Nuts & Bolts of Chemical Hygiene Plans David L. Patterson Retired Director of Environmental Health and Safety California State Polytechnic University Email: dlpatterson@cpp.edu (Revised: 01/26/2016)

Outline/Topics for Discussion Occupational Exposure to Hazardous Chemicals in Laboratories – Summary of the Regulation Chemical Hygiene Plan Construction Questions/Discussion

Summary of the Regulation Scope and Application   Applies “laboratory use of hazardous chemicals” which is “Laboratory scale” chemical manipulations; Multiple chemical procedures/chemicals; Non-production/Non-simulated process ; and "Protective practices and equipment" are available and in common use to minimize potential chemical exposure. Scope and Application   Applies to all employers engaged in the “laboratory use of hazardous chemicals”. Note: Laboratory use of hazardous chemicals. Handling/use in which all the following are met: “Laboratory scale” chemical manipulations; Multiple chemical procedures/chemicals; Non-production process procedures/Non-simulate production process; and "Protective practices and equipment" are available and in common use to minimize potential chemical exposure. Supersede, for laboratories, the requirements of Cal/OSHA’s Cotton Dust and Regulated Carcinogens Regulations, when a written Chemical Hygiene Plan has been developed and implemented. Except as follows: Exposure limits. When that particular regulation states otherwise (e.g. Section 5209(c)(6) which covers carcinogen safe work practices in laboratory activities) Prohibition or prevention of eye and skin contact where specified by any health regulation shall be observed. Where the action level (or in the absence of an action level, the exposure limit) is exceeded for a regulated substance with exposure monitoring and medical surveillance requirements. Carcinogen Report of Use Requirements. Formaldehyde Regulation (Section 5217) shall apply to anatomy, histology and pathology laboratories. This regulation shall not apply to: Uses of hazardous chemicals which do not meet the definition of laboratory use even if such use occurs in a laboratory. Laboratory uses of hazardous chemicals which provide no potential for employee exposure. Examples of such conditions might include: Procedures using chemically-impregnated test media such as Dip-and-Read tests where a reagent strip is dipped into the specimen to be tested and the results are interpreted by comparing the color reaction to a color chart supplied by the manufacturer of the test strip; Commercially prepared kits such as those used in performing pregnancy tests in which all of the reagents needed to conduct the test are contained in the kit.

Summary of the Regulation Scope and Application Conti-   Supersedes Cotton Dust and Carcinogens Regulations, if written Chemical Hygiene Plan has been implemented. Except as follows: Exposure limits. When the regulation states otherwise Prohibition or prevention of eye and skin contact. Where the action level (or in the absence of an action level, the exposure limit) is exceeded. Carcinogen Report of Use. Formaldehyde Regulation (Section 5217) applies to anatomy, histology and pathology laboratories. Scope and Application   Applies to all employers engaged in the “laboratory use of hazardous chemicals”. Note: Laboratory use of hazardous chemicals. Handling/use in which all the following are met: “Laboratory scale” chemical manipulations; Multiple chemical procedures/chemicals; Non-production process procedures/Non-simulate production process; and "Protective practices and equipment" are available and in common use to minimize potential chemical exposure. Supersede, for laboratories, the requirements of Cal/OSHA’s Cotton Dust and Regulated Carcinogens Regulations, when a written Chemical Hygiene Plan has been developed and implemented. Except as follows: Exposure limits. When that particular regulation states otherwise (e.g. Section 5209(c)(6) which covers carcinogen safe work practices in laboratory activities) Prohibition or prevention of eye and skin contact where specified by any health regulation shall be observed. Where the action level (or in the absence of an action level, the exposure limit) is exceeded for a regulated substance with exposure monitoring and medical surveillance requirements. Carcinogen Report of Use Requirements. Formaldehyde Regulation (Section 5217) shall apply to anatomy, histology and pathology laboratories. This regulation shall not apply to: Uses of hazardous chemicals which do not meet the definition of laboratory use even if such use occurs in a laboratory. Laboratory uses of hazardous chemicals which provide no potential for employee exposure. Examples of such conditions might include: Procedures using chemically-impregnated test media such as Dip-and-Read tests where a reagent strip is dipped into the specimen to be tested and the results are interpreted by comparing the color reaction to a color chart supplied by the manufacturer of the test strip; Commercially prepared kits such as those used in performing pregnancy tests in which all of the reagents needed to conduct the test are contained in the kit.

Summary of the Regulation  Scope and Application Conti- This regulation shall not apply to: Any use of chemicals not meeting the definition of laboratory use. Laboratory uses of chemicals which provide no potential for exposure. Examples might include: Procedures using chemically-impregnated test media such as Dip-and-Read tests; Commercially prepared kits such as those used in performing pregnancy tests.

Summary of the Regulation  Definitions Chemical Hygiene Officer. Designated and qualified employee to provide technical guidance in the development and implementation of the Chemical Hygiene Plan. Chemical Hygiene Plan. A written program which sets forth procedures, equipment, personal protective equipment and work practices that Capable of protecting employees from the health hazards presented by chemicals and Meets the requirements of a Chemical Hygiene Program listed below. Laboratory. A facility where the "laboratory use of hazardous chemicals" occurs. A workplace where relatively small quantities of chemicals are used on a non-production basis.

Summary of the Regulation  Definitions Conti- Laboratory scale. Work in which the containers used are designed to be easily and safety manipulated by one person. “Does not include workplaces to produce commercial quantities of materials. Laboratory use of hazardous chemicals. Handling or use of such chemicals in which all of the following conditions are met: “Laboratory scale“ Chemical manipulations; Multiple chemical procedures or chemicals; Not part of a production process/simulated production process; and "Protective laboratory practices and equipment" are available and in common use to minimize potential exposure.

Summary of the Regulation Exposure Limit - Exposures shall not exceed Cal OSHA exposure limits. Employee Exposure Determination for Regulated Substances   Initial exposure monitoring. If there is reason to believe that levels exceed the action level (or in the absence of an action level, the exposure limit). Periodic monitoring. If the initial monitoring indicated an exposure over the action level (or in the absence of an action level, the exposure limit. Termination of monitoring. Monitoring may be terminated in accordance with the relevant regulation. Notification of monitoring results. Within 15 working days after the receipt of results, in writing either individually or by posting results. 

Summary of the Regulation  Chemical Hygiene Plan (Written) Develop/carry out the Chemical Hygiene Plan capable of : Protecting employees from chemical health hazards and Keeping exposures below Cal OSHA exposure limits. Plan shall be readily available. Plan shall include the following elements and specific measures: Standard operating procedures for the safe/healthful use of chemicals; Criteria to determine/implement control measures to reduce exposure to chemicals. Particular attention shall be given to the selection of control measures for extremely hazardous chemicals. Control measures include: Engineering controls, Personal protective equipment and Hygiene practices

Summary of the Regulation  Chemical Hygiene Plan (Written) Conti- Fume Hoods and Protective Equipment: Requirement that fume hoods comply with Cal/OSHA Regulations(Section 5154.1) Protective equipment function properly Specific measures shall be taken to ensure proper and adequate performance of such equipment; Provisions for employee information and training (see Training); Prior approval circumstances for particular laboratory operations, procedures or activities;

Summary of the Regulation  Chemical Hygiene Plan (Written) Conti- Provisions for additional protection for particularly hazardous substances. These include: "select carcinogens," Reproductive toxins and Substances which have a high degree of acute toxicity. For particularly hazardous substances, specific consideration shall be given to the following which shall be included where appropriate; Establishment of a designated area; Use of containment devices such as fume hoods or glove boxes; Procedures for safe removal of contaminated waste; and Decontamination procedures.

Summary of the Regulation  Chemical Hygiene Plan (Written) Conti- Provisions for medical consultation and medical examinations (see medical consultation and medical examinations ); Designation of personnel responsible for implementation of the Plan Assignment of a Chemical Hygiene officer and If appropriate, establishment of a Chemical Hygiene Committee; Review and evaluate the effectiveness of the Chemical Hygiene Plan at least annually and update it as necessary.

Summary of the Regulation  Employee Information and Training Provide information/training to ensure that they are apprised of the hazards of chemicals or classes if appropriate. Information/training shall be provided initially and prior to new exposure situations. The frequency of refresher information and training shall be determined by the employer. Employees shall be informed of: Regulation and appendices which shall be available to employees; Location and availability of the Plan; Cal/OSHA exposure limits or recommended exposure limits for other chemicals; Signs and symptoms of chemical exposure; and Location/availability of reference material on the hazards, safe handling, storage and disposal of chemicals including, but not limited to, SDSs.

Summary of the Regulation  Employee Information and Training Conti- Training shall include: Methods and observations to detect the presence or release of a chemical (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.); The physical and health hazards of chemicals in the work area; and The measures to protect themselves from these hazards, including specific procedures implemented to protect employees from exposure to chemicals, such as: Appropriate work practices, Emergency procedures, and Personal protective equipment The applicable details of the Chemical Hygiene Plan.

Summary of the Regulation  Medical Consultation and Medical Examinations Employees shall have an opportunity to receive medical attention, including any follow-up examinations determined by the examining physician, under the following circumstances; Whenever an employee develops signs or symptoms associated with a chemical they may have been exposed to in the laboratory. Where monitoring reveals an exposure level above the Cal/OSHA action level (or in the absence of an action level, the exposure limit) Medical surveillance shall be established. Whenever an event takes place in the work area resulting in the likelihood of an exposure, the affected employee shall be provided an opportunity for a medical consultation to determine the need for a medical examination. Medical examinations and consultations shall be performed by or under the direct supervision of a licensed physician, at no cost to the employee, without loss of pay and at a reasonable time and place.

Summary of the Regulation  Medical Consultation and Medical Examinations Conti- The employer shall provide the following information to the physician; Chemical(s) to which the employee may have been exposed; Conditions under which the exposure occurred including quantitative exposure data, if available; and Description of the signs/symptoms of exposure Employer shall obtain a Physician's written opinion which includes: Any recommendation for further medical follow-up; Results and any associated tests, if requested by the employee; Any medical condition which may place the employee at increased risk as a result of chemical exposure and Statement that the employee has been informed of the results and any condition that may require further examination or treatment. The written opinion shall not reveal specific findings of diagnoses unrelated to occupational exposure.

Summary of the Regulation  Hazard Identification Labels on incoming containers of hazardous chemicals shall not be removed or defaced. Maintain safety data sheets and ensure that they are readily accessible . The following provisions shall apply to chemical substances developed in the laboratory; If the composition of the chemical substance which is produced exclusively for the laboratory's use is known, the employer shall determine if it is a hazardous chemical as defined above under “Definitions”. If the chemical is determined to be hazardous, the employer shall provide appropriate training as required under “Employee Information and Training” above.

Summary of the Regulation  Hazard Identification Conti- The following provisions shall apply to chemical substances developed in the laboratory Conti-; If the chemical produced is a byproduct whose composition is not known, the employer shall assume that the substance is hazardous and shall implement the Chemical Hygiene Plan. If the chemical substance is produced for commercial purposes by another user outside of the laboratory, the employer shall comply with the Hazard Communication Regulation (Section 5194) including the requirements for preparation of safety data sheets and labeling.

Summary of the Regulation  Use of Respirators   Where the use of respirators is necessary to maintain exposure below permissible exposure limits, the employer shall provide, at no cost to the employee, the proper respiratory equipment. Respirators shall be selected and used in accordance with Cal/OSHA’s Respiratory Protection Regulation (Section 5144).

Summary of the Regulation  Recordkeeping   Establish and maintain employee records with: An accurate record of any measurements taken to monitor employee exposures Any medical consultation and examinations including tests or written opinions required by this regulation. The employer shall ensure that such records are kept, transferred, and made available in accordance with Cal/OSHA’s Access to Employee Exposure and Medical Records Regulation (Section 3204). Dates Develop and implemented a written Chemical Hygiene Plan no later than October 31, 1991.

Chemical Hygiene Plan Construction Standard operating procedures (Example in Appendix B); Criteria to determine control measures (Example in Appendix C) Particular attention for control of extremely hazardous chemicals. Control measures include: Engineering controls: Fume Hoods, Glove Boxes, Local Exhaust Systems (Example in Appendix D), Personal protective equipment: Goggles, Lab Coats, Gloves (Example on Gloves in Appendix E) and Hygiene practices (Hand washing, cleaning equipment/surfaces, eating)

Chemical Hygiene Plan Construction Fume Hoods and Protective Equipment (Example in Appendix D) Information and training (Examples in Appendices F, G); Hazards of chemicals or classes if appropriate. Initially, prior to new exposure situations and refresher. Employees shall be informed of: Regulation and appendices which shall be available to employees; Location/availability of the Plan; Cal/OSHA exposure limits or recommended exposure limits for other chemicals; Signs and symptoms of exposure; and Location/availability of reference material on the hazards, handling, storage and disposal.

Chemical Hygiene Plan Construction Information and training Conti- Training shall include: Methods and observations to detect the presence or release of a chemical The physical and health hazards of chemicals in the work area; and The measures/ specific procedures to protect themselves, such as: Appropriate work practices, Emergency procedures, and Personal protective equipment The applicable details of the Chemical Hygiene Plan.

Chemical Hygiene Plan Construction Prior approval circumstances for particular laboratory operations, procedures or activities (Examples in Appendix H, & I); Provisions for additional protection for particularly hazardous substances. These include: "select carcinogens," Reproductive toxins and Substances which have a high degree of acute toxicity (Appendix I A.5. for Example Definition). For particularly hazardous substances, specific consideration shall be given to the following (Appendix J): Establishment of a designated area; Use of containment devices such as fume hoods or glove boxes; Procedures for safe removal of contaminated waste; and Decontamination procedures.

Chemical Hygiene Plan Construction Medical consultation and examinations; Employee medical attention, consultation and Initial/follow-up examinations under the following circumstances; Signs or symptoms associated with a chemical they may have been exposed to in the laboratory. Where monitoring reveals an exposure level above the Cal/OSHA action level (or in the absence of an action level, the exposure limit) Medical surveillance shall be established. Event resulting in the likelihood of an exposure. Medical examinations and consultations shall be performed by or under the direct supervision of a licensed physician, at no cost to the employee, without loss of pay and at a reasonable time and place.

Chemical Hygiene Plan Construction Information to the physician; Chemical(s); Conditions under which the exposure occurred; and Description of the signs/symptoms of exposure Employer shall obtain a Physician's written opinion which includes: Recommendation for medical follow-up; Results and any associated tests; Medical condition which may place the employee at increased risk and Statement that the employee has been informed of the results and any condition that may require further examination or treatment. The written opinion shall not reveal specific findings of diagnoses unrelated to occupational exposure. Designation of personnel responsible for implementation of the Plan Assignment of a Chemical Hygiene officer and If appropriate, establishment of a Chemical Hygiene Committee;