. CalVet anticipates that the regulation will benefit the health and welfare of members, employees, and visitors of the Veterans Homes of California.
The regulation seeks to ensure that Veterans Home members continue to reside in a safe and secure environment by providing for the exclusion of prospective members whose history indicates they may not be adaptable to the Veterans Home environment or might jeopardize the safety and security of members. CalVet has not identified any benefits in the areas of the state’s environment. The reason no benefits were identified it that the regulation does not address the state’s environment. BENEFITS OF PROPOSED ACTION The proposed changes to CCR
Section 505.2 Eligibility Determination will clarify the basic eligibility determination and admission criteria for applicants to the California Veterans Homes. SMALL BUSINESS DETERMINATION CalVet has determined that the proposed regulation will not affect small business. This proposed regulation does not apply to small business in any manner; it simply clarifies the basic eligibility determination and admission criteria for applicants to the California Veterans Homes. BUSINESS REPORT The proposed regulation does not require a business report.
CONSIDERATION OF ALTERNATIVES CalVet must determine that no reasonable alternative it considered or that has otherwise been identified and brought to its attention would 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 proposed action, or would be more cost–effective to affected private persons and equally effective in implementing the statutory policy or other provision of law. The proposed changes are necessary to provide clarity to the existing regulation language.
CONTACT PERSON Inquiries concerning the proposed administrative action may be directed to: Phil McAllister, Regulatory Actions Coordinator California Department of Veterans Affairs 1227 O Street, Suite 500 Sacramento, California 95814 Telephone: (916) 653–1961 Fax: (916) 653–2456 Email: phil.mcallister@calvet.ca.gov Thomas Martin California Department of Veterans Affairs 1227 O Street, Suite 500 Sacramento, California 95814 Telephone: (916) 503–8035 Email: thomas.martin@calvet.ca.gov Please direct requests for copies of the proposed text (the “express terms”) of the regulations, the initial statement of reasons, the modified text of the regulations, if any, or other information upon which the rulemaking is based to Phil McAllister at the above address.
A VAILABILITY OF STATEMENT OF REASONS, TEXT OF PROPOSED REGULATIONS, AND RULEMAKING FILE CalVet will make the entire rulemaking file available for inspection and copying throughout the rulemaking process at its office at the above address. As of the date this notice is published in the Notice Register, the rulemaking file consists of this notice, the proposed text of the regulations, the initial statement of reasons, the text of these proposed regulations and relevant state and federal law. Copies may be obtained by contacting Phil McAllister at the address or phone number listed above.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 936 AVAILABILITY OF CHANGED OR MODIFIED TEXT After holding the hearing and considering all timely and relevant comments received, CalVet may adopt the proposed regulations substantially as described in this notice. If CalVet makes modifications which are sufficiently related to the originally proposed text, it will make the modified text (with the changes clearly indicated) available to the public for at least 15 days before CalVet adopts the regulations as revised.
Please send requests for copies of any modified regulations to the attention of Phil McAllister at the address indicated above. CalVet will accept written comments on the modified regulations for 15 days after the date on which they are made available. A VAILABILITY OF THE FINAL STATEMENT OF REASONS Upon its completion, copies of the Final Statement of Reasons may be obtained by contacting Phil McAllister at the above address.
A V AILABILITY OF DOCUMENTS ON THE INTERNET Copies of the Notice of Proposed Action, the Initial Statement of Reasons, and the text of the regulations in underline and strikeout can be accessed through our website at https://www.calvet.ca.gov/about–us/ laws–regulations. TITLE 16. BOARD OF PHARMACY AMEND
SECTION 1709 TO ADD TRUSTS TO THE TYPES OF ENTITIES THAT CAN OWN, MANAGE AND/OR CONTROL A PHARMACY NOTICE IS HEREBY GIVEN that the California State Board of Pharmacy (board) proposes taking the rulemaking action described below. Any person interested may present statements or arguments relevant to the action proposed in writing. Written 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 no later than September 7, 2021. The board has not scheduled a public hearing on this proposed action.
The board will, however, hold a hearing if it receives a written request for a public hearing from any interested person, or the interested person’s authorized representative, no later than 15 days prior to the close of the written comment period. The board may, after considering all timely and relevant comments, adopt the proposed regulations substantially as described in this Notice, or may modify the proposed regulations if such modifications are sufficiently related to the original text.
With the exception of non–substantive 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 Person 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:
Section 4005 of the Business and Professions Code (BPC) authorizes the board to adopt these regulations. The proposed regulations implement, interpret, and make specific BPC sections 4035, 4058, 4101, 4110, 4111, 4112, 4113, 4120, 4130, 4131, 4201, 4207, 4302, 4305, 4307, 4308, and 4330. Goals and objectives of the proposed regulations: The board proposes to amend California Code of Regulations (CCR), title 16,
section 1709, to reflect statutory changes regarding ownership structures for pharmacies and other business entities, including as they relate to trust ownership of a pharmacy.
Summary of existing law and regulatory changes to be made: The board tracks the beneficial interest of business owners, whether the owners are a natural person or an entity. Previously, pharmacy law did not recognize a “trust” as a “person” to whom the board was authorized to issue a license. This prevented the board from issuing a license, usually pharmacies, when the ownership structure included a trust. Senate Bill (SB) 1193 (Hill,
Chapter 484, Statutes of 2016) amended, among other things, BPC Sections 4035 and 4201 to make the following changes: ● BPC
section 4035 — Added “trust” to the definition of “person;” and ● BPC
section 4201 — Added requirements to disclose information of any person with management or control over the license to the Board. This proposal will make the board’s regulation text at
section 1709 more specific with respect to the statutory changes made as a result of SB 1193. Specifically, the proposal would: ● Change the term “permit” to “license”; ● Specify that a license shall not be transferred from one owner to another without written notification to the board; ● Specify the reporting time frame as required by BPC
section 4201; and ● Identify the board’s ability to issue a license to an entity controlled by a trust and specify
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 937 the requirements for disclosure and notice to the board, including identifying who must be identified (by role), when disclosure or notice is required, what information is required, and how notification is to be provided. INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW The board proposes clarifying and making specific the disclosure and notice standards for applicants and licensees relating to ownership, management, and control of pharmacies and other business entities licensed by the board.
Existing pharmacy law specifies that protection of the public is the highest priority for the board in exercising 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. Additionally, existing law establishes which businesses, in the pharmacy industry, must be licensed, and to whom the board is authorized to issue a license and to whom it cannot issue a license.
Existing law provides the notification requirements when a change in ownership of the license takes place. The existing regulation explains when notice is required and when a new application for a license is required. Pharmacy law requires owners and other individuals, with management and control over a license issued by the board, to meet certain criteria to hold the license or the position, respectively.
To fulfill its regulatory functions, the board monitors the persons who have a beneficial interest in, as well as the management and control over, pharmacies and other business entities, whether the persons are a natural person or an entity. Previously, pharmacy law did not recognize a “trust” as a person to whom the board was authorized to issue a license. This prevented the board from issuing a license to a pharmacy, or other business entity, when the ownership structure included a trust.
This proposal will modify requirements relating to the ownership of, and the management control over, pharmacies and other business entities regulated by the board. It will, primarily, implement the statutory changes made by SB 1193, by specifying what information businesses, that are beneficially owned by a trust, must disclose upon application for a license and when any such ownership changes. ANTICIPATED BENEFITS OF PROPOSAL This proposal is necessary to implement the new statutory requirements enacted in SB 1193.
These changes will help ensure that the board is able to monitor the beneficial ownership of a pharmacy, or other regulated business entity under its supervision, when it is owned by a trust, and help ensure that previously disciplined owners or prohibited forms of ownership (i.e. prescriber ownership) are not occurring. It will also provide clarity to applicants and licensees about what, when and how they must disclose ownership interests, thus increasing transparency in the board’s regulatory functions.
Ultimately, it will protect the public by prohibiting individuals or entities, who are not qualified from operating a pharmacy or other regulated business entity, and by preventing hidden ownership. 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 incompatible, 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: The proposed regulations do not result in a fiscal impact to the state. The Board has been providing licensure to trust–ownership business entities under current law since 2017. This proposal aligns the Board’s regulations with existing practice, as authorized under current law.
The Board typically receives and process approximately 30 to 35 license applications from trust– owned business entities per year and currently has approximately 100 licensed trust–owned pharmacies. Because the regulations implement the Board’s current policies and procedures related to issuing a license and regulating a trust–owned pharmacy consistent with existing statutory authority, no fiscal impact is anticipated. Nondiscretionary Costs/Savings to Local Agencies: None. Local Mandate: None.
Cost to Any Local Agency or School District for Which Government Code (GC) Sections 17500 – 17630 Require Reimbursement: None. Business Impact: The board has made an initial determination that the proposed regulatory action will have no significant statewide adverse economic impact directly affecting businesses and/or employees, including the ability of California businesses to complete with businesses in other states. This determination is based on the absence of testimony to that effect, during the development of
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 938 the proposed regulation, which occurred over several months. Additionally, while the proposed regulation requires the disclosure of additional information, by the applicant and/or licensee, the proposed regulation clarifies existing licensing standards and specifies what and when information must be disclosed and reported to the board. Cost Impact on Representative Private Person or Business: The regulations do not result in an economic im - pact to the state.
Because the Board currently provides licensure to these entities under current law no addi - tional costs are anticipated. The Board notes applicants for a new business li - cense currently incur nominal additional costs to make copies of the trust documents and the time to report the additional information on the application documents. Additionally, for existing business licensees who wish to transfer business ownership into a trust, the estimated cost, to the business, will be determined by the ownership structure of the existing licensee and the ownership, management and control within the trust.
If the existing licensee ownership and the owner - ship, management and control within the trust are identical, the cost to the business entity to report the changes and update the licensee ownership, manage - ment and control, with the trust, would be $130 [BPC
section 4400(o)] for a change of permit, plus the cost of paper and time to complete the application. Note: A change of permit is the process of updat - ing the ownership or officer structure of an existing license, when a change of ownership has not occurred. If the ownership and/or management and control structure, within the trust, is different than the exist - ing licensee ownership, the cost to the business entity to report the changes and update the licensee owner - ship, management, and control, within the trust, would vary according to BPC
section 4400 and 16 CCR 1749, based on the license type for a new license, as these changes would alter the ownership of the existing li - cense. BPC
section 4201 (f)–(
h) specifies that a license is non–transferable, so a new license must be issued if the ownership is changed. However, because business entities currently incur these costs and because the proposed regulations do not result in additional costs, the board is not aware of any cost impacts that a representative private per - son or business would necessarily incur in reasonable compliance with the proposed action. Effect on Housing Costs: None. BUSINESS REPORT The proposed action will require a business to make a report under certain circumstances.
The board has made a preliminary finding that the reports are necessary for the health, safety, or welfare of the people of the state that the regulation apply to businesses. EFFECT ON SMALL BUSINESS The board does not have, nor maintain, data to define if any of its licensees (pharmacies or other licensed entities) are a “small business,” as defined in GC
section 11342.610. While the board is unable to determine if any of its licensees are considered a small business, based on its experience in dealing with applicants and licensees for pharmacy or other related business licenses, the board determined that this regulatory proposal is more likely to affect a small business, as a small business is more likely to have an ownership structure that includes a trust. The board, however, made an initial determination that the proposed regulatory action will not have a significant adverse impact directly affecting small businesses.
While the proposed regulation requires the disclosure of additional information, by the applicant and/or licensee, the proposed regulation clarifies existing licensing standards and specifies the information that must be disclosed, at the time of application, and when the information must be reported to the board. RESULTS OF ECONOMIC IMPACT ASSESSMENT/ANALYSIS Impact on Jobs/New Businesses: The board concludes that it is:
(1) Unlikely that the proposal will create or eliminate any jobs within California;
(2) Unlikely that the proposal will create new, or eliminate existing, businesses in California; and/ or
(3) Unlikely that the proposal will expand businesses currently doing business within the state. Benefits of Regulation: This regulatory proposal benefits the health and welfare of California residents. The proposed regulation implements SB 1193, which gave the board authority to issue licenses to entities owned by trusts. The proposed regulation will make it less likely that prohibited forms of ownership, management, and/ or control (i.e. prescriber Owned, control by those previously disciplined) will occur. This will provide increased protection to the residents of California by
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 939 making it less likely that prohibited individuals are able to obtain ownership, management and/or control over a licensee distributing dangerous drugs and devices within California, which could impact patient and public safety. Finally, the proposed regulation increases transparency and clarifies the application process with respect to the disclosure requirements relating to ownership, management and control of an entity licensed by the board. The regulatory proposal is not anticipated to benefit worker safety or the state’s environment.
CONSIDERATION OF ALTERNATIVES The board must determine that no reasonable alternative, which 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 proposal described in this Notice, or would be more cost effective to affected private persons and equally effective in implementing the statutory policy or other provision of law.
Any interested person may present statements or arguments, 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 Statement of Reasons for the proposed action and has made available all the information upon which the proposal is based.
TEXT OF PROPOSAL Copies of the exact language of the proposed regulations, any document incorporated by reference therein, the Initial Statement of Reasons, and all of the information upon which the present proposal is based, may be obtained upon request from the Board of Pharmacy, at 2720 Gateway Oaks Dr., Suite 100, Sacramento, California 95833, or from the Board of Pharmacy’s website at the web address noted below.
AVAILABILITY AND LOCATION OF THE FINAL STATEMENT OF REASONS AND RULEMAKING FILE All the information upon which the proposed regulations are based is contained in the rulemaking file, which is available for public inspection by contacting the person named below. You may obtain a copy of the Final Statement of Reasons, once it has been prepared, by making a written request to the contact person, named below, or by accessing the website listed below.
CONTACT PERSON Inquiries or comments concerning the proposed rulemaking action may be addressed to: Name: Lori Martinez Address: 2720 Gateway Oaks Drive Suite 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 Suite 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: https://www.pharmacy. ca.gov/laws_regs/pending_regs.shtml.
TITLE 27. OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 PROPOSITION 65 PROPOSED AMENDMENT TO
ARTICLE 6 CLEAR AND REASONABLE WARNINGS WARNINGS FOR EXPOSURES TO GLYPHOSATE FROM CONSUMER PRODUCTS NEW SECTIONS 25607.48 AND 25607.49 NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to amend certain sections of
Article 6 of Title
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 940 27 of the California Code of Regulations. 1 OEHHA is proposing to adopt a new safe harbor warning regulation to address the content of warnings for exposure to glyphosate in consumer products. This proposed rulemaking would add Sections 25607.48 and 25607.49 to the Title 27,
Article 6 Clear and Reasonable Warnings regulations. The proposed regulations would provide safe harbor guidance for businesses that cause consumer product exposures to glyphosate that require warning. PUBLIC PROCEEDINGS Written Comment Period Any written comments concerning this proposed regulatory action, regardless of the form or method of transmission, must be received by OEHHA no later than September 7, 2021, the designated close of the 45–day written comment period required under the Administrative Procedure Act.
All written comments will be posted on the OEHHA website at the close of the public comment period. OEHHA recommends that the public submit written information electronically, rather than in paper form. Comments may be submitted electronically through our website at https://oehha.ca.gov/comments. Comments submitted in paper form can be mailed or delivered in person to the address below.
OEHHA encourages all commenters to submit their comments in a format compliant with the accessibility requirements of the Americans with Disabilities Act, so that they can be read using screen reader technology and those with visual impairments are able to listen to them. All non–electronic submissions should be directed to: Monet Vela Office of Environmental Health Hazard A ssessment 1001 I Street, 23rd Floor P.O. Box 4010 Sacramento, California 95812–4010 Telephone: 916–323–2517 OEHHA is subject to the California Public Records Act and other laws that require the release of certain information upon request.
If you provide comments, please be aware that your name, address, and e–mail may be available to third parties. Public Hearing A public hearing on this proposed regulatory amendment will only be scheduled upon request. The hearing may be web–based due to the COVID–19 emergency 2. To request a hearing, send an e–mail 1 A ll further references are to sections of Title 27, Cal. Code of Regs., unless indicated otherwise. 2 E xecutive Orders N–25–20 and N–29–20. to Monet Vela at monet.vela@oehha.ca.gov or to the address listed above.
The request must be received no later than August 23, 2021, which is 15 days prior to the close of the comment period. If a hearing is scheduled, OEHHA will e–mail a notice of the hearing to the requester and interested parties, and the notice will be posted on OEHHA ’s website at least ten days before the public hearing date. The notice will provide the date, time, and information for accessing the hearing. CONTACT Please direct inquiries concerning the proposed regulatory action described in this notice to Monet Vela at (916) 323–2517, or by e–mail to monet.vela@ oehha.ca.gov.
Mario Fernandez is the back–up contact person for inquiries concerning processing of this action and is available at (916) 323–2635 or mario. fernandez@oehha.ca.gov. AUTHORITY Health and Safety Code
section 25249.12. REFERENCE Health and Safety Code sections 25249.6, 25249.7 and 25249.11(f). INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW OEHHA is the lead agency that implements Proposition 65 3 and has the authority to promulgate and amend regulations to further the purposes of the Act.
The Act requires businesses to provide a clear and reasonable warning before they cause an exposure to a chemical listed as known to the state to cause cancer or reproductive toxicity. 4 The Act also prohibits the discharge of listed chemicals to sources of drinking water. 5 The new regulation would further the “right–to–know” purposes of the Act and provide warning language tailored for exposures to glyphosate that exceed its NSRL.
The content and methods provided in the proposed regulation are deemed “clear and reasonable” by the lead agency for purposes of the Act. 6 The proposed warning content is 3 H ealth and Safety Code
section 25249.5 et seq., The Safe Drink - ing Water and Toxic Enforcement Act of 1986, commonly known as “Proposition 65.” Hereafter referred to as “Proposition 65” or “the Act.” 4 H ealth and Safety Code
section 25249.6. 5 H ealth and Safety Code
section 25249.5. 6 O EHHA is aware that a permanent injunction against the en - forcement of the warning requirement for glyphosate exposures was entered by the Federal District Court; however, that case is on appeal and in any event does not prohibit businesses from pro - viding a warning.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 941 also intended to provide balanced and understandable information to individuals who may be exposed to glyphosate. This proposed rulemaking would add Sections 25607.48 and 25607.49 to the Title 27,
Article 6 Clear and Reasonable Warning regulations. The proposed regulations would provide safe harbor guidance for businesses that cause consumer product exposures to glyphosate that require a warning. The new regulation would further the “right–to–know” purposes of the Act and provide warning language tailored for these exposures. Businesses who choose to provide the safe harbor warning language for such exposures would comply with the Act, because the content and methods provided in the regulation are deemed “clear and reasonable” by the lead agency for purposes of the Act.
The warning content is intended to provide balanced and understandable information to individuals who may be exposed to glyphosate at levels requiring warning. SPECIFIC BENEFITS OF THE PROPOSED REGULATIONS The proposed regulatory action will facilitate businesses’ compliance with the Act by providing clarifying guidance concerning the provision of safe harbor warnings under Proposition 65. The health and welfare of California residents will likely benefit by increasing the public’s ability to understand the warnings they receive for certain consumer products containing glyphosate they may choose to purchase.
NO INCONSISTENCY OR INCOMPATIBILITY WITH EXISTING REGULATIONS OEHHA has conducted an evaluation and has determined that
Article 6 is the only regulation concerning Proposition 65 warnings. Therefore, the proposed regulatory action is neither inconsistent nor incompatible with any other existing state regulations. The action does not change the existing mandatory requirements on businesses subject to Proposition 65, or state or local agencies and does not address compliance with any other law or regulation. LOCAL MANDATE/FISCAL IMPACT Because Proposition 65 by its terms 7 does not apply to local agencies or school districts, OEHHA has determined the proposed regulatory action would not impose a mandate on local agencies or school districts; nor does it require reimbursement by the State pursuant to
Part 7 (commencing with
Section 17500) of Division 4 of the Government Code. OEHHA has also determined that no nondiscretionary costs or 7 S ee Health and Safety Code
section 25249.11(b). savings to local agencies or school districts will result from the proposed regulatory action, nor will there be any costs or savings to the state or in federal funding to the state because of the proposed regulatory action. EFFECT ON HOUSING COSTS OEHHA has initially determined that the proposed regulatory action will have no effect on housing costs because it does not impose any new mandatory requirements on any business.
SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE The proposed regulatory action provides compliance assistance to businesses subject to the Act by providing guidance on the method of transmitting and the content of safe harbor warnings for consumer product exposures to glyphosate that exceed its NSRL.
OEHHA has therefore made an initial determination that the adoption of this action will not have a significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states. RESULTS OF ECONOMIC IMPACT ANALYSIS (Gov. Code
section 11346.3(b)) Creation or Elimination of Jobs Within the State of California The proposed regulatory action will not impact the creation or elimination of jobs within California. The action provides specific guidance by adding methods of transmitting and the content of safe harbor warnings for consumer product exposures to glyphosate that exceed its NSRL. Creation of New Businesses or Elimination of Existing Businesses Within the State of California The proposed regulatory action will not impact the creation of new businesses or the elimination of existing businesses within California.
The action provides specific guidance by adding methods of transmitting and the content of safe harbor warnings for consumer product exposures to glyphosate that exceed its NSRL. The Expansion of Businesses Currently Doing Business Within the State OEHHA does not anticipate any major impact on the expansion of businesses currently doing business within the state. The action provides specific guidance by adding methods of transmitting and the content of
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 942 safe harbor warnings for consumer product exposures to glyphosate that exceed its NSRL. BENEFITS OF THE PROPOSED REGULATION Affected businesses will likely benefit from the proposed regulatory action because the amendments provide guidance concerning safe harbor warnings for high dose exposures to glyphosate.
The proposed regulatory action will benefit worker safety, the state’s environment, and the health and welfare of California residents by providing more meaningful information and increasing the public’s understanding of the potential risk posed by exposures to glyphosate. COST IMPACTS ON REPRESENTATIVE PERSON OR BUSINESS OEHHA is not aware of any cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed regulatory action. The action does not impose any new requirements upon private persons or businesses.
EFFECT ON SMALL BUSINESSES The proposed regulatory action will not adversely impact very small businesses because Proposition 65 is limited by its terms to businesses with 10 or more employees. 8 REASONABLE ALTERNATIVES TO THE REGULATION AND THE AGENCY’S REASONS FOR REJECTING THOSE ALTERNATIVES Pursuant to Government Code
section 11346.5(a)(13), OEHHA must determine that no reasonable alternative considered by OEHHA, or that has otherwise been identified and brought to the attention of OEHHA, would be more effective in carrying out the purpose for which Proposition 65 is proposed, would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost–effective to affected private persons and equally effective in implementing the statutory policy or other provision of law. A VAILABILITY OF STATEMENT OF REASONS AND TEXT OF PROPOSED REGULATIONS OEHHA has prepared and has available for public review an Initial Statement of Reasons for the 8 H ealth and Safety Code
section 25249.11(b). proposed regulation, all the information upon which the regulation is based, and the text of the proposed regulation. These documents are available on OEHHA ’s website at www.oehha.ca.gov. AVAILABILITY OF CHANGED OR MODIFIED TEXT The full text of any proposed regulation that is changed or modified from the express terms of this proposed action will be made available at least 15 days prior to the date on which OEHHA adopts the resulting regulation.
Notice of the comment period on the revised proposed regulation and the full text will be mailed to individuals who testified or submitted oral or written comments at the public hearing, whose comments were received by OEHHA during the public comment period, and anyone who requests notification from OEHHA of the availability of such change. Copies of the notice and the changed regulation will also be available on the OEHHA web site at www.oehha.ca.gov.
A VAILABILITY OF THE FINAL STATEMENT OF REASONS A copy of the Final Statement of Reasons may be obtained, when it becomes available, from Monet Vela at the e–mail or telephone number indicated above. The Final Statement of Reasons will also be available on OEHHA ’s website at www.oehha.ca.gov. TITLE 28. D EPARTMENT OF MANAGED HEALTH CARE ADOPTION OF
SECTION 1300.63.4 IN TITLE 28 OF THE CALIFORNIA CODE OF REGULATIONS (CCR), “SUMMARY OF DENTAL BENEFITS AND COVERAGE DISCLOSURE MATRIX”; CONTROL NO. 2020–DEN. Notice is hereby given that the Director of the Department of Managed Health Care (Department or DMHC) proposes to make final the emergency regulations under the Knox–Keene Health Care Service Plan Act of 1975 (Knox–Keene Act), Title 28, California Code of Regulations (CCR),
section 1300.64.4. This regulation was adopted on December 29, 2020 as an Emergency File and Print regulation, became effective January 25, 2021, and remains
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 943 in effect until September 25, 2021. 1 Amendments proposed to the previous text and incorporated documents are noted in underline and strikeout. The Department is incorporating by reference the File and Print emergency filing, File No: 2021–0115–01EFP. Before undertaking this action, the Director of the Department will conduct written public proceedings, during which time any interested person, or such person’s duly authorized representative, may present statements, arguments, or contentions relevant to the action described in this notice.
PUBLIC HEARING No public hearing is scheduled. Any interested person or his or her duly authorized representative, may submit a written request for a public hearing pursuant to Government Code
section 11346.8(a). The written request for a hearing must be received by the Department’s contact person, designated below, no later than 15 days before the close of the written comment period. WRITTEN COMMENT PERIOD Any interested person, or his or her authorized representative, may submit written statements, arguments, or contentions (hereafter referred to as comments) relating to the proposed regulatory action by the Department. Comments must be received by the Department, Office of Legal Services, by September 8, 2021, which is hereby designated as the close of the written comment period.
Please address all comments to the Department’s Office of Legal Services, Attention: Pamela Stone, Attorney III. Comments may be transmitted by regular mail, fax, email, or via the Department’s website: Website: http://www.dmhc.ca.gov/LawsRegulations. aspx#open Email: regulations@dmhc.ca.gov Mail: D epartment of Managed Health Care O ffice of Legal Services A ttn: Pamela Stone, Attorney III 98 0 9th Street, Suite 500 S acramento, CA 95814 Fax: ( 916) 322–3968 Please note: If comments are sent via the website, email, or fax, there is no need to send the same comments by mail delivery.
All comments, including those submitted via the website, email, fax, or mail, 1 T he Office of Administrative Law (OAL) approval of the emer - gency regulations provides that they remain in effect only until September 25, 2021. Nevertheless, Government Code
section 11346.1(
h) permits the Department to seek OAL approval of two separate readoptions of the regulations, each for a period of no more than 90 days. should include the author’s name and a U.S. Postal Service mailing address so the Department may provide commenters with notice of any additional proposed changes to the regulation text. Please identify the action by using the Department’s rulemaking title and control number,
Summary of Dental Benefits and Coverage Disclosure Matrix: Proposed Adoption of
Section 1300.63.4 in Title 28 of the California Code of Regulations (CCR). Control No. 2020–DEN, in any of the above inquiries.
CONTACTS Inquiries concerning the proposed adoption of these regulations may be directed to: Pamela Stone Attorney III Department of Managed Health Care Office of Legal Services 980 9 th Street, Suite 500 Sacramento, CA 95814 (916) 414–0794 fax (916) 322–3968 fax Pamela.Stone@dmhc.ca.gov OR Kim Bollenbach Regulations Coordinator Department of Managed Health Care Office of Legal Services 980 9 th Street, Suite 500 Sacramento, CA 95814 (916) 414–0794 (916) 322–3968 Kim.Bollenbach@dmhc.ca.gov A VAILABILITY OF INITIAL STATEMENT OF REASONS, TEXT OF PROPOSED REGULATIONS, AND RULEMAKING FILE The Department has prepared and has available for inspection and copying the Initial Statement of Rea - sons, text of the proposed regulation, and all infor - mation upon which the proposed regulation is based (rulemaking file).
This information is available upon request to the Department of Managed Health Care, Office of Legal Services, 980 9 th Street, Sacramento, CA 95814, Attention: Regulations Coordinator. AVAILABILITY OF CHANGED OR MODIFIED TEXT After considering all timely and relevant comments received, the Department may adopt the proposed
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 944 regulations substantially as described in this notice. If the Department makes modifications that are sufficiently related to the originally proposed text, it will make the modified text (with the changes clearly indicated) available to the public. The full text of any modified regulation, unless the modification is only non–substantial or solely grammatical in nature, will be made available to the public at least 15 days before the date the Department adopts the regulation. A request for a copy of any modified regulation(
s) must be addressed to the Regulations Coordinator. The Director will accept comments via the Department’s website, mail, fax, or email on the modified regulation(
s) for 15 days after the date on which they are made available. A VAILABILITY OF THE FINAL STATEMENT OF REASONS You may obtain a copy of the Final Statement of Reasons once it has been prepared by contacting the Regulations Coordinator named above. A V AILABILITY OF DOCUMENTS ON THE INTERNET The Notice of Proposed Rulemaking Action, the proposed text of the regulation, including documents incorporated by reference, and the Initial Statement of Reasons are also available on the Department’s website at http://www.dmhc.ca.gov/LawsRegulations. aspx#open. AUTHORITY AND REFERENCE Health and Safety Code
section 1344 grants the Director authority to adopt, amend, and rescind regulations as necessary to carry out the provisions of the Knox–Keene Act, including rules governing applications and reports, and defining any terms as are necessary to carry out the provisions of the Knox– Keene Act. Health and Safety Code
section 1363.04 provides authority for the regulations. The regulations implement, interpret and make specific Health and Safety Code
section 1363.04. The Department proposes to adopt the emergency regulation as final with changes as described below. INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW
Summary of Existing Laws and Regulations Health and Safety Code (HSC)
section 1341, subdivision (a), authorizes the Department to regulate health plans. Pursuant to HSC
section 1341.9, the Department is vested with all duties, powers, purposes, responsibilities, and jurisdiction as they pertain to health care service plans and the health care service plan business. HSC
section 1349 provides that any person that engages in business as a health care service plan must be licensed by the director of the Department. HSC
section 1345, subdivision (f)(1), defines a “health care service plan” or “specialized health care service plan” as “any person who undertakes to arrange for the provision of health care services to subscribers or enrollees, or to pay for or to reimburse any part of the cost of those services in return for a prepaid or periodic charge paid by or on behalf of subscribers or enrollees.” HSC
section 1345, subdivision (
o) defines a “specialized health care service plan contract” as “a contract for health care services in a single specialized area of health care, including dental care ….” HSC
section 1344 authorizes the director to adopt rules to carry out
chapter 2.2, division 2, HSC, known as the Knox–Keene Health Care Service Plan Act of 1975. HSC
section 1363.04 provides in part: “a health care service plan that issues, sells, renews, or offers a contract that covers dental services in this state, in addition to any other applicable disclosure requirements, shall utilize a uniform benefits and coverage disclosure matrix, which shall be developed by the department, in conjunction with the Department of Insurance, and in consultation with stakeholders.” HSC
section 1363.04 also describes the minimum contents of the matrix and outlines requirements for use and distribution of the matrix. In addition, the law authorized Department’s adoption of emergency regulations to implement
section 1363.04. The Department proposes to adopt the emergency regulation as final with some changes as described below. The proposed regulation adopts the emergency regulation and does the following: Revises the regulation text,
section 1300.63.4 as follows: ● Amend subdivision (a)(1) by establishing the compliance date of on or after January 1, 2022; ● Amend subdivision (b)(1) to correct a typographical error in a cross–referenced citation; ● Amend subdivision (
c) to correct an error in the subject of the regulation; ● Amend subdivision (c) (1) to revise the dates of the two incorporated documents,
Summary of Dental Benefits and Coverage Disclosure Matrix, and the Instruction Guide for
Summary of Dental Benefits and Coverage Disclosure Matrix; ● Amend subdivision (c)(3) to specify the date by which health care service plans and specialized health care service plans must affirm to the Department compliance with the proposed regulation;
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 945 ● Amend subdivision (d)(1)(E)3. by making a nonsubstantive grammatical change; ● Amend subdivision (d)(1)(E)3.d. to replace a reference to the group with a reference to the enrollee; ● Amend subdivision (d)(2)(
B) to insert a word that was inadvertently omitted; ● Amend subdivision (d)(2)(D)3. by making a nonsubstantive, grammatical change; ● Amend subdivision (d)(2)(D)3.c. for consistency with a previous reference to federal and state law in the text; ● Amend subdivision (d)(3)(E)3. to clarify the group contractholder’s required website delivery method of the SDBC; and ● Amend subdivision (
j) to insert a reference to the code in which the
section of law is found. Modifies the two incorporated documents, the Instruction Guide and SDBC, by revising the dates of the documents. Revises the Instruction Guide for
Summary of Dental Benefits and Coverage Disclosure Matrix as follows: ● Amend
Part II to clarify the information to be included in the
Summary of Dental Benefits and Coverage Disclosure Matrix; ● Amend
Part III to add a fourth option, which is to enter a dollar amount; and ● Amend
Part V to revise the description of three of the listed dental services. Revises the SDBC as follows: ● Remove the Department logo; remove the identifying information from the header and substitute a footnote with identifying information; ● Amend
Part III to clarify the information to be included and to add an option to enter a dollar amount; ● Amend
Part V to revise the description of two of the listed dental procedures; ● Amend
Part VI to revise the dollar amounts in the Coverage Example, Total Cost of Care; and ● Amend
Part VI to add an option to enter a dollar amount for the maximum out–of–network cost. Purpose of the Proposed Regulations The purpose of this rulemaking action is to implement, clarify and make specific Health and Safety Code
section 1363.04. A major component of the proposed regulation is the incorporation by reference of two documents: the “Summary of Dental Benefits and Coverage Disclosure Matrix” (SDBC) and “Instruction Guide of
Summary of Dental Benefits and Coverage Disclosure Matrix” (Instruction Guide), which consists of directions for plans to follow when filling out the SDBC. The purpose and necessity of each proposed provision is detailed in the Initial Statement of Reasons for this rulemaking package. Anticipated Benefits of the Proposed Regulations: The text of the regulation clarifies the requirements of the statute by identifying who must provide the SDBC, to whom it must be provided, and methods for delivering the SDBC. As noted above, the text also incorporates two documents by reference: the SDBC and the Instruction Guide.
The Department anticipates that these regulations will benefit California residents and protect public health by ensuring that they have access to useful and comparable information regarding the extent of coverage and costs of dental services offered by various health plans and dental plans. The regulations serve an important purpose in increasing transparency in the area of dental plan coverage. The regulations serve to inform consumers of the relative costs and benefits of different dental plans.
The requirements of the regulations will allow prospective enrollees to compare coverage and costs among dental plans. The SDBC and the Instruction Guide are described in detail in the Initial Statement of Reasons document for this regulation package. Briefly, the SDBC is beneficial because it provides consumers an overall
summary of the benefits and coverage of the dental plan. The SDBC serves as a reference guide to benefits available, the limitations for those benefits, and the exclusions to those benefits in a short, easy to read format. The Instruction Guide is beneficial because it provides comprehensive instructions for the health plans and dental plans in completing the SDBC, thereby simplifying the plans’ task. Further, comprehensive instructions will ensure plans are uniformly filling out the SDBC.
The Department believes the adoption of these proposed regulations will have significant benefits for consumers in accessing appropriate dental health care services and will enable consumers to compare available dental benefits in the marketplace. Evaluation of consistency/compatibility with existing state regulations The DMHC has determined that these proposed regulations are not inconsistent or incompatible with existing state regulations.
After conducting a review for any regulations that would relate to or affect this area, the DMHC has concluded that the regulations at issue are the only regulations that concern disclosures by health plans regarding their coverage for dental services.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 946 FORMS INCORPORATED BY REFERENCE Pursuant to Title 1, California Code of Regulations,
section 20(c)(3), and as cited to in the proposed regulations, the DMHC is incorporating by reference the following:
Summary of Dental Benefits and Coverage Disclosure Matrix, DMHC 10–278, and the Instruction Guide for
Summary of Dental Benefits and Coverage Disclosure Matrix, DMHC 10–277. Both documents were also incorporated by reference in the emergency regulation, and both are proposed to be amended by this rulemaking. The SDBC and Instruction Guide are explained in detail in the Initial Statement of Reasons for this proposed regulation package. FEDERAL REGULATIONS OR STATUTES The DMHC has determined there are no existing comparable federal regulations or statutes.
OTHER MATTERS PRESCRIBED BY STATUTE There are no other requirements prescribed by statute that are applicable to the DMHC or to any specific regulation or class of regulations. DISCLOSURES REGARDING THE PROPOSED ACTION The Department has made the following initial determinations: ● Mandate on local agencies or school districts: None. ● Cost to Any Local Agency or School District Required to be Reimbursed under
Part 7 (commencing with
Section 17500) of Division 4 of the Government Code: None. ● Cost or Savings to any State Agency: None. ● Other non–discretionary cost or savings imposed upon local agencies: None. Costs or Savings in Federal Funding to the State: None. ● Effect on Housing Costs. None. ● Significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states. None. STATEMENT OF THE RESULTS OF THE ECONOMIC IMPACT ANALYSIS/ASSESSMENT Introduction The Department is mandated to promulgate this regulation pursuant to Senate Bill 1008 (Skinner, Stats. 2018, ch. 933, § 2). This bill added Health and Safety Code
section 1363.04 to the Knox–Keene Act and requires health care plans offering dental coverages that issue contracts covering dental benefits use a uniform benefits and coverage disclosure matrix to be developed by the Department. The statute further requires that the matrix represent a particular set of benefits and cost–sharing, to facilitate consumers understanding of dental benefits and to allow consumers to compare dental benefits available in the marketplace. The Affordable Care Act (ACA), under 45 Code of Federal Regulations (CFR)
section 147.200, requires health plans to provide a
Summary of Benefits and Coverage to consumers who are previewing health coverage and who are enrolled in health coverage. In adopting SB 1008, the California legislature intended to provide the same transparency for dental benefits as is currently offered in federal law for health benefits. One of the goals of the ACA is to increase insurance market competition by enabling consumers to more completely and accurately compare benefits. The ACA seeks to improve transparency and comparability in health benefits through the health insurance marketplace and consumer–friendly tools such as the standardized
summary of benefits and coverage. The standardized SDBC required under SB 1008 helps consumers make such comparisons between dental plan coverage regulated by the Department. All of the provisions within the proposed regulation are clarifying and making specific the requirements of Health and Safety Code
section 1363.04. Particularly, the proposed regulation provides health plans with the SDBC template, instructions on how to fill out the template, and describes when the SDBC is to be delivered to consumers and how it is to be delivered to consumers. The statute mandates the Department to develop the SDBC and the statute requires plans offering dental coverage to provide the template to consumers or enrollees at certain times and in certain circumstances. The Department clarifies delivery methods and delivery times in the proposed regulation.
There are no additional requirements for plans offering dental coverage beyond clarifying and making specific the statutory requirements. Health and dental plans subject to the statute may be required to undergo some costs related to updating computer systems, printing costs, or other costs associated with distributing the SDBC to consumers; however,
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 947 those costs are attributed to the requirement in the statute that health and dental plans provide SDBCs to enrollees and consumers. Therefore, the Department has made a determination that no additional workload to the Department or impacted health and dental plans exist that are specifically associated with the proposed regulation itself beyond what is required in the statute.
The Department has also concluded that any savings a plan may realize following implementation of the regulations would be due to the requirements of the statute, not the regulations. Creation or elimination of jobs within California As this regulation would impose no costs or savings to plans, it would not cause plans to create or eliminate jobs. This regulation is designed to help consumers and enrollees easily review and compare the different dental benefits available in the marketplace.
When choosing a dental plan, consumers weigh many options, including premium costs and benefits available under a particular dental plan product. Any decisions by consumers following implementation of the regulations that result in plans creating or eliminating jobs creation of new businesses or elimination of existing businesses would be due to the requirements of the statute, not the regulation. Accordingly, the Department has determined that no new jobs will be created or eliminated in the state of California as a result of the regulation.
Creation of new businesses or elimination of existing businesses within California This regulation is designed to assist health plans offering dental coverage and enrollees in determining their dental benefit coverage as well as to help consumers and enrollees easily review and compare the different dental benefits available in the marketplace. When choosing a dental plan, consumers weigh many options, including premium costs and benefits available under a particular dental plan product.
Any decisions by consumers following implementation of the regulation that result in creation of new businesses or elimination of existing businesses would be due to the requirements of the statute, not the regulation. Accordingly, the Department has determined the proposed regulation will neither create new businesses nor eliminate existing businesses in the State of California.
Expansion of businesses currently doing business within California This regulation is designed to assist health and dental plans and enrollees in determining their dental benefit coverage as well as to help the enrollees easily review and compare the different dental benefits. The health plan marketplace is competitive within California. When choosing a health plan, consumers weigh many options, including premium costs and benefits available under a particular dental plan product.
As noted above, any increase in jobs or shift of consumers from one plan to another following implementation of the regulation would be due to the dictates of the statute, not the regulation. Accordingly, the Department has determined the proposed regulation will not result in the expansion of businesses currently doing business within the State of California.
Benefits of the regulation to the health and welfare of California residents, worker safety, and the state’s environment: The proposed regulations benefit the health and welfare of California residents by ensuring that prospective and current enrollees in health care plans covering dental services are given the information needed to select a dental plan. Because the cost comparisons are thus made clear to consumers, they are more likely to select a plan that they can afford and that protects their dental health.
For additional benefit analysis, please see “Anticipated Benefits of the Proposed Regulation” found under the Informative Digest/Policy Statement Overview. There are no anticipated benefits to worker safety and the State’s environment by the proposed action. COST IMPACTS ON REPRESENTATIVE PERSON OR BUSINESS The Department is not aware of any cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action.
BUSINESS REPORTING REQUIREMENT The proposed regulation incorporates by reference the SDBC, which enables enrollees to understand and compare dental coverage available in the marketplace. The proposed regulation and SDBC are necessary for the health, safety, or welfare of the people of the state. SMALL BUSINESS DETERMINATION The Department has determined the regulation does not affect small businesses. Health care service plans are not considered a small business under Government Code
section 11342.610(
b) and (c). ALTERNATIVES CONSIDERED Pursuant to Government Code
section 11346.5(a)(13), the Department must determine that no reasonable alternative considered by the agency or that has otherwise been identified and brought to the attention of the agency (1) would be more effective in carrying out the purpose for which the action is
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 948 proposed, (2) would be as effective and less burdensome to affected private persons than the proposed action, (3) there are no anticipated benefits to worker safety and the State’s environment by the proposed action, or (4) would be more cost effective to affected private persons and equally effective in implementing the statutory policy or other provision of law.
The Department invites interested persons to present statements or arguments with respect to alternatives to the requirements of the proposed regulations during the written comment period.
GENERAL PUBLIC INTEREST DEPARTMENT OF FISH AND WILDLIFE CALIFORNIA ENDANGERED SPECIES ACT CONSISTENCY DETERMINATION NUMBER 2080R–2021–006–01 Project: P aynes Creek Bend Water Users Fish P assage Restoration Project Location: T ehama County Applicant: T rout Unlimited Background Trout Unlimited (Applicant), as represented by Benjamin Cook, proposes to restore fish passage and reduce fish mortality associated with a water diversion facility. The Bend Water Users (BWU) diversion dam has been identified as a barrier to fish passage, particularly during low flow periods.
The associated unscreened irrigation ditch is believed to contribute to fish mortality due to salmonids entering the ditch. The Paynes Creek Bend Water Users Fish Passage Restoration Project (Restoration Project) includes four primary components: (1) construct a new roughened rock ramp to provide fish passage over the dam; (2) install a new on–channel cone screen to prevent fish from entering the BWU diversion ditch; (3) abandon the existing diversion ditch and replace it with an approximately 1,100–foot pipeline; and (4) revegetate the site following construction.
The Restoration Project also includes improving an existing road and establishing Restoration Project staging, post– construction revegetation maintenance, and post– construction facilities monitoring. The Restoration Project activities described above are expected to take 1 Central Valley spring–run Chinook salmon ( Oncorhynchus tshawytscha ) and Sacramento River winter–run Chinook salmon (Oncorhynchus tshawytscha ) (collectively, Covered Species) where those activities take place within Paynes Creek.
In particular, the Covered Species could be taken as a result of dewatering, fish relocation activities, and the placement of structures or materials in the stream channel. Spring–run Chinook salmon is designated as a threatened species pursuant to the federal Endangered Species Act (ESA) (16 U.S.C. § 1 531 et seq.) and a threatened species pursuant to the California Endangered Species Act (CESA) (Fish & Game Code, § 2 050 et seq.). (See Cal.
Code Regs., title 14, § 6 70.5, subdivision (b)(2)(C).) Winter–run Chinook salmon is designated as an endangered species pursuant to the ESA and an endangered species pursuant to CESA. (See Cal. Code Regs., title 14, § 6 70.5, subdivision (a)(2)(M).) Covered Species individuals are documented as potentially present at the Restoration Project site and there is suitable habitat for the Covered Species within and adjacent to the Restoration Project site.
Because of the potential for Covered Species to utilize the Restoration Project site for non–natal rearing, the National Marine Fisheries Service (Service) determined that the Covered Species are reasonably certain to occur within the Restoration Project site and that Restoration Project activities are expected to result in take of the Covered Species. Take is likely to occur if Covered Species are encountered during Restoration Project dewatering activities.
According to the Service, with respect to the Covered Species, the Restoration Project will result in the temporary dewatering of less than 1,000 linear feet of Paynes Creek and temporary Restoration Project staging will be less than 0.50 acre. The Service assumes that on Avenue,rage, up to three percent of captured individuals of the Covered Species may be injured or killed. Because the Restoration Project is expected to result in take of species designated as threatened and endangered under the federal ESA, the NOAA Restoration Center (NOAA RC), the U.S.
Army Corps of Engineers, and the United States Fish and Wildlife Service (Federal Action Agencies) consulted with the Service, as required by the ESA. On August 31, 2018, the Service issued a programmatic biological opinion, entitled NOAA Restoration Center’s Program 1 P ursuant to Fish and Game Code
section 86, “ ‘ Take’ means hunt, pursue, catch, capture, or kill, or attempt to hunt, pursue, catch, capture, or kill.” See also Environmental Protection In - formation Center v. California Department of Forestry and Fire Protection (2008) 44 Cal.4th 459, 507.
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 949 to Facilitate Implementation of Restoration Projects in the Cent ral Valley of Califor n ia (Ser vice file No. WCR– 2017–8532) (PBO) to the Federal Action Agencies for the Restoration Project. The PBO describes the covered project types, requires all project applicants operating under the PBO to comply with terms of the PBO and its incidental take statement (ITS), and incorporates additional measures. The Service issued a project–specific approval to Applicant for the Restoration Project on May 28, 2021, incorporated herein as Exhibit 1.
On June 4, 2021, the Director of the Department of Fish and Wildlife (CDFW) received a notice from the Applicant requesting a determination pursuant to Fish and Game Code
section 2080.1 that the ITS, the related PBO, and the project–specific approval for the Restoration Project are collectively consistent with CESA for purposes of the Restoration Project and the Covered Species. (Cal. Reg. Notice Register 2021, No. 25–Z, p. 801.) Determination CDFW has determined that the ITS, along with its accompanying PBO, is consistent with CESA as to the Restoration Project and the Covered Species because the measures contained in the PBO and ITS meet the conditions set forth in Fish and Game Code
section 2081, subdivisions (
a) and (c), for authorizing take of CESA–listed species. Specifically, CDFW finds that: (1) take of the Covered Species will be for management purposes; (2) the measures required are roughly proportional in extent to any impact on the Covered Species that is caused by the Restoration Project; (3) the measures required maintain the Permittee’s project purpose to the greatest extent possible; and (4) the Restoration Project will not jeopardize the continued existence of the Covered Species. Avoidance, Minimization, and Mitigation Measures. The avoidance, minimization, and mitigation measures in the ITS and PBO include, but are not limited to, the following: 1. Work shall not begin until (
a) the NOAA RC has notified the applicant that the requirements of the ESA have been satisfied and that the activity is authorized, and (
b) all other necessary permits and authorizations are finalized. Prior to construction, any contractor shall be provided with the specific protective measures to follow during implementation of the Restoration Project. In addition, a qualified professional, approved by the Service, shall provide the construction crew with information on the protected species potentially found in the Restoration Project vicinity, the protection afforded the species by the ESA and CESA, and guidance on those specific protection measures that must be implemented as part of the Restoration Project. 2.
The general construction season shall be from June 15 to October 31. Restoration, construction, fish relocation, and dewatering within any wetted or flowing stream channel shall only occur within this period. Revegetation outside of the active channel may continue beyond October 31, if necessary. 3. In cases where it is deemed necessary to work in flowing water, the work area shall be isolated, and all flowing water shall be temporarily diverted around the work site to maintain downstream flows during construction. 4.
Exclude fish from occupying the work area by blocking the stream channel above and below the work area with fine–meshed net or screens. Mesh will be no greater than one eighth inch diameter. The bottom of a seine must be completely secured to the channel bed. 5. Prior to dewatering, determine the best means to bypass flow through the work area to minimize disturbance to the channel and avoid direct mortality of fish and other aquatic vertebrates (as described more fully in the PBO under General conditions for all fish capture and relocation activities). 6.
Prior to dewatering a construction site, qualified individuals will capture and relocate fish and amphibians to avoid direct mortality and minimize adverse effects. This is especially important if listed species are present within the project site. 7. All seining, electrofishing, and relocation activities shall be performed by a qualified fisheries biologist, who shall capture and relocate listed salmonids prior to construction of the water diversion structures (e.g., cofferdams).
The biologist shall note the number of salmonids observed in the affected area, the number and species of salmonids relocated, where they were relocated to, and the date and time of collection and relocation. The biologist shall have a minimum of three years’ field experience in the identification and capture of salmonids, including juvenile salmonids, considered in this biological opinion. The biologist will adhere to the following requirements for capture and transport of salmonids: a. Determine the most efficient means for capturing fish (i.e., seining, dip netting, trapping, electrofishing).
Complex stream habitat generally requires the use of electrofishing equipment,
whereas in outlet pools, fish may be concentrated by
CALIFORNIA REGULATORY NOTICE REGISTER 2021, VOLUME NUMBER 30-Z 950 pumping–down the pool and then seining or dip netting fish. b. Notify the Service one week prior to capture/relocation of salmonids to provide an opportunity to monitor. c. Initial fish relocation efforts will be conducted several days prior to the start of construction. This provides the fisheries biologist an opportunity to return to the work area and perform additional electrofishing passes immediately prior to construction. In many instances, additional fish will be captured that eluded the previous day’s efforts. d.
In streams with high water temperature, perform relocation activities during morning periods. e. Prior to capturing fish, determine the most appropriate release location(s). Consider the following when selecting release site(s): (
a) Similar water temperature as capture location; (
b) Ample habitat for captured fish; (
c) Low likelihood of fish reentering work site or becoming impinged on exclusion net or screen; (
d) Fish must be released in a nearby location within the same HUC 8 watershed. f. Periodically measure air and water temperatures. Cease activities when water temperatures exceed 17.8 °C. Temperatures will be measured at the head of riffle tail of pool interface. g. Submit reports of fish relocation activities to CDFW and the Service in a timely fashion. 8. If more than three percent of the Covered Species captured are killed or injured, the project lead shall contact the Service and CDFW.
The purpose of the contact is to allow the agencies a courtesy review of activities resulting in take and to determine if additional protective measures are required. All Covered Species mortalities must be retained, placed in an appropriately sized whirl– pak or zip–lock bag, labeled with date and time of collection, fork length, location of capture, and frozen as soon as possible. Frozen samples must be retained until specific instructions are provided by the Service. Monitoring and Reporting Measures . The m