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 January 3, 2005 OSHA Docket Office Re: Comments on Proposed Rule on Occupational Exposure to Hexavalent Chromium, 69 Fed. Reg. 59305 (October 4, 2004); OSHA Docket No. H-054A To Whom It May Concern: The Society of the Plastics Industry, Inc. ("SPI") submits these comments in response to the Occupational Safety and Health Administration's ("OSHA's") Request for Comments on its Proposed Rule on Occupational Exposure to Hexavalent Chromium issued on October 4, 2004.[1] OSHA proposed three standards to address workplace exposures to hexavalent chromium in Construction, General Industry and Maritime sectors. SPI's comments focus on the proposed rule for General Industry, and extending some of the provisions of the proposed Construction standard to General Industry. SPI appreciates the opportunity to comment on the proposed rule for occupational exposure to hexavalent chromium, as it has the potential to have a great impact on the plastics industry. Founded in 1937, SPI is the trade association representing one of the largest manufacturing industries in the United States. SPI's members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw material suppliers. The U.S. plastics industry employs more than 1.4 million workers and provides more than $310 billion in annual shipments. For more information on SPI, please visit our web site at www.plasticsindustry.org. SPI's comments are based on its longstanding experience with promoting safe and healthful working conditions in the plastics industry. On September 19, 2002, SPI and OSHA entered into an alliance to provide employers and employees in the plastics industry with information and guidance geared toward identifying and eliminating hazards in the workplace. Products of the Alliance include train-the-trainer modules for machine safety (machine guarding and lockout/tagout) for injection molding (June 2003), rollstock and sheet extrusion (April 2004), and roll-fed and inline thermoforming (August 2004). These machine safety training modules are available on OSHA's website as a result of this on-going collaboration. SPI actively promotes these resources to its members and is using these tools in training programs across the country. For more information on the Alliance, the public may visit http://www.plasticsindustry.org/public/worksafe/alliance.htm or OSHA's web site at http://www.osha.gov/dcsp/alliances/spi/spi.html. I. HIGHLIGHTS OF THE PROPOSED RULE As recognized by OSHA, plastic colorant producers and users are among the employers that are affected by the Proposed Rule.[2] OSHA indicates that CrVI exposure may occur in the plastics industry because hexavalent chromium-containing pigments are used in colorants for plastics - e.g., chrome yellow, chrome orange, molybdate orange, and chrome greens. These pigments are used to color vinyl, low-temperature polyolefin and polystyrene resins, and epoxy-phenolics and polyurethanes. As a result, OSHA identified plastic colorant producers and users as one of the major industries and processes where CrVI is used.[3]> The CrVI proposal is expected to significantly affect virtually every other sector of the plastics industry as well. CrVI can be produced during welding of metals containing chromium, such as stainless steel or other high chromium steels. Therefore, welding operations associated with maintenance or construction at plastics manufacturing, processing, and equipment facilities are potentially affected. In addition, CrVI exposure may occur during chrome plating of plastic substrates to improve corrosion resistance and provide protective coatings for automotive and equipment accessories, and the proposed rule would apply to exposures that may result from the use of portland cement in General Industry.[4]. OSHA is proposing a permissible exposure limit (PEL) of one microgram (µg) of CrVI per cubic meter (m3) of air as an 8-hour time weighted average (8-hr. TWA). The existing PEL for hexavalent chromium is 52 µg/m3 and was adopted in 1971. Cal-OSHA has established a PEL of 0.01 mg/m3.[5] The proposed standard for General Industry includes a 0.5 µg/m3 action level (8-hr. TWA). The purpose of the action level is to trigger the requirements for exposure monitoring and medical surveillance. As in other standards, the action level has been set at one-half of the PEL (there is no action level proposed in corresponding rules for Construction and Maritime activities). In addition, the following control measures are proposed:
II. THE LEGAL CRITERIA REQUIRED TO SUSTAIN AN OCCUPATIONAL SAFETY AND HEALTH STANDARD OSHA is generally authorized to adopt occupational safety and health standards, as defined in § 3(8) of the Occupational Safety and Health Act (OSH Act), in accordance with the procedures and criteria in § 6(b) of the OSH Act. We say "generally" because the exercise of that authority is also subject to the Administrative Procedures Act, the Paperwork Reduction Act, the Regulatory Flexibility Act, Executive Order 12866, the Small Business Regulatory Enforcement and Fairness Act, and the U.S. Constitution. Section 3(8) of the OSH Act defines the term occupational safety and health standard as follows:
Generally, to sustain a standard on judicial review as being reasonably necessary or appropriate, OSHA must demonstrate the following:[6]
In the case of health standards proposed to address toxic substances, a proposed standard must, to the extent technically and economically feasible, reduce workplace exposures to a level below that which presents a significant risk of material impairment of health or functional capacity to employees. [Emphasis added].[12] In addition to the foregoing statutory criteria, OSHA must also satisfy the following requirements:
Executive Order (EO) No. 12866, titled "Regulatory Planning and Review", sets forth the guidelines that OSHA and other executive branch agencies must follow when seeking to adopt new rules.[18] These guidelines include the following:
Further, pursuant to P.L. 106-554, The Data Quality Act, Congress directed the Office of Management and Budget (OMB) to issue government-wide guidelines (and each covered agency to adopt conforming guidelines) for ensuring and maximizing the quality, objectivity, utility and integrity of information distributed by Federal agencies.[19] The term "quality" encompasses "objectivity", "utility" and "integrity." The term "utility" refers to the usefulness of the information to its intended users, which in this case would be primarily OSHA, the employer community and the employee community. The term "objectivity" means the information is both (a) accurate, reliable and unbiased, and (b) presented in an accurate, clear, complete and unbiased manner with transparent documentation to the source (subject to confidentiality protections that we do not believe are present in this case). To ensure accurate, reliable and unbiased information in a scientific, financial or statistical context - as is this case - the original and supporting data must be generated and the analytical results developed using sound statistical and research methods. Where the information is "influential scientific, financial or statistical information" - information that will or does have a clear and substantial impact on important public policies or private sector decisions - it is subject to stricter quality standards that would facilitate reproducibility by qualified third parties. The term "integrity" means the information is protected from unauthorized access or revision. We compare OSHA's proposed rule with the foregoing legal requirements and offer suggestions for addressing certain deficiencies, first as they affect the plastics colorant industry, and then as they affect the entire plastics industry. III. AREAS IN WHICH COMPLIANCE COSTS FOR THE PLASTICS INDUSTRY HAVE BEEN UNDERESTIMATED During the course of this rulemaking, OSHA's compliance cost estimate for the plastics colorant manufacturers and users has changed significantly. In its initial cost estimates, OSHA had presumed that engineering and work practice control measures would be implemented for each employee with ambient airborne exposures above the PEL at least one day per year. Under section (f)(1)(ii) of the proposed General Industry rule, an employer may rely on PPE (rather than engineering controls and work practices) to meet the PEL and is exempt from the medical surveillance requirements with respect to employees who are exposed above the PEL for less than 30 days in a 12-month period. SPI supports OSHA's decision to include this 29-day provision. After proposing this 29-day provision, OSHA adjusted its projected engineering costs for affected industries, including plastics colorant producers and users. Based on the assumed impact of the 29-day provision, OSHA determined that the entire plastic colorant producer and user industry could comply with the PEL without incurring any additional costs for the purchase, modification or maintenance of engineering controls. We believe this determination is incorrect and is not supported by any evidence. Furthermore, OSHA's analysis does not account for the likely costs associated with welding operations in connection with maintenance activities in the plastics industry. A significant portion of the welding activities in plastics industry facilities is performed by contract welders who are likely to have more than 30 days per year of ambient exposures above the PEL. This means that either directly or indirectly the plastics industry will bear the costs of any required engineering controls. Currently, OSHA estimates that the plastic colorant producers and users industry will not face any costs in implementing engineering controls.[20] Engineering control costs for this sector should be included in the rulemaking. In its industry specific cost factors study performed during the SBREFA process,[21] OSHA estimated that the cumulative annualized costs to Large Plastic Colorant Producer and User Establishments for engineering capital costs would be $1,636,534.00 to meet the action level, and $238,134.00 to meet the proposed PEL.[22] This drastic difference is due to the costs associated with the installation of "toxic material bag openers" that OSHA claims would be required to reduce exposures below the proposed action level. In the same analysis, OSHA estimated that the cumulative annualized costs to small plastic colorant producer and user establishments for engineering controls would cost $996,551.00 to meet the proposed action level and $312,551.00 to meet the proposed PEL.[23] Again, the difference in costs is due to the installation of toxic material bag openers. Subsequently, OSHA has amended its supporting industry profile document for plastic colorant producers and users to reflect that: "[d]ue to the limited use of hexavalent chromium in this industry sector, it is estimated that each of the establishments in this industry sector use hexavalent chromium for less than 29 days per year."[24] It is unclear how or why OSHA determined that the 29-day rule would exempt an entire industry from engineering controls.[25] It is also unclear why OSHA has not accounted for potential costs associated with welding activities in the plastic colorant producer and user industries. As a general matter, SPI supports the concept of the 29-day provision. SPI thinks that this provision will assist many of its members with respect to certain limited activities, such as the spot-welding activities of on-site maintenance personnel. The use of respirators is an effective means of compliance for employees whose exposure above the PEL does not exceed 29 days per year. This provision is especially practical in plastics facilities where spot welding activities are performed for short periods of time throughout the year. SPI supports OSHA in allowing these and other employers to use respirators to manage exposures to CrVI. Nevertheless, SPI cautions OSHA not to presume that the 29-day engineering control exemption will satisfy the compliance needs of all plastics colorants producers and users, due to the wide variety of products they produce and the manner in which they produce them. OSHA itself estimates that 37.5% of large plants, and 38% of small plants in the plastics colorant producers and users sector have workers exposed to levels of CrVI above the proposed PEL.[26]. This is a significant estimate, and OSHA does not provide an adequate explanation as to why the approximately 38% of the plastics industry that is above the proposed PEL would qualify for the 29-day exemption. OSHA only states that "...in some industries (e.g., color pigment manufacturing), exposure to CrVI is typically infrequent (i.e., few than 30 days, over 12 consecutive months)."[27]. It is not realistic for OSHA to expect that the entire industry will be able to use the 29-day provision as the sole means of compliance for all potentially affected activities. While SPI is very supportive of OSHA's decision to include a 29-day rule for engineering control practices, this 29-day rule is unlikely to benefit plastic colorant users whose employees work around dry color blending and packaging areas all year. At some facilities, employees who mix dry colorants into the pre-mixing hoppers may be exposed to CrVI at low levels throughout the year for a cumulative duration of 30 or more days per year. Exposures can occur where small quantities of a colorant containing CrVI are used to make larger batches of another color or plastic. While some colorant producers may solely produce one CrVI pigment for less than 30 days in a year, it is likely that pigments containing CrVI are being used as one component of other colorants for more than 29 days in a 12-month period. Because colorants containing CrVI are used in small quantities for several different products, exposures may occur in some facilities throughout the year. The use of respirators is currently an effective means of keeping exposure levels below the proposed PEL. The way the proposed rule is currently structured may necessitate very expensive engineering controls, such as the toxic material bag openers discussed by OSHA in this rulemaking[28] and addressed further below. Colorant users mix and blend pigments to achieve a particular tint, which may necessitate the addition of pigments containing trace amounts of CrVI in very small amounts throughout the year. In contradiction to its zero-engineering cost finding for this sector, OSHA has made several findings concerning the need for add-on engineering controls in relation to plastics colorant producers and users. OSHA states that new or better maintained local exhaust ventilation ("LEV") may be needed in the plastic colorants sector as a result of the proposed rule.[29] OSHA states that plastic colorants producers may need to install process enclosures for difficult to control operations such as dusty operations.[30] These represent add-on engineering control costs for the industry. OSHA does not provide information on the estimated cost of new LEV systems or process enclosures for plastics colorant producers and users. In addition, OSHA has stated that plastic colorant producers and users would have to install and maintain air replacement systems and "toxic material bag openers" to control exposures to levels below the action level so as to avoid the costs of complying with the control measures that would be triggered by exposures above the action level.[31] SPI is not clear how OSHA decided upon this specific and costly technology recommendation. OSHA estimated that the cost of toxic material bag openers for the small plastic colorant producers and users would total $684,000.00.[32] During the SBREFA process, and before changing its estimated engineering costs to zero, OSHA estimated the costs of individual bag openers at $74,943.00.[33] OSHA also initially estimated that the total cost for small employers to achieve exposure levels below the proposed action level during the first year alone is $996,551.00.[34] SPI, through research in the industry, estimates that the preferred stainless steel toxic material bag opener model that is equipped to handle 50 lb. bags will cost employers $60 - 65,000.00. This does not include a secondary collector, secondary compactor, and secondary dust filter, all of which would be needed in handling dry pigments because of the residual pigments released when the bags are opened. The stainless steel secondary collector would cost an additional $7500.00. The secondary compactor for empty 50 lb. bags would cost approximately $12,000.00. The secondary stainless steel dust filter would cost approximately $12,750.00. The total approximate cost for one of these machines is approximately $90,250.00.[35] This does not include shipping or installation (OSHA's estimate includes shipping, installation and start-up costs). Another cost associated with these machines is the cost of lost product. Many times the ventilation devices on these machines can draw in resins, solvents and other miscellaneous products to which the dry pigments are added. By taking away liquids, the toxic material bag openers have the capability of changing the viscosity and form of the intended plastics colorant. The cost of this lost product, and the time it takes to cure the problem (if there is a viable solution), are costs that OSHA has not taken into consideration. OSHA has underestimated the costs associated with initial and ongoing exposure monitoring under the proposed rule. OSHA estimates that the time, in hours, for an outside contractor (industrial hygiene technician) to conduct the initial monitoring is a total of 12 hours.[36] This estimate could only be accurate under the assumption that a facility could perform all of the monitoring for every task and employee in the same day. Many facilities have different shifts. Many facilities do not perform all of the tasks that may result in employee exposure to CrVI during the same day. For example, on the site visit to "Company O", a General Industry plastic colorant production facility, (discussed in more detail in Section IV of these comments) the IT Corporation notes that the facility manufactures batches of coating product that contain lead chromate only once every 3 to 5 months.[37] If the industrial hygiene technician came during a shift where a batch of lead chromate product was not being produced, clearly the technician would have to return for more monitoring. SPI argues that it would take an industrial hygiene technician a total of approximately 36 hours in order to conduct initial monitoring for every shift and task that may involve exposure to CrVI. Also, OSHA has failed to consider costs associated with retrofitting and upgrading existing ventilation systems, and the costs associated with placing ventilation units onto batch mixers and other similar vessels in close proximity to each other. The duct work of ventilation systems generally must be designed and constructed with a minimum number of 90 degree turns so that dry pigments do not build up and empty bags do not become lodged in the duct work. It is likely that existing plastic colorant producer and user facilities would face substantial construction and engineering costs (as well as down time) to reconfigure their processes to accommodate such new engineering controls. Thus, OSHA's data indicate the proposed rule is likely to put a significant economic burden on small businesses in this sector due to add-on engineering controls that would be needed to comply with the rule. The cost is extremely burdensome, and likely impossible to absorb, for many small employers in the plastics industry. Many employers in the plastics industry will have to incur these costs. As stated above, OSHA has a duty to promulgate rules that are both technically and economically feasible,[38] and a duty to base its decisions on the best available information relating to the economic consequences of the intended regulation.[39] In order to meet these legal requirements, alternatives are needed so that small businesses are not placed in the untenable position of having to choose between going out of business or non-compliance. IV. THE PROPOSED RULE OVERLOOKS PLASTIC COLORANT USERS OSHA has placed in the docket what it describes as an industry profile for the Plastic Colorant Producers and Users industry,[40] as well as a Site Visit Report prepared by IT Corporation at a plastic colorant production facility.[41]. Unfortunately, this information fails to capture the majority of operations in the plastics colorant producers and users industry. The "plastic colorant producer and user" industry consists of several distinct types of operations. Some "producers" manufacture the pigment that may contain some quantity of CrVI for color. Other types of "producers" take the dry pigments and mix them to produce a colorant that may be used in plastics products. Other types of plastics facilities will use the colorant to produce and color plastic pellets that may be shipped downstream for use in a final plastics product. These are very distinct operations, and they all involve different types and levels of potential exposure to CrVI. It appears that OSHA based its entire analysis of the plastics colorant producers and users industry on a single site visit to "Company O," a colorant producer.[42]. Producing color dispersions is only one aspect of a diverse plastics colorant community. Color dispersions are produced by combining dry powder pigments with resins, solvents, and other miscellaneous ingredients. As OSHA notes in the Company O visit, employee exposures may occur while dumping dry ingredients into the hoppers in the pre-mixing area. This is where the bags of dry pigments are opened and dumped into hoppers to be mixed with the liquid solvents. Once the dry colorant is blended with the solvent, there is little chance of exposure to CrVI. Based on this site visit, OSHA concluded that dumping dry pigments may create exposure levels above the proposed PEL. According to the site report, the local exhaust system in the pre-mixing area for Company O "...appeared to be ineffective, however, based on visual observation combined with ventilation measurements."[43] It is not clear whether this statement reflected a preliminary finding that the system might not be adequately designed and/or maintained, whether the system might lack adequate capacity or not be suited to the task, or whether there was some other meaning. In any event, we believe the standard for statistical reliability proposed by 1910.1026(d)(2)(ii) provides useful guidance as to when a single set of monitoring observations may be treated as representative of conditions involving a similar task. Using those criteria, or any comparable criteria, we believe it is fair to conclude that there is no sound scientific basis for treating the observations at one plastics colorant facility as representative of the range of different tasks performed across the entire plastics industry. It does not seem possible then for OSHA to be able to conclude, based on a visit to one facility, whether that facility is representative of the industry as a whole or met the standard of reliability for reliance on historical monitoring in proposed section 1910.1026(d)(2)(ii). Moreover, a site visit to an employer that is not listed under the same SIC codes as the industry being regulated is an insufficient basis upon which to characterize those other facilities. Company O is classified in SIC 2851, Paints, Varnishes, Lacquers, Enamels Allied Products. Company O produces some lead chromate-containing pigments. The SIC codes OSHA is relying on for plastic colorant users are: 2821, Plastics Materials and Resins and 308, Miscellaneous Plastics Products, nec.[44] It is improper to characterize Company O as a Plastic Colorant Product Facility, when Company O is properly classified in the SIC code for Paints and Varnishes. OSHA's decision to rely solely on Company O data leaves the Agency without a sufficient record on which to base its conclusions concerning the effect of the proposed rule on plastics colorant users. The regulations issued by OMB under the Information Quality Act require that federal agencies ensure the quality, utility and integrity of the information it disseminates.[45] In evaluating the impact of this rule on an entire industry without obtaining sufficient information, OSHA has not fulfilled its information quality requirements with regard to the plastics industry because it has no sampling data or analysis for plastic colorant users. The Agency also has not met its mandate under Executive Order 12866 that the agency base its decisions on the best reasonably obtainable scientific, technical, economic and other information concerning the need for, and consequences of this regulation.[46]. V. CONVERSION TO CrVI In the preamble to the Proposed Rule, OSHA discussed the potential for chemical conversion of other chromium containing compounds to CrVI. For example, OSHA discusses the fact that CrVI can be produced during welding operations where the chromium was originally present in another valence state. OSHA also notes that CrIII present in refractory bricks and coal ashes can be converted to CrVI during kiln heating. Because OSHA raises the possibility of conversion in the Preamble to this Proposed Rule, SPI would like to establish in the record the fact that conversion from CrIII to CrVI is highly unlikely to occur in plastics facilities using colorants containing CrIII. The processing conditions at plastics facilities are well below the temperatures and oxidization atmosphere necessary to achieve conversion. Any conversion to CrVI in the plastics industry would be immediately detected because it would change the color of the plastics products. SPI is unable to locate any references or literature that would suggest conversion is possible in the plastics industry, and SPI is unaware of any such conversions occurring in its members' facilities. In the absence of an effective catalyst, which would not be present during the plastics manufacturing process, conversion only occurs at temperatures of approximately 1900ºC. Plastics facilities are only heating plastics and colorants to areas that range from 200º to 300ºC. SPI is not aware of any evidence to suggest that conversion from CrIII to CrVI is possible at those temperatures and without the presence of highly oxidative conditions or some other chemical reaction. Additionally, free chromium ions must exist in order for CrIII to be converted to CrVI. In the absence of extreme levels of heat, conversion is unlikely where there are no alkalis or alkaline earth metal present in the raw materials as contaminants. Because none of these conditions exist in the plastic colorant producers or users facilities, it is not likely that conversions could take place under those conditions. If the chromium is bound, or "encapsulated" as is the case in some downstream plastics processes, the potential for oxidation to the hexavalent state is low. Finally, it would require highly oxidative conditions that do not exist in plastics facilities to convert CrIII to CrVI. SPI would like OSHA to recognize that because conversion is not possible in the plastics industry, plastic colorant producers and users that do not have CrVI-containing products in their facilities should not be subject to the monitoring requirements or any other provisions of the proposed rule. VI. SIGNIFICANT RISK AND FEASIBILITY ISSUES A. The Significant Risk Determination In performing its risk assessment for this proposed rule, OSHA relied primarily on two studies: the Gibb study conducted in Baltimore, MD,[47] and the Luippold study conducted in Painesville, OH.[48] The Gibb study was based on male workers initially employed in a chromate production facility between 1950 and 1974.[49] The Luippold study was based on male workers employed for at least one year between 1940 and 1972 at a chromate production facility.[50]. As noted above, Section 6(b) of the OSH Act authorizes the adoption of a standard that imposes the minimum burden necessary to control significant risks, and OSHA's ability to impose that burden is further subject to feasibility, reasonableness and other constraints. These restrictions apply to every requirement that would be imposed by the standard. For example, the PEL may not be set any lower than necessary to control the significant risk to be addressed by that PEL. B. Proposed PEL OSHA initiated Small Business Regulatory Enforcement Act ("SBREFA") proceedings for this rule in 2003. In accordance with the Regulatory Flexibility Act, as amended by SBREFA, OSHA developed a draft proposed standard and supporting materials to be evaluated by a review panel of agency personnel (from OSHA, Office of Management and Budget, and the Small Business Administration) with the assistance of small business representatives from industry sectors likely to be impacted by any new rule. OSHA's draft proposed standard suggested lowering the PEL from the current 100 µg/m3 (ceiling for chromic acid) to a level between 0.25 and 10 µg/m3, calculated as a time-weighted average (TWA). Many small business representatives suggested that the proposed PEL of 1.0 µg/m3 was too low to be feasible for them to meet, and recommended that OSHA consider a PEL in the range of 20-26 µg/m3. In addition, the SBREFA report maintains that the underlying data in this docket support an alternative exposure level.[51] The K.S. Crump Group, Inc. prepared an evaluation of physiologic, kinetic, and mechanistic data for OSHA.[52] The Group evaluated the Painesville, Ohio data that was relied on in the study performed by Luippold. The Crump Group concluded in that study that "critical information is lacking" with regard to dose metrics in the data that Luippold used (and OSHA partly relied on in proposing a PEL of 1.0 µg/m3).[53] Similarly, the Environ Corporation prepared an evaluation of the Gibbs et al. 2000 cohort study and its suitability for a quantitative risk assessment of inhaled chromium.[54] That evaluation concludes that the Gibbs study which OSHA relies on in promulgating this rule has several limitations.[55] Specifically, the study found the following limitations:
OSHA has not done an adequate job in addressing the limitations and inadequacies with the studies that the Agency has used to justify the proposed PEL. More recent reports by the Crump group have concluded that "...there was no statistically significant increased lung cancer risk below lifetime cumulative occupational exposures of 1.0 mg-yr/ m3," - 22 times the cumulative exposure that would result from lifetime exposure at the proposed PEL - "and no excess risk for workers whose highest average monthly exposure did not exceed the current Permissible Exposure Limit (52 µg/m3)."[57] That study also elaborates on the flaws in the Painesville, Ohio data relied on by Luippold, et al. in performing their study: "Briefly, the uncertainties in the exposure assessment, which was used by Mancuso, are substantial because only exposures to airborne total soluble and insoluble chromium were measured - rather than exposures to CrVI. Airborne concentrations were estimated from a single sampling survey performed more than a decade after occupational exposures began, and only lifetime cumulative exposures were estimated."[58]. Another report suggests that more recent information could provide an opportunity for "significant improvements to previously published data."[59]. While these studies are in the Docket for the Proposed Rule, OSHA has not adequately considered these more recent studies in proposing the PEL and action level. OSHA appears to casually dismiss these other data by stating that the Gibb and Luippold studies "...eliminates the need to rely on these more problematic cohorts to assess lung cancer risk from occupational CrVI exposure."[60] Clearly there are data supporting the determination that a higher PEL is safe and appropriate. OSHA has a legal duty to consider all relevant data and make its significant risk determination based on the best available data.[61]. SPI believes that OSHA has not met this burden in conveniently dismissing "more problematic cohorts" that tend to show that the studies OSHA has relied on are flawed, and that a higher PEL is warranted. OSHA must consider raising the PEL from 1.0 µg/m3 to a more feasible level that would still eliminate significant risks to exposed employees. C. Exposure Monitoring The extent to which SPI members can meet the proposed PEL is currently unknown. There are no data in the OSHA record to suggest that plastic colorant user facilities, in particular, can meet the PEL without significant capital investment. An informal survey indicates that the majority of these facilities appear to monitor for total chrome at the current time. There are valid technical reasons for such a measuring approach. Indeed, several SPI members that currently monitor for total chrome have commented that it is not known if it will be feasible to consistently and accurately measure CrVI at the action level proposed by OSHA for many workplace activities. SPI is concerned that general industry facilities will find it impossible to consistently monitor for exposure levels at the proposed action level, and that OSHA has not provided adequate analysis and information to ensure that this requirement is feasible. For example, it appears that many activities, such as spot welding and bag dumping often will not be of a duration that is long enough to collect the sampling data necessary to determine exposure levels or whether controls are necessary for compliance. If a welding task takes one hour, the employer monitors the employee for that hour, and if CrVI that is collected is below the level of detection, it is unclear what the employer should do when the next welding task takes more than one hour but less than eight hours. Does the process continue indefinitely until (if ever) the results are either below the level of detection after 8 hours of welding or are above the PEL or action level? Would this process apply to each different type of welding rod and task? If so, it again points to the need to at least give employers the option of treating General Industry maintenance welding activities in the same fashion as Construction welding. D. Dermal Protection Another area of concern is OSHA's proposal to expand the scope of the rule beyond the life threatening effects of cancer through inhalation to encompass allergic skin reactions. First, the number of workers exhibiting a sensitization to CrVI is unknown. Second, we believe the existing provisions of OSHA's hazard communication[62] and PPE[63] standards are adequate and appropriate to address this issue. We do not believe that whatever skin sensitization may be caused by dermal exposure to CrVI is of such a magnitude as to justify the highly burdensome special control measures proposed under this comprehensive OSHA standard. More specifically, many chemicals cause skin reactions of one type or another. However, we do not believe any caused by exposure to CrVI rise to a level that would justify requiring specially established change rooms, washing facilities and clean rooms as well as the elaborate handling and cleaning procedures for clothes having virtually any detectable level of CrVI. The proposed requirements intended to address dermal exposure in this rulemaking include changing rooms with storage facilities, washing facilities capable of removing CrVI from the skin, and separate eating and drinking areas at worksites where CrVI is present. Under the proposed rule, these measures would be required when a hazard is present or likely to be present from skin or eye contact with CrVI.[64] OSHA has not provided adequate guidance as to when employers would need to install dermal exposure measures such as changing rooms. OSHA only states that the facilities are to be used "when necessary,"[65] and when a hazard is present or likely to be present from skin or eye contact with CrVI.[66]. We believe good industrial hygiene practice would provide for a spectrum of control measures based on the particular conditions involved (e.g., concentration, quantity, particle size) rather than an all or nothing approach tied to a determination as to whether a dermal hazard is present. Logically, if one measure is adequate, the dermal hazard is no longer present and further control measures would not be necessary, but the proposed rule does not appear to be written with that approach in mind. Furthermore, under the legal standards established by the OSH Act, Executive Order 12866 and the Data Quality Act, OSHA may not require employers to implement the proposed dermal exposure controls without establishing not only that dermal exposures present a significant risk, but that the proposed engineering controls are "reasonably necessary and appropriate" -- as that phrase has been interpreted -- to control those risks. OSHA has not demonstrated that the burdensome controls it has proposed to address dermal exposure are necessary, feasible and cost-effective, and we do not believe it will be able to do so. These requirements are especially important in light of the high costs associated with clean/change rooms and other controls designed to address dermal exposures. As the Report of the Small Business Advocacy Review Panel states, some estimates for the installation and maintenance of clean rooms run as high as $500,000.00.[67] The industry cost model for a facility with 20 employees is calculated at approximately $50,000.00.[68] That kind of expense may not be feasible for many small employers in the plastics industry. Requiring washing facilities would create an even larger unwarranted burden on industry. The scientific evidence does not show that these measures are necessary. On the other hand, it is clear that they would impose a tremendous economic burden, particularly on small business. As noted previously, many activities involving CrVI are performed by both General Industry employers and Construction employers. There is no basis for subjecting the General Industry activities to the proposed standard when OSHA has determined that those same activities do not pose a significant risk to Construction employees. Most of the studies and data addressing hazards from exposure to CrVI that are cited in the Proposed Rule involve inhalation hazards and the risk of injury as a result of inhalation at certain levels. OSHA recognizes that not all exposures to CrVI create a significant dermal exposure hazard. Unfortunately, the Proposed Rule does not provide any useful guidance in making a hazard determination and then imposes control measures that go far beyond what is necessary to address that hazard. This seems to indicate that these measures would be required regardless of the presence of a hazard and in lieu of a hazard determination. If OSHA determines that there is a need for greater understanding of the requirements of its Hazard Communication and PPE standards as they apply to CrVI, we suggest the agency undertake the same type of outreach efforts it has planned to address the dermal hazards associated with exposure to portland cement in construction settings.[69]. In the case of welding operations, OSHA apparently has determined that welding fumes do not present a dermal hazard from CrVI exposure and the experience of our members supports that determination. The cost factor study that OSHA apparently approved, relied on and implicitly adopted in issuing the Proposed Rule does not include any compliance costs for PPE (other than respiratory protection) or housekeeping for general industry welding because it concludes those requirements would not apply to welding activities. The cost study states that PPE (aside from respiratory protection) "...is not required of welders as the welding fume does not pose any problems dermally."[70] That report also reflects a determination that housekeeping controls and laundry controls are not necessary for welding operations in General Industry: "Any welding operation will not generate any appreciable amount of accumulable material from welding fume, therefore, estimating that HEPA vacuums not required by these establishments."[71]. We believe OSHA's determination that welding poses only CrVI inhalation hazards and does not pose CrVI dermal hazards is a critical determination that must be appropriately reflected in any final rule. In other words, in the event OSHA retains provisions addressing the dermal hazards posed by exposure to CrVI, the regulatory text of the final rule should contain a provision exempting the CrVI generated by welding from all provisions of the rule not directed at inhalation hazards. That would eliminate a tremendous cloud of uncertainty and make it clear that welding operations do not require special change rooms, wash facilities and clothing laundering procedures. The costs associated with changing facilities, protective work clothing and equipment, and other dermal exposure measures are not subject to the 29-day exemption. These measures would be required in general industry whenever a hazard is present or likely to be present from skin or eye contact with CrVI.[72] Because these expenses will put a large (and sometimes impossible) economic burden on the industry, OSHA must perform the proper studies and data analysis to determine whether dermal exposures present a significant risk. VII. SPECIFIC RECOMMENDATIONS A. Action Level for General Industry OSHA has proposed rules that would impose substantially different requirements on substantially identical activities depending on whether they are General Industry or Construction activities. For example, OSHA proposes an action level for General Industry welding but not Construction welding. From a safety standpoint, many of the General Industry tasks would likely be of shorter duration. However, the distinction between Construction activities and General Industry (manufacturing and maintenance) activities is often unclear as is illustrated by various interpretations and citations issued by OSHA over the years and by the extended analysis necessary to explain why the extensive work involved in removal and replacement of large steel tanks, piping and structure supports was construction rather maintenance.[73] Given that extended analysis, industry has no basis for knowing whether the addition or extension of a stainless steel guardrail on a machine, or the installation or extension of a stainless steel table or platform is a General Industry activity or Construction activity, whether in the manufacturing area of a plant or a plant cafeteria. Furthermore, OSHA should not create rules that create inappropriate incentives to outsource work. While OSHA has issued some interpretations regarding the types of activities that might be considered construction activities, it is far from clear how some activities might be categorized. In theory, whether a welding activity is considered "construction" should turn on the nature of the activity, rather than who is performing the work or the Standard Industrial Classification ("SIC") Code of the employer. OSHA's regulations ambiguously define "construction work" as "construction, alteration, and/or repair, including painting and decorating."[74] There is no OSHA-specified definition of what constitutes "maintenance activities," but the term is interpreted by the Agency in opinion letters as including activities that involve making or keeping a structure, fixture or foundations (substrates) in proper condition in a routine, scheduled, or anticipated fashion.[75] "Maintenance activities" are those intended for "keeping equipment working in its existing state, i.e., preventing its failure or decline"(emphasis in original).< <[76]. However, OSHA also states in other interpretations that construction activities are not limited to new construction, but "...can include the repair of existing facilities or the replacement of structures and their components."[77]. The determination is made on a case-by-case basis, taking into account the information available at a particular site. OSHA advises that where an activity cannot be easily classified as "construction" or "maintenance," employers should classify the activity using the more protective standard.[78] OSHA's compliance and guidance assistance representatives suggested that most operations which do not involve altering the structure of a building could be considered "maintenance" activities. This would encompass the majority of welding operations performed at plastics facilities, as most do not alter the structure of the facility. OSHA must clarify the types of activities that qualify as "construction" or "maintenance" if it is going to promulgate a rule that has different requirements depending on how an activity is classified. SPI would argue that an activity should not be classified as construction unless it would generally require a construction permit from state or local authorities. We say "generally" because permit requirements will vary depending on the state and locality. However, OSHA must provide further guidance on the classification of activities. OSHA has not provided sufficient evidence in the docket as to why the action level should apply to general industry when many of the maintenance activities performed in general industry are identical to those performed in the construction industry. OSHA has not met its burden in applying a stricter action level to general industry without supplying sufficient data suggesting that there is a greater risk or hazard in general industry than construction. SPI urges OSHA to remove the action level requirement from general industry, as many of the activities are identical to construction and present no greater hazard. B. Employee Rotation Employee rotation may be an effective means of managing exposures at levels where there is no significant risk. There is precedent in other OSHA rules for the role of employee rotation in compliance. Other substance specific standards that allow employers to implement employee rotation as an administrative control include the standards for occupational exposure to inorganic arsenic and occupational exposure to lead.[79] The proposed standard for CrVI is very similar in structure to the standard for occupational exposure to lead. In the preamble to the final rule on lead, OSHA noted that: "Further, administrative controls such as worker rotation may prove effective in reducing exposures in many small firms."[80] The same principles apply for exposures to CrVI.[81]. Employers should be permitted to implement employee rotation where it will result in exposure levels that bring the estimated excess risk of cancer to less than 1 per 1000 workers. In the preamble to the rule, OSHA suggests that the estimated excess cancer deaths per 1000 workers for the proposed PEL is 0.85 to 4.4 for a 20-year exposure, and 2.1 - 9.1 for a 45-year exposure.[82] For the proposed action level, those estimated deaths drop to 0.43 - 2.2 for a 20-year exposure, and 1.1 - 4.6 for a 40-year exposure.[83] OSHA's own estimates indicate that in some instances the expected excess cancer deaths drop to below 1 per 1000 workers at these exposure levels. Employers can safely use rotation to reduce the exposure levels to where there is no significant risk that would justify regulating exposures to below that level. Just as OSHA recognized in the rulemaking for lead, employee rotation is an effective administrative control that can reduce exposures to safe levels. OSHA has not provided sufficient evidence in the docket to suggest that employee rotation will create a significant risk to employees who are exposed to CrVI levels. C. Monitoring Requirements OSHA states that initial monitoring for CrVI need not be conducted in two situations:
SPI respectfully submits that there is no need for the 12-month limitation. If the conditions of the original monitoring are adequately documented and representative and recognized monitoring procedures were followed, the results are representative regardless of the time that has elapsed. The test for reliability should be whether the monitored work operations were conducted under workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions used when the tests were initially conducted. SPI requests that OSHA remove this 12-month limitation from the rule because it is an unnecessary burden that would force employers to engage in redundant monitoring. Employers who monitor and find CrVI levels below the proposed PEL should not be required to perform monitoring again until there is a significant change in the work environment that would suggest CrVI levels may have risen as a result of those changes. Respirator Use Plastic Colorants is not one of the industry sectors identified by OSHA where respirators will be needed for some workers, yet the engineering controls identified by OSHA would put many small businesses in this industry out of business.[85]. Rather than place a significant burden on the industry to implement engineering controls and install expensive equipment such as bag openers at the cost of millions of dollars, OSHA should allow employers to provide employees with respirators. The Proposed Rule currently requires the use of respirators where engineering and administrative controls are not adequate or are not feasible, but appears to place the burden of proof on the employer to demonstrate infeasibility. That is not a realistic approach for many small employers who lack the resources to make the necessary analysis, some of which are likely to involve trial and error. As an alternative, SPI encourages OSHA expand the 29-day provision to 59 days, or develop the record more fully so as to establish appropriate separate engineering control air limits ("SECALS") that would permit greater reliance on the use of respirators. For example, at operations that use CrVI pigments for small portions of the day but have exposures above the PEL for greater than 29 days in a 12-month period, respirators provide effective and adequate protection, and are a more cost effective source of protection for those short periods of time. E. EPA Air and Water Permits Effect on Air and Water Permits Executive Order (EO) No. 12866, titled "Regulatory Planning and Review", requires that agencies avoid promulgating regulations that are inconsistent, duplicative or incompatible with those of other Federal agencies. In this regard, SPI members believe that it may not be feasible to implement engineering controls without impacting their federal and state air and water permits. As stated earlier, many employers in the plastics industry would not be exempt from engineering requirements under the proposed rule and OSHA recommended during the SBREFA process that the industry upgrade ventilation and exhaust systems and install toxic material bag openers to achieve the proposed PEL and action level. Both of these engineering controls have the capability of affecting EPA air permits. The exhaust systems, such as the ones attached to toxic material bag openers, can pull in substances such as CrVI that could have an impact on the EPA air permits. Additionally, OSHA has not accounted for the costs or time associated with obtaining new EPA air permits if the proposed rule made it necessary. If improved LEV systems or toxic material bag openers would require new EPA air permits, employers would incur considerable expenses in obtaining those new permits. Therefore, SPI respectfully requests that OSHA allow facilities adequate time to determine what engineering controls will be required to comply with the rule, amend their air permits as needed to make these changes, and come into compliance. It would be acceptable to require the use of respirators in the interim. Environmental Impact Analysis OSHA has declared that an environmental impact analysis is not necessary because the proposed CrVI standard would have no significant environmental impacts.[86] The purpose of the National Environmental Policy Act ("NEPA") is to assure that Federal Agencies are fully aware of the present and future environmental impact of their decision.[87] Compliance with the Act also ensures that other officials, Congress and the public can evaluate the environmental consequences independently. The pertinent excerpts from the Department of Labor's NEPA regulations bearing on the requirement for an environmental assessment and an environmental impact statement are quoted below:
In this rulemaking, OSHA has not demonstrated that it has taken into consideration all of the potential environmental impacts of the proposed rule. SPI argues that OSHA should perform an impact analysis under NEPA because of the potential environmental impact of this proposed rule. Because many employers will have to install or modify ventilation systems, LEV's, and other equipment to comply with the proposed action level and PEL, these new ventilation systems will deposit not only CrVI, but other substances into the outside air. It is quite possible that many employers will need to apply for new air and water permits as a result of installation, modification or maintenance of facility ventilation systems, LEV's, and equipment such as toxic material bag openers in order to reduce exposure levels to below the proposed action level and/or PEL. OSHA has provided inadequate information or analysis that addresses the potential for increased emissions as a result of more powerful ventilation systems and greater loading of waste water treatment systems. Start-up Dates and Implementation Schedule SPI is supportive of OSHA's determination that engineering controls must be implemented by General Industry employers no later than two years after the effective date of the proposed rule.[88] SPI believes that this is an appropriate amount of time for implementing engineering controls and is consistent with previous OSHA standards such as the standard for occupational exposures to cadmium.[89]. However, General Industry employers (especially small employers) will need more than 90 days from the effective date of the standard to implement and meet many of the other requirements in the proposed rule. OSHA proposed that all obligations under the new rule would commence 90 days after the effective date.[90] Many employers that were previously in compliance with the current PEL will need to implement respirator programs where (a) employees are exposed to levels above the PEL for fewer than 30 days in a 12-month period, (b) facilities are unable to reduce exposure levels below the PEL through engineering controls, and (c) facilities must implement respirator programs on an interim basis while engineering controls are installed or modified. Employers that do not have respirator programs already in place will require far more than 90 days to implement a new program. Employers will have to purchase and receive an adequate supply of respirators, draft and implement an appropriate respirator program under 29 C.F.R. § 1910.134, obtain medical appointments and fit test employees for the respirators, and provide training for all employees using the new respirators. This does not take into account the amount of time it will take to review the Preamble to the final rule (the Preamble to the proposed rule is 170 pages in length) and consult with safety and health experts to determine the requirements under the new standard. SPI argues that this will take longer than 90 days, and that OSHA should extend the start-up date for respirator use to 180 days from the effective date of the final rule. All General Industry employers who may be covered by the standard will have to perform initial exposure monitoring to determine if any employee is exposed to levels of CrVI above the action level.[91] This will create a great demand for industrial hygienists capable of monitoring workplaces. As SPI has stated already, it is unclear whether employers will be able to consistently monitor at levels as low as the proposed action level. Therefore, there may be fewer industrial hygienists with the ability to monitor at such low levels. It will take all General Industry employers (again, small employers will have an even tougher time meeting this start-up date) much longer than 90 days from the effective date of the rule to perform initial monitoring under section 1910.1026(d)(2)(i) of the proposed standard. SPI argues that small employers should receive more time to meet the requirements of the new rule when it becomes effective. Many small employers in the plastics industry do not have the resources to provide respirators and implement respirator programs, exposure monitoring, training and education programs, provide other forms of protective work clothing and PPE, install warning signs and regulated areas, and implement medical surveillance programs all within 90 days of the effective date of the new rule. Small employers will need even more time to implement all of these provisions because many will not have the resources to review the entire preamble to the proposed rule and make appropriate determinations within 90 days. Furthermore, OSHA is required to publish a guidance document for small employers under SBREFA. The time for implementation of the new measures under the proposed rule should not begin until after OSHA publishes the guidance document as required by SBREFA. This will provide small employers in the plastics industry with needed guidance on the requirements under the new rule. CONCLUSION Due to some significant gaps in this rulemaking, its true impact on both the plastics colorant producers and users industry and the broader plastics industry is unknown. This is especially the case for plastic colorant users, who OSHA has characterized as amongst the most impacted by the rule, yet there are no data or analyses on any plastic colorant users in the record. The costs of engineering controls will place a significant burden on the plastic colorants producers and users industry, and those costs should be included in a revised OSHA analysis of costs in any final rule. With these comments, SPI has tried to assess the areas in which we believe plastics colorant producers and users will be most affected and areas where changes in the Proposed Rule would help them comply. SPI appreciates the opportunity to take part in this proceeding, and asks for OSHA's consideration of its specific requests. Thank you for your consideration of our comments. Should you have any questions, or if we can provide further information, please contact me. Respectfully submitted, Susan R. Howe
Of Counsel: [1] Occupational Exposure to Hexavalent Chromium, Proposed Rule, Request for Comments and Scheduling of Informal Public Hearings, OSHA, 69 Fed. Reg. 59305 (October 4, 2004). [2] 69 Fed. Reg. at 59405; OSHA Table IX-2 "Exposure Profile by Application Group for Cr(VI)." [3] Plastic colorant producers and users were defined in one study as: "companies that produce hexavalent chromium-containing colorants for use in plastics, and it includes companies that use dry hexavalent chromium-containing pigments or pigment blends in the manufacture of plastic products. The applicable Standard Industrial Classification (SIC) codes for this industry are: 2821, Plastics Materials and Resins and; 308, Miscellaneous Plastics Products, nec. The applicable NAICS codes for this industry category are: 325211, Plastics Materials and Resin Manufacturing; 325991, Custom Compounding of Purchased Resin; and 3261, Plastics Product Manufacturing." OSHA Docket H-54-A, Exhibit 35-50-12, "Plastic Colorant Producers and Users." Information in the docket also notes that the consumption of lead chromate pigments used in plastics decreased by approximately 42 percent between 1993 and 1999. OSHA estimates that there are currently 37 facilities where CrVI-containing dry color, solid color concentrates, liquid color concentrates, and/or pre-colored resins are produced. In addition to the production facilities, OSHA estimates that there are 100 plastics facilities using these materials. [4] We support OSHA's determination to exclude portland cement from the Construction standard based on its finding that exposure to portland cement in the construction industry does not pose a significant safety and health concern. Accordingly, it is only appropriate to extend that exemption to General Industry maintenance activities where the same types of exposures to portland cement would occur, but on a much smaller scale. [5] Cal. Code Regs. Tit. 8, § 5155 "Airborne Contaminants." Table AC-1. [6] See Control of Hazardous Energy Sources, Supplemental Statement of Reasons, 58 Fed. Reg. 16612, 16614, cols. 2 and 3 (March 30, 1993), upheld in International Union, UAW v. Occupational Safety and Health Administration U.S. Department of Labor, 37 F.3d 665 (D.C. Cir. 1994) (Lockout/Tagout III). [7] Industrial Union Department, AFL-CIO v. American Petroleum Institute et al., 448 U.S. 607, 100 S.Ct. 2844 (1980); AFL-CIO v. OSHA, 965 F.2d 962, 973 - 975 (11th Cir. 1992). [8] Id. [9] Id. [10] American Federation of Labor and Congress of Industrial Organizations v. OSHA, 965 F.2d 962 (11th Cir. 1992) (PELs), ADA v. Secretary of Labor, 61 USLW 2459, 15 O.S.H. cas. (BNA) 2097, 61 USCW 2459 (7th Cir. 1992) (Bloodborne Pathogens) 965 F.2d 962 (1992) [11] American Textile Mfrs. Inst. v. Donovan, 452 U.S. 490 at 514 (1981). [12] Industrial Union Department, supra. [13] OSH Act § 6(f), 29 U.S.C. § 655(f). [14] OSH Act §§ 6(b)(5), 6(f), 29 U.S.C. § 655(b)(5), 655(f); Executive Order 12866, Section 1(b)(7). [15] American Textile Mfrs. Inst., 452 U.S. at 514. [16] OSH Act § 6(b), 29 U.S.C. §655(b)(1); Administrative Procedure Act Section 553(b), [17] National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. § 4321 et seq. [18] Exec. Order No. 12866, 58 Fed. Reg. 51735 (October 4, 1993). [19] Pub. L. No. 106-554 (Dec. 21, 2000)(published at 44 U.S.C. § 3516). [20] 69 Fed. Reg. at 59411, Table IX-4. "Annualized Costs for All Establishments Affected by OSHA's Proposed Standard for Hexavalent Chromium (by Application Group and Regulatory Requirement for a PEL of 1 ug/m3)" [21] Docket H054-A, Exhibit 35-48-12. [22] Id. at pg. 7. [23] Id. at pg. 8. [24] Docket H054A, Exhibit 35-390-14, pg. 10-5. [25] The site visit report for the plastic colorant producer, "Company O", performed by IT Corporation (Docket H054-A, Exhibit 35-46-36) states: "Since a batch of coating product that contains lead chromate is produced once every 3 to 5 months, the site visit was scheduled to coincide with the production of plastic colorant dispersant product batches that contain lead chromate as an ingredient." Since OSHA does not provide any explanation on this issue, we are left to speculate that this may be the basis for OSHA's conclusion that the entire industry operates on a similar schedule and therefore should not incur engineering control costs. However, as SPI notes in its discussion below, Company O is not representative of the entire plastics industry. Therefore, it would be inappropriate for OSHA to exclude engineering costs for an entire industry under the 29-day provision based on the lead chromate production schedule of one company that is not representative of the entire industry. [26] Docket H054-A, Exhibit 35-390-53, at pg. 5. [27] 69 Fed. Reg. at 59453. [28] Docket H054-A, Exhibit 35-48-12: "Sector 10. Plastic Colorant Producers and Users. Cost Factors." Pg. 4 of 33. [29] 69 Fed. Reg. at 59407. [30] Id. [31] Docket H054-A, Exhibit 35-48-12, at pg. 4. [32] Id. at pg. 8. [33] Id. at pg. 4. [34] Id. at pg. 8. [35] Estimate supplied by Luxme, Inc. (Dec. 2004). [36] Docket H054-A, Exhibit 35-390-53, at Pg. 9 of 35. [37] Docket H054-A, Exhibit 35-45-36, at Pg. 12. [38] American Textile Mfrs. Inst., 452 U.S. at 514. [39] Exec. Order No. 12866, 58 Fed. Reg. 51735 (October 4, 1993). [40] Docket H054-A; Exhibit 35-390-14. [41] Docket H054-A; Exhibit 35-45-36. [42] Docket H-054A, Exhibit 35-45-36. [43] Docket H054-A; Exhibit 35-45-36, at pg. 6. [44] Docket H054-A, Exhibit 35-390-14, at 10-1. [45] Pub. L. No. 106-554, § 1(a)(3) (Dec. 21, 2000)(published at 44 U.S.C. § 3516). [46] Exec. Order No. 12866, 58 Fed. Reg. 51735 (October 4, 1993). [47] 69 Fed. Reg. at 59319 - 59325; Docket H054-A, Exhibit 31-22-11. Gibb, Herman J., et al., "Lung Cancer Among Chromium Chemical Production." (2000). [48] 69 Fed. Reg. at 59319 - 59325; Docket H054-A, Exhibit 31-18-4, Luippold, R.S., et al., "Lung Cancer Mortality Among Chromate Production Workers." (2003). [49] 69 Fed. Reg. at 59319, "Table VI-1. - Summary of Selected Epidemiologic Studies of Lung Cancer In Workers Exposed to Hexavalent Chromium - Chromate Production." [50] Id. [51] Docket H054-A, Exhibit 34-2. [52] Docket H054-A, Exhibit 35-47, "Selection of an Appropriate Dose Metric for Chromium Carcinogenicity: Evaluation of Physiologic, Kinetic, and Mechanistic Data." (September 2000). [53] Docket H054-A, Exhibit 35-47, at Pg. 34. "Currently, although much chromium-specific quantitative data are available, critical information is lacking to complete any modeling effort for developing relevant does metrics. For example, to estimate the deposited dose, information on the pulmonary ventilation rate and the particle size distribution for the critical study is needed. However, for the critical study (Mancuso and Hueper 1951; Mancuso 1975), quantitative information on particle size distribution is lacking." [54] Docket H054-A, Exhibit 31-22-11. "Cohort Study of Workers at a Chromium Chemical Production Plant (Gibbs et al. 2000): Evaluating Its Suitability for Quantitative Risk Assessment of Inhaled Chromium." Prepared by: Environ Corporation, Ruston, Louisiana. [55] Id. at Pg. 4-5. [56] Id. at Pg. 5. [57] Docket H054-A, Exhibit 35-58. Crump, et al. "Dose-Response and Risk Assessment of Airborne Hexavalent Chromium and Lung Cancer Mortality." Risk Analysis, Vol. 23, No. 6 (2003). Pp. 1147 - 1163. [58] Id. at Pg. 1148. [59] Docket H054-A, Exhibit 35-61. D.M. Proctor, et al. "Workplace Airborne Hexavalent Chromium Concentrations for the Painesville, Ohio, Chromate Production Plant (1943 - 1971)." Applied Occupational and Environmental Hygiene, Volume 18(6): 430-449 (2003), at Pg. 448. [60] 69 Fed. Reg. at 59361. [61] See Exec. Order No. 12866, 58 Fed. Reg. 51735 (October 4, 1993); Pub. L. No. 106-554 (Dec. 21, 2000)(published at 44 U.S.C. § 3516). [62] 29 C.F.R. § 1910.1200. [63] 29 C.F.R. § 1910.132 - 138. [64] 69 Fed. Reg. at 59465 - 59466. [65] 69 Fed. Reg. at 59457. [66] 69 Fed. Reg. at 59465 - 59466. [67] Report of the Small Business Advocacy Review Panel On the Draft OSHA Standards for Hexavalent Chromium, April 20, 2004. OSHA Docket H-054-A, Exhibit 34-2, at Pg. 22 (McBride and Ghandi, p. 3). [68] Id. [69] 69 Fed. Reg. at 59309. [70] Docket H054-A; Exhibit 35-390-44, “Sector 2. Welding. Cost Factors.” at Pg. 47, 48 of 238, note 2. [71] Id. at Pg. 51, 52 of 238, note 1. [72] 69 Fed. Reg. at 59465. [73] Standard Interpretations, 11/18/2003 - Clarification of maintenance vs. construction activities; standards applicable to the removal and replacement of steel tanks and structural steel supports; Letter to Raymond V. Knobbs, Minnotte Contracting Corporation from Russell B. Swanson, Directorate of Construction. [74] 29 C.F.R. § 1910.12(b). [75] Standard Interpretations, 08/11/1994 - Construction vs. Maintenance; Memorandum for OSHA Regional Administrators from James W. Stanley, Deputy Assistant Secretary. [76] Id. [77] Standard Interpretations, 11/18/2003 – Clarification of maintenance vs. construction activities; standards applicable to the removal and replacement of steel tanks and structural steel supports; Letter to Raymond V. Knobbs, Minnotte Contracting Corporation from Russell B. Swanson, Directorate of Contruction. [78] Standard Interpretations, 08/11/1994 - Construction vs. Maintenance; Memorandum for OSHA Regional Administrators from James W. Stanley, Deputy Assistant Secretary. In this case, the General Industry standard (1910) would be considered the "more protective" because of the proposed action level that does not apply to the Construction or Maritime industries. [79] 29 C.F.R. § 1910.1018; 29 C.F.R. § 1910.1025. [80] 43 Fed. Reg. 52952 (November 14, 1978). [81] OSHA does state that the provision does not prohibit worker rotation when it is conducted for reasons other than compliance with the proposed PEL. 69 Fed. Reg. at 59454. [82] 69 Fed. Reg. at 59391. [83] Id. [84] 69 Fed. Reg. at 59450. [85] 69 Fed. Reg. at 59408, Table IX-3. "Respiratory Use by Industry at Various Potential PELs after Engineering and Work Practice Controls Have Been Applied." [86] 69 Fed. Reg. at 59445. [87] 42 U.S.C. § 4321 et seq. [88] 69 Fed. Reg. at 59468. [89] 29 C.F.R. § 1910.1027(p)(2)(v). [90] 69 Fed. Reg. at 59468. OSHA provides that change rooms must be installed no later than one year after the effective date. [91] 69 Fed. Reg. at 59465. More
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