SETTLEMENT AGREEMENT
The parties to this Settlement Agreement ("Agreement") are the American Petroleum Institute (referred to as "API"), and the Occupational Safety and Health Administration, U.S. Department of Labor, and the Secretary of Labor (collectively referred to as "OSHA").
- Background
On March 26, 2012, OSHA promulgated its Final Rule, at 77 Fed. Reg. 17574, revising its Hazard Communication Standard, 29 CFR 1910.1200 ("HCS 2012"). On May 23, 2012, API filed a timely Petition for Review styled American Petroleum Institute v. United States Department of Labor, Occupational Safety and Health Administration, Appeal No. 12-1227, in the United States Court of Appeals for the District of Columbia Circuit. The International Union, United Automobile, Aerospace, and Agricultural Implement Workers of America, United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO, and Change to Win ("Union Intervenors") intervened in the matter.
API and OSHA diligently engaged in complex settlement discussions regarding API's challenge to HCS 2012 since shortly after API filed its petition for review in this matter. For purposes ofreaching a settlement, API identified four sets of issues involving: (1) combustible dust; (2) hazards not otherwise classified ("HNOCs"); (3) Specific Target Organ Toxicity ("STOT"); and (4) petroleum streams.
API's challenge with respect to the petrolelum streams issues was triggered by the reference to "petroleum streams" in the following paragraph of the Preamble to the Final Rule adopting HCS 2012:
Concentration ranges, rather than concentrations, may be used in other situations. For example, the final standard includes the longstanding provision that addresses the use of a single SDS for complex mixtures in paragraph (g)(4). Under this provision, where complex mixtures have similar hazards and contents (the ingredients are essentially the same, but the specific composition varies from mixture to mixture), one SDS may be used for all of these similar mixtures. Petroleum streams would be an example of a type of complex mixture to which this provision applies. In this situation, concentration ranges may be used for the ingredients that vary from stream to stream [emphasis added].
API's position on this issue is that the quoted statement with respect to petroleum streams (1) conflicts with the text of HCS 1994 and HCS 2012; (2) conflicts with the interpretation of the HCS followed by the petroleum industry for 30 years; (3) conflicts with the text of the Toxic Substances Control Act of 1976 ("TSCA"), which was the source of the terms "substance" and "mixture" as used in the HCS; and (4) conflicts with the interpretation of TSCA followed by EPA and the petroleum industry for 37 years. OSHA disagrees with API. OSHA's position is that petroleum streams are mixtures (1) is consistent with the plain meaning of the text of HCS 1994 and HCS 2012; (2) is supported by decades of agency interpretative statements under the HCS to which OSHA has received no objection; and (3) unaffected by the definitions of "substance" and "mixture" under TSCA since the HCS's definitions of those terms are taken from the GHS and use different language from TSCA.
In light of the complexity of the issues raised by this matter, and to avoid the expense and uncertainty of litigation, the parties have reached a settlement in which OSHA has formally advised API as to how OSHA will apply the classification and safety data sheet composition disclosure requirements of HCS 2012 to complex petroleum streams, regardless of whether they are treated as substances or mixtures (see Exhibit D).
Accordingly, the parties to this Agreement have now reached a mutually agreeable settlement of API's Petition for Review.
- Agreement
The parties to this Agreement agree to the following terms:
- Within two weeks after final execution of this Settlement Agreement, OSHA will issue and deliver the letters of interpretation that are attached hereto as Exhibits A, B, C, and D by email and U.S. First Class mail, postage prepaid, to the listed addressee and person designated to receive a copy. Within the next forty-five (45) days thereafter, OSHA will post the letters in the Standard Interpretations section of its web page.
- OSHA further agrees that it will include language equivalent to the language in Exhibits A, B, C and D in: (1) its forthcoming Hazard Communication Standard Directive ("Directive"), and any modification or revision of that Directive (unless OSHA's interpretation has changed as described in paragraph 5): and (2) any other OSHA guidance materials to the extent that the materials address any of the issues addressed by this Agreement.
- API will move to dismiss its Petition for Review of the Standard in the abovereferenced case on or before February 21, 2014.
- OSHA agrees that once this Agreement is executed, any OSHA employee enforcing the provisions of HCS 2012 addressed herein will do so in accordance with the Letters of Interpretation attached hereto as Exhibits A, B, C, and D until such time as these documents may be revised or become obsolete through the procedure set out in Paragraph 5.
- Other than by notice and comment rulemaking, OSHA will not change any interpretation of HCS 2012 contained in this Agreement, and/or Exhibits A, B, C, and D, without first satisfying all of the following conditions1:
- OSHA will notify API and the Union Intervenors in writing at least 90 days before OSHA adopts any such change;
- The written notice to API and the Union Intervenors will provide API and the Union Intervenors with a detailed written explanation of what OSHA is considering and why OSHA is considering that change;
- OSHA will provide API and the Union Intervenors with a reasonable opportunity to meet with OSHA to discuss the contemplated change at least 30 days before the change is adopted and no sooner than 30 days after OSHA notifies API and the Union Intervenors of the contemplated change unless API and the Union Intervenors agree to an earlier meeting; and,
- No change will go into effect until at least 180 days after it is publicly adopted, except that any SDSs must be updated within 90 days after the change is publicly adopted. Chemicals that are properly labeled under the interpretations covered by this agreement when they are shipped by the manufacturer or importer need not be updated by distributors, unless the distributor has become the responsible party by altering the manufacturer or importer's label or preparing its own label.
- OSHA's satisfaction of the conditions listed in Paragraph 5(a)-(d) is not intended to, and does not in any way, relieve OSHA from any legal obligation it may have under the OSH Act, or the Administrative Procedure Act, to initiate a rulemaking before adopting any planned change in interpretation of HCS 2012; nor does it waive any challenge under those provisions by API.
- Neither this Agreement, nor anything in it, constitutes an admission by either party.
- API reserves the right to challenge OSHA's position that petroleum streams are mixtures in future proceedings.
- Footnote 2 to Exhibit A states as follows:
OSHA provides further guidance on what it considers to be a container under the HCS in its directive entitled Inspection Procedures for the Hazard Communication Standard, CPL 2-2.38D, March 20, 1998.
API understands that OSHA intends to update its Hazard Communication Directive (CPL 2-2.38D) after the agency issues the letter of interpretation contained in Exhibit A. API has no objection to OSHA unilaterally amending that letter of interpretation for the limited purpose of properly identifying future OSHA HCS compliance directives (e.g., to reflect the new name, identifier and date) once they have been issued, provided the directives continue to include guidance on what OSHA considers to be a container under the HCS. The fact that such an amendment was made should be noted in the footnote to avoid any suggestion that the substance of the letter was amended.
- Each party agrees to bear its own attorneys' fees, costs, and other expenses that have been incurred in connection with the negotiation of this Agreement.
- Any notices that OSHA is required to provide to API pursuant to this Agreement shall be addressed to the representatives of API listed below or any successor representatives designated by APL That designation shall be in a written notice addressed to the representative of OSHA listed below or any successor representative designated by OSHA.
- This Agreement constitutes the complete and exclusive statement of agreement between OSHA and API with respect to the application of HCS 2012 to the issues covered by this Agreement. All prior or contemporaneous statements, understandings, and agreements by and between the parties, whether written or oral, with respect to the issues covered by this Agreement are deemed to be superseded by this Agreement.
Agreed to this 19th day of February, 2014.
____________________
Harry M. Ng, Esq.
Vice President, General Counsel & Corporate Secretary
American Petroleum Institute
1220 L Street, N.W.
Washington, DC 20005-4070
(202) 682-8037____________________
Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Suite 500W
1001 G Street, N.W.
Washington, D.C. 20001
202-434-4177
Attorney for the American Petroleum Institute____________________
Edmund C. Baird, Esq.
Attorney for OSHA
United States Department of Labor
200 Constitution Avenue, NW
Room S4004
Washington, DC 20210
(202) 693-5445
[Exhibit A: OSHA Letter of Interpretation Addressing Combustible Dust Issues]
[Date]
Erik C. Baptist
Counsel
American Petroleum Institute
1220 L Street, NW
Washington, DC 20005
Re: Request for Interpretation of Application of OSHA's Amended Hazard Communication Standard (HCS 2012) to Combustible Dust
Dear Mr. Baptist:
This letter is being issued to API to clarify how the March 26, 2012, revisions to OSHA's Hazard Communication Standard (HCS 2012) apply to combustible dust. Below I summarize each of your questions and provide our response to it.
- Modification of Required Hazard Statement. Under HCS 2012, chemicals that have been classified as combustible dusts must include the following hazard statement on their labels and safety data sheets (SDSs): "May form combustible dust concentrations in air." You ask whether, for chemicals that pose a combustible dust hazard when processed but not in the current shipped form, the responsible party1 may include additional language with the hazard statement. You propose two alternatives (indicated by italics):
- If converted to small particles during further processing, handling, or by other means, may form combustible dust concentrations in air.
- If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
OSHA RESPONSE: Paragraph C.3.1 of Appendix C to HCS 2012 states that the responsible party may provide additional information on a label "when it provides further detail and does not contradict or cast doubt on the validity of the standardized hazard information." OSHA views either of the alternatives you propose as falling within C.3.1 because they provide additional detail and do not contradict or cast doubt on the validity of the required hazard statement where the chemical does not present a combustible dust hazard in the form shipped. Similarly, the required elements listed in Appendix D for SDSs are the minimum information required and OSHA believes that additional information that satisfies C.3.1 may be included in Section 2 of the SDS if the additional information concerns hazard identification. Therefore, it would be acceptable to OSHA if responsible parties included either alternative in conjunction with the required hazard statement on labels and SDSs for such chemicals.
- Safety Data Sheets.
- Your first question concerns a chemical that is not a combustible dust in the form shipped, and does not present any other hazard under HCS 2012 in the form shipped, and will not present a combustible dust hazard or any other hazards under HCS 2012 in normal conditions of use or foreseeable emergencies unless they are processed by a downstream user in such a manner which reduces its particle size. You ask whether, for such a chemical, the responsible party may include the following additional language at the beginning of the SDS:
This product is not hazardous in the form in which it is shipped by the manufacturer, but may become hazardous through downstream activities (e.g. grinding, pulverizing) that reduce its particle size. Those hazards are described below.
OSHA RESPONSE: Yes. These types of additional statements may be added to the SDS so long as they are relevant and do not contradict or cast doubt on the validity of the classification or other information in the SDS.
- You ask whether Section 2 of the SDS for a chemical posing a combustible dust hazard may include precautionary statements about the combustible dust hazard although none are specified by Appendix C of HCS 2012.
OSHA RESPONSE: Yes. OSHA has no required precautionary statements for combustible dust, and therefore none is required in Section 2 of the SDS. Responsible parties may add their own precautionary statements to Section 2 so long as they are relevant and do not contradict or cast doubt on the validity of the other information in the SDS.
- You ask whether Section 2 of the SDS for a chemical posing a combustible dust hazard may include Hazard Management Information System (HMIS) and National Fire Protection Association (NFPA) ratings.
OSHA RESPONSE: Yes. Responsible parties may include HMIS and NFPA ratings in Section 2 of the SDS as long as they do not contradict or cast doubt on the HCS 2012 classification.
- Your first question concerns a chemical that is not a combustible dust in the form shipped, and does not present any other hazard under HCS 2012 in the form shipped, and will not present a combustible dust hazard or any other hazards under HCS 2012 in normal conditions of use or foreseeable emergencies unless they are processed by a downstream user in such a manner which reduces its particle size. You ask whether, for such a chemical, the responsible party may include the following additional language at the beginning of the SDS:
- Labels on shipped containers
- You ask whether it is acceptable for a shipped container containing a chemical that presents a combustible dust hazard to include an HMIS label in addition to the information required by 1910.1200(f)(1) and C.4.30.
OSHA RESPONSE: Yes, so long as the ratings in the HMIS label do not contradict or cast doubt on the validity oflabel information required by HCS 2012 (C.3.1) or impede the user's ability to identify the information required by HCS 2012 (C.3.2).
- Appendix C.4.30, footnote 2, states that where chemicals are not shipped in a dust form but may be processed under normal conditions of use by a downstream user in such a way as to create a combustible dust hazard, the responsible party may provide labels in accordance with Section 1910.1200(f)(4). That provision allows labels to be provided once to downstream users, either with the initial shipment or with the SDS for the chemical. You ask whether, when Section 1910.1200(f)(4) applies, the shipped container may bear a label containing only product identifiers, manufacturer name and address, and an emergency phone number.
OSHA RESPONSE: Yes, where Section 1910.1200 (f)(4) applies and the HCS 2012 label has already been provided by other means, it is acceptable to provide only this information on a shipped container. In fact, OSHA encourages responsible parties to provide product identifier and contact information on each shipped product whenever they take advantage of the Section 1910.1200 (f)(4) option. However, any information that appears may not contradict or cast doubt on the validity of the label information required by HCS 2012.
- Finally, you ask whether, under footnote 2 to C.4.30, the Section 1910.1200 (f)(4) partial labeling exemption is available for a liquid that under normal conditions of use may (by evaporation or other process) tum into a solid form that presents a combustible dust hazard.
OSHA RESPONSE: Yes, assuming the liquid in its shipped form presents no other hazards that would be classified under HCS 2012. If the liquid presents any other hazards, then (f)(4) would not apply. Again, OSHA encourages responsible parties to provide the product identifier and contact information on each such product.
- You ask whether it is acceptable for a shipped container containing a chemical that presents a combustible dust hazard to include an HMIS label in addition to the information required by 1910.1200(f)(1) and C.4.30.
- Workplace labels. This issue concerns the workplace labeling requirements under Section 1910.1200(f)(6) in situations where a chemical is not a combustible dust in the form shipped, but may become one when processed by a downstream user. Your first question is whether, when the responsible party provides the label in accordance with Section 1910.1200 (f)(4), the downstream user must label any containers containing the chemical in the workplace. Second, you ask that we clarify the labeling obligations of the downstream user once the product is processed in a way to create the combustible dust hazard.
OSHA Response:
(1) The one-time label rule of Section 1910.1200(f)(4) applies when the product is a solid metal, solid wood, solid plastic or whole grain, and is not limited to chemicals whose only downstream hazard is the combustible dust hazard. In addition, under footnote 2 to C.4.30, the Section 1910.1200 (f)(4) exemption is also available to other products, including liquids, that present only a combustible dust hazard under normal conditions of use and foreseeable emergencies, but not in the form shipped (as discussed in section 3.c of this letter above).
(2) In situations where a chemical is not a combustible dust in the form shipped, but may become one when processed or handled by a downstream user, and the responsible shipper-party provides the one-time container label in accordance with Section 1910.1200(f)(4), the downstream user's obligation to label any workplace containers of that chemical are determined as follows:
(a) If the chemical will not be processed or handled in a way that creates a combustible dust hazard or any other hazard that would be classified under HCS 2012, there is no Section 1910.1200(f)(6) labeling requirement.
(b) If the chemical will first be placed in a stationary process container (e.g., grinder) where it will be processed in a way that creates a combustible dust hazard, the downstream user would be required to label the stationary process container with the Section 1910.1200(f)(6) label, or may comply with the alternative labeling methods provided by Section 1910.1200(f)(7), and need not label the shipping container.
(c) If the chemical will first be placed in a non-stationary process container where it will be processed in a way that creates a combustible dust hazard, the downstream user would be required to label the nonstationary process container with the Section 1910.1200(f)(6) label, but not the shipping container.
(d) If the chemical will be processed or handled in a way that creates a combustible dust hazard before it is placed in a process container, the chemical would be subject to the Section 1910.1200(f)(6) labeling requirement once the chemical is brought into the work area where it will be processed in a way to create the combustible dust hazard. If the chemical is not in a container when brought into the area where it will be processed, no Section 1910.1200(f)(6) labeling would be required prior to processing.
(e) Finally, the workplace labeling requirements in Section 1910.1200(f)(6) apply only to chemicals that are in containers2. Thus, individual boards or pipes that might create a combustible dust hazard when cut do not need to be labeled under Section 1910.1200 (f)(6). It is permissible (and OSHA encourages) the use of signs or placards to advise workers of the hazard in such circumstances, but signs and placards are not required.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be superseded by changes to OSHA rules, including but not limited to future revisions to the Hazard Communication Standard and the adoption of a standard concerning combustible dust.
Sincerely,
David Michaels, Ph.D, MPH
Assistant Secretary of Labor for
Occupational Safety and Health
cc: Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Attorney for API
[Exhibit B: OSHA Letter of Interpretation Addressing HNOC Issues]
[Date]
Erik C. Baptist
Counsel
American Petroleum Institute
1220 L Street, NW
Washington, DC 20005
Re: Request for Interpretation of OSHA's Amended Hazard Communication Standard (HCS 2012) about Hazards Not Otherwise Classified
Dear Mr. Baptist:
This letter is being issued to API to provide additional guidance on how to apply the requirements for Hazards Not Otherwise Classified (HNOC) under the March 26, 2012, revisions to OSHA's Hazard Communication Standard (HCS 2012).
Under OSHA's Hazard Communication Standard, an HNOC is defined as follows:
an adverse physical or health effect identified through evaluation of scientific evidence during the classification process that does not meet the specified criteria for the physical and health hazard classes addressed in this section. This does not extend coverage to adverse physical and health effects for which there is a hazard class addressed in this section, but the effect either falls below the cut-off value/concentration limit of the hazard class or is under a GHS hazard category that has not been adopted by OSHA (e.g., acute toxicity Category 5).
29 C.F.R. § 1910.1200(c).
Classifiers may rely on the following guidance in applying the definition of an HNOC under HCS 2012:
- An adverse physical or health effect is a material impairment of health or functional capacity, as that phrase is used in section 6(b)(5) of the OSH Act, 29 U.S.C. § 655(b)(5), resulting from workplace exposure to a chemical.
- A health effect is determined in accordance with the weight of evidence criteria in A.0.3.
- The term physical effect generally refers to a material impairment of health or functional capacity caused by the intrinsic hazard(s) of a particular chemical in normal conditions of use or foreseeable emergencies. Scalds caused by exposure to chemicals at high temperatures, and slips and falls caused by treading on a solid chemical shaped in a rounded form or spilled liquids are not covered physical effects under the HNOC definition. By way of example, water is not classified as an HNOC merely because an employee might be scalded by contact with boiling water or because an employee might contract hypothermia by being immersed in cold water for a long period of time. Similarly, water is not classified as an HNOC by virtue of the fact that an employee might be injured when slipping and falling on a wet surface or when sprayed by water at high pressure. The foregoing examples of adverse physical effects that are outside the scope of HNOCs are designed to assist in better understanding the concept of HNOCs. They are not intended to be exhaustive or limited to chemicals, such as water, which are not hazardous chemicals.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules.
Sincerely,
David Michaels, Ph.D, MPH
Assistant Secretary of Labor for
Occupational Safety and Health
cc: Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Attorney for API
[Exhibit C: OSHA Letter oflnterpretation Addressing STOT Issues]
[Date]
Erik C. Baptist
Counsel
American Petroleum Institute
1220 L Street, NW
Washington, DC 20005
Re: Request for Interpretation of OSHA's Amended Hazard Communication Standard (HCS 2012) about classification criteria for Single Target Organ Toxicity
Dear Mr. Baptist:
This letter is being issued to API to provide additional guidance on how to apply the classification criteria for Single Target Organ Toxicity (STOT) to mixtures under the March 26, 2012, revisions to OSHA's Hazard Communication Standard (HCS 2012).
In particular, for mixtures containing from 1% to less than 10% of a Category 1 STOT (single exposure (SE) or repeat exposure (RE)), you asked whether there were any circumstances in which OSHA might accept a classification of the mixture as a Category 2 STOT. OSHA agrees that under the following limited circumstances, such a classification would be acceptable.
Mixtures containing from 1% to less than 10% of Category 1 STOT-SE ingredients may be classified as Category 2 STOT-SE under the limited following circumstances. A.8.3.1 allows for the classification of mixtures under the criteria as used for substances. Where the classification of the ingredients is based on animal data only (see A.8.2.1.6), the use of the guidance values in Table A.8.1 is appropriate as a part of the total weight of evidence approach. It may be appropriate, in light of the guidance values, to classify a mixture containing from 1% to less than 10% of Category 1 STOT-SE substances as a Category 2 STOT-SE hazard, where warranted by the weight of evidence. Such a classification must be consistent with all of the criteria in A.8.2.1 ("Substances of Category 1 and Category 2"), including consideration of the severity of the effect observed. However, OSHA would not accept a determination not to classify a mixture based on this approach.
Mixtures containing from 1% to less than 10% of Category 1 STOT-RE ingredients may be classified as Category 2 STOT-RE under the limited following circumstances. A.9.3.1 allows for the classification of mixtures under the criteria as used for substances. Where the classification of the ingredients is based on animal data only (see A.9.2.6) the use of the guidance values in Tables A.9.1 and A.9.2 is appropriate as a part of the total weight of evidence approach. It may be appropriate, in light of the guidance values, to classify a mixture containing from 1% to less than 10% of Category 1 STOT-RE substances as a Category 2 STOT-RE hazard, where warranted by the weight of evidence. Such a classification must be consistent with all of the criteria in A.9.2 ("Classification Criteria for Substances"), including consideration of the severity of the effect observed. However, OSHA would not accept a determination not to classify a mixture based on this approach.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules.
Sincerely,
David Michaels, Ph.D, MPH
Assistant Secretary of Labor for
Occupational Safety and Health
cc: Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Attorney for API
[Exhibit D: OSHA Letter of Interpretation Addressing Petroleum Stream Issues]
[Date]
Erik C. Baptist
Counsel
American Petroleum Institute
1220 L Street, NW
Washington, DC 20005
Re: Request for Interpretation OSHA's Amended Hazard Communication Standard (HCS 2012) regarding Petroleum Streams
Dear Mr. Baptist:
This letter is being issued to API to provide guidance on how to apply the March 26, 2012, revisions to OSHA's Hazard Communication Standard (HCS 2012). Classifiers may rely on the following guidance in applying the classification and SDS requirements of HCS 2012 to petroleum streams.
For purpose of this letter, a petroleum stream includes crude oil and anything derived from crude oil that is:
- a well-defined chemical compound defined by a Chemical Abstracts Service Number, such as butane or propane, aside from impurities and stabilizers; or
- a Substance of Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs) defined by a Chemical Abstracts Service Number.
Petroleum Stream Classification
The obligation to classify the health hazards of petroleum streams under the Hazard Communication Standard may be satisfied by following the below guidance, in conjunction with the general guidance found in A.0.1-A.0.3, in the application of the classification criteria in Appendix A of the standard.
- For hazard classes other than carcinogenicity, germ cell mutagenicity, and reproductive toxicity ("CMR"), a petroleum stream shall be classified as follows:
(a) Where test data are available for the petroleum stream, the classification of the stream will always be based on those data.
(b) Where test data are not available for the stream itself, the classification may be based on a toxicologically appropriate read across from test results of a substantially similar stream. A substantially similar stream is one that has a similar starting material, production process, and range of physico-chemical properties (e.g., boiling point and carbon number) and similar constituent compositions.
(c) If test data are not available either for the stream itself or a substantially similar stream, then the method(s) described in each chapter of Appendix A for estimating the hazards based on the information known will be applied to classify the stream (i.e., application of cut-off values/concentration limits).
- For the CMR hazard classes:
(a) When reliable and good quality data are available to classify a petroleum stream—based on testing of the stream or the toxicologically appropriate read-across to a substantially similar stream—a weight of evidence analysis supported by that data may be relied upon for classification regardless of whether a CMR constituent is present in the stream. A substantially similar stream is one that has a similar starting material, production process, and range of physico-chemical properties (e.g., boiling point and carbon number) and similar constituent compositions.
(b) To be reliable and good quality test data, the data must be from one or more tests that reflect appropriate study design and performance. The study or studies must appropriately take into account dose and other factors such as duration, observations, and analysis (e.g. statistical analysis, test sensitivity) so as to conclusively exclude the possibility that the lack of effect(s) is due to a poor study design, e.g., insufficient dose or number of subjects. A study (or studies) is conclusive in this sense if, when viewed in conjunction with all relevant information about the chemical, its results are consistent with the relevant information and allow a strong inference that the lack of effects is not due to a poor study design.
(c) Where reliable and good quality data are not available on the stream or a substantially similar stream, then the method(s) described in each chapter of Appendix A for estimating the hazards based on the information known will be applied to classify the stream (i.e., application of cut-off values/concentration limits).
Safety Data Sheet Disclosure
Many petroleum streams are of unknown or variable concentration, and cannot be represented by unique structures, molecular formulas, or fixed concentration percentages. In addition, petroleum industry test data are largely based on the testing of streams rather than the hundreds or thousands of individual constituents of those streams. In light of these facts, application of the disclosure requirements in Section 3 of table D.1 to petroleum streams may be infeasible and/or undermine the usefulness of the SDS. Thus, SDSs for petroleum streams that are in accordance with the following guidance will be considered to be in compliance with the standard for enforcement purposes.
- When dealing with petroleum streams, it may be more important for the user to know the concentrations of particular groups of constituents that are toxicologically similar. For example, in the classification of a petroleum stream, it may be more relevant to know the total concentration of a class of constituents such as polycyclic aromatic hydrocarbons (PAH) to understand the health hazards of the stream, rather than knowing the concentration of each particular PAH. Further, information about the presence and concentration of particular constituents of the group might not be available, or even if it were, inclusion of every one could lead to the listing of hundreds of constituents. This is likely to undermine the effectiveness of the disclosure requirements in Section 3. Thus, where the classifier can show that it is toxicologically appropriate to treat a particular set of constituents as a group, and all of the toxicologically useful information about the constituents in that group is conveyed by treating them as a group, SDS need only include the name and concentration of that group in Section 3 if present above the cutoff/concentration limit (or if the group presents a health risk below the cutoff/concentration limit). The foregoing example of PAHs is designed to assist in better understanding the concept of this paragraph. It is not intended to limit the application of this approach to any particular type or group of constituents.
- Other constituents, such as benzene or n-hexane, that are known to be present in the stream, and that present classified health hazards, must be listed individually in Section 3 along with their concentrations if present above the cut-off/concentration limit (or if the constituent presents a health risk below the cut-off/concentration limit).
- Where there is "reliable and good quality" data supporting a weight of evidence determination that a constituent in a petroleum stream poses no health risk (as per A.0.4.3.3) in a downstream use of the stream, it need not be disclosed on the SDS.
- Where the classifier does not know the exact concentration of a constituent or group of constituents included in Section 3 of the SDS, it may use a range of concentrations instead. Concentration ranges, if used, must be based on the information available to the classifier, such as analysis results, product specifications, or nature of the process, and the high end of the range reported may not affect the reported hazard classification.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules.
Sincerely,
David Michaels, Ph.D, MPH
Assistant Secretary of Labor for
Occupational Safety and Health
cc: Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Attorney for API
Footnote 1. The terms and conditions set forth in paragraph 5 of this Settlement Agreement are intended to apply only to this unique case, and only with respect to this settlement agreement, and do not constitute a new procedure to be entertained by OSHA in any other situation where the Agency is considering updates to its interpretation of a standard.
Exhibit A Footnote 1. In this letter, the term "responsible party" refers to a person required by HCS 2012 to provide labels and SDSs to downstream users.
2. OSHA provides further guidance on what it considers to be a container under the HCS in its directive entitled Inspection Procedures for the Hazard Communication Standard, CPL 2-2.38D, March 20, 1998.