Introduction
Purpose
The purpose of this Laboratory Safety and Chemical Hygiene Plan is to provide guidance for the safe handling of all hazardous chemicals in laboratories; ensure compliance with OSHA, EPA, and other applicable regulations; and demonstrate that this Plan meets or exceeds the requirements of OSHA’s Laboratory Safety Standard, 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories.
Regulatory Basis
On January 31, 1990, the Occupational Safety and Health Administration (OSHA) promulgated a final rule entitled Occupational Exposures to Hazardous Chemicals in Laboratories (commonly known as "The Laboratory Standard" - see 1910.1450, Appendix A). The basis for this standard is a determination that laboratories differ from industrial operations in their use and handling of hazardous chemicals and that a different approach than that found in OSHA's substance specific health standards is warranted to protect workers. This standard does not establish new exposure limits, but sets other performance provisions designed to protect laboratory workers from potential hazards in their work environment.
The development and implementation of a chemical hygiene plan (Laboratory Safety and Chemical Hygiene Plan) is a central requirement of the “Laboratory Standard” (1910.1450, Appendix A). The Laboratory Standard defines a laboratory as a “workplace where relatively small quantities of hazardous chemicals are used on a non-production basis.” It is clear from this definition that the Laboratory Standard applies to all laboratories that use chemicals at Indiana University.
Laboratories that do not meet the above definition or areas where chemicals are used for non-laboratory purposes are governed by other state and federal regulations including OSHA’s “Toxic and Hazardous Substances” standard (29 CFR part 1910, subpart Z,) which contains the hazard communication (Hazcom) standard and permissible exposure limits for all hazardous chemical usage. Assistance in determining which regulatory requirements apply to specific work areas is provided by Indiana University Environmental Health and Safety.
Applicability
The Laboratory Standard applies to all employees engaged in the laboratory use of hazardous chemicals. Laboratory use of hazardous chemicals is defined as the use or handling of chemicals in which all of the following conditions are met:
- Chemical manipulations are carried out on a "laboratory scale". Laboratory scale is defined as work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person. This definition excludes those workplaces whose function is to produce commercial quantities of materials.
- Multiple chemical procedures or chemicals are used.
- The procedures involved are not part of a production process, nor in any way simulate a production process.
This standard does not apply to:
- Uses of hazardous chemicals which do not meet the definition of laboratory use, and in such cases, the employer shall comply with the relevant standard in 29 CFR part 1910, subpart Z,, even if such use occurs in a laboratory.
- Laboratory uses of hazardous chemicals which provide no potential for employee exposure.
Where the standard does apply, it shall supersede, for laboratories, the requirements of all other OSHA health standards in 29 CFR part 1910, subpart Z, except as follows:
- For any OSHA health standard, only the requirement to limit employee exposure to the specific permissible exposure limit shall apply for laboratories, unless that particular standard states otherwise or unless the action level (or in the absence of an action level, the PEL) is routinely exceeded. Where the action level (or in the absence of an action level, the PEL) is routinely exceeded for an OSHA regulated substance with exposure monitoring and medical surveillance requirements, the employee exposure monitoring and medical monitoring requirements of this standard shall apply.
- Prohibition of eye and skin contact where specified by any OSHA health standard shall be observed.
Any substance specific standard can require coverage to remain under that standard rather than under the laboratory standard. In the absence of a statement of preemption in a substance specific standard, the determination of whether the laboratory standard applies must be dependent on both “laboratory use” and “laboratory scale” criteria. Where these criteria are met, the laboratory standard applies.
Organization and Content
The Laboratory Safety and Chemical Hygiene Plan (CHP) is intended to serve as an operational guide for the incorporation of prudent safety practices into the day-to-day use of chemicals within laboratories. It was developed and issued in a general form which shall be adapted and expanded by particular departments and research groups to meet their specific needs. The CHP was organized in a format that should enable desired information to be quickly found and readily updated. The content of the CHP was established directly from the requirements of the Laboratory Standard and includes the following information:
- Designation of the personnel responsible for the implementation of the Laboratory
- Safety and Chemical Hygiene Plan.
- Provisions for personnel training and sources of information.
- Hazard identification.
- Criteria that the employer will use to implement control measures to reduce individual exposures to chemicals. These measures include administrative controls,containment and engineering controls, procedural controls, and the use of personal protective equipment.
- Standard operating procedures (SOPs) relevant to the safety and health considerations that must be observed for the use of hazardous chemicals in the laboratory. Generic SOPs for handling of all hazardous chemical groups are included in the CHP. However, each laboratory group must develop and add specific SOPs that are appropriate for their particular uses of chemicals.
- Personal exposure monitoring.
- Provisions for medical consultations and examinations.
- Circumstances under which a laboratory procedure shall require prior approval before implementation.
- Provisions for additional personnel protection for work with carcinogens, reproductive toxins, and chemicals with high acute toxicity known as “particularly hazardous substances.”
- A requirement that fume hoods and other protective equipment function properly and that measures will be taken to ensure this.
Definitions
ACGIH – American Conference of Governmental Industrial Hygienist.
Action level - A concentration designated in the OSHA (29 CFR) Part 1910 (or in the absence of an action level, the PEL) for a specific substance, calculated as an eight-hour
time-weighted average, which initiates certain required activities such as exposure monitoring and medical surveillance.
ANSI - American National Standards Institute.
Chemical Hygiene Officer - The Chemical Hygiene Officer (CHO) is an employee who is designated by the employer, and who is qualified by training or experience, to provide technical guidance in the development and implementation of the provisions of the Chemical Hygiene Plan.
Chemical Hygiene Plan - The Chemical Hygiene Plan (CHP) is a written program developed and implemented by the employer which (1) sets forth procedures, equipment, personal protective equipment, and work practices that are capable of protecting employees from the health hazards presented by hazardous chemicals used in that particular workplace, and (2) meets the requirements of OSHA's Laboratory Safety Standard; 29 CFR 1910.1450(e).
CHO - Chemical Hygiene Officer.
CHP - Laboratory Safety and Chemical Hygiene Plan (CHP).
Chemical Hygiene Committee - established to assist and guide the Chemical Hygiene Officer with the implementation of the Laboratory Safety and Chemical Hygiene Plan (CHP). It consists of representatives from departments with laboratory facilities and personnel that are affected by the programs and procedures applicable to laboratory chemical safety. Designated area - An area which may be used for work with ‘‘select carcinogens,’’ reproductive toxins or substances which have a high degree of acute toxicity. A designated area may be the entire laboratory, an area of a laboratory or a device such as a laboratory hood.
IUEHS - University Environmental Health and Safety.
EPA - Environmental Protection Agency.
Hazardous chemical - Any chemical which is classified as health hazard or simple asphyxiant in accordance with the Hazard Communication Standard (29 CFR 1910.1200).
Health hazard - Any chemical that is classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); aspiration hazard or simple asphyxiant.
Laboratory - OSHA defines a laboratory as “a workplace where relatively small quantities of hazardous chemicals are used on a non-productive basis”. Lab Manager - A staff employee responsible for managing laboratory operations.
Lab Safety Coordinator - The Lab Safety Coordinator (LSC) is a safety officer designated for each school, department, or other subdivision by the dean, chairman, or director to serve as liaison to IUEHS. Lab Supervisor - A staff employee responsible for supervising laboratory personnel.
Laboratory use of hazardous chemicals - the handling or use of such chemicals in which all of the following conditions are met:
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- Chemical manipulations are carried out on a "laboratory scale;"
- Multiple chemical procedures or chemicals are used;
- The procedures involved are not part of a production process, nor in any way simulate a production process; and
- "Protective laboratory practices and equipment" are available and in common use to minimize the potential for employee exposure to hazardous chemicals.
Lab Workers - The Laboratory Workers referred to in the Lab Standard are employees. OSHA defines an employee as "an individual employed in a laboratory workplace who may be exposed to hazardous chemicals in the course of his or her assignments." An example of a Laboratory Worker would be a University teaching assistant, research assistant or faculty member instructing an academic lab. OSHA does not consider students in an academic laboratory to be workers. However, instructors are expected to ensure that students in academic laboratory classes adhere to the principles of this plan. Also included, are visiting professors and volunteers that might be working in a laboratory. Thus, Laboratory Supervisors must ensure that these groups that are in their laboratories are adequately instructed in safe laboratory procedures.
NFPA - National Fire Protection Association.
OSHA - Occupational Safety and Health Administration.
Oxidizer - A chemical, other than a blasting agent or explosive as defined in 29 CFR 1910.109(a) that initiates or promotes combustion in other materials, thereby causing fire either of itself or through the release of oxygen or other gases.
Particularly Hazardous Substances - Chemicals that are a select carcinogen, a reproductive toxin, or a chemical having a high degree of acute toxicity.
PEL - Permissible Exposure Limit. PELs are the regulatory limit or maximum concentration of a substance in the air that personnel can be exposed to without personal protective equipment or engineering controls (such as a fume hood). These chemicals may also have a “skin designation” that prohibits skin contact.
Physical hazard - Any chemical which is classified as posing one of the following hazardous effects: explosives, flammables (gases, aerosols, liquids, or solids), oxidizers (liquid, solid, or gas), self-reactive; pyrophorics (gas, liquid or solid), self-heating, organic peroxides, chemicals corrosive to metal, gases under pressure, water reactives that emit flammable gases, or combustible dusts.
PPE - Personal Protective Equipment. Principal Investigator (PI) - The lead scientist that plans and/or conducts the laboratory research and assumes the overall supervisory responsibility for laboratory operations and project completion.
PI - The Principal Investigator
Reproductive Toxin - Chemicals that affect the reproductive capabilities including adverse effects on sexual function and fertility in adult males and females, as well as adverse effects on the development of the offspring including but not limited to those that damage chromosomes (mutagens) or the fetus (teratogens).
Select Carcinogen - Any substance which meets one of the following criteria: (1) it is regulated by OSHA as a carcinogen; or (2) it is listed under the category "known to becarcinogens" in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or (3) it is listed under Group 1 ("carcinogenic to humans") by the International Agency for Research on Cancer Monographs (IARC) (latest editions); or (4) it is listed in either Group 2A or 2B by IARC or under the category "reasonably anticipated to be carcinogens" by NTP, and causes statistically significant tumor incidence in experimental animals in accordance with any of the following criteria: (a) after inhalation exposure of 6-7 hours per day, 5 days per week, for a significant portion of a lifetime to dosages of less than 10 mg/m3; (b) after repeated skin application of less than 300 (mg/kg of body weight) per week; or (c) after oral dosages of less than 50 mg/kg of body weight per day.
TLV - Threshold Limit Value.
SOP - Standard Operating Procedure.
Authority and Responsibility
Indiana University supports the use of chemicals and other potentially hazardous materials for purposes of research and teaching.
The University is committed to ensuring the safety of its students, employees, and visitors and to complying with all regulatory requirements which impact its facilities and operations relating to the environment, health and safety. University administration, faculty, staff, and students are asked to support this goal in all university activities.
Indiana University has designated the following specific responsibilities for developing and implementing the Laboratory Safety and Chemical Hygiene Plan.
- University Environmental Health and Safety
Indiana University Environmental Health and Safety (IUEHS) is an administrative unit under the Executive Vice President for University Academic Affairs which has responsibility for the development and implementation of all university programs concerning safety and environmental quality. IUEHS developed the Laboratory Safety and Chemical Hygiene Plan and has the primary role in overseeing its implementation. This role is accomplished by IUEHS staff through the provision of a range of safety services including project reviews and consultations, formal training sessions, and periodic laboratory audits (see Appendix A, Form LCS-1 IUEHS Laboratory Safety Audit).
Specific responsibilities include:
- Perform annual chemical hygiene and housekeeping inspections including inspections of emergency equipment.
- Provide and document training for laboratory employees’ concerning requirements of the program and their responsibilities.
- Provide guidance for the preparation of procedures, chemical inventories, and training programs required by the CHP.
- Maintain a master file of documentation and records associated with the CHP, including training, personal exposure, medical surveillance, chemical inventories, and Material Safety Data Sheets (MSDSs) or Safety Data Sheets (SDSs).
- Respond to requests for Material Safety Data Sheets (MSDSs) or Safety Data Sheets (SDSs).
- Evaluate non-injury near misses and communicate lessons learned to laboratory personnel.
- Chemical Hygiene Officer
The Chemical Hygiene Officer (CHO) is an employee who is qualified by training or experience, to provide technical guidance for the continuing implementation of the CHP. The Chemical Hygiene Officer for Indiana University is the Laboratory Safety Manager. Specific responsibilities of the CHO include:
- Work with administrators and other employees to develop and implement appropriate chemical hygiene programs and practices.
- Monitor procurement and use of chemicals in the lab, including determining that facilities and training levels are adequate for the chemicals in use.
- Maintain current knowledge concerning the requirements for storage and use of regulated substances in the laboratory.
- Review the Chemical Hygiene Plan annually and revise as necessary.
- Chair the Chemical Hygiene Committee.
- Maintain overall responsibility for the laboratory chemical safety program.
- Monitor adherence to the requirements of the Laboratory Safety and Chemical Hygiene Plan.
- Provide guidance for determining the proper level of personal protective equipment.
- Chemical Hygiene Committee
The Chemical Hygiene Committee (CHC) is established to assist and guide the Chemical Hygiene Officer with the implementation of the Laboratory Safety and Chemical Hygiene Plan (CHP). It consists of representatives from departments with laboratory facilities and personnel that are affected by the programs and procedures applicable to laboratory chemical safety. The primary responsibilities of the CHC are to:
- Review the Laboratory Safety and Chemical Hygiene Plan at least annually to provide recommendations for improvement.
- Provide a mechanism or point of contact to distribute important information to departments with laboratory facilities.
- Support the Chemical Hygiene Officer with the authority to send letters containing recommendations regarding non-compliance to the appropriate individuals in accordance with the Corrective Action Procedures.
- Department Chair
The Chair of each academic department (or head of each academic unit) is responsible for the safety of all individuals working in the department’s laboratories. The Chair fulfills this responsibility, in part, by ensuring that all departmental faculty members understand and take seriously their roles in implementing the Laboratory Safety and Chemical Hygiene Plan. To facilitate this process, each Chair must appoint a Laboratory Safety Coordinator (LSC) who will coordinate and monitor the implementation of the CHP within the department.
- Laboratory Safety Coordinator
A Laboratory Safety Coordinator (LSC) will be designated for each school, department, or other subdivision by the Dean, Chairman, or Director to serve as liaison to IUEHS and the CHO. Responsibilities of the LSC include:
- Provide information about chemical hazards to contract employees or maintenance employees working in the area.
- Serve as a conduit for information between laboratories in their area and IUEHS and the CHO.
- Review laboratory safety inspections on behalf of the department and help ensure that all required deficiencies have been corrected.
- Provide safety information to all departmental lab users when IUEHSfurnishes it to LSC.
- Update IUEHS when there are changes in professional staff (chairman, director, professor, post-doc, etc.) or changes in mailing addresses of existing staff.
- Alert IUEHS of any suspected deficiencies during routine walkthroughs of laboratories.
- Faculty, Principal Investigators, Lab Managers, and Lab Supervisors
Each faculty member (or principal investigator) is responsible for the safety of individuals working within his or her laboratories. Faculty members must work with the department’s respective Laboratory Safety Coordinator (LSC) to adapt and implement the provisions of the Laboratory Safety and Chemical Hygiene Plan. This includes ensuring that each individual working within the lab is provided with appropriate training on safety and regulatory requirements; that required safety equipment and personal protective devices are provided, maintained, and used; that specific standard operating procedures incorporating safety considerations are developed and observed; that their laboratory personnel receive the appropriate procedure-specific instruction and are proficient at performing those procedures; That laboratory personnel follow the procedures, and that prompt action is taken to correct any unsafe acts or conditions which have been observed or reported.
Specific responsibilities include:
- Review laboratory safety inspection reports and ensure that all required deficiencies have been corrected.
- Attend training provided by IUEHS concerning the requirements of this Plan and their responsibilities and ensure all laboratory employees are trained.
- Ensure that the Chemical Hygiene Plan is incorporated into routine training sessions for new laboratory personnel.
- Ensure employee training at the time of initial assignment to the area, whenever a new hazard is introduced to the area or when the employee is reassigned to an area using new or different materials and/or processes.
- Provide appropriate personal protective equipment and require its proper use and maintenance.
- Ensure an inventory is completed for all reportable chemicals used in their work areas following the instructions provided by IUEHS.
- Review and understand MSDSs/SDSs on materials used by employees under their direct supervision and inform employees as new MSDSs /SDSs become available.
- Ensure MSDSs/SDSs are available in the work area and are readily accessible to employees.
- Ensure that employee requests for MSDSs/SDSs and other materials are promptly handled, and/or requesting any necessary information or help from IUEHS.
- Ensure that all containers of hazardous materials are labeled with the chemical name or trade name.
- Ensure that safe work conditions are maintained.
- Laboratory Workers
Each laboratory worker is responsible for implementing the requirements of the Laboratory Safety and Chemical Hygiene Plan. This includes but is not limited to:
- Participating in required training;
- Wearing appropriate lab apparel and using personal protection equipment (such as lab coat, safety glasses, gloves);
- Utilizing the appropriate safety equipment properly (such as the fume hood);
- Following the established standard operating procedures; and
- Informing the PI, Lab Supervisor, or Lab Manager of any accident or unsafe conditions.
Chemical Laboratory Inspections and Corrective Action Procedures
Compliance with federal, state, and local regulations is the responsibility of the laboratory Principal Investigator (PI), Lab Manager, or Lab Supervisor. Many agencies require regulatory compliance depending on the activity being performed. Chemicals are primarily regulated by OSHA, the EPA, and the Department of Homeland Security at the state or federal level. During an actual regulatory inspection, the University and the department can be cited and fined for violations.
Because of the potential safety problems and liability that exists when laboratory safety deficiencies are identified, this corrective action process has been prepared to enforce compliance.
The PI, Lab Manager, or Lab Supervisor is responsible for ensuring that all safety deficiencies documented in a laboratory inspection are corrected. A corrective action process will be implemented if correction of the deficiencies has not begun within 10-15 business days (2-3 weeks) of an inspection. It is anticipated that the vast majority of laboratories will complete the process during the first stage of inspection before corrective action will need to be taken.
Imminent danger or egregious violations are cause to terminate laboratory operations immediately. University Environmental Health and Safety (IUEHS) provides free compliance assistance upon request.
Annual Laboratory Inspection
A Laboratory Safety Inspection shall be completed annually by IUEHS Laboratory Safety Personnel. The department or school will be notified two weeks in advance of the upcoming inspection. Appointments for the inspection can be made with IUEHS as necessary.
Following the initial laboratory inspection, results will be e-mailed to the PI, Lab Manager, or Lab Supervisor within 3 business days. The PI, Lab Manager, or Lab Supervisor will be given 10-15 business days (or 2-3 weeks) from the inspection date to begin to correct violations. At the completion of the initial inspections for each Department (or building) copies of the initial inspection report will be sent to the Laboratory Safety Coordinator, and/or Safety Committee Chair (if a committee has been appointed for the Department) by IUEHS Laboratory Safety Personnel. A written verification of complete or partial corrections is required by the end of that time period and can be sent by one of the following methods:
- Within the IUEHS Assistant (EHSA) inspection system at www.ehs.iu.edu for IUB and Regional Campuses or at www.ehs.iupui.edu for IUPUI.
- E-mail IUEHS representative for your respective campus.
- Hard copy sent via campus mail to IUEHS for your respective campus.
A follow-up inspection will be conducted 2-3 weeks after the initial inspection to ensure that sufficient progress has been made unless written verification is deemed sufficient. Follow-up inspections at the regional campuses are the responsibility of the IUEHS representatives for the respective campus.
If an infrastructure or facility-related issue is documented as a laboratory deficiency, submission of a request for repair will qualify as an attempt for correction. Action items must be noted in the written verification.
Corrective Action Procedure
- Level 1
Failure to take sufficient corrective action by the follow-up inspection or the severity of remaining violations will determine if the process proceeds to Level 1. If very little or no progress has been made a Level 1 response will be necessary and a full reinspection of the laboratory will be conducted. IUEHS Laboratory Safety Personnel will send copies of the Level 1 re-inspection report to the PI, Lab Manager, or Lab Supervisor, Laboratory Safety Coordinator, and/or Departmental Safety Committee Chair (if one exists).
The IUEHS Laboratory Safety Personnel will discuss the Level 1 re-inspection report with the PI, Lab Manager, or Lab Supervisor to agree upon corrective actions. The PI, Lab Manager, or Lab Supervisor will be given an additional ten (10) business days to correct all violations. Written verification of corrected deficiencies must be submitted to IUEHS within that time period. A follow-up inspection will be conducted to verify that all corrections have been made unless written verification is deemed sufficient.
- Level 2
If written verification has not been submitted within the additional ten (10) day time period, a re-inspection and follow up inspection will be conducted by IUEHS personnel if necessary.
The IUEHS Laboratory Safety Manager will send a letter and copies of inspections and any PI, Lab Manager, or Lab Supervisor responses to the PI, Lab Manager, or Lab Supervisor, the Laboratory Safety Coordinator, the Department Safety Committee Chair (if one exists), and the Department Chair or Director.
The letter will give the PI, Lab Manager, or Lab Supervisor an additional five (5) business days to correct remaining violations and submit written verification.
Mandatory retraining of lab personnel will be considered if the violations reveal a lack of understanding or deliberate avoidance of lab safety guidelines.
- Level 3
If written verification of completed corrective actions has not been submitted to IUEHS by the end of the process through Level 2 (a total of 25-30 business days), the Chemical Hygiene Committee will send a letter of non-compliance to the PI Lab Manager, or Lab Supervisor, the Laboratory Safety Coordinator, the Department Safety Committee Chair (if one exists), the Department Chair or Director, and the administrative head of the college, school, or unit. A re-inspection and follow up inspection will be conducted as necessary.
Failure of the PI, Lab Manager, or Lab Supervisor to submit verification of corrections will impact their ability to obtain approvals for permits and grant certifications requiring validation of compliance with applicable state and federal regulations, including Federal Certification of Environmental Compliance.
Extensions to provide corrective action may be requested in writing at any stage of this process from IUEHS Laboratory Safety Personnel for your respective campus.
- Level 4
If the steps taken in the previous action levels have not resulted in the submission of a written verification of completed corrective actions to IUEHS within the established timeline then the laboratory will be deemed noncompliant.
The chief academic officer of the campus where the laboratory is located and the University Director of Environmental Health and Safety will be notified of the noncompliant laboratory and punitive action will be requested which may include prohibiting employee access to the laboratory until corrective action has been taken.
If the action taken by the chief academic officer does not result in compliance by the noncompliant laboratory then the Executive Vice President for University Academic Affairs will be requested to take punitive action to ensure compliance.