“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 arerequired on containers of toxic chemicals that leave the manufacturer’sworkplace. At issue is whether American Cyanamid Co. (\”Cyanamid\”), achemical manufacturer, violated the requirements of the HazardCommunication Standard (\”HCS\”), 29 C.F.R. ? 1910.1200, promulgated bythe Secretary of Labor’s Occupational Safety and Health Administration(\”OSHA\”). More specifically, the Secretary charges that Cyanamid failedto label containers of hazardous chemicals with \”appropriate hazardwarnings\” as required by ? 1200 (f)(l)(ii), and failed to include thefill Threshold Limit Value (\”TLV\”) of the American Conference ofGovernmental Industrial Hygienists (\”ACGIH\”) on certain of its materialsafety data sheets (\”MSDS’s\”), as required by 1200(g)(2)(vi).The Commission’s administrative law judge found violations of both thoseprovisions. 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 broadrequirement of \”appropriate hazard warnings,\” as used in the HCS, isinconsistent with the manner in which the Secretary sees to enforce thestandard in this case.Specifically, we find that the Secretary’s insistence on target organwarnings in this case is a departure from the original policy under theHCS, and that the current policy is not enforceable, because thedeparture has not been adequately explained on this record. Morefundamentally, we find that the policy is not enforceable because itwould change the substance of the cited provision, by depriving theemployer of the opportunity to show that label warnings not containingthe target organ warnings advocated by the Secretary are nevertheless\”appropriate hazard warnings.\” The Secretary’s enforcement position inthis case would create, in effect, an irrebuttable presumption that atarget organ warning is required on the container label whenever aspecific target organ effect is \”known.\” We find that its enforcementposition is inconsistent with the broad, performance-oriented languageof the cited standard, which requires the Secretary to show, by apreponderance of the evidence in each case, that the container labels donot contain \”appropriate hazard warnings.\” The Secretary failed to makethat 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, theSecretary failed to establish that the cited containers lacked\”appropriate hazard warnings.\” We affirm a violation as to Fibercore. Wealso affirm the judge’s holding that Cyanamid violated {sym}1200(g)(20(vi). No penalties were proposed by the Secretary, and nonewill be assessed.*BACKGROUND *Cyanamid is a chemical manufacturing company with headquarters in Wayne,New Jersey. The plant involved here is in Perrysburg, Ohio, whereCyanamid produces resins and molding compounds for \”out of plantshipment\” (sale and distribution) to customers in the plastics industry.The five products at issue here were among those compounds. The productsare Cyglas, Fibercore, Glaskyd, XC-4001 resin,and XC-4005 resin.OSHA Compliance Officer (\”CO\”) Ralph Mericle inspected the Perrysburgplant on December 6, 1985, to determine compliance with the HCS. The COreviewed the MSDS’s for the five products at issue and reviewed thecorresponding labels on their containers. The chemicals at issue in theproducts are as follows: (1) for Cyglas — vinyl toluene and amorphoussilica (2) for Fibercore — styrene and vinyl toluene: (3) for Glaskydamorphous silica and talc: (4) for XC-4001 resin — n-Butanol andpropylene glycol methyl ether; and (5) for XC-4005 resin — n-Butanol.Each of the chemicals at issue is classified as a hazardous chemicalunder the standard, because they all are identified as hazardouschemicals 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, 494U.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 hazardwarnings.\” \”Hazard warning\” is defined in ? 1910.1200(c) as \”any words,pictures, symbols, or combination thereof appearing on a label or otherappropriate form of warning which convey the hazard(s) of thechemical(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 werenot \”appropriate,\” because they did not warn of certain target organeffects of the chemicals at issue. Instead, Cyanamid’s container labelsfor XC-4001 resin, XC-4005 resin, Cyglas and Glaskyd had hazard warningsthat generally conformed to the language recommended at that time by theAmerican National Standards Institute (\”ANSI\”). ANSI Z 129.1-1982Hazardous Industrial Chemicals: Precautionary Labeling. ANSI is anational industry consensus standard-setting group to which Cyanamidbelonged. 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 andInstructions generally used the same language and format recommended byANSI at the time for irritants, and substances that are toxic byinhalation. 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, andvinyl toluene may cause central nervous system depression, includingdizziness, headache, nausea, and other symptoms. Nor did the labelsspecifically warn that silica and talc may cause lung damage. [[4]] Wewill address the Secretary’s interpretation of the standard, under whichlabel warnings of every \”‘known\” target organ effect would be required.Our role is to determine whether that interpretation is \”a permissiblegloss\” on the standard, in light of the standard’s language, structureand 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 containerlabels, in light of Appendix A to the HCS. [[5]] Target organ effectsare among the health effects defined in Appendix A. The Appendix statesthat employees must be apprised of the organs that may be harmed, andthe signs and symptoms of potential harm.That appendix does not state, however, whether all that information mustbe conveyed on container labels. The inclusion of target organ effectswithin the scope of \”health hazards\” does not establish, by itself, thateach such effect must be described on container labels. Label warningsare 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 signsand symptoms of exposure, must be stated on the MSDS, under ?1200(g)(2)(iv). [[6]] See Durez, supra note 2 (MSDS’s must list targetorgans regardless of whether exposures to chemical may foreseeablyexceed OSHA permissible exposure limits). MSDS’s are to be readilyavailable to the employees at each worksite. ?? 1200(g)(8) and (10).Another means of conveying detailed safety information is employeetraining. ? 1200(h). In this case, the compliance officer testified thatprofessional judgment is needed to determine which hazards identified onthe MSDS are important enough to list on the container label. Thus, wemust 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 authoritativestatement of the agency’s intent in promulgating the labelingrequirements. It made clear that the requirement of \”appropriate hazardwarnings\” was a performance standard, and that only \”minimalinformation\” was required for label warnings, 48 Fed. Reg. at 53,301,53,336. The Preamble also indicated that the employer was given broaddiscretion in choosing the warnings. \”The employer is responsible forselecting the message and ensuring that it is effective for the purposeinvolved.\” 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 numerousexisting labeling systems \”would generally be in compliance.\” Id.Specifically, it named the ANSI system followed by Cyanamid. It alsonamed the Hazardous Materials Identification System (HMIS) of theNational Paint and Coatings Association (NPCA). It noted that, as underthe 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 informationrequired under the (1982) proposal is sufficient, and remains the sameunder the final standard.\” 48 Fed.Reg. at 53,301. [[7]] The 1982 proposal called for \”a simpleperformance-oriented standard. 47 Fed. Reg. at 12,101 (emphasis added).The Iabeling requirements are very much performance-oriented in thatmost existing labeling systems could be used to satisfy therequirements…. 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 hazardouschemical containers. That earlier proposal, which would have deprivedemployers of much of the discretion that is provided under the finalstandard, Hazards Identification: Notice of Proposed Rulemaking andPublic Hearings, 46 Fed. Reg. 4412 (1981), was withdrawn only weeksafter it was published. 46 Fed. Reg. 12,214 (1981). It was aspecification standard, requiring particular language for labels oncontainers of hazardous chemicals. Proposed ? 1200(q)(3) and Appendix C,46 Fed. Reg. at 4443, 4451-53. For chemicals classified only as toxicsubstances, 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, whereappropriate, statements of (1) appropriate precautions to avoid exposure(such as \”[w]ear rubber gloves\”), (2) antidotes, (3) instructions incase of fire, spill, or leak, and (4) instructions for containerhandling and storage. Proposed Appendix C. ?? (b)(4), (c)(l), 46 Fed.Reg. at 4452. The 1982 proposal specifically noted the change from the1991 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 raisedregarding the excessive costs and paperwork burdens imposed by theJanuary [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 toprovide employers flexibility and discretion in determining how to\”convey the hazards of the chemicals in the containers.\” Yet, theenforcement policy on which the Secretary’s case is based goes in theopposite direction. As noted above, even the 1981 proposal would nothave required target organ warnings for chemicals classified merely astoxic substances, such as those involved here. We conclude, based on thePreamble, that the HCS originally was intended not to create a generalrequirement, or irrebuttable presumption, that a target organ warning isrequired on the container label whenever a specific target organ effectis \”known.\” We will defer to the reasonable intent of the Secretary inpromulgating the standard, as that intent is authoritatively explainedin the standard’s Preamble. Phelps Dodge Corp., 11 BNA OSHC1441,1444,1983-84 CCH OSHD 26,552, pp. 33,920-21 (No. 80-3203,1983),aff’d, 725 F.2d 1237, 1240 (9th Cir. 1984) (where standard issusceptible to different interpretations, \”the preamble is the best andmost authoritative statement of the Secretary’s legislative intent\”).*3. Exemptions from HCS labeling requirements*The exemptions from the labeling requirements of the HCS, as explainedin the Preamble, are consistent with our conclusion that the Secretaryoriginally did not intend to establish an inflexible rule that containerlabels, for the kinds of chemicals involved here. include the kinds oftarget organ warnings sought here. Those exemptions are not consistentwith an intent to require target organ warnings whenever a target organeffect 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 subjectto labeling requirements under other Federal laws. ? 1200(b)(5). [[9]]We have reviewed the labeling requirements under those other Federallaws. We have found no target organ warning requirements in thoselabeling provisions that relate to toxic chemical hazards comparable tothose for which the Secretary seeks target organ warnings here. [[10]]The HCS Preamble indicates that the Secretary considered the labelingrequirements of the other Federal agencies sufficient, regarding thosechemicals:In the case of pesticides. the purpose of such labeling [labelingrequired by EPA] is mainly the protection of workers exposed to thepesticide. In the case of the other substances, the purpose of thelabels 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 thepotentially more dangerous situation where \”worker exposure issignificantly greater than that of consumers,\” OSHA believed that theprotective components of the HCS other than container labels (forexample, training and the availability of MSDS’s) would be adequate todeal with the \”unique hazards\” to workers. Based on that belief, thelabeling requirements of the other Federal agencies, which are generallyless stringent than the requirements that the Secretary urges here,would be acceptable. Thus, the exemptions under ? 1200(b)(5), asexplained in the Preamble are consistent with our conclusion aboveregarding the Secretary’s original intent under the HCS. Thoseexemptions, as discussed in the Preamble, are inconsistent with the viewthat the HCS container labeling provision was intended to mandate targetorgan 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 wasproperly explained in OSHA Instruction CPL 2-2.38, Inspection Proceduresfor the Hazard Communication Standard, 29 CFR 1910.1200 (1985) (the\”Instruction\”). She argues that the interpretation in that Instructionis entitled to deference, and that therefore her current policy must beupheld.The Instruction was originally prepared by the Office of HealthCompliance Assistance. It was signed by Acting Assistant Secretary forOSHA Patrick R. Tyson on August 5, 1985, more than 20 months after theHCS was promulgated, and less than four months before the effective dateof the requirements at issue here. The Instruction was an internaldirective to OSHA’s field staff, intended to establish internal OSHApolicies and provide clarifications to promote uniform enforcement ofthe HCS. OSHA did not disseminate the Instruction to the public.The interpretation the Secretary relies on is found in Appendix A to theInstruction. That Appendix notes that the phrase \”appropriate hazardwarning\” 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 isintended to be specific information regarding the hazard — the specifichazards 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 ofthe standard by themselves. The definition of hazard warning states thatthe 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 situationswhere the specific target organ effect is not known. Where this is thecase, the more general warning statement would be permitted. Forexample, if the only information available is an L^c 50 [11] testresult, \”harmful if inhaled\” may be appropriate.\/Id\/. at A-7 (footnote and emphasis added).The Supreme Court recently held that the Secretary’s interpretations ofher regulations in enforcement guidelines such as the Instruction areentitled to some weight:[T]he Secretary regularly employs less formal means [than standards andcitations] of interpreting regulations prior to issuing a citation.These include the promulgation of interpretive rules . . . and thepublication of agency enforcement guidelines, see United StatesDepartment of Labor, OSHA Field Operations Manual [\”FOM\”] (3d ed.1989)…. Although not entitled to the same deference as norms thatderive from the exercise of the Secretary’s delegated lawmaking powers,these informal interpretations are still entitled to some weight onjudicial review. See Batterton v. Francis, 432 U.S. 416, 425-426, andn.9 (1977); Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944). Areviewing court may certainly consult them to determine whether theSecretary has consistently applied the interpretation embodied in thecitation, a factor bearing on the reasonableness of the Secretary’sposition.M\/artin L. OSHRC ICF & I Steel Corp.\/, 111 S. Ct. 1171, 1179 (1991).Furthermore, the agency’s interpretation of the regulation as expressedin 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 bereasonable. \”[W]e emphasize that the reviewing court should defer to theSecretary only if the Secretary’s interpretation is reasonable.\” Id. at1180 (emphasis in original). \”Varying degrees of deference are accordedto administrative interpretations. based on such factors as the timingand consistency of the agency’s position, and the nature of itsexpertise.\” Batterton, 432 U.S. at 425. The Court sometimes has\”declined to follow administrative guidelines in the past where theyconflicted with earlier pronouncements of the agency.\” General ElectricCo. 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’sunpublished interpretation of its regulation upheld, where there was noclaim that it was inconsistent with the governing statute or with theagency’s intent when the regulation was promulgated).The Secretary’s current enforcement position, which she claims that shestated in the Instruction, represents a departure from the originalinterpretation of the cited standard in the HCS Preamble. [[12]] Asdiscussed above, the HCS originally was not intended to require, acrossthe board, the kinds of target organ warnings sought here, whereas theInstruction suggests that they generally would be required. Anadministrative agency is free to chance its policies pursuant toexisting requirements, so long as the change in policy is adequatelyexplained. 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 inOhio 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 interpretationwhen it flatly contradicts agency’s previous position, stated closer toenactment of governing statute). See Motor Vehicle Mfrs. Ass’n of UnitedStates, 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 phrasessuch as \”Harmful it inhaled\” on container labels are inadequate todescribe \”known\” [[13]] target organ effects. because such phrases donot \”convey the hazard\” in that situation. However, the original intentof the standard, discussed above, was to allow employers to select anyeffective language on labels to convey the hazards, including languagebased 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 proveneffective within the industry.Because the Secretary misconstrues the original intent of the HCS, weconclude that OSHA did not properly consider that original intent informulating its current target organ warning policy. In the words of theGreater Boston court, quoted above, the Secretary does not \”supply areasoned analysis indicating that prior policies … are beingdeliberately changed rather than casually ignored.\” Thus, theenforcement policy does not merit the deference that we have it the thatwe have accorded to the previous, authoritative interpretation oflabeling requirements which the Secretary trade in the HCS Preamble.Beyond the lack of adequate explanation for the Secretary’s departurefrom prior policy, there is a more fundamental problem with theSecretary’s position. She essentially seeks, by interpretation, tochange the broad performance standard, \”appropriate hazard warnings,\”into a narrow specification standard that would require a target organwarning for each \”known\” target organ effect. She relies on her currentenforcement position as if it created an irrebuttable presumption that atarget organ warning is required on the container label whenever aspecific target organ effect is \”known.\”\”An agency’s interpretation of a regulation is valid, however, only ifthat interpretation complies with the actual language of theregulation.\” Fluor Constructors, Inc v. OSHRC, 861 F.2d 936, 942 (6thCir. 1988). [[14]] See, e.g., Bonessa v. United States Steel Corp., 884F.2.d 726, 732 (3d Cir. 1989), and cases cited therein (agency may notrewrite regulations through interpretation). \”Appropriate hazardwarnings,\” as used in the HCS, is a broad performance criterion. Itclearly calls for a factual, case-by-case determination of theeffectiveness of the hazard warning. As discussed above, the otherprovisions of the HCS do not put the employer on fair notice that itmust state all \”known\” target organ effects on container labels, inaddition to stating them in its MSDS’s. Any doubts about whether theterm \”appropriate hazard warnings\” was intended to be a broadperformance standard are resolved by the Preamble.If the Secretary’s current interpretation were given deference it wouldhave binding effect and the standard would be substantively amended,because Cyanamid would have no opportunity to show factually that itshazard warnings were \”appropriate.\” A substantive amendment of astandard 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 requirementsimposed by Congress, Including applicable notice and comment proceduresof APA). Thus, we cannot adopt the Secretary’s current Interpretation.The Secretary’s current enforcement position is not entitled to Judicialdeference, 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 theevidence at the hearing, that the employer’s hazard warnings in fact arenot appropriate. See, e.g., Limerick Ecology Action v. NRC, 869 F.2d719, 733-36 (3d Cir. 1989) (when agency applies general statement ofpolicy to specific case, it must support policy \”just as it the policystatement had never been issued\”). Thus, we hold that the Secretary isnot authorized, through the Instruction or otherwise, to enforce herinterpretation as controlling, or as if it created an irrebuttablepresumption that target organ warnings are required on container labelsfor 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 tocreate appropriate hazard warnings\” in this case. The Secretary’s onlywitness was the CO, who had no background in product labeling or hazardwarnings. He did not testify as to why the target organ warnings soughthere are required on container labels to warn employees effectively. Hemerely applied the Secretary’s current enforcement policy. Thus, we findthat the Secretary failed to prove by a preponderance of the evidence,as required, that the container labels did not have \”appropriate hazardwarnings.\” We also hold that, in any event, the Secretary’s departurefrom the original HCS policy on container labeling is unenforceablebecause it was not adequately explained at the hearing. [[16]]The CO acknowledged that the determination as to which hazards, listedon the MSDS are important enough to list on the container label is amatter of judgment, and that normally the people who make thosejudgments are toxicologists. However, the CO was not a toxicologist.Marvin A. Friedman, Ph.D., a very experienced toxicologist andCyanamid’s Director of Toxicology and Product Safety, testified as towhy Cyanamid does not include all the target organ warnings on labelsthat 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, testifiedthat the basic philosophy of the chemical industry toward labeling is\”that a label should be as brief as possible and understandable aspossible.\” She also testified that \”we attempt to reduce the language[so] that someone with less than a high school education could possiblyunderstand.\” She testified that Cyanamid uses the ANSI standard as thebasis for labeling industrial chemicals. Ms. Hanavan holds a B.A. inchemistry and, at the time of the hearing, had 11 years of experience inchemical labeling. She was on the Board of Directors of the AmericanConference of Chemical Labeling.Many of the warnings that the Secretary has endorsed in this case werespecifically criticized by Ms. Hanavan. The CO testified that OSHA wouldaccept on the labels the statements of affected organs in Cyanamid’sMSDS’s. Typical of the statements regarding central nervous system(\”CNS\”) effects and silica hazards are those on Cyanamid’s MSDS, forFibercore: 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 forXC-4001 resin:Direct contact with the liquid may cause mild skin and moderate eyeirritation. Overexposure to butanol and propylene glycol methyl ethermay cause eyeand respiratory tract irritation, headache, dizziness or nausea.Ms. Hanavan gave the opinion that the statement, \”Warning! Causescentral nervous system depression,\” is less effective than \”Harmful ifinhaled,\” because the average worker would not comprehend the formerphrase unless it were explained. As to the suggestion that a list ofspecific CNS effects be given, she testified that she doubted that afull list would be as effective as \”Harmful if inhaled,\” because aworker would \”not have a tendency to read through all that.\” (PotentialCNS effects include lightheadedness, nausea, fatigue, depression,dizziness ataxia, and headache.) Ms. Hanavan also testified that listingonly a single CNS symptom, such as \”Warning! May cause dizziness,\” wouldnot be quite accurate, because it would describe only one of many thingsthat could occur. Cf. supra note 12.Based on the discussion above, we find that the Secretary has faded toshow by a preponderance of the evidence, as required, that the hazardwarnings put on the labels of Cyglas, Glaskyd, XC-4001 resin and XC-4005resin were not \”appropriate hazard in any even warnings.\” [[17]] Wefurther hold that,in any event, she has not adequately explained herdeparture from the original intent of the HCS labeling provision in thiscase.*6. The General Carbon decision*The Secretary notes a case in which the D.C. Circuit rejected achallenge to the requirement in the Secretary’s citation that a chemicalmanufacturer include certain target organ warnings on its containerlabels. General Carbon Co., Div. of St. Mary’s Carbon Co. v. OSHRC, 860F.2d 479 (D.C. Cir. 1988). However, the court did not rule on the meritsof the issue. The basis for the court’s action was that General Carbonhad not raised that challenge before this Commission, and thus hadfailed to exhaust its administrative remedies. Id at 486. It also notedthat OSHA had \”demonstrated some willingness to negotiate over thecontent of the required label.\” \/Id\/.The Secretary relies on the court’s comments relevant to the extent ofwarnings 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 \”omittedentirely\” from the labels, that does not negate the broad discretionleft to the employer by the standard, regarding, how to best \”convey thehazards.\” As discussed above, the record indicates that effective hazardlabeling involves a good deal of judgment. and that label warnings mustbe sufficiently clear to employees who have limited formal education.For example, in the HCS Preamble, OSHA specifically rejected anextensive label warning requirement because of the \”potential forinformation 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 generallymust be described on container labels under the HCS. We also note thatGeneral Carbon did not address the effect of the HCS Preamble on thereasonableness of the Secretary’s current target organ warning policyunder the cited standard. Nor did Durez, in which the court upheld therequirement 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 thatexpressly required employers to specifically describe all \”known\” targetorgan effects on container labels would be reasonable. We merely holdthat the cited standard does not impose that requirement but ratherrequires a case-by-case, factual analysis of whether the employer’slabel warnings are \”appropriate\” in the circumstances. We further holdthat the Secretary’s interpretation of the standard to impose auniversal target organ warning requirement is unenforceable in this casein any event, because it departs from the original interpretation in theHCS Preamble, and the Secretary does not adequately explain why theinterpretation is being changed.*B. Other Alleged Deficiencies in Cyanamid’s Label Warnings*At oral argument, the Secretary asserted that statements on Cyanamid’slabels such as \”‘Harmful if inhaled\” to describe the toxic substances atissue are ineffective under any test. The evidence presented at thehearing does not establish that proposition, however, for the reasonsgiven above. The Instruction states that phrases such as \”harmful ifinhaled\” do not meet the intent of the standard by themselves where atarget organ effect is \”known.\” However, as discussed above, theSecretary may not establish that the employer’s warnings wereinappropriate simply by citing its Instruction. We have no basis on thisrecord for concluding that Cyanamid’s hazard warnings on the containerlabels of Cyglas, Glaskyd, XC-4001 or XC-4005 were not \”appropriatehazard warnings\” at the time. [[18]]*C. Lack of Warning Labels on the Fibercore Containers*Cyanamid’s label on Fibercore containers contained no hazard warning atthe time of the inspection. The hazardous substances in Fibercore thatare at issue are styrene and vinyl toluene. There is no dispute thatthose substances are hazardous chemicals under ? 1200(d)(3), see supranote 2, and thus are subject to the standard’s requirements. It also isundisputed that Cyanamid did not comply with the terms of the citedprovision, and that it knew. or with the exercise of reasonablediligence could have known, of the lack of hazard warnings.Cyanamid’s counsel claimed at oral argument that the way the case hasbeen tried, the only basis on which the Secretary has pursued aviolation with respect to the Fibercore labels is the lack of targetorgan warnings. We reject Cyanamid’s claim. Item 1(b) of the Secretary’scitation referenced Fibercore in alleging a lack of appropriate hazardwarnings, and did not restrict the allegation to the target organwarning issue. [[19]] Cyanamid adduced evidence that the Fibercore labelhad no warnings at the time of the inspection. The judge understood thatthat issue was before him. The record does not show that the Secretaryhas abandoned the issue.Cyanamid does not contest the sufficiency of the evidence that employeespotentially would be exposed to the styrene and vinyl toluene inFibercore. Nonetheless, the parties have extensively addressed thequestion of whether the Secretary bears a burden, under the citedstandard, of proving that employees would be potentially or actuallyexposed to the hazardous chemicals involved. The basic issue is whetherthe Secretary must show that employees in \”downstream\” workplaces (thatis, workplaces to which the chemicals are shipped) would be exposed tothe hazards. The burden of proof Issue is an important one that affectschemical manufacturers, importers and distributors under the HCSgenerally. 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 presentin such a manner that employees may be exposed to it under normalconditions of use or in a foreseeable emergency.\” The Secretary arguesthat under the cited standard, she has no burden of proving exposureonce she establishes that \”hazardous chemicals\” are leaving the chemicalmanufacturer’s workplace. She argues that \”the Standard presumes arisk….Once the chemicals have been found to be per se hazardous [bybeing listed in the source documents named in ? 1200(d)(3)], theStandard presumes they will be released downstream.\” As discussed above,the Secretary’s interpretation of her own regulation is entitled todeference where reasonable. CF & I Steel Corp., 111 S.Ct. at 1176 (\”Insituations in which ‘the meaning of [regulatory] language is not freefrom doubt,’ the reviewing court should give effect to the agency’sinterpretation 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 theSecretary’s interpretation of the burden of proof as to employeeexposure under the cited standard is reasonable. The scope provision ofthe 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 theSecretary’s interpretation of the burden of proof of exposure, inGeneral 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 toaffirmatively prove downstream employee exposure under ? 1200(f)(l),once she shows that the chemicals involved are hazardous chemicalswithin the meaning of the HCS. Cases under that provision present muchgreater difficulties of proof for the Secretary, regarding employeeexposure, than most OSHA citation cases. In most OSHA inspections, theemployees who are exposed to a hazard are on the inspected worksite.Thus, the general rule is that the Secretary bears the burden of proofof employee access to the hazards: that is, that the employee was, orpredictably 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 willinspect a chemical manufacturing plant (or an importer’s ordistributor’s facility) from which chemicals are shipped downstream to avariety of workplaces. The inspected facility may be far removed fromthe workplaces where employees are actually or potentially exposed tothe hazards of the chemicals shipped. Thus, the Secretary in many caseswill be unable to determine whether those downstream employees will beexposed to the hazards, without extensively investigating those distantworkplaces. As a result, it would be unduly burdensome on the Secretaryif she were required to prove downstream employee exposure in casesunder the cited standard.We also note that the Secretary’s position that she bears no such burdenunder that standard is consistent with general principles governingburdens of proof. A standard treatise on the law of evidence summarizesthe 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\”) (citationomitted). Here, the Secretary’s position is supported by the specialpolicy considerations underlying the HCS, as well as by convenience,fairness, and the probabilities of the situation. The overall policy ofthe HCS is to protect employees by giving them Information about the\”hazards of all chemicals produced or imported.\” ? 1200(a)(l) (emphasisadded). The HCS Preamble indicates that speculation about whetherdownstream 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 theoverall policy of the HCS to deny enforcement to a citation merely onthe basis that the Secretary did not have an accurate prediction of theemployee exposure downstream. A defense based on speculation orpresumption that there would be no such exposure is disfavored under theHCS.As to convenience and fairness, we have found above that it would beunfair and inconvenient in cases under the cited standard to require theSecretary to investigate the details of each product’s use to determineexposure. That is particularly true, considering that the party cited,who relies on lack of exposure, predictably will have far better accessto 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 andfairness support the Secretary’s interpretation of the burden of proofunder the cited standard.Finally, as to the probabilities of the situation, the more probableassumption is that employees are potentially exposed to the hazardouschemicals with which they work. Although employee exposure to hazardouschemicals shipped to downstream employers may be presumed, under thecited standard, this does not mean that the presumption is irrebuttable.We note that the HCS provides an explicit exemption for \”articles,\” thatis, manufactured items that are formed to a specific shape or designduring manufacture, that have end use function(s) dependent on thatshape or design, and that do not result in exposure to a hazardouschemical under normal conditions of use. ? 1200(c).Thus, we find that the Secretary’s interpretation of the burden of proofof exposure under ? 1200(f)(l) is reasonable, and we defer to it, forthe reasons stated in General Carbon, and for the further reasonsdiscussed above. Under ? 1200(f)(I) the Secretary need not prove thatemployees will be potentially or actually exposed to the chemicalhazards, once she shows that the chemicals leaving the \”upstream\”workplace are hazardous under 1200(d)(3). Neither the Act nor theCommission’s Rules of Procedure require placing the burden of proof onthe Secretary here. [[21]]For the reasons discussed above, all the necessary elements of aviolation have been established as to Fibercore. To summarize, styreneand vinyl toluene, which are components of Fibercore, are hazardouschemicals under the HCS. Cyanamid had no hazard warning on the Fibercorecontainers at the time of the inspection. as required. Also, it had therequisite knowledge of the violative conditions. Thus, we affirm aviolation 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, styreneand vinyl toluene, which are contained in one or more of Cyanamid’sproducts at Issue. [[23]] The judge found that Cyanamid had violated thecited standard ? 1910.1200(g)(2)(vi), because it failed to include theapplicable short-term exposure limits (\”STEL’s\”) of the AmericanConference of Governmental Industrial Hygienists (\”ACGIH\”) in itsmaterial 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 thecited standard does not require listing the STEL. We disagree with thisargument. The standard requires that employers have an MSDS for eachhazardous chemical they use, and that it list the \”ACGIH Threshold LimitValue (TLV)\” for exposure to the chemical, and other exposure limits. Asource for determining the \”ACGIH Threshold Limit Value (TLV)\” isreferenced in ? 1910.1200(d)(3)(ii) (supra note 2). That source is theACGIH Threshold Limit Values for Chemical Substances and Physical Agentsin the Work Environment.That document is part of the ACGIH publication, Threshold Limit Valuesand Biological Exposure Indices for 1985-86, which was introduced intoevidence by the Secretary. It defines the term \”Threshold Limit Values\”to include the STEL and ceiling limits as well as the 8-hour TimeWeighted Average, (\”TWA\”).[[24]] The document lists STEL’s for each ofthe chemicals involved here. [[25]] Cyanamid’s MSDS’s for the products atIssue did not list a STEL for any of those chemicals.Cyanamid argues that the CO’s testimony supports it position that theSTEL is not properly considered as part of the ACGIH TLV. It quotes thefollowing 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, becausehe agreed only that the \”time weighted average is sometimes eighthours,\” not that the TLV is restricted to an eight-hour period.Moreover, he testified that the actual definition of \”threshold limitvalue is \”essentially what this document [the ACGIH document discussedabove] indicates.\” He also testified that the STEL is \”a different kindof threshold limit value\” from an 8-hour TWA.In any event, the ACGIH definition, expressly incorporated in the HCS by1200(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 revealedto Cyanamid the actual meaning of \”ACGIH Threshold Limit Value.\”Thus, Cyanamid failed to comply with the terms of the standard, and knewor reasonably could have known of the noncompliance. The requisiteshowing was made of potential employee exposure to propylene glycolmethyl ether, styrene and vinyl toluene, for the reasons discussed aboveregarding Item 1(c). We therefore affirm Item 2(c).*PENALTIES*No penalties were proposed by the Secretary for the alleged violationsand none will be assessed. The HCS had just gone into effect when theinspection occurred. As discussed above, the major issues in dispute inthis case are difficult legal issues that had not been addressedpreviously. The Secretary presented no evidence in support of a penaltyassessment. 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) isaffirmed. No penalties are assessed.Edwin G. Foulke, Jr.ChairmanDonald G. Wiseman CommissionerVelma MontoyaCommissionerDated: February 7, 1992————————————————————————SECRETARY OF LABORComplainant,v.AMERICAN CYANAMID COMPANY,Respondent.OSHRC Docket No. 86-681APPEARANCES: Bruce C. Heslop, Esquire, Office of the Solicitor, U. S.Department of Labor, Cleveland, Ohio, on behalf of complainantKenneth B. Stark, Esquire, Cleveland, Ohio, on behalf of respondent*DECISION AND ORDER*SALYERS, Judge: Respondent, American Cyanamid Company, is a chemicalmanufacturer headquartered in Wayne, New Jersey. It has a plant facilitylocated in Perrysburg, Ohio, where it produces resins and moldingcompounds for sale and distribution to customers engaged in the plasticsindustry. On December 6, 1985, Compliance Officer Ralph Mericleconducted an inspection of respondent’s Perrysburg plant to determine ifrespondent was complying with the Hazard Communication Standard (29C.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 chemicalmanufacturers on November 25, 1985.As a result of this inspection, the Secretary of Labor cited respondentfor alleged violations of the HCS, and the citation was duly contestedwith respect to certain items. [[1\/]] At the hearing the partiesannounced the only matters remaining at issue were item 1b of thecitation and item 2c insofar as it relates to listing short-termexposure limits (STEL) on the material safety data sheets prepared forcertain products (Tr. 5- 6). The parties also stipulated at the set ofthe hearing that the respondent is a \”chemical manufacturer ascontemplated by the HCS and that the involved products of respondentwere 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 failureto ensure that containers of XC-4005 resin, glaskyd, XC-4001 resin,cyglas and fibercore were labeled, tagged or marked with appropriatehazard warnings prior to shipment to \”downstream\” employers.2. Did respondent violate 29 C.F.R. ? 1910.1200(g)(2)(vi) by its failureto list on its material safety data sheets (MSDS) developed forfibercore, XC-4001 resin and cyglas, the applicable ACGIH STEL forcertain hazardous chemical components contained in these substances.I.The HCS was developed by the Secretary over a period of years beginningin 1974 with the appointment of a Standards Advisory Committee onHazardous Materials Labeling to study the need for such regulations andto recommend guidelines for categorizing and ranking chemical hazards.Following receipt of the committee’s report and recommendations receivedfrom the National Institute for Occupational Safety and Health (NIOSH),the Secretary published an advance notice of proposed rulemaking onchemical labeling in the Federal Register (42 Fed. Reg. 5,372)requesting comments and suggestions from the public and input wasreceived from a variety of government agencies, trade associations,businesses and labor organizations. On March 19, 1982, the Secretarypublished his final notice of rulemaking proceedings (47 Fed. Reg.12,092) which established a 60-day period for submission of writtencomments and notices of intent to appear at public hearings. Theforegoing culminated in the issuance of the HCS (29 C.F.R. ? 1910.1200)which was published in the Federal Register on November 25, 1985. 48Fed. 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 ofinformation regarding hazardous chemicals from chemical manufacturersand importers to employer-purchasers of such products. See ?1910.1200(b)(l). The full and accurate downstream flow of informationregarding hazardous chemicals is essential to complete implementation ofthe standard’s requirements by manufacturing sector employers whopurchase such products. See generally ? 1910.1200(d)(l), ? 1910.1200(a)and ? 1910.1200(h). To initiate this downstream flow of information, thestandard requires chemical manufacturers, such as respondent, toevaluate chemical substances produced in their workplace to determine ifthey are hazardous, see ? 1910.1200(b)(l) and (d), to ensure that eachcontainer of hazardous chemicals leaving its workplace is appropriatelylabeled, tagged or marked, see ? 1910.1200(f), and to develop a materialsafety data sheet for each hazardous chemical they produce, see ?1910.1200(g).The standard imposes an obligation on manufacturers shipping chemicalsto downstream employers as follows:(1) The chemical manufacturer, importer or distributor shall ensure thateach 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 chemicalsshall treat the following sources as establishing that the chemicalslisted 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 examinedthe labels and corresponding MSDS for each of the products enumerated inthe contested citation, ie., XC-4005 resin, glaskyd, XC-4001 resin,cyglas and fibercore (Exs. C-1 thru C-5). First, he determined thepresence of hazardous ingredients in each substance by referring to theappropriate section of the respondent’s MSDS. The substance listed ashazardous included butanol, vinyl toluene, styrene, amorphous silica,and talc. Mericle verified that each of these substances was identifiedas hazardous in Table Z-1 of 29 C.F.R. ? 1910.1000 (Ex. C-7) and in theThreshold Limit Values prepared by the American Conference ofGovernmental Industrial Hygienists (Ex. C-8). He noted that respondent’slabel for fibercore (Ex. C-3) listed no hazard warning. The labels forthe remaining substances gave the general warning, \”harmful if inhaled,\”\”causes eye irritation,\” may cause skin irritation,\” \”avoid breathingdust,\” etc., but did not warn of possible target organ effects ifexposed to the hazardous chemical (Exs. C-1 thru C-5). Mericle thenconsulted 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 hazardouschemical. Based upon his review of respondent labels and the foregoingtechnical sources, he determined that respondent had not complied withthe 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 ComplianceDirective CPL 2-2.38 dated August 5, 1985 (Ex. C-6). which was in effectat 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-6and 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 usedby respondent in connection with the substances cited by the Secretarywere marked with \”appropriate hazard warnings\” as contemplated by thestandard. The Secretary takes the position that the labels utilized byrespondent were inadequate since they did not identify the target organeffects of exposure to the hazardous chemicals contained in the citedsubstances. Respondent maintains its labels were appropriate, that thelabel need not convey comprehensive information concerning potentialhazards, and that target organ effects are more appropriately relegatedto the material safety data sheets.The Review Commission has not yet considered or ruled on the questionpresented in this case. However, two Administrative Law Judges in threeseparate 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 involvedare \”health hazards\” as this term is defined in ? 1910.1200(c). [[3\/]]In this case, this requirement has been satisfied since each of thechemicals contained in respondent’s products is specifically listed inthe source documents prescribed by ? 1910.1200(d)(3). Under thesecircumstances, the Secretary has made out a prima facie case sincechemicals 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 respectto styrene, vinyl toluene and butanol and agrees that \”these chemicalsare sufficiently hazardous to warrant a label warning\” [[4\/]](Respondent’s Brief, pg. 41). Respondent does not concede, however, thatamorphous silica and talc are hazardous based upon the testimony of itstoxicologist, Dr. Marvin A. Friedman, who testified toxicologicalstudies do not confirm the hazardous nature of these substances (Tr.176-177). Dr. Friedman gave no specifics to support this generalizedconclusion. On cross-examination Dr. Friedman admitted each of theinvolved substances are mixtures and that respondent has made noindependent studies of these mixtures to determine the hazards of themixture as a whole (Tr. 229-230). The standard does not require amanufacturer 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 ofamorphous silica and talc in excess of one percent. In the absence ofindependent studies to rebut the presumption of the standard, thesemixtures must be considered to present the same hazards as its components.Respondent argues that the history of the HCS reveals it is the MSDS andnot the label where the Secretary reposed the requirement for detailingtarget organ effects (Respondent’s Brief. pgs. 4-12, 33-34). It aversthat the interpretation urged by the Secretary in this case is contraryto prevailing industry practices (Id., pgs. 28-29) and is inconsistentwith requirements contained in substance-specific OSHA standards forother hazardous substances (Id., pgs. 12, 36-38). It urges that theSecretary’s interpretation would lead to label \”overload\” and iscounterproductive to the standard’s purpose (Id., pgs. 20-22). Whilethese arguments are well presented and have been considered, thepervading question in this case is whether the Secretary’sinterpretation that labels must reflect target organ effects is inaccord with the purpose and scheme of the HCS and is reasonable.This issue was specifically and definitively addressed in Hilton-DavisCo., 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 onlabels in connection with the shipping of hazardous chemicals is areasonable interpretation of the standard. Accordingly, the labels withrespect to the products in question containing one or more hazardouschemicals should have included an appropriate warning advising Ofpotential target organ effects. The Secretary does not insist that anyparticular language be used in conveying this information, andCompliance Officer Mericle indicated at the hearing that the informationcontained in respondent’s MSOS would constitute sufficient warnings (Tr.121-126). Appropriate language is also available in the NIOSH\/OSHAGuidelines for Chemical Hazards for each of the involved substances(Exs. C-9 thru C-13). The key requirement is that the label transmit animmediate warning of the hazards of the chemical as it may affect one ormore of the target organs, i.e., eyes, lungs, nervous system, etc.The second issue in this case relates to whether respondent violated 29C.F.R. 1910.1200(g)(2)(vi) [[5\/]] by its failure to specify the ShortTerm Exposure Limit (STEL) for hazardous chemicals continued infibercore, (styrene and vinyl toluene), XC-4001 resin (propylene glycolmenthyl ether) and cyglas (vinyl toluene).During his inspection Compliance Officer Mericle examined the MSDS foreach of the products in question (Exs. C-1, C-3, C-5) and determinedthese documents listed TLV for each substance but did not specify STELinformation (Tr. 57-59).Respondent does not dispute that STEL information was missing from theMSDS but maintains that the standard requires only a reflection of theeight-hour, time-weighted average (TLV), which respondent maintains isthe \”common understanding of Threshold Limit Value\” (Respondent’s Brief,pgs. 49-50). Respondent further urges that the \”plain words of thestandard are in the singular\” (_Id_., pg. 49) and that requiringrespondent to list both the TLV and STEL imposes an additional burdenover and above that required by the standard.In making his determination, Compliance Officer Mericle referred toThreshold Limit Values and Biological Exposure Indices. (Ex. C-8; Tr.150-151), a document approved by the American Conference of GovernmentalIndustrial Hygienists. This source lists both a time-weighted average(TWA) and a short-term exposure limit (STEL) for each hazardous chemicalspecified in the document. The document explains that the STEL is \”a 15minute time-weighted average exposure which should not be exceeded atany time during a work day\” and is a \”supplement to the TWA.\” Id., pg.3. This information is of important concern to the downstream employerwho most inform and advise employees of the potential hazards of theseproducts. The information conveyed by the STEL is no less vital to thedownstream employer than the information imparted regarding the TWA. Towithhold this information from the MSDS is inconsistent with the purposeof furnishing thorough and complete information as contemplated by thestandard. Accordingly, the STEL information must be specified in the MSDS._FINDINGS OF FACT_1. Respondent is a chemical manufacturer engaged at Perrysburg, Ohio, inthe production of resins and molding compounds for sale and distributionto customers in the plastics industry.2. On December 6, 1985, an inspection of respondent was conducted by theOccupational Safety and Health Administration to determine itscompliance with the provisions of the HCS, 29 C.F.R. ? 1910.1200.3. During the course of this inspection, it was determined thatrespondent produced products identified as XC-4001 resin, XC-4005 resin,glaskyd, cyglas and fibercore, each of which contained one or morehazardous substances (butanol, vinyl toluene, styrene, amorphous silica,and talc) listed in Subpart Z of 29 C.F.R. ? 1910 or in TLVs forChemical Substances and Physical Agents in the Work Environment (ACGIH).4. The labels utilized by respondent for the aforesaid products did notprovide warnings advising of the target organ effects of exposure to thehazardous chemicals contained in these products.5. The Secretary’s inspection also disclosed that respondent’s MSDSrelating to XC-4001 resin, fibercore and cyglas did not specify theshort-term exposure limits (STEL) set forth in TLVs and BiologicalExposure Indices for 1985-86 ACGIH (Ex. C-8) for the hazardoussubstances (styrene, vinyl toluene and methyl ether) contained in theseproducts._CONCLUSIONS OF LAW_1. Respondent is an employer engaged in an industry affecting commerce,and the Review Commission has jurisdiction of the parties and subjectmatter in this case.2. The Secretary’s interpretation that the HCS requires a warning oftarget organ effects on labels used in shipping hazardous chemicals isreasonable and in keeping with the overall scheme and objectives of thestandard.3. Respondent has violated 29 C.F.R. ? 1910.1200 (f)(l)(ii) by itsfailure to include target organ effects on labels used in shippingXC-4001 resin, XC-4005 resin, glaskyd, cyglas and fibercore todownstream employers.4. The Secretary’s requirement that the MSDS reflect STEL information isreasonable and is consistent with the standard’s objectives to furnishthorough information to downstream employers.5. Respondent has violated 29 C.F.R. ? 1910.1200 (g)(2)(vi) by itsfailure to list short-term exposure limit information on its materialsafety 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. SALYERSJudgeJuly 6, 1987————————————————————————FOOTNOTES:[[1]] A target organ warning is a warning of the effect that a chemicalhas on a specific organ of the body.[[2]]Section 1200(d)(3) provides:The chemical manufacturer, importer or employer evaluating chemicalsshall treat the following sources as establishing that the chemicalslisted 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 Agentsin the Work Environment, American Conference of Governmental IndustrialHygienists (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 forhighly toxic chemicals, but there is so evidence that the chemicalsinvolved here would be classified as highly toxic. There has been nosuggestion that Cyanamid’s warnings regarding flammability andcombustibility of any of the products at issue were inadequate.[[4]] We will assume, for the sake of argument in this case, that thesesymptoms are in fact properly characterized as target organ effects,although Cyanamid submitted evidence challenging the claim that centralnervous system depression is a genuine target organ effect, and thatsilica and talc may came lung damage.[[5]] He adopted the reasoning of Commission Administrative Law JudgeJames Burroughs in a previous case on the same issue. Hilton-DavisChemical Co., 87 OSAHRC 21\/A5, 13 BNA OSHC 1182 (full text), 1967 CCHOSHD 27,872 (digest) (No. 86-494, 1987) (ALJ). Judge Burroughs heldthere that target organ data is required because the hazards of thechemical are to be conveyed on the container label and the scope of\”health hazards\” includes target organ effects. Judge Burroughs alsorelied 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 byincluding in it the target organ classification of hazards that wasproposed to Appendix A. This should clarify the required scope ofhazards to be evaluated. In addition, it has been clarified that healthhazards to be included are those for which there is scientific (i.e.statistically significant) evidence based on at least one positive studyconducted 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 andsymptoms of exposure and any medical conditions which are generallyrecognized 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 ofProposed Rulemaking and Public 47 Fed. Reg. 12,092, 12,121 (1982). Theonly relevant difference is that the 1982 proposal did not contain theword \”appropriate\” before \”hazard warnings.\”[[8]] Toxic substances were classified as Category B Hazards under the1981 proposal. Proposed ? 1200(gg)(22), 46 Fed. Reg. at 4447. Table 2 toAppendix C specified the required hazard warnings for Category B hazards.The 1981 proposal would have required language akin to target organwarnings only for irritants, carcinogens and reproductive toxins, andcertain miscellaneous \”adverse health effects.\” The evidence does notindicate that any of Cyanamid’s chemicals at issue in this case werecarcinogens 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 in1981 was to read: \”Warning – Irritant: Causes [eye] [eye and skinirritation] [lung (chest)] irritation.\” 46 Fed. Reg. at 4452. Asdiscussed at p. 10 supra. Cyamamid had comparable warnings for eye andskin irritants.[[9]] The chemicals excluded from the HCS labeling requirements – butnot its other requirements – are as follows: (1) pesticides regulated byEPA under the Federal Insecticide, Fungicide, and Rodenticide Act 7U.S.C. ? 136 et seq.; (2) substances regulated by the Food and DrugAdministration (\”FDA\”) under the Federal Food, Drug and Cosmetic Act, 21U.S.C 301 et seq., (3) alcoholic beverages regulated by the Bureau ofAlcohol, Tobacco and Firearms under the Federal Alcohol AdministrationAct. 27 U.S.C ? 201 et seq.; and (4) products regulated by the ConsumerProduct Safety Commission (\”CPSC\”) under the Consumer Product SafetyAct, 16 U.S.C. 2051 et seq. and the Federal Hazardous Substances Act. 15U.S.C. 1261 et seq.[[10]] The EPA pesticide labeling regulations at 29 C.F.R. Part 156require 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 Secretaryhas not claimed or shown that Cyanamids labels did act contain adequatetarget organ warnings regarding eye and side damage Those labelsmentioned that the chemical \”causes\” or \”may cause\” eye of skinirritation, as to those chemicals which were identified as eye or skinhazards. See supra pp. 4-5).Among the other labeling regulations that we have reviewed are the FDAregulations at 21 C.F.R. 1.20, 1.21, and the CPSC regulations at 16C.F.R. 1500.121. Those regulations do not contain the kinds of targetorgan warnings that the Secretary seeks to require here. Although ourreview of the relevant regulations has not been exhaustive, the factthat numerous regulations regarding the chemicals exempted from HCSlabeling requirements have not contained the kind of target organwarning requirements that the Secretary seeks to impose here issignificant. It is consistent with our conclusion that the Secretaryoriginally did not intend to impose the general target organ warningrequirement advocated here, even for chemicals not exempt from HCSlabeling provisions.[[11]] An L[c]50 test is designed to determine the median lethalconcentration 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 tothe public. The Court noted in Martin v. OSHRC:the decision to use a citation as the initial means for announcing aparticular interpretation may bear on the adequacy of notice toregulated parties,… the quality of the Secretary’s elaboration ofpertinent policy considerations…and other factors relevant to thereasonableness of the Secretary’s exercise of delegated lawmaking powers.111 S. Ct. at 1180 (citations omitted). For example, an interpretationmade publicly available for the first time in a citation might beentitled to only prospective effect in some cases. Thus, it might not bea 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 theInstruction. However, as mentioned above, the evidence needed toestablish a \”health hazard\” under the HCS generally is \”statisticallysignificant evidence used on at least one study conducted in accordancewith established scientific principles that acute or chronic healtheffects may occur in exposed employees.\” ? 1200(c).[[14]] We do not rely on any statements by the Fluor court regarding thedeference due to the interpretations of OSHA standards. The SupremeCourt has definitively resolved the different positions of the lowercourts, ruling that the Secretary’s reasonable interpretation of herregulations are entitled to deference. notwithstanding a differentinterpretation favored by the Commission. CF & I Steel Corp.[[15]] We note that the official file contains a document marked asComplainant’s Exhibit 15, which purports to be OSHA’s 1986 changes toCPL 2-2.38, and which contains an interpretation of the cited standardthat seems consistent with our holding, and inconsistent with the onethe Secretary urges here. OSHA Instruction CPL 2-2.38A CH-1, Change tothe Inspection Procedures for the Hazard Communication Standard 29 CFR1910.1200 (July 18, 1986). The transcript does not reflect that it wasintroduced in evidence, and the parties do not rely on it. We do notrely on that document for any purpose. However, for the parties’information, we am that the document interprets the cited standard, inthe context of container labeling for carcinogens, in a manner thatseems inconsistent with OSHA’s interpretation of target organ warningrequirements.The HCS requires \”appropriate hazard warnings,\” but does not specifywhen a warning of carcinogenicity would be \”appropriate.\” This isconsistent with the performance-oriented approach to the hazarddetermination and labeling requirements. The information which followsis intended to provide general guidance for compliance officers[\”CSHO’s\”] in assessing labels for substances which are potentiallycarcinogenic. Employees may deviate this guidance as long as they canscientifically defend their position regarding the appropriateness ofwarning about carcinogenicity on the label for the particular substanceinvolved.This general guidance does not supplant the professionaljudgment of the employer evaluating the hazards, nor of the CSHO inassessing compliance.Id. at A-12 The HCS is no more specific about when a warning of targetorgan effects would be \”appropriate\” on a container label, than it isabout when a warning of carcinogenicity would be \”appropriate\” Thus, itComplainant’s Exhibit 15 is what it purports to be, OSHA interpreted thecited standard’s requirements for carcinogen labeling in a manner thatseems contrary to in enforcement position regarding target organwarnings, and consistent with our holding. Finally, we note that the1986 Instruction was issued between the time of the citation and thehearing in this case.[[16]] At oral argument before the Commission on review of the judge’sdecision, the Secretary suggested that target organ warnings an neededbecause employees have become inured to general warnings such as\”Harmful if inhaled,\” and tend not to need them. This proposition may becorrect, but it was not supported by evidence having been pressed forthe first time on review. We decline to evaluate this proposition in thecircumstance E.g. 29 C.F.R. 2200.92(c) (\”The Commission will ordinarilynot review issues that the Judge did not have the opportunity to passupon.\”)[[17]] It bears noting that Cyanamid had an extensive program to achievecompliance with the HCS. As noted above, it followed the ANSI labelwarning standard, and there was so claim or proof that its labels forthe containers at issue failed to comply with the ANSI standard that wasin effect at that time. Dr. Friedman’s department performs Cyanamid’shazard evaluations on new products. His staff looks at each individualcomponent of the product and comprehensively reviews the availableliterature relative to its safety. If then is not enough information inthe literature to determine the safety of a component, his staffarranges for toxicological studies of it.Once the hazards of a new product are determined, a warning Iabel isdrafted 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 thecompany, and which develops a consensus as to whether or not the labelis correct, legally and otherwise. Dr. Friedman testified that duringthe year before the hearing, his staff managed the production of about1200 labels, at a cost of $700.000 or more.[[18]] We note that as the state of the art in labeling improves, themeaning of \”appropriate\” may also change. For example, ANSI periodicallyissues a revised standard for chemical container labeling. E.g. ANSIZ129.1-1988. Those revisions may be relevant to whether certaincompanies’ 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 andCyglas did not identify the effects of inhalation overexposure, targetorgans were not identified and the label for fibercore listed no hazardwarnings.[[20]] The court in General Carbon noted that this last passage occurredin a discussion of the manufacture’s duty to provide an MSDS, and thusdid not focus directly on the labeling requirement. However, the courtproperly noted that \”it would make little sense to insist that aparticular chemical be identified in the MSDS while imposing nocorresponding labeling requirement.\” 860 F.2d at 485.[[21]] The Commission’s Rule of Procedure do not impose on the Secretaryan automatic burden of proof of employee exposure or access to thealleged hazards. Rule 35, governing Complaints, states:(b) Complaints concerning contested alleged violation… A paragraphalleging a violation shall in separate subparagraphs, state clearly andconcisely–(4) Where pertinent, the factual basis for the allegation that employeeshad 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 anallegation of access is \”pertinent.\” An allegation of access is notrequired to the extent that it goes beyond the Secretary’s burden ofproof on the issue. (The current Rules of Procedure were in effect attime 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 erredin concluding that the Secretary has authority to require chemicalmanufacturers to conform to the HCS for the protection of employees ofother employers. That issue was not raised or discussed by the partiesor the judge, and neither party addressed the issue in response to thedirection for review. In the circumstances, Cyanamid has waived anyreliance on the issue, and the Commission will not address it. SeeCommission Rule 92(c), 29 C.F.R. ? 2200.92(c) (Commission ordinarilywill not review issues that judge did not have opportunity to address)The direction for review also raised the issue whether the evidenceestablished that butanol, vinyl toluene mid styrene produce \”targetorgan effects\” as that term is used in the HCS. In light of ourdisposition of this item, we need not address that issue.[[23]] Cyanamid argues that both disputed citation items should bevacated insofar as they relate to amorphous silica and tale on thegrounds that (1) the Secretary failed to prove that employees werepotentially exposed to amorphous silica and talc, and that (2) thosechemicals do not in fact pose health hazards. We need not address theseissues, because the aspects of the citation which we affirm do notrelate to amorphous silica and talc.[[24]] The documents state, in pertinent part:Definitions. Three categories of Threshold Limit Values (TLVs) arespecified herein, a follows:a) The Threshold Limit Value-Time Weighted Average (TLV-TWA) — thetime-weighted average concentration for a normal 8-hour workday and a40-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) — theconcentration to which workers can be exposed continuously for a shortperiod of time without suffering from 1) irritation, 2) chronic orirreversible tissue damage, or 3) narcosis of sufficient degree toincrease the likelihood of accidental injury, impair self-rescue ormaterially reduce work efficiency, and provided that the daily TLV-TWAis not exceeded. It is not a separate independent exposure limit, ratherit supplements the time-weighted average (TWA) limit where there arerecognized acute effects from a substance whose toxic effects areprimarily of a chronic nature. STELs are recommended only where toxiceffect have been reported from high short-term exposures in eitherhumans or animals.A STEL is defined as a 15-minute time-weighted average exposure whichshould not be exceeded at any time during a work day even if theeight-hour time- weighted average is within the TLV.c) Threshold Limit Value-Ceiling (TLV-C) — the concentration thatshould not be exceeded during any part of the working exposure…[[25]] The listed STEL for propylene glycol methyl ether is 150 ppm or540 mg\/m 3. That chemical is actually listed by ACGIH as \”Propyleneglycol monomethyl ether.\” (Emphasis added). However, the two terms aresynonymous. I. Sax, Dangerous Properties of Industrial Materials 943-44(5th ed. 1979) They have the same identifying Chemical Abstract ServiceNumber (CASE No. 000107-98-2). The listed STEL for \”Styrene, monomer\” is100 ppm or 425 mg\/m3 The listed STEL for vinyl toluene is 100 ppm or 485mg\/m 3. [[1\/]] Respondent did not contest items 1a, 1c, 2a, certain portions of2c and 2d of the citation. These items have, therefore, become finalpursuant to section 10(a) of the Act. Prior to the hearing, theSecretary withdrew item 2b (See Judge’s Ex. J-15). The Secretary alsodeleted XC-4011 resin from the products included in the citation sincethis product had been discontinued by respondent (Tr. 5).[[2\/]] These documents are jointly prepared by the U. S. Department ofHealth and Human Services and the Department of Labor as a source ofinformation for employees, employers, physicians, industrial hygienistsand other occupational health professionals. They contain informationconcerning the identity and properties of each chemical and includehealth 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 statisticallysignificant evidence based on at least one study conducted in accordancewith established scientific principles that acute or chronic healtheffects 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 ofhealth hazards covered by this section, and Appendix P describes thecriteria to be used to determine whether or not a chemical is to beconsidered hazardous for purposes of this standard.[[4\/]] Although respondent concedes the hazardous nature of thesechemicals, it maintains its warning on the label is appropriate underits principal theory that target organ effects are not reasonablyrequired on the label.[[5\/]] Section 1910.1200(g)(2)(vi) states as follows:(2) Each material safety data sheet shall be in English and shallcontain 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 chemicalmanufacturer, importer, or employer preparing the material safety datasheet, where available.”