Back to Background Information

 

Table of Contents   

PARAGRAPH (b) - SCOPE AND APPLICATION (b)-1
General Requirements - (b)(1)
Potential for Exposure - (b)(2)
Requirements for Laboratories - (b)(3)
Sealed Containers - (b)(4)
Limited Exemptions from Labeling Requirements - (b)(5)
Exemptions from Scope of HCS - (b)(6)
        Hazardous Waste - (b)(6)(i)
        Wood or Wood Products - (b)(6)(iv)
        Articles - (b)(6)(v)
        Food or Alcoholic Beverages - (b)(6)(vi)
        Drugs - (b)(6)(vii)
        Consumer Products - (b)(6)(ix)
        Nuisance Particulates - (b)(6)(x)
        Ionizing and Nonionizing Radiation - (b)(6)(xi)
        Biological Hazards - (b)(6)(xii)

PARAGRAPH (b) - SCOPE AND APPLICATION

Application of the HCS to physicians

29 CFR 1910.1200(b)

[OSHA] believe[s] the HCS is a common sense regulation. It applies only to hazardous chemicals which are known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency....The standard requires that for each hazardous chemical in the workplace, the employer is required to maintain a copy of the MSDS.

The HCS exempts several product categories, some of which would be pertinent to a physician employer. These exemptions include: any consumer product where the individual employer can show that it is used for the purpose intended by the manufacturer, and that the duration and frequency of exposure is no greater than the range of exposures experienced by consumers; drugs which are in solid, final form for direct administration to the patient (i.e., tablets or pills); drugs which are packaged by the manufacturer for sale to consumers and which employees do not administer to patients (e.g., over-the-counter medicines); and medicines which are intended for personal consumption by employees. However, non-solid, hazardous drugs are covered by the standard, and the physician employer would need to maintain a copy of the MSDS for such drugs, and include these products in the workplace hazard communication program.

OSHA'S HCS provides workers exposed to hazardous chemicals with information as well as training about the identities and hazards of those chemicals, as well as protective measures. OSHA believes that when workers have such information, they are better able to take steps to protect themselves from experiencing adverse effects from exposure. In addition, providing such information to employers helps them to design better protective programs for exposed employees.

OSHA believes that significant benefits are associated with the implementation of the HCS in the workplace. Employers may use the information, for example, to select personal protective equipment, design engineering controls, and substitute less hazardous chemicals. These actions will improve protection of workers. In addition, the written information may be used to train workers to properly handle the chemical.

letter: BGoodlatte 03-31-94

Application of HCS to the help supply services industry, Standard Industrial Code (SIC) 7363 and to the construction industry in general

29 CFR 1910.1200(b)

Question: How does hazard communication training tie into the SIC code 7363?

The current HCS final rule covers all Standard Industrial Classification (SIC) codes. In 1987 the Office of Management and Budget (OMB) prevented OSHA from enforcing HCS in the construction industry. On OMB's advice, OSHA published a statement of concurrence in the Federal Register on August 8, 1988 (Volume 53, page 29822). However, on August 19, 1988, the U.S. Court of Appeals for the Third Circuit invalidated OMB's actions as being outside OMB's authority under the Paperwork Reduction Act (see United Steelworkers of America v. Pendergrass, 855 F.2d 108, (3rd Cir. 1988), Ex. 4-190). As ordered by the Court, OSHA published a notice in the Federal Register on February 15, 1989 (Volume 54 page 6886) to inform affected employers and employees that all provisions of the HCS would be in effect in all industries, and set March 17, 1989, as the date for initiation of programmed compliance inspections.

letter: MMoreau 02-03-94

see also: MRoss 08-21-89

MSDS requirements for drugs that do not contain hazardous chemicals

29 CFR 1910.1200(b)

Question: Must the pharmacy keep MSDSs for products that DO NOT contain hazardous chemicals and that are intended to be crushed or mixed prior to use?

MSDSs are not required for non hazardous drugs. MSDSs are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drugs and pharmaceutical products except for drugs as defined by the Federal Food, Drug and Cosmetic Act which are in solid, final form for direct administration to the patient (i.e., tablets, pills, or capsules) or which are packaged for sale to consumers in a retail establishment.

letter: CCoe 01-03-94

Broad scope and appropriateness of HCS

29 CFR 1910.1200(b)

The Hazard Communication Standard (HCS) provides workers exposed to chemicals with the right-to-know the identities and hazardous nature of them. The scope of the rule is broad, covering as many as 650,000 hazardous chemical products. There are over 30 million American workers exposed to these chemicals in about 3.5 million establishments. Having complete information available about the chemicals in a workplace allows workers to ensure that they are properly protected, and employers to properly design employee protection programs. ... In fact, it is reasonable and appropriate, and is based on an extensive rulemaking record developed over many years.

letter: TDeLay 06-22-92 Congress

OSHA authority applies only to workplaces

29 CFR 1910.1200(b)

OSHA has no authority, under the Occupational Safety and Health Act of 1970 (OSH Act), to prescribe or enforce regulations that affect situations outside the Agency's jurisdiction, e.g., OSHA cannot require distributors to provide a material safety data sheet (MSDS) in a non employer-employee situation.

The reason ... that the Hazard Communication Standard (HCS) does not apply to consumers is that OSHA has no statutory authority to regulate safety and health situations outside the workplace.

[Originally written for the hardware industry]

letters: DWolf 05-16-90, CWylie 05-18-90 Congress, BMcEwen 10-08-90 Congress

Application of HCS to farm workers exposed to pesticides

29 CFR 1910.1200(b)

The issue of the applicability of the Hazard Communication Standard (HCS) to farm workers exposed to pesticides has raised complex jurisdictional questions concerning regulations issued by OSHA and the Environmental Protection Agency (EPA).

The limited enforcement of the HCS for farm workers is only for workers not in the fields who may be exposed to pesticides are still covered by the provisions of the standard. Hazardous chemicals other than pesticides continue to be covered by HCS.

As indicated in the Notice of Proposed Rulemaking on the standard, 53 Federal Register 29822, 29827-28 (August 8, 1988), EPA has some regulations for employees applying restricted use pesticides. OSHA will not enforce the HCS for employees certified to apply restricted use pesticides or those employees under the direct supervision of such certified applicators.

letter: KBrown 02-21-89

Radioactive materials not covered

29 CFR 1910.1200(b)

The ionizing hazard from radioactive materials are not covered by the Hazard Communication Standard. If a radioactive material, however, presents other types of chemical hazards, such as those defined in Appendix A of the standard, then the chemical would be covered for those hazards. The hazards of radioactivity itself are usually covered under the rules of other Federal agencies, or if not regulated by another Federal agency, by OSHA's standard for ionizing radiation, 29 CFR 1910.96.

OSHA will shortly be publishing a notice of proposed rulemaking (NPRM) and notice of public hearing. It is the agency's intention to address in the NPRM that ionizing and nonionizing radiation are exempt from coverage under the standard.

letter: RUhlar 03-22-88

Scope of HAZCOM extended to RCRA treatment, storage, and disposal facilities

29 CFR 1910.1200(b) and 29 CFR 1910.120(p)

Question: Does 29 CFR 1910.120(p)(1) extend the application of the Hazard Communication Standard (29 CFR 1910.1200)?

Yes. RCRA facilities that fall under the scope of 29 CFR 1910.120(a)(2)(iii) of the standard must implement a hazard communication program meeting the requirements of 29 CFR 1910.1200 for those chemicals used incidentally in the treatment or disposal of the hazardous waste. For example, caustic solutions used to neutralize acidic wastes and chlorinated solvents used to clean equipment would fall under this coverage, but not the actual wastes themselves.

memorandum: TShepich (DCP) to RAs 09-11-87 [HAZWOPER Q & A Document]

Lift trucks: labeling of components not required

29 CFR 1910.1200(b)

OSHA considers lift trucks to be machines and not containers. Containers are required to be labeled according to the standard. Labeling vehicle components seems to be impractical and would be cumbersome.

Material safety data sheets do not have to be provided for lift trucks. However, material safety data sheets are required for the gasoline and other fuels used by the lift trucks. Employees should be aware of the potential for exposure to carbon monoxide and associated physical hazards of petroleum fuel products such as fire and explosion.

Labeling of vehicle components is not necessary. Lift trucks do not meet the current definition of an "article" because of potential exposures to carbon monoxide and physical hazards of petroleum fuel products.

letter: KDonaghue 03-17-86

General Requirements - (b)(1)

Applicability of HCS to fire extinguishers

29 CFR 1910.1200(b)(1), 49 CFR 172.101, 49 CFR 173.306(c)

...[B]ased on the manufacturers'/importers' hazard determination, if [a] fire extinguisher is classified as a hazardous chemical, then it would be subject to HCS labeling requirement. The HCS defines hazardous chemicals as any chemical which is a physical or a health hazard. Under the standard, a compressed gas (defined as a gas or mixture of gases having, in a container, an absolute pressure exceeding 40 psi at 70 degrees, or a liquid having a vapor pressure exceeding 40 psi at 100 degrees), is considered a physical hazard and therefore, is considered a hazardous chemical. In addition, several extinguishing agents (Halon 1211 and potential substitutes such as hydrogenated chlorofluorocarbons) are also considered hazardous chemicals by nature of their associated health hazards. Consistent with the definitions in the HCS, any fire extinguisher containing a hazardous chemical is subject to the requirements of the HCS. DOT also classifies fire extinguishers as hazardous materials (49 CFR 172.101) with specific exceptions noted at 49 CFR 173.306(c). Questions concerning DOT labeling requirements for shipping fire extinguishers should be directed to DOT at (202) 366-4488.

letter: CTrafelet 03-15-95

Applicability of the HCS to inert gases

29 CFR 1910.1200(b)(1)

OSHA agrees...that inert gases are classified as a simple asphyxiants. Patty's Industrial Hygiene and Toxicology defines a simple asphyxiant as: "physiologically inert gases that can act principally by dilution of the atmospheric oxygen below partial pressure necessary to maintain an oxygen saturation in the blood sufficient for normal tissue respiration."

Inert gases, such as argon, nitrogen and helium, have the potential to create a hazardous atmosphere (less than 19.5% oxygen) and, where that potential exists, are considered by OSHA as hazardous chemicals presenting an acute health hazard and covered by the standard. The HCS would not apply where employees are not occupationally exposed, under normal conditions of use or in a reasonably foreseeable emergency, to the oxygen displacing hazard associated with inert gases. Obviously, argon, nitrogen and helium occur naturally in the atmosphere, and under those conditions they are not hazardous chemicals.

The HCS requires chemical manufacturers, or importers to assess the hazards of chemicals which they produce or import, and all employers to provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, material data safety sheets (MSDSs), and information and training. Included in the HCS is paragraph (c) which contains a broad definition of the term "health hazard." Appendix A of the HCS also provides further definition and explanations of the scope of health hazards including acute health hazards....

[With regard] to the language in [a] March 4, 1993, [OSHA] letter to Matthew McFarland stating that toxicity has been established in inert gases, and that the manufacturer, importer, and/or distributor has the duty of performing a complete hazard determination. To elaborate on the underlined phrase we mean the toxic effects of excessive levels of inert bases has been well established.

letter: RAndree 01-25-95

see also: MMcFarland 03-04-93

Applicability of the HCS to the storage, handling, and disposal of parenteral cytotoxic pharmaceuticals

29 CFR 1910.1200(b)(1)

Questions: Is [the requirement to dispose of cytotoxic waste in distinctively labelled and color-coded bags] [as specified in OSHA's 1986 publication containing guidelines for disposal of hospital wastes contaminated with cytotoxic drugs] designed to comply with the Hazard Communication Standard so that employees can define the appropriate hazard and handle the waste appropriately?

[Is the requirement to place] needles, syringes, and breakable or sharp items used with cytotoxic drugs...in specially designated puncture proof boxes...designed to comply with the Hazard Communication Standard?

No. Although the requirements of the HCS do apply to the storage and handling of parenteral cytotoxic pharmaceuticals, the HCS does not address proper disposal of hazardous materials and does not apply to hazardous waste [(29 CFR 1910.1200(b)(6)(i))]. The guidelines in OSHA's 1986 document are intended to address the safety and health of workers handling cytotoxic waste while meeting the disposal requirements of EPA's National Hazardous Waste Program and equivalent state laws.

Question: Can empty IV bags and tubing or gowns and gloves used...be placed in with infectious waste as these are only residually contaminated? If not, do they need to be placed in specially labelled and color-coded bags or containers?

OSHA's Bloodborne Pathogens Standard permits disposing of residually contaminated protective clothing with infectious waste, so long as such waste was labelled in accordance with 29 CFR 1910.1030. In lieu of labeling, such waste may be placed in red bags or red containers. OSHA's Hazard Communication Standard would not apply to the labeling of non-infectious waste that is contaminated with cytotoxic residues. Of course, disposal of material contaminated with cytotoxic chemicals must conform to state law.

letter: LMurphy 11-21-94

Transmittal of chemical hazard information--copper chromated arsenate (CCA) pressure-treated wood

29 CFR 1910.1200(b)(1)

The HCS does not require manufacturers to obtain prior OSHA approval of their product labeling. Likewise, it is not the responsibility of OSHA to evaluate the consumer information sheet for CCA [(copper chromated arsenate)] pressure-treated wood. Further, OSHA's evaluation of the proposed label for CCA pressure-treated wood would compromise the responsibility of the manufacturer to complete all hazard determinations for this product. Under the HCS, the manufacturers of CCA pressure-treated lumber are responsible for chemical hazard information (Material Safety Data Sheets, labels, etc.) to be transmitted to downstream employers [(29 CFR 1910.1200(b)(1))].

...[If a] hazard evaluation for CCA pressure-treated lumber has not been completed[,]...[then a] proposed label for CCA pressure-treated wood may not provide employees with the appropriate hazard warning information. For example, any chemical additives present in the wood which represent a health hazard must be included on the MSDSs and/or label as appropriate.

letter: MSessa 08-31-94

HCS applicability to medical offices

29 CFR 1910.1200(b)(1)

You requested clarification on [whether a] medical office or surgery center needs to have [Material Safety Data Sheets (MSDSs)] on orally administered and injectable medications. OSHA published a notice in the Federal Register on February 15, 1989, to inform affected employers and employees that all provisions of the [Hazard Communication Standard (HCS)] would be in effect in all industries, including employers whose employees are exposed to Food and Drug Administration (FDA) regulated drugs that pose a hazard. If hazardous FDA-regulated drugs are administered by injection or orally, they would be covered by the HCS.

There are exemptions to the standard that may cover many of the products in your facility. The scope and application of HCS exempts drugs that are in solid final form.The final form exemption would also apply to tablets or pills that are occasionally crushed, if the pill or tablet is not designed to be dissolved or crushed prior to administration.

letter: JHarris 09-13-93

Applicability of the HCS to tuberculocidal disinfectants used to comply with the OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030

29 CFR 1910.1200(b)(1) and 29 CFR 1910.1030

The U.S. Environmental Protection Agency (EPA) is the governmental agency which is responsible for overseeing the registration of sterilants, tuberculocidal disinfectants, and anti-microbial products. Under the bloodborne pathogens standard, OSHA requires that contaminated items and surfaces be decontaminated with an appropriate disinfectant. EPA-registered tuberculocidal disinfectants and solutions of 5.25 sodium hypochlorite (household bleach) diluted between 1:10 and 1:100 with water are considered appropriate for this purpose.

As required by the 29 CFR 1910.1200[(b)(1) and (g)(1)], "Hazard Communication Standard," manufacturers and distributors of hazardous materials, including tuberculocidal disinfectants and bleach, are to send a material safety data sheet (MSDS) to the purchaser of the product. In turn, the employer who receives the MSDSs is responsible for communicating the hazard information therein to the employees who will be using the product(s). In this way, employees can take the appropriate measures necessary to prevent health problems related to use of the disinfectants.

letter: KPeebles 04-30-93

Application to pharmaceutical products used in long term health care facilities

29 CFR 1910.1200(b)(1)

You asked whether your long term health care facilities would fall under the scope of the Hazard Communication standard (HCS) in cases where your residents buy their medications from pharmacies that are independent from your facilities and which are prescribed to them by outside physicians.

The HCS applies to your staff of health professionals in many ways. For example, you would have to inform employees of the hazards involved in using standard (i.e., foreseeable) medications used in practicing health care in your facility, such as "house drugs". However, in cases where the residents of your facilities purchase drugs from independent/outside pharmacies, and the drug and its potential hazards are not known until an outside physician orders a prescription, the HCS would not apply.

Employees must be allowed to have access to information; therefore, if employees find themselves working with a medication brought in by a resident they may ask their employer to obtain a material safety data sheet for the medication. The HCS requires employers to provide information on "any chemical which is known to be in the workplace in such a manner that employees may be exposed..." (29 CFR 1910.1200(a)). Your facilities must incorporate their individual method of compliance into their existing HCS program.

letter: SHill 12-29-92

Compressed gas as a hazardous chemical in the workplace

29 CFR 1910.1200(b)(1)

... [Gas] is present in the workplace in compressed gas cylinders, hence it is covered by virtue of being a compressed gas. I think you will find that such cylinders must be carefully handled in the workplace as the state of being a compressed gas presents certain hazards--particularly in the event of an emergency such as a fire. Thus it is not unreasonable or inappropriate to treat compressed gases as hazardous chemicals in the workplace.

[Originally written about oxygen cylinders]

letter: TDeLay 06-22-92 Congress

Application of the HCS to drugs in liquid form

29 CFR 1910.1200(b)(1)

Question: To what extent does the Hazard Communication Standard (HCS) apply to drugs and medicines in liquid form (e.g., alcohol, Betadine) which are diluted and/or repackaged before administration or application?

Liquid drugs which are hazardous chemicals would be covered if there is a potential for employee exposure to them.

Question: To what extent does the frequency with which ointments, alcohol, or other similar items are used by an employee on patients impact on how that employee is covered under the HCS?

Coverage under the HCS for ointments, alcohol and other similar items is not determined by the frequency of employee exposure. The employer is required to comply with the material safety data sheet (MSDS) and training requirements in the HCS for any ointment, alcohol, or similar medication in liquid form that the manufacturer has found to be hazardous (as defined in the HCS).

letter: RRay 06-11-91

HCS applicability to many business types

29 CFR 1910.1200(b)(1)

The Hazard Communication Standard (HCS) was expanded to include all industries where employees are exposed to hazardous chemicals on August 24, 1987. It provides all exposed workers with the right-to-know information about the hazards of the chemicals they work with, as well as appropriate protective measures. In addition to having a right-to-know, exposed workers have a need to know this information. OSHA's rulemaking record indicates that the rule is both necessary and feasible in all industries where such exposures occur.

As the HCS is a performance-oriented rule, employers in all types of establishments have the flexibility to adapt implementation of the requirements to address the specific needs of their workplaces. There are many types of businesses which have a large number of chemicals and do not have fixed worksite locations. The HCS has been successfully applied by employers to many different work environments.

[Originally written for the janitorial services industry]

letter: LFriedman 05-23-91

OSHA not responsible for list of covered chemicals

29 CFR 1910.1200(b)(1)

The Occupational Safety and Health Administration (OSHA) does not maintain a list of chemicals covered under the Hazard Communication Standard (HCS). The rule requires chemical manufacturers and importers to evaluate the information available regarding the hazards of any chemical they produce or import, and to make that information available to their customers by means of appropriate labels and material safety data sheets (MSDS). It has been estimated that under this approach, the HCS applies to some 600,000 hazardous chemical products in use in American workplaces.

As a user of chemicals, you may rely on the evaluations performed by the suppliers of the chemicals you use. If you receive a label or MSDS from your suppliers that indicate the chemical you are using is hazardous, then you must include it in your employees' hazard communication program.

letter: BHughes 02-04-91

Anticipated equipment failure and HCS application

29 CFR 1910.1200(b)(1)

If there is the potential for overheating during workplace use of the product, i.e., if equipment failure can be normally anticipated during workplace processing operations and result in overheating the ... product causing employee exposure to hazardous chemicals, then the product would not be exempt from coverage.

[Originally written about heat shrink products]

letter: KFinney 12-21-90

Consumer products under the HCS

29 CFR 1910.1200(b)(1)

If the use of the chemical products ... is of a nature that employees would need to be afforded the protections of the Hazard Communication Standard (HCS), then you must obtain material safety data sheets (MSDS) from the chemical manufacturer or distributor and develop a Hazard Communication Program (HCP) for your employees. The written HCP would need to address the way labeling, MSDS access and employee training will be implemented, and would also have to include a list of hazardous chemicals known to be present, along with a description of the methods you will use to inform employees of the hazards associated with non-routine tasks.

The HCS is a performance-oriented rule, which means you have not only the flexibility but also the responsibility to adapt the rule to the needs of your workplace, as opposed to having to follow specific, rigid requirements. The performance-orientation of the HCS also means you have to exercise more judgement in implementing an appropriate and effective program, especially when dealing with the worksite use of chemicals which are also consumer products.

letter: SSmith 06-01-90

Application of the hazard communication standard to asbestos removal operations

29 CFR 1926.59 [1910.1200](b)(1) and 1926.58

The scope and application section (b) of the HCS requires "all employers to provide information to their employees about the hazardous chemicals [to] which they are exposed by means of a hazard communication program..." etc. Further, the HCS at section (e), requires employers to develop, implement and maintain a written hazard communication program which includes (among other things) a list of the hazardous chemicals known to be present and a description of how the company will comply with sections (f),(g) and (h) of the standard. Section (e)(2) additionally requires employers on a multi-employer worksite who "produce, use or store hazardous chemicals" to develop a written hazard communication program. The HCS defines "use" as packaging, handling, reacting or transferring. The employees at an asbestos removal operation certainly are "handling" the hazardous chemical asbestos. Employers of employees involved in asbestos removal would therefore be required to develop a written hazard communication program not only to protect their employees, but also for the employees of other employers who may be exposed to the hazard of asbestos that is being created by the removal operations. Again, we believe these requirements are triggered by the scope and application section (b), the written program requirements at section (e), and the definitions section (c) (see definitions for "employee", "employer", "exposure" and "use").

...[T]he construction asbestos standard, 1926.58 does not require a MSDS for asbestos. We agree with the argument...that since 1926.58 does not specifically require that a written hazard communication program be developed for the hazards of asbestos exposure during removal operations, the more general requirement of 29 CFR 1926.59(e)[, the HCS,] applies to the situation. While we believe that 1926.59(e) of the HCS applies as set forth above to the hazards of asbestos-exposed employees during asbestos removal, we also acknowledge that a MSDS for "asbestos" cannot be required under 1926.59. It is the responsibility of the chemical manufacturer to develop the MSDS and send it to the downstream employer(s) for their information and use in their hazard communication programs. Obviously, asbestos-removal contractors have no way of obtaining the MSDS for the specific asbestos-containing materials they are removing. Employers may be encouraged, however, to obtain or develop a "generic" MSDS for "asbestos" for use in their overall hazard communication program, but they cannot be required to do so.

...[W]e question the validity of [an] employer's assertion that "no other chemicals" (besides asbestos itself) are "used" during asbestos removal operations. We understand that this is the employer's defense for not having a written hazard communication program. Usually these types of removal operations involve the use and application of certain surfactants and wetting agents which would themselves be subject to the provision of the HCS and for which a written hazard communication program would need to have been developed. In any event, the multi-employer requirements of section (e) of the HCS obligates the employer on a multi-employer worksite who may be exposing the employees of another employer to hazardous chemicals, (in this situation the asbestos he is causing exposure to through his removal operations), to develop a written hazard communication program which includes the methods that will be used to inform the other employers of the potential hazards.

memorandum: TShepich to LAnku 12-26-89

HCS expanded to construction industry--overview of requirements

29 CFR 1910.1200(b)(1)

OSHA's Hazard Communication Standard, 29 CFR 1910.1200, was first promulgated by the Agency in 1983. The scope of the standard was expanded on August 24, 1987 to include all employers with employees exposed to hazardous chemicals, including employers in the construction industry. Chemical manufacturers and importers have the responsibility to review scientific evidence concerning the health and physical hazards of the chemicals they produce or import. Under the expanded Hazard Communication rule, construction employers are now the recipients of this downstream flow of information. The identified hazards are required to be transmitted to downstream employers and distributors on a material safety data sheet (MSDS), and these MSDSs must then be made readily available to employees in order for them to have access to information on the potential hazards of the substances they work with. Labels must be placed on containers of hazardous chemicals in the workplace, and employers must establish a training and information program for employees exposed to hazardous chemicals in their work areas.

[Originally written about silica sand]

letter: MRoss 08-21-89

see also: MMoreau 02-03-94

Exhaust emissions: obligations of manufacturer and employer

29 CFR 1910.1200(b)(1)

Diesel exhaust emissions per se are not covered by the HCS. Diesel fuel however is covered by the HCS and any known hazards associated with this fuel must be reported on the material safety data sheet, including the hazards associated with the combustion of the fuel.

All employers are required to develop and implement employee training programs regarding hazards of chemicals and protective measures for all employees exposed to hazardous chemicals in their work areas under normal operating conditions or in foreseeable emergencies. Employees in terminal operations exposed to hazardous chemicals would fall under these provisions. If employees in terminal operations are exposed to diesel fuel in their work areas, the hazards of diesel fuel must be incorporated in the training program. Trucks or other vehicles are not considered work areas for the purposes of the standard. Vehicle operators would not be covered while operating a motor vehicle, however operators would be covered while performing terminal operations.

The chemical manufacturer, importer, or distributor is responsible for labeling containers of diesel fuel. Employers are required to ensure that all containers of hazardous chemicals in the workplace are labeled. Engines, fuel tanks or other operating systems in a vehicle are not considered to be containers for purpose of the HCS and would require labeling.

Manufacturers and importers of diesel fuel are responsible for performing the hazard determination and transmitting the hazard information of diesel fuel to their downstream customers. Employers are not required to evaluate chemicals unless they choose not to rely on the evaluation performed by the chemical manufacturer or importer for the chemical.

Chemical manufacturers and importers are required to provide appropriate MSDS with their initial shipment and with the first shipment after a sheet has been updated. If the MSDS is not provided prior to or with the shipment, it is recommended that the employer write to both the supplier and the product manufacturer to request MSDS as soon as possible. Should the employer fail to receive the requested information, the nearest OSHA Area Office should be contacted for assistance in this matter.

letter: ASchaeffer 12-22-88

Hazard communication requirements for the dental industry

29 CFR 1910.1200(b)(1)

As a general matter, the dental industry has fairly straightforward requirements. They do not produce chemicals, and therefore are entitled to receive information regarding hazards and protective measures from their suppliers. Any hazardous chemical purchased by the dentist must be appropriately labeled by the manufacturer or distributor, and at the time of the first shipment, a properly completed material safety data sheet must be provided. These labeling requirements for shipped containers have been in place since November 25, 1985, and the material safety data sheet transmittal to dental employers has been required since September 24, 1987. Dentists must have a written program, must maintain labels on containers, obtain, maintain and provide employees access to material safety data sheets, and train employees.

The only time dental employers would ever have to prepare a label would be if they transferred material into a different container. If the material is to be used immediately by the employee performing the transfer, the container may be subject to the portable container exemption (see paragraph (f)(7)). If not, copying the identity and hazard warnings form the supplier's label will suffice. This can be a simple handwritten tag. There is no requirement for professionally printed labels. The HCS [Hazard Communication Standard] also does not require labels to include a rating of the severity of the hazard, and does not require users of chemicals to evaluate hazards or device label information.

Material safety data sheets may be in any format, as long as they contain the required information. Suppliers are required to provide this information to their employer customers, thus there is no need for dentists to develop or obtain material safety data sheets from other sources.

Employers are permitted to use generic data sheets if they choose to do so. However, since consulting firms and other organizations developing such materials do not have any responsibility to do so under the HCS, whereas chemical manufacturers, importers, and distributors do, the employer may become liable if such materials are found to be deficient. If the employer relies on the information received from suppliers, and it is found to be deficient, OSHA will ensure that the supplier is held responsible for correcting that deficiency.

letter: SSmith 09-13-88

Grain dust

29 CFR 1910.1200(b)(1)

On August 24, 1987, OSHA extended the application of [the Hazard Communication Standard] from the manufacturing industries (which includes some grain processing operations) to all industries where employees are exposed to any type of hazardous material (which would include grain elevators).

Grain dust is a hazardous material under the definition of the rule. In addition to evidence regarding its physical hazard potential (i.e., explosions in grain elevators), there are a number of studies which indicate that it causes respiratory problems in workers. It is thus subject to the rule to provide information to workers and to ensure that they are aware of proper protective measures. These types of activities have been implemented by many employers for years, but promulgation of the standard ensures a minimum level of protection for all exposed workers. The rule does not require grain dust to be eliminated nor does it set a permissible exposure limit for grain dust. It merely requires hazard information to be transmitted.

letter: GEnglish 11-20-87

Potential for Exposure - (b)(2)

The definition of exposure is discussed as a subsection under Paragraph (c), Definitions.

Applicability of HCS to varying airborne concentrations of cadmium

29 CFR 1910.1200(b)(2) and 1910.1027(m)

Question: [H]ow [do] the particular provisions under [the Hazard Communications and Cadmium standards] apply to the following conditions, (1) airborne cadmium exposure is less than the limit of detection where the limit of detection is below 10% of the PEL and (2) where airborne cadmium exposure is detectable but less than the action level[?]

...[T]he Cadmium standard applies to all occupational exposures to cadmium and cadmium compounds. Further, paragraph 1910.1027(m) specifies the requirement for communication of cadmium hazards to employees including referencing the Hazard Communication (HCS) standard.

Under the HCS, employers are required to provide information to their employees about the hazardous chemicals which are known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency. Exposure is defined to include both possible and accidental exposure.

The HCS addresses chemical hazards which are inherent properties of the hazardous chemical and would exist no matter what quantity was present in the workplace. Risk is a function of the inherent hazard and level of exposure. A substance either is or is not a hazardous chemical; the HCS definition cannot be read to indicate that a substance could be a hazardous chemical in some concentrations but not in others.

The HCS and therefore the Cadmium standard requirements for training, MSDS, and labels would apply to the conditions presented in [the above question], unless the manufacturer or importer of the fasteners have claimed an "article" exemption. An article is defined in paragraph (c) of the HCS as: "a manufactured item other than a fluid or particle; (i) which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical (as determined under paragraph (d) of this section), and does not pose a physical hazard or health risk to employees."

Question: ...[Does] the HCS appl[y] when cadmium dust is visible in a container or on the worker.

Application of the HCS is not based on whether the hazardous chemical is visible. It applies whenever cadmium is known to be present in the workplace. [However,] [t]he absence or presence of visible cadmium dust would be important information in terms of personal protective equipment and hygiene practices.

letter: RBoggs 10-06-94

see also: ROpatick 05-30-90

Application of HAZCOM to pharmaceuticals

29 CFR 1910.1200(b)(2)

Question: Does the HCS apply to all pharmaceuticals -- or only to pharmaceuticals that the manufacturer has determined as hazardous?

The HCS only applies to pharmaceuticals that the drug manufacturer has determined to be hazardous and that are known to be present in the workplace in such a manner that employees are exposed under normal conditions of use or in a foreseeable emergency. The pharmaceutical manufacturer and the importer have the primary duty for the evaluation of chemical hazards [(29 CFR 1910.1200(d))]. The employer may rely upon the hazard determination performed by the pharmaceutical manufacturer or importer.

letter: CCoe 01-03-94

Iron oxide (dust and fume) covered by HCS despite FDA approval

29 CFR 1910.1200(b)(2)

An OSHA [Permissible Exposure Limit] (PEL) has been established for iron oxide (dust and fume) [see Federal Register Vol. 54, No. 12], and therefore an MSDS [Material Safety Data Sheet] and label must be developed and transmitted by the chemical manufacturer, distributor, or importer.

The toxicity of iron oxide in humans is conflicting. However, "McLaughlin, whose opinion on the subject is widely accepted, believes that the presence of iron oxide dust or fume in the lung causes pigmentation (termed siderosis) that is responsible for the changes seen in exposed individuals' chest x-rays" [FR Vol. 54, No. 12]. Additionally, "OSHA believes that any occupational exposure that causes foreign substance to lodge in body tissues is undesirable" [FR Vol. 54, No. 12].

We realize the [Food and Drug Administration] (FDA) has granted approval to iron oxides for use as a food colorant. However, their approval is based on evidence indicating no adverse health effects at concentrations associated with its use as a food additive. FDA approval of iron oxide as a food colorant is not entirely relevant to occupational exposure from iron oxide. In general, occupational exposures are higher in concentration, of longer duration, and at greater frequency. Therefore, it is inappropriate to conclude that FDA approval, as an approved colorant, is evidence that iron oxide dust is not hazardous.

letter: SGill 03-12-93

Inert gases may be hazardous and are covered by HCS

29 CFR 1910.1200(b)(2)

Inert gas is normally present in the workplace in compressed gas cylinders and is covered by virtue of being a compressed gas. Such cylinders must be carefully handled as the compressed gases present certain physical hazards-- particularly in the event of an emergency, such as a fire. In construction, the most frequent documented origin of a fire in a burning and cutting operation is when molten slag burns through the welding hose, causing free flowing fuel gas to ignite and potentially spread to other volatile gas cylinders. Furthermore, the sudden release of pressure from a compressed gas bottle can convert a cylinder into an uncontrollable rocket.

It is the responsibility of the manufacturer to perform the hazard determination of a substance. Substances such as methane and ethane are pharmacologically "inert", belonging to a group of gases called simple asphyxiants. These gases can be tolerated at high concentrations in the air without producing systemic effects. At high concentrations, however, these substances dilute or exclude oxygen from the air resulting in toxicity from oxygen deprivation or asphyxia. Furthermore, a simple asphyxiant such as methane is odorless with its chief danger being an explosion hazard. Accordingly, toxicity has been established in inert gases and the manufacturer, importer, and/or distributor has the duty of performing a complete hazard determination.

letter: MMcFarland 03-04-93

see also: RAndree 01-25-95

Copier toner is covered only for employees with regular exposures

29 CFR 1910.1200(b)(2)

Chemicals, such as copier toner in a business office, that are only used by employees incidentally in non-routine and isolated instances, are not covered by the standard. [The Hazard Communication Standard] (HCS) would apply if copier toner was used by an employee whose job involves routine work with the toner. For example, employees who work in a copy room of an office or in a business establishment that professionally duplicates documents, must be trained and informed of hazards in accordance with HCS.

letter: CLober 12-24-92

Bricks are covered by the HCS

29 CFR 1910.1200(b)(2)

When bricks are sawed or cut they are capable of releasing crystalline silica, which has been found by the International Agency for Research on Cancer to be a potential human carcinogen. Since bricks are capable of releasing a hazardous substance under normal conditions of use the HCS applies, and manufacturers of bricks are expected to create [Material Safety Data Sheets] (MSDSs).

You may contact the National Institute for Occupational Safety and Health for additional studies done on the hazards of crystalline silica at the following phone number: 1-800-356-4674.

letter: TSanford 11-10-92

see also: DWeinblatt 04-04-92; WBunn 09-25-91

Exposure to crystalline silica: potential for release in respirable form.

29 CFR 1910.1200(b)(2)

The Hazard Communication Standard (HCS) applies to hazardous chemicals to which employees may be exposed. In the case of crystalline silica, it must be released in respirable form in the workplace in order to be available for exposure. We have been given some examples of products containing crystalline silica where it is bound in such a manner that it cannot be released in respirable form. These products would not be subject to the requirements of the HCS as there is no exposure to workers.

Your determination of the coverage of your products must be scientifically defensible. If you have already determined that your products are covered based on the total concentration of crystalline silica, this should be sufficient. An assumption can be made that if crystalline silica can be released from the product, some portion of it will be respirable dust. Measurements used by OSHA to establish exposure are based on airborne concentrations of crystalline silica in respirable form. OSHA has not established methods of determining concentrations in bulk samples.

letter: DWeinblatt 04-04-92

see also: TSanford 11-10-92 and WBunn 09-25-91

"Finished products" and potential for exposure.

29 CFR 1910.1200(b)(2)

If a hazardous material such as crystalline silica is present in a finished product, and if, under normal conditions of use, an employee could be exposed to more than very small quantities of that material, appropriate material safety data sheets and labels must be prepared and utilized to communicate the hazard. If the release is a very small quantity, but it still poses a physical hazard or health risk to workers, data sheets and labels must be prepared and utilized.

Any assessment of risk which may arise as a result of actual, measurable exposure must be separately evaluated by the end user and minimized through their development of suitable engineering or work practice controls for their situation.

letter: WBunn 09-25-91

see also: TSanford 11-10-92 and DWeinblatt 04-04-92

Direct vs. Indirect exposure to ventilating system anticorrosives

29 CFR 1910.1200(b)(2)

Exposures to employees incidentally exposed to trace amounts of nitrosated compounds from ventilating apparatus is not a situation that is or would be covered under the information transmittal provisions of the Hazard Communication Standard (HCS). Certainly all employees who work directly with these chemicals such as maintenance workers, building engineers, or other employees exposed or potentially exposed by directly handling or storing the anti-corrosive chemicals would be covered by the provisions of the rule. These employees' employers must make material safety data sheets (MSDSs) available to them, train them on the hazards associated with exposure, and ensure that container labels provide adequate required information, including, through use of the same identification, a link to the more detailed information on the MSDS.

For directly exposed workers, material safety data sheets for steam humidification compounds should include information on the formation of these n-nitrosamine compounds if, under their normal conditions of use in the workplace, employees (again, the maintenance workers, engineers, building personnel, etc., who work directly with the compounds) may be exposed to the byproducts formed. Transmittal of hazard communication information, i.e., labels, material safety data sheets (MSDSs), and training, does not extend to other employees in the building who may or may not be subsequently and incidentally "exposed" to the trace amounts which may be emitted from the building ventilation system.

Information transmittal, under the Hazard Communication Standard (HCS), does not extend to the downstream workers who may be incidentally exposed to a material generated in a ventilation system. The statement from the OSHA compliance directive, CPL 2-2.38B, on hazard communication that "if a hazardous chemical is known to be present (e.g., nitrosamines are a known byproduct of the process) then it is covered by the standard" is now obsolete. This statement, which has been deleted from the current directive, CPL 2-2.38C, dated October, 1990, was written to address the formation and coverage of byproducts in industrial processes to which employees who work directly with the chemical may be exposed during the process.

OSHA also does not have specific Permissible Exposure Limits (PELs) for the N-Nitroso compounds. OSHA has no regulations which specifically prohibit exposure to compounds which may be generated in steam humidification systems. While the presence of these compounds may contribute to indoor air pollution, the Agency can enforce no specific exposure limits which would limit and control workplace exposure levels.

letter: MMunk 09-23-91

Information required in hazard determination: fibrous glass

29 CFR 1910.1200(b)(2)

You expressed concern about OSHA's position that fibrous glass products are to be considered as a carcinogen for product label and material safety data sheet (MSDS) purposes. You stated that "... this position does not differentiate between glass wool and textile glass fibers" and asked "if it is OSHA's intent to require all fibrous glass be treated as posing a similar risk."

Hazard determinations under the Hazard Communication Standard (HCS) are substance-specific, and data required under OSHA's HCS to be reported on MSDSs and product labels is specific to the information available for the particular hazardous chemical. The HCS, 29 CFR 1910.1200, requires employers to perform a hazard determination for the product(s) they manufacture to determine if, under normal conditions of use or in an emergency, workplace handling or use of their product could result in employee exposure to a hazardous chemical(s). OSHA does not perform these hazard determinations for employers; rather, it is up to the employer to consider all available scientific evidence concerning the hazardous effects of that chemical. No testing is required and the evaluation may be based solely on information currently available in the scientific literature.

If statistically significant evidence exists that exposure to the textile glass products you manufacture ... or the or the fibers emitted during workplace handling of these products, is or has been associated with a health effect from those exposures, then that information must appear on the MSDS, and appropriate hazard warnings conveying that information must appear on container labels for the product. ... the hazard determination, ... is your responsibility as the manufacturer to perform and substantiate.

You must identify the studies that involve the type of fiber you produce. Hazard determinations are not based on analogy (as to the recent OSHA news release on "fibrous glass"), but rather must assess existing data on the specific material involved. If the material is not available for exposure due to its physical form, this should also be factored into the hazard determination. For example, if fibers are not ever of respirable size, inhalation hazards would not be of concern.

A copy of the Agency's July 28 news release on this topic is included for your reference.

letter: DCross 10-18-91

see also: RMunson 05-06-91

Humidification system anti-corrosives: exposed workers

29 CFR 1910.1200(b)(2)

The requirements of the Hazard Communication Standard (HCS) would apply to employers of personnel such as maintenance workers, building engineers, or any other employees who would be exposed or potentially exposed by handling or storing the anti-corrosive chemicals or actually adding them to the humidification system. The chemical manufacturer or distributor of the chemicals is responsible for transmitting with the initial shipment a material safety data sheet (MSDS) which provides information on the chemical and safe handling procedures, among other things. The receiving or downstream employer must make the sheets available to all employees working with these chemicals as part of his overall hazard communication program. Such employees who are or may be exposed in their workplace need the protections afforded by the information that must be provided to them in their workplace hazard communication program.

However, employees such as office workers who may be incidentally exposed to the chemicals in trace amounts from the humidification system would not be covered under the provisions of the HCS. These workers' exposures would be the same as the general public or other people in the building. According to the preamble to the final Hazard Communication Standard (Federal Register, Vol. 52, No. 163, August 24, 1987, pg. 31862), "... to the extent that workers are exposed to the substances in a manner similar to that of the general public, there is no need for any HCS requirements."

letter: WMacht 05-08-91

Chemical by-products vs. Machinery by-products (e.g., Ozone and welding)

29 CFR 1910.1200(b)(2)

Although by-products are covered by the Hazard Communication Standard (HCS), the standard only requires chemical manufacturers or distributors to anticipate the downstream workplace uses of their chemical products and as part of their hazard determination procedures, account for worker exposure to hazardous by-products that may be formed during normal conditions of use. Under the HCS, the manufacturers of welding rods or other chemical products that are utilized during welding and other operations which are capable of resulting in employee exposures would be responsible for chemical hazard information (Material safety data sheets, labels, etc.) to be transmitted to downstream employers.

However, Manufacturers of "high energy machines," welding machines or photocopiers are not considered to be chemical manufacturers under the HCS since they produce machines and not chemicals, for use or distribution to downstream employers. Because ozone is not generated by the welding rod or flux, but rather results from the ionization of the air surrounding the arc or high voltage gap, ozone is not a by-product of the welding rod or photocopier chemical but of the welding or photocopying process. Ozone generated in this fashion would not fall within the scope of 29 CFR 1910.1200(b)(1).

.... The presence of [hazardous by-products of machinery operation such as] ozone in the workplace should be addressed in the employer's hazard communication program.... Employers would not have to "produce" a Material safety data sheet or a label, but should provide information in their hazard communication program to inform their employees "about the hazardous chemical to which they are exposed."

memorandum: PClark (DCP) to LAnku, RA 11-19-90

HCS not applicable where there is no potential for exposure

29 CFR 1910.1200(b)(2)

Any substance which is inextricably bound in a product is not covered under the Hazard Communication Standard (HCS). For example, a hazard determination for a product containing crystalline silica may reveal that it is bound in a rubber elastomer and under normal conditions of use or during foreseeable emergencies cannot become airborne and therefore cannot present an inhalation hazard. In such a situation, the crystalline silica need not be indicated as a hazardous ingredient since it cannot result in employee exposure.

CPL 2-2.38C: A-10 10-22-90

Hazardous by-products under the HCS

29 CFR 1910.1200(b)(2)

By-products are also covered by the Hazard Communication Standard (HCS). Employers' hazard determination procedures must anticipate the downstream use of their products and account for any hazardous by-products which may be formed. For example, a manufacturer of gasoline must inform downstream users of the hazards of carbon monoxide, since carbon monoxide is a hazardous chemical and is a "known to be present" by-product resulting from use of gasoline. Similarly, manufacturers of diesel fuel must inform downstream users of the potential human carcinogenicity of diesel exhaust on the Material safety data sheet for diesel fuel. (See NIOSH Current Intelligence Bulletin No. 50, August, 1988.)

CPL 2-2.38C: A-2 10-22-90

Potential for exposure

29 CFR 1910.1200(b)(2)

The terminology "exposed under normal conditions of use or in a foreseeable emergency" excludes products or chemicals that do not meet this condition. For example, a chemical that is inextricably bound in a mixture and presents no potential for exposure would not be covered. This paragraph must be read in conjunction with the definition of exposure which specifically includes potential (either accidental or possible) exposure. (See the OSHA Field Operations Manual for guidance on citing potential exposure.) Further, employees such as office workers who encounter chemicals only in non-routine, isolated instances are not covered. However, an office worker who works in a graphic arts department and routinely uses paints, adhesives, etc., would be covered by the Hazard Communication Standard (HCS).

CPL 2-2.38C: A-2 10-22-90

Exposure calculations and degree of risk

29 CFR 1910.1200(b)(2)

It is OSHA policy that exposure calculations are not permitted in determining whether a hazard must appear on a label. If there is a potential for exposure, other than in minute or trace quantities, the hazard must be included when well-substantiated.. Suppliers may not exclude hazards based on presumed levels of exposure downstream (i.e., omitting a carcinogenic hazard warning because, in the supplier's estimate, presumed exposures will not be high enough to cause the effect)....

The hazard is an intrinsic property of the chemical. Exposure determines degree of risk and should be addressed in training programs by the downstream employer.

[Originally written for the electrical manufacturing industry]

letter: ROpatick 5-30-90

see also: RBoggs 10-06-94

Employee exposure to hazards under varied conditions of use

29 CFR 1910.1200(b)(2)

Applicability of the provisions of the Hazard Communication Standard (HCS), including labeling and material safety data sheet (MSDS) transmittal requirements, is based on the potential for employee exposure to hazardous chemicals which are known to be present under normal conditions of use. Under normal conditions of use, wet concrete is poured and then is left to set or dry. If employees' normal conditions of use of wet concrete involve exposure to airborne levels of [chemicals] that could occur with exposure to the concrete after it is dried (such as might occur during clean-up operations of hardened cement), then information on the potential hazards must be transmitted on the MSDS and label. The responsibility to perform a hazard determination on the chemical product is the chemical manufacturer's. If hazardous exposure potentials could occur based on anticipated downstream exposures under normal conditions of use of the chemical product, then the material would be covered under the provisions of the HCS. Appropriate hazard information would be required on the labels and/or MSDS.

[Originally written about crushed stone and crystalline silicate]

letter: RBartlett 05-16-90

Low level exposures

29 CFR 1910.1200(b)(2)

You raise the difficult issue of the applicability of the Hazard Communication Standard [HCS] to "de minimis," or trivial releases. Articles that emit minute or trace amounts of a hazardous chemical are not covered. For example, emissions from toner on pieces of paper would not be covered. However, where there is a potential for exposure above minute or trace amounts, the hazard must be communicated to employees on labels and material safety data sheets.

letter: DBumpers 05-02-90

Chemical manufacturer responsible for determining exposure potential

29 CFR 1910.1200(b)(2)

...[H]azard determinations are always the responsibility of the chemical manufacturer. OSHA does not "exempt" specific manufacturers from the responsibilities of the Hazard Communication Standard. It is up to the chemical manufacturer to anticipate the downstream uses and potential exposure scenarios of the hazardous chemicals he produces and label his products accordingly. If a hazardous chemical could be released in such a way as to result in employee exposure, employees have the right to be informed of this. If there is not the potential for exposure, the chemical is not subject to the rule.

[Originally written about the chemical manufacturing industry]

[Originally written about aerosol products]

letter: LLoreth 11-22-89

"Everyday life" vs. workplace usage

29 CFR 1910.1200(b)(2)

The fact that a chemical substance does not appear to pose a health threat in "everyday" lives does not exclude the possibility of potential exposure to hazardous concentrations of the substance during conditions of use found at the workplace. Any substance that presents a potential health or physical hazard to which an employee may be exposed must be included in an employer's hazard communication program.

[Originally written for the construction industry]

letter: MRoss 08-21-89

Application of HCS relies on employee exposure

29 CFR 1910.1200(b)(2)

...[T]he standard does not cover hazardous chemicals when the material is bound in such a way that employees cannot be exposed. If there is no exposure, either under normal conditions of use or in a foreseeable emergency, then the chemical is not covered by the standard, and the hazard information for the chemical would not be required on the label. However, if under normal conditions of use, an action is performed downstream on the product that could release the hazardous chemical, then the substance would be covered under the Hazard Communication Standard (HCS) and the provisions of the standard would apply.

letter: RKasten 07-26-89 Congress

Hazard determination based on intrinsic properties rather than anticipated used

29 CFR 1910.1200(b)(2)

The U.S. Court of Appeals ... upheld OSHA's interpretation of the labeling requirements of the Hazard Communication Standard (HCS)... against [the Company] for failing to label containers of [the substance] with information about health hazards associated with over-exposure to [the substance] dust. [The Company] stipulated that the [substances] are "hazardous chemicals" within the meaning of the standard, but argued that it would be unreasonable to require labeling in this case because the amount of [the substance] dust released ... did not endanger the health of employees.

The court concluded that the standard requires labeling based on the intrinsic properties of hazardous chemicals, not on predictions about the level of risk experienced by particular employees. "[U]nder the definition given in the HCS, an identification of a substance as a hazardous chemical does not depend upon the product's anticipated use at any particular worksite. A substance (e.g., [the substances]) either is or is not a hazardous chemical; the HCS definition cannot be read to indicate that a substance could be a hazardous chemical in some concentrations but not in others.

The court also ruled that (1) because they release more than a "few molecules" of [the substances], the [items] were not "articles" exempt from coverage, and (2) the violation could not be characterized as de minimis, because such a characterization would be inconsistent with the premise of the standard, that "as a general matter, providing workers with comprehensive information regarding possible workplace dangers bears a direct and immediate relationship to safety and health."

[Originally written about copper and graphite brushes]

court: General Carbon v. OSHRC, Docket No. 860 F.2d 479, 1988

Office workers not covered

29 CFR 1910.1200(b)(2)

The standard does not apply to "office workers" who encounter hazardous chemicals in non-routine work situations. For example, an employee who uses a solvent to clean a typewriter once or twice a year does not have to be provided with a material safety data sheet.

letter: MNeville 09-17-87

Welding operations, shipbuilding covered by the standard

29 CFR 1910.1200(b)(2)

Any process, including welding, capable of resulting in employee exposure to hazardous chemicals... is covered by the standard. Chemical manufacturers and importers are required to provide material safety data sheets for all hazardous chemicals sold to distributors and manufacturing purchasers. Your members who perform welding should have access to material safety data sheets for each type of metal and welding rod used. Material safety data sheets are to be provided with the initial shipment and with the first shipment after the material safety data sheet has been updated.

The Hazard Communication Standard applies to shipbuilding and repair activities. Federal shipyards engaged in these activities are covered be the standard. Therefore [shipbuilding and repair] employees working with hazardous chemicals must be provided access to material safety data sheets for the chemicals they are or may be exposed to.

letter: DBeem 05-19-86

Requirements for Laboratories - (b)(3)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, paragraph (b)(3) was modified. New wording is indicated in quotation marks:

(ii) Employers shall ensure that MSDS "are readily accessible during each workshift to laboratory employees when they are in their work areas;"

(iii) Employers shall ensure that laboratory employees "are provided information and training in accordance with paragraph (h) of this section, except for the location and availability of the written hazard communication program under paragraph (h)(2)(iii) of this section;"

Further, a new subsection, paragraph (b)(3)(iv), has been added:

"(iv) Laboratory employers that ship hazardous chemicals are considered to be either a chemical manufacturer or a distributor under this rule, and thus must ensure that any containers of hazardous chemicals leaving the laboratory are labeled in accordance with paragraph (f)(1) of this section, and that a material safety data sheet is provided to distributors and other employers in accordance with paragraphs (g)(6) and (g)(7) of this section."

Protecting laboratory employees

29 CFR 1910.1200(b)(3) and 29 CFR 1910.1450

In addition to the Hazard Communication Standard (HCS), OSHA promulgated the Lab Standard in 1990. This rule requires laboratories to establish and implement a Chemical Hygiene Plan to ensure laboratory employees are properly protected from chemical exposures. The requirements in the Lab Standard were based on commonly accepted practices of laboratory safety.

Neither of the OSHA standards [1910.1200 or 1910.1450] ... require signs on laboratory doors. You may be confusing the requirements of Federal OSHA with non-mandatory guidelines on laboratory safety or with state or local right-to-know laws.

[Originally written for the medical laboratory industry]

letters: MSegal 02-24-92, DDeConcini 09-10-91 Congress

Application of the HCS to laboratories

29 CFR 1910.1200(b)(3)

Your question asks whether an employer can implement a comprehensive chemical hygiene plan for all laboratory operations regardless of whether they are covered by [the laboratory standard] and be in compliance with the Hazard Communication Standard (HCS), including the secondary container labeling requirements. The answer is yes, if all requirements of the Laboratory Standard (the comprehensive chemical hygiene plan being just one of the more important requirements) are met, compliance with HCS with respect to coverage of laboratories would also be achieved.

The Laboratory Standard covers only facilities meeting the criteria of "laboratory use" and "laboratory scale" and exclude procedures that are part of a production process. Facilities such as dental laboratories or photographic laboratories are considered production facilities and are covered under the full requirements of HCS. Laboratories, such as quality control laboratories, are covered by the more limited provisions of the HCS (see 29 CFR 1910.1200(b)(3)); not all provisions of the HCS are applicable to these types of operations.

With regard to container labeling in laboratories, employers are only required to ensure labels on incoming containers of hazardous chemicals are not removed or defaced.

letter: WBernhart 04-24-91

QC laboratories are covered under the HCS

29 CFR 1910.1200(b)(3)

These labs assuring quality control of the production process would not be covered under 1910.1450 but would be covered under other general industry standards including

29 CFR 1910.1200.

The coverage of laboratories is limited under the Hazard Communication Standard (HCS) because it was expected that most laboratories would be covered by the Laboratory Standard. However, the directive [CPL 2-2.38C] does state that QC laboratories would generally be covered by the HCS.

letter: TOzimek 01-17-91

Distinction of laboratory functions designates applicable standard

29 CFR 1910.1200(b)(3)

Laboratories that meet the definition of "laboratory scale" and "laboratory use" would be within the scope of the standard [29 CFR 1910.1450]. Laboratories that are part of the production process or performing quality control of production would be covered by other appropriate general industry standards including 29 CFR 1910.1200. For example, evaluating the suitability of raw materials may be considered research. Once raw materials are selected and will be incorporated into the formulation of a product, the laboratory activities would be considered part of the production process and therefore not be within the scope of the Laboratory Standard.

letter: NKaleta 01-16-91

QC laboratories as adjunct of production operations

29 CFR 1910.1200(b)(3)

29 CFR 1910.1450, Exposure to Hazardous Chemicals in Laboratories, addresses hazard communication requirements in laboratories. It is consistent with the Hazard Communication Standard (HCS), but also has some additional requirements that must be applied in laboratories covered by that rule. The operating definition of a laboratory is not the same for both standards. 29 CFR 1910.1450 covers only laboratories meeting criteria of "laboratory use" and "laboratory scale" and excludes procedures that are part of a production process (55 FR 3328). The preamble to 29 CFR 1910.1450 states "... most quality control laboratories are not expected to meet the qualification for coverage under the Laboratory Standard. Quality control laboratories are usually adjuncts of production operations..." (55 FR 3312). Quality control laboratories would therefore generally be covered by the HCS.

CPL 2-2.38C: A-3 10-22-90

Limited coverage of the HCS in laboratories

29 CFR 1910.1200(b)(3)

The coverage of laboratories is limited under the Hazard Communication Standard (HCS). Although the standard does not specifically define the term "laboratory", it is intended to mean a workplace where relatively small quantities of hazardous chemicals are used on a nonproduction basis; i.e., bench-scale operations. The definition would include research facilities as well as quality control laboratory operations located within manufacturing facilities.

Establishments, however, which produce samples or chemical standards to be sent out to other employers covered by the HCS would not fall under the standard's term for a laboratory. Those employers who ship hazardous chemicals would be considered either chemical manufacturers or distributors and must label in accordance with paragraph (f)(1) and provide material safety data sheets (MSDS) per paragraphs (g)(6) and (g)(7).

Under the HCS, laboratories do not have to have a written hazard communication program. Therefore, when the required training is performed, the part that deals with the program availability will simply point out that such written programs are not required for laboratories.

Some manufacturers of chemical specialty products have interpreted the laboratory provisions as exempting them from coverage. These operations are considered to be manufacturing processes, and are not exempted. Furthermore, a pilot plant operation is also considered to be a manufacturing operation, not a research laboratory operation. In addition, establishments such as dental, photofinishing, and optical laboratories clearly are not considered laboratory operations for the purposes of this standard since they are engaged in the production of a finished product.

Quality control samples taken in a plant must be labeled, tagged, or marked unless the person taking the sample is also going to be performing the analysis, and thus the sample would come under the portable container exemption. A hand-written label may be utilized as long as required label information is present. The rack in which samples are placed could be labeled in lieu of labeling individual samples if the contents and hazards are similar.

CPL 2-2.38C: A-3&4 10-22-90

MSDS requirements for laboratories

29 CFR 1910.1200(b)(3)(ii)

The HCS addresses laboratories in a more limited fashion than it does for other types of establishments. An employer is only required to maintain those MSDS which the supplier sends. There is no affirmative obligation for a laboratory to request or otherwise procure data sheets.

letter: DJohnson 06-05-89

Sealed Containers - (b)(4)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, paragraph (b)(4) has been modified. New wording is indicated in quotation marks:

(ii) Employers "shall obtain a material safety data sheet as soon as possible" for a container received without an MSDS if an employee requests one.

Accessibility of material safety data sheets

29 CFR 1910.1200(b)(4)(ii)

Questions:

1. Can a central repository of MSDS be kept at one location in one of the buildings that support seven buildings?

2. ...[F]ifty buildings are on city blocks which are all contiguous in a five square block area, with the same personnel and security situation as noted in [question] #1 above. Can a single MSDS repository serve all these buildings?

3. ...[D]oes a single repository provided for each building with security having twenty-four hour a day access to them for all departments in that building meet the intent of the OSHA regulations?

The key to compliance with the HCS is that employees have no barriers to access to the information and that the MSDSs be available during all workshifts. The HCS is a performance oriented standard. A performance-oriented standard gives employees the flexibility to adapt the rule to the needs of the workplace situation, instead of having to follow specific rigid requirements. Situations #1, #2, and #3 would have to be evaluated within the context of the employers Hazard Communication Program.

...[T]he HCS specifies that MSDS must be maintained on site and readily accessible during each workshift to employees when they are in their work area(s) [(29 CFR 1910.1200(b)(4), 1910.1200(g)(8))]. Again, the situations you describe above could meet that requirement as long as there are no barriers to employees accessing the MSDSs.

[Originally addressed MSDS requirements for sealed containers]

letter: JBalsamo 02-01-94

Working with sealed containers

29 CFR 1910.1200(b)(4)(iii)

Since all containers are subject to leakage and breakage, employees who work in operations where they handle only sealed containers (such as warehousing) are potentially exposed to hazardous chemicals and therefore need access to information as well as training. The training required for employees who handle sealed containers is dependent upon the type of chemicals involved, the potential size of any spills or leaks, the type of work performed and what actions employees are expected to take when a spill or leak occurs.

Employers are required to obtain material safety data sheets (MSDSs) for chemicals in sealed containers if an employee requests one. The employer's attempt must begin promptly (within a day) in order to be consistent with the requirement that available sheets be accessible during each shift in the work area.

CPL 2-2.38C: A-4 10-22-90

Application to stevedores and sealed container handlers

29 CFR 1910.1200(b)(4)(iii) and 29 CFR 1918.90(b)(4)(iii)

The standard itself addresses the issue of sealed containers in section 29 CFR 1918.90(b)(4)(iii): "Employers shall ensure that employees are provided with information and training... to the extent necessary to protect them in the event of a spill or leak of a hazardous chemical from a sealed container." Although, as you state, stevedores may not directly handle individual sealed containers, the trailers, with their sealed cargo, would also be considered sealed containers and therefore covered by the limited provisions of the standard under paragraph (b)(4).

Since the standard addresses the handling of hazardous chemicals in sealed containers, OSHA cannot exempt stevedores in the containerized shipping industry from the training requirements of the HCS. Employers can develop training programs to reflect the type of work performed. For example, if an employer's work practice procedures for leaks and spills is to evacuate the work area, then the employer's training program could just address the proper action to take, such as evacuation procedures, cleanup responsibility, etc.

Specific training is not required concerning the hazards of each chemical stevedores may encounter in a sealed container, provided that employees are aware of general precautions to take in the event of a spill or leak of the chemical. If an employer has employees who open sealed containers, then those employees would be covered by the more comprehensive provisions of the standard.

letter: AKaplan 11-17-88

Limited Exemptions from Labeling Requirements - (b)(5)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the following modifications have been made to paragraph (b)(5):

The labeling exemption for beverage alcohols subject to the labeling requirements of the Bureau of Alcohol, Tobacco and Firearms is now under (b)(5)(iv), with no changes in wording;

The labeling exemption for consumer products and hazardous substances subject to the labeling requirements of the Consumer Product Safety Commission is now under (b)(5)(v), with no changes in wording;

The labeling exemption for chemicals subject to FDA labeling requirements is now under (b)(5)(iii), with changes in wording indicated in quotation marks:

(iii) Any food, food additive, color additive, drug, cosmetic, "or medical or veterinary device or product" as defined in the Federal Food, Drug, and Cosmetic Act" or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;"

Two additional labeling exemptions have been added, as follows:

"(ii) Any chemical substance or mixture as such terms are defined in the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Environmental Protection Agency;"

"(vi) Agricultural or vegetable seed treated with pesticides and labeled in accordnace with the Federal Seed Act (7 U.S.C. 1551 et seq.) and the labeling regulations issued under that Act by the Department of Agriculture."

 

Pesticide labeling under HCS: Environmental Protection Agency (EPA) requirements

29 CFR 1910.1200(b)(5)(i)

If OSHA is certain that the chemical is a pesticide--and that the lack of a label is therefore a violation of EPA's requirements and not OSHA's--no citation would be issued, but a referral would be made to EPA. However, the CSHO [Compliance Safety and Health Officer] cannot objectively ascertain that the container holds a covered pesticide unless an appropriate pesticide label--with an EPA registration number--is produced by the employer. Existence of such a label needs to be established for OSHA to be certain that the chemical is an EPA-regulated pesticide. This is particularly important since many pesticides are used for other purposes....

Thus, from a practical perspective, if the CSHO finds an unlabeled container of chemicals in the workplace, the employer should be cited for violating the labeling provisions of the Hazard Communication Standard (HCS) unless: 1) it is exempted under the portable container provisions; 2) the employer can demonstrate that the chemical is not hazardous, and therefore not subject to the HCS; or 3) the employer can demonstrate that the chemical is subject to labeling requirements of EPA (or other Federal agency) by producing the appropriate label.

If the appropriate pesticide label is produced after the citation is issued, we will withdraw it upon proof that the chemical is covered under EPA regulations.

memorandum: PClark (DCP) to LAnku, RA 05-08-91

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, this labeling exemption was modified. Changes in wording are indicated in quotation marks:

(iii) Any food, food additive, color additive, drug, cosmetic, "or medical or veterinary device or product" as defined in the Federal Food, Drug, and Cosmetic Act" or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;"

The exemption from coverage of drugs in solid, final dosage form; drugs packaged for retail sale; and drugs intended for personal consumption by employees are discussed under Subparagraph (b)(6)(vii)

 

Exemptions for drugs and veterinary products

29 CFR 1910.1200(b)(5)(iii)

The [HCS] standard does not apply to nonhazardous drugs, but any drug that meets the criteria of a hazardous chemical in the HCS generally would be covered. The HCS contains some exemptions that would apply to some drug and veterinary products. Section (b)(5)(iii) of the HCS states that drugs that are subject to labeling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard. Please note that this section of the HCS exempts only labeling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS).

Another section of the standard that is relevant...is 1910.1200(b)(6)(vii)[,] which exempts from coverage under the standard drugs as defined by the Federal Food, Drug and Cosmetic Act that are in solid final form, ready for direct administration to the patient such as tablets, capsules or pills. If these drugs are not in final form in that they are designed to be dissolved or crushed by employees prior to administration, then they are covered by the HCS. (There may be situations where a tablet, capsule or pill is dissolved or crushed for purposes of administration when that is not generally the way it is dispensed. The final form exemption would apply in this situation.) Consequently, MSDS are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drug and veterinary products, except for products which are in solid final form for direct administration to patient.

letter: CStowe 12-22-93

see also: GBaril 12-28-89

Applying HCS to all chemicals used by employees

29 CFR 1910.1200(b)(5)(v)

OSHA and the Department of Labor are precluded under Section 4(b)(1) of the Occupational Safety and Health Act of 1970 (OSH Act) from exercising "statutory authority to prescribe or enforce standards or regulations" over areas or issues that other Federal agencies already "prescribe or enforce." The Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) regulate the use of consumer products and/or hazardous substances outside the workplace. The labeling, therefore, of consumer products is under the Consumer Product Safety Commission's authority, while the requirement to provide material safety data sheets (MSDSs) and train employees in their safe handling in the workplace falls under OSHA's jurisdiction if, again, their use is of a greater frequency or duration (and therefore a greater exposure risk) than what a normal consumer would experience.

letter: DHelm 11-27-90

Patch test kits exempt from HCS labeling requirements

29 CFR 1910.1200(b)(5)(iii)

You requested guidance on whether "patch test kits" are exempt from the labeling requirements of [Hazard Communication Standard] (HCS). If the patch test kit and its contents are subject to the labeling requirements of the Federal Food, Drug and Cosmetic Act and are labeled in accordance with the Food and Drug Administration, the kit would be exempt from the labeling requirements of HCS. This exemption only applies to labels; employers must still comply with all other provisions of the standard.

letter: CLober 12-24-92

Labeling of food or food products

29 CFR 1910.1200(b)(5)(iii)

The Hazard Communication Standard (HCS), at section (b)(5)(ii) specifically exempts from the labeling requirements of the HCS any food or food additive that is subject to the labeling requirements of the Food and Drug Administration (FDA).

[Originally written for the food industry]

letter: JLee 01-24-90

Labeling of pharmaceutical drugs

29 CFR 1910.1200(b)(5)(iii)

Pharmaceutical drugs that are subject to labeling requirements administered by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard (HCS) (see the HCS at section (b)(5)(ii)), since they are required to meet FDA's specific labeling requirements.

[Originally written for the medical industry]

letter: GBaril 12-28-89

see also: CStowe 12-22-93

Exemptions from Scope of HCS - (b)(6)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the following modifications were made to paragraph (b)(6):

The exemption for tobacco products is now under (b)(6)(iii), with no changes in wording;

The exemption for wood products is now under (b)(6)(iv), with changes in wording indicated in quotation marks:

(iv) Wood or wood products "including lumber which will not be processed, where the chemical manufacturer or importer can establish that the only hazard they pose to employees is the potential for flammability or combustibility (wood or wood products which have been treated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut, generating wood dust, are not exempted);"

The exemption for articles is now under (b)(6)(v), with changes in wording indicated in quotation marks:

(v) Articles "(as that term is defined in paragraph (c) of this section);"

The exemption for consumer products is now under (b)(6)(ix), with changes in wording indicated in quotation marks:

(ix) Any consumer product or hazardous substance where the employer can show that "it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended;"

The exemptions for food, drugs and cosmetics have been reworked as follows:

"(vi) Food or alcoholic beverages which are sold, used, or prepared in a retail establishment (such as a grocery store, restaurant, or drinking place), and foods intended for personal consumption by employees while in the workplace,"

"(vii) Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to customers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies);"

"(viii) Cosmetics which are packaged for sale to consumers in a retail establishment, and cosmetics intended for personal consumption by employees while in the workplace;"

Four additional exemptions have been added, as follows:

"(ii) Any hazardous substance as such term is defined by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) (42 U.S.C. 9601 et seq.), when subject to regulations issued under that Act by the Environmental Protection Agency

"(x) Nuisance particulates where the chemical manufacturer or importer can establish that they do not pose any physical or health hazard covered under this section,"

"(xi) Ionizing and nonionizing radiation," and

"(xii) Biological hazards."

 

Hazardous Waste - (b)(6)(i)

Applicability of the HCS to the storage, handling, and disposal of parenteral cytotoxic pharmaceuticals

29 CFR 1910.1200(b)(6)(i)

Questions: Is [the requirement to dispose of cytotoxic waste in distinctively labelled and color-coded bags] [as specified in OSHA's 1986 publication containing guidelines for disposal of hospital wastes contaminated with cytotoxic drugs] designed to comply with the Hazard Communication Standard so that employees can define the appropriate hazard and handle the waste appropriately?

[Is the requirement to place] needles, syringes, and breakable or sharp items used with cytotoxic drugs...in specially designated puncture proof boxes...designed to comply with the Hazard Communication Standard?

No. Although the requirements of the HCS do apply to the storage and handling of parenteral cytotoxic pharmaceuticals, the HCS does not address proper disposal of hazardous materials and does not apply to hazardous waste [(29 CFR 1910.1200(b)(6)(i))]. The guidelines in OSHA's 1986 document are intended to address the safety and health of workers handling cytotoxic waste while meeting the disposal requirements of EPA's National Hazardous Waste Program and equivalent state laws.

Question: Can empty IV bags and tubing or gowns and gloves used...be placed in with infectious waste as these are only residually contaminated? If not, do they need to be placed in specially labelled and color-coded bags or containers?

OSHA's Bloodborne Pathogens Standard permits disposing of residually contaminated protective clothing with infectious waste, so long as such waste was labelled in accordance with 29 CFR 1910.1030. In lieu of labeling, such waste may be placed in red bags or red containers. OSHA's Hazard Communication Standard would not apply to the labeling of non-infectious waste that is contaminated with cytotoxic residues. Of course, disposal of material contaminated with cytotoxic chemicals must conform to state law.

letter: LMurphy 11-21-94

Hazardous waste exemption

29 CFR 1910.1200(b)(6)(i)

Hazardous waste is specifically exempted from inclusion under the [Hazard Communication Standard] (HCS) by subparagraph 1910.1200(b)(6)(i), not because the concept of conveying information to the worker does not apply, but rather because another standard does; i.e., EPA's [the Environmental Protection Agency] Resource Conservation and Recovery Act (RCRA).

The following is a presentation of our responses to your questions in the order in which they were raised:

Question: Does this regulation exclude a container (drum) of hazardous waste in a satellite accumulation area that is in the process of being filled but has yet to be moved to an approved hazardous storage area and properly labeled as hazardous waste as outlined in RCRA regulations?

No. All containers of hazardous chemicals in the workplace must be labeled. In order to claim the exemption allowed at (b)(6)(i) of the HCS, the drum must meet the requirements of that rule, including proper labeling as required by RCRA. One such applicable RCRA standard, 40 CFR 262.34(c)(1)(ii), requires that containers of hazardous waste at satellite collection areas within a plant be labeled or marked "either with the words hazardous waste or with other words that identify the contents of the container."

Question: Does this regulation exclude drums of waste defined as hazardous materials but not hazardous wastes such as asbestos contaminated waste/PCB-contaminated wastes, etc. that are labeled in accordance with other applicable regulations such as TSCA [Toxic Substances Control Act] and RCRA?

If these materials are labeled in accordance with the requirements of RCRA, and the employer can prove that all other applicable provisions of that Act have been met at the worksite, such materials would not be covered under the provisions of the Hazard Communication Standard. Section (b)(6)(i) of the HCS exempts from coverage any hazardous waste (as defined under the Solid Waste Disposal Act and amended by the Resource Conservation and Recovery Act and its amendments) when that material is subject to regulations issued by EPA. Therefore, if these materials are subject to those regulations and labeled in accordance with RCRA requirements, they are exempt from coverage under OSHA's HCS. The HCS does not grant any exemption for materials regulated under EPA's TSCA.

It is always the employer's responsibility to be able to prove a claimed exemption to OSHA's HCS. With regard to the "hazardous waste exemptions" allowed at (b)(6)(i) of the HCS, the employer must be able to demonstrate that the material is subject to the RCRA regulations. Employers claiming this exemption must be able to produce the appropriate RCRA label and any other RCRA required identification materials to an inspecting OSHA compliance officer.

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, a labeling exemption was added for chemicals subject to EPA labeling requirements under the Toxic Substances Control Act (TSCA).

letter: VCormier 11-01-91

Interface of HCS and HAZWOPER

29 CFR 1910.1200(b)(6)(i) and 29 CFR 1910.120

The Hazard Communication Standard does not, however, cover hazardous wastes as defined and regulated by the [Environmental Protection Agency] (EPA). For other hazardous chemicals known to be present at the workplace, the standard states that health hazard information is required to be transmitted from the chemical manufacturer or importer and flow "downstream" with the substance as it is used by industry.

In general, "hazardous materials generators who are using, packaging and transporting hazardous materials" may be required to train their employees by 1910.1200 and by [the Hazardous Waste Operations and Emergency Response Standard] 1910.120, depending on the chemicals they work with and the actions they are required to take during an emergency. The content and objective of the required training from the two standards are different.

The required Hazard Communication covers all employees who work near chemicals. It requires the employer to train workers about workplace specific safety and health hazards, how the employee can access information pertaining to those hazards and how the employee can use the information effectively to protect his or her health. The Hazard Communication Standard has limited training requirements with regard to emergency procedures. The employer must provide employees with training on recognizing hazardous incidents and how to evacuate during an emergency.

In contrast, HAZWOPER only covers employees at hazardous waste sites, Treatment, storage and Disposal Facilities and those employees that will respond to emergencies involving the spill of hazardous material.

Besides 1910.120 and 1910.1200 training requirements, there are specific training requirements for those employees required to wear personal protective equipment (PPE). The training required depends on the equipment to be used by the employee. Please refer to 29 CFR 1910.134 for a more in depth discussion of required training for those using PPE.

letter: FWilliams 06-10-91

PCBs are covered under HCS

29 CFR 1910.1200(b)(6)(i)

Polychlorinated biphenyls (PCB's) are not defined as hazardous waste under [The Resource Conservation and Recovery Act] (RCRA), and therefore do not meet the exemption for coverage under the Hazard Communication Standard 29 CFR 1910.1200(see subparagraph (b)(6)(i)). The employer must comply with the requirements of 1910.1200 and must implement a hazard communication program at that site. If the PCB's are being handled at a permitted (under RCRA) [Treatment, Storage and Disposal] (TSD) area and no hazard communication program has been implemented, then a violation of both 1910.120(p)(2) and 1910.1200 exist. These violations may be grouped, as appropriate, on any citation issued.

memorandum: PClark (DCP) to GSaulter, RA 02-15-91

Exemption for RCRA hazardous waste

29 CFR 1910.1200(b)(6)(i)

This paragraph, [1910.1200 (b)(6)(i)], totally exempts certain categories of substances from coverage under the Hazard Communication Standard (HCS). Hazardous waste is completely exempted from the standard when subject to regulation by the Environmental Protection Agency (EPA), under the Resource Conservation and Recovery Act (RCRA). If the waste is not regulated under RCRA, then the requirements of the standard apply. Once the material is designated as hazardous waste as defined under RCRA, it is totally exempted. Other chemicals which are used by employees at a hazardous waste site that are not hazardous waste are covered under the HCS. (An example would be an acid brought on site by the employer to neutralize a waste product.)

CPL 2-2.38C: A-5 10-22-90

Laboratory analysis of hazardous waste

29 CFR 1910.1200(b)(6)(i)

Since the laboratory analysis is part of the preparation for the disposal of the chemicals and the waste manifest accompanies the sample bottles to the laboratory, it would, therefore, still be considered hazardous waste. Such samples would be exempted from coverage under the Hazard Communication Standard, if the waste is defined as a hazardous waste by the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, when subject to regulations issued under that Act by the Environmental Protection Agency.

letter: LMaglin 08-17-88

Hazardous waste must be regulated by EPA to be exempt from OSHA's HCS

29 CFR 1910.1200(b)(6)(i)

OSHA is unpersuaded by your contention that the Environmental Protection Agency (EPA) decision not to regulate [this type of hazardous waste] under authority of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA) exempts scrap metal from OSHA's HCS coverage. The HCS hazardous waste exemption, exempts hazardous waste that is "subject to regulations" issued by EPA. The HCS exemption was intended to avoid duplicate coverage by the two Federal agencies. Where EPA ensures that employees are protected during the processing, handling and use of "hazardous waste," by requiring transmittal of chemical hazard information through labels, material safety data sheets and training, there is no apparent need for OSHA to regulate. However, hazardous wastes not subject to EPA's RCRA regulations are not subject to duplicative hazard communication requirements. Hazardous waste not subject to RCRA regulations is not exempted from OSHA's HCS coverage.

It also does not follow that where EPA has decided not to regulate, OSHA must do the same. EPA's judgment that it needed to study this issue further "before deciding on an appropriate regulatory regime (if any)," does not lessen OSHA's obligation to protect employees, nor does it make unnecessary the application of the HCS to [your] industry.

letter: EMerrigan 05-23-86, re: scrap metal recycling

Wood or Wood Products - (b)(6)(iv)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, this exemption was modified. Changes in wording are indicated in quotation marks:

(iv) Wood or wood products "including lumber which will not be processed, where the chemical manufacturer or importer can establish that the only hazard they pose to employees is the potential for flammability or combustibility (wood or wood products which have been treated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut, generating wood dust, are not exempted)."

On April 13, 1994, OSHA issued a temporary stay of effective date for wood products under the amended Final Rule. OSHA has stayed until August 11, 1994 coverage of wood and wood products which will be processed in a manner creating wood dust or which are treated with hazardous chemicals. This will allow sufficient time for development of labels and material safety data sheets.

Clarification of the wood products exemption

29 CFR 1910.1200(b)(6)(iv)

The amendments to the standard with respect to wood products reflect a clarification of OSHA's intent in the original standard; the amended standard does not impose new or additional requirements. Wood and wood products are still exempted from the hazard communication standard if the only hazard presented from use of the product is flammability or combustibility, which are hazards that are well-known among users of wood products. However, it may not be generally known among users that inhalation of certain types of wood dust or chemicals used to treat wood can present a serious lung disease hazard. For this reason, OSHA has always required under the hazard communication standard that distributors of wood products provide MSDS to employers whose employees may be exposed to these inhalation hazards.

letter: SEarnest 12-05-94

Wood dust PEL vacated

29 CFR 1910.1200(b)(6)(iv) and 29 CFR 1910.1000

Wood dust will now be regulated as a [particulate not otherwise regulated] PNOR, because the wood dust [permissible exposure limit (PEL)] has been vacated.

memorandum: RClark (DCP) to Directorate Heads and RAs 08-05-93

Wood dust is not exempted

29 CFR 1910.1200(b)(6)(iv)

The wood and wood products exemption was never intended by OSHA to exclude wood dust from coverage. This fact was clarified in the preamble to the final rule published August 24, 1987. (See Federal Register, Vol. 52, No. 163, page 31863.) The permissible exposure limits [PELs] for wood dust recently adopted under OSHA's PEL Project must be included on the material safety data sheets (MSDSs), which will generally be developed by the sawmill. Further, any chemical additives present in the wood which represent a health hazard must also be included on the MSDSs and/or label as appropriate.

CPL 2-2.38C: A-7 10-22-90

Articles - (b)(6)(v)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, this exemption was modified. Changes in regulatory language are indicated in quotation marks:

(v) Articles "(as that term is defined in paragraph (c) of this section)."

The definition of "article" is discussed as a subsection under Paragraph (c), Definitions.

Coverage of gas calibration bottles

29 CFR 1910.1200(b)(6)(v)

As mentioned in the HCS preamble (August 24, 1987), exposures to releases of "very small quantities"; e.g., a trace amount, are not considered to be covered by the HCS. The definition has been interpreted to permit the release of very small quantities of a hazardous chemical and still qualify as an article [(see 29 CFR 1910.1200(c))] provided that a physical or health risk is not posed to the employees. Examples of very small quantities would be trace amounts of a hazardous chemical.

Based on...information provided...the release of hazardous chemicals from the gas calibration bottles, i.e., [bottles of calibration gas containing a 2 ounce quantity of pure gas such as ammonia, chlorine, hydrogen sulfide, and carbon monoxide used to calibrate gas monitors,] could result in employee exposure and do not appear to satisfy the criteria of "very small quantities". Consequent[ly], the standard does apply and the employees would have the right to be informed of these chemical hazards as per the requirements of the HCS.

letter: JMcCann 01-03-94

"Articles" are not covered

29 CFR 1910.1200(b)(6)(v)

Manufactured items which meet the definition of an "article" under section (c) of the [Hazard Communication Standard(HCS)] are exempted from the requirements of the standard. A product classified as an article, such as a tire, a brake shoe, or metal workstation, which does not release a hazardous chemical during normal handling and use and in reasonably foreseeable emergencies, would not be covered by the HCS provisions. Releases of "very small quantities" (preamble to the August 24, 1987 Final Hazard Communication Rule) are not considered to be covered by the HCS, however where chemicals are released above trace amounts the HCS would apply. For example, bricks for use in construction operations are covered, since under normal conditions of use, bricks are cut or sawed, thereby resulting in exposure to crystalline silica.

letter: HPowell 06-17-93

"Articles" exemption from HCS

29 CFR 1910.1200(b)(6)(v)

You requested OSHA's opinion on whether your company's right angle gear boxes are exempt from the Hazard Communication Standard (HCS). While we cannot give individual products exemption or approval status, we will explain how "articles" are considered exempt from the HCS.

The current definition of "article" in 29 CFR 1910.1200 is provided as follows:

"Article" means a manufactured item: (i) which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which does not release, or otherwise result in exposure to , a hazardous chemical, under normal conditions of use.

If a machine such as yours does not potentially release chemicals during normal operating conditions it would be considered an article exempt from the HCS's requirements, as per 29 CFR 1910.1200(b)(6)(v). If chemicals were released during normal operating conditions your company would have to create an MSDS [Material Safety Data Sheet].

letter: JJackson 01-27-93

Article exemption in demolition

29 CFR 1910.1200(b)(6)(v)

The preamble to the Hazard Communication Standard which was published in the Federal Register on August 24, 1987 ... [includes] a discussion of the article exemption, OSHA states:

"... OSHA does not believe that the possibility that exposure could occur when the item is repaired or worked on need be considered in the determination of when information must be transmitted downstream. Employers of the employees performing repairs must provide the best information they have concerning the potential exposures. There would be no way to ensure, for example, that a material safety data sheet prepared for a lead pipe would be available to a worker repairing the pipe some years following installation. The employer would provide the employees with general information concerning the hazards of the operations they were performing in lieu of specific information on the pipe itself".

letter: RBrooks 01-25-90

Exemption of article--incineration of medical supplies

29 CFR 1910.1200(b)(6)(v)

OSHA agrees ... that devices such as metal bed pans and crutches are "articles" under the definition given in section (c) of the Standard. The article exemption is based upon a lack of employee exposure potential to hazardous chemicals during normal conditions of use of that article. Incineration of [products] may be a routine disposal operation but does not constitute "a normal condition of use." "Use" is defined in the Hazard Communication Standard (HCS) as meaning to "package, handle, react or transfer." Such [products] do not release material while workers are using them in the normal course of their employment.

The manufacturers of such items do not have to anticipate their ultimate destruction. For purposes of the HCS, the [devices] would be considered "articles" under the HCS if, during their normal condition of use, no employee exposure potential to hazardous materials exists. Further, ... the incineration of [such] devices is performed in order to destroy biological hazards and standards governing the disposal and incineration of biological and other hazardous wastes are developed and enforced under the statutory purview of the Environmental Protection Agency.

While OSHA is the Agency responsible for ensuring employee safety and health and the purpose of the HCS is to ensure employees have access to the information about hazardous chemicals that they work with, ... manufacturers of articles do not have to anticipate exposures that might occur during the ultimate destruction (incineration) of the products they produce as long as exposures that could result from normal conditions of use are addressed on the material safety data sheet (MSDS) and/or labels.

[Originally written for the medical supplies industry]

letter: RWilbur 01-05-90

Drill bits as articles

29 CFR 1910.1200(b)(6)(v)

The key to the definition of an "article," and thus exemption, is the requirement that the manufactured item does "... not release, or otherwise result in exposure to, a hazardous chemical under normal conditions of use ..." Manufacturers must consider their products' end use before the "article" exemption may apply.

Your letter states that you have been informed that if the drill bit is used properly, with a coolant, no dusts will become airborne; and that the steel will not heat up to the 1200-degree temperature necessary to release a toxic gas. The Hazard Communication Standard requires "chemical manufacturers" to evaluate the chemicals produced in their workplace to determine if they are hazardous. If your hazard determination indicates that downstream employees will not be exposed to any hazardous chemicals contained in your drill bit, then your product would meet the definition of an article.

The Occupational Safety and Health Administration (OSHA) cannot make an across-the-board determination of a products' exclusion as an "article." The standard's definition by its very wording imposes the need to make case-by-case evaluations. Consequently, a blanket exemption for specific products cannot be given by OSHA.

letter: CMullen 10-02-86

Food or Alcoholic Beverages - (b)(6)(vi)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the exemptions under paragraph (b)(6) relating to food products and alcoholic beverages were consolidated into one exemption, as follows:

"(vi) Food or alcoholic beverages which are sold, used, or prepared in a retail establishment (such as grocery store, restaurant, or drinking place) and foods intended for personal consumption by employees in the workplace."

Food products under the HCS

29 CFR 1910.1200(b)(6)(vi)

Food and food products are therefore not totally exempt from coverage under the provisions of the Hazard Communication Standard (HCS).

letter: JLee 01-24-90

Drugs - (b)(6)(vii)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the exemptions under paragraph (b)(6) relating to drugs were consolidated into one exemption, as follows:

"(vii) Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies)."

The exemption from labeling requirements for chemicals subject to the labeling requirements of the Food and Drug Administration is discussed under Subparagraph (b)(5)(iii).

Exemption of pharmaceuticals

29 CFR 1910.1200(b)(6)(vii)

Question: Are pharmaceuticals in a retail establishment which are packaged for sale to consumers exempt from the HCS?

Yes, Section (b)(6)(vii) of the HCS exempts, "drugs...in a retail establishment which are packaged for sale to consumers[.]"

Question: Must the pharmacy keep MSDSs for hazardous chemical containing products in a solid dosage form (e.g., tablets and capsules) intended for direct administration to the patient -- or -- are these products exempt from the MSDS requirements?

Drugs, as defined in the Federal Food, Drug and Cosmetic Act, in solid, final form for direct administration to the patient (i.e., tablets, pills, capsules) are exempt from coverage under section (b)(6)(vii) of the HCS.

Question: Must the pharmacy keep MSDSs for hazardous chemical containing products in a solid dosage form (e.g., tablets and capsules) that are intended to be crushed or mixed prior to administration?

Must the pharmacy keep MSDSs for hazardous chemical containing products in solid dosage form (e.g., tablets and capsules) that are NOT intended to be crushed or mixed prior to administration -- even though it is possible that a nurse might choose to crush or mix them prior to administration?

Tablets, capsules or pills which are designed to be dissolved or crushed by employees prior to administration to a patient are not in "final form", and are covered by the HCS. There may be situations where the tablet, capsule or pill is dissolved or crushed to facilitate patient administration when that is not typically the way it is dispensed. The "final form" exemption would apply in this situation.

letter: CCoe 01-03-94

see also: LBierlein 06-20-89

Exemptions for drugs and veterinary products

29 CFR 1910.1200(b)(6)(vii)

The [HCS] standard does not apply to nonhazardous drugs, but any drug that meets the criteria of a hazardous chemical in the HCS generally would be covered. The HCS contains some exemptions that would apply to some drug and veterinary products. Section (b)(5)(ii) of the HCS states that drugs that are subject to labeling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard. Please note that this section of the HCS exempts only labeling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS).

Another section of the standard that is relevant...is 1910.1200(b)(6)(vii)[,] which exempts from coverage under the standard drugs as defined by the Federal Food, Drug and Cosmetic Act that are in solid final form, ready for direct administration to the patient such as tablets, capsules or pills. If these drugs are not in final form in that they are designed to be dissolved or crushed by employees prior to administration, then they are covered by the HCS. (There may be situations where a tablet, capsule or pill is dissolved or crushed for purposes of administration when that is not generally the way it is dispensed. The final form exemption would apply in this situation.) Consequently, MSDS are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drug and veterinary products, except for products which are in solid final form for direct administration to patient.

letter: CStowe 12-22-93

HCS applicability to medical offices

29 CFR 1910.1200(b)(6)(vii)

You requested clarification on [whether a] medical office or surgery center needs to have [Material Safety Data Sheets (MSDSs)] on orally administered and injectable medications. OSHA published a notice in the Federal Register on February 15, 1989, to inform affected employers and employees that all provisions of the [Hazard Communication Standard (HCS)] would be in effect in all industries, including employers whose employees are exposed to Food and Drug Administration (FDA) regulated drugs that pose a hazard. If hazardous FDA-regulated drugs are administered by injection or orally, they would be covered by the HCS.

There are exemptions to the standard that may cover many of the products in your facility. The scope and application of HCS exempts drugs that are in solid final form. The final form exemption would also apply to tablets or pills that are occasionally crushed, if the pill or tablet is not designed to be dissolved or crushed prior to administration.

letter: JHarris 09-13-93

HCS applies to drugs not in solid, final form

29 CFR 1910.1200(b)(6)(vii)

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the [Hazard Communication Standard (HCS)]. However, the HCS exempts FDA drugs when in solid final form, such as tablets or pills, for direct administration to the patient.

In your letter you have emphasized that the [Material Safety Data Sheet (MSDS)] for the drug SoluMedrol does not clearly state if it is a hazardous drug. OSHA does not determine if a drug is hazardous. The drug manufacturer or distributor is responsible for conducting the hazard determination based upon the criteria specified in the standard. If there is any question if a drug is hazardous or not, please contact the drug manufacturer for clarification. If the drug manufacturer is not responsive you may refer the issue to your local OSHA Area Office.

As a user of chemicals you may rely on the evaluations performed by the suppliers of the chemicals you use. If you receive a label or MSDS from your suppliers that indicates the chemical being used is hazardous, then you must include it in your hazard communication program.

letter: JWilley 08-13-93

Situations where HCS does not apply to drugs

29 CFR 1910.1200(b)(6)(vii)

Three situations exist where the HCS [Hazard Communication Standard] does not apply to drugs. First, the HCS does not apply to drugs which are packaged for sale to consumers in a retail establishment. Second, it does not apply to drugs intended for personal consumption by employees while in the workplace. And finally, when a drug is in solid final form for direct administration to the patient (i.e., tablets or pills). If however, the solid pill or tablet is pulverized or crushed to facilitate administration then it is covered by the HCS.

 

letter: GPoshard 05-11-93

Exemptions for certain types of drugs

29 CFR 1910.1200(b)(6)(vii)

The scope and application of [Hazard Communication Standard (HCS)] exempts drugs that are in solid final form, as per 29 CFR 1910.1200(b)(6)(viii), and drugs whose hazards are biological or radiological as opposed to chemical. The final form exemption would also apply to tablets or pills that are occasionally crushed, if the pill or tablet is not designed to be dissolved or crushed prior to administration.

 

The new exemptions for radiological and biological hazards are discussed under Subparagraphs (b)(6)(xi) and (b)(6)(xii), respectively.

letter: MRichards 12-30-92

Application to pharmaceutical products used in long term health care facilities

29 CFR 1910.1200(b)(6)(vii)

You asked whether your long term health care facilities would fall under the scope of the Hazard Communication standard (HCS) in cases where your residents buy their medications from pharmacies that are independent from your facilities and which are prescribed to them by outside physicians.

The HCS applies to your staff of health professionals in many ways. For example, you would have to inform employees of the hazards involved in using standard (i.e., foreseeable) medications used in practicing health care in your facility, such as "house drugs". However, in cases where the residents of your facilities purchase drugs from independent/outside pharmacies, and the drug and its potential hazards are not known until an outside physician orders a prescription, the HCS would not apply.

Employees must be allowed to have access to information; therefore, if employees find themselves working with a medication brought in by a resident they may ask their employer to obtain a material safety data sheet for the medication. The HCS requires employers to provide information on "any chemical which is known to be in the workplace in such a manner that employees may be exposed..." (29 CFR 1910.1200(a)). Your facilities must incorporate their individual method of compliance into their existing HCS program.

letter: SHill 12-29-92

HCS and drugs in the nonmanufacturing sector

29 CFR 1910.1200(b)(6)(vii)

As a result of a February 21, 1990, Supreme Court decision (see Dole, Secretary of Labor, et. al., v. United Steelworkers of America, et. al., No. 88-1434), all provisions of the rule are now in effect for all industrial segments, including the coverage of drugs and pharmaceuticals in the nonmanufacturing sector. Material safety data sheets (MSDS)s are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drugs and pharmaceutical products except for drugs as defined by the Federal Food, Drug and Cosmetic Act which are in solid, final form for direct administration to the patient (i.e., tablets, pills, or capsules) or which are packaged for sale to consumers in a retail establishment.

[Originally written for the research industry]

letter: CParker 09-09-91

Application to pharmaceutical products

29 CFR 1910.1200(b)(6)(vii)

It is the chemical manufacturer's responsibility to perform a hazard determination on their pharmaceutical products to determine if, under normal conditions of use or in foreseeable emergencies, use of their product could result in an employee exposure to any hazardous chemical(s) present in that product. If so, the product is covered under the requirements of the [Hazard Communication Standard (HCS)] and the manufacturer must develop and transmit a material safety data sheet (MSDS) with the initial shipment of the chemical to the downstream user, and with the first shipment after the MSDS is updated. The downstream employer must have an MSDS for all non-solid or final form drugs (i.e., drug products which contain hazardous chemicals that are not in tablet, pill or capsule form) to which their employees may be exposed.

letter: BBlack 07-22-91

Nonsolid drugs: frequency of exposure is not a valid criterion

29 CFR 1910.1200(b)(6)(vii)

Question: To what extent does the Hazard Communication Standard (HCS) apply to drugs and medicines in liquid form (e.g., alcohol, Betadine) which are diluted and/or repackaged before administration or application?

Liquid drugs which are hazardous chemicals would be covered if there is a potential for employee exposure to them.

Question: To what extent does the frequency with which ointments, alcohol, or other similar items are used by an employee on patients impact on how that employee is covered under the HCS?

Coverage under the HCS for ointments, alcohol and other similar items is not determined by the frequency of employee exposure. The employer is required to comply with the material safety data sheet (MSDS) and training requirements in the HCS for any ointment, alcohol, or similar medication in liquid form that the manufacturer has found to be hazardous (as defined in the HCS).

letter: RRay 06-11-91

Component pharmaceuticals are not exempted

29 CFR 1910.1200(b)(6)(vii)

The Hazard Communication Standard (HCS) does not apply to drugs, as defined in the Federal Food, Drug and Cosmetic Act, when in solid, final form for direct administration to the patient (i.e. tablets, or pills). Therefore, "pharmaceutical grade" chemicals used as a component of an end product pharmaceutical are to be included in the HCS program. If an end product pharmaceutical is itself being used as a component of an end product pharmaceutical, then it must be included in the HCS program.

letter: FRoth 09-01-89

Drug product exemption

29 CFR 1910.1200(b)(6)(vii)

Material Safety Data Sheets (MSDS) are required for all drugs as defined in the Federal Food, Drug and Cosmetic Act, except for drugs in solid, final form for direct administration to the patient (i.e., tablets, pills, or capsules). The package inserts and the Physician's Desk References cannot be accepted in lieu of MSDSs, as these documents do not meet the specification requirements of MSDSs under the present rule.

[Originally written for the medical industry]

letter: LBierlein 06-20-89

see also: CCoe 01-03-94

Consumer Products - (b)(6)(ix)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, this exemption was modified. Changes in wording are indicated in quotation marks:

(ix) Any consumer product or hazardous substance where the employer can show that "it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended."

Application of HCS to flammable lubricants in aerosol cans used in the workplace to prevent foods from sticking to heated cookware

29 CFR 1910.1200(b)(6)(ix)

...[T]he Hazard Communication standard would apply to...flammable lubricant in aerosol cans [used in a restaurant kitchen from time to time to prevent foods from sticking to heated cookware, such as frying pans] unless the employer can demonstrate it is used in the workplace in the same manner as normal consumer use and which use results in a duration and frequency of exposure which is not greater than exposures experienced by consumers. Please note that the Consumer Products Safety Council (CPSC) requires "flammable" labels on aerosol cans used by consumers pursuant to their authority under the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.). The CPSC uses the test method 16 CFR 1500.45 to determine whether the aforementioned containers are covered as flammable aerosol cans.

letter: MJohnsen 10-04-94

Application of the HCS to consumer products used by employees in a group home

29 CFR 1910.1200(b)(6)(ix)

Question: [Does] OSHA...require small group homes to obtain material data sheets on ordinary consumer products used in such homes by its employees, and to train employees in the safe use of these products [?]

...OSHA has no policy that specifically addresses the application of its hazard communication standard in group homes. Employment conditions in group homes vary from establishment to establishment, and the application of standards can only be assessed with respect to the hazards faced by the employees in each establishment.

The agency does have an explicit policy of not applying the hazard communication standard to employee use of consumer products when those products are used in the same manner as an ordinary consumer -- i.e., when employees would not be exposed to more significant hazards than ordinary consumers due to duration or frequency of exposure. This policy applies to any employer, including group homes.

Specifically, paragraph (b)(6)(ix) of the final standard, published on February 9 of this year, provides that:

Any consumer product ... where the employer can show that it is used in the workplace for the purpose intended by the chemical manufacturer ... and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended;

It is possible that in a very small group home, for example, with only five residents, that the range of exposures encountered by the staff would be no greater than that experienced by consumers for products such as dish detergent or floor wax. In that case, no Material Safety Data Sheet (MSDS) would be required. However, based on the limited information [available] it is not possible for us to make such a determination. OSHA could only make this determination through actual observation of conditions of use in the group home and by interviewing the employer and employees.

The purpose of the HCS is to ensure that employers and employees have ready access to information regarding the hazards of chemicals used in their workplaces. ...OSHA has conducted extensive analyses demonstrating that these information provision requirements are necessary to protect workers from hazardous exposures, and further, do not place excessive burdens on the employer.

The MSDS contains valuable information on the hazards of a product, particularly regarding safe handling, clean-up, and first-aid procedures. If an MSDS is not received for a product labeled as hazardous, the employer may simply write to the address listed on the label to request an MSDS.

Regarding training, [a] group home does not need to train workers on each individual product. Workers must be trained so that they understand the various hazards of the products they work with and how to protect themselves from these hazards. For example, workers need to understand the need for using household rubber gloves with products which can irritate the skin (e.g., many cleaning products), and the need for ensuring adequate ventilation when 'using products which are inhalation hazards (e.g., floor wax, solvents)

letter: TAndrews 07-15-94

Non-consumer use of sodium chloride may be covered by HCS

29 CFR 1910.1200(b)(6)(ix)

The company created the [Material Safety Data Sheet (MSDS)] in question because when chemicals which are normally used by a consumer, such as sodium chloride, are used by employees in a manner that is not comparable to typical consumer use, the [Hazard Communication Standard (HCS)] requires that a hazard determination be done. In this case the sodium chloride is probably being used in an industrial setting, and most likely in very large quantities. It is not being used as ordinary table salt available to consumers.

The HCS exempts consumer products that meet the criteria in 29 CFR 1910.1200(b)(6), which requires that the employer demonstrate that its use would result in a duration and frequency of exposure which is not greater than exposures experienced by consumers. Employers are required by HCS to determine whether workplace use of a consumer product is more frequent or of longer duration than would be expected during normal consumer use. Exposures in these industrial or commercial situations would be greater, and thus there is a need for the transmittal of hazard information for employee protection.

letter: RLugar 02-25-93

Workplace use of windex may be covered by HCS

29 CFR 1910.1200(b)(6)(ix)

Consumer products are only covered by [the Hazard Communication Standard (HCS)] if the employees who use them experience exposures that are of greater duration and frequency than those of normal consumers, or if the product is not used in a manner that is consistent with normal consumer use. A bottle of Windex could fall under the scope of chemicals that are covered by the company's HCS program if employees use the cleaner more frequently than normal consumer use, or if it is not used in the same manner that a normal consumer would use Windex. For example, cleaning staff who use the product repeatedly on a daily basis would need information on the hazards of Windex because they use the product more frequently than a normal consumer would.

letter: CLober 12-24-92

Higher exposure to cleaning products from regular workplace use

29 CFR 1910.1200(b)(6)(ix)

It is important to note that the use of consumer products can be hazardous. The fact that a product is labeled in accordance with the provisions of the Consumer Product Safety Act and exempt from OSHA Hazard Communication Standard (HCS) labeling, does not render that product "safe" to use by workers. This is especially pertinent when, as a condition of employment, an employee must utilize a (hazardous) consumer product with a greater frequency and resultant greater duration of exposure than that is typical of normal consumer or household use. In these situations, the employee has a "right to know" about the hazards of the chemicals he or she is expected to work with and therefore is exposed to. This is the obvious intent of the standard with regard to workplace consumer product exposure.

memorandum: PClark (DCP) to BChadwick, RA 08-15-91

Enforcement strategy for consumer product use in a workplace

29 CFR 1910.1200(b)(6)(ix)

During the course of an inspection, it is imperative that the compliance officer document that any employee use of a consumer product containing hazardous ingredients at his or her workplace is of a "frequency or duration" that clearly exceeds what a reasonable person would concede to be "normal consumer" use in a home or household environment. Situations where employee use of a product is close or similar to the way or to the amount of times a consumer could be envisioned to use a product should not be cited as violations of the Hazard Communication Standard (HCS).

In cases involving employee workplace exposures to hazardous consumer products, the employer has the initial burden of proving that the product is used in its workplace in a manner contemplated by the exemption language of 1910.1200(b)(6). That is, the employer must demonstrate that the consumer product is used by employees in the same manner as normal consumer use and that the duration and frequency of exposure is not greater than that experienced by general public.

Employers must be able to demonstrate that an employee is using, for example, [a product] with the same frequency of duration of use as would be expected at home. If it is the employee's job to [use the product] all day, or part of the day, with such frequency that is greater than one would be expected to be experienced at home, then the employee is entitled to the hazard communication information available through the material safety data sheet (MSDS) and required employee training provisions of the HCS.

Under this example, it is essential that OSHA establish through employee interviews that the worker did in fact repeatedly [use the product] throughout his or her workshift in a manner that any reasonable person would agree resulted in exposures significantly greater than those of a consumer. This evidence would be used to rebut the employer's potential offer of proof that his or her employees used the hazardous cleanser in a manner similar to that of a normal consumer.

While we agree that clear lines delineating when the HCS applies and when it would not apply may be difficult to define for all workplace situations and depends on specific workplace conditions, the intent of the HCS, to provide employees information on hazardous chemicals they work with, is clear.

[Originally written about cleaning chemicals]

memorandum: PClark (DCP) to BChadwick, RA 08-15-91

Applying HCS to all chemicals used by employees

29 CFR 1910.1200(b)(6)(ix)

OSHA and the Department of Labor are precluded under Section 4(b)(1) of the Occupational Safety and Health Act of 1970 (OSH Act) from exercising "statutory authority to prescribe or enforce standards or regulations" over areas or issues that other Federal agencies already "prescribe or enforce." The Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) regulate the use of consumer products and/or hazardous substances outside the workplace. The labeling, therefore, of consumer products is under the Consumer Product Safety Commission's authority, while the requirement to provide material safety data sheets (MSDSs) and train employees in their safe handling in the workplace falls under OSHA's jurisdiction if, again, their use is of a greater frequency or duration (and therefore a greater exposure risk) than what a normal consumer would experience.

letter: DHelm 11-27-90

Application of the HCS to use of consumer products in an occupational setting

29 CFR 1910.1200(b)(6)(ix)

Under the current rule, whenever a consumer product is used in a manner that is not comparable to typical consumer use, it is covered by the Hazard Communication Standard (HCS). The standard requires the employer to ascertain whether the workplace use is more frequent, or of longer duration than would be expected in normal consumer use. Exposures in these situations would be greater, and thus the need increases for additional information for employee protection. The use of cans of spray paint during production run rather than for occasional, short, one-time applications that typify consumer use is an example of hazardous chemical use which would not qualify as consumer product use.

CPL 2-2-38C: A-5 10-22-90

Consumer product exemption criteria

29 CFR 1910.1200(b)(6)(ix)

OSHA does not require that material safety data sheet (MSDS) be provided to purchasers of household consumer products when the products are used in the workplace in the same manner that a consumer would use them, i.e.: where the duration and frequency of use (and therefore exposure) is not greater than what the typical consumer would experience. This exemption in OSHA's regulation is based, however, not upon the chemical manufacturer's intended use of his product, but upon how it actually is used in the workplace. Employees who are required to work with hazardous chemicals in a manner that results in a duration and frequency of exposure greater than what a normal consumer would experience have a right to know about the properties of those hazardous chemicals.

[Originally written for the chemical manufacturing industry]

letter: SSchatzow 01-09-90

Office supplies and copy machine use

29 CFR 1910.1200(b)(6)(ix)

Office workers who encounter hazardous chemicals only in isolated instances are not covered by the rule. The Occupational Safety and Health Administration (OSHA) considers most office products (such as pens, pencils, adhesive tape) to be exempt under the provisions of the rule, either as articles or as consumer products. OSHA has previously stated that intermittent or occasional use of a copying machine does not result in coverage under the rule. However, if an employee handles the chemicals to service the machine, or operates it for long periods of time, then the program would have to be applied.

letter: JBunning 03-31-89 Congress

Nuisance Particulates - (b)(6)(x)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, an exemption was added for:

"(x) Nuisance particulates where the chemical manufacturer or importer can establish that they do not pose any physical or health hazard covered under this section."

This exemption formalizes OSHA's previous enforcement policy, which was to categorize as "de minimis" those violations in which the manufacturer failed to provide a label or material safety data sheet (MSDS) for a particulate shown by a valid hazard determination to pose no hazard other than being a physical irritant. (Citations are not issued for de minimis violations, and no abatement is required.)

Under the Amended Final Rule, the manufacturer is still required to evaluate the hazards of nuisance particulates, as with any other chemical. Where the only hazard is nuisance irritation, the product is exempt from the remaining requirements of the standard (i.e., no label or MSDS is required).

The quips that follow discuss OSHA's de minimis policy or nuisance particulates, which predated the exemption added to the Hazard Communication Rule in the February 9, 1994 Amendments.

Substances with same PEL as PNORs which present physical irritant effects only

29 CFR 1910.1200(b)(6)(x)

The October 22, 1990 Hazard Communication Compliance Instruction, CPL 2-2.38C, changed OSHA's classification for violations of MSDS [Material Safety Data Sheet] and label requirements for substances formerly classified as PNORs [Particulates Not Otherwise Regulated] with no specific PEL [Permissible Exposure Limit] but which were assigned specific PELs in the January 1989 PEL rulemaking (Air Contaminants, 54 FR 2584-7 et al., January 19, 1989). The current directive reiterates the HCS [Hazard Communication Standard] requirement that any substance with a specific OSHA PEL is considered one of the "floor" of hazardous substances and is covered under the requirements of the HCS. Chemical manufacturers or importers must develop and transmit a MSDS and label for any substance with a specific OSHA PEL.

The previous HCS directive, CPL 2-2.38B, August 1988, allowed a "de minimis" exemption for classification of violations of MSDS and label requirements for substances which had been assigned an ACGIH TLV [American Conference of Governmental Industrial Hygienists Threshold Limit Value] (but which did not have, at that time, a specific or individual OSHA PEL value; these substances' PELs were listed under the broad category of "PNORs"). Citation guidance given in CPL 2-2.38C does not allow the "de minimis" exemption for violations of label or MSDS requirements. Recently, OSHA was questioned why a change in policy was made for substances such as "vegetable oil mist" for which no other change in hazard information exists except that they now have a specifically listed PEL (with the same numerical value as other PNORs), and available evidence shows they present no adverse health effect other than being a physical irritant.

We have carefully reviewed this issue and will be changing the guidance in CPL 2-2.38C to reflect our previous policy, as stated in CPL 2-2.38B, that violations for lack of an MSDS or label for these substances will be considered "de minimis."

memorandum: PClark (DCP) to RAs 03-28-91

De minimis policy on PNOR/nuisance dusts

29 CFR 1910.1200(b)(6)(x)

In OSHA's compliance directive, OSHA Instruction CPL 2-2.38C, "Inspection Procedures for the Hazard Communication Standard," the agency issued new enforcement policies with regard to hazard communication requirements for substances formerly designated as "nuisance dusts." CPL 2-2.38C states that any substance with a specific OSHA Permissible Exposure Limit (PEL), regardless of the health effects, is covered by the Hazard Communication Standard (HCS).

The new language in the compliance directive was added to ensure consistency with the requirement of the Hazard Communication Standard (HCS) that any substance with an OSHA Permissible Exposure Limit (PEL) be considered one of a "floor" of hazardous chemicals covered under the HCS. All chemicals with a specific OSHA PEL or a specific American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) are automatically covered by the HCS and a material safety data sheet (MSDS) and label must be developed and transmitted downstream by the chemical manufacturer or importer. "Vegetable oil mist" was assigned specific OSHA PELs in the revision of the Air Contaminants Standard (29 CFR 1910.1000, Subpart Z, January 19, 1989).

The previous compliance directive for the HCS, CPL 2-2.38B, had provided specific guidance for situations where a chemical manufacturer or importer did not produce a label or material safety data sheet (MSDS) for any substance listed in Appendix D of the 1987-88 ACGIH TLVs as an example of a "nuisance dust" and for which a valid hazard determination showed that the substance presented no potential hazard to exposed employees "other than being a nuisance." In these situations, a violation of the HCS would have been considered by OSHA to bear no direct or immediate relationship to safety and health. In those instances, any violation for the lack of an MSDS or label for these substances would have been classified as "de minimis."

Thus, even though employers and employees should expect that a substance with a specific OSHA PEL would require a MSDS and label to be transmitted downstream, in consideration of the evidence discussed, if a chemical manufacturer's hazard determination produces evidence that the substance poses no hazard (including potential hazard) to exposed employees other than being a physical irritant, then the Agency will consider the lack of an MSDS and/or a label to have no direct or immediate relationship to safety and health. As such, any violation for these deficiencies would be classified as "de minimis."

The new policy does not address the "de minimis" classification for lack of MSDSs and labels for vegetable oil mist and other substances that have been assigned specific OSHA PELs even though the evidence suggests that they do not present a physical or health hazard other than physical irritation. In the 1989 Air Contaminants final rule, OSHA included a new category for compounds formerly designated as "nuisance dusts." This new category is entitled "Particulates Not Otherwise Regulated" (PNOR) and sets PELs for compounds in this category at 15 mg/m3 (total dust), 5 mg/m3 (respirable fraction).

This is consistent with OSHA's previous policy which sets forth the same citation guidance. Again, since the health effects data and the PELs are identical to those of PNORs, OSHA will change its enforcement guidance currently given in CPL 2-2.38C, page A-11, to be similar to guidance given in the previous Instruction, CPL 2-2.38B. We will communicate this change to our field staff initially by memorandum, then follow by the issuance of a change to the directive.

[Originally written for the chemical manufacturing industry]

[Originally written for the "floor" of hazardous chemicals]

letter: PWakelyn 03-19-91

Nuisance dust or particulates

29 CFR 1910.1200(b)(6)(x)

The term "nuisance dust" is no longer used in 1910.1000. A number of particulates now have specific Permissible Exposure Limits (PELs) and are covered by the Hazard Communication Standard (HCS). The particulates not otherwise regulated are exempt unless evidence exists that they present a health or physical hazard other than physical irritant effects. For these chemicals, the "Particulates not otherwise regulated" PELs must be included on the material safety data sheets (MSDSs).

CPL 2-2.38C: A-11 10-22-90

Hazard determinations for particulates

29 CFR 1910.1200(b)(6)(x)

Manufacturers of nuisance particulate are still required to perform a hazard evaluation and determine whether or not their products present any of the specific hazards covered by the HCS. OSHA has reason to believe that a number of these particulate do present physical hazards, such as the potential for fire and explosion, and others may have some health effect, such as irritation. For example, according to Bureau of Mines report entitled, The Explosibility of Agricultural Dust, corn starch and powdered sugar are considered to be "strong" explosion hazards. This information is published in the scientific literature, and would have to be taken into account when performing hazard evaluations.

letter: MMattingly 01-16-86

Ionizing and Nonionizing Radiation - (b)(6)(xi)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, an exemption was added for:

"(xi) Ionizing and nonionizing radiation."

 

Radioactive and biological hazards not covered by HCS

29 CFR 1910.1200(b)(6)(xi)

OSHA has never considered either radioactivity or biological hazards to be covered by the Hazard Communication Standard (HCS). If, however, another type of hazard is presented along with the material (e.g., a container with a biological sample packed in a hazardous solvent), then the container would be subject to the requirements of the HCS for the other hazardous chemical.

CPL 2-2.38C: A-3 10-22-90

Radioactive materials not covered

29 CFR 1910.1200(b)(6)(xi)

The ionizing hazard from radioactive materials are not covered by the Hazard Communication Standard. If a radioactive material, however, presents other types of chemical hazards, such as those defined in Appendix A of the standard, then the chemical would be covered for those hazards. The hazards of radioactivity itself are usually covered under the rules of other Federal agencies, or if not regulated by another Federal agency, by OSHA's standard for ionizing radiation, 29 CFR 1910.96.

Ionizing and nonionizing radiation are exempt from coverage under the standard.

letter: RUhlar 03-22-88

Biological Hazards - (b)(6)(xii)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, an exemption was added for:

"(xii) Biological hazards."

Biological samples packed with hazardous chemicals

29 CFR 1910.1200(b)(6)(xii)

The HCS does not cover biological hazards, including pharmaceuticals that are radioactive or biological. If a chemical hazard is present in a container with a biological sample packed in a hazardous solvent, then the container would be subject to the requirements of the HCS for the hazardous chemical. OSHA encourages employers to go beyond the prescribed requirements of the standard, and recommends that all hazards be addressed in an employer's Hazard Communication Program.

letter: JHarris 09-13-93

Vaccines

29 CFR 1910.1200(b)(6)(xii)

Vaccines whose hazards are biological rather than chemical, are exempt from the standard.

letter: CLober 12-24-92

Back to Background Information

About Us Position Statement Register Your Support Help FAQ's Ask A Question Feedback Background Information MSDS Dictionary Last Resort
The First Place To Look for An MSDSHome
Send mail to Webmaster  with questions or comments about this web site.
Copyright 1998-2002 MSDS-SEARCH.COM, Inc.