Document e7R0rx402wREGVr1pOZZkZR5y

TO: Lynn Royston Inter-Office Correspondence DATE: June 16, 1988 FROM: J. A. Barter JSUBJECT: Lake Charles Liver / Function Tests There are no formal reports, in the EA files, on the liver function tests or the meetings in which the medical surveillance protocol was developed through several draft stages. Two copies of the final pro tocol are attached for your use. I have also enclosed a portion of a Proposed Rule, on Air Contaminants, from the Occupational Safety and Health Administration (Federal Register 52/ 2095^21398, June 7, 1988). This proposal is an attempt by OSHA to revise a number of OSHA exposure limits in one action. The rule bases proposed exposure limits on rationales for avoiding certain kinds of health effects, one of which is avoidance of liver and kidney effects. The section dealing with the part of the rule is attached. This section contains the background scientific information for these effects. The section discusses the nature of the effects, the reversibility of most occupationally caused liver effects, and the sensitivity and utility of liver enzymes as a diagnostic tool. I believe that this document should be very helpful in justifying what we are doing since both ethylene dichloride (EDC) and 1,1,2,2-tetrachloroethane are potentially present in our derivatives area as well as several other materials which are potential liver toxins but not specifically on the OSHA list. I'll be in the office June 20-23, 1988 if you have a need to discuss this further. SL 0427" SL 042800) 21046 ) Federal Register / Vol. 53. No. 109 / Tuesday, June 7, 1938 / Proposed Rules CAS: 1330-20-7; 95-47-6:108-38-3:106-12-3: OSHA's current PEL for zinc chloride from levels that have been associated Chemical Formula: CsH,(CHi)j is 1 mg/m3 as an 8-hour TWA. The with these effects to levels where such " H.S. No. 1431 ACGIH has established a TLV-TWA of consequences are substantially less *' The current OSHA limit for xylene is 100 ppm as an 0-hour TWA. The ACGIH : also recommends a TLV-TWA of 100 ppm, but adds a 15-minute STEL of 150 ppm. NIOSH recommends an exposure limit of 100 ppm TWA. with a 200-ppm . 10-minute ceiling. Xylene and Its isomers are clear, flammable liquids with an aromatic hydrocarbon odor. ' Rats and rabbits exposed to a mixture of xylene isomers at a concentration of 690 ppm for 8 hours daily, six days per week showed no blood abnormalities, but rabbits exposed on the same regimen at 1150 ppm for 55 days showed a decrease in red and white blood cell counts and an increase in platelet count. (Fabre and Truhaut 1954). 1 mg/m3, with a STEL of 2 mg/m3. Zinc chloride fume is white and has an acrid odor. Zinc chloride fume is highly caustic and damages the mucous membranes of the nasopharynx and respiratory tract. Exposure to the fumes of.zinc chloride may result in a severe pneumonitis that is caused by irritation of the respiratory tract (Gafafer 1964). One instance in which a worker Inhaled zinc chloride fumes resulted in advanced pulmonary fibrosis that ended in death (Milliken, - Waugh, and Kadish 1983), and 10 deaths and 25 non-fatal cases of pneumonitis occurred in workers caught in a tunnel when 79 smoke generators caught fire and generated zinc chloride fumes (Humter 1955). Other studies have likely to occur will reduce the risk posed to workers at cun-ent levels. . , ,:V-B The health evidence for these asubstances-forms a reasonable basis for'proposing revised or new limit's. At the. time of the final rule, OSHA will establish new or revised limits for these; sensory Irritants if the Agency determines that these limits will substantially reduce significant risks. 4. Substances for Which Proposed . Limits Are Based on Avoidance of Uver'- or Kidney Effects Introduction - - - . - '^ The liver or kidneys are the primary^ target organs affected by toxic exposures to a number of industrial r. Studies of workers exposed to xylene . revealed headache, fatigue, lassitude, irritability, and gastrointestinal shown that zinc chloride exposures cause skin ulceration (Sax 1957). It has. also been suggested that zinc chloride chemicals. In recognition of this target 'organ toxicity, OSHA is proposing new;p or revised limits for 17 hepato- or --t/f disturbances as the most common exposure may have chronic effects nephrotoxic compounds (12 symptoms (Gerarde 1960). At (Hamilton and Hardy 1974). In an . hepatotoxins and five nephrotoxins). For unspecified exposure levels, Browning investigation of the adverse effects of these substances, the liver or kidney la (1965) also noted gastrointestinal zinc chloride fume exposures. Ferry probably the organ most sensitive to the disturbances, in addition to kidney, (personal communication 1966, as cited effects of exposure. Thus, establishing "i. heart, liver, and neurological damage: in the ACGIH 1986. p. 643) reported that permissible exposure limits that are low-: blood dvscrasias, some of which result no sensory effects occurred when 30 . - enough to prevent toxicity to these. in death, were also reported in these minute exposures were limited to 0.07 . . target organs generally also protects - workers. A study by Nelson, Ege, Ross and 0.4 mg/m3: however, this researcher other organ systems. et al. (1943). in which human volunteers noted that these levels did conode . .... Seventeen compounds for which .^ja were exposed to 200 ppm xylene, found metal. rovised limits are being proposed _ _ eye, nose, and throat irritation in the ' OSHA preliminarily concludes that. . . produce kidney or Uver effects in subjects at this level of exposure. the risk of damage to the eyes, skin, and overexposed individuals. For seven of NIOSH developed a Criteria respiratory-tract associated with these substances, OSHA is proposing to Document for xylene in 1975, in which exposure to zinc chloride fume should lower the PEL, and for one other. fj'* the work of Morlsy and his colleagues be substantially reduced by establishing substance, OSHA is also proposing the (1970) was discussed. These authors a STEL and TWA to protect against adoption of a short-term exposure limit observed liver dysfunction and renal elevated short-term and long-term, ; For five Uver or kidney toxins, OSHA is ./- impairment in three workers exposures to this substance. The health proposing a PEL where,none formerly . overexposed to xylene (estimated , concentration of 10,000 ppm). One of these workers died, but the others recovered slowly. Furniture polishers were reported by Matthaus (1964) to have suffered comeal damage as a evidence forms a reasonable basis for existed, and in three cases, OSHA . proposing a revision to this level. At the proposes to retain the current PEL but to . time of the final rule. OSHA will add a STEL where none formerly . establish a new limit for zinc chloride if existed. For four chemicals in this " the Agency determines that this limit . < category, NIOSH recommends limits r:,,. will substantially reduce significant risk. - lower than those established by the result of exposure to xylene at unknown concentrations. OSHA preliminarily concludes that both a TWA and STEL are necessary to prevent risk of narcosis, blood effects, - and irritant effects at the elevated levels passible at the current exposure limit.' To reduce this risk, OSHA is proposing a 150-ppm STEL and a 100-ppm TWA. The health evidence forms a reasonable basis for proposing a revision to this level. At the time of the finafrule, OSHA will establish a new limit for xylene if the Agency determines that this limit will substantially reduce significant risk. Preliminary Conclusions ! . ACGIH. and for one of these substances, ' OSHA proposes adoption of the NIOSH OSHA's preliminary finding is that sensory irritation poses an occupational RELs; in three cases, the NIOSH and : * ACGIH limits are essentially the same. health risk to workers exposed to these substances at the existing hazardous levels. Among the adverse health consequences of exposure to sensory irritants are acute breathing difficulty, .eye tearing, conjunctivitis, sensitization, persistent coughing, and upper respiratory tract irritation. In addition to The sections below discuss Uver and kidney toxins separately. Table C4-1 shows these hepatotoxic substances, , > their OSHA, ACGIH, and NIOSH limits, and their CAS and HS numbers: Table C4-2 provides the same information for the nephrotoxins in this group,. -J the pain and suffering associated with Liver Toxicity these signs and symptoms, workers experiencing irritant effects find it Description of the Health Effects yth:)., difficult if not impossible to concentrate Although the precise mechanism* by * ^ ZINC CHLORIDE-(FUME) on the job at hand; thus they work less which these compounds cause liver - CAS: 7646-85-7: Chemical Formula: ZnCli safely and less productively than non- damage are only partly understood, the H.S. No. 1435 exposed employees. Reducing exposures development and manifestation of Uver SL 042801) Federal Register / Vol, 53, No, 109 / Tuesday, June 7, 1988 / Proposed Rules ____ .21047 toxicity are similar for all of them. In general, liver toxicity is a graded response, i.e,, the severity of the lesion is directly proportional to the intensity/ duration of exposure. Although many of the effects caused by exposure to these substances are reversible, some are not. Liver damage is not a single entity; the manner in which it is manifested depends on the dose, duration, and particular chemical agent involved. For example, acute exposures may cause lipid to accumulate in the hepatocytes, cellular death, and/or hepatobiliary enzyme activities. These may be dysfunction. In contrast, chronic accompanied by changes in the - . exposures may lead to cirrhotic changes morphology of specific organelles in and the development of neoplasms. hepatocytes. For example, relatively low Fatty accumulation and necrosis can be -- doses of halogenated aliphatic -- either localized or widespread, and hydrocarbons, such as ailyl chloride, chemical-induced lesions resulting from carbon tetrabromide. and 1,1- '> chronic exposures can cause marked dichloroethane, cause an increase in the changes of the entire liver (Plaa 1986). activity of microsomal mixed function - Typically, the earliest and most oxidase enzymes. This increase is ~~ sensitive indicators of liver toxicity are ordinarily accompanied by proliferation alterations in biochemical liver of the endoplasmic reticulum. functions, such as changes in specific WUING CODE 450-3-M .. ' Vu M- SL 042802 21048 Federal Register / Vol, 53. No. 109 / Tuesday, June 7,1988 / Proposed Rules ' Table C4-1. List of Substance's For Which Limits Are Based Primarily on Avoidance of Liver Toxicity ' ...... H.S. Number/ Chemical Name 1011 Allyl chloride CAS No. 107-05-1 Current PEL* 1 ppm TWA * ACGIH TLV** ' 1 ppm TWA 2 ppm STFL ' NI0SH ftEL*** 1 ppm TWA. 3 ppm Ceiling , (15 min) 1072 Carbon tetrabromide * 558-13-4 0.1 ppm TWA 0.3 ppm STF.L - 1089 o-Chlorostyrene 2039-87-4 - 50 ppm TWA 75 ppm STFL ' - 1108 Cyclohexanone , 108-94-1 50 ppm TWA 25 ppm TWA, Skin 25 ppm TWA 1145 Oioxane 123-91 -1 100 ppm TWA, Skin 25 ppm TWA, Skin 1 ppm Ceiling (30 min) 1168 Ethylene dichloride* 107-06-2 50 ppm TWA 100 ppm STFL . 200 ppm Ceiling 10 ppm TWA 1 ppm TWA 2 ppm Ceiling (15 min) 1205 Hydrazine 302-01 1 1 ppm TWA, Skin. 0.1 ppm TWA, Skin 0.63 ppm Ceiling (120 min) 1269 Me thy1eye 1ohexano1 - 25639-42-3 100 ppm TWA 50 ppm TWA 1295 Octachloronaphthalene 2234-13 1 3 0.1 mg/m TWA, Skin O.t mg/m^ TWA 0.3 mg/m^ STFL Skin - - 0A2803 SL Federal Register / Vol. 53, No. 109 / Tuesday, June 7,1988 / Proposed Rules Table C4-1. List of Substances For Which Limits Are Based Primarily on Avoidance of Liver Toxicity (continued) 21049 H.S. Number/ Chemical Name CAS No. Current PEL* ACGIH TLV** NIOSH REL*** 1341 Propylene dichloride 78-87-5 75 ppm TWA 75 ppm TWA 110 ppm STEL -- 1385 1,1,2,2-Tetrachloroethane 79-34-5 5 ppm TWA, Skin : 1 ppm TWA, Skin Lowest feasible level 1407 1,2,3-Trichloropropane 96-18-4 50 ppm TWA . ` 10 ppm TWA, Skin - * OSSIA's TWA limits are for 8-hour exposures; its STELs are for the durations specified; and its ceilings are peaks not to be exceeded for any period of time. '' : ** The ACGIH TWA-TLV is for an 8-hour exposure; its STELs are 15-minute limits not to be exceeded more than 4 times per day with a minimum of 60 minutes between successive_STEL,exposures; and-.its ceilings are peaks not to be exceeded for any period of time. *** NIOSH TWA limits are for 10-hour exposures unless otherwise specifred,'and its ceilings are peaks not to be exceeded for any period of time unless a duration is specified in parentheses'. + Proposed limit is the NIOSH RF.L. * x* SL 042804) ; t if V? ' * 21030 Federal Register / Vol. 53, No. 109 / Tuesday, June 7,1988 / Proposed Rules Table C4-2. List of Substances For Which Limits are Based Primarily on Avoidance of Kidney Toxicity H.S. Number/ Chemical Marne CAS Mo. Current PEL* ACGIH TLV** 1129 1,3-0ichloropropene 542-75-6 1 ppm TWA, Skin 1132 Oicyclopcntadiene 1166 Ethyl silicate t . 77-73-6 - 78-10-4 100 ppm TWA 5. ppm TWA 10 ppm.TMA 1195 Hexachlorobutadiene 87-63-3 0.02 ppm TWA, - Skin 1203 Hexone (Methyl isobutyl ketone) 108-10-1 100 ppm TWA 50 ppm TWA 75 ppm STEL NIOSH REL*** - e 50 ppm TWA * OSHA's TWA limits are for 8-hour exposures; its STELs are for the durations specified; and its ceilings are peaks not to be exceeded for any period of time. ,,' ** The ACGIH TWA-TLV is for an 8-hour exposure; its STELs are 15-minute limits not to be exceeded more than 4 times per day with a minimum of 60 minutes between successive STEL exposures; and its ceilings are peaks not to be exceeded for any period of time. *** N10SH TWA limits are for 10-hour exposures unless otherwise specified, and its ceilings are peaks not to be exceeded for any period of time unless a duration is specified in parentheses. ettJLmQ CODE 4510-26-C M SL 042805) f v. -i*X' Federal Register / Vol. 53, No. 109 / Tuesday, June 7. 1988 / Proposed Rules 21051 Many compounds that damage the trier. such as 1,1,2,2-tetrachloroethane, also cause an abnormal accumulation of f.it. especially triglycerides, in liver ceils. In experimental animals this effect is manifested as an accumulation of microscopic vacuoles in liver celis. In humans, however, the only grossly detectable manifestation of this effect is increased liver size, which is an indication of severe fat accumulation in. the liver. At sufficiently high doses, most substances that damage the liver cause cr.il death that leads to tissue necrosis or gangrene. This necrosis may initially be localized, but at higher or more sustained exposure levels the entire liver may be involved. Moderate to severe liver necrosis is usually accompanied by increased concentrations of marker enzymes such as glutamate-pyruvate transaminase or g'.utamaie-oxaloacetate transaminase in the serum: the detection of these substances in the serum of exposed individuals can thus be a useful diagnostic tool- Doss-Response Characteristics The development of liver and other organ damage in humans and animals is progressive; it begins with subcellular changes, progresses to the cellular level, and is finally manifested as whole-organ damage. This progression is related to the intensity/duration of dose; t.e,, as dose increases, cellular death becomes widespread and eventually causes liver dysfunction. The extent to which liver damage is reversible follows a similar continuum; since the liver can regenerate, minor cellular damage or transient disease states are usually reversible if exposure ceases. However, if exposure continues, the capacity of the liver to regenerate is exceeded and permanent damage results. As is the case for some chemically induced toxic effects, there appears to be a NOE level below which hepatotoxic effects do not occur. The following paragraphs describe OSHA's preliminary results for all of the substances in this group of hepatotoxins and discuss the nature of the risk experienced by exposed workers. ALLYL CHLORIDE CAS: 107-05-1: Chemical Formula: CH;sCHCHiCI H.S.No. 1011 The current OSHA PEL for ally! chloride is a 1 ppm (3 mg/m*J frhour TWA; the ACGlH-recommended TLVTWA is also 1 ppm. with a 15-ralnute STEL of 2 ppm. NiOSH has recommended a 1 ppm 10-hour TWA and a 3 ppm lS-minute STEL for this substance. Allyl chloride is a colorless proposing a new limit for carbon liquid with an unpleasant, pungent odor. tetrabromide. At the time of the final Studies of animal exposures to allyl rule, OSHA will promulgate a new limit chloride indicate that the chemical is if the Agency determines that this limit among the most toxic of the halogenated will substantially reduce significant risk. aliphatic hydrocarbons, producing mucous membrane irritation, mild narcosis, and, at higher concentrations, histologic lesions of the lungs and kidneys (Adams, Spencer, and Irish 1940). Even single exposures lasting only a few minutes at concentrations between 1 and 100 mg/liter (332 to 32,000) caused mucous membrane irritation in various laboratory animals (Adams, Spencer, and Irish 1940). Further animal studies have confirmed liver and kidney pathology in many species (Torkelson. Wolf, Oyen, et at 1959) and female rats exhibited kidney . pathology after exposure to 3 ppm for 6 months. Human exposures to concentrations of 1 to 113 ppm caused abnormal liver test results (Hausler and Lenich 1963). o-CHLOROSTYRENE CAS: 2039-87--t; Chemical Formula: QHtCI H.S. No. 1089 OSHA has no current limit for o- - chlorostyrene. The ACGIH recommends a TLV-TWA of 50 ppm with a TLV- . STEL of 75 ppm. o-Chlorostyrene is a liquid* > In an unpublished report, the Dow Chemical Company (19tf3) describes the results of an o-dilorostyrene inhalation study in rats, rabbits, guinea pigs, and dogs. Dow exposed the animals to an average concentration of 101 ppm for 7 hours daily, S days a week, for a total of 130 exposures in 180 days. No adverse effects were observed in any species in terms of appearance, growth, behavior, mortality, hematology, BUN. alkaline OSHA therefore proposes that bath a STEL of 2 ppm and'a 1 ppm TWA are required. The Agency preliminarily concludes that a combined limit is necessary to protect employees from the risk of mucous membrane irritation potentially associated with the elevated short-term exposures to allyl chloride currently permitted by the 8-hour TWA alone. The health evidence forms a reasonable basis for proposing a revision to this level. At the time of the final rule. OSHA will establish a new limit for allyl chloride if the Agency determines that this limit will substantially reduce significant risk, CARBON TETRASROMIDE CAS: 558-13-4: Chemical Formula: CBr, H.S. No. 1072 phosphatase, SGPT, BSP. organ weights, or gross pathology (Dow Chemical Company, unpublished report, 1973). Microscopic examination of animal tissue revealed a somewhat higher incidence of pathological liver and kidney changes. There ia evidence indicating that the warning properties of o-chlorostyrene da not permit workers to recognize concentrations of o~ chlorostyrene of 100 ppm. Based on o- chlorostyrene's structural analogy to ~ styrene, for which short-term exposures of 100 ppm have been demonstrated to produce neuropathic and narcotic . effects (Stewart, Dodd. Baretta, end Schaffer 1968), a short-term timit is necessary (ACGIH 1988. pL 136). > OSHA is proposing a PEL of 50 ppm OSHA's current Z tables have no limits for exposure to carbon tetrabromide. The ACGIH limit is a 0.1 ppm TWA and a 0.3 ppm STEL. Carbon tetrabromide's hepatotoxic effects include both fatty infiltration and necrosis. The 0.1 ppm and 0.3 ppm levels were selected based on an observed no- effect level at 0.1 ppm; this finding derives from a study in which rats were exposed to carbon tetrabromide by inhalation for 7 hours per day, 5 days per week for 6 months (Torkelson and Rowe 19Sl). OSHA believes that controlling workplace exposures to these levels will prevent adverse effects in exposed workers. OSHA as an 8-hour TWA and a 15-tninute STEL of 75 ppm for o-chlorostyrene. The Agency preliminarily concludes that both of these limits will protect against the risk of narcosis and neuropathy to which woikers could potentially be exposed in the absence of any OSHA limit. The health evidence forms a reasonable basis for proposing a revision to this leveL At the time of the final rule, OSHA will establish a new ' limit for o-chlorostyrene if the Agency determines that tliis limit will substantially reduce significant risk. CYCLOHEXANONE CAS: 108-94-1; Chemical Formula: CiHhO H.S. No. 1108 preliminarily concludes that establishing OSHA has a current limit of 50 ppnr ; a limit for this previously unregulated TWA for cyclohexanone. Both the chemical will protect workers against ACGIH and NIOSH recommend a time-' the risk of experiencing its hepatotoxic weighted average of 25 ppm, and the effects and will achieve a substantial ACGIH also recommends a skin reduction in this risk. The health notation. Cyclohexanone is a white to evidence forms a reasonable basis for . pale yellow oily liquid with an odor SL 042806^ 21052 Federal Register / Vol. 53, No, 109 / Tuesday, June 7, 1988 / Proposed Rules similar to that of acetone and peppermint. Cyclohexanone has a low order of acute toxicity in animals. A concentration of 2000 ppm inhaled for 4 hours was lethal to 1 of 6 rats: at 4000 ppm. all of the exposed animals died. In rabbits, the dermal LD50 was 1000 mg/kg (Smyth et al. 1969). Rabbits showed marked irritation and some corneal injury when undiluted cyclohexanone was instilled in the eye (Carpenter and Smyth 1946). Guinea pigs exposed to 4000 ppm for 6 hours showed narcotic symptoms, lacrimation, salivation, depression of body temperature and heart rate, and corneal opacity (Specht et al. 1940). Rabbits exhibited degenerative changes of the liver and kidneys after 50 daily 6-hour inhalation exposures to 190 ppm (Treon. Crutchfield, and Kitzmiller 1943). Exposures to 309 ppm cyclohexanone on the same regimen caused conjunctival congestion, while exposures to 3000 ppm were lethal to some of the exposed animals (Treon. Crutchfield, and Kitzmiller 1943). In humans. Nelson and co-workers (1943) report that irritation caused by exposure to cyclohexanone was intolerable at 50 ppm. however, 25 ppm was not objectionable to mosl subjects in 3- to 5-minute exposures. OSHA is proposing a 25-ppm 8-hour TWA and a skin notation for cyclohexanone. The Agency preliminarily concludes that these two limits will prevent the risk of respiratory and skin irritation associated with cyclohexanone exposures at levels below the existing PEL of 50 ppm. The health evidence forms a reasonable basis for proposing a revision to this level. At the time of the final rule, OSHA will establish a new limit for cyclohexanone if the Agency determines that this limit will substantially reduce significant risk. DIOXANE CAS: 123-91-1: Chemical Formula: OlCILCIbkO H.S. No. 1145 OSHA's current PEL for dioxane is 100 ppm as an 8-hour TWA. with a skin notation. NIOSH recommends a t-ppm 30-minute ceiling for dioxane. and the ACGIII has established a 25-ppm TLVTWA. with a skin notation. The proposed 25-ppm PEL reflects new toxicological data for this substance. A 2-year drinking water study conducted by the Dow Chemical Company, in which male and female rats were given water containing 1.0,0.1, or 0.01 percent dioxane. showed that animals given the highest dose developed liver and nasal tumors, as well as pathological changes In the liver and kidney. Rats in the 0.1- percent group showed renal tubular paper by Kozik (1957) reported that sloughing and hepatocellular workers generally exposed below 16 degeneration but no significant increase ppm but occasionally exposed to levels in neoplasms. Because this study between 30 and 50 ppm experienced demonstrated hepato- and nephrotoxic adverse liver and nervous system effects at doses 10 times lower than the effects. In addition. Brzozowski (1954) dose causing cancer in animals, the reported abnormal changes in the blood ACGJH established the TLV based on of 50 percent of workers (8 of 16) dioxane's liver and kidney effects rather exposed to between 10 and 37 ppm of * - than its carcinogenicity. A study by ethylene dichloride. The ACGIH also - Torkelson et al. (1974) irr four species of cited numerous animal studies that animals exposed to multiple daily consistently show hepatotoxic effects ' airborne exposures of dioxane at 50 ppm caused by exposure to ethylene - = `; showed no gross or histopathologic - - dichloride: the ACGIH concluded that ' ' organ changes, leading the ACGIH to . ethylene dichloride "clearly belongs in recommend 25 ppm as an appropriate the group of hepatotoxic halogenated . r level to protect against liver and kidney hydrocarbons" (ACGIH 1986). Based on effects in exposed workers (ACGIH these findings, the ACGIH (1986) - - 1986). In this case, the ACGIH is using a recommended a reduction in the 8-hour :-jj? safety factor to establish the 8-hour TLV-TWA to 10 ppm. ~ is limit, i.e.. is applying a safety factor of 2 to the results of an animal study in four species that showed no gross or histopathological changes at 50 ppm. The 25-ppm TLV is based on hepatoand nephrotoxic effects, since the ACGIH evaluation-determined that these effects were more severe than the potential for carcinogenicity. OSHA does not generally accept such a rationale: however, OSHA is unable to perform the necessary risk assessment to evaluate the question of carcinogenicity in time for this rulemaking. The 1-pprn (ceiling) REL is based on cancer potential and appears to represent the "lowest concentratfon reliably measured," a criterion that would not satisfy OSHA feasibility requirements. OSHA therefore proposes that a PEL of 25 ppm TWA. with a skin notation, be adopted at the present time to reduce the risk that currently exists. As future priorities permit, OSHA will consider the need for a more stringent PEL In August 1978, NIOSH recommended that exposure to ethylene dichloride be minimized in response to an NCI Y"'.-# bioassay (1976) showing that ethylene ` dichloride induced liver cancer in both .^g sexes of mice and rats. NIOSH (1978) subsequently recommended a 1-ppm 10-' hour TWA and a 2-ppm 15-minute short-.. ^ term limit, ' OSHA preliminarily concludes that .j&t the studies of Kozik (1957) and 1 Brzozowski (1954) clearly indicate that a risk of hepatotoxicity, nervous system ' effects, and hematopoietic effects exists at the current 50-ppm 8-hour TWA PEL vjg The 10-ppm TLV recommended by the ^ ACGIH does not afford protection at the' levels (10 to 37 ppm) where abnormal ,yr blood changes were measured in 50 , ^ percent of the workers studied. .. Therefore, OSHA believes it necessary' to reduce its current limits for ethylene ^ dichloride to reduce this risk (as well asp^ to protect against potential carcinogenic, effects) and is proposing to revise these limits to 1 ppm as a TWA and 2 ppm a* ETHYLENE DICHLORIDE * * a STEL The Agency's preliminary .. CAS: 107-06-2: Chemical Formula: CICHCHiCl H.S- No. 1166 t feasibility analysis is based on limited data at these levels: OSHA requests additional feasibility information front The current OSHA standard for . the public. The health evidence forms fc.vjs- ethylene dichloride is SO ppm as an 8- reasonable basis for proposing a ' hour TWA. a 100-ppra ceiling (maximum revision to thU level. At the time of the ' duration of 3 minutes in any 3 hours), ; final rule. OSHA will establish a new ' p'.-lp and a 200-ppm peak; these limits were limit for ethylene dichloride if the derived from limits recommended by the Agency determines that this limit will "..'CS American National Standards Institute substantially reduce significant risk. ` in 1969. In 1980. the ACGIH reduced its TLV to 10 ppm as an 8-hour TV/A. NIOSH (1978) has concluded that ethylene dichloride should be HYDRAZINE ' ' :t CAS: 302-01-2: Chemical Formula: HjN-NH - . H.S.N0.120S .- considered a potential human . The current OSHA.limit for hydrazine ` g carcinogen and has recommended 1- is.l ppm as an 8-hour TWA. with a skin ^ ppm 10-hour TWA and 2-ppm 15-minute notation. The ACGIH (1986) has short-term limits. Several studies recommended a TLV-TWA of 0.1 ppm."'iTrvf indicate that the current OSHA PELs are also with a skin notation. Because of its insufficient to protect workers against potential carcinogenic hazard. NIOSI1 hepatotoxic and other adverse effects. A (1978a) has recommended that SL 042807) r C 8/10/87 PROTOCOL FOR WED X COL SURVEILLANCE OF THE LAKE CHARLES PERIV PURPOSE s/k /? PPG Industries' policy is to protect being of its employees and to be inc applicable laws, standards, rules and in. the Blueprint. These guidelines a Charles physicians assessing employee the Derivative Area of that plant. T meant to assist the Lake Charles plan implementing the policy. PPG physici exercise their clinical judgements an consult with the PPG Corporate Medica EMPLOYEES INCLUDED -- Employees assigned, or with the potential for assignment (shipping and operations employees and maintenance employees) to the Derivative Area, will participate in the Lake Charles "Derivative" medical surveillance program. EXAMINATION FREQUENCY Examinations will be given prior to assignment in the Derivatives Area, and at least annually thereafter. Employees who have worked in the area for ten (10) years or longer will have semi-annual examinations (containing the elements in the following section titled SCOPE OF EXPMIN-- . ATIONS) done in addition to their annual examinations. Employees who are covered must be followed under the corporate Health Care Policy until applicable latency periods have expired. SCOPE OF EXAMINATIONS The annual examinations include the following elements from the OSHA Vinyl.Chloride Standard (9 CFR 1910.1017): 1. A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalities in the skin, connective tissue and the pulmonary system, 2. Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), 3. Medical and Woi-k History (see those listed under section titled MEDICAL AND WORK HISTORY). The examinations provided semiannually to those employees r c 8/10/87 PROTOCOL FOR MEDICAL SURVEILLANCE OF EMPLOYEES AS5IGNED TO THE LAKE CHARLES DERIVATIVE AREA PURPOSE PPG Industries' policy is to protect the health and well, being of its employees and to be in compliance with all applicable laws, standards, rules and regulations as outlined in the Blueprint. These guidelines are provided for the Lake Charles physicians assessing employees assigned to work in the Derivative Area of that plant. These guidelines are meant to assist the Lake Charles plant physician in implementing the policy. PPG physicians will continue to exercise their clinical judgements and are encouraged to consult with the PPG Corporate Medical Director. EMPLOYEES INCLUDED Employees assigned, or with the potential for assignment (shipping and operations employees and maintenance employees) to the Derivative Area, will participate in the Lake Charles "Derivative" medical surveillance program. EXAMINATION FREQUENCY Examinations will be given prior to assignment in the Derivatives Area, and at least annually thereafter. Employees who have worked in the area for ten (10) years or longer will have semi--annual examinations (containing the elements in the following section titled SCOPE OF EXAMIN ATIONS) done in addition to their annual examinations. Employees who are covered must be followed under the corporate Health Care Policy until applicable latency periods have expired. SCOPE OF EXAMINATIONS The annual examinations include the following elements from the OSHA Vinyl .Chloride Standard (29 CFR 1910.1017)1 .1- 2. 3. A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalities in the skin, connective tissue and the pulmonary system, Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), Medical and Work History (see those listed under section titled MEDICAL AND WORK HISTORY). The examinations provided semiannually to those employees SL 042809 r c 8/10/87 with ten CIO) on more yeans of possible exposure to vinyl chloride include the following: 1. Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), 2. A clinical examination that includes a stethoscope examination of the heart and lungs, 3. Palpation of the abdomen and back for abnormalities of liver, spleen and kidneys. 4. Examination of the skin. BLOOD CHEMISTRY PROGRAM 1. Fasting blood chemistries will be drawn for all examinations per the above criteria. These chemistries must include those mandated by the OSHA Vinyl Chloride Standard. These are: Total Bilirubin Alkaline Phosphatase Aspartate Aminotransferase (AST or SGOT) Alanine Aminotransferase (ALT or SGPTJ Gamma--G1utamyl Transpeptidase (GGTP) In addition to these, a triglyceride and cholesterol analysis must also be performed. 2. If any of the screening tests are abnormal (by the limits of the laboratory performing the analysis), a second sample should be obtained within four weeks. If this is normal, an additional confirming sample must be obtained in not than four nor more than 12 weeks following the first sample). less (normal 3. If the analysis of the second sample yields more than one blood chemistry as abnormal (especially if an increasing trend is noted in a test result), or if there is an isolated result that is greater than 2.0 times normal, consideration should be given to restricting the individual from the Derivatives Area. Additional tests which may be useful are included in Appendix A of the OSHA Vinyl Chloride Standard. specific for liver disease and the examining physician must therefore evaluate each employee on an individual basis. If the plant physician feels the need clinically for a second opinion to help arrive at a decision on restriction, a gastroenterologist (who is knowlegable of the OSHA Vinyl loride Standard) should be consulted. MED I CAL and IJDRK HISTORY An employee medical and work history must be taken and kept i The medical-------------------- j history topics identified by the OSHA 1- alcohol intake\ taken Vinyl swhiiuaal*l AiniicLliuuduter tuhiiousae Chloride Standard: SL 042810) Revised 5/11/89 2. past history of hepatitis; 3. work history and past exposure to hepatotoxic agents; including drugs and chemicals; 4. past history of blood transfusions; 5* past history of hospitalization. In addition, information as to exposure to hepatotoxins can be obtained from the current industrial hygiene air monitoring data base for the job assigned the employee. RISK FACTORS The physicians and his staff will work with each employee on an individual basis to determine and suggest modifications to reduce any risk factors which could be causing or contributing to abnormal blood chemistry results. WORK RESTRICTIONS An employee must be restricted from the Derivatives Area whenever the examination reveals clinical findings that, coupled with abnormal blood chemistries, indicate a medical condition which could place the employee at risk. Employees at risk will remain restricted and followed until the condition returns to normal or until the etiology of the condition has been possibly identified and documented. AIR MONITORING REQUIREMENT 1. A current exposure profile for each job and a copy of the employees individual monitoring results shall also be maintained in the medical records for review by the plant physician. SL 0*2811 PROTOCOL FOR MEDICOL SURVEILLANCE OF EMPLOYEES ASSIGNED TO THE LAKE CHARLES DERIVATIVE AREA PURPOSE PPG Industries' policy is to protect th being of its employees.and to be in com, applicable -laws, standards, rules and -r in the Blueprint. These guidelines are .Charles physicians assessing employees the Derivative Area of that plant. The meant to assist the Lake Charles plant implementing the policy. PPG physician exercise their clinical Judgements and . consult with the PPG Corporate Medical : EMPLOYEES INCLUDED Employees assigned, or with the potent1 (shipping and operations employees and to the Derivative Area, will participate *t. "Derivative" medical surveillance program. EXAMINATION FREQUENCY i_tane uidr' Jt ea Examinations will be given prior to assignment in the Derivatives Area, and at least annually thereafter. Employees who have worked in the area for ten (10) years or longer will have semi-annual examinations (containing the elements in the following section titled SCOPE OF EXAMIN ATIONS) done in addition to their annual examinations^ Employees who are covered must be followed under the corporate Health Care Policy until applicable latency periods have expired. SCOPE OF EXAMINATIONS The annual examinations include the following elements from the OSHA Vinyl Chloride Standard (29 CFR 1910.1017) : 1. A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and foe abnormalities in the skin, connective tissue and the pulmonary system, 2. Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), 3. Medical and Work History (see those listed under section titled MEDICAL AND WORK HISTORY). The examinations provided semiannually to those employees SL 042812 PROTOCOL FOR MEDICAL SURVEILLANCE OF EMPLOYEES ASSIGNED TO THE LAKE CHARLES DERIVATIVE AREA PURPOSE PPG Industries' policy is to protect the health and well being of its employees and to be in compliance with all, applicable laws, standards, rules and regulations as outlined in the Blueprint. These guidelines are provided for the Lake Charles physicians assessing employees assigned to work in the Derivative Area of that plant. These guidelines are meant to assist the Lake Charles plant physician in implementing the policy. PPG physicians will continue to exercise their clinical judgements and are encouraged to consult with the PPG Corporate Medical Director. EMPLOYEES INCLUDED Employees assigned, or with the potential for assignment (shipping and operations employees and maintenance employees) to the Derivative Area, will participate in the Lake Charles "Derivative'* medical surveillance program. EXAMINATION FREQUENCY Examinations will be given prior to assignment in the Derivatives Area, and at least annually thereafter. Employees who have worked in the area for ten (lO) years or longer will have semi-annual examinations (containing the elements in the following section titled SCOPE OF EXAMIN ATIONS) done in addition to their annual examinations. Employees who are covered must be followed under the corporate Health Care Policy until applicable latency periods have expired. SCOPE OF EXAMINATIONS The annual examinations include the following elements from the OSHA Vinyl Chloride Standard (29 CFR 1910.1017): 1. A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormal it ies in the skin, connective tissue and the pulmonary system, . Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), 3. Medical and Work History (see those listed under section titled MEDICAL AND WORK HISTORY). The examinations provided semiannually to those employees SL 042813 with ten (lO) or* more years of possible exposure to vinyl chloride include the following: 1. Blood chemistries (see those listed under section titled BLOOD CHEMISTRY PROGRAM), 2. A clinical examination that includes a stethoscope examination of the heart and lungs, 3. Palpation of the abdomen and back for abnormalities of liver, spleen and kidneys. 4. Examination of the skin. BLOOD CHEMISTRY PROGRAM 1. Fasting blood chemistries will be drawn for all examinations per the above criteria. These chemistries must include those mandated by the OSHA Vinyl Chloride Standard. These are: Total Bilirubin Alkaline Phosphatase Aspartate Aminotransferase (AST or SGOT) Alanine Aminotransferase (ALT or SGPT) Gamma--G1utamyl Transpeptidase (GGTP) In addition to these, a triglyceride and cholesterol analysis must also be performed. 2. If any of the screening tests are abnormal (by the limits of the laboratory performing the analysis), a second sample should be obtained within four weeks. If this is normal, an additional confirming sample must be obtained in not less than four nor more than 12 weeks following the first (normal sample). 3. If the analysis of the second sample yields more than one blood chemistry as abnormal (especially if an increasing trend is noted in a test result), or if there is an isolated result that is greater than 2.0 times normal, consideration should be given to restricting the individual from the Derivatives Area. Additional tests which may be useful are included in Appendix A of the OSHA Vinyl Chloride Standard. The blood chemistries are primary screening tests performed to detect abnormal liver function ; however, they are not specific for liyer disease and the examining physician must therefore evaluate each employee on an individual basis. If the plant physician feels the need clinically for a second opinion to help arrive at a decision on restriction, a gastroenterologist (who is knowlegable of the OSHA Vinyl Chloride Standard) should be consulted. MEDICAL and 14QRK HISTORY An employee medical and work history must be taken and kept current. The medical history taken shall include those topics identified by the OSHA Vinyl Chloride Standard: 1. alcohol intake; 2. past history of hepatitis 3. work history and past exposure to hepatotoxic agents, including drugs and chemicals; 4. past history of blood transfusions; 5. past history of hospitalization. In addition, information as to exposure to hepatotoxins can be obtained from the current industrial hygiene air monitoring data base for the job assigned the employee. RI5K FACTORS The physician and his staff will work with each employee on an individual basis to determine and suggest modifications to reduce any risk factors which could be causing or contributing to abnormal blood chemistry results. WORK RESTRICTIONS An employee must be restricted from the Derivatives Area whenever the examination reveals clinical findings that, coupled with abnormal blood chemistries, indicate a medical condition which could place the employee at risk. Employees at risk will remain restricted and followed until the condition returns to normal or until the etiology of the condition has been possibly identified and documented. SPECIAL AIR MONITORING REQUIREMENT 1. Employees with abnormal blood chemistries will have personal monitoring performed weekly as long as the employee remains in the Derivative Area. .% 2. A current exposure profile for each job and a copy of the employees individual monitoring results shall be maintained in the medical records for review by the plant physician. SL 042815 /