Notices of Public Hearing (Published 10/27/2023)
Energy and Environmental Affairs, Executive Office of
301 CMR 41.00 - Toxic or Hazardous Substance List
Notice is hereby given that the Massachusetts Administrative Council on Toxics Use Reduction,under its authority pursuant to M.G.L. Chapter 211, Sections 4, in conformance with M.G.L.30A, will hold a public hearing on proposed amendments to 301 CMR 41.00 Toxic or Hazardous Substance List. These proposed regulations implement changes to the list of chemicals maintained by the Administrative Council on Toxics Use Reduction pursuant to the Toxics Use Reduction Act (TURA, M.G.L. Chapter 211). Specifically, on August 10, 2023, the Administrative Council voted to list twenty-two substances added by USEP A to the Toxics Release Inventory (TRI) under EPCRA Section 313 in 2022 and 2023. Please note that this hearing is being conducted remotely.
A public hearing will be conducted via Zoom at 1 p.m. on November 3, 2023 to receive comments on the proposed amendments. Testimony may be presented orally at the hearing or in writing. Meeting access information is below:
Public Hearing on Revisions to TURA Toxic or Hazardous Substance List
When: Nov 3, 2023 01:00 PM Eastern Time (US and Canada)
Join hearing: https://zoom.us/j/92952463054
Or Telephone: + 1 309 205-3325, Webinar ID: 929 5246 3054
Written testimony will be accepted until 5 p.m. on November 3, 2023. Written testimony
should be submitted via email to Tiffany Skogstrom at tiffany.skogstrom@mass.gov or via
mail to:
Tiffany Skogstrom, Executive Director
TURA Administrative Council, Executive
Office of Energy and Environmental Affairs
100 Cambridge Street,
10th Floor, Boston,
MA 02114.
Copies of the proposed regulations are available on the Executive Office of Energy and Environmental Affairs web site at https://www.mass.gov/doc/proposed-revisions-to-301-cmr-41-2023/download, or may be obtained by sending an email or calling Tiffany Skogstrom at tiffany.skogstrom@mass.gov or + 1 857-275-1561
To request written language translation or oral interpretation at the public hearings, please contact Melixza.Esenyie2@mass.gov For oral language interpretation, the request must be received at least three (3) business days prior to the public hearing date at which the interpretation is requested. To request other reasonable accommodations, please contact Melixza Esenyie, ADA and Diversity Manager at Melixza.Esenyie2@mass.gov or + 1 617-626-1282.
301 CMR 41.00
Small Business Impact Statement
CMR No: 301 CMR 41:00 Toxic or Hazardous Substance List
Estimate of the Number of Small Businesses Impacted by the Regulation:
5-7
Will small businesses have to create, file, or issue additional reports?
Yes. A principal reason for TURA's success is that companies covered by the program are required to develop and use a chemical tracking system. The tracking system helps companies understand their use of chemicals and where losses occur in the manufacturing process. Companies annually report their chemical use and the waste generation from that use to the Massachusetts Department of Environmental Protection (MassDEP).
These same companies develop plans that identify options and evaluate alternatives that would reduce or eliminate the use of these hazardous chemicals and the waste they generate. Companies are not required to adopt the toxics use reduction techniques they identify, but when alternatives that make good business sense are available, companies will frequently adopt these cost-effective strategies, which leads to more efficient chemical use and a reduction in waste generation. Companies provide the MassDEP with a progress update on their planning activity every other year.
All small businesses with less than 10 full-time equivalents (FTEs) are exempt from the proposed regulation; however, facilities that use toxic chemicals are still entitled and encouraged to utilize the free and confidential environmental compliance and chemical assistance services provided by the TURA program.Will small businesses have to implement additional recordkeeping procedures?
Yes. The companies are required to develop and use a chemical tracking system. They will need to keep track of the amount of the reportable chemical purchased and used on site; the amount released to the workplace and environment, or generated as waste during manufacturing operations; and the amount of the chemical incorporated into products and sold in commerce. However, companies already must track chemical use for federal annual waste and emissions reporting for substances that are already on the EPA EPCRA 313 list.
Will small businesses have to provide additional administrative oversight?
Yes. The annual reports and plan update summaries that are submitted to the MassDEP are reviewed and signed by a senior management official at the company.
Will small businesses have to hire additional employees in order to comply with the proposed regulation?
No. Most businesses prepare the annual report and toxics plan using in-house expertise and staff. About half the companies use an outside consultant to certify their toxics use reduction plan. Existing staff in the environment, health and safety; process engineering; or facilities management categories are most
commonly responsible for preparing toxics reports and plans.Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)?
No. A toxics use reduction plan must be certified by a MassDEP certified toxics use reduction planner (TURP). Most businesses prepare the chemical evaluation plan using in-house expertise and staff (inhouse planner) and some choose to use/hire a general practice TURP (a consultant from outside the
company).Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation?
No. Businesses subject to TURA are not required to make any capital investment to comply with the regulation. Program evaluation has shown that businesses are likely to adopt and implement options evaluated in the planning process that have a positive economic benefit (companies adopt alternatives
when they make good business sense).Are performance standards more appropriate than design standards?
No. TURA is neither a performance nor a design standard, but employs right to know disclosure and what has been termed a "management" standard. It leaves the decision of whether to switch chemicals or make manufacturing process changes up to the company based on the self-evaluation of their business
needs. This approach ensures that companies subject to TURA only undertake changes that are technically and financially feasible and make good business sense.-
Does the regulation require small businesses to cooperate with audits, inspections, or other regulatory enforcement activities?
Yes. Massachusetts companies that are toxics users are already subject to inspections from the MassDEP, Mass Department of Fire Services, USEPA and local boards of health. This regulation only applies to MassDEP, expanding what a MassDEP inspector may examine at a facility which is already subject to
inspection. Will the regulation have the effect of creating additional taxes and/or fees for small businesses?
Yes. The reports that are submitted to the MassDEP and signed by a senior management offical are accompanied by an annual reporting fee. If a facility reduces use below threshold, the fee no longer applies.
Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements?
No. There are continuing education requirements for the Toxics Use Reduction Planner - the individual who certifies that the toxics use reduction plan conforms with the MassDEP regulations. Many of these educational services are provided at little or no cost by the TURA program and are not required to be
provided by the company. A company that hires an outside consultant to certify its plan does not bear the costs of this education.Is the regulation likely to deter the formation of small businesses in Massachusetts?
No. The regulation is not likely to deter the formation of small businesses in Massachusetts. The regulation supports the formation and maintenance of responsible businesses. For those businesses that use toxic chemicals, complying with TURA provides a way to structure and organize responsible chemical
management. There are also important business opportunities associated with adoption of safer alternatives.Is the regulation likely to encourage the formation of small businesses in Massachusetts?
Yes. The regulation may encourage the formation or location in Massachusetts of companies providing safer alternatives to the relevant toxic chemicals.
-
Can the regulation provide for less stringent compliance or reporting requirements for small businesses?
Yes. TURA specifically exempts companies with fewer than ten full-time equivalent employees. All large quantity toxics users above this threshold are subject to the same reporting and compliance requirements, but the fee varies by the size of the business (number of employees), with smaller businesses paying significantly less than larger businesses. The law also allows companies to remove themselves from the regulatory requirements by reducing use below threshold amounts.
-
Can the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses?
No. All large quantity toxics users are subject to the same reporting and compliance requirements. The statute requires they be treated equally and does not allow for less stringent schedules or deadlines for compliance. However, reporting and complance assistance is offered to small companies at no charge.
The TURA program also provides business assistance grants, educational events, research assistance, and on-site technical assistance, helping both small and large businesses to overcome barriers to toxics use reduction and identify opportunities for financial savings. Can the compliance or reporting requirements be consolidated or simplified for small businesses?
No.
Can performance standards for small businesses replace design or operational standards?
No. Setting either performance, design or operational standards (for example, where the Commonwealth phases out the use of a chemical or sets strict reductions in its use, or requires specific processing changes), would be more burdensome than what the law currently requires, which is characterized as a
"management" standard. TURA's reporting requirements are not burdensome and are considered good chemical management practices. TURA's planning standard is regarded as "business friendly" in that it requires the company, not the state, to identify its options and evaluate alternatives. TURA leaves the
responsibility for making the decision to make changes or switch to an alternative chemical, or to do nothing at all, up to the company.Are there alternative regulatory methods that would minimize the adverse impact on small businesses?
No. None have been identified by the program that are within its statutory discretion.
-
Were any small businesses or small business organizations contacted during the preparation of this document? If so, please describe
Yes. Announcement of the public meetings with an agenda was sent to the list ofTURA program stakeholders that are notified of each Administrative Council and Advisory Committee meeting. Those contacted included stakeholders and trade associations such as the American Chemistry Council (ACC), Associated Industries of Massachusetts (AIM), Massachusetts Chemistry and Technology Alliance (MCTA), the Household and Consumer Products Association (HCPA), and companies that distribute products that contain these chemicals.
Are there regulations of the promulgating agency, or of another agency or department of the commonwealth, which may duplicate or conflict with the proposed regulation?
No.
▲Top of page
Health and Human Services, Executive Office of:
101 CMR 307.00: Rates for Psychiatric Day Treatment Center Services
Pursuant to the authority of M.G.L. c. 118E and in accordance with M.G.L. c. 30A, the Executive Office of Health and Human Services (EOHHS) will hold a remote public hearing on Friday, November 3, 2023, at 9:00 a.m. relative to the adoption of: 101 CMR 307.00: Rates for Psychiatric Day Treatment Center Services
The proposed regulation amendments to 101 CMR 307.00 amend the payment rates used by governmental units to eligible providers of Psychiatric Day Treatment Center (PDT) services provided under the MassHealth program.
The proposed regulations are anticipated to become effective March 1, 2024. The regulations propose to increase the existing rates for PDT services based on developing a model budget using 2021 Massachusetts Bureau of Labor Statistics (BLS) median salary benchmarks and FY2022 Uniform Financial Report (UFR) data, and the application of a two-year prospective cost adjustment factor (CAF) of 2.71%. As a result, the proposed amended regulation increases the rates for code H2012 from $16.57 to $28.77 per hour, and code H2012-U1 from $46.15 to $80.13 per hour.
EOHHS is proposing these changes, subject to federal approval, to ensure that payment rates are consistent with efficiency, economy, and quality of care and satisfy the requirements of M.G.L. 118E, sections 13C and 13D. It is estimated that annual aggregate fiscal impact on the fee-for-service (FFS) MassHealth expenditure will increase by approximately $1,504,550 as a result of these proposed rates. There is no fiscal impact on cities or towns.
To register to testify at the hearing and to get instructions on how to join the hearing online, go to www.mass.gov/service-details/executive-office-of-health-and-humanservices- public-hearings. To join the hearing by phone, call (646) 558-8656and enter meeting ID 935 397 8200# when prompted.
You may also submit written testimony instead of, or in addition to, live testimony. To submit written testimony, please email your testimony to ehs-regulations@mass.gov as an attached Word or PDF document or as text within the body of the email with the name of the regulation in the subject line. All written testimony must include the sender’s full name, mailing address, and organization or affiliation, if any. Individuals who are unable to submit testimony by email should mail written testimony to:
EOHHS,
c/o D. Briggs
100 Hancock Street, 6th Floor
Quincy, MA 02171
Written testimony will be accepted through 5:00 p.m. on Friday, November 3, 2023. EOHHS specifically invites comments as to how the amendments may affect beneficiary access to care.
To review the current draft of the proposed actions, go to www.mass.gov/servicedetails/ executive-office-of-health-and-human-services-public-hearings or request a copy in writing from:
MassHealth Publications
100 Hancock Street, 6th Floor,
Quincy, MA
02171.
Special accommodation requests may be directed to the Disability Accommodations Ombudsman by email at ADAAccommodations@mass.gov or by phone at (617) 847-3468 (TTY: (617) 847-3788 for people who are deaf, hard of hearing, or speech disabled). Please allow two weeks to schedule sign language interpreters.
EOHHS may adopt a final, revised version of the emergency regulation taking into account relevant comments and any other practical alternatives that come to its attention.
In case of inclement weather or other emergency, hearing cancellation announcements will be posted on the MassHealth website at www.mass.gov/service-details/executiveoffice-of-health-and-human-services-public-hearings.
CMR No: 101 CMR 307.00:
Small Business Impact Statement
The Massachusetts Cannabis Control Commission (Commission) files this small business impact statement in accordance with M.G.L. c. 30A, §§ 2, 3 and 5 relative to draft regulations revising 935 CMR 500.000: Adult Use of Marijuana and 935 CMR 501.000: Medical Use of Marijuana. The revisions primarily effectuate the statutory mandates under Chapter 180 of the Acts of 2022: An Act Relative to Equity in the Cannabis Industry passed by the Massachusetts Legislature and signed by Governor Baker on August 11, 2022. The proposed changes will impact registered agents, municipalities, applicants for licensure, licensees, and specifically:
Estimate of the Number of Small Businesses Impacted by the Regulation:
There are 11 providers governed by the proposed regulation.
Will small businesses have to create, file, or issue additional reports?
No.
Will small businesses have to implement additional recordkeeping procedures?
No.
Will small businesses have to provide additional administrative oversight?
No. Small businesses are not required by 101 CMR 307.00 to provide additional administrative oversight. The proposed regulation establishes the rates to be paid by governmental units for psychiatric day treatment services.
Will small businesses have to hire additional employees in order to comply with the proposed regulation?
No.
Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)?
No.
Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation?
No.
Are performance standards more appropriate than design standards?
No. Performance standards are not more appropriate than design or operational standards to accomplish the regulatory objective of establishing rates for EOHHS health care services as the proposed regulation is required by statute under M.G.L. Chapter 118E, Section 13C.
-
Do any other regulations duplicate or conflict with the proposed regulation?
No.
Does the regulation require small businesses to cooperate with audits, inspections or other regulatory enforcement activities?
Yes. This regulation uniformly requires all providers to periodically file cost data.
Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements?
No. 101 CMR 307.00 does not require small businesses to provide educational services to keep up to date with regulatory requirements.
Is the regulation likely to deter the formation of small businesses in Massachusetts?
No.
Is the regulation likely to encourage the formation of small businesses in Massachusetts?
No.
-
Does the regulation provide for less stringent compliance or reporting requirements for small businesses?
No. The proposed regulation does not distinguish between small and other businesses.
-
Does the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses?
No.
Did the agency consolidate or simplify compliance or reporting requirements for small businesses?
No.
Can performance standards for small businesses replace design or operational standards?
No. Distinguishing between small and other businesses would not be practicable to implement the proposed regulation.
Are there alternative regulatory methods that would minimize the adverse impact on small businesses?
No.
▲Top of page
Medical Assistance, Division of
130 CMR 402.000: Vision Care Services
Under the authority of M.G.L. c. 6A, section 16 and in accordance with M.G.L. c. 30A, the Division of Medical Assistance (the Division) will hold a remote public hearing on Friday, November 3, 2023, at 1:00 p.m. relative to the adoption of amendments to the following regulation. 130 CMR 402.000: Vision Care Services.
The proposed regulation is planned to go into effect no sooner than March 15, 2024. There is no fiscal impact on cities and towns.
The proposed amendments include a clearer definition of date of service for fitting and dispensing eye wear, reporting allowances for fitting or dispensing to be billed only once at the provider’s discretion, an adjustment of the exclusion language, and removal of the prior authorization (PA) requirement for fundus photography (CPT code 92250), as well as certain other technical updates.
To register to testify at the hearing and to get instructions on how to join the hearing online, go to www.mass.gov/service-details/masshealth-public-hearings. To join the hearing by phone, call (646) 558-8656 and enter meeting ID 935 397 8200# when prompted.
You may also submit written testimony instead of, or in addition to, live testimony. To submit written testimony, please email your testimony to masshealthpublicnotice@mass.gov as an attached Word or PDF document or as text within the body of the email with the name of the regulation in the subject line. All written testimony must include the sender’s full name, mailing address, and organization or affiliation, if any. Individuals who are unable to submit testimony by email should mail written testimony to:
EOHHS, c/o D. Briggs,
100 Hancock Street, 6th Floor,
Quincy, MA
02171
Written testimony will be accepted through 5:00 p.m. on November 3, 2023. The Division specifically invites comments as to how the amendments may affect beneficiary access to care.
To review the current draft of the proposed regulation, go to www.mass.gov/servicedetails/masshealth-public-hearings or request a copy in writing from
MassHealth
Publications
100 Hancock Street, 6th Floor
Quincy, MA 02171.
Special accommodation requests may be directed to the Disability Accommodations Ombudsman by email at ADAAccommodations@mass.gov or by phone at (617) 847-3468 (TTY: (617) 847-3788 for people who are deaf, hard of hearing, or speech disabled). Please allow two weeks to schedule sign language interpreters.
The Division may adopt a revised version of the proposed regulation taking into account relevant comments and any other practical alternatives that come to its attention.
In case of inclement weather or other emergency, hearing cancellation announcements will be posted on the MassHealth website at www.mass.gov/service-details/masshealthpublic-hearings.
130 CMR 402.000: Vision Care Services
Small Business Impact Statement
(As required by M.G.L. c. 30A §§ 2, 3 & 5)
Estimate of the Number of Small Businesses Impacted by the Regulation:
Unknown
Will small businesses have to create, file, or issue additional reports?
No.
Will small businesses have to provide additional administrative oversight?
No.
Will small businesses have to hire additional employees in order to comply with the proposed regulation?
No.
Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)?
No.
Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation?
No.
Are performance standards more appropriate than design/operational standards to accomplish the regulatory objective?
(Performance standards express requirements in terms of outcomes, giving the regulated party flexibility to achieve regulatory objectives and design/operational standards specify exactly what actions regulated parties must take.)
No.
Do any other regulations duplicate or conflict with the proposed regulation?
No.
Does the regulation require small businesses to cooperate with audits, inspections or other regulatory enforcement activities?
No.
Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements?
No.
Is the regulation likely to deter the formation of small businesses in Massachusetts?
No.
Is the regulation likely to encourage the formation of small businesses in Massachusetts?
Yes. By removing prior authorization (PA) on code 92250 fundus photography, the regulation will cut down the administrative burden for providers, and providers will also get paid for dispensing or fitting glasses – this will encourage new providers.
Does the regulation provide for less stringent compliance or reporting requirements for small businesses?
No.
Does the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses?
No.
Did the agency consolidate or simplify compliance or reporting requirements for small businesses?
No. The regulation does not distinguish between small and other businesses.
Can performance standards for small businesses replace design or operational standards without hindering delivery of the regulatory objective?
No. Distinguishing small businesses from other businesses would not be practicable for this regulation.
Are there alternative regulatory methods that would minimize the adverse impact on small businesses?
No. EOHHS must amend the vision manual regulations in order to update requirements.
▲Top of page
Public Health, Department of
105 CMR 700.000 – Implementation of M.G.L. c. 94C.
Notice is hereby given pursuant to M.G.L. c. 30A, §2, that the Department of Public Health will hold a public hearing on emergency amendments to the following regulation: 105 CMR 700.000 – Implementation of M.G.L. c. 94C.
The emergency amendments update the regulation which implements M.G.L. c. 94C, the Controlled Substances Act. The emergency amendments implement the statutory authorization for pharmacists to prescribe hormonal contraceptives. They were duly filed with the Secretary of the Commonwealth on October 13, 2023 and are currently in effect.
The public hearing will be held on Monday, November 6, 2023, at 1:30 pm. This hearing will be conducted on a moderated conference call. The information for the moderated conference call is:
Dial-in Telephone Number: 888-603-6976
Participant Passcode: 6938553
A copy of the proposed amendments to 105 CMR 700.000 may be viewed on the Department’s website at www.mass.gov/dph/proposed-regulations or requested from the Office of the General Counsel by calling 617-624-5220.
The Department encourages all interested parties, including those who testify at the public hearing, to submit written testimony electronically to Reg.Testimony@mass.gov. Please submit electronic testimony as an attached Word document and type “105 CMR 700.000 Emergency Regulations” in the subject line of the email. All submitted testimony must include the sender’s full name and address. The Department will post all electronic testimony that complies with these instructions on its website. Parties who are unable to submit electronic testimony should mail submissions to:
William Anderson, Office of the General Counsel
Department of Public
Health
250 Washington Street
Boston, MA 02108
All comments must be submitted by 5:00 p.m. Monday, November 6, 2023. All comments received by the Department may be released in response to a request for public records.
If you are deaf or hard of hearing, or are a person with a disability who requires accommodation, please contact Alex Gomez at least 5 days before the hearing at Tel 617-624-5928, Fax # 617-624-5075, email Alex.Gomez@mass.gov, or TTY 617-624-6001.
105 CMR 700.000, Implementation of M.G.L. c. 94C
Small Business Impact Statement
(As required by M.G.L. c. 30A §§ 2, 3 & 5)
Estimate of the Number of Small Businesses Impacted by the Regulation:
Not expected to impact small businesses.
Will small businesses have to create, file, or issue additional reports?
No. The proposed regulatory amendments implement a statutory authorization and are not expected to impact small businesses.
Will small businesses have to implement additional recordkeeping procedures?
No.
Will small businesses have to provide additional administrative oversight?
No.
Will small businesses have to hire additional employees in order to comply with the proposed regulation?
No.
Does compliance with the regulation require small businesses to hire other professionals (e.g. a lawyer, accountant, engineer, etc.)?
No.
Does the regulation require small businesses to purchase a product or make any other capital investments in order to comply with the regulation?
No.
Are performance standards more appropriate than design/operational standards to accomplish the regulatory objective?
(Performance standards express requirements in terms of outcomes, giving the regulated party flexibility to achieve regulatory objectives and design/operational standards specify exactly what actions regulated parties must take.)
No. The proposed changes must be made through regulation to implement statutory changes to practitioner scope of practice.Do any other regulations duplicate or conflict with the proposed regulation?
No. There are no other regulations that duplicate or conflict with the proposed amendments to this regulation, although complimentary changes may also be made in pharmacists’ scope of practice regulations.
Does the regulation require small businesses to cooperate with audits, inspections or other regulatory enforcement activities?
No. The proposed regulatory amendments will be accompanied by detailed guidance that includes provisions clarifying statutory requirements for pharmacists who prescribe and dispense contraceptives.
Does the regulation require small businesses to provide educational services to keep up to date with regulatory requirements?
No.
Is the regulation likely to deter the formation of small businesses in Massachusetts?
No.
Is the regulation likely to encourage the formation of small businesses in Massachusetts?
No.
Does the regulation provide for less stringent compliance or reporting requirements for small businesses?
No.
Does the regulation establish less stringent schedules or deadlines for compliance or reporting requirements for small businesses?
No.
Did the agency consolidate or simplify compliance or reporting requirements for small businesses?
No.
Can performance standards for small businesses replace design or operational standards without hindering delivery of the regulatory objective?
No. The proposed changes must be made through regulation to implement statutory changes to pharmacists’ scope of practice.
Are there alternative regulatory methods that would minimize the adverse impact on small businesses?
No. The proposed regulation is required by statutes and its goals could not be achieved through alternative methods.