Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by December 1, 2026, require the division to submit to the board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume. The bill would require the division, when developing regulations, to consider, among other things, recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health. The bill would require the board to consider for adoption a proposed regulation by June 1, 2027.

This bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

This bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by December 1, 2026, require the division to submit to the board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume. The bill would require the division, when developing regulations, to consider, among other things, recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health. The bill would require the board to consider for adoption a proposed regulation by June 1, 2027.

This bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

This bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by January 1, 2025, December 1, 2026, require the division to submit to the board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume. The bill would require the division, when developing regulations, to consider, among other things, recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health. The bill would require the board to consider for adoption a proposed regulation by July 1, 2025. June 1, 2027.

This bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

This bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by June 1, 2024, January 1, 2025, require the division to submit to the board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume. The bill would require the division, when developing regulations, to consider, among other things, recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health. The bill would require the board to adopt consider for adoption a proposed regulation by January 1, 2025. July 1, 2025.

This bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

This bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by June 1, 2024, require the division to submit to the board a proposed regulation requiring a health facility to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume. The bill would require the division, when developing regulations, to consider, among other things, recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health. The bill would require the board to adopt a proposed regulation by January 1, 2025.

This bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

This bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1007

Author:(Ortega)

As Amended Ver:September 8, 2023

Majority vote

SUMMARY

Requires the Division of Occupational Safety and Health (Cal/OSHA) to, by December 1, 2026, submit to the Occupational Safety and Health Standards Board (Board) a proposed regulation requiring a health facility to evacuate or remove plume using plume-scavenging systems in all settings that employ techniques that involve the creation of plume. This bill also requires the Board to consider the proposed regulation for adoption by June 1, 2027.

Senate Amendments

1. Delay the deadline for Cal/OSHA to submit a proposed regulation to the Board, requiring a health facility to evacuate or eliminate plume, from June 1, 2024, to December 1, 2026.
2. Revise the definition of "plume scavenging system" to mean smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that, when used in concert with other engineering controls and equipment, and to the extent technologically feasible, capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.
3. Specify that the requirement for a health care facility to remove or evacuate plume is only required to the extent that the removal of the plume is technologically feasible.
4. Delay the deadline for the Board to consider the proposed regulation requiring a health facility to evacuate or eliminate plume, from January 1, 2025, to June 1, 2027.
5. Require Cal/OSHA, in developing regulations, to do the following:
   1. Include a requirement that a plume scavenging system be included as engineering or work practice controls.
   2. Include a requirement for appropriate practices and other controls necessary to prevent employee exposure to plume in situations where a plume scavenging system could interfere with a medical procedure.
6. Clarify that the Board is not required to adopt the regulation by June 1, 2027, but instead is required to consider the proposed regulation for adoption by June 1, 2027.
7. Clarify that any plume scavenging standards adopted by the Board are in addition to general room ventilation standards or requirements, as specified.

COMMENTS

According to the National Institute for Occupational Safety and Health (NIOSH), "during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential."^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. "But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA)."^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. "Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery."^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

According to the Author

"[This bill] would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to prevent workplace exposure to toxic surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and [this bill] is a critical step forward in achieving this goal."

In addition, the author points out that [this bill] will promote equity solutions and maximize benefits for underserved and marginalized communities by addressing "a pressing worker safety issue, allowing nurses, a mostly female workforce, doctors, and other healthcare workers to stay safe as frontline workers and available for their respective communities and families."

Arguments in Support

The California Nurses Association/National Nurses United (CNA), sponsor of the bill, states, "Surgical plume is also known to contain mutagenic (cancer producing) particles.

Peer-reviewed studies have confirmed surgical plume's mutagenic potential. One study equated the mutagenic condensate, generated from just one gram of tissue destroyed by lasers, to smoking three cigarettes, and a gram of tissue destroyed by electrocautery smoke, to smoking six cigarettes! Surgical plume can also cause ocular and upper respiratory tract irritation. It has even been linked to cases involving laryngeal papillomatosis.

California is one of only 21 states (plus Puerto Rico) that has an OSHA approved state plan that allows for the adoption of occupational standards without having to resort to the onerous federal process. California can and should take the lead on this critical issue as it has in other areas, such as occupational exposure to blood borne pathogens, Ebola virus, safe patient handling, and workplace violence standards. CNA is proud to have led the way in promoting these and other occupational protections for healthcare workers and for the minimal cost of 1,000 - $5,000 for equipment operated at about 11 cents per second, this legislation is a critical next step in the ongoing need for protection of healthcare workers."

Arguments in Opposition

The California Hospital Association, in opposition, states, "First, the definition of a "plume scavenging system" does not reflect current technological capabilities. Specifically, the bill would require that the system either neutralizes or captures all plume, yet there does not appear to exist any plume system that captures or neutralizes all plume. Rather, existing plume systems are capable only of reducing the amount of plume by capturing particles. Also, the legislation is unclear if the requirement that the plume scavenging system neutralize all plume "before plume can make ocular contact or contact with the respiratory tract of employees" refers to the plume system in isolation or working in concert with other engineering controls or equipment.

Second, the regulatory process set out by [this bill] is a sharp departure from existing practice and law. Specifically, [this bill] would require that the Division of Occupational Safety and Health (Cal/OSHA) develop a regulatory framework to address plume and then requires that the Occupational Safety and Health Standards Board (OSHSB) adopt the regulations from the division. Under Labor Code Section 142.3, the OSHSB has the authority to develop occupational safety standards, and failure to follow existing law could diminish hospitals' ability to work through the regulatory process to address patient care and operational concerns."

FISCAL COMMENTS

According to the Senate Appropriations Committee DIR would incur first-year costs of $332,000, and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). DIR notes that 1) although this bill would require adoption of a final regulation by July 1, 2025, the regulatory process often takes multiple years to conclude, and 2) Cal/OSHA could incur enforcement costs once the regulations are in place.

The bill would likely result in unknown, but potentially significant costs to the Standards Board resulting from additional rulemaking activities.

VOTES:

ASM LABOR AND EMPLOYMENT: 5-2-0

YES: Kalra, Haney, Ortega, Reyes, Ward

NO: Flora, Chen

ASM APPROPRIATIONS: 11-4-1

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Ortega

NO: Megan Dahle, Dixon, Mathis, Sanchez

ABS, ABST OR NV: Robert Rivas

ASSEMBLY FLOOR: 61-16-3

YES: Addis, Aguiar-Curry, Alvarez, Arambula, Bains, Bauer-Kahan, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Grayson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO: Alanis, Chen, Megan Dahle, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Hoover, Mathis, Jim Patterson, Joe Patterson, Sanchez, Ta, Wallis

ABS, ABST OR NV: Bennett, Lackey, Stephanie Nguyen

UPDATED

VERSION: June 29, 2023

CONSULTANT: Martin Vindiola / L. & E. / (916) 319-2091 FN: 0002391

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke From Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑

 THIRD READING  

Bill No: AB 1007

Author: Ortega (D)

Amended: 9/8/23 in Senate

Vote: 21

SENATE LABOR, PUB. EMP. & RET. COMMITTEE: 4-0, 6/28/23

AYES: Cortese, Durazo, Laird, Smallwood-Cuevas

NO VOTE RECORDED: Wilk

SENATE APPROPRIATIONS COMMITTEE: 5-2, 9/1/23

AYES: Portantino, Ashby, Bradford, Wahab, Wiener

NOES: Jones, Seyarto

ASSEMBLY FLOOR: 61-16, 5/31/23 - See last page for vote

SUBJECT: Occupational safety and health standards: plume

SOURCE: California Nurses Association/National Nurses United

DIGEST:

This bill requires the Division of Occupational Safety and Health (Cal/OSHA) to, by December 1, 2026, submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove plume using plume-scavenging systems in all settings that employ techniques that involve the creation of plume. This bill also requires the Standards Board to consider the proposed regulation for adoption by June 1, 2027.

Senate Floor Amendments of 9/8/23 delay the date by which Cal/OSHA must submit a proposed regulation on plume (previously January 1, 2025) and by which Standards Board must consider adopting it (previously July 1, 2025).

ANALYSIS:

Existing law:

1. Establishes Cal/OSHA, within the Department of Industrial Relations (DIR), to, among other things, propose, administer, and enforce occupational safety and health standards. (Labor Code §6300 et seq.)
2. Requires, under the California Occupational Safety and Health Act, an employer to:
   1. Furnish employment and a place of employment that is safe and healthful for its employees.
   2. Furnish and use safety devices and safeguards, and to adopt and use practices, means, methods, operations, and processes, which are reasonably adequate to render employment and the place of employment safe and healthful.
   3. Do everything reasonably necessary to protect the life, safety, and health of employees. (Lab. Code, § 6300 et seq.)
3. Establishes the Occupational Safety and Health Standards Board (Standards Board), within DIR, as the standards-setting agency to promote, adopt and maintain reasonable and enforceable standards that will ensure a safe and healthful workplace for workers. (Labor Code §140, §142.3, and §144.6).
4. Stipulates that in promulgating standards dealing with toxic materials or harmful physical agents, the Board shall adopt standards to prevent employees from suffering adverse health effects even if these employees have regular exposure to a regulated hazard (Labor Code §144.6).

This bill:

1. Requires Cal/OSHA, by December 1, 2026, to submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and requires the Standards Board to consider adopting such a regulation by June 1, 2027.
2. Requires Cal/OSHA in developing regulations to do all of the following:
   1. Evaluate plume evacuation standards using, as a benchmark, the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization and the standards titled “Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings” (CSA Z305.13-13) adopted by the CSA Group.
   2. Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
   3. Take into consideration the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
   4. Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume including, but not limited to, training on the following:
      1. General education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility.
   5. Include a requirement that a plume scavenging system be included as engineering or work practice controls.
   6. Include a requirement for appropriate practices and other controls necessary to prevent employee exposure to plume in situations where a plume scavenging system could interfere with a medical procedure.
3. Provides that the provisions of this bill do not limit the authority of Cal/OSHA to develop a regulation, or the authority of Board to adopt a regulation, that is broader in scope or broader in application than required by this bill.
4. Specifies that these provisions do not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that any plume scavenging standards adopted by the board are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this bill.
5. Requires the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of these provisions when installed, operated, and maintained in accordance with the manufacturer’s instructions.
6. Specifies that the use of surgical masks and the use of respirators do not satisfy the requirements of this bill except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.
7. Defines “electrocautery device” as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
8. Defines “electrosurgical device” as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
9. Defines “energy-based device” as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
10. Defines “health facility” as defined in subdivision (a) of Section 1250 of the Health and Safety Code including a general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
11. Defines “plume” as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
12. Defines “plume scavenging system” as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that, when used in concert with other engineering controls and equipment, and to the extent technologically feasible, capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.

Background

According to the National Institute for Occupational Safety and Health (NIOSH), “during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke “plume” can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.”^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. “But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA).”^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. “Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery.”^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

Pending Standard on Plume: This bill [AB 1007] is a reintroduction of two previous bills [AB 402 (Thurmond, 2017) and AB 2272 (Thurmond, 2016)] which would have required Cal/OSHA to propose, and the Standards Board to adopt, a standard on plume. Both previous measures were vetoed by then Governor Brown. In his veto message for AB 402, Governor Brown stated that he “agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.”

On February 15, 2018, the California Nurses Association/National Nurses United submitted a petition to the Occupational Safety and Health Standards Board (Petition File No. 567) requesting the Standards Board amend Title 8, General Industry Safety Orders, to add standards addressing the removal of surgical plume/smoke. The Standards Board granted the petition to the extent that an advisory committee is convened by Cal/OSHA to determine if the Standards Board should move forward with a rulemaking. Cal/OSHA convened one meeting since and the rulemaking for the plume standard does not appear to be moving forward.

Comments

Need for this bill? According to the author, “AB 1007 would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. This bill would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to abate workplace exposure to surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and AB 1007 is a critical step forward in achieving this goal.”

Related/Prior Legislation

AB 402 (Thurmond, 2017) was nearly identical to AB 2272 from 2016. The bill was vetoed by the Governor.

AB 2272 (Thurmond, 2016), was substantially similar to this bill, would have required Cal/OSHA to convene an advisory committee to develop a regulation regarding the protection of health care personnel and patients from exposure to vaporized human tissue, defined as "plume”. The bill was vetoed by Governor Brown.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee:

• DIR would incur first-year costs of $332,000, and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). DIR notes that (1) although this bill would require adoption of a final regulation by July 1, 2025, the regulatory process often takes multiple years to conclude, and (2) Cal/OSHA could incur enforcement costs once the regulations are in place.
• This bill would likely result in unknown, but potentially significant costs to the Standards Board resulting from additional rulemaking activities.

SUPPORT: (Verified 9/11/23)

California Nurses Association/National Nurses United (source)

Board of Registered Nursing, California Department of Consumer Affairs

California Labor Federation

California Nurses Association

United Nurses Associations of California/Union of Health Care Professionals

OPPOSITION: (Verified 9/11/23)

California Chamber of Commerce

California Hospital Association

ARGUMENTS IN SUPPORT: The sponsors of this bill, the California Nurses Association/National Nurses United, writes, “Surgical plume or smoke, which is the toxic byproduct of laser and electrosurgery procedures that destroy human tissue, poses an occupational hazard to nurses and other health care workers. Fortunately, workplace protection from surgical smoke is relatively simple - a smoke evacuation device (also known as plume scavenging systems) should be used every time electro- or laser surgery is performed and surgical smoke is generated. AB 1007 would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025.”

ARGUMENTS IN OPPOSITION: The California Hospital Association and the California Chamber of Commerce are opposed unless amended arguing, among other things, “it is important to recognize that plume scavenging systems directly influence patient care decisions. Hospital leaders, alongside their clinician partners, select devices that may generate plume (including those that minimize exposure to plume) because of the patient care considerations. In situations where a plume scavenging system creates patient safety or care concerns, physicians and hospitals should not be asked to choose between best care practices and patient safety and compliance with the law. This special concern about patient safety must be accounted for.”

Additionally, they argue that this bill “would limit the use of respirators as a tool to comply with the plume regulatory standard. While existing plume standards discourage the use of surgical masks as a plume remediation tool, there is no evidence to support the prohibition of respirators as a compliance method. Respirators provide high levels of protection against numerous airborne contaminates. The language restricting the use of respirators should be removed.”

ASSEMBLY FLOOR: 61-16, 5/31/23

AYES: Addis, Aguiar-Curry, Alvarez, Arambula, Bains, Bauer-Kahan, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Grayson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NOES: Alanis, Chen, Megan Dahle, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Hoover, Mathis, Jim Patterson, Joe Patterson, Sanchez, Ta, Wallis

NO VOTE RECORDED: Bennett, Lackey, Stephanie Nguyen

Prepared by: Alma Perez-Schwab / L., P.E. & R. / (916) 651-1556

9/11/23 12:48:37

**** END ****

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke from Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑

 THIRD READING  

Bill No: AB 1007

Author: Ortega (D)

Amended: 6/29/23 in Senate

Vote: 21

SENATE LABOR, PUB. EMP. & RET. COMMITTEE: 4-0, 6/28/23

AYES: Cortese, Durazo, Laird, Smallwood-Cuevas

NO VOTE RECORDED: Wilk

SENATE APPROPRIATIONS COMMITTEE: 5-2, 9/1/23

AYES: Portantino, Ashby, Bradford, Wahab, Wiener

NOES: Jones, Seyarto

ASSEMBLY FLOOR: 61-16, 5/31/23 - See last page for vote

SUBJECT: Occupational safety and health standards: plume

SOURCE: California Nurses Association/National Nurses United

DIGEST:

This bill requires the Division of Occupational Safety and Health (Cal/OSHA) to, by January 1, 2025, submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove plume using plume-scavenging systems in all settings that employ techniques that involve the creation of plume. This bill also requires the Standards Board to consider the proposed regulation for adoption by July 1, 2025.

ANALYSIS:

Existing law:

1. Establishes the Division of Occupational Safety and Health (Cal/OSHA), within the Department of Industrial Relations (DIR), to, among other things, propose, administer, and enforce occupational safety and health standards. (Labor Code §6300 et seq.)
2. Requires, under the California Occupational Safety and Health Act, an employer to:
   1. Furnish employment and a place of employment that is safe and healthful for its employees.
   2. Furnish and use safety devices and safeguards, and to adopt and use practices, means, methods, operations, and processes, which are reasonably adequate to render employment and the place of employment safe and healthful.
   3. Do everything reasonably necessary to protect the life, safety, and health of employees. (Lab. Code, § 6300 et seq.)
3. Establishes the Occupational Safety and Health Standards Board (Standards Board), within DIR, as the standards-setting agency to promote, adopt and maintain reasonable and enforceable standards that will ensure a safe and healthful workplace for workers. (Labor Code §140, §142.3, and §144.6).
4. Stipulates that in promulgating standards dealing with toxic materials or harmful physical agents, the Board shall adopt standards to prevent employees from suffering adverse health effects even if these employees have regular exposure to a regulated hazard (Labor Code §144.6).

This bill:

1. Requires Cal/OSHA, by January 1, 2025, to submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove plume to the extent technologically feasible through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and requires the Standards Board to consider adopting such a regulation by July 1, 2025.
2. Requires Cal/OSHA in developing regulations to do all of the following:
   1. Evaluate plume evacuation standards using, as a benchmark, the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization and the standards titled “Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings” (CSA Z305.13-13) adopted by the CSA Group.
   2. Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
   3. Take into consideration the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
   4. Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume including, but not limited to, training on the following:
      1. General education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility.
   5. Include a requirement that a plume scavenging system be included as engineering or work practice controls.
   6. Include a requirement for appropriate practices and other controls necessary to prevent employee exposure to plume in situations where a plume scavenging system could interfere with a medical procedure.
3. Provides that the provisions of this bill do not limit the authority of Cal/OSHA to develop a regulation, or the authority of Board to adopt a regulation, that is broader in scope or broader in application than required by this bill.
4. Specifies that these provisions do not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that any plume scavenging standards adopted by the board are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this section.
5. Requires the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of these provisions when installed, operated, and maintained in accordance with the manufacturer’s instructions.
6. Specifies that the use of surgical masks and the use of respirators do not satisfy the requirements of this bill except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.
7. Defines “electrocautery device” as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
8. Defines “electrosurgical device” as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
9. Defines “energy-based device” as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
10. Defines “health facility” as defined in subdivision (a) of Section 1250 of the Health and Safety Code including a general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
11. Defines “plume” as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
12. Defines “plume scavenging system” as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that, when used in concert with other engineering controls and equipment, and to the extent technologically feasible, capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.

Background

According to the National Institute for Occupational Safety and Health (NIOSH), “during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke “plume” can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.”^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. “But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA).”^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. “Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery.”^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

Pending Standard on Plume: This bill [AB 1007] is a reintroduction of two previous bills [AB 402 (Thurmond) of 2017 and AB 2272 (Thurmond) of 2016] which would have required Cal/OSHA to propose, and the Standards Board to adopt, a standard on plume. Both previous measures were vetoed by then Governor Brown. In his veto message for AB 402, Governor Brown stated that he “agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.”

On February 15, 2018, the California Nurses Association/National Nurses United submitted a petition to the Occupational Safety and Health Standards Board (Petition File No. 567) requesting the Standards Board amend Title 8, General Industry Safety Orders, to add standards addressing the removal of surgical plume/smoke. The Standards Board granted the petition to the extent that an advisory committee is convened by Cal/OSHA to determine if the Standards Board should move forward with a rulemaking. Cal/OSHA convened one meeting since and the rulemaking for the plume standard does not appear to be moving forward.

Need for this bill? According to the author, “AB 1007 would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. This bill would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to abate workplace exposure to surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and AB 1007 is a critical step forward in achieving this goal.”

Related/Prior Legislation

AB 402 (Thurmond, 2017, Vetoed) was nearly identical to AB 2272 from 2016.

AB 2272 (Thurmond, 2016, Vetoed), was substantially similar to this bill, would have required Cal/OSHA to convene an advisory committee to develop a regulation regarding the protection of health care personnel and patients from exposure to vaporized human tissue, defined as "plume”. This bill was vetoed by Governor Brown.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee:

• DIR would incur first-year costs of $332,000, and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). DIR notes that (1) although this bill would require adoption of a final regulation by July 1, 2025, the regulatory process often takes multiple years to conclude, and (2) Cal/OSHA could incur enforcement costs once the regulations are in place.
• The bill would likely result in unknown, but potentially significant costs to the Standards Board resulting from additional rulemaking activities.

SUPPORT: (Verified 9/1/23)

California Nurses Association/National Nurses United (source)

Board of Registered Nursing, CA Department of Consumer Affairs
California Labor Federation
California Nurses Association
United Nurses Associations of California/Union of Health Care Professionals

OPPOSITION: (Verified 9/1/23)

California Chamber of Commerce

California Hospital Association

ARGUMENTS IN SUPPORT: The sponsors of the measure, the California Nurses Association/National Nurses United, writes, “Surgical plume or smoke, which is the toxic byproduct of laser and electrosurgery procedures that destroy human tissue, poses an occupational hazard to nurses and other health care workers. Fortunately, workplace protection from surgical smoke is relatively simple - a smoke evacuation device (also known as plume scavenging systems) should be used every time electro- or laser surgery is performed and surgical smoke is generated. AB 1007 would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025.”

ARGUMENTS IN OPPOSITION: The California Hospital Association and the California Chamber of Commerce are opposed unless amended arguing, among other things, “it is important to recognize that plume scavenging systems directly influence patient care decisions. Hospital leaders, alongside their clinician partners, select devices that may generate plume (including those that minimize exposure to plume) because of the patient care considerations. In situations where a plume scavenging system creates patient safety or care concerns, physicians and hospitals should not be asked to choose between best care practices and patient safety and compliance with the law. This special concern about patient safety must be accounted for.”

Additionally, they argue that this bill “would limit the use of respirators as a tool to comply with the plume regulatory standard. While existing plume standards discourage the use of surgical masks as a plume remediation tool, there is no evidence to support the prohibition of respirators as a compliance method. Respirators provide high levels of protection against numerous airborne contaminates. The language restricting the use of respirators should be removed.”

ASSEMBLY FLOOR: 61-16, 5/31/23

AYES: Addis, Aguiar-Curry, Alvarez, Arambula, Bains, Bauer-Kahan, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Grayson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NOES: Alanis, Chen, Megan Dahle, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Hoover, Mathis, Jim Patterson, Joe Patterson, Sanchez, Ta, Wallis

NO VOTE RECORDED: Bennett, Lackey, Stephanie Nguyen

Prepared by: Alma Perez-Schwab / L., P.E. & R. / (916) 651-1556

9/2/23 14:07:35

**** END ****

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke from Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 1007 (Ortega) - Occupational safety and health standards: plume

Bill Summary:

AB 1007 would (1) require the Department of Industrial Relations’ (DIR) Division of Occupational Safety and Health (Cal/OSHA) to submit to the Occupational Safety and Health Standards Board (Standards Board) a proposed regulation requiring a health facility to evacuate or remove “plume” with the use of plume scavenging systems in all settings where plume is created, as specified, and (2) require the Standards Board to consider for adoption such a proposed regulation by July 1, 2025.

Fiscal Impact:

• DIR would incur first-year costs of $332,000, and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). DIR notes that (1) although this bill would require adoption of a final regulation by July 1, 2025, the regulatory process often takes multiple years to conclude, and (2) Cal/OSHA could incur enforcement costs once the regulations are in place.
• The bill would likely result in unknown, but potentially significant costs to the Standards Board resulting from additional rulemaking activities.

Background:

According to the National Institute for Occupational Safety and Health (NIOSH), “during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research confirms that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations ,the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.”

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. “But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA).”

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. “Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery.” AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.

On February 15, 2018, the California Nurses Association/National Nurses United submitted a petition to the Standards Board requesting that it add standards addressing the removal of surgical plume/smoke. The Standards Board granted the petition to the extent that an advisory committee is convened by CalOSHA to determine if the Standards Board should move forward with a rulemaking. In response, Cal/OSHA convened an advisory meeting to consider development of a rulemaking proposal to protect employees from surgical plume and smoke.

The first advisory committee meeting held on the matter was in November, 2018 where a discussion draft for a standard was discussed. Stakeholders and the public had an opportunity to provide input on information and scientific data on surgical plume and smoke hazards, control measures, feasibility, or costs. Written comments were subsequently accepted. Cal/OSHA has not held another advisory committee meeting since and formal rulemaking of the plume standard does not appear to be moving forward. However, the COVID-19 pandemic and the emergency actions and regulations that had to be taken and developed to protect workers statewide required much of Cal/OSHA’s resources in recent years.

Proposed Law:

This bill would, among other things, do the following:

• Require Cal/OSHA, by January 1, 2025, to submit to the Standards Board a proposed regulation requiring a health facility to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and requires the Board to consider for adoption such a regulation by July 1, 2025.
• Require Cal/OSHA in developing regulations to do all of the following:
  • Evaluate plume evacuation standards using, as a benchmark, the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization and the standards titled “Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings” (CSA Z305.13-13) adopted by the CSA Group.
  • Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
  • Take into consideration the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
  • Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume including, but not limited to, training on the following: general education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility.
  • Include a requirement that a plume scavenging system be included as engineering or work practice controls.
  • Include a requirement for appropriate practices and other controls necessary to prevent employee exposure to plume in situations where a plume scavenging system could interfere with a medical procedure.
• Specify that these provisions do not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that these plume scavenging standards are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this section.
• Require the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of these provisions when installed, operated, and maintained in accordance with the manufacturer’s instructions.
• Specify that the use of surgical masks and the use of respirators do not satisfy the requirements of this bill except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.
• Define “electrocautery device” as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
• Define “electrosurgical device” as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
• Define “energy-based device” as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
• Define “health facility” as defined in subdivision (a) of Section 1250 of the Health and Safety Code including a general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
• Define “plume” as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
• Define “plume scavenging system” as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that, when used in concert with other engineering controls and equipment, and to the extent technologically feasible, capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.

Related Legislation:

• AB 402 (Thurmond, 2017) was nearly identical to AB 2272, and was vetoed by the Governor.
• AB 2272 (Thurmond, 2016), was substantially similar to this bill, and would have required Cal/OSHA to convene an advisory committee to develop a regulation regarding the protection of health care personnel and patients from exposure to vaporized human tissue, defined as "plume”. This bill was vetoed by Governor Brown who stated:

Staff Comments:

Any local government costs resulting from the mandate in this measure are not state-reimbursable because the mandate only involves the definition of a crime or the penalty for conviction of a crime.

-- END --

SENATE COMMITTEE ON LABOR, PUBLIC EMPLOYMENT AND RETIREMENT

Senator Dave Cortese, Chair

2023 - 2024 Regular

Bill No: AB 1007 Hearing Date: June 28, 2023

SUBJECT: Occupational safety and health standards: plume

KEY ISSUE

Should the Legislature require the Division of Occupational Safety and Health to submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove “plume” with the use of plume scavenging systems in all settings where plume is created?

Should the Occupational Safety and Health Standards Board be required to adopt such a proposed regulation by January 1, 2025?

ANALYSIS

Existing law:

1. Establishes the Division of Occupational Safety and Health (Cal/OSHA), within the Department of Industrial Relations (DIR), to, among other things, propose, administer, and enforce occupational safety and health standards. (Labor Code §6300 et seq.)
2. Requires, under the California Occupational Safety and Health Act, an employer to:
   1. Furnish employment and a place of employment that is safe and healthful for its employees.
   2. Furnish and use safety devices and safeguards, and to adopt and use practices, means, methods, operations, and processes, which are reasonably adequate to render employment and the place of employment safe and healthful.
   3. Do everything reasonably necessary to protect the life, safety, and health of employees. (Lab. Code, § 6300 et seq.)
3. Establishes the Occupational Safety and Health Standards Board (Standards Board), within DIR, as the standards-setting agency to promote, adopt and maintain reasonable and enforceable standards that will ensure a safe and healthful workplace for workers. (Labor Code §140, §142.3, and §144.6).
4. Stipulates that in promulgating standards dealing with toxic materials or harmful physical agents, the Board shall adopt standards to prevent employees from suffering adverse health effects even if these employees have regular exposure to a regulated hazard (Labor Code §144.6).

This bill:

1. Requires Cal/OSHA, by June 1, 2024, to submit to the Occupational Safety and Health Standards Board a proposed regulation requiring a health facility to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and requires the Board to adopt such a regulation by January 1, 2025.
2. Requires Cal/OSHA in developing regulations to do all of the following:
   1. Evaluate plume evacuation standards using, as a benchmark, the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization and the standards titled “Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings” (CSA Z305.13-13) adopted by the CSA Group.
   2. Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
   3. Take into consideration the standards titled “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
   4. Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume including, but not limited to, training on the following:
      1. General education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility.
3. Provides that the provisions of this bill do not limit the authority of Cal/OSHA to develop a regulation, or the authority of Board to adopt a regulation, that is broader in scope or broader in application than required by this bill.
4. Specifies that these provisions do not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that these plume scavenging standards are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this section.
5. Requires the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of these provisions when installed, operated, and maintained in accordance with the manufacturer’s instructions.
6. Specifies that the use of surgical masks and the use of respirators do not satisfy the requirements of this bill except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.
7. Defines “electrocautery device” as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
8. Defines “electrosurgical device” as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
9. Defines “energy-based device” as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
10. Defines “health facility” as defined in subdivision (a) of Section 1250 of the Health and Safety Code including a general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
11. Defines “plume” as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
12. Defines “plume scavenging system” as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.

COMMENTS

1. Background on Plume:

According to the National Institute for Occupational Safety and Health (NIOSH), “during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.”^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. “But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA).”^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. “Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery.”^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

2. Pending Standard on Plume:

This bill [AB 1007] is a reintroduction of two previous bills [AB 402 (Thurmond) of 2017 and AB 2272 (Thurmond) of 2016] which would have required Cal/OSHA to propose, and the Standards Board to adopt, a standard on plume. Both previous measures were vetoed by then Governor Brown. In his veto message for AB 402, Governor Brown stated that he “agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.”

On February 15, 2018, the California Nurses Association/National Nurses United submitted a petition to the Occupational Safety and Health Standards Board (Petition File No. 567) requesting the Standards Board amend Title 8, General Industry Safety Orders, to add standards addressing the removal of surgical plume/smoke. The Standards Board granted the petition to the extent that an advisory committee is convened by the Division of Occupational Safety and Health to determine if the Standards Board should move forward with a rulemaking. In response, Cal/OSHA convened an advisory meeting to consider development of a rulemaking proposal to protect employees from surgical plume and smoke.

The first advisory committee meeting held on the matter was on November 8, 2018 where a discussion draft for a standard was discussed. Stakeholders and the public had an opportunity to provide input on information and scientific data on surgical plume and smoke hazards, control measures, feasibility, or costs. Written comments were subsequently accepted. Cal/OSHA has not held another advisory committee meeting since and formal rulemaking of the plume standard does not appear to be moving forward. However, staff notes that since 2019 the COVID-19 pandemic and the emergency actions and regulations that had to be taken and developed to protect workers statewide required much of Cal/OSHA’s resources.

3. Need for this bill?

According to the author, “AB 1007 would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. This bill would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to abate workplace exposure to surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and AB 1007 is a critical step forward in achieving this goal.”

4. Proponent Arguments:

The sponsors of the measure, the California Nurses Association/National Nurses United, writes, “Surgical plume or smoke, which is the toxic byproduct of laser and electrosurgery procedures that destroy human tissue, poses an occupational hazard to nurses and other health care workers. Fortunately, workplace protection from surgical smoke is relatively simple - a smoke evacuation device (also known as plume scavenging systems) should be used every time electro- or laser surgery is performed and surgical smoke is generated. AB 1007 would simply require Cal/OSHA and the OSHSB finalize an occupational safety and health standard on surgical smoke, which has been in development for over 5 years, by January 1, 2025.”

The sponsors additionally note that, “While California has led on other critical occupational safety and health issues in other areas, our state is behind the curve on protecting health care workers and patients from the hazards of surgical plume. Both the Joint Commission on Accreditation of Healthcare Organizations and NIOSH have called for the reduction of surgical plume exposure to health care workers.^[5] To date, several states, including Arizona, Colorado, Connecticut, Georgia, Illinois, Kentucky, New Jersey, New York, Oregon, Rhode Island, and Washington have already passed legislation to make the use of smoke evacuators in operating theaters mandatory.” They conclude that stating that this legislation is a critical next step in the ongoing need for protection of health care workers.

5. Opponent Arguments:

The California Hospital Association and the California Chamber of Commerce are opposed unless amended arguing, “First, the definition of a “plume scavenging system” does not reflect current technological capabilities. Specifically, the bill would require that the system either neutralizes or captures all plume, yet there does not appear to exist any plume system that captures or neutralizes all plume. Rather, existing plume systems are capable only of reducing the amount of plume by capturing particles. Also, the legislation is unclear if the requirement that the plume scavenging system neutralize all plume “before plume can make ocular contact or contact with the respiratory tract of employees” refers to the plume system in isolation or working in concert with other engineering controls or equipment.”

They additionally argue that, “the legislature cannot compel an independent regulatory board (such as Cal/OSHA) to adopt a draft regulation. Instead, AB 1007 should be amended to reflect the legal truth: the Board can be compelled to consider the draft before it, but cannot be compelled to approve, as the bill currently suggests.” Furthermore, they note, “it is important to recognize that plume scavenging systems directly influence patient care decisions. Hospital leaders, alongside their clinician partners, select devices that may generate plume (including those that minimize exposure to plume) because of the patient care considerations. In situations where a plume scavenging system creates patient safety or care concerns, physicians and hospitals should not be asked to choose between best care practices and patient safety and compliance with the law. This special concern about patient safety must be accounted for.”

Lastly, they write, “as currently drafted, AB 1007 would limit the use of respirators as a tool to comply with the plume regulatory standard. While existing plume standards discourage the use of surgical masks as a plume remediation tool, there is no evidence to support the prohibition of respirators as a compliance method. Respirators provide high levels of protection against numerous airborne contaminates. The language restricting the use of respirators should be removed.”

6. Staff Comments:

The California Hospital Association has raised concerns, noted above, and recommended amendments to the bill to address them. Specifically, the opposition notes that the bill would require that the plume scavenging system either neutralizes or captures all plume, yet there does not appear to exist any plume system that captures or neutralizes all plume. They argue that existing plume systems are capable only of reducing the amount of plume by capturing particles. The author may wish to address this concern by specifying that until technologies that completely eliminate plume are available, the scavenging systems shall reduce plume.

Additionally, CHA raised concerns with the provision of the bill that requires the Standards Board to adopt the standard proposed by Cal/OSHA by the specified date. As noted by CHA and Governor Brown in the veto message for AB 2272 (noted below), mandating the Standards Board to adopt the Cal/OSHA proposal divests the Board of its discretion to consider a proposed standard for adoption. The author may wish to address this issue by instead requiring the Standards Board to consider for adoption the proposed standard by the specified date.

CHA is also concerned with how plume scavenging systems directly influence patient care decisions. The author may wish to include a provision requiring Cal/OSHA, in the process of developing regulations, to also consider and include guidance on the proper use of plume scavenging systems while ensuring patient care.

Committee staff is working with the author and legislative counsel on amendments to address the concerns outlined above.

7. Prior Legislation:

AB 402 (Thurmond, 2017, Vetoed) was nearly identical to AB 2272 from 2016. The bill was vetoed by Governor Brown who stated:

The creation of new occupational safety and health standards does not require legislation; any member of the public may petition the Standards Board to consider creating a new safety regulation. I agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.

AB 2272 (Thurmond, 2016, Vetoed), was substantially similar to this bill, would have required Cal/OSHA to convene an advisory committee to develop a regulation regarding the protection of health care personnel and patients from exposure to vaporized human tissue, defined as "plume”. This bill was vetoed by Governor Brown who stated:

I agree with the author and sponsor that the potentially hazardous effects of plume merits thorough review. By specifically requiring the adoption of the regulation, however, the bill divests the Standards Board of its discretion to consider a proposed standard for adoption and instead mandates it to do so. This Board was created as an independent body and I believe that independence must be maintained in order for it to effectively perform its mission and protect all California workers.

SUPPORT

California Nurses Association/National Nurses United (Sponsor)

Board of Registered Nursing, CA Department of Consumer Affairs
California Labor Federation
California Nurses Association
United Nurses Associations of California/Union of Health Care Professionals

OPPOSITION

California Chamber of Commerce

California Hospital Association

-- END --

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke from Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑

5. U.S. Department of Health and Human Services, National Institute of Occupational Safety and Health, “Control of Smoke From Laser/Electric Surgical Procedures,” DHHS (NIOSH) Publication Number 96-128, 1996, available at: https://www.cdc.gov/niosh/docs/hazardcontrol/hc11.html. ↑

ASSEMBLY THIRD READING

ATR Bill Id:AB 1007

Author:(Ortega)

As Introduced Ver:February 15, 2023

Majority vote

SUMMARY

Requires, by June 1, 2024, the Division of Occupational Safety and Health (Cal/OSHA) to submit a proposed regulation to the Occupational Safety and Health Standards Board (Board), requiring a health facility to evacuate or remove plume, as defined, in all settings that employ techniques that involve the creation of plume and requires the Board to adopt a regulation proposed by Cal/OSHA by January 1, 2025.

Major Provisions

1. Defines "electrocautery device" as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
2. Defines "electrosurgical device" as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
3. Defines "energy-based device" as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
4. Defines "health facility" as general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
5. Defines "plume" as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
6. Defines "plume scavenging system" as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.
7. Requires Cal/OSHA in developing regulations to do all of the following:
   1. Evaluate plume evacuation standards using, as a benchmark, "Systems for evacuation of plume generated by medical devices" (ISO 16571) adopted by the International Organization for Standardization and the standards titled "Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings" (CSA Z305.13-13) adopted by the CSA Group.
   2. Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
   3. Take into consideration, specified existing international standards, in developing a standard establishing how much plume will be captured by a plume scavenging system.
   4. Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume.
8. Provides that the provisions of this bill do not limit the authority of Cal/OSHA to develop a regulation, or the authority of Board to adopt a regulation, that is broader in scope or broader in application than required by this section.
9. Specifies that this section does not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that these plume scavenging standards are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this section.
10. Requires the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of this section when installed, operated, and maintained in accordance with the manufacturer's instructions.
11. Specifies that use of surgical masks does not satisfy the requirements of this section and the use of respirators does not satisfy the requirements of this section except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.

COMMENTS

According to the National Institute for Occupational Safety and Health (NIOSH), "during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential."^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. "But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA)."^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. "Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery."^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

According to the Author

"[This bill] would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to prevent workplace exposure to toxic surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and [this bill] is a critical step forward in achieving this goal."

In addition, the author points out that [this bill] will promote equity solutions and maximize benefits for underserved and marginalized communities by addressing "a pressing worker safety issue, allowing nurses, a mostly female workforce, doctors, and other healthcare workers to stay safe as frontline workers and available for their respective communities and families."

Arguments in Support

The California Nurses Association/National Nurses United (CNA), sponsor of this bill, states, "Surgical plume is also known to contain mutagenic (cancer producing) particles.

Peer-reviewed studies have confirmed surgical plume's mutagenic potential. One study equated the mutagenic condensate, generated from just one gram of tissue destroyed by lasers, to smoking three cigarettes, and a gram of tissue destroyed by electrocautery smoke, to smoking six cigarettes! Surgical plume can also cause ocular and upper respiratory tract irritation. It has even been linked to cases involving laryngeal papillomatosis.

California is one of only 21 states (plus Puerto Rico) that has an OSHA approved state plan that allows for the adoption of occupational standards without having to resort to the onerous federal process. California can and should take the lead on this critical issue as it has in other areas, such as occupational exposure to blood borne pathogens, Ebola virus, safe patient handling, and workplace violence standards. CNA is proud to have led the way in promoting these and other occupational protections for healthcare workers and for the minimal cost of 1,000 - $5,000 for equipment operated at about 11 cents per second, this legislation is a critical next step in the ongoing need for protection of healthcare workers."

Arguments in Opposition

The California Hospital Association, in opposition, states, "First, the definition of a "plume scavenging system" does not reflect current technological capabilities. Specifically, the bill would require that the system either neutralizes or captures all plume, yet there does not appear to exist any plume system that captures or neutralizes all plume. Rather, existing plume systems are capable only of reducing the amount of plume by capturing particles. Also, the legislation is unclear if the requirement that the plume scavenging system neutralize all plume "before plume can make ocular contact or contact with the respiratory tract of employees" refers to the plume system in isolation or working in concert with other engineering controls or equipment.

Second, the regulatory process set out by [this bill] is a sharp departure from existing practice and law. Specifically, [this bill] would require that the Division of Occupational Safety and Health (Cal/OSHA) develop a regulatory framework to address plume and then requires that the Occupational Safety and Health Standards Board (OSHSB) adopt the regulations from the division. Under Labor Code Section 142.3, the OSHSB has the authority to develop occupational safety standards, and failure to follow existing law could diminish hospitals' ability to work through the regulatory process to address patient care and operational concerns."

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

1. Costs of approximately $332,000 in the first year and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). Although this bill requires adoption of a final regulation by January 1, 2025, the regulatory process often takes multiple years to conclude. Cal/OSHA also anticipates additional enforcement costs, dependent on the scope of the enacted plume regulation.
2. Costs of an unknown, but potentially significant, amount to the OSHA Board in staff workload to undertake additional rulemaking activities.

VOTES

ASM LABOR AND EMPLOYMENT: 5-2-0

YES: Kalra, Haney, Ortega, Reyes, Ward

NO: Flora, Chen

ASM APPROPRIATIONS: 11-4-1

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Ortega

NO: Megan Dahle, Dixon, Mathis, Sanchez

ABS, ABST OR NV: Robert Rivas

UPDATED

VERSION: February 15, 2023

CONSULTANT: Martin Vindiola / L. & E. / (916) 319-2091 FN: 0000506

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke From Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑

Date of Hearing: April 19, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 1007

Author:(Ortega) – As Introduced Ver:February 15, 2023

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires the Division of Occupational Safety and Health (Cal/OSHA) to submit, by June 1, 2024, and the Occupational Safety and Health Standards Board (OSHA Board) to adopt, by January 1, 2025, a proposed regulation requiring a health facility to remove plume through the use of a plume scavenging system.

Specifically, this bill:

1. Requires Cal/OSHA to consider recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration (OSHA) and other specified resources when developing the proposed regulation.
2. Requires Cal/OSHA’s proposed regulation to include a requirement for employers to provide specified training to all workers foreseeably participating in procedures involving the creation of plume.
3. Provides that certain interventions, such as compliance with general room ventilation standards or use of surgical masks, do not satisfy plume protection requirements.
4. Requires the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when operated in accordance with the manufacturer’s instructions.

FISCAL EFFECT:

1. Costs of approximately $332,000 in the first year and $281,000 for each subsequent year the proposed rulemaking is underway at Cal/OSHA (Occupational Safety and Health Fund). Although this bill requires adoption of a final regulation by January 1, 2025, the regulatory process often takes multiple years to conclude. Cal/OSHA also anticipates additional enforcement costs, dependent on the scope of the enacted plume regulation.
2. Costs of an unknown, but potentially significant, amount to the OSHA Board in staff workload to undertake additional rulemaking activities.

COMMENTS:

1. Purpose. According to the author, requiring the use of a plume scavenging system “would ensure that feasible control measures are utilized to prevent workplace exposure to toxic surgical plume and smoke” and “provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke.”
2. Support and Opposition. This bill is sponsored by the California Nurses Association/National Nurses United, which argues the mutagenic (cancer producing) condensate generated from one gram of tissue destroyed by lasers is equivalent to smoking three cigarettes, with the mutagenic condensate from the same amount of tissue destroyed by electrocautery smoke equivalent to smoking six cigarettes. This bill is also supported by the California Labor Federation.

This bill is opposed by the California Hospital Association (CHA), which argues “there does not appear to exist any plume system that captures or neutralizes all plume” as required by this bill. CHA also notes this bill’s deviation from the existing regulatory process “could diminish hospitals’ ability to work through the regulatory process to address patient care and operational concerns.”

1. What is Plume? This bill defines “plume” as noxious airborne contaminants generated as byproducts of the use of electric devices or mechanic tools during surgical, diagnostic, or therapeutic procedures. According to the National Institute for Occupational Safety and Health (NIOSH):

Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon.

When engineering controls such as smoke evacuation cannot control plume during a procedure, OSHA and other organizations recommend the use of particulate respirators to reduce airborne particulate exposures in certain situations. However, a 2016 NIOSH study found only 14% of healthcare personnel exposed to surgical smoke reported evacuation of plume during electrosurgery and 47% of personnel reported evacuation of plume during laser surgery. As part of a national effort by the Association of Preoperative Registered Nurses, Rhode Island and Colorado became the first states to require surgical smoke evacuation polices. This bill requires development and adoption of a proposed regulation requiring plume removal at health facilities in California.

1. Prior Legislation. AB 402 (Thurmond), of the 2017-18 Legislative Session, would have required Cal/OSHA to convene an advisory committee to develop a regulation requiring a health facility to evacuate plume through a plume scavenging system, and would have required the OSHA Board to adopt this proposed regulation. AB 402 was vetoed by Governor Brown, who stated:

The creation of new occupational safety and health standards does not require legislation; any member of the public may petition the Standards Board to consider creating a new safety regulation. I agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.

AB 2272 (Thurmond), of the 2015-16 Legislative Session, was substantively identical to AB 402. AB 2272 was also vetoed by Governor Brown, with a similar message:

By specifically requiring the adoption of the regulation, however, the bill divests the Standards Board of its discretion to consider a proposed standard for adoption and instead mandates it to do so. The Board was created as an independent body and I believe that independence must be maintained in order for it to effectively perform its mission and protect all California workers.

Analysis Prepared by: Irene Ho / APPR. / (916) 319-2081

Date of Hearing: March 22, 2023

ASSEMBLY COMMITTEE ON LABOR AND EMPLOYMENT

Ash Kalra, Chair

ABPCA Bill Id:AB 1007 (

Author:Ortega) – As Introduced Ver:February 15, 2023

SUBJECT: Occupational safety and health standards: plume

SUMMARY: Requires, by June 1, 2024, the Division of Occupational Safety and Health (Cal/OSHA) to submit a proposed regulation to the Occupational Safety and Health Standards Board (Board), requiring a health facility to evacuate or remove plume, as defined, in all settings that employ techniques that involve the creation of plume and requires the Board to adopt a regulation proposed by Cal/OSHA by January 1, 2025. Specifically, this bill:

1. Defines “electrocautery device” as a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
2. Defines “electrosurgical device” as a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
3. Defines “energy-based device” as a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
4. Defines “health facility” as general acute care hospital having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services.
5. Defines “plume” as noxious airborne contaminants generated as byproducts of the use of energy-based devices, electrosurgical devices, electrocautery devices, or mechanical tools during surgical, diagnostic, or therapeutic procedures.
6. Defines “plume scavenging system” as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of employees.
7. Requires Cal/OSHA in developing regulations to do all of the following:
   1. Evaluate plume evacuation standards using, as a benchmark, “Systems for evacuation of plume generated by medical devices” (ISO 16571) adopted by the International Organization for Standardization and the standards titled “Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings” (CSA Z305.13-13) adopted by the CSA Group.
   2. Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
   3. Take into consideration, specified existing international standards, in developing a standard establishing how much plume will be captured by a plume scavenging system.
   4. Include a requirement in the regulation for employers to provide training, as specified, to all workers foreseeably participating in procedures that involve the creation of plume.
8. Provides that the provisions of this bill do not limit the authority of Cal/OSHA to develop a regulation, or the authority of Board to adopt a regulation, that is broader in scope or broader in application than required by this section.
9. Specifies that this section does not alter, amend, expand, or reduce existing general room ventilation standards or requirements and that these plume scavenging standards are in addition to general room ventilation standards or requirements, and compliance with general room ventilation standards does not satisfy the requirements of this section.
10. Requires the manufacturers to provide evidence that the plume scavenging system conforms to the minimum requirements of this section when installed, operated, and maintained in accordance with the manufacturer’s instructions.
11. Specifies that use of surgical masks does not satisfy the requirements of this section and the use of respirators does not satisfy the requirements of this section except when, due to medical necessity, the plume scavenging system is unable to be located where it effectively captures plume.

EXISTING LAW:

1. Establishes Cal/OSHA within the Department of Industrial Relations (DIR) to, among other things, propose, administer, and enforce occupational safety and health standards.
   (Labor Code §6300 et seq.)
2. Requires, under the California Occupational Safety and Health Act, an employer to:
   1. Furnish employment and a place of employment that is safe and healthful for its employees.
   2. Furnish and use safety devices and safeguards, and to adopt and use practices, means, methods, operations, and processes, which are reasonably adequate to render employment and the place of employment safe and healthful.
   3. Do everything reasonably necessary to protect the life, safety, and health of employees. (Lab. Code, § 6300 et seq.)
3. Establishes the Board within DIR, to promote, adopt, and maintain reasonable and enforceable standards that will ensure a safe and healthful workplace for workers.
   (Lab. Code, § 140 et seq.)
4. Requires the Board, when promulgating standards dealing with toxic materials or harmful physical agents, to adopt a standards to prevent employees from suffering adverse health effects even if those employees have regular exposure to a regulated hazard.
   (Lab. Code, § 144.6.)

FISCAL EFFECT: Unknown

COMMENTS: According to the National Institute for Occupational Safety and Health (NIOSH), “during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.”^[1]

The current line of risk management strategies indicates that the primary means for controlling laser plume and electrocautery emissions is through effective engineering controls, such as smoke evacuation among other engineering controls. “But if the plume cannot be controlled through these means, then the use of particulate respirators (within respiratory protection program standards) to reduce airborne particulate exposures (those that may be subject to more uncertain pathogen exposure characteristics and subsequent health implications) during laser surgery is recommended in certain situations by the Association of Preoperative Registered Nurses (AORN), Center for Disease Control (CDC)/NIOSH and the Occupational Safety and Health Administration (OSHA).”^[2]

Since the 1990s, AORN has recommended the evacuation of all surgical smoke. “Yet, surgical smoke is still inhaled daily by nurses in the operating room. In a 2016 study, NIOSH surveyed health care personnel who were exposed to surgical smoke. Their results indicated that of respondents who worked within five feet of the source of surgical smoke only 14% reported that it was evacuated during electrosurgery and 47% during laser surgery.”^[3] AORN is currently leading legislative efforts for surgical smoke-free operating rooms across the United States. Rhode Island and Colorado became the first states to require surgical smoke evacuation policies by law.^[4]

According to the author, “[This bill] would provide necessary protection for healthcare workers and patients against the toxic chemicals, infectious particles, and gases found in surgical smoke. By requiring the use of a plume scavenging system, this bill would ensure that feasible control measures are utilized to prevent workplace exposure to toxic surgical plume and smoke. It is imperative that California takes action to prioritize the health and safety of our healthcare workers and patients, and [this bill] is a critical step forward in achieving this goal.”

In addition, the author points out that [this bill] will promote equity solutions and maximize benefits for underserved and marginalized communities by addressing “a pressing worker safety issue, allowing nurses, a mostly female workforce, doctors, and other healthcare workers to stay safe as frontline workers and available for their respective communities and families.”

Arguments in Support

The California Nurses Association/National Nurses United (CNA), sponsor of the bill, states, “Surgical plume is also known to contain mutagenic (cancer producing) particles.

Peer-reviewed studies have confirmed surgical plume’s mutagenic potential. One study equated the mutagenic condensate, generated from just one gram of tissue destroyed by lasers, to smoking three cigarettes, and a gram of tissue destroyed by electrocautery smoke, to smoking six cigarettes! Surgical plume can also cause ocular and upper respiratory tract irritation. It has even been linked to cases involving laryngeal papillomatosis.

California is one of only 21 states (plus Puerto Rico) that has an OSHA approved state plan that allows for the adoption of occupational standards without having to resort to the onerous federal process. California can and should take the lead on this critical issue as it has in other areas, such as occupational exposure to blood borne pathogens, Ebola virus, safe patient handling, and workplace violence standards. CNA is proud to have led the way in promoting these and other occupational protections for healthcare workers and for the minimal cost of 1,000 - $5,000 for equipment operated at about 11 cents per second, this legislation is a critical next step in the ongoing need for protection of healthcare workers.”

Arguments in Opposition

The California Hospital Association, in opposition, states, “First, the definition of a “plume scavenging system” does not reflect current technological capabilities. Specifically, the bill would require that the system either neutralizes or captures all plume, yet there does not appear to exist any plume system that captures or neutralizes all plume. Rather, existing plume systems are capable only of reducing the amount of plume by capturing particles. Also, the legislation is unclear if the requirement that the plume scavenging system neutralize all plume “before plume can make ocular contact or contact with the respiratory tract of employees” refers to the plume system in isolation or working in concert with other engineering controls or equipment.

Second, the regulatory process set out by [this bill] is a sharp departure from existing practice and law. Specifically, [this bill] would require that the Division of Occupational Safety and Health (Cal/OSHA) develop a regulatory framework to address plume and then requires that the Occupational Safety and Health Standards Board (OSHSB) adopt the regulations from the division. Under Labor Code Section 142.3, the OSHSB has the authority to develop occupational safety standards, and failure to follow existing law could diminish hospitals’ ability to work through the regulatory process to address patient care and operational concerns.”

Prior Legislation

AB 402 (Thurmond) of 2017 would have required the Board to adopt standards to protect healthcare personnel and patients from noxious airborne contaminants "plume" generated during specified medical procedures. This bill was vetoed by Governor Brown.

AB 2272 (Thurmond) of 2016 would have required Cal/OSHA to convene an advisory committee to develop a regulation regarding the protection of health care personnel and patients from exposure to vaporized human tissue, defined as "plume”. This bill was vetoed by Governor Brown.

REGISTERED SUPPORT / OPPOSITION:

Support

California Nurses Association (Sponsor)
California Labor Federation

Oppose Unless Amended

California Hospital Association

Analysis Prepared by: Martin Vindiola / L. & E. /

1. National Institute for Occupational Safety and Health. Publication Number 96-128: Control of Smoke From Laser/Electric Surgical Procedures, 1996. ↑

2. 3M Science Applied to Life™: Technical Bulletin. Particulate Respirator Use for Surgical Smoke, July 2020. ↑

3. Ogg, Mary, J. Surgical Smoke Inhalation: Dangerous Consequences for the Surgical Team. NIOSH Science Blog, June 2018. ↑

4. Ibid. ↑