SECRETARY OF LABOR, Complainant. v. AMERICAN CYANAMID COMPANY, Respondent. OSHRC DOCKET NO. 86-0681 /*DECISION */ Before: FOULKE, Chairman; WISEMAN and MONTOYA, Commissioners. BY THE COMMISSION: This case primarily involves the types of label warnings that are required on containers of toxic chemicals that leave the manufacturer's workplace. At issue is whether American Cyanamid Co. ("Cyanamid"), a chemical manufacturer, violated the requirements of the Hazard Communication Standard ("HCS"), 29 C.F.R. § 1910.1200, promulgated by the Secretary of Labor's Occupational Safety and Health Administration ("OSHA"). More specifically, the Secretary charges that Cyanamid failed to label containers of hazardous chemicals with "appropriate hazard warnings" as required by § 1200 (f)(l)(ii), and failed to include the fill Threshold Limit Value ("TLV") of the American Conference of Governmental Industrial Hygienists ("ACGIH") on certain of its material safety data sheets ("MSDS's"), as required by 1200(g)(2)(vi). The Commission's administrative law judge found violations of both those provisions. He found that Cyanamid's container labels did not have "appropriate hazard warnings," because they did not contain certain "target organ warnings." [[1]] that the Secretary argues are necessary. We reverse the judge's decision on this issue. We find that the broad requirement of "appropriate hazard warnings," as used in the HCS, is inconsistent with the manner in which the Secretary sees to enforce the standard in this case. Specifically, we find that the Secretary's insistence on target organ warnings in this case is a departure from the original policy under the HCS, and that the current policy is not enforceable, because the departure has not been adequately explained on this record. More fundamentally, we find that the policy is not enforceable because it would change the substance of the cited provision, by depriving the employer of the opportunity to show that label warnings not containing the target organ warnings advocated by the Secretary are nevertheless "appropriate hazard warnings." The Secretary's enforcement position in this case would create, in effect, an irrebuttable presumption that a target organ warning is required on the container label whenever a specific target organ effect is "known." We find that its enforcement position is inconsistent with the broad, performance-oriented language of the cited standard, which requires the Secretary to show, by a preponderance of the evidence in each case, that the container labels do not contain "appropriate hazard warnings." The Secretary failed to make that factual showing in this case. We therefore find that except for the containers of one of the chemicals (Fibercore), which did not have any hazard warnings on the label, the Secretary failed to establish that the cited containers lacked "appropriate hazard warnings." We affirm a violation as to Fibercore. We also affirm the judge's holding that Cyanamid violated {sym} 1200(g)(20(vi). No penalties were proposed by the Secretary, and none will be assessed. *BACKGROUND * Cyanamid is a chemical manufacturing company with headquarters in Wayne, New Jersey. The plant involved here is in Perrysburg, Ohio, where Cyanamid produces resins and molding compounds for "out of plant shipment" (sale and distribution) to customers in the plastics industry. The five products at issue here were among those compounds. The products are Cyglas, Fibercore, Glaskyd, XC-4001 resin,and XC-4005 resin. OSHA Compliance Officer ("CO") Ralph Mericle inspected the Perrysburg plant on December 6, 1985, to determine compliance with the HCS. The CO reviewed the MSDS's for the five products at issue and reviewed the corresponding labels on their containers. The chemicals at issue in the products are as follows: (1) for Cyglas -- vinyl toluene and amorphous silica (2) for Fibercore -- styrene and vinyl toluene: (3) for Glaskyd amorphous silica and talc: (4) for XC-4001 resin -- n-Butanol and propylene glycol methyl ether; and (5) for XC-4005 resin -- n-Butanol. Each of the chemicals at issue is classified as a hazardous chemical under the standard, because they all are identified as hazardous chemicals by 29 C.F.R. Part 1910, Subpart Z, and by ACGIH. [[2]] The HCS is intended to: ensure that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees. This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training § 1200(a)(l). See. e.g., Secretary of Labor v. United Steelworkers, 494 U.S. 26 (1990). *ITEM 1 (b): HAZARD WARNINGS ON CONTAINER LABELS* The cited subsection. § 1200(f)(1)(ii), and its surrounding provisions state: (f) Labels and other forms of warning. (1) The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked with the following information: (i) Identity of the hazardous chemical(s); (ii) Appropriate hazard warnings: and (iii) Name and address of the chemical manufacturer, importer, or other responsible party. The cited provision requires, but does not define, "appropriate hazard warnings." "Hazard warning" is defined in § 1910.1200(c) as "any words, pictures, symbols, or combination thereof appearing on a label or other appropriate form of warning which convey the hazard(s) of the chemical(s) in the container(s)." The definition of "health hazard" given there is very broad: "Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard. §1200(c). *A. The Target Organ Warning Issue* The Secretary argues that the hazard warnings on Cyanamid's labels were not "appropriate," because they did not warn of certain target organ effects of the chemicals at issue. Instead, Cyanamid's container labels for XC-4001 resin, XC-4005 resin, Cyglas and Glaskyd had hazard warnings that generally conformed to the language recommended at that time by the American National Standards Institute ("ANSI"). ANSI Z 129.1-1982 Hazardous Industrial Chemicals: Precautionary Labeling. ANSI is a national industry consensus standard-setting group to which Cyanamid belonged. For example, Cyanamids label for XC-4001 stated: WARNING! FLAMMABLE LIQUID AND VAPOR HARMFUL IF INHALED CAUSES EYE IRRITATION MAY CAUSE SKIN IRRITATION Keep away from heat, sparks, and flame. Avoid breathing vapor. Avoid contact with eyes, skin, and clothing. Keep container closed. Use with adequate ventilation. Wash thoroughly after handling. The label also contained first aid instructions. The warnings and Instructions generally used the same language and format recommended by ANSI at the time for irritants, and substances that are toxic by inhalation. E.g., ANSI Z129.1-1982, at 10-11, 19, 2I. [[3]] However, as the Secretary notes, the labels did not specifically state, for example, that n-Butanol propylene glycol methyl ether, styrene, and vinyl toluene may cause central nervous system depression, including dizziness, headache, nausea, and other symptoms. Nor did the labels specifically warn that silica and talc may cause lung damage. [[4]] We will address the Secretary's interpretation of the standard, under which label warnings of every "'known" target organ effect would be required. Our role is to determine whether that interpretation is "a permissible gloss" on the standard, in light of the standard's language, structure and regulatory history. See Whirlpool Corp. v. Marshall, 445 U.S. 1, 11 (1980). *1. Appendix A to the HCS* The judge held that target organ warnings are required on container labels, in light of Appendix A to the HCS. [[5]] Target organ effects are among the health effects defined in Appendix A. The Appendix states that employees must be apprised of the organs that may be harmed, and the signs and symptoms of potential harm. That appendix does not state, however, whether all that information must be conveyed on container labels. The inclusion of target organ effects within the scope of "health hazards" does not establish, by itself, that each such effect must be described on container labels. Label warnings are only one part of a comprehensive scheme of hazard communication: OSHA's stated purpose for the labels within the comprehensive hazard communication program [is] serving as an immediate warning and as a reminder of the more detailed information provided in other forums. Hazard Communication: Final Rule, 48 Fed. Reg. 53,280, 53,301 (1983). Those other forums include MSDS's. All health hazards. including signs and symptoms of exposure, must be stated on the MSDS, under § 1200(g)(2)(iv). [[6]] See Durez, supra note 2 (MSDS's must list target organs regardless of whether exposures to chemical may foreseeably exceed OSHA permissible exposure limits). MSDS's are to be readily available to the employees at each worksite. §§ 1200(g)(8) and (10). Another means of conveying detailed safety information is employee training. § 1200(h). In this case, the compliance officer testified that professional judgment is needed to determine which hazards identified on the MSDS are important enough to list on the container label. Thus, we must look beyond the HCS labeling provisions and Appendix A to the HCS, to determine what the Secretary meant to require on container labels. *2. The HCS Preamble on labeling requirements generally* The 1983 HCS Preamble ("the Preamble") contained an authoritative statement of the agency's intent in promulgating the labeling requirements. It made clear that the requirement of "appropriate hazard warnings" was a performance standard, and that only "minimal information" was required for label warnings, 48 Fed. Reg. at 53,301, 53,336. The Preamble also indicated that the employer was given broad discretion in choosing the warnings. "The employer is responsible for selecting the message and ensuring that it is effective for the purpose involved." Id. at 53,336. Since there is no information in the record to indicate that one type of labeling system is inherently more effective than another, and since the labeling provisions of the standard are supplemented by a training program where the employer will have to explain to employees the labeling aspects of the hazard communication program in their workplace, OSHA does not find that the record warrants disruption of current labeling practices to implement a standardized system. Id. at 53,301 (emphasis added). The Preamble reaffirmed that numerous existing labeling systems "would generally be in compliance." Id. Specifically, it named the ANSI system followed by Cyanamid. It also named the Hazardous Materials Identification System (HMIS) of the National Paint and Coatings Association (NPCA). It noted that, as under the 1982 proposal. Use of these systems would not mean that employers would not be held accountable for providing the information required. It simply meant that they would not have to after the format of their information presentation. Id. (emphasis added). However, the Preamble stated that "the information required under the (1982) proposal is sufficient, and remains the same under the final standard." 48 Fed. Reg. at 53,301. [[7]] The 1982 proposal called for "a simple performance-oriented standard. 47 Fed. Reg. at 12,101 (emphasis added). The Iabeling requirements are very much performance-oriented in that most existing labeling systems could be used to satisfy the requirements.... One issue of concern in this area is the extent of information required to be included on the label. In the proposal, OSHA's intent has been to limit the information, to what is needed for immediate protection. More extensive will be required on material safety data sheets, which will be available to employees. /Id/. at 12,103 (emphasis added). The 1982 proposal criticized a 1981 OSHA labeling proposal for hazardous chemical containers. That earlier proposal, which would have deprived employers of much of the discretion that is provided under the final standard, Hazards Identification: Notice of Proposed Rulemaking and Public Hearings, 46 Fed. Reg. 4412 (1981), was withdrawn only weeks after it was published. 46 Fed. Reg. 12,214 (1981). It was a specification standard, requiring particular language for labels on containers of hazardous chemicals. Proposed § 1200(q)(3) and Appendix C, 46 Fed. Reg. at 4443, 4451-53. For chemicals classified only as toxic substances, such as the ones here, the label was to state: ''Warning -- Toxic: May be fatal if [inhaled], [absorbed through skin], [swallowed]."[[8]] The 1981 proposal also would have required, where appropriate, statements of (1) appropriate precautions to avoid exposure (such as "[w]ear rubber gloves"), (2) antidotes, (3) instructions in case of fire, spill, or leak, and (4) instructions for container handling and storage. Proposed Appendix C. §§ (b)(4), (c)(l), 46 Fed. Reg. at 4452. The 1982 proposal specifically noted the change from the 1991 approach: Container labels are limited to a hazard warning [e.g., flammable] and a chemical identifier. Their primary purpose is to alert users to potential hazards. The identifier on the label would provide the link to the corresponding MSDS which would serve as the sole source of more detailed information in the specific characteristics of the chemical (instead of each container as provided in the January [1981] proposal). 47 Fed. Reg. at 12,110. The 1982 proposal stated that "[s]erious concerns have been raised regarding the excessive costs and paperwork burdens imposed by the January [1981] proposal." Id. at 12,109. The HCS Preamble added: the requirement for an extensive label would ignore proven industry practices. Changes in these practices to comply with a requirement for extensive labeling of containers would involve significant costs with no gains in terms of the effectiveness of the overall hazard communication program. 48 Fed. Reg. at 53,326-27. Thus, OSHA clearly indicated its intention to provide employers flexibility and discretion in determining how to "convey the hazards of the chemicals in the containers." Yet, the enforcement policy on which the Secretary's case is based goes in the opposite direction. As noted above, even the 1981 proposal would not have required target organ warnings for chemicals classified merely as toxic substances, such as those involved here. We conclude, based on the Preamble, that the HCS originally was intended not to create a general requirement, or irrebuttable presumption, that a target organ warning is required on the container label whenever a specific target organ effect is "known." We will defer to the reasonable intent of the Secretary in promulgating the standard, as that intent is authoritatively explained in the standard's Preamble. Phelps Dodge Corp., 11 BNA OSHC 1441,1444,1983-84 CCH OSHD 26,552, pp. 33,920-21 (No. 80-3203,1983), aff'd, 725 F.2d 1237, 1240 (9th Cir. 1984) (where standard is susceptible to different interpretations, "the preamble is the best and most authoritative statement of the Secretary's legislative intent"). *3. Exemptions from HCS labeling requirements* The exemptions from the labeling requirements of the HCS, as explained in the Preamble, are consistent with our conclusion that the Secretary originally did not intend to establish an inflexible rule that container labels, for the kinds of chemicals involved here. include the kinds of target organ warnings sought here. Those exemptions are not consistent with an intent to require target organ warnings whenever a target organ effect is "known," or with an irrebuttable presumption to that effect. From its inception, the HCS has exempted from its labeling requirements -- but not its other requirements -- certain chemicals which are subject to labeling requirements under other Federal laws. § 1200(b)(5). [[9]] We have reviewed the labeling requirements under those other Federal laws. We have found no target organ warning requirements in those labeling provisions that relate to toxic chemical hazards comparable to those for which the Secretary seeks target organ warnings here. [[10]] The HCS Preamble indicates that the Secretary considered the labeling requirements of the other Federal agencies sufficient, regarding those chemicals: In the case of pesticides. the purpose of such labeling [labeling required by EPA] is mainly the protection of workers exposed to the pesticide. In the case of the other substances, the purpose of the labels is more general consumer protection.... OSHA recognizes ... that there may be situations where worker exposure is significantly greater than that of consumers, and that under these circumstances, substances which are safe for contemplated consumer use may pose unique hazards in the workplace. For this reason, the standards exclusion is limited to labeling. 48 Fed. Reg. at 53,289. Thus, the Preamble indicated that even in the potentially more dangerous situation where "worker exposure is significantly greater than that of consumers," OSHA believed that the protective components of the HCS other than container labels (for example, training and the availability of MSDS's) would be adequate to deal with the "unique hazards" to workers. Based on that belief, the labeling requirements of the other Federal agencies, which are generally less stringent than the requirements that the Secretary urges here, would be acceptable. Thus, the exemptions under § 1200(b)(5), as explained in the Preamble are consistent with our conclusion above regarding the Secretary's original intent under the HCS. Those exemptions, as discussed in the Preamble, are inconsistent with the view that the HCS container labeling provision was intended to mandate target organ warnings across the board, for "known" target organ effects. *4. CPL Instruction 2-2.38* The Secretary argues that her current target organ warning policy was properly explained in OSHA Instruction CPL 2-2.38, Inspection Procedures for the Hazard Communication Standard, 29 CFR 1910.1200 (1985) (the "Instruction"). She argues that the interpretation in that Instruction is entitled to deference, and that therefore her current policy must be upheld. The Instruction was originally prepared by the Office of Health Compliance Assistance. It was signed by Acting Assistant Secretary for OSHA Patrick R. Tyson on August 5, 1985, more than 20 months after the HCS was promulgated, and less than four months before the effective date of the requirements at issue here. The Instruction was an internal directive to OSHA's field staff, intended to establish internal OSHA policies and provide clarifications to promote uniform enforcement of the HCS. OSHA did not disseminate the Instruction to the public. The interpretation the Secretary relies on is found in Appendix A to the Instruction. That Appendix notes that the phrase "appropriate hazard warning" is performance-oriented and "allows the use of many different, existing labeling systems." Instruction at A-6. However, it states: The "hazard warning" must convey the hazard of the chemical. This is intended to be specific information regarding the hazard -- the specific hazards indicated in the standard's definitions for "physical" and "health" hazards would be appropriate. Phrases such as "caution," "danger," or "harmful if inhaled," generally do not meet the intent of the standard by themselves. The definition of hazard warning states that the warning must convey the hazard of the chemical. If, when inhaled, the chemical causes lung damage, then that is the appropriate warning. Lung damage is the hazard not inhalation. There are some situations where the specific target organ effect is not known. Where this is the case, the more general warning statement would be permitted. For example, if the only information available is an L^c 50 [11] test result, "harmful if inhaled" may be appropriate. /Id/. at A-7 (footnote and emphasis added). The Supreme Court recently held that the Secretary's interpretations of her regulations in enforcement guidelines such as the Instruction are entitled to some weight: [T]he Secretary regularly employs less formal means [than standards and citations] of interpreting regulations prior to issuing a citation. These include the promulgation of interpretive rules . . . and the publication of agency enforcement guidelines, see United States Department of Labor, OSHA Field Operations Manual ["FOM"] (3d ed. 1989).... Although not entitled to the same deference as norms that derive from the exercise of the Secretary's delegated lawmaking powers, these informal interpretations are still entitled to some weight on judicial review. See Batterton v. Francis, 432 U.S. 416, 425-426, and n.9 (1977); Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944). A reviewing court may certainly consult them to determine whether the Secretary has consistently applied the interpretation embodied in the citation, a factor bearing on the reasonableness of the Secretary's position. M/artin L. OSHRC ICF & I Steel Corp./, 111 S. Ct. 1171, 1179 (1991). Furthermore, the agency's interpretation of the regulation as expressed in the citation may be entitled to great weight: [W]hen embodied in a citation, the Secretary's interpretation assumes a form expressly provided for by Congress. See 29 U.S.C. § 658. Under these circumstances, the Secretary's litigating position before the Commission is as much an exercise of delegated lawmaking powers as is the Secretary's promulgation of a workplace health and safety standard. /Id./ However, whatever the source of the interpretation, it must be reasonable. "[W]e emphasize that the reviewing court should defer to the Secretary only if the Secretary's interpretation is reasonable." Id. at 1180 (emphasis in original). "Varying degrees of deference are accorded to administrative interpretations. based on such factors as the timing and consistency of the agency's position, and the nature of its expertise." Batterton, 432 U.S. at 425. The Court sometimes has "declined to follow administrative guidelines in the past where they conflicted with earlier pronouncements of the agency." General Electric Co. v. Gilbert, 429 U.S. 125, 143 (1976), and cases cited therein. Cf, e.g., Gardebring v Jenkins, 485 U.S. 415, 429-30 (1988) (agency's unpublished interpretation of its regulation upheld, where there was no claim that it was inconsistent with the governing statute or with the agency's intent when the regulation was promulgated). The Secretary's current enforcement position, which she claims that she stated in the Instruction, represents a departure from the original interpretation of the cited standard in the HCS Preamble. [[12]] As discussed above, the HCS originally was not intended to require, across the board, the kinds of target organ warnings sought here, whereas the Instruction suggests that they generally would be required. An administrative agency is free to chance its policies pursuant to existing requirements, so long as the change in policy is adequately explained. However, [A]n agency changing its course must supply a reasoned analysis indicating that prior policies and standards are being deliberately changed, not casually ignored, and if an agency glosses over or swerves from prior precedents without discussion it may cross the line from the tolerably terse to the intolerably mute. Greater Boston Television Corp. v. FCC, 444 F.2d 841. 852 (D.C. Cir. 1970), cert. denied, 403 U.S. 923 (1971) (citations omitted), (quoted in Ohio Fast Freight Inc. v. United States, 574 F.2d 316, 319 (6th Cir. 1978)), and Mazza v. Secretary, Dept of HHS, 903 F.2d 953, 959 (3d Cir. 1990) (courts do not accept revision in administrative interpretation when it flatly contradicts agency's previous position, stated closer to enactment of governing statute). See Motor Vehicle Mfrs. Ass'n of United States, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S 29, 43 (1983), cited in CF & I Steel Corp., 111 S. Ct at 1180. The Instruction states that the intent of the standard is that phrases such as "Harmful it inhaled" on container labels are inadequate to describe "known" [[13]] target organ effects. because such phrases do not "convey the hazard" in that situation. However, the original intent of the standard, discussed above, was to allow employers to select any effective language on labels to convey the hazards, including language based on "proven industry practices." 48 Fed. Reg. at 53,326-27, 53,336. Thus, contrary to the enforcement policy, a general warning such as "'harmful if inhaled" would be appropriate under the original intent, even as to a "known" target organ effect, if the warning had proven effective within the industry. Because the Secretary misconstrues the original intent of the HCS, we conclude that OSHA did not properly consider that original intent in formulating its current target organ warning policy. In the words of the Greater Boston court, quoted above, the Secretary does not "supply a reasoned analysis indicating that prior policies ... are being deliberately changed rather than casually ignored." Thus, the enforcement policy does not merit the deference that we have it the that we have accorded to the previous, authoritative interpretation of labeling requirements which the Secretary trade in the HCS Preamble. Beyond the lack of adequate explanation for the Secretary's departure from prior policy, there is a more fundamental problem with the Secretary's position. She essentially seeks, by interpretation, to change the broad performance standard, "appropriate hazard warnings," into a narrow specification standard that would require a target organ warning for each "known" target organ effect. She relies on her current enforcement position as if it created an irrebuttable presumption that a target organ warning is required on the container label whenever a specific target organ effect is "known." "An agency's interpretation of a regulation is valid, however, only if that interpretation complies with the actual language of the regulation." Fluor Constructors, Inc v. OSHRC, 861 F.2d 936, 942 (6th Cir. 1988). [[14]] See, e.g., Bonessa v. United States Steel Corp., 884 F.2.d 726, 732 (3d Cir. 1989), and cases cited therein (agency may not rewrite regulations through interpretation). "Appropriate hazard warnings," as used in the HCS, is a broad performance criterion. It clearly calls for a factual, case-by-case determination of the effectiveness of the hazard warning. As discussed above, the other provisions of the HCS do not put the employer on fair notice that it must state all "known" target organ effects on container labels, in addition to stating them in its MSDS's. Any doubts about whether the term "appropriate hazard warnings" was intended to be a broad performance standard are resolved by the Preamble. If the Secretary's current interpretation were given deference it would have binding effect and the standard would be substantively amended, because Cyanamid would have no opportunity to show factually that its hazard warnings were "appropriate." A substantive amendment of a standard is ineffective unless preceded by new rulemaking. Administrative Procedure Act ("APA"), section 4, 5 U.S.C. § 553. See, e.g., Chrysler Corp v. Brown, 441 U.S. 281. 301-03, 315-16 (1979) (substantive agency rules must conform to procedural requirements imposed by Congress, Including applicable notice and comment procedures of APA). Thus, we cannot adopt the Secretary's current Interpretation. The Secretary's current enforcement position is not entitled to Judicial deference, just as a general statement of agency policy would not be. The Secretary's opinion as to what are "appropriate hazard warnings" does not eliminate her burden of proving, by a preponderance of the evidence at the hearing, that the employer's hazard warnings in fact are not appropriate. See, e.g., Limerick Ecology Action v. NRC, 869 F.2d 719, 733-36 (3d Cir. 1989) (when agency applies general statement of policy to specific case, it must support policy "just as it the policy statement had never been issued"). Thus, we hold that the Secretary is not authorized, through the Instruction or otherwise, to enforce her interpretation as controlling, or as if it created an irrebuttable presumption that target organ warnings are required on container labels for all "known" target organ effects.[[15]] *5. The Secretary's evidence at the hearing* The evidence does not show that target organ warnings were necessary to create appropriate hazard warnings" in this case. The Secretary's only witness was the CO, who had no background in product labeling or hazard warnings. He did not testify as to why the target organ warnings sought here are required on container labels to warn employees effectively. He merely applied the Secretary's current enforcement policy. Thus, we find that the Secretary failed to prove by a preponderance of the evidence, as required, that the container labels did not have "appropriate hazard warnings." We also hold that, in any event, the Secretary's departure from the original HCS policy on container labeling is unenforceable because it was not adequately explained at the hearing. [[16]] The CO acknowledged that the determination as to which hazards, listed on the MSDS are important enough to list on the container label is a matter of judgment, and that normally the people who make those judgments are toxicologists. However, the CO was not a toxicologist. Marvin A. Friedman, Ph.D., a very experienced toxicologist and Cyanamid's Director of Toxicology and Product Safety, testified as to why Cyanamid does not include all the target organ warnings on labels that it states on its MSDS's: if we have [to] go through [every] substance which is in every product and put a [target organ] label warning on that substance, we are going to have long labels that are virtually illegible. And, it's just going to take enormous amounts of time that really result in a negative impact on what we think employee health will be. [Also], I'm going to have to develop new label wording which is unique to the industry because the industry just doesn't do this. It's not practiced. Cyanamid's manager of hazard communication, Linda Hanavan, testified that the basic philosophy of the chemical industry toward labeling is "that a label should be as brief as possible and understandable as possible." She also testified that "we attempt to reduce the language [so] that someone with less than a high school education could possibly understand." She testified that Cyanamid uses the ANSI standard as the basis for labeling industrial chemicals. Ms. Hanavan holds a B.A. in chemistry and, at the time of the hearing, had 11 years of experience in chemical labeling. She was on the Board of Directors of the American Conference of Chemical Labeling. Many of the warnings that the Secretary has endorsed in this case were specifically criticized by Ms. Hanavan. The CO testified that OSHA would accept on the labels the statements of affected organs in Cyanamid's MSDS's. Typical of the statements regarding central nervous system ("CNS") effects and silica hazards are those on Cyanamid's MSDS, for Fibercore: Prolonged inhalation of vinyl toluene or styrene vapors can cause depression of the central nervous system including headache, dizziness and drowsiness. While this product contains inorganic materials such as silicates which may cause lung fibrosis after chronic overexposure, these components are not likely to be released from this product. Typical of the other relevant statements is that in Cyanamid's MSDS for XC-4001 resin: Direct contact with the liquid may cause mild skin and moderate eye irritation. Overexposure to butanol and propylene glycol methyl ether may cause eye and respiratory tract irritation, headache, dizziness or nausea. Ms. Hanavan gave the opinion that the statement, "Warning! Causes central nervous system depression," is less effective than "Harmful if inhaled," because the average worker would not comprehend the former phrase unless it were explained. As to the suggestion that a list of specific CNS effects be given, she testified that she doubted that a full list would be as effective as "Harmful if inhaled," because a worker would "not have a tendency to read through all that." (Potential CNS effects include lightheadedness, nausea, fatigue, depression, dizziness ataxia, and headache.) Ms. Hanavan also testified that listing only a single CNS symptom, such as "Warning! May cause dizziness," would not be quite accurate, because it would describe only one of many things that could occur. Cf. supra note 12. Based on the discussion above, we find that the Secretary has faded to show by a preponderance of the evidence, as required, that the hazard warnings put on the labels of Cyglas, Glaskyd, XC-4001 resin and XC-4005 resin were not "appropriate hazard in any even warnings." [[17]] We further hold that,in any event, she has not adequately explained her departure from the original intent of the HCS labeling provision in this case. *6. The General Carbon decision* The Secretary notes a case in which the D.C. Circuit rejected a challenge to the requirement in the Secretary's citation that a chemical manufacturer include certain target organ warnings on its container labels. General Carbon Co., Div. of St. Mary's Carbon Co. v. OSHRC, 860 F.2d 479 (D.C. Cir. 1988). However, the court did not rule on the merits of the issue. The basis for the court's action was that General Carbon had not raised that challenge before this Commission, and thus had failed to exhaust its administrative remedies. Id at 486. It also noted that OSHA had "demonstrated some willingness to negotiate over the content of the required label." /Id/. The Secretary relies on the court's comments relevant to the extent of warnings required on labels: [T]he MSDS is intended to set forth more detailed information than are the labels. The standards contain no suggestion, though, that a health hazard which is required to be reported on the MSDS can be omitted entirely from the labels. In fact, given the label's function in alerting employees to the more detailed information contained in the MSDS, it would make little sense to insist that a particular chemical be identified in the MSDS while imposing no corresponding labeling requirement. /Id/ at 484-85. Assuming arguendo that no health hazard may be "omitted entirely" from the labels, that does not negate the broad discretion left to the employer by the standard, regarding, how to best "convey the hazards." As discussed above, the record indicates that effective hazard labeling involves a good deal of judgment. and that label warnings must be sufficiently clear to employees who have limited formal education. For example, in the HCS Preamble, OSHA specifically rejected an extensive label warning requirement because of the "potential for information overload" with such labels. 48 Fed. Reg. at 53,326; See id. at 53,301. Thus, General Carbon does not hold that target organ effects generally must be described on container labels under the HCS. We also note that General Carbon did not address the effect of the HCS Preamble on the reasonableness of the Secretary's current target organ warning policy under the cited standard. Nor did Durez, in which the court upheld the requirement of target organ information in MSDS's. 906 F.2d at 2-4. We wish to emphasize that we are not addressing whether a standard that expressly required employers to specifically describe all "known" target organ effects on container labels would be reasonable. We merely hold that the cited standard does not impose that requirement but rather requires a case-by-case, factual analysis of whether the employer's label warnings are "appropriate" in the circumstances. We further hold that the Secretary's interpretation of the standard to impose a universal target organ warning requirement is unenforceable in this case in any event, because it departs from the original interpretation in the HCS Preamble, and the Secretary does not adequately explain why the interpretation is being changed. *B. Other Alleged Deficiencies in Cyanamid's Label Warnings* At oral argument, the Secretary asserted that statements on Cyanamid's labels such as "'Harmful if inhaled" to describe the toxic substances at issue are ineffective under any test. The evidence presented at the hearing does not establish that proposition, however, for the reasons given above. The Instruction states that phrases such as "harmful if inhaled" do not meet the intent of the standard by themselves where a target organ effect is "known." However, as discussed above, the Secretary may not establish that the employer's warnings were inappropriate simply by citing its Instruction. We have no basis on this record for concluding that Cyanamid's hazard warnings on the container labels of Cyglas, Glaskyd, XC-4001 or XC-4005 were not "appropriate hazard warnings" at the time. [[18]] *C. Lack of Warning Labels on the Fibercore Containers* Cyanamid's label on Fibercore containers contained no hazard warning at the time of the inspection. The hazardous substances in Fibercore that are at issue are styrene and vinyl toluene. There is no dispute that those substances are hazardous chemicals under § 1200(d)(3), see supra note 2, and thus are subject to the standard's requirements. It also is undisputed that Cyanamid did not comply with the terms of the cited provision, and that it knew. or with the exercise of reasonable diligence could have known, of the lack of hazard warnings. Cyanamid's counsel claimed at oral argument that the way the case has been tried, the only basis on which the Secretary has pursued a violation with respect to the Fibercore labels is the lack of target organ warnings. We reject Cyanamid's claim. Item 1(b) of the Secretary's citation referenced Fibercore in alleging a lack of appropriate hazard warnings, and did not restrict the allegation to the target organ warning issue. [[19]] Cyanamid adduced evidence that the Fibercore label had no warnings at the time of the inspection. The judge understood that that issue was before him. The record does not show that the Secretary has abandoned the issue. Cyanamid does not contest the sufficiency of the evidence that employees potentially would be exposed to the styrene and vinyl toluene in Fibercore. Nonetheless, the parties have extensively addressed the question of whether the Secretary bears a burden, under the cited standard, of proving that employees would be potentially or actually exposed to the hazardous chemicals involved. The basic issue is whether the Secretary must show that employees in "downstream" workplaces (that is, workplaces to which the chemicals are shipped) would be exposed to the hazards. The burden of proof Issue is an important one that affects chemical manufacturers, importers and distributors under the HCS generally. Thus, we will address it. Cyanamid argues that the Secretary bears the burden of establishing, by [a] preponderance of the evidence, that a hazardous chemical is present in such a manner that employees may be exposed to it under normal conditions of use or in a foreseeable emergency." The Secretary argues that under the cited standard, she has no burden of proving exposure once she establishes that "hazardous chemicals" are leaving the chemical manufacturer's workplace. She argues that "the Standard presumes a risk....Once the chemicals have been found to be per se hazardous [by being listed in the source documents named in § 1200(d)(3)], the Standard presumes they will be released downstream." As discussed above, the Secretary's interpretation of her own regulation is entitled to deference where reasonable. CF & I Steel Corp., 111 S.Ct. at 1176 ("In situations in which 'the meaning of [regulatory] language is not free from doubt,' the reviewing court should give effect to the agency's interpretation so long as it is 'reasonable,' Ehlert v. United States, 402 U.S. 99, 105 (1971).....") A number of provisions of the HCS are directly relevant to whether the Secretary's interpretation of the burden of proof as to employee exposure under the cited standard is reasonable. The scope provision of the HCS states: This section applies to any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency. § 1910.1200(b)(2). "Exposure" under the HCS is defined as follows: "Exposure" or "exposed" means that an employee is subjected to a hazardous chemical in the course of employment through any route of entry (inhalation ingestion, skin contact or absorption, etc.), and includes potential (e.g. accidental or possible) exposure. § 1200(c). "Foreseeable emergency" is defined as follows: any potential occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical into the workplace. /Id./ The United States Court of Appeals for the D. C. Circuit agreed with the Secretary's interpretation of the burden of proof of exposure, in General Carbon. 860 F.2d at 482-83. The court stated: The agency's reading of the HCS, however, is supported both by the plain language of the standard and by the Preamble issued at the time of promulgation. The Secretary's interpretation of the standard is in our view not merely reasonable, but is the only plausible reading of the rule. /Id/. at 483. There is a compelling reason for not requiring the Secretary to affirmatively prove downstream employee exposure under § 1200(f)(l), once she shows that the chemicals involved are hazardous chemicals within the meaning of the HCS. Cases under that provision present much greater difficulties of proof for the Secretary, regarding employee exposure, than most OSHA citation cases. In most OSHA inspections, the employees who are exposed to a hazard are on the inspected worksite. Thus, the general rule is that the Secretary bears the burden of proof of employee access to the hazards: that is, that the employee was, or predictably would be, in the "zone of danger." E.g., Wyman Gordon Co., 15 BNA OSHC 1433, 1449, 1992 CCH OSHD 29,550, p. 39,940 (No. 84-785, 1991). By contrast, in cases under the cited standard, the Secretary will inspect a chemical manufacturing plant (or an importer's or distributor's facility) from which chemicals are shipped downstream to a variety of workplaces. The inspected facility may be far removed from the workplaces where employees are actually or potentially exposed to the hazards of the chemicals shipped. Thus, the Secretary in many cases will be unable to determine whether those downstream employees will be exposed to the hazards, without extensively investigating those distant workplaces. As a result, it would be unduly burdensome on the Secretary if she were required to prove downstream employee exposure in cases under the cited standard. We also note that the Secretary's position that she bears no such burden under that standard is consistent with general principles governing burdens of proof. A standard treatise on the law of evidence summarizes the major considerations: [T]he apportionment of the burdens of proof ... either initially or ultimately, will depend upon the weight that is given to any one or more of several factors, including: (1) the natural tendency to place the burdens on the party desiring change, (2) special policy considerations such as those disfavoring certain defenses, (3) convenience, (4) fairness, and (5) the judicial estimate of the probabilities. McCormick on Evidence § 337 at 952 (3d ed. 1984) ("McCormick") (citation omitted). Here, the Secretary's position is supported by the special policy considerations underlying the HCS, as well as by convenience, fairness, and the probabilities of the situation. The overall policy of the HCS is to protect employees by giving them Information about the "hazards of all chemicals produced or imported." § 1200(a)(l) (emphasis added). The HCS Preamble indicates that speculation about whether downstream employees would be exposed is inappropriate: [J]ust as a chemical manufacturer cannot make specific control measure recommendations for unknown downstream uses, it also cannot accurately predict the hazard presented by the chemical downstream. Therefore, the chemical manufacturer must provide thorough hazard information, which would be applicable to a full range of reasonably foreseeable exposure situations, rather than limiting the information on the basis of presumed use. The downstream employer will then be assured of having the information reasonably necessary to make informed choices for control measures. 48 Fed. Reg. at 53,307 [[20]] Thus, it would be inconsistent with the overall policy of the HCS to deny enforcement to a citation merely on the basis that the Secretary did not have an accurate prediction of the employee exposure downstream. A defense based on speculation or presumption that there would be no such exposure is disfavored under the HCS. As to convenience and fairness, we have found above that it would be unfair and inconvenient in cases under the cited standard to require the Secretary to investigate the details of each product's use to determine exposure. That is particularly true, considering that the party cited, who relies on lack of exposure, predictably will have far better access to evidence on the issue of employee exposure. In fact, A doctrine often repeated by the courts is that where the facts with regard to an issue lie peculiarly in the knowledge of a party, that party has the burden of proving the issue. /McCormick/. § 337 at 950. Thus, considerations of convenience and fairness support the Secretary's interpretation of the burden of proof under the cited standard. Finally, as to the probabilities of the situation, the more probable assumption is that employees are potentially exposed to the hazardous chemicals with which they work. Although employee exposure to hazardous chemicals shipped to downstream employers may be presumed, under the cited standard, this does not mean that the presumption is irrebuttable. We note that the HCS provides an explicit exemption for "articles," that is, manufactured items that are formed to a specific shape or design during manufacture, that have end use function(s) dependent on that shape or design, and that do not result in exposure to a hazardous chemical under normal conditions of use. § 1200(c). Thus, we find that the Secretary's interpretation of the burden of proof of exposure under § 1200(f)(l) is reasonable, and we defer to it, for the reasons stated in General Carbon, and for the further reasons discussed above. Under § 1200(f)(I) the Secretary need not prove that employees will be potentially or actually exposed to the chemical hazards, once she shows that the chemicals leaving the "upstream" workplace are hazardous under 1200(d)(3). Neither the Act nor the Commission's Rules of Procedure require placing the burden of proof on the Secretary here. [[21]] For the reasons discussed above, all the necessary elements of a violation have been established as to Fibercore. To summarize, styrene and vinyl toluene, which are components of Fibercore, are hazardous chemicals under the HCS. Cyanamid had no hazard warning on the Fibercore containers at the time of the inspection. as required. Also, it had the requisite knowledge of the violative conditions. Thus, we affirm a violation of § 1910.1200(f)(l)(ii) as to Fibercore [[22]]. *ITEM 2(c): STATEMENTS OF THRESHOLD LIMIT VALUES ON CERTAIN MSDS's * The chemicals involved here are propylene glycol methyl ether, styrene and vinyl toluene, which are contained in one or more of Cyanamid's products at Issue. [[23]] The judge found that Cyanamid had violated the cited standard § 1910.1200(g)(2)(vi), because it failed to include the applicable short-term exposure limits ("STEL's") of the American Conference of Governmental Industrial Hygienists ("ACGIH") in its material safety data sheets ("MSDS's") for the chemicals at issues here. The standard provides: (g) Material safety data sheets. (1) Chemical manufacturers and importers shall obtain or develop a material safety data sheet for each hazardous chemical they produce or import. Employers shall have a material safety data sheet for each hazardous chemical which they use. (2) Each material safety data sheet shall be in English and shall contain at least the following information: (vi) The OSHA permissible exposure limit, ACGIH Threshold Limit Value, and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the material safety data sheet, where available[.] (Emphasis added). The company argues that the judge erred because the cited standard does not require listing the STEL. We disagree with this argument. The standard requires that employers have an MSDS for each hazardous chemical they use, and that it list the "ACGIH Threshold Limit Value (TLV)" for exposure to the chemical, and other exposure limits. A source for determining the "ACGIH Threshold Limit Value (TLV)" is referenced in § 1910.1200(d)(3)(ii) (supra note 2). That source is the ACGIH Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment. That document is part of the ACGIH publication, Threshold Limit Values and Biological Exposure Indices for 1985-86, which was introduced into evidence by the Secretary. It defines the term "Threshold Limit Values" to include the STEL and ceiling limits as well as the 8-hour Time Weighted Average, ("TWA").[[24]] The document lists STEL's for each of the chemicals involved here. [[25]] Cyanamid's MSDS's for the products at Issue did not list a STEL for any of those chemicals. Cyanamid argues that the CO's testimony supports it position that the STEL is not properly considered as part of the ACGIH TLV. It quotes the following passage: A common understanding of what a TLV or threshold limit value is [would be] an eight hour time weighted average. Isn't that right? A A time weighted average is sometimes eight hours, yes, sir. Q And in Industrial Hygiene parlance, it's different than a short-term exposure limit, isn't it? A Yes, sir; as commonly discussed, yes, sir. The CO's testimony dotes not actually support Cyanamid's, claim, because he agreed only that the "time weighted average is sometimes eight hours," not that the TLV is restricted to an eight-hour period. Moreover, he testified that the actual definition of "threshold limit value is "essentially what this document [the ACGIH document discussed above] indicates." He also testified that the STEL is "a different kind of threshold limit value" from an 8-hour TWA. In any event, the ACGIH definition, expressly incorporated in the HCS by 1200(d)(3), clarifies any ambiguity that might exist about whether "threshold limit value" includes the STEL. A reading of that document, which is required to assure compliance with the HCS, would have revealed to Cyanamid the actual meaning of "ACGIH Threshold Limit Value." Thus, Cyanamid failed to comply with the terms of the standard, and knew or reasonably could have known of the noncompliance. The requisite showing was made of potential employee exposure to propylene glycol methyl ether, styrene and vinyl toluene, for the reasons discussed above regarding Item 1(c). We therefore affirm Item 2(c). *PENALTIES* No penalties were proposed by the Secretary for the alleged violations and none will be assessed. The HCS had just gone into effect when the inspection occurred. As discussed above, the major issues in dispute in this case are difficult legal issues that had not been addressed previously. The Secretary presented no evidence in support of a penalty assessment. See 29 U.S.C. § 666(j). Accordingly, Item 1(b) is affirmed as to the Fibercore container labels, and vacated as to the other four products at issue. Item 2(c) is affirmed. No penalties are assessed. Edwin G. Foulke, Jr. Chairman Donald G. Wiseman Commissioner Velma Montoya Commissioner Dated: February 7, 1992 ------------------------------------------------------------------------ SECRETARY OF LABOR Complainant, v. AMERICAN CYANAMID COMPANY, Respondent. OSHRC Docket No. 86-681 APPEARANCES: Bruce C. Heslop, Esquire, Office of the Solicitor, U. S. Department of Labor, Cleveland, Ohio, on behalf of complainant Kenneth B. Stark, Esquire, Cleveland, Ohio, on behalf of respondent *DECISION AND ORDER* SALYERS, Judge: Respondent, American Cyanamid Company, is a chemical manufacturer headquartered in Wayne, New Jersey. It has a plant facility located in Perrysburg, Ohio, where it produces resins and molding compounds for sale and distribution to customers engaged in the plastics industry. On December 6, 1985, Compliance Officer Ralph Mericle conducted an inspection of respondent's Perrysburg plant to determine if respondent was complying with the Hazard Communication Standard (29 C.F.R. § 1910.1200) of the Occupational Safety and Health Act (29 U.S.C. § 651, et seq.), which standard became effective With regard to chemical manufacturers on November 25, 1985. As a result of this inspection, the Secretary of Labor cited respondent for alleged violations of the HCS, and the citation was duly contested with respect to certain items. [[1/]] At the hearing the parties announced the only matters remaining at issue were item 1b of the citation and item 2c insofar as it relates to listing short-term exposure limits (STEL) on the material safety data sheets prepared for certain products (Tr. 5- 6). The parties also stipulated at the set of the hearing that the respondent is a "chemical manufacturer as contemplated by the HCS and that the involved products of respondent were intended for "out of plant shipment" (Tr. 7). The issues to be decided are as follows: 1. Did respondent violate 29 C.F.R. § 1910.1200(f)(l)(ii) by its failure to ensure that containers of XC-4005 resin, glaskyd, XC-4001 resin, cyglas and fibercore were labeled, tagged or marked with appropriate hazard warnings prior to shipment to "downstream" employers. 2. Did respondent violate 29 C.F.R. § 1910.1200(g)(2)(vi) by its failure to list on its material safety data sheets (MSDS) developed for fibercore, XC-4001 resin and cyglas, the applicable ACGIH STEL for certain hazardous chemical components contained in these substances. I. The HCS was developed by the Secretary over a period of years beginning in 1974 with the appointment of a Standards Advisory Committee on Hazardous Materials Labeling to study the need for such regulations and to recommend guidelines for categorizing and ranking chemical hazards. Following receipt of the committee's report and recommendations received from the National Institute for Occupational Safety and Health (NIOSH), the Secretary published an advance notice of proposed rulemaking on chemical labeling in the Federal Register (42 Fed. Reg. 5,372) requesting comments and suggestions from the public and input was received from a variety of government agencies, trade associations, businesses and labor organizations. On March 19, 1982, the Secretary published his final notice of rulemaking proceedings (47 Fed. Reg. 12,092) which established a 60-day period for submission of written comments and notices of intent to appear at public hearings. The foregoing culminated in the issuance of the HCS (29 C.F.R. § 1910.1200) which was published in the Federal Register on November 25, 1985. 48 Fed. Reg. 53,280. The HCS is designed: [T]o ensure that the hazards of all chemicals produced or imported by chemical manufacturers, or importers are evaluated, and that information concerning their hazards is transmitted to affected employers and employees within the manufacturing sector. This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training. § 1910.1200(a)(l) The standard is unique in its requirement for "downstream" disclosure of information regarding hazardous chemicals from chemical manufacturers and importers to employer-purchasers of such products. See § 1910.1200(b)(l). The full and accurate downstream flow of information regarding hazardous chemicals is essential to complete implementation of the standard's requirements by manufacturing sector employers who purchase such products. See generally § 1910.1200(d)(l), § 1910.1200(a) and § 1910.1200(h). To initiate this downstream flow of information, the standard requires chemical manufacturers, such as respondent, to evaluate chemical substances produced in their workplace to determine if they are hazardous, see § 1910.1200(b)(l) and (d), to ensure that each container of hazardous chemicals leaving its workplace is appropriately labeled, tagged or marked, see § 1910.1200(f), and to develop a material safety data sheet for each hazardous chemical they produce, see § 1910.1200(g). The standard imposes an obligation on manufacturers shipping chemicals to downstream employers as follows: (1) The chemical manufacturer, importer or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked with the following information: (i) Identity of the hazardous chemical(s); (ii) Appropriate hazard warnings; and, (iii) Name and address of the chemical manufacturer, importer, or other responsible party. § 1910.1200(f)(l) The standard further provides at § 1910.1200(d)(3): The chemical manufacturer, importer or employer evaluating chemicals shall treat the following sources as establishing that the chemicals listed in them are hazardous: (i) 29 CFR Part 1910, Subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration (OSHA); or, (ii) Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment, American Conference of Government Industrial Hygienists (ACGIH). (Latest Edition) During the course of his inspection, Compliance Officer Mericle examined the labels and corresponding MSDS for each of the products enumerated in the contested citation, ie., XC-4005 resin, glaskyd, XC-4001 resin, cyglas and fibercore (Exs. C-1 thru C-5). First, he determined the presence of hazardous ingredients in each substance by referring to the appropriate section of the respondent's MSDS. The substance listed as hazardous included butanol, vinyl toluene, styrene, amorphous silica, and talc. Mericle verified that each of these substances was identified as hazardous in Table Z-1 of 29 C.F.R. § 1910.1000 (Ex. C-7) and in the Threshold Limit Values prepared by the American Conference of Governmental Industrial Hygienists (Ex. C-8). He noted that respondent's label for fibercore (Ex. C-3) listed no hazard warning. The labels for the remaining substances gave the general warning, "harmful if inhaled," "causes eye irritation," may cause skin irritation," "avoid breathing dust," etc., but did not warn of possible target organ effects if exposed to the hazardous chemical (Exs. C-1 thru C-5). Mericle then consulted the target organ effects section of the standard (Appendix A, para. 7) and the NIOSH/OSHA Guidelines for Chemical Hazards [[2/]] (Exs. C-9 thru C-13) to identify the target organ effects of each hazardous chemical. Based upon his review of respondent labels and the foregoing technical sources, he determined that respondent had not complied with the standard's requirement to provide "appropriate hazard warnings" since the labels in question did not specify target organ effects. In reaching this conclusion, Mericle relied upon OSHA Compliance Directive CPL 2-2.38 dated August 5, 1985 (Ex. C-6). which was in effect at the time of his inspection and on the date the citation was issued. In particular, he referred to Appendix A of this directive, pages A-6 and A- 7 (Tr. 37) which reads, in pertinent part, as follows: The "hazard warning" must convey the hazard of the chemical. This is intended to be specific information regarding the hazard - the specific hazards Indicated in the standard's definitions for "physical" and "health" hazards would be appropriate. Phrases such as "caution." "danger," or "harmful if inhaled," generally do not most the intent of the standard by themselves. The definition of "hazard warning" a states that the warning must convey the hazard of the chemical. If, when inhaled, the chemical causes lung damage, then that is the appropriate warning. Lung damage, then that is the appropriate warning. Lung damage is the hazard, not inhalation. There are some situations where the specific target organ effect is not known. Where this is the case, the more general warning statement would be permitted. For example, if the only information available is an L950 test result, "harmful if inhaled" may be appropriate. The crucial question in this case is centered on whether the labels used by respondent in connection with the substances cited by the Secretary were marked with "appropriate hazard warnings" as contemplated by the standard. The Secretary takes the position that the labels utilized by respondent were inadequate since they did not identify the target organ effects of exposure to the hazardous chemicals contained in the cited substances. Respondent maintains its labels were appropriate, that the label need not convey comprehensive information concerning potential hazards, and that target organ effects are more appropriately relegated to the material safety data sheets. The Review Commission has not yet considered or ruled on the question presented in this case. However, two Administrative Law Judges in three separate cases have thus far decided the issue in the Secretary's favor. Secretary v. Hilton-Davis Chemical Co., (Burroughs), 13 OSHC 1182 (No. 86-494, 1987); Secretary v. Monsanto Company (Burroughs), No. 86-391; Secretary v. Emery Chemicals (Sparks), No. 86-457. The Secretary must establish at the outset that the chemicals involved are "health hazards" as this term is defined in § 1910.1200(c). [[3/]] In this case, this requirement has been satisfied since each of the chemicals contained in respondent's products is specifically listed in the source documents prescribed by § 1910.1200(d)(3). Under these circumstances, the Secretary has made out a prima facie case since chemicals so listed are per se hazardous under the standard. Hilton-Davis Co., supra, at pages 3-4. Respondent does not dispute the hazardous characterization with respect to styrene, vinyl toluene and butanol and agrees that "these chemicals are sufficiently hazardous to warrant a label warning" [[4/]] (Respondent's Brief, pg. 41). Respondent does not concede, however, that amorphous silica and talc are hazardous based upon the testimony of its toxicologist, Dr. Marvin A. Friedman, who testified toxicological studies do not confirm the hazardous nature of these substances (Tr. 176-177). Dr. Friedman gave no specifics to support this generalized conclusion. On cross-examination Dr. Friedman admitted each of the involved substances are mixtures and that respondent has made no independent studies of these mixtures to determine the hazards of the mixture as a whole (Tr. 229-230). The standard does not require a manufacturer to conduct independent studies of mixtures but § 1910.1200 (d)(5)(ii) provides: (ii) If a mixture has not been tested as a whole to determine whether the mixture is a health hazard, the mixture shall be assumed to present the saw health hazards as do the components which comprise one percent (by weight or volume) or greater of the mixture . . . . The MSDS for glaskyd and cyglas (Exs. C-4, C-S) reflect the presence of amorphous silica and talc in excess of one percent. In the absence of independent studies to rebut the presumption of the standard, these mixtures must be considered to present the same hazards as its components. Respondent argues that the history of the HCS reveals it is the MSDS and not the label where the Secretary reposed the requirement for detailing target organ effects (Respondent's Brief. pgs. 4-12, 33-34). It avers that the interpretation urged by the Secretary in this case is contrary to prevailing industry practices (Id., pgs. 28-29) and is inconsistent with requirements contained in substance-specific OSHA standards for other hazardous substances (Id., pgs. 12, 36-38). It urges that the Secretary's interpretation would lead to label "overload" and is counterproductive to the standard's purpose (Id., pgs. 20-22). While these arguments are well presented and have been considered, the pervading question in this case is whether the Secretary's interpretation that labels must reflect target organ effects is in accord with the purpose and scheme of the HCS and is reasonable. This issue was specifically and definitively addressed in Hilton-Davis Co., supra, as follows: In determining the proper interpretation of the "appropriate hazard warning(s)" requirement, one must look primarily to the language of the standard. Bunge Corporation, 12 BNA OSHC 1785, 1986 CCH OSHD 27,565 (Nos. 77-1622, 78-838, 78-2213, 1986). Any one particular provision of a standard "should be interpreted in the context of the entire standard." Bunge Corporation, supra, 12 BNA at 1790. In reaching the proper interpretation, "OSHA standards must be interpreted in accordance with the natural and plain meaning of their words; they cannot be construed to mean what the agency may have intended but did not adequately express." Bunge Corporation, Supra, 12 BNA OSHC at 1791. Since the provision of the HCS cited, § 1910.1200(f)(l)(ii), makes no reference to target organs, it must be interpreted in the context of the whole standard. The definition of "hazard warning" makes it clear that the hazards of the chemical are to be conveyed on the container label. The definition of "health hazard" incIudes the reference to Appendix A which provides further definitions and explanations of the scope of the health hazards covered. The first paragraph of Appendix A makes it clear that employees exposed to health hazards must be apprised of both the change in the body function and the signs and symptoms that may occur to signal the change. The paragraph is as follows: Although safety hazards related to the Physical characteristics of a chemical can be objectively defined in terms of testing requirements (e.g. flammability), health hazard definitions are less precise and more subjective. Health hazards may cause measurable changes in the body--such as decreased pulmonary function. These changes are generally indicated by the occurrence of signs and symptoms in the exposed employees--such as shortness of breath, a nonmeasurable, subjective feeling. Employees exposed to such hazards must be apprised of change in body function and the signs and both the change in body function and the signs that may occur to signal that change. (Underlining added) Appendix A includes a target organ categorization of health effects that may occur. Examples of signs and symptoms of exposure, as well as indications of substances which have been found to affect the target organs, are set forth at the end of Appendix A. The reference to the change in body function and to target organ effects in Appendix A makes it clear that "appropriate hazard warnings" for any given hazardous substance are those that warn about potential danger of significant risk. Appendix A, in referring to target organ effects, states: ***These examples are presented to illustrate the range and diversity of effects and hazards found in the workplace, and the broad scope employers must consider in this area. (Underlining added) The change in body function caused by the hazards of the chemical is required by Appendix A to be included on the label. The change in body function is, in essence, a requirement to include target organ effects. In interpreting a standard, it is proper to look to the preamble for the administrative construction of the standard. Udall v. Tallman, 380 U.S. 1, 17, 85 S. Ct. 792 (1965); Fidelity Federal Savings & Loan Assn. v. De La Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). The preamble accompanying and explaining the standard in this case supports the target organ interpretation. In commenting on the definition of "health hazard," the preamble states as follows (48 Fed. Reg. 53,295): The definition for "health hazard" has been modified somewhat by including in it the target organ classification of hazards that are proposed in Appendix A. This should clarify the required scope of hazards to be evaluated. The preamble makes the following further comment under the hazard determination provision of § 1910.1200(d) (48 Fed. Reg. 53,296): The term "health hazard" was defined very broadly in the proposal as a "chemical which; upon exposure, may result in the occurrence of acute or chronic health effects in employees." This.definition was further expanded upon Appendix A, which included a discussion of the difficulty of defining health hazards, and a categorization of health effects according to target organ. Included in the categorization were examples of both the signs and symptoms of overexposure and some specific substance which may affect those target organs. (Underlining added) The "hazard warning" must convey the hazard of the chemical. Appendix A of the standard makes it clear that employees must be apprised of the change in body function and the signs and symptoms that may occur to signal that change. When § 1910.1200(f)(l)(ii) is read in conjunction with the definitions of *hazard warning" and "health hazard," set forth at § 1910.1200(d), it is clear that the intent of the labeling requirement goes far beyond the HMIS numerical rating system used by Hilton-Davis. The conclusion that target organ effects must be included on the label is a reasonable interpretation of the "appropriate hazard warning" requirement. This interpretation is consistent with the underlying goal of the standard. Id., pgs. 10-13. The Secretary's conclusion that target organ effects must be included on labels in connection with the shipping of hazardous chemicals is a reasonable interpretation of the standard. Accordingly, the labels with respect to the products in question containing one or more hazardous chemicals should have included an appropriate warning advising Of potential target organ effects. The Secretary does not insist that any particular language be used in conveying this information, and Compliance Officer Mericle indicated at the hearing that the information contained in respondent's MSOS would constitute sufficient warnings (Tr. 121-126). Appropriate language is also available in the NIOSH/OSHA Guidelines for Chemical Hazards for each of the involved substances (Exs. C-9 thru C-13). The key requirement is that the label transmit an immediate warning of the hazards of the chemical as it may affect one or more of the target organs, i.e., eyes, lungs, nervous system, etc. The second issue in this case relates to whether respondent violated 29 C.F.R. 1910.1200(g)(2)(vi) [[5/]] by its failure to specify the Short Term Exposure Limit (STEL) for hazardous chemicals continued in fibercore, (styrene and vinyl toluene), XC-4001 resin (propylene glycol menthyl ether) and cyglas (vinyl toluene). During his inspection Compliance Officer Mericle examined the MSDS for each of the products in question (Exs. C-1, C-3, C-5) and determined these documents listed TLV for each substance but did not specify STEL information (Tr. 57-59). Respondent does not dispute that STEL information was missing from the MSDS but maintains that the standard requires only a reflection of the eight-hour, time-weighted average (TLV), which respondent maintains is the "common understanding of Threshold Limit Value" (Respondent's Brief, pgs. 49-50). Respondent further urges that the "plain words of the standard are in the singular" (_Id_., pg. 49) and that requiring respondent to list both the TLV and STEL imposes an additional burden over and above that required by the standard. In making his determination, Compliance Officer Mericle referred to Threshold Limit Values and Biological Exposure Indices. (Ex. C-8; Tr. 150-151), a document approved by the American Conference of Governmental Industrial Hygienists. This source lists both a time-weighted average (TWA) and a short-term exposure limit (STEL) for each hazardous chemical specified in the document. The document explains that the STEL is "a 15 minute time-weighted average exposure which should not be exceeded at any time during a work day" and is a "supplement to the TWA." Id., pg. 3. This information is of important concern to the downstream employer who most inform and advise employees of the potential hazards of these products. The information conveyed by the STEL is no less vital to the downstream employer than the information imparted regarding the TWA. To withhold this information from the MSDS is inconsistent with the purpose of furnishing thorough and complete information as contemplated by the standard. Accordingly, the STEL information must be specified in the MSDS. _FINDINGS OF FACT_ 1. Respondent is a chemical manufacturer engaged at Perrysburg, Ohio, in the production of resins and molding compounds for sale and distribution to customers in the plastics industry. 2. On December 6, 1985, an inspection of respondent was conducted by the Occupational Safety and Health Administration to determine its compliance with the provisions of the HCS, 29 C.F.R. § 1910.1200. 3. During the course of this inspection, it was determined that respondent produced products identified as XC-4001 resin, XC-4005 resin, glaskyd, cyglas and fibercore, each of which contained one or more hazardous substances (butanol, vinyl toluene, styrene, amorphous silica, and talc) listed in Subpart Z of 29 C.F.R. § 1910 or in TLVs for Chemical Substances and Physical Agents in the Work Environment (ACGIH). 4. The labels utilized by respondent for the aforesaid products did not provide warnings advising of the target organ effects of exposure to the hazardous chemicals contained in these products. 5. The Secretary's inspection also disclosed that respondent's MSDS relating to XC-4001 resin, fibercore and cyglas did not specify the short-term exposure limits (STEL) set forth in TLVs and Biological Exposure Indices for 1985-86 ACGIH (Ex. C-8) for the hazardous substances (styrene, vinyl toluene and methyl ether) contained in these products. _CONCLUSIONS OF LAW_ 1. Respondent is an employer engaged in an industry affecting commerce, and the Review Commission has jurisdiction of the parties and subject matter in this case. 2. The Secretary's interpretation that the HCS requires a warning of target organ effects on labels used in shipping hazardous chemicals is reasonable and in keeping with the overall scheme and objectives of the standard. 3. Respondent has violated 29 C.F.R. § 1910.1200 (f)(l)(ii) by its failure to include target organ effects on labels used in shipping XC-4001 resin, XC-4005 resin, glaskyd, cyglas and fibercore to downstream employers. 4. The Secretary's requirement that the MSDS reflect STEL information is reasonable and is consistent with the standard's objectives to furnish thorough information to downstream employers. 5. Respondent has violated 29 C.F.R. § 1910.1200 (g)(2)(vi) by its failure to list short-term exposure limit information on its material safety data sheets developed for fibercore, XC-4001 resin and cyglas. _ORDER_ It is hereby ORDERED: 1. Item 1b of "other" Citation No. 1 is affirmed with no penalties assessed. 2. Item 2c of "other" Citation No. 1 is affirmed with no penalties assessed. EDWIN G. SALYERS Judge July 6, 1987 ------------------------------------------------------------------------ FOOTNOTES: [[1]] A target organ warning is a warning of the effect that a chemical has on a specific organ of the body. [[2]]Section 1200(d)(3) provides: The chemical manufacturer, importer or employer evaluating chemicals shall treat the following sources as establishing that the chemicals listed in them are hazardous: (i) 29 CFR Part 1910. Subpart Z Toxic and Hazardous Substances, Occupational Safety and Health Administration (OSHA); or (ii) Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment, American Conference of Governmental Industrial Hygienists (ACGIH) (latest edition). See Durez Div. of Occidental Chemical Corp. v. OSHA, 906 F.2d 1, 2 (D.C. Cir. 1990) ("Durez"). [[3]] Additional warning statements would be required under ANSI for highly toxic chemicals, but there is so evidence that the chemicals involved here would be classified as highly toxic. There has been no suggestion that Cyanamid's warnings regarding flammability and combustibility of any of the products at issue were inadequate. [[4]] We will assume, for the sake of argument in this case, that these symptoms are in fact properly characterized as target organ effects, although Cyanamid submitted evidence challenging the claim that central nervous system depression is a genuine target organ effect, and that silica and talc may came lung damage. [[5]] He adopted the reasoning of Commission Administrative Law Judge James Burroughs in a previous case on the same issue. Hilton-Davis Chemical Co., 87 OSAHRC 21/A5, 13 BNA OSHC 1182 (full text), 1967 CCH OSHD 27,872 (digest) (No. 86-494, 1987) (ALJ). Judge Burroughs held there that target organ data is required because the hazards of the chemical are to be conveyed on the container label and the scope of "health hazards" includes target organ effects. Judge Burroughs also relied on the discussion in the HCS Preamble of the definition of "health hazard." The key remarks in that preamble are as follows: The definition for "health hazard" has been modified somewhat by including in it the target organ classification of hazards that was proposed to Appendix A. This should clarify the required scope of hazards to be evaluated. In addition, it has been clarified that health hazards to be included are those for which there is scientific (i.e. statistically significant) evidence based on at least one positive study conducted in accordance with established Scientific Principles. 48 Fed. Reg. 53,280, 53,295 (1983). [[6]] That subsection specifically provides that each MSDS must state: The health hazards of the hazardous chemical, including signs and symptoms of exposure and any medical conditions which are generally recognized as being aggravated by exposure to the chemical(.) [[7]] The section cited here is essentially comparable to the proposed § 1910.1200(d)(3) in the 1982 proposal. Hazard Communications: Notice of Proposed Rulemaking and Public 47 Fed. Reg. 12,092, 12,121 (1982). The only relevant difference is that the 1982 proposal did not contain the word "appropriate" before "hazard warnings." [[8]] Toxic substances were classified as Category B Hazards under the 1981 proposal. Proposed § 1200(gg)(22), 46 Fed. Reg. at 4447. Table 2 to Appendix C specified the required hazard warnings for Category B hazards. The 1981 proposal would have required language akin to target organ warnings only for irritants, carcinogens and reproductive toxins, and certain miscellaneous "adverse health effects." The evidence does not indicate that any of Cyanamid's chemicals at issue in this case were carcinogens or reproductive toxins, or that they had the miscellaneous "adverse health effects" referred to in the 1991 proposal. For irritants, depending on the organ affected, the warning proposed in 1981 was to read: "Warning - Irritant: Causes [eye] [eye and skin irritation] [lung (chest)] irritation." 46 Fed. Reg. at 4452. As discussed at p. 10 supra. Cyamamid had comparable warnings for eye and skin irritants. [[9]] The chemicals excluded from the HCS labeling requirements - but not its other requirements - are as follows: (1) pesticides regulated by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act 7 U.S.C. § 136 et seq.; (2) substances regulated by the Food and Drug Administration ("FDA") under the Federal Food, Drug and Cosmetic Act, 21 U.S.C 301 et seq., (3) alcoholic beverages regulated by the Bureau of Alcohol, Tobacco and Firearms under the Federal Alcohol Administration Act. 27 U.S.C § 201 et seq.; and (4) products regulated by the Consumer Product Safety Commission ("CPSC") under the Consumer Product Safety Act, 16 U.S.C. 2051 et seq. and the Federal Hazardous Substances Act. 15 U.S.C. 1261 et seq. [[10]] The EPA pesticide labeling regulations at 29 C.F.R. Part 156 require the statement, "causes eye and skin damage [or eye irritation]," for the most highly toxic pesticides. 40 C.F.R. 156(i); see id. 156(h)(i) (definitions of toxicity categories). However, the Secretary has not claimed or shown that Cyanamids labels did act contain adequate target organ warnings regarding eye and side damage Those labels mentioned that the chemical "causes" or "may cause" eye of skin irritation, as to those chemicals which were identified as eye or skin hazards. See supra pp. 4-5). Among the other labeling regulations that we have reviewed are the FDA regulations at 21 C.F.R. 1.20, 1.21, and the CPSC regulations at 16 C.F.R. 1500.121. Those regulations do not contain the kinds of target organ warnings that the Secretary seeks to require here. Although our review of the relevant regulations has not been exhaustive, the fact that numerous regulations regarding the chemicals exempted from HCS labeling requirements have not contained the kind of target organ warning requirements that the Secretary seeks to impose here is significant. It is consistent with our conclusion that the Secretary originally did not intend to impose the general target organ warning requirement advocated here, even for chemicals not exempt from HCS labeling provisions. [[11]] An L[c]50 test is designed to determine the median lethal concentration of a substance in an animal species See, e.g. HCS, Appendix A, 6(c). [[12]] As mentioned above, OSHA did not disseminate the Instruction to the public. The Court noted in Martin v. OSHRC: the decision to use a citation as the initial means for announcing a particular interpretation may bear on the adequacy of notice to regulated parties,... the quality of the Secretary's elaboration of pertinent policy considerations...and other factors relevant to the reasonableness of the Secretary's exercise of delegated lawmaking powers. 111 S. Ct. at 1180 (citations omitted). For example, an interpretation made publicly available for the first time in a citation might be entitled to only prospective effect in some cases. Thus, it might not be a proper basis for penalizing the violation alleged in that citation. See, eg., Diebold, Inc. v. Marshall, 585 F.2d 1327, 1338 (6th Cir. 1978). [[13]] The term "known" target organ effect is not defined in the Instruction. However, as mentioned above, the evidence needed to establish a "health hazard" under the HCS generally is "statistically significant evidence used on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees." § 1200(c). [[14]] We do not rely on any statements by the Fluor court regarding the deference due to the interpretations of OSHA standards. The Supreme Court has definitively resolved the different positions of the lower courts, ruling that the Secretary's reasonable interpretation of her regulations are entitled to deference. notwithstanding a different interpretation favored by the Commission. CF & I Steel Corp. [[15]] We note that the official file contains a document marked as Complainant's Exhibit 15, which purports to be OSHA's 1986 changes to CPL 2-2.38, and which contains an interpretation of the cited standard that seems consistent with our holding, and inconsistent with the one the Secretary urges here. OSHA Instruction CPL 2-2.38A CH-1, Change to the Inspection Procedures for the Hazard Communication Standard 29 CFR 1910.1200 (July 18, 1986). The transcript does not reflect that it was introduced in evidence, and the parties do not rely on it. We do not rely on that document for any purpose. However, for the parties' information, we am that the document interprets the cited standard, in the context of container labeling for carcinogens, in a manner that seems inconsistent with OSHA's interpretation of target organ warning requirements. The HCS requires "appropriate hazard warnings," but does not specify when a warning of carcinogenicity would be "appropriate." This is consistent with the performance-oriented approach to the hazard determination and labeling requirements. The information which follows is intended to provide general guidance for compliance officers ["CSHO's"] in assessing labels for substances which are potentially carcinogenic. Employees may deviate this guidance as long as they can scientifically defend their position regarding the appropriateness of warning about carcinogenicity on the label for the particular substance involved.This general guidance does not supplant the professional judgment of the employer evaluating the hazards, nor of the CSHO in assessing compliance. Id. at A-12 The HCS is no more specific about when a warning of target organ effects would be "appropriate" on a container label, than it is about when a warning of carcinogenicity would be "appropriate" Thus, it Complainant's Exhibit 15 is what it purports to be, OSHA interpreted the cited standard's requirements for carcinogen labeling in a manner that seems contrary to in enforcement position regarding target organ warnings, and consistent with our holding. Finally, we note that the 1986 Instruction was issued between the time of the citation and the hearing in this case. [[16]] At oral argument before the Commission on review of the judge's decision, the Secretary suggested that target organ warnings an needed because employees have become inured to general warnings such as "Harmful if inhaled," and tend not to need them. This proposition may be correct, but it was not supported by evidence having been pressed for the first time on review. We decline to evaluate this proposition in the circumstance E.g. 29 C.F.R. 2200.92(c) ("The Commission will ordinarily not review issues that the Judge did not have the opportunity to pass upon.") [[17]] It bears noting that Cyanamid had an extensive program to achieve compliance with the HCS. As noted above, it followed the ANSI label warning standard, and there was so claim or proof that its labels for the containers at issue failed to comply with the ANSI standard that was in effect at that time. Dr. Friedman's department performs Cyanamid's hazard evaluations on new products. His staff looks at each individual component of the product and comprehensively reviews the available literature relative to its safety. If then is not enough information in the literature to determine the safety of a component, his staff arranges for toxicological studies of it. Once the hazards of a new product are determined, a warning Iabel is drafted by Cyanamid's toxicologists and chemical hazard specialists. Every label then is reviewed by a committee, chaired by Dr. Friedman, which includes a representative of each relevant profession within the company, and which develops a consensus as to whether or not the label is correct, legally and otherwise. Dr. Friedman testified that during the year before the hearing, his staff managed the production of about 1200 labels, at a cost of $700.000 or more. [[18]] We note that as the state of the art in labeling improves, the meaning of "appropriate" may also change. For example, ANSI periodically issues a revised standard for chemical container labeling. E.g. ANSI Z129.1-1988. Those revisions may be relevant to whether certain companies' hazard warnings an currently "appropriate" under the HCS. [[19]] Item 1(c) of the citation stated: The labels for XC-4005 resin, glaskyd, XC-4001 resin, XC-4011 resin and Cyglas did not identify the effects of inhalation overexposure, target organs were not identified and the label for fibercore listed no hazard warnings. [[20]] The court in General Carbon noted that this last passage occurred in a discussion of the manufacture's duty to provide an MSDS, and thus did not focus directly on the labeling requirement. However, the court properly noted that "it would make little sense to insist that a particular chemical be identified in the MSDS while imposing no corresponding labeling requirement." 860 F.2d at 485. [[21]] The Commission's Rule of Procedure do not impose on the Secretary an automatic burden of proof of employee exposure or access to the alleged hazards. Rule 35, governing Complaints, states: (b) Complaints concerning contested alleged violation... A paragraph alleging a violation shall in separate subparagraphs, state clearly and concisely-- (4) Where pertinent, the factual basis for the allegation that employees had access to or were exposed to the cited circumstances, conditions, practices or operations[.] 29 U.S.C. § 2200.35(b) (emphasis added). The Rule does not state when an allegation of access is "pertinent." An allegation of access is not required to the extent that it goes beyond the Secretary's burden of proof on the issue. (The current Rules of Procedure were in effect at time of the hearing in 1987. 51 Fed. Reg. 32,002 (September 8, 1986) (new rules took effect on December 8. 1986).) [[22]] The direction for review raised the issue whether the judge erred in concluding that the Secretary has authority to require chemical manufacturers to conform to the HCS for the protection of employees of other employers. That issue was not raised or discussed by the parties or the judge, and neither party addressed the issue in response to the direction for review. In the circumstances, Cyanamid has waived any reliance on the issue, and the Commission will not address it. See Commission Rule 92(c), 29 C.F.R. § 2200.92(c) (Commission ordinarily will not review issues that judge did not have opportunity to address) The direction for review also raised the issue whether the evidence established that butanol, vinyl toluene mid styrene produce "target organ effects" as that term is used in the HCS. In light of our disposition of this item, we need not address that issue. [[23]] Cyanamid argues that both disputed citation items should be vacated insofar as they relate to amorphous silica and tale on the grounds that (1) the Secretary failed to prove that employees were potentially exposed to amorphous silica and talc, and that (2) those chemicals do not in fact pose health hazards. We need not address these issues, because the aspects of the citation which we affirm do not relate to amorphous silica and talc. [[24]] The documents state, in pertinent part: Definitions. Three categories of Threshold Limit Values (TLVs) are specified herein, a follows: a) The Threshold Limit Value-Time Weighted Average (TLV-TWA) -- the time-weighted average concentration for a normal 8-hour workday and a 40-hour workweek, to which nearly all workers may be repeatedly exposed, day after day, without adverse effect. b) Threshold Limit Value-Short Term Exposure Limit (TLV-STEL) -- the concentration to which workers can be exposed continuously for a short period of time without suffering from 1) irritation, 2) chronic or irreversible tissue damage, or 3) narcosis of sufficient degree to increase the likelihood of accidental injury, impair self-rescue or materially reduce work efficiency, and provided that the daily TLV-TWA is not exceeded. It is not a separate independent exposure limit, rather it supplements the time-weighted average (TWA) limit where there are recognized acute effects from a substance whose toxic effects are primarily of a chronic nature. STELs are recommended only where toxic effect have been reported from high short-term exposures in either humans or animals. A STEL is defined as a 15-minute time-weighted average exposure which should not be exceeded at any time during a work day even if the eight-hour time- weighted average is within the TLV. c) Threshold Limit Value-Ceiling (TLV-C) -- the concentration that should not be exceeded during any part of the working exposure... [[25]] The listed STEL for propylene glycol methyl ether is 150 ppm or 540 mg/m 3. That chemical is actually listed by ACGIH as "Propylene glycol monomethyl ether." (Emphasis added). However, the two terms are synonymous. I. Sax, Dangerous Properties of Industrial Materials 943-44 (5th ed. 1979) They have the same identifying Chemical Abstract Service Number (CASE No. 000107-98-2). The listed STEL for "Styrene, monomer" is 100 ppm or 425 mg/m3 The listed STEL for vinyl toluene is 100 ppm or 485 mg/m 3. [[1/]] Respondent did not contest items 1a, 1c, 2a, certain portions of 2c and 2d of the citation. These items have, therefore, become final pursuant to section 10(a) of the Act. Prior to the hearing, the Secretary withdrew item 2b (See Judge's Ex. J-15). The Secretary also deleted XC-4011 resin from the products included in the citation since this product had been discontinued by respondent (Tr. 5). [[2/]] These documents are jointly prepared by the U. S. Department of Health and Human Services and the Department of Labor as a source of information for employees, employers, physicians, industrial hygienists and other occupational health professionals. They contain information concerning the identity and properties of each chemical and include health hazard information concerning the effects of overexposure. [[3/]] Section 1910.1200(c) defines "health hazard" as follows: "Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix P describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard. [[4/]] Although respondent concedes the hazardous nature of these chemicals, it maintains its warning on the label is appropriate under its principal theory that target organ effects are not reasonably required on the label. [[5/]] Section 1910.1200(g)(2)(vi) states as follows: (2) Each material safety data sheet shall be in English and shall contain at least the following information: (vi) The OSHA permissible exposure limit, ACGIN Threshold Limit Value, and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the material safety data sheet, where available.