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Table of Contents   

PARAGRAPH (d) - HAZARD DETERMINATION (d)-1
Evaluation - (d)(1)
Criteria for Health Hazards - (d)(2)
Sources - (d)(3)
        Particulates Not Otherwise Regulated (Nuisance Dusts) (d)(3)-7
Carcinogens - (d)(4)
Mixtures - (d)(5)
Written Hazard Evaluation Procedures - (d)(6)

PARAGRAPH (d) - HAZARD DETERMINATION

Appendix B of 29 CFR 1910.1200 provides mandatory guidelines for performing a hazard determination. In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the following has been added to Part 4 of Appendix B:

"In vitro studies alone generally do not form the basis for a definitive finding of hazard under the HCS since they have a positive or negative result rather than a statistically significant finding."

Subparagraph (d)(5)(iv) has also been modified slightly. Please refere to the section for paragraph (d)(5), where the wording is shown.

Hazard determination requirements for manufacturers and importers of hazardous paints

29 CFR 1910.1200(d)

...[T]he OSHA Hazard Communication Standard, 29 CFR 1910.1200(copy enclosed), requires the manufacturer OR importer of a hazardous paint to conduct a hazard determination and to prepare a material safety data sheet (MSDS) for the paint and to provide the MSDS [to] employers who use the paint.

letter: DHorn 04-04-95

Hazard determination of respirable crystalline silica

29 CFR 1910.1200(d)

The requirement to transmit information under OSHA's Hazard Communication Standard (HCS) is not tied to downstream exposure amounts (with the exception of subparagraph (d)(5)(iv) that, even if a carcinogen is present in a mixture in quantities less than 0.1 percent but could still be emitted in a level above an OSHA Permissible Exposure Limit (PEL), then that mixture must be assumed to present the same hazard as that hazardous component). OSHA's compliance directive for the HCS, CPL 2-2.38C, issued October 22, 1990, provides further clarification.

The HCS is based on the potential for exposure to a hazardous chemical, and in the case of crystalline silica, exposure can only occur when crystalline silica is present in respirable form. While OSHA does not take bulk samples of products to analyze for respirable crystalline silica, our Analytical Laboratory has confirmed that there is no validated method to perform such an analysis. If employers were to use such a determination to avoid labeling their products, a validated method would have to be followed. Furthermore, as you know, handling and processing of many products that contain only large-sized particles of crystalline silica may generate respirable particles in the workplace. If OSHA were to find that workers are exposed to crystalline silica in respirable form from use of such a product in the workplace, a violation of the HCS would be alleged.

letter: ELapp 02-11-91

Evaluation - (d)(1)

Evaluation of hazards associated with coatings on automobile parts that will be cut and sanded

29 CFR 1910.1200(d)(1)

Question: [Are] MSDS [necessary] for coatings on automobile parts that will be sanded and cut[?]

Manufacturers and importers are both required by the HCS to perform a hazard evaluation on the products they manufacture or import. This hazard evaluation is the responsibility of the manufacturer/importer. If, under normal conditions of use, a manufactured item meets OSHA's definition of an "article" in the standard, then the item would be exempted and an MSDS would not be required. If the hazard evaluation indicates that a product does not meet the exemption for articles, an MSDS is to be developed and transmitted to downstream employers.

The standard allows employers such as body shops to rely in good faith on the hazard evaluation performed by the manufacturer or importer. If a body shop employer is concerned because their supplier did not automatically supply an MSDS, OSHA recommends that the body shop employer contact the distributor or manufacturer/importer and verify that the manufacturer/importer has determined that no MSDS is necessary.

[As to] whether "particles in the sheet metal on parts, such as zinc," would need to be listed on the MSDS[,] [h]azards that are associated with the processing of steel materials, such as oxide fume and dusts of zinc are to be considered hazardous by virtue of being included in the "floor" list of chemicals incorporated by reference under paragraphs (d)(3) and (d)(4) of the HCS.

letter: SLoftus 11-16-94

Requirements for drug manufacturers and distributors to perform a hazard determination

29 CFR 1910.1200(d)(1)

Drugs regulated by the U.S. Food and Drug Administration (FDA) are covered by the [Hazard Communication Standard (HCS)]. However, section (b)(6)(viii) of 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

Manufacturers of inert gases required to perform a hazard determination

29 CFR 1910.1200(d)(1)

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

Hazards of inhaled wood dust and sand

29 CFR 1910.1200(d)(1)

There is significant evidence that indicates wood dust presents a carcinogenic hazard when inhaled by exposed workers. Thus where there are work operations that generate respirable wood dust, it is appropriate to ensure that workers avoid inhalation and are apprised of the possible carcinogenic hazards. Similarly, sand often contains respirable crystalline silica, which causes silicosis, a chronic and debilitating respiratory disease, as well as being potentially carcinogenic. Again, where workers are exposed to respirable dust containing crystalline silica, prudent practice dictates they be informed of the hazards and take appropriate protective measures.

letter: TDeLay 06-22-92 Congress

Hazard determination requirements

29 CFR 1910.1200(d)(1)

OSHA's [Hazard Communication Standard (HCS)] requires, and has always required, 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 can or could result in employee exposures to a hazardous chemical(s). OSHA does not perform these hazard determinations for the manufacturer; rather, it is up to the manufacturer 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 (see 29 CFR 1910.1200, paragraph (d)).

letter: RSullivan 11-14-91

Overheating of equipment must be considered in hazard determination

29 CFR 1910.1200(d)(1)

Chemical manufacturers are responsible for performing a hazard determination on the chemicals they produce to determine if, during their anticipated or known use, exposure to hazardous chemicals might occur to downstream employees. The OSHA Instruction [CPL 2-2.38C], on page A-9, includes equipment failure and failure of control equipment as situations that could cause a "foreseeable emergency" and result in the release of hazardous chemicals with resultant employee exposure. The chemical manufacturer must consider potential exposures, including accidental or possible exposures that may occur when downstream employees use the product. Only by considering all the exposure scenarios that may occur during normal use can the manufacturer truly assess the hazards encountered during anticipated use of his product. Equipment failure that results in the accidental overheating of the product is certainly an exposure scenario that should be anticipated by a manufacturer during his hazard determination process.

OSHA does not perform hazard determinations on chemical products for manufacturers and is not doing so by this response for the ... products you produce. If, however, as the chemical manufacturer, you have information that overheating via equipment failure or maladjustment, etc., can be expected to occur a percentage of time during normal workplace handling of your product, then employees have a right to know the hazard information associated with the resultant potential exposure and your product would be covered under the requirements of the Hazard Communication Standard.

The standard does not require hazard information transmittal for exposures that result from intentional misuse. However, exposures resulting from "accidental misuse" ... are covered since hazardous chemical exposures can be expected to occur a percentage of time with normal use when equipment fails, overheats, or otherwise is not operating as the manufacturer intended. Accidental exposures are part of normal operating procedures and should be anticipated by the chemical manufacturer during the hazard evaluation process.

[Originally written about heat shrink products]

letter: KFinney 12-21-90

Responsibility for the accuracy of the hazard determination

29 CFR 1910.1200(d)(1)

Although the chemical manufacturer and the importer have the primary duty for hazard evaluation, it is expected that some employers will choose to do their own evaluations. Whoever does the evaluation is responsible for the accuracy of the information. The evaluation must assess the hazards associated with the chemicals including those hazards related to any anticipated or known use which may result in worker exposure.

Known intermediates and by-products are covered by the Hazard Communication Standard (HCS). Decomposition products which are produced during the normal use of the product or in foreseeable emergencies (e.g., plastics which are injection molded, diesel fuel emissions) are covered if the hazardous chemicals are known to be present. "Foreseeable emergency" does not include employee exposures in the event of an accidental fire, but does include equipment failure, rupture of containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical.

An employer may rely upon the hazard determination performed by the chemical manufacturer. Normally, the chemical manufacturer possesses knowledge of hazardous intermediates, by-products and decomposition products that can be emitted from his chemical product. However, if the employer obtains information regarding the hazards from a source other than the manufacturer, the employer is responsible for including such information in his hazard communication program.

CPL 2-2.38C: A-9&10 10-22-90

Fabricators of chemically unchanged products

29 CFR 1910.1200(d)(1)

Under the Hazard Communication Standard (HCS), a fabricator of a product capable of resulting in downstream exposure to employees working with it is responsible for transmitting hazard information just as a chemical manufacturer would under the HCS. Therefore, the fabricator is responsible for performing a hazard determination on each product he produces.

As the manufacturer of the "value-added product", you are responsible under the HCS to make a similar hazard determination for all the materials comprising your final product ... and the material used to adhere the facing to the [product]. You may rely on the hazard determination performed by the manufacturer of each of the materials used in your fabrication process.

[Originally written for the insulation industry]

letter: RTripp 07-23-90

Hazard determination for food products

29 CFR 1910.1200(d)(1)

Under the Hazard Communication Standard (HCS), chemical manufacturers and importers are responsible for performing a hazard determination on the chemicals they produce to determine if, under normal conditions of use, their product could result in a hazardous exposure situation for downstream employees who will be working with or otherwise handling that product. "Chemical" is broadly defined in the HCS as "any element, chemical compound, or mixture of elements and/or compounds," and therefore includes food and food additives. Food products ..., like any other chemical product, must be evaluated for their downstream hazardous exposure potential. If there is no potential for worker exposure to any health or physical hazard (as defined in Appendix A of the standard), then the product is not subject to the provisions of the HCS and no material safety data sheet need be prepared for it or kept by the receiving employer.... [I]t is the employer's responsibility to assess the exposure potential of all hazardous chemicals utilized at his workplace and the duty of the importer, chemical manufacturer or distributor to conduct a hazard assessment of all the chemicals they produce or import. While in most circumstances [certain food products would not be a hazard], in some work environments [powdered products] may represent a significant explosion hazard when suspended in air. This information is required to be transmitted via the material safety data sheet (MSDS) to employers who then must assess the hazard potential created by usage of these materials in their workplace.

[Originally written for the veterinary medicine industry]

letter: LSmith 06-14-90

Hazard determination requirements of an importer

29 CFR 1910.1200(d)(1)

If you manufacture a product that will be imported into and distributed to employers within the United States, you, as the manufacturer or importer, must perform a hazard determination on your product to determine if, under normal conditions of use or in a foreseeable emergency, employees using the product could be exposed to a hazardous chemical, as defined under the Hazard Communication Standard (HCS). If so, it will be necessary ... to develop appropriate hazard information as described ... (material safety data sheets (MSDSs) and labels) to accompany the product in its distribution into the United States.

letter: VMassi 06-14-90

Responsible party for hazard evaluation

29 CFR 1910.1200(d)(1)

It is also important to emphasize ... that the manufacturer or importer of a hazardous chemical as defined under the Hazard Communication Standard (HCS) is the responsible party for performing the hazard evaluation of his products. This evaluation must assess the hazards associated with actual or potential worker exposures, including all routes of entry, that may occur during the normal use of the product or in foreseeable emergencies.

[Originally written for the electrical manufacturing industry]

letter: ROpatick 5-30-90

Universal number code not feasible to identify individual hazardous chemicals

29 CFR 1910.1200(d)(1)

It is the responsibility of the chemical manufacturer or importer to evaluate and compile all the hazard information known about the chemicals he produces. It is also his responsibility to transmit and update that information on material safety data sheets (MSDS) sent to downstream users. It has been estimated that there are about 650,000 hazardous chemical products utilized in American workplaces, and hundreds more are introduced into the workplace annually. Chemical manufacturers and importers are the ones who perform the hazard evaluation on the chemicals, they generate or keep the data, they are the ones who know about their products and are therefore in the best position to provide and keep up-to-date the hazard information data required under the Hazard Communication Standard (HCS). Many different options to this requirement were considered during the final rulemaking on the standard. The method required in the current rule was found to be the most feasible way of accomplishing the required information transmittal.

Further, OSHA does not have the capability to perform individual chemical hazard evaluations and therefore the "code number" option on the MSDS could not feasibly be administered by the Agency. Again, the accuracy, timeliness, and distribution of information is the chemical manufacturer's responsibility. Since it has been estimated that 90 percent of all chemicals manufactured by or imported into this country are unique to a single chemical manufacturer (the party who,..., has in its possession the required information about the chemical), the Agency require[s] the manufacturer/ importer [to] be the one responsible for the completeness and distribution of accurate and up-to-date information ... .

[Originally written for the hardware industry]

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

Hazard determination: low concentration of respirable substance

29 CFR 1910.1200(d)(1)

While it may be true that [the particulate hazard] contained in ... products which are in a wet (slurry) form would not be available for respiration and hence would not present an inhalation hazard while the product was in that (wet) form, if an employee would be required to work with the product either before it is mixed (and therefore capable of causing an inhalation hazard due to its dry, respirable form) or after it has dried and hardened (and therefore also capable of presenting an inhalation hazard), the potential for exposure to respirable [substance] would be present and must therefore be addressed in the chemical manufacturer's hazard determination. If ...[a] product, under normal conditions of use, always remains in a wet slurry form and is never dried nor handled in a manner that could result in employee exposure, then no potential hazard exists and no information transmittal under the Hazard Communication Standard (HCS) would be required. However, as addressed above, if exposure to these [substance] containing products occurs in such a way that employees may be exposed, information regarding the hazards associated with those potential exposures must be addressed on the material safety data sheet (MSDS) and on the label.

..., your clients have performed a hazard determination on their (dry) ... products and have found that they contain less than 0.1 percent respirable [substance]. These products would be exempt from coverage under the provision of paragraph (d) of the HCS, "Hazard determination." This paragraph exempts from coverage under the HCS chemical mixtures that contain as components carcinogens present in less than 0.1 percent concentrations.

[Originally written for the china producers industry]

[Originally written about crystalline silicate and china clay products]

letter: GPehrson 03-07-90

OSHA policy concerning product endorsement

29 CFR 1910.1200(d)(1)

According to the product literature, the product claims to "meet

or exceed OSHA requirements for health and safety. (Material safety data sheets are available)." The Occupational Safety and Health Administration does not set "requirements" for [any] chemicals. OSHA's Hazard Communication Standard (HCS), 29 CFR 1910.1200 does, however, require that the hazards of all chemicals produced or imported into the United States be evaluated and that information concerning any associated health or physical hazards be transmitted to employees via comprehensive hazard communication programs. The programs are to include container labeling and other forms of warning, material safety data sheets (MSDS) and employee training. ... OSHA does not prohibit the manufacturer of the product in question from stating that his product "meets OSHA requirements" if he is providing materials safety data sheets and hazard information as required under the HCS.

[Originally written for the chemical manufacturing industry]

[Originally written about cleaning chemicals]

letter: GVanderJagt 01-29-90 Congress

Court reaffirms hazard disclosure in low downstream exposures

29 CFR 1910.1200(d)(1)

... The court reaffirmed that the Hazard Communication Standard (HCS) requires chemical manufacturers to disclose all potential adverse health effects of chemical substances they produce, even where the manufacturer estimates that downstream exposure to the particular substance will be low.

First, the court held that the case was controlled by its prior decision in General Carbon Co. v. OSHRC, 860 F.2d 479 (D.C. Cir. 1979). In light of General Carbon's interpretation of the scope of the HCS's disclosure requirements for labels, the court found that it would be anomalous to accept Durez's argument that it need not disclose on the generally more comprehensive material safety data sheet (MSDS), health risks that it believed would not materialize at projected levels of exposure.

Second, the court held that, apart from General Carbon's force as precedent, the Secretary's interpretation of the HCS was reasonable and therefore entitled to deference.

court: Durez v. OSHRC, 906 F.2d 1 (D.C. Cir. 1990)

Hazard determination concerning chemical release

29 CFR 1910.1200(d)(1)

...[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 nickel]

letter: LLoreth 12-04-89

Hazards of soldering: lead fumes and solder flux

29 CFR 1910.1200(d)(1)

OSHA has enforced, since 1981, its standard for occupational exposure to inorganic lead. Solder contains, ..., a large percentage of lead. During soldering operations, personnel risk being exposed to lead fume. OSHA's current standard for occupational exposure to lead during soldering operations is set at 50 micrograms lead per cubic meter of air ..., measured as an 8-hour time weighted average exposure (e.g., employee exposure to lead in air, measured and averaged over an 8-hour work day). OSHA's Lead Standard sets requirements for the provision of environmental (workplace) monitoring, recordkeeping, employee education and training, medical surveillance, medical removal protection, hygiene facilities and other requirements that must be met by employers if their employee's exposure to lead exceeds the specified limits. "Solder flux" generally refers to a substance applied in soldering and brazing operations to portions of a surface to be joined and which acts, with the application of heat, to prevent oxide formation and to facilitate the flow of solder. Fluxes may contain hydrazine salts and/or other harmful or toxic compounds, exposure to which may in themselves represent a health hazard, depending again on the duration and amount (or dose) of the exposure. Information on the chemical composition of any solder flux compounds ... should be obtainable from the labels on the material safety data sheets (MSDS) that comes with the fluxes, if manufactured in the United States.

[Originally written for the communication industry]

letter: CSeymour 07-11-89

Hazard determination based on intrinsic properties rather than anticipated use

CFR 1910.1200(d)(1)

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

Criteria for Health Hazards - (d)(2)

Hazard determination for pharmaceutical products

29 CFR 1910.1200(d)(2)

Question: [Are] Material Safety Data Sheets (MSDSs)...required for drugs and pharmaceutical products even if the drug or pharmaceutical product is not a hazardous chemical (e.g., not a physical or health hazard) as defined in the HCS[?]

Please bear in mind that the scope and application of the HCS exempts drugs that are in solid, final form (i.e., tablets or pills) for direct administration to the patient. If, however, the solid pill or tablet is pulverized or crushed to facilitate administration, then it is covered by the HCS.

The standard requires every chemical manufacturer and importer to evaluate all chemicals to determine if they are hazardous. The employer is not required to do an evaluation, unless they choose not to rely on the evaluation by the manufacturer or the importer. The evaluation shall identify and consider the available scientific evidence concerning each hazard.

In the specific case of a health hazard, the evidence shall be statistically significant, which is based on at least one positive study conducted in accordance with the scope of Appendix A, and the criteria of Appendix B, of the HCS.

If a drug is determined to be a hazardous chemical, and not exempted by the HCS, then the labeling, MSDS, and training requirements must be met. Conversely, if a drug is not a hazardous chemical it is not covered by the standard, and, accordingly, an MSDS is not required.

letter: MRoybal 08-15-94

Hazard determination for mixtures containing suspected mutagens

29 CFR 1910.1200(d)(2)

Question: If a mixture contains a known quantity of one or more mutagenic ingredients, is the mixture deemed to be mutagenic, or is further testing required to prove mutagenic potential?

OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200) does not specifically address mutagenicity in either the text of the standards final rule (Federal Register, August 24, 1987) or the preamble discussions. It is the agency's position that in vitro tests, independent of other data, do not establish a health hazard as specified under the hazard determination provisions of the standard. Under the HCS the manufacturer does have the responsibility to review all available scientific data when performing a hazard determination for the chemicals they produce. If an in vitro study is the only data available linking a mutagenic response to a chemical exposure, then these studies do not have to be reported on the product's MSDS. Also in terms of testing for mutagenic potential, the HCS does not require testing of chemicals to determine their hazards.

Question: Is there a minimum level of a mutagenic ingredient contained in a mixture above which the mixture does not need testing, but can be assumed to be mutagenic?

Please refer to the answer above, the standard does not require testing. For mixtures of hazardous chemicals the HCS requires the following:

If a hazardous chemical is present in the mixture in quantities (i.e., 0.1% for carcinogens, and 1% for other health hazards), it must be reported unless the mixture has been tested as a whole or unless the material is bound in such a way that employees cannot be exposed. If there really is no exposure (and the standard defines exposure as including potential as well as measurable exposure by any route of entry), either under normal conditions of use or in a foreseeable emergency, then the chemical is not covered by the standard, (See Paragraph (b)(2) of 29 CFR 1910.1200). Further, information must also be included on a MSDS for ingredients of a mixture present in concentrations of less than 1% (or 0.1% for carcinogens) when the hazardous substance may be released in a concentration which exceeds an OSHA Permissible Exposure Limit or an American Conference of Governmental Industrial Hygienist's Threshold Limit Value or may present a health risk to exposed employees. An example of the latter may be TDI because it is a sensitizer in very small concentrations, thereby presenting a health risk that must be noted on the MSDS.

letter: JBunyan 11-04-93

Hazard determination for fibrous mineral products

29 CFR 1910.1200(d)(2)

If statistically significant evidence exists that exposure to the rock wool product you manufacture, or the fibers emitted during workplace handling of the product, is or has been associated with a health effect from those exposures, then that information must appear on the [Material Safety Data Sheet (MSDS)], and appropriate hazard warnings conveying that information must appear on container labels for the product. For health hazards including carcinogenicity, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient evidence to establish a hazardous effect. If there is at least one statistically significant epidemiological study which indicates an increased risk of cancer in humans, a cancer warning statement must be included on the label.

As discussed above, the hazard determination, in this regard, 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, 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.

letter: RSullivan 11-14-91

see also: RMunson 05-06-91

Information required in hazard determination: fibrous glass

29 CFR 1910.1200(d)(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 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 (see the OSHA 7/28/91 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.

letter: DCross 10-18-91

see also: RMunson 05-06-91

In vitro studies alone do not establish a health hazard

29 CFR 1910.1200(d)(2)

The use of short term tests (i.e., in vitro studies) have not been specifically addressed in either the text of the Hazard Communication Standard (HCS) final rule (FR, August 24, 1987) or the preamble discussions. However, it is the Agency's intent under the hazard determination provisions of HCS that the use of in vitro tests do not provide results of significant findings which, in and of themselves, meet the requirements of the rule for a finding of a "significant health hazard". Stated in another way, the results of in vitro tests alone do not represent significant enough information to establish a health hazard for purposes of the hazard communication standard.

It is, of course, the manufacturer's responsibility to review all available scientific data when performing a hazard determination for the chemicals they produce. If the in vitro studies mentioned are the only data available linking a mutagenic response to [chemical] exposure, these studies do not have to be reported on the product's material safety data sheet (MSDS).

The Hazard Communication Compliance Instruction, CPL 2-2.38C, mentions the use of in vitro test results briefly in Appendix C, page C-3: "In general, uncorroborated case reports and in vitro studies, such as Ames tests, are useful pieces of information, but not definitive findings of hazards." This also speaks to the Agency's intent that data from in vitro studies alone is not sufficient enough evidence to indicate a health hazard for hazard communication purposes.

[Originally written for the chemical manufacturing industry]

[Originally written about sodium hypochlorite]

This issue is clarified in the February 9, 1994 Amendments to the Final Hazard Communication Rule. The following has been added to Part 4 of Appendix B:

"In vitro studies alone generally do not form the basis for a definitive finding of hazard under the HCS since they have a positive or negative result rather than a statistically significant finding."

memorandum: PClark (DCP) to JStanley, RA 10-16-91

Carcinogen hazards

29 CFR 1910.1200(d)(2)

The Hazard Communication Standard (HCS) 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 can or could result in employee exposure to a hazardous chemical(s). OSHA does not perform these hazard determinations for manufacturers; rather, it is up to the manufacturer 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 (see 29 CFR 1910.1200, paragraph (d)).

... the International Agency for Research on Cancer (IARC) "concluded that [certain products] are not classifiable as carcinogenic to humans" and therefore, you requested that OSHA "confirm" that no carcinogen warning label is needed for these products. IARC is recognized in the text of the HCS itself as one source manufacturers of hazardous chemicals must consider regarding a chemical's carcinogenicity, but it is not the only source. For health hazards including carcinogenicity, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect.

If statistically significant evidence exists that exposure to the ... products your client manufactures, or the [items] 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 material safety data sheet (MSDS), and appropriate hazard warnings conveying that information must appear on container labels for the product. As discussed above, the hazard determination, in this regard, is your client's responsibility as the manufacturer to perform and substantiate.

[Originally written about differing types of fibrous glass products]

letter: AThompson 09-06-91

Existing hazard determination studies on fiber glass

29 CFR 1910.1200(d)(2)

The existence of positive human evidence, based on one valid study conducted in accordance with established scientific principles indicating carcinogenic effects in humans triggers the requirement that the label contain an appropriate carcinogen hazard warning. It is the responsibility of the chemical manufacturer or importer of a product to identify and evaluate all relevant scientific data when conducting a hazard determination.

A review of the available scientific literature for health effects associated with exposure to fibrous glass products was conducted by our Directorate of Health Standards Programs. Several epidemiological studies of fibrous glass production workers were found which showed a statistically significant increase in respiratory tract cancer. Therefore, appropriate hazard warnings on fibrous glass products would have to indicate that fibrous glass may cause lung cancer in humans.

.... If, upon inspection, an OSHA Compliance Officer becomes aware of incorrectly labeled fibrous glass products being used in the workplace, according to OSHA referral procedures, the chemical manufacturer will be contacted and asked to correct the hazard.

letter: RMunson 05-06-91

see also: DCross 10-18-91

Determining health hazards

29 CFR 1910.1200(d)(2)

The preparer of the material safety data sheets (MSDSs)/labels is required to consider all available scientific evidence concerning the hazard(s) of a chemical in addition to consulting the floor reference sources listed in paragraph (d)(3) of the standard. (See Appendix C of CPL 2-2.38C for further guidance on evaluating health effects.) No testing of chemicals to determine hazards is ever required; the evaluation is to be based on information currently available in the literature.

Where at least one positive scientific study exists which is statistically significant and demonstrates adverse health effects, the MSDSs must include the adverse health effects found. This does not necessarily mean that the results of all such studies would also appear on the label.

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

Diesel fuel exhaust and hazard determination studies

29 CFR 1910.1200(d)(2)

The Hazard Communication Standard (HCS) requires manufacturers to perform a hazard determination for the chemicals they produce. As part of the evaluation, the manufacturer must anticipate the intended uses of the product, and consider the potential physical and health hazards to which employees may be exposed as a result of those uses. For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles, is a sufficient basis for a hazard determination and must be reported on the material safety data sheet (MSDS).

Diesel fuel exhaust is produced as a result of combustion, which is a normal condition of use for diesel fuel. Any health or physical hazards associated with the exhaust must therefore be included on the MSDS. In addition to respiratory irritation and reversible pulmonary effects of exposure to diesel exhaust, in August, 1988, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 50, Carcinogenic Effects of Exposure to Diesel Exhaust, which summarizes recent studies on the potential carcinogenicity of diesel exhaust. NIOSH concluded in this bulletin that the toxicologic and epidemiologic findings suggest a "potential occupational carcinogenic hazard exists in human exposure to diesel exhaust." Under the HCS requirement to examine all relevant data when performing the hazard determination, these studies which indicate the potential carcinogenicity of diesel exhaust must be included as part of the overall evaluation and the carcinogenic hazards must be noted on the MSDS.

Manufacturers, importers or employers may also report the results of other scientifically valid studies which tend to refute the findings of hazard. However, the positive data must always be reported.

memorandum: PClark (DCP) to Regional Administrators 04-04-90

and attached letter to diesel fuel manufacturers 03-14-90

General criteria for coverage of chemicals

29 CFR 1920.1200 (d)(2)

In terms of health hazards, the Hazard Communication Standard (HCS) covers every chemical for which there is one toxicological study that provides statistically significant evidence that the chemical has the potential to cause an adverse health effect.

[Originally written about carcinogens]

letter: DCanter 04-24-89

Hazard determination requirements: role of scientific and regulatory organizations

29 CFR 1910.1200(d)(2)

In order to ensure that all employees receive adequate information, it was necessary to establish a threshold for determining when a chemical is to be considered hazardous. For health hazards, if there is one study, conducted according to established scientific principles, which reports statistically significant evidence that the chemical poses the potential to cause an adverse health effect, the results of that study must be reported. (HCS, paragraph (d)(2)). This is an appropriate threshold for an information transmittal standard, which is intended to ensure that affected employees, as well as downstream employers, are aware of all existing scientific information regarding a chemical.

In addition to the one study criterion, participants in the rulemaking supported the need for further thresholds for chemicals that are considered to be hazardous by well-recognized scientific or regulatory organizations. The rulemaking record supports OSHA's conclusion that knowledge of these organizations' findings on a chemical is an important piece of information for affected employees and employers, separate and apart from an individual evaluation by a chemical manufacturer or importer of what they believe the scientific studies indicate a chemical's hazards are. (See, e.g., 48 FR 53298-99, November 25, 1983.)

Therefore, if OSHA has regulated a substance, the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended a Threshold Limit Value (TLV) for it, or the National Toxicology Program (NTP) or the International Agency for Research on Cancer (IARC) have found the substance to be a potential or confirmed carcinogen, the substance must be considered hazardous and information provided as required. All of these organizations require substantial evidence before making a finding that a chemical presents a hazard, and it is important for users of such chemicals to be aware of what those findings are.

To address the concerns of those chemical manufacturers or importers that disagree with the findings of these organizations, the HCS specifically permits them to present negative data as well. (HCS, Appendix B.) They are also allowed to include on a MSDS their own evaluations of the chemical, as long as they do not state anything that is inaccurate or scientifically indefensible.

Contrary to the assertions in your letter, this is not a delegation of rulemaking authority to IARC or any of the other organizations involved. It is an assurance that all available information is provided, an approach that is necessary to provide employees with the right to know about the chemicals they are exposed to while working. The fact that IARC classifies a substance as a potential carcinogen is important information that is already public, and needs to be included with the hazard information provided to downstream employers and employees. The standard permits you to report whatever other negative information you believe is appropriate. Therefore, concerns of exposed employees, as well as the concerns of the producers of the chemicals, have been addressed in the regulatory design.

The HCS is a generic rule, covering as many as 575,000 hazardous chemical products, and the hazard determination process is not an approach that is to be reconsidered for each individual substance. The rule clearly indicates that the latest editions of IARC and NTP are to be used. One of the primary advantages of a generic approach is the dynamic nature of the rule, requiring chemical producers and importers to continually update the chemical hazard information provided to downstream employers and to employees as information becomes available. Certainly the rule cannot reasonably be interpreted to be limited to information available as of 1983. This clearly was not the intent, and would not protect workers to the extent feasible as required under the occupational Safety and Health Act.

letter: TGarrett 09-20-88

Sources - (d)(3)

Evaluation of hazards associated with coatings on automobile parts that will be cut and sanded

29 CFR 1910.1200(d)(3)

Question: [Are] MSDS [necessary] for coatings on automobile parts that will be sanded and cut[?]

Manufacturers and importers are both required by the HCS to perform a hazard evaluation on the products they manufacture or import. This hazard evaluation is the responsibility of the manufacturer/importer. If, under normal conditions of use, a manufactured item meets OSHA's definition of an "article" in the standard, then the item would be exempted and an MSDS would not be required. If the hazard evaluation indicates that a product does not meet the exemption for articles, an MSDS is to be developed and transmitted to downstream employers.

The standard allows employers such as body shops to rely in good faith on the hazard evaluation performed by the manufacturer or importer. If a body shop employer is concerned because their supplier did not automatically supply an MSDS, OSHA recommends that the body shop employer contact the distributor or manufacturer/importer and verify that the manufacturer/importer has determined that no MSDS is necessary.

[As to] whether "particles in the sheet metal on parts, such as zinc," would need to be listed on the MSDS[,] [h]azards that are associated with the processing of steel materials, such as oxide fume and dusts of zinc are to be considered hazardous by virtue of being included in the "floor" list of chemicals incorporated by reference under paragraphs (d)(3) and (d)(4) of the HCS.

letter: SLoftus 11-16-94

Chemicals without OSHA PELs that are recognized as hazardous.

29 CFR 1910.1200(d)(3)(i) and 29 CFR 1910.1000

Sources that could be used for demonstrating hazard recognition are studies used in the preamble of the 1989 Air Contaminants Standard, documentation of National Institute of Occupational Safety and Health (NIOSH) Recommended Exposure Levels (REL), documentation of American Conference of Government Industrial Hygienist (ACGIH) Threshold Limit Values (TLV) and industry studies and publications....

[originally written about Violations under the General Duty Clause of the OSH Act for Employee Exposures to Hazardous Levels of substances without an OSHA Permissible Exposure Limit (PEL)]

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

Threshold limit values as the floor of hazardous chemicals

29 CFR 1910.1200(d)(3)

Any compound of a substance regulated in part 1910, Subpart Z, including those listed in the Z Tables or for which there is a [Threshold Limit Value (TLV)] in the latest edition of the American Conference of Governmental Industrial Hygienists (ACGIH), Threshold Limit Values listing, is considered to be part of the floor of hazardous chemicals covered by the standard.

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

Hazard determination requirements: role of scientific and regulatory organizations

29 CFR 1910.1200(d)(3)

In order to ensure that all employees receive adequate information, it was necessary to establish a threshold for determining when a chemical is to be considered hazardous. For health hazards, if there is one study, conducted according to established scientific principles, which reports statistically significant evidence that the chemical poses the potential to cause an adverse health effect, the results of that study must be reported. (HCS, paragraph (d)(2)). This is an appropriate threshold for an information transmittal standard, which is intended to ensure that affected employees, as well as downstream employers, are aware of all existing scientific information regarding a chemical.

In addition to the one study criterion, participants in the rulemaking supported the need for further thresholds for chemicals that are considered to be hazardous by well-recognized scientific or regulatory organizations. The rulemaking record supports OSHA's conclusion that knowledge of these organizations' findings on a chemical is an important piece of information for affected employees and employers, separate and apart from an individual evaluation by a chemical manufacturer or importer of what they believe the scientific studies indicate a chemical's hazards are. (See, e.g., 48 FR 53298-99, November 25, 1983.)

Therefore, if OSHA has regulated a substance, the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended a Threshold Limit Value (TLV) for it, or the National Toxicology Program (NTP) or the International Agency for Research on Cancer (IARC) have found the substance to be a potential or confirmed carcinogen, the substance must be considered hazardous and information provided as required. All of these organizations require substantial evidence before making a finding that a chemical presents a hazard, and it is important for users of such chemicals to be aware of what those findings are.

To address the concerns of those chemical manufacturers or importers that disagree with the findings of these organizations, the HCS specifically permits them to present negative data as well. (HCS, Appendix B.) They are also allowed to include on a MSDS their own evaluations of the chemical, as long as they do not state anything that is inaccurate or scientifically indefensible.

Contrary to the assertions in your letter, this is not a delegation of rulemaking authority to IARC or any of the other organizations involved. It is an assurance that all available information is provided, an approach that is necessary to provide employees with the right to know about the chemicals they are exposed to while working. The fact that IARC classifies a substance as a potential carcinogen is important information that is already public, and needs to be included with the hazard information provided to downstream employers and employees. The standard permits you to report whatever other negative information you believe is appropriate. Therefore, concerns of exposed employees, as well as the concerns of the producers of the chemicals, have been addressed in the regulatory design.

The HCS is a generic rule, covering as many as 575,000 hazardous chemical products, and the hazard determination process is not an approach that is to be reconsidered for each individual substance. The rule clearly indicates that the latest editions of IARC and NTP are to be used. One of the primary advantages of a generic approach is the dynamic nature of the rule, requiring chemical producers and importers to continually update the chemical hazard information provided to downstream employers and to employees as information becomes available. Certainly the rule cannot reasonably be interpreted to be limited to information available as of 1983. This clearly was not the intent, and would not protect workers to the extent feasible as required under the occupational Safety and Health Act.

letter: TGarrett 09-20-88

Metals as hazardous chemicals

29 CFR 1910.1200(d)(3)

All of the primary metals meet the definition of "chemical" under the rule (being elements, or compounds of elements), and generally they would all be expected to present one or more of the hazards covered by the standard (see 1910.1200(c) for definitions of health and physical hazards). In fact, under the rule, many of the metals are to be considered hazardous in all situations by virtue of being included in the "floor" list of chemicals incorporated by reference under paragraphs (d)(3) and (d)(4) of the hazard determination provision.

letter: EMerrigan 05-23-86

Court decision, 1989 air contaminants standard-- enforcement of transitional limits.

29 CFR 1910.1200(d)(3)(i) and 29 CFR 1910.1000

On January 19, 1989, OSHA updated its existing Air Contaminants Standard, 29 CFR 1910.1000. OSHA amended [Permissible Exposure Limits (PELs)] for 212 substances to more protective levels, increased an existing PEL for one substance, set new PELs for 164 substances that were not previously regulated, and after consideration, left the existing PELs of 51 substances unchanged. In addition, the existing PELs for 172 substances were not considered in the rulemaking and remained unchanged. The PELs were consolidated in a single table, Table Z-1-A, which also included the existing 1971 PELs under the "Transitional Limits" columns.... The final rule was the subject of several legal challenges.... A stay of the Court's mandate ... allowed OSHA to continue to enforce the 1989 PELs while further legal action was considered.

On March 23 [1993], the Agency ceased enforcement of the 1989 PELs and began enforcement of the PELs listed in the "Transitional Limits" columns of Table Z-1-A, and in Table Z-2 and Table Z-3 of 29 CFR 1910.1000. On June 30, OSHA published at 58 FR 35338-351 an amended 29 CFR 1910.1000 to reflect the Court's decision. The amended 29 CFR 1910.1000 includes a new Table Z-1 which includes the exposure limits that had been contained in the Transitional Limits columns of Table Z-1-A and a new grain dust limit and reprints the existing Tables Z-2 and Z-3 with minor corrections....

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

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

29 CFR 1910.1200(d)(3)(i)

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

If a PEL exists for a chemical, it is covered by HCS

29 CFR 1910.1200(d)(3)(i)

Employees have a right to know about the hazards associated with chemicals used in their workplace. If a [Permissible Exposure Limit (PEL)] exists for a chemical, it is covered under the [Hazard Communication Standard's (HCS)] information transmittal requirements. If there is no exposure (and the standard defines exposure as including potential as well as measurable exposure by any route of entry), either under normal conditions of use or in a foreseeable emergency, then the chemical is not covered by the standard.

In the situation described in your letter, unless you have data that indicate that the hazardous chemical in question cannot be generated under normal conditions of use, the chemical is covered under the standard.

letter: BNarloch 03-22-91

OSHA's permissible exposure limits (PELs)

29 CFR 1910.1200(d)(3)(i)

OSHA standards require an employer to maintain employee exposure levels to regulated hazardous substances at or below established Permissible Exposure Limits (PELs). OSHA's PELs (which have recently been revised and updated in a major rulemaking effort by the Agency) are air contaminant limits that have been set to provide protection to workers against a wide variety of health effects that could cause material impairment of health or functional capacity, including such effects as cancer, cardiovascular, liver and kidney damage and/or lung diseases. Allergic reactions to certain chemicals may be experienced by some people who have become sensitized to exposure to very small quantities of certain chemicals, quantities that may not cause any harmful effects to the majority of the population. OSHA does not regulate worker exposure to hazardous chemicals by setting PELs based on exposure levels necessary to cause allergic response reactions.

[Originally written for the chemical manufacturing industry]

letter: JWillman 07-17-89

Particulates Not Otherwise Regulated (Nuisance Dusts)

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.

PEL being considered for fibrous glass

29 CFR 1910.1200(d)(3)

Requiring hazard warnings under the HCS [Hazard Communication Standard] regarding potential carcinogenicity does not indicate that the agency has made a decision to regulate fibrous glass as a carcinogen. OSHA is considering establishing a permissible exposure limit (PEL) for workers exposed to fibrous glass, and will examine whether the agency should regulate it as a carcinogen in that regulatory process. OSHA currently regulates exposure to airborne concentrations of fibrous glass under the PEL for "particulates not otherwise regulated" ("PNORs"), of 15 mg/m3 (total dust), 5 mg/m3 (respirable fraction), determined as an 8-hour time weighted average exposure.

Reports that OSHA plans to ban the use of fibrous glass are not correct. The agency does not "ban" the use of hazardous materials, but rather establishes permissible exposure limits based on a risk assessment of the data regarding health effects, and an analysis of the technological feasibility.

letter: DMudie 11-19-93

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

29 CFR 1910.1200(d)(3)

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 di 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 doe snot 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(d)(3)

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" fand for which a valid hazard determination showed that the subtance 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 emplyees should expect that a substance with a specific OSHA PEL would require a MSDS and label to be transmitted downstrea, 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(d)(3)

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

Organic dust as particulates not otherwise regulated (PNOR)

29 CFR 1910.1000 and 29 CFR 1910.1200(d)(3)(i)

The substances regulated as inert or nuisance dusts were changed to Particulates Not Otherwise Regulated (PNOR) in the 1989 rulemaking to reflect OSHA's intention to cover all particulates, including organic dusts. Tables Z-1, Z-1-A, and Z-3 give adequate notice of that clarification and indicate that organic particulates are covered. OSHA will continue to regulate organic particulates under the PEL [Permissible Exposure Limit] for PNOR which references Table Z-3 under inert or nuisance dust. The June 30, 1992 Federal Register notice (pp 3539-40) indicates that the PNOR entry of Table Z-1 and the "Inert or Nuisance Dust" entry of Table Z-3 are the same (duplication is only for purpose of clear notice to the public) and both clearly indicate that organic and inorganic particulates are covered.

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

Carcinogens - (d)(4)

Guidance for label and MSDS designations for carcinogens is provided under paragraph (f)(1).

Evaluation of hazards associated with coatings on automobile parts that will be cut and sanded

29 CFR 1910.1200(d)(4)

Question: [Are] MSDS [necessary] for coatings on automobile parts that will be sanded and cut[?]

Manufacturers and importers are both required by the HCS to perform a hazard evaluation on the products they manufacture or import. This hazard evaluation is the responsibility of the manufacturer/importer. If, under normal conditions of use, a manufactured item meets OSHA's definition of an "article" in the standard, then the item would be exempted and an MSDS would not be required. If the hazard evaluation indicates that a product does not meet the exemption for articles, an MSDS is to be developed and transmitted to downstream employers.

The standard allows employers such as body shops to rely in good faith on the hazard evaluation performed by the manufacturer or importer. If a body shop employer is concerned because their supplier did not automatically supply an MSDS, OSHA recommends that the body shop employer contact the distributor or manufacturer/importer and verify that the manufacturer/importer has determined that no MSDS is necessary.

[As to] whether "particles in the sheet metal on parts, such as zinc," would need to be listed on the MSDS[,] [h]azards that are associated with the processing of steel materials, such as oxide fume and dusts of zinc are to be considered hazardous by virtue of being included in the "floor" list of chemicals incorporated by reference under paragraphs (d)(3) and (d)(4) of the HCS.

letter: SLoftus 11-16-94

Determination of carcinogenicity of a mixture containing attapulgite clay

29 CFR 1910.1200(d)(4)

[Scenario:] The...MSDS [for a product containing attapulgite clay] specifies that attapulgite clay contains 1-10% crystalline silica. The Attapulgite clay mixture has been "tested as a whole" by the International Agency for Research on Cancer (IARC) and classified as a Group 3 substance.

An IARC Group 3 classification indicates that insufficient evidence is available to classify an agent as to its carcinogenicity (i.e., interpretations of human and animal data are restricted and limited, respectively).

The IARC classifies crystalline silica as a probable human carcinogen (Group 2A).

In addition to IARC classifications, OSHA requires a health hazard to be listed on the MSDS whenever one positive study conducted in accordance with established scientific principles indicates a hazardous effect.

[Question:] [Given the above information, is it] necessary to include a carcinogenic statement or an inference of a carcinogenic hazard on the MSDS for the product containing Attapulgite?

[The importer or manufacturer of this product] would be required to list crystalline silica as a hazardous component, with the statement that crystalline silica is a probable human carcinogen, for the following reasons:

1. Appendix B of 29 CFR 1910.1200 establishes the criteria in making hazard determinations of products that meet the requirements of this standard. The appendix states that: "Hazard evaluation is a process which relies heavily on the professional judgement of the evaluator, particularly in the area of chronic hazards. The performance-orientation of the hazard determination does not diminish the duty of the chemical manufacturer, importer, or employer to conduct a thorough evaluation, examining all relevant data and producing a scientifically defensible evaluation. The appendix also requires that, "all available scientific data on carcinogenicity must be evaluated in accordance with this appendix and the requirements of the rule."

Given that Attapulgite has been tested as a whole, and the result is inconclusive, the statistically significant and scientifically valid evidence supporting carcinogenicity for crystalline silica cannot be discounted and must be presented on the MSDS. We believe that this position is consistent with section 1910.1200(d)(5)(i) of the standard that addresses mixtures tested as a whole.

2. The April 18, 1989 version of the MSDS for Attapulgite clay states that the percent composition for crystalline silica is between 1% and 10%. There is no indication that the composition of the Attapulgite clay has changed. Therefore, since...[the] product [identified on the MSDS] contains roughly one third Attapulgite, it clearly contains greater than 0.1% crystalline silica.

3. Further, no evidence is presented to indicate that crystalline silica is inextricably bound in Attapulgite. Therefore, under normal conditions of use or during foreseeable emergencies crystalline silica [should] be indicated as a hazardous ingredient, since it potentially results in employee exposure.

letter: DSperanza 06-16-94

Hazard determination for carcinogenic compounds

29 CFR 1910.1200(d)(4)

...OSHA's compliance directive, Inspection Procedures for the Hazard Communication Standard (CPL 2-2.38C)...states the following: "For purposes of compliance with the MSDS and labeling requirements, the IARC monograph's summary evaluation for the chemical can generally be relied upon but it may be necessary to review the actual evaluations. In some cases, a group of compounds may be listed in the summary as carcinogenic but closer examination of the appropriate monograph will reveal that IARC had data to support the carcinogenicity of only certain compounds. Those compounds are the only ones covered by the HCS."

Under the Hazard Communication Standard, chemical manufacturers have the responsibility to "identify and consider" all available scientific evidence for the chemicals they produce or import to determine if they are hazardous. In general, if an IARC monograph does not address a specific chemical or group of chemicals, the results of the monograph would not apply. However, it is...the chemical manufacturer['s duty] to evaluate all other scientific evidence and available studies to determine if any other evidence exists that may indicate a carcinogenic health hazard is associated with exposure to [hazardous chemicals such as] cobalt phthalocyanine sulfonate compounds. The fact that [a] product was not addressed in the IARC monograph does not relieve [the chemical manufacturer] of the mandate to look elsewhere for other statistically significant evidence that carcinogenic or other health effects may result from employee exposure to [chemicals such as] cobalt phthalocyanine sulfonate compounds.

letter: AMack 02-03-94

see also: CPL 2-2.38C: A-25 & 26 10-22-90

Determination of acetaldehyde as a carcinogen

29 CFR 1910.1200(d)(4)

You pointed out what seemed to be discrepancies in describing the hazards of the chemical acetaldehyde. The Hazard Communication Standard requires chemical manufacturers and importers to consider a chemical carcinogenic if the International Agency for Research on Cancer (IARC), National Toxicology Program (NTP) or OSHA designates the chemical as a carcinogen or potential carcinogen (please see 29 CFR 1910.1200(d)(4)). This must be noted, and the health hazard explained, in the Material Safety Data Sheet if the chemical is in concentrations of 0.1% or more. We see no conflicting information since the document which you enclosed states that both NTP and IARC classify acetaldehyde as a carcinogen.

You also pointed out that the Food and Drug Administration [FDA] recognizes acetaldehyde as safe "for use as a flavoring," and that this conflicting information makes the judgment call difficult. When offered conflicting information that would affect employee safety and health, employers should take the more conservative approach to ensure that the work place is hazard free. In this case, however, OSHA gives solid guidance in its Hazard Communication Standard [HCS] on which chemicals to label carcinogenic. FDA classification is not required by the HCS; however, if you are interested in the FDA's studies we suggest that you contact the FDA to request their studies on the health effects of acetaldehyde as a flavoring and preservative in consumer products.

letter: NBrown 11-10-92

Requirements for determining carcinogen hazards

29 CFR 1910.1200(d)(4)

The Hazard Communication Standard (HCS) 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 can or could result in employee exposure to a hazardous chemical(s). OSHA does not perform these hazard determinations for manufacturers; rather, it is up to the manufacturer 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 (see 29 CFR 1910.1200, paragraph (d)).

... the International Agency for Research on Cancer (IARC) "concluded that [certain products] are not classifiable as carcinogenic to humans" and therefore, you requested that OSHA "confirm" that no carcinogen warning label is needed for these products. IARC is recognized in the text of the HCS itself as one source manufacturers of hazardous chemicals must consider regarding a chemical's carcinogenicity, but it is not the only source. For health hazards including carcinogenicity, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect.

If statistically significant evidence exists that exposure to the ... products your client manufactures, or the [items] 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 material safety data sheet (MSDS), and appropriate hazard warnings conveying that information must appear on container labels for the product. As discussed above, the hazard determination, in this regard, is your client's responsibility as the manufacturer to perform and substantiate.

[Originally written about differing types of fibrous glass products]

letter: AThompson 09-06-91

Man-made mineral fibers (MMMF) and IARC 2B designation

29 CFR 1910.1200(d)(4)

Your letter included an article from Professional Roofing which stated that chemical manufacturers are required to include information on material safety data sheets (MSDSs) for man made mineral fibers (MMMF) regarding their designation by the International Agency for Research on Cancer (IARC) as an IARC class 2B carcinogen. You stated you were unable to find this requirement stated in the [Hazard Communication Standard] (HCS).

The HCS specifically considers substances designated by IARC as carcinogens (or the National Toxicology Program (NTP) or OSHA itself) as hazardous substances which are automatically covered under the requirements of the rule (see 1910.1200(d)(4)). Chemicals which have been indicated as positive or suspect carcinogens by any of these sources are considered to be carcinogenic (and therefore meet the definition of "hazardous chemical" - see Appendix A of the rule) and are covered under the requirements of the HCS. An IARC designation of 2B is indicative that the agent is possibly carcinogenic to humans. OSHA has interpreted that chemicals listed by IARC in groups 1 (carcinogenic to humans) and 2A (probably carcinogenic to humans) must include appropriate entries regarding these designations on both the MSDSs and on the label. Manufacturers of chemicals listed by IARC in group 2B need only include that information on the data sheet.

letter: TSoles 04-24-91

IARC monograph and hazard determination responsibility

29 CFR 1910.1200(d)(4)

Under Hazard Communication Standard (HCS), chemical manufacturers have the responsibility to "identify and consider" all available scientific evidence for the chemicals they produce or import to determine if they are hazardous. ... In general, if an IARC [International Agency for Research on Cancer] monograph does not address a specific chemical or group of chemicals, the results of the monograph would not apply. ... It is your duty as the chemical manufacturer to evaluate all other scientific evidence and available studies to determine if any other evidence exists that may indicate a carcinogenic (or other) health hazard is associated with exposure to these [products] ... the fact that your type of ... process or [product] type was not addressed in the IARC monograph, does not relieve you of the mandate to look elsewhere for other statistically significant evidence that carcinogenic or other health effects may result from employee exposure to [the product].

[Originally written about refining oil]

letter: DPeel 11-09-90

Hazard determination for carcinogens

29 CFR 1910.1200(d)(4)

The Permissible Exposure Limit (PEL) rulemaking did not change [the] other hazard communication obligations. Under relevant OSHA guidelines, each of these substances should have been considered a carcinogen for hazard communication purposes even before promulgation of the PEL Standard. [The products] are classified as carcinogens by the National Toxicology Program (NTP). Mandatory Appendix B to the Hazard Communication Standard (HCS) indicates that this classification constitutes "conclusive evidence' of carcinogenicity for purposes of the standard. OSHA ... recognizes that 'a carcinogen warning may be required for a chemical that is not listed by IARC [International Agency for Research on Cancer] or NTP but significant animal studies indicate carcinogenicity.' ... Similarly, if there is "one valid, positive study indicating carcinogenic potential [and including] positive human evidence, then the label must contain hazard warnings (on carcinogenicity)."

[Originally written for the chemical manufacturing industry]

letter: WNorman 06-22-89

Hazard determination requirements: role of scientific and regulatory organizations

29 CFR 1910.1200(d)(4)

In order to ensure that all employees receive adequate information, it was necessary to establish a threshold for determining when a chemical is to be considered hazardous. For health hazards, if there is one study, conducted according to established scientific principles, which reports statistically significant evidence that the chemical poses the potential to cause an adverse health effect, the results of that study must be reported. (HCS, paragraph (d)(2)). This is an appropriate threshold for an information transmittal standard, which is intended to ensure that affected employees, as well as downstream employers, are aware of all existing scientific information regarding a chemical.

In addition to the one study criterion, participants in the rulemaking supported the need for further thresholds for chemicals that are considered to be hazardous by well-recognized scientific or regulatory organizations. The rulemaking record supports OSHA's conclusion that knowledge of these organizations' findings on a chemical is an important piece of information for affected employees and employers, separate and apart from an individual evaluation by a chemical manufacturer or importer of what they believe the scientific studies indicate a chemical's hazards are. (See, e.g., 48 FR 53298-99, November 25, 1983.)

Therefore, if OSHA has regulated a substance, the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended a Threshold Limit Value (TLV) for it, or the National Toxicology Program (NTP) or the International Agency for Research on Cancer (IARC) have found the substance to be a potential or confirmed carcinogen, the substance must be considered hazardous and information provided as required. All of these organizations require substantial evidence before making a finding that a chemical presents a hazard, and it is important for users of such chemicals to be aware of what those findings are.

To address the concerns of those chemical manufacturers or importers that disagree with the findings of these organizations, the HCS specifically permits them to present negative data as well. (HCS, Appendix B.) They are also allowed to include on a MSDS their own evaluations of the chemical, as long as they do not state anything that is inaccurate or scientifically indefensible.

Contrary to the assertions in your letter, this is not a delegation of rulemaking authority to IARC or any of the other organizations involved. It is an assurance that all available information is provided, an approach that is necessary to provide employees with the right to know about the chemicals they are exposed to while working. The fact that IARC classifies a substance as a potential carcinogen is important information that is already public, and needs to be included with the hazard information provided to downstream employers and employees. The standard permits you to report whatever other negative information you believe is appropriate. Therefore, concerns of exposed employees, as well as the concerns of the producers of the chemicals, have been addressed in the regulatory design.

The HCS is a generic rule, covering as many as 575,000 hazardous chemical products, and the hazard determination process is not an approach that is to be reconsidered for each individual substance. The rule clearly indicates that the latest editions of IARC and NTP are to be used. One of the primary advantages of a generic approach is the dynamic nature of the rule, requiring chemical producers and importers to continually update the chemical hazard information provided to downstream employers and to employees as information becomes available. Certainly the rule cannot reasonably be interpreted to be limited to information available as of 1983. This clearly was not the intent, and would not protect workers to the extent feasible as required under the occupational Safety and Health Act.

letter: TGarrett 09-20-88

Crystalline silica recognized as carcinogenic: IARC

29 CFR 1910.1200(d)(4)

Information regarding the evidence of carcinogenicity must be included on required labels and material safety data sheets [MSDS] for crystalline silica, and for products containing crystalline silica, where employee exposure to the crystalline silica may occur.

Generally speaking, IARC's [The International Agency for Research on Cancer] determinations involve a review of scientific studies that are already available in the literature on a particular chemical. The existence of one such study is sufficient evidence for coverage under the HCS. Of course, crystalline silica poses various respiratory effects that must already be included on labels and material safety data sheets. In your letter, you indicate that companies have "generally advised their workers and customers that exposures to mineral dusts which contain silica may cause silicosis." This information is certainly required under the HCS for employers covered under OSHA's rules.

But in addition to the longstanding evidence of the respiratory effects caused by exposure to crystalline silica, there has also been evidence in the published scientific literature that there are potential carcinogenic effects. This evidence should already have been included in information regarding crystalline silica prepared under the HCS. Whether IARC had published a monograph on the subject or not, the pre-existing scientific information must be reported to be in compliance with the rule. The existence of an IARC evaluation of the data is simply an additional piece of important health information.

As described in the IARC monograph on silica, there are at least five animal studies in the published scientific literature which resulted in "significant increases in the incidence of adeno carcinomas and squamous cell carcinomas of the lung" in the animals exposed to crystalline silica. In addition, there are a number of epidemiological studies which show an increased incidence of lung cancer in workers exposed to silica. As the HCS requires only one study to be considered sufficient evidence of carcinogenicity it is clear that in the case of crystalline silica, the evidence exceeds that threshold for determining the existence of a hazard. In addition, due to the weight of the evidence, a label warning as well as inclusion on an MSDS is warranted.

In addition to the scientific evidence which clearly indicates that information regarding potential carcinogenicity of crystalline silica must be made available under the HCS, the National Institute for Occupational Safety and Health (NIOSH) recently recommended to OSHA in another context that the substance be designated a carcinogen. In testimony presented at informal public hearings on OSHA's proposed rule on permissible exposures to air contaminants (August 1, 1988), NIOSH specifically stated that the final rule should designate that crystalline silica is a potential occupational carcinogen.

letter: TGarrett 09-20-88

Criteria for carcinogens

29 CFR 1910.1200(d)(4)

There are two avenues to be pursued in the determination of whether a chemical is carcinogenic according to the Hazard Communication Standard. The first is whether the chemical in question is part of the "floor" of carcinogens as defined in the standard.

Chemical manufacturers, importers and employers evaluating chemicals are required by the standard to treat the following sources as establishing that a chemical is a carcinogen or potential carcinogen for hazard communication purposes:

1) National Toxicology Program (NTP), Annual Report on Carcinogens (latest edition);

2) International Agency for Research on Cancer (IARC) Monographs (latest editions); or

3) 29 CFR Part 1910, Subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration.

Second, in the case of a chemical which has not been listed by one of the above sources, a chemical manufacturer or importer must consider all scientific evidence available for that chemical. Statistically significant results of any one positive study which is designed and conducted according to established scientific principles regarding the health effects of a chemical would be sufficient basis for reporting the findings on a material safety data sheet. Further, if such studies include positive human evidence of carcinogenicity then the label must contain a hazard warning for carcinogenicity.

letter: WLowry 03-03-87

Metals as hazardous chemicals

29 CFR 1910.1200(d)(4)

All of the primary metals meet the definition of "chemical" under the rule (being elements, or compounds of elements), and generally they would all be expected to present one or more of the hazards covered by the standard (see 1910.1200(c) for definitions of health and physical hazards). In fact, under the rule, many of the metals are to be considered hazardous in all situations by virtue of being included in the "floor" list of chemicals incorporated by reference under paragraphs (d)(3) and (d)(4) of the hazard determination provision.

letter: EMerrigan 05-23-86

MSDS notations for negative findings regarding carcinogenicity

29 CFR 1910.1200(d)(4)

The standard specifies the minimum amount of information that is required on the material safety data sheet, such as physical and chemical characteristics. This type of information must always appear on the material safety data sheet. However, with carcinogens the standard requires that the material safety data sheet must state "whether" a chemical is a carcinogen, and not "whether or not" it is a carcinogen. Only when the condition is affirmative must this indication appear. A section for carcinogenicity would not even have to appear on a material safety data sheet if a chemical was not a carcinogen. However, if a space for carcinogenicity does appear on the material safety data sheet being used, then that area has to be addressed and no blank spaces are permitted; see 29 CFR 1910.1200(g)(3). If a chemical is not a carcinogen then phrases such as "no information found" or "not applicable" would have to be used in the space provided for carcinogenicity.

letter: GSchoolfield 05-21-86

Carcinogenicity findings on MSDSs: amorphous silica

29 CFR 1910.1200(d)(4)(ii)

The hazard determination process is the responsibility of the chemical manufacturer or importer, and is based on the information they determine is applicable to their product. If you are sure that your product is what the International Agency for Research on Cancer (IARC) is referring to as amorphous silica, then you may apply their evaluation for amorphous silica to your product. However, we would like to point out that while IARC concludes that amorphous silica is not classifiable as to its carcinogenicity for humans, the monograph does report that there is at least one positive animal study indicating carcinogenic effects. Under the Hazard Communication Standard (HCS), the findings of this study would have to be included on the material safety data sheet (MSDS) for amorphous silica products. See page 109 of the monograph for a description of the animal evidence. You may also report the negative findings of other studies, but the positive findings must be indicated.

[Originally written for the minerals industry]

letter: PFlynn 06-29-92

Carcinogenicity of mildly hydrotreated naphthenic lubricating oils

29 CFR 1910.1200(d)(4)(ii)

On December 20, 1985, OSHA published an interpretive notice in the Federal Register regarding the carcinogenicity of lubricating oils (VOL. 50 FR 51852). The notice was published in response to a number of inquiries which were received regarding the applicability of the Hazard Communication Standard (HCS) requirements to naphthenic lubricating oils which are refined using a hydrotreatment process. These types of oils may be found in a number of industrial operations, including ink manufacture and the production of synthetic rubber.

Positive findings of carcinogenicity by the International Agency for Research on Cancer (IARC) must be reported under the HCS. The IARC Monograph 33 concludes that there is sufficient evidence to indicate that mildly hydrotreated and mildly solvent refined oils are carcinogenic. Therefore, under the requirements of the HCS, producers of such materials must report such findings on the material safety data sheets (MSDSs) for the substance and include appropriate hazard warnings on labels.

IARC also stated that there is inadequate evidence to conclude that severely hydrotreated oils are carcinogenic, and that there is no evidence to indicate that severely solvent-refined oils are carcinogenic. In the absence of any valid, positive evidence from sources other than IARC regarding the carcinogenicity of severely hydrotreated or severely solvent-refined oils, no reference to carcinogenicity need be included on the MSDSs and labels for such materials. IARC has also concluded that when an oil is refined using sequential processing of mild hydrotreatment and mild solvent refining, there is no evidence of carcinogenicity.

The questions posed to OSHA concerned the process parameters used for mild hydrotreatment. OSHA examined the studies upon which IARC based its positive findings of carcinogenicity to determine the process parameters used to refine the oils studied. Any oil will be considered to be mildly hydrotreated if the hydrotreatment process was conducted using pressures of 800 pounds per square inch or less, and temperatures of 800 degrees Fahrenheit or less, independent of other process parameters. If the oil is being produced within the specified parameters, it must be considered to be potentially carcinogenic under the requirements of the HCS.

It should also be noted that negative evidence generated by a producer does not negate the positive IARC finding and cannot be used to dispute positive findings relating to any substance. The producer is free to report any negative findings as well, but there is a positive duty to report IARC's conclusions.

CPL 2-2.38C: A-11&12 10-22-90

IARC classifications and MSDS/labelling requirements

29 CFR 1910.1200(d)(4)(ii)

IARC [International Agency for Research on Cancer] evaluates chemicals, manufacturing processes, and occupational exposures as to their carcinogenic potential. The IARC criteria for judging the adequacy of available data and for evaluating carcinogenic risk to humans were established in 1971 (Volumes 1-16) and revised in 1977 (Volumes 17 and following).

The individual monographs contain evaluations on specific chemicals or processes. At the conclusion of each evaluation, IARC provides a summary evaluation for the individual chemical. Periodically, IARC publishes Supplements in which chemicals that have already been evaluated in previous monographs are reevaluated. In cases where a chemical has been reevaluated, the most recent IARC evaluation shall be relied upon.

IARC provides a summary in Supplement 7 [1987] of the chemicals which have been evaluated in Volumes 1-42. Table I of Supplement 7 provides a summary evaluation of all chemicals for which human and animal data were considered. Table I of Supplement 7 also provides a summary classification of a chemical's carcinogenic risk:

Group 1 - The agent is carcinogenic to humans.

Group 2A - The agent is probably carcinogenic to

humans.

Group 2B - The agent is possibly carcinogenic to

humans.

Group 3 - The agent is not classifiable as to its

carcinogenicity to humans.

Group 4 - The agent is probably not carcinogenic

to humans.

All IARC listed chemicals in Groups 1 and 2A must include appropriate entries on both the material safety data sheet (MSDS) and on the label. Group 2B chemicals need be noted only on the MSDSs.

Individual monographs have been published subsequent to Supplement 7. For purposes of compliance with the MSDSs and labeling requirements, the IARC monograph's summary evaluation for the chemical can generally be relied upon but it may be necessary to review the actual evaluations. In some cases, a group of compounds may be listed in the summary as carcinogenic but closer examination of the appropriate monograph will reveal that IARC had data to support the carcinogenicity of only certain compounds. Those compounds are the only ones covered by the Hazard Communication Standard (HCS). IARC also evaluates specific industrial processes or occupations for evidence of increased carcinogenicity. Findings that an occupation is at increased risk of carcinogenicity, without identification of specific causative agents, do not affect label or MSDSs requirements.

In addition, the existence of one valid, positive study indicating carcinogenic potential in either animals or humans is sufficient basis for a notation on the MSDSs. Further, if such studies include positive human evidence, then the label must contain carcinogen hazard warnings.

CPL 2-2.38C: A-25&26 10-22-90

see also: AMack 02-03-94

MSDS and labelling requirements for carcinogens

29 CFR 1910.1200(d)(4)(ii)

It appears that there is a potential for exposure to [certain chemicals] under their normal conditions of use in downstream processing operations. If [the chemical] is an IARC [International Agency for Research on Cancer] listed group 2B carcinogen, that health hazard information must be reflected on the material safety data sheet (MSDS). In addition, if there is a valid scientific study indicating positive human evidence of carcinogenicity, then the label must contain hazard warning(s) on carcinogenicity. It should also be noted that the chemical manufacturer is free to report any negative findings as well, as long as the positive findings by IARC are included.

[Originally written for the textile industry]

letter: PTyson no date

Mixtures - (d)(5)

In the February 9, 1994, Amendments to the Final Hazard Communication Rule, the following modifications were made to subparagraph (d)(5)(iv). New regulatory language is indicated in quotation marks:

(iv) If a hazardous component present at less than one percent (or less than 0.1 percent for carcinogens) could be released in concentrations exceeding an OSHA Permissible Exposure Limit (PEL) or American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), or could present a "health risk" to employees in those concentrations, the mixture shall be assumed to present the same hazard.

Determination of carcinogenicity of a mixture containing attapulgite clay

29 CFR 1910.1200(d)(5)

[Scenario:] The...MSDS [for a product containing attapulgite clay] specifies that attapulgite clay contains 1-10% crystalline silica. The Attapulgite clay mixture has been "tested as a whole" by the International Agency for Research on Cancer (IARC) and classified as a Group 3 substance.

An IARC Group 3 classification indicates that insufficient evidence is available to classify an agent as to its carcinogenicity (i.e., interpretations of human and animal data are restricted and limited, respectively).

The IARC classifies crystalline silica as a probable human carcinogen (Group 2A).

In addition to IARC classifications, OSHA requires a health hazard to be listed on the MSDS whenever one positive study conducted in accordance with established scientific principles indicates a hazardous effect.

[Question:] [Given the above information, is it] necessary to include a carcinogenic statement or an inference of a carcinogenic hazard on the MSDS for the product containing Attapulgite?

[The importer or manufacturer of this product] would be required to list crystalline silica as a hazardous component, with the statement that crystalline silica is a probable human carcinogen, for the following reasons:

1. Appendix B of 29 CFR 1910.1200 establishes the criteria in making hazard determinations of products that meet the requirements of this standard. The appendix states that: "Hazard evaluation is a process which relies heavily on the professional judgement of the evaluator, particularly in the area of chronic hazards. The performance-orientation of the hazard determination does not diminish the duty of the chemical manufacturer, importer, or employer to conduct a thorough evaluation, examining all relevant data and producing a scientifically defensible evaluation. The appendix also requires that, "all available scientific data on carcinogenicity must be evaluated in accordance with this appendix and the requirements of the rule."

Given that Attapulgite has been tested as a whole, and the result is inconclusive, the statistically significant and scientifically valid evidence supporting carcinogenicity for crystalline silica cannot be discounted and must be presented on the MSDS. We believe that this position is consistent with section 1910.1200(d)(5)(i) of the standard that addresses mixtures tested as a whole.

2. The April 18, 1989 version of the MSDS for Attapulgite clay states that the percent composition for crystalline silica is between 1% and 10%. There is no indication that the composition of the Attapulgite clay has changed. Therefore, since...[the] product [identified on the MSDS] contains roughly one third Attapulgite, it clearly contains greater than 0.1% crystalline silica.

3. Further, no evidence is presented to indicate that crystalline silica is inextricably bound in Attapulgite. Therefore, under normal conditions of use or during foreseeable emergencies crystalline silica [should] be indicated as a hazardous ingredient, since it potentially results in employee exposure.

letter: DSperanza 06-16-94

Hazard determination for mixtures containing suspected mutagens

29 CFR 1910.1200(d)(5)

Question: If a mixture contains a known quantity of one or more mutagenic ingredients, is the mixture deemed to be mutagenic, or is further testing required to prove mutagenic potential?

OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200) does not specifically address mutagenicity in either the text of the standards final rule (Federal Register, August 24, 1987) or the preamble discussions. It is the agency's position that in vitro tests, independent of other data, do not establish a health hazard as specified under the hazard determination provisions of the standard. Under the HCS the manufacturer does have the responsibility to review all available scientific data when performing a hazard determination for the chemicals they produce. If an in vitro study is the only data available linking a mutagenic response to a chemical exposure, then these studies do not have to be reported on the product's MSDS. Also in terms of testing for mutagenic potential, the HCS does not require testing of chemicals to determine their hazards.

Question: Is there a minimum level of a mutagenic ingredient contained in a mixture above which the mixture does not need testing, but can be assumed to be mutagenic?

Please refer to the answer above, the standard does not require testing. For mixtures of hazardous chemicals the HCS requires the following:

If a hazardous chemical is present in the mixture in quantities (i.e., 0.1% for carcinogens, and 1% for other health hazards), it must be reported unless the mixture has been tested as a whole or unless the material is bound in such a way that employees cannot be exposed. If there really is no exposure (and the standard defines exposure as including potential as well as measurable exposure by any route of entry), either under normal conditions of use or in a foreseeable emergency, then the chemical is not covered by the standard, (See Paragraph (b)(2) of 29 CFR 1910.1200). Further, information must also be included on a MSDS for ingredients of a mixture present in concentrations of less than 1% (or 0.1% for carcinogens) when the hazardous substance may be released in a concentration which exceeds an OSHA Permissible Exposure Limit or an American Conference of Governmental Industrial Hygienist's Threshold Limit Value or may present a health risk to exposed employees. An example of the latter may be TDI because it is a sensitizer in very small concentrations, thereby presenting a health risk that must be noted on the MSDS.

letter: JBunyan 11-04-93

Hazard determination for products with potential for release of respirable crystalline silica

29 CFR 1910.1200(d)(5)

Under the Hazard Communication Standard (HCS), appropriate hazard warning labels are required for materials containing 0.1 [or greater] percent crystalline silica by weight or volume which have anticipated downstream uses where crystalline silica may become airborne and present an inhalation hazard to employees working with that material. This is due to the fact that oftentimes free silica particles of respirable size are created in the processes (sand blasting, grinding, etc.) utilizing silica particles which initially may be too large to be classified as respirable.

If OSHA were to find worker exposures to crystalline silica in a workplace and the product from which the exposure resulted was not labeled in accordance with the requirements of the HCS, a violation of 1910.1200 would be alleged. For all practical purposes, therefore, the requirements of the HCS to provide an appropriate warning label, apply to products containing greater than 0.1 percent crystalline silica or total quartz by weight or volume, as determined by analysis of a bulk sample of the original product.

If the manufacturer has objective evidence to indicate that exposures to respirable silica would not occur when the product is used then this may be factored into the determination of an appropriate hazard warning. For example, we are aware that manufacturers of wallboard products that contain crystalline silica have taken numerous measurements during use of their products, and no respirable crystalline silica was detected. They have decided not to label based on this evidence.

letter: ELapp 02-11-91

Hazard determination testing of mixtures as a whole

29 CFR 1910.1200(d)(5)

While the Hazard Communication Standard (HCS) does not require testing of chemicals to determine their hazards, some preparers of material safety data sheets (MSDSs) are apparently considering testing mixtures as a whole so as not to have to list individual hazardous ingredients on the MSDSs. Should employers choose to pursue this option; i.e., to test the mixture as a whole, a full range of tests would have to be performed, including tests to determine health hazards (acute and chronic) and physical hazards. Employers may also choose to test for certain hazards or properties and rely on the literature for published information on the other hazards.

Compliance officers can expect to see MSDSs which use both the tested and untested mixture approaches; e.g., perhaps an employer has determined a flashpoint for the mixture, but has not tested it for health hazards but has relied instead on information in the published literature for this section of the MSDSs. Such an approach to hazard determination is acceptable under the HCS. Where the physical characteristics have not been objectively determined, the employer may present data on the components in ranges; e.g., flash points range from 70 to 100 degrees fahrenheit.

CPL 2-2.38C: A-12&13 10-22-90

Hazard warning for decomposition products released during normal operations

29 CFR 1910.1200(d)(5)

Specifically, decomposition products released during normal operations, such as hot wire cutting of plastic, must be reported on the material safety data sheet if they pose a health hazards and:

1. They are present in concentrations of 1 percent or greater (by weight or volume), or

2. They are carcinogens and are present in concentrations [of] 0.1 percent [or greater] (by weight or volume), or

3. They are present in concentrations of less than those given in Subparagraphs 1 and 2 above; but, nevertheless, present a health hazard to employees at that lower level of concentration, or

4. They are present in concentrations of less than those given in the Subparagraphs 1 and 2 above, but on release could exceed an OSHA Permissible Exposure Limit (PEL) or American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV).

Decomposition products of chemicals exposed to a fire, where exposure to fire is not a normal use of the product, are not covered by the standard and do not have to be listed on the material safety data sheet.

memorandum: TShepich (DCP) to LAnku, RA 02-17-89

Corrosive component at varying concentrations

29 CFR 1910.1200(d)(5)

It would be reasonable to assume that if a component that is corrosive by itself is not shown to be so when tested in a mixture where it comprises 25% of the compound, it would also not render the mixture corrosive when it comprises 1-5%. Of course, that assumption is also based upon the diluent being the same, and not something which could produce a synergistic effect. When you state that the label would only cover the acute hazards of the mixture, I assume that you mean there are no chronic hazards associated with the mixture. I am also assuming that corrosivity is the only health hazard ZDDP contributes to the mixture.

letter: TAllen 09-04-85

MSDS for "gasoline" or "antifreeze" from different vendors with different additives

29 CFR 1910.1200(d)(5)(ii)

Your question requests interpretation of the material safety data sheet (MSDS) requirements for products purchased in bulk quantities. Your letter described the following scenario. Bulk quantities of antifreeze, gasoline, hydraulic fluid, kerosene, engine oils, lubricants, and propane are delivered to your manufacturing site, transferred from the vendor's truck into large on-site storage tanks. These generic substances may necessitate mixing of similar products, such as gasoline, from different vendors.

According to our phone conversation of December 3, there was agreement that the MSDS from the most current vendor was to be used. However, if a previous vendor has ethylene dibromide as an additive and the most current vendor does not, which is the appropriate MSDS? In this situation, a facility would be required to maintain both MSDSs. Gasolines, oils, lubricants, kerosene, antifreeze may have the same base stock, but depending on user specifications, other substances with hazardous properties may be added. For example, ethylene dibromide is used as an antiknock compound in gasoline. Ethylene dibromide is an irritant and is injurious to the skin.

Although gasoline has been used as the example, the same logic applies to antifreeze with different rust prohibitors, and other products containing hazardous chemicals. Even where a vendor that subsequently delivers gasoline without ethylene dibromide which dilutes the one that contains ethylene dibromide, employees may have been exposed to the gasoline with ethylene dibromide and thus the MSDS for that product must be maintained. More importantly, exposure calculations are not permitted in determining whether a hazard be identified. An employer may not exclude hazards based on presumed levels of exposure (i.e., omitting a central nervous system hazard warning because, in the employer's estimate, presumed exposures will not be high enough to cause the effect). The hazard is the intrinsic property of the chemical. Types of exposure situations should be addressed in [your company's] training programs.

letter: HKerschner 04-15-93

Hazard determination requirements for mixtures

29 CFR 1910.1200(d)(5)(ii)

Chemical manufacturers must either determine the hazards of the product as a whole or assume that the mixture presents the same health hazards as its components. In cases where a chemical mixture or compound has not been tested as a whole, the manufacturer's [Material Safety Data Sheet] MSDS must list all of the chemical components that have been determined to be hazardous which comprise one percent or greater of the mixture, or 0.1 percent or greater for compounds that are considered carcinogenic. In either case, where the hazard has been determined for the mixture or the individual components of the mixture, all of the information should be provided for the employer and employees in the MSDS.

If you feel that the MSDS provided to you does not adequately notify you of all hazards, you may contact the chemical manufacturer for more information or refer the inadequacy to your OSHA area office.

letter: RBliss 12-22-92

Hazard determination: low concentration of respirable substance

29 CFR 1910.1200(d)(5)(ii)

While it may be true that [the particulate hazard] contained in ... products which are in a wet (slurry) form would not be available for respiration and hence would not present an inhalation hazard while the product was in that (wet) form, if an employee would be required to work with the product either before it is mixed (and therefore capable of causing an inhalation hazard due to its dry, respirable form) or after it has dried and hardened (and therefore also capable of presenting an inhalation hazard), the potential for exposure to respirable [substance] would be present and must therefore be addressed in the chemical manufacturer's hazard determination. If ...[a] product, under normal conditions of use, always remains in a wet slurry form and is never dried nor handled in a manner that could result in employee exposure, then no potential hazard exists and no information transmittal under the Hazard Communication Standard (HCS) would be required. However, as addressed above, if exposure to these [substance] containing products occurs in such a way that employees may be exposed, information regarding the hazards associated with those potential exposures must be addressed on the material safety data sheet (MSDS) and on the label.

..., your clients have performed a hazard determination on their (dry) ... products and have found that they contain less than 0.1 percent respirable [substance]. These products would be exempt from coverage under the provision of paragraph (d) of the HCS, "Hazard determination." This paragraph exempts from coverage under the HCS chemical mixtures that contain as components carcinogens present in less than 0.1 percent concentrations.

[Originally written for the china producers industry]

[Originally written about crystalline silicate and china clay products]

letter: GPehrson 03-07-90

Chemicals bound in a compound

29 CFR 1910.1200(d)(5)(ii)

[The] specific question concerned whether [a chemical], when bound in a polymeric compound and silicone rubber elastomers used to fabricate rubber articles, is covered by the Hazard Communication Standard (HCS). If a hazardous chemical is present in a mixture in reportable quantities (i.e., 0.1 percent for carcinogens and 1.0 percent for other health hazards), it is covered by the standard unless the mixture has been tested as a whole or the material is bound in such a way that employees cannot be exposed.

[Originally written about crystalline silica]

letter: DPolsinelli 02-08-89

Threshold amount in a mixture and cadmium-coated or cadmium-plated fasteners

29 CFR 1910.1200(d)(5)(iii)

[Although] the amount of cadmium [in a cadmium-coated or cadmium plated fastener] is less than the 0.1% of the HCS's threshold level for mixtures not tested as a whole (refer to 1910.1200(d)(5)(iii))[,] OSHA does not believe that the mixture (0.1%) trigger level is relevant in this case. The mechanical coating or plating of cadmium to the fasteners does not combine to form a mixture. The cadmium adheres to the outer surface layer of the fastener. Consequently, the weight of cadmium coating in relation to the total weight of the fasteners is unrelated to what is released and available for employee exposure. However, the percentage of cadmium in the coating material alone would be relevant to the 0.1% trigger level and therefore, employee exposure.

letter: RBoggs 10-06-94

Only chemicals available for exposure need be included in evaluation of a mixture

29 CFR 1910.1200(d)(5)(iv)

Question: If a hazardous material, crystalline silica in this situation, is present in the finished product at greater than the HCS-listed thresholds of 0.1% for suspected or known carcinogens, or 1% for other hazardous ingredients, and if the potential exists for exposure, appropriate MSDSs and labels must be prepared to communicate the hazard. (e.g. the product used contains >O.l% crystalline silica and is in a form which will release dust (powder) when handled, or will be cut or fabricated releasing dust.)"

The percentage cut-offs you referred to are in the hazard determination provisions of the rule. The hazard determination provisions are only applied to the release, or the chemical(s) employees are actually or potentially exposed to under normal conditions of use. For more complete explanation of this interpretation, please see the notice of proposed rulemaking (NPRM) published on August 8, 1988, pp. 29833 through 29898.

letter: WBunn 09-25-91

Hazard determination in a mixture: hazardous residues

29 CFR 1910.1200(d)(5)(iv)

Substance A and Substance B are reacted to form Substance C. However, a residual of Substance A remains after the reaction occurs. Therefore, the new product is Substance C, plus less than 0.1% of Substance A, or Mixture D.

Given that Substance A constitutes less than 0.1% of Mixture D ... the information of the hazards of Substance A [would not be required] on the material safety data sheet (MSDS). The exceptions would be if, under paragraph (d)(5)(iv) of the Hazard Communication Standard (HCS), you perform a hazard determination and find there is evidence that the chemical can still present a health hazard to workers in that concentration, or that it could be released and exceed established permissible exposure limits or threshold limit values. In these situations, information regarding Substance A would have to be included on the MSDS for Mixture D.

[Originally written for the chemical manufacturing industry]

letter: TPetranovic 10-02-90

Hazardous residue is equally dangerous in chemicals and mixtures

29 CFR 1910.1200(d)(5)(iv)

[The Company] attempted to attach significance to distinctions between the Hazard Communication Standard's (HCS) treatment of mixtures and that of "pure" chemicals. It argues that the presence in a pure chemical,..., of a residuum of unreacted raw material which is hazardous does not trigger HCS disclosure requirements unless the constituent material is actually harmful -- that is, unless exposure would exceed the Permissible Exposure Limit (PEL) or would otherwise pose an actual danger to downstream workers. However, the court found that the HCS's rationale of allowing downstream users to determine the actual risks posed by hazardous substances in light of conditions of use applied equally to chemicals and mixtures, and that a hazardous residue is no less dangerous when contained in a chemical than when contained in a mixture. While the court did note an apparent anomaly in the HCS's treatment of chemicals and mixtures which might be relevant in future cases, it concluded on the facts of this case that the Secretary reasonably interpreted the HCS as attributing to a chemical the hazardous properties of its unreacted raw materials.

court: Durez v. OSHRC, 906 F.2d 1 (D.C. Cir. 1990)

Hexavalent chromium in photocopier toner

29 CFR 1910.1200(d)(5)(iv)

As we mentioned in our November 24, 1987, letter, an analysis of the photocopier toner indicated that hexavalent chromium was present at .003 percent and therefore did not, under the Hazard Communication Standard, have to be reported on a material safety data sheet. In addition, we asked you if you had evidence that a health hazard existed or if an Occupational Safety and Health Administration's (OSHA) permissible exposure limit could be exceeded where toner chromium concentration is .003 percent.

Like you, OSHA is concerned about employee exposure to chromium. The evidence you presented in your letter, however, is not sufficient to support that a permissible exposure limit would be exceeded or that a health hazard exists at a chromium concentration of .003 percent. Additional support such as actual sampling data and animal and/or human studies demonstrating a carcinogenic effect (at a .003 percent concentration) would be needed before OSHA could require manufacturers to inform employees of the carcinogenic risk of chromium at a .003 percent concentration. Our review of the current scientific literature indicates that such evidence does not exist at this time.

In addition, present scientific evidence indicates that only hexavalent chromium is carcinogenic. Therefore, when evaluating the effects of chromium or its compounds only chromium in the hexavalent state would be considered carcinogenic.

You state that your client is concerned that his employees might be exposed to chromium. Under the Occupational Safety and Health Act of 1970 each employer is responsible for the safety and health of his or her employees. It would, therefore, [it would] be your client's responsibility to ensure that his employees are not being exposed above the permissible exposure limit (0.5 mg/m3 for soluble chromic or chromous salts as chromium and 1 mg/m3 for metal and insoluble salts). This responsibility applies even though an employer may not have received a material safety data sheet.

letter: DBond 02-16-88

Written Hazard Evaluation Procedures - (d)(6)

Citing hazard determination studies

29 CFR 1910.1200(d)(6)

The manufacturer must identify the studies that involve the type of [product] they produce. Hazard determinations are not based on analogy ... , 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 [items] are not ever of respirable size, inhalation hazards would not be of concern.

[Originally written about differing types of fibrous glass products]

letter: AThompson 09-06-91

Access to written hazard evaluation procedures

29 CFR 1910.1200(d)(6)

Employers who are not planning to evaluate the hazards of chemicals they purchase can satisfy the requirement for written hazard evaluation procedures by stating in their written program that they intend to rely on the evaluations of the chemical manufacturer or importer.

Downstream employers/employees do not have access to the written procedures maintained by the chemical manufacturer/importer. If there appears to be a problem with the information received, and it cannot be resolved with the supplier of the product, the matter should be referred to OSHA for investigation. OSHA does have access to the written procedures.

CPL 2-2.38C: A-13 10-22-90

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