Federal Registers - Table of Contents|
| Publication Date:||07/15/1991|
| Publication Type:||Proposed Rules|
| Fed Register #:||56:32302|
| Standard Number:||1910.1048|
| Title:||Response to Court Remand for Proposed Rule on Occupational Exposure to Formaldehyde|
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
Docket No. H-225D
Occupational Exposure to Formaldehyde
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Response to Court remand; proposed rule.
SUMMARY: The Occupational Safety and Health Administration (OSHA) is proposing to amend its existing regulation for occupational exposure to formaldehyde, 29 CFR 1910.1048, in response primarily to a remand by the U.S. Court of Appeals for the D.C. Circuit in UAW v. Pendergrass, 878 F.2d 389 (D.C. Cir. 1989). The proposed amendments would lower the permissible exposure level for formaldehyde from the existing level of 1 ppm (parts per million) as an 8-hour time-weighted average to an 8- hour time-weighted average of 0.75 ppm. OSHA is also proposing to add medical removal protection provisions to supplement the existing medical surveillance requirements for those employees suffering significant eye, nose or throat irritation and for those suffering from dermal irritation or sensitization from occupational exposure to formaldehyde. In addition, certain changes are being proposed to the standard's hazard communication and employee training requirements. These amendments would establish specific hazard labeling requirements for solid materials capable of off-gassing formaldehyde between 0.1 ppm and 0.5 ppm and other hazard labeling requirements for those solid materials capable of off-gassing above 0.5 ppm under reasonably foreseeable conditions of use.
DATES: Comments on these proposed amendments must be postmarked by [insert date 30 days from date of publication].
ADDRESS: Written comments should be sent in quadruplicate to the Docket Officer, Docket No. H-225D, U. S. Department of Labor, Room N-2625, 200 Constitution Avenue, N.W., Washington, D. C. 20210; (202) 523-7894. Any written comments received will be available for inspection and copying in Room N-2625, at the above address, from 8:15 a.m. to 4:45 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Mr. James Foster, Office of Information and Consumer Affairs, Occupational Safety and Health Administration, U. S. Department of Labor, Room N-3647, 200 Constitution Avenue, N. W., Washington, D. C. 20210. Telephone: (202) 523-8151.
Background and History of the Regulation
On December 4, 1987, after an extensive rulemaking proceeding, detailed in the preamble to the final rule (52 FR at 46169-46171), OSHA issued a comprehensive regulation covering occupational exposure to formaldehyde at 29 CFR 1910.1048. This new rule reduced the permissible exposure limits (PELs) to 1 part formaldehyde per million parts of air (ppm) as an 8-hour time-weighted average (TWA), and established a 2 ppm 15- minute short term exposure limit (STEL). The new comprehensive standard also included an "action level" of 0.5 ppm, measured as an 8- hour TWA, and provisions for employee exposure monitoring, medical surveillance, recordkeeping, regulated areas, emergency procedures, preferred methods to control exposure, maintenance and selection of personal protective equipment, and hazard communication. OSHA's new rule was based on the consideration of a wide range of new evidence including animal bioassays and epidemiological evidence. It was based in part on OSHA's recognition of formaldehyde as a potential occupational carcinogen as well as its irritating and sensitizing effects.
The standard was challenged in the United States Court of Appeals for the District of Columbia Circuit, pursuant to section 6(f) of the Act, 29 U.S.C. 655(f), by both industry and labor. Four unions, the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America (UAW), the Amalgamated Clothing and Textile Workers Union (ACTWU), the International Ladies' Garment Workers Union (ILGWU) and the International Molders and Allied Workers Union, and Public Citizen, a public interest group, challenged the standard as being insufficiently protective. They contended that the PEL was not set low enough to eliminate all significant risk of harm from both cancer and from formaldehyde's irritant effects. They also objected to OSHA's decision not to include a medical removal protection (MRP) provision in the standard, and to a number of other aspects of the standard, including the setting of the action level, the lack of a requirement for annual medical examinations, and the provisions regarding labeling and training.
The Formaldehyde Institute (FI), on the other hand, sought review of the hazard communication provisions in paragraph (m) of the standard. While challenging these provisions in court, the FI, along with others, petitioned OSHA for an administrative stay of the hazard communication provisions and reconsideration of these provisions. On December 13, 1988, after giving the public an opportunity to comment on this petition, OSHA stayed the hazard communication provisions, paragraphs (m)(1)(i) through (m)(4)(ii), and announced its intention to consider further regulatory action on these provisions (53 FR 50198). The effect of the stay was to continue the implementation of OSHA's generic Hazard Communication Standard (29 CFR 1910.1200) in effect with respect to formaldehyde. The administrative stay was subsequently continued to allow the Agency more time to resolve the issue (54 FR 35639, 8/29/89; 55 FR 24070, 6/13/90; 55 FR 32616, 8/10/90; 55 FR 51698, 12/17/91; 56 FR 10377, 3/12/91; 56 FR 26909, 6/12/91).
The Court of Appeals affirmed the final standard in most respects but concluded that OSHA had failed to adequately explain why it had not adopted a lower PEL to protect against the carcinogenic effects of formaldehyde exposure and why it had not included medical removal protection (MRP) provisions in the standard. UAW v. Pendergrass, 878 F.2d 389 (D.C. Cir. 1989). The Court's decision required OSHA to better explain or reevaluate the risk assessment that led it to choose a PEL of 1 ppm. Should OSHA conclude that a significant risk remains at 1 ppm, according to the Court the Agency could then adjust the standard accordingly. The Court's decision also required OSHA to better explain or reevaluate its decision not to include an MRP provision in the standard.
The Court did not review the hazard communication provisions of the standard because they had been administratively stayed for reconsideration at the time. Because all of the provisions of the standard are interconnected, OSHA has determined that the hazard communication provisions should be reconsidered together with the remand issues.
The Parties' Recommendation Following the remand, parties to the litigation developed recommendations for revisions to the standard that they believed represented a reasonable resolution of all outstanding issues. Their recommendation, which was presented to OSHA on June 27, 1990, would (1) lower the PEL to 0.75 ppm TWA; (2) include in the standard certain provisions for MRP benefits; and (3) modify the standard's hazard communication provisions by revising labeling requirements for solid materials off-gassing small amounts of formaldehyde and providing annual training in formaldehyde hazards for all employees exposed at or above 0.1 ppm (Ex. 278).
OSHA has given these recommendations careful consideration. A recommendation advanced by representatives of the primary employee and employer organizations affected by the standard is likely to incorporate provisions that will adequately protect employees, within the limits of current knowledge, while not burdening employers with compliance costs that will produce little or no benefit in improved employee safety and health.
While a recommendation by interested persons cannot relieve the Agency of its statutory duty to independently decide regulatory issues, OSHA believes this recommendation is entitled to considerable weight. The Agency has carefully evaluated these recommendations in light of the entire rulemaking record in determining how best to resolve the remaining issues and respond to the Court's concerns.
OSHA's proposal to respond to the remand is consistent with the recommendations of the parties to the litigation and incorporates them. The final proposal significantly increases employee protection over the existing standard by lowering the PEL, adding a provision for MRP, and requiring annual training for all workers exposed at or above 0.1 ppm. The final proposal also requires less inclusive labels on certain formaldehyde-containing products. All containers of products that required labels under the original standard will still require labels. The revised labels will give employees access to complete hazard information, and employees will be better able to evaluate these hazards because they will now receive annual training instead of one-time training. OSHA believes that these changes in the unique case of formaldehyde will not reduce employee protection.
The Agency plans to use expedited rulemaking in this proceeding. OSHA is asking for comments on the proposal but believes that there will be very few comments submitted because the proposal is consistent with a consensus of the parties who were active during the rulemaking proceeding and the issues addressed have been fully ventilated in the comprehensive rulemaking record already compiled. Therefore, the comment period will be limited to 30 days, which will allow interested persons an opportunity to voice legitimate concerns, but will not cause unwarranted delay. Although this document is a proposal, OSHA believes that it represents its best judgment as to how to resolve the remaining issues before it. Therefore, in the absence of significant comments to the contrary, the Agency gives notice that the amendments as proposed will probably be adopted as a final rule as they appear in this document.
Should the Agency receive significant objections to this proposal or in the unlikely event that issues are raised that have not been fully considered in developing this proposed final rule, the Agency would give the public notice of this fact, and proceed with further rulemaking under section 6(b) of the Act.
The Agency is proceeding with this expedited rulemaking in this case because of the unusual circumstances present here. This action is taken in the face of a court ordered remand, much public participation, a full airing of all sides of these issues and perhaps most importantly, an emerging consensus of the parties as to the necessary and appropriate action to resolve all remaining issues. It is felt that this expedited proceeding will serve the interests of all the parties as well as those men and women presently working with formaldehyde. This procedure will also avoid further needless delay and will help conserve scarce Agency resources that can, at this point, be better used to help protect workers from other dangers present in their workplaces.
OSHA has chosen this procedure with several considerations in mind. In remanding the PEL and MRP issues to OSHA, the Court of Appeals clearly contemplated that these issues could be resolved on the existing record, for the Court left open to the Agency the option of retaining the existing provisions and better explaining its rationale. While the hazard communication provisions were not remanded by the Court, they were part of the litigation before the Court and are closely related to the issues which were remanded. Section (6)(b)(7) of the Act allows the Secretary to follow the notice-and-comment procedures of the Administrative Procedure Act (5 U.S.C. 553) to make modifications in regulations dealing with the use of labels or other forms of warning (as well as those dealing with monitoring or measuring and medical examinations) "as may be warranted by experience [or] information . . . acquired subsequent to the promulgation of the relevant standard." OSHA has concluded that the same procedures should be followed for all of the provisions of the standard currently being reconsidered. These provisions are inextricably intertwined; whenever a change is made in one of these provisions, its effect on the other provisions must be carefully evaluated. For example, as discussed more fully below, OSHA has concluded that the effectiveness of a provision for MRP will be enhanced by annual training that will enable workers to be better able to identify the signs and symptoms of formaldehyde exposure. Similarly, the effectiveness of the labeling provisions is greatly enhanced by the training requirements. It is sensible and efficient to consider all contemplated changes together. OSHA has therefore concluded that a single rulemaking action should encompass all the issues that remain outstanding.
OSHA has also concluded that an extensive rulemaking, including a lengthy comment period and hearings, is unnecessary in the absence of any indication that such procedures would add useful information to the already extensive rulemaking record. The issues under consideration were subject to extensive public participation and rulemaking procedures, and an extensive record has been compiled (52 FR at 46171). OSHA believes that a further opportunity for extensive re-discussion may not yield significant evidence or information that is not already in the record. However, a procedure that would foreclose the public from any opportunity to comment would not be appropriate. OSHA has therefore determined that an opportunity for public comment should be afforded, but that the issuance of a final standard can be expedited if no significant evidence or comments are offered. The procedure OSHA has chosen will expedite the issuance of a final standard while assuring procedural fairness to all persons interested in the standard. Good cause is hereby found to use the procedure outlined above.
Properties, Manufacture, and Uses of Formaldehyde
The chemical "formaldehyde" is a colorless, pungent gas at room temperature with an approximate odor threshold of about 1 ppm [Ex. 73- 120]. While the term "formaldehyde" is also used to describe various mixtures of formaldehyde, water, and alcohol, the term "formalin" more precisely describes aqueous solutions, particularly those containing 37 to 50 percent formaldehyde and 6 to 15 percent alcohol stabilizer. Most formaldehyde enters commerce as formalin. Alcoholic solutions of formaldehyde are available for processes that require low water content [Ex. 73-53]. Paraformaldehyde, a solid, also serves as a source of formaldehyde gas. Formaldehyde gas per se is not available commercially. The Chemical Abstracts Service (CAS) has assigned the number "50-00-0" to formaldehyde. This number applies to both formaldehyde gas and its aqueous or alcohol stabilized solutions.
Formaldehyde is a major industrial chemical, ranked 24th in production volume in the United States [Ex. 138-F]. In 1985, 5.7 billion pounds of 37 percent formaldehyde (by weight) was produced. Formaldehyde has four basic uses: as an intermediate in the production of resins; as an intermediate in the production of industrial chemicals; as a bactericide or fungicide; and as a component in the formulation of end- use consumer items. The manufacture of three types of resins: urea- formaldehyde, phenol-formaldehyde, and melamine formaldehyde, accounts for about 59 percent of total consumption [Exs. 70-2; 73-52]. An additional seven percent is consumed in the production of thermoplastic acetal resins [Ex. 8]. About one-third is used in the synthesis of high volume chemical derivatives, including pentaerythritol, hexamethylenetetramine, and butanediol [Ex. 8]. Two percent is used in textile treating and small amounts of formaldehyde are present as preservatives or bactericides in consumer and industrial products, such as cosmetics, shampoos and glues. Some products prepared from formaldehyde contain unreacted formaldehyde residues which may be released from the product over its useful life. One example is urea-formaldehyde resin. Urea-formaldehyde resin is a generic name that actually represents an entire class of related formulations. Over 60 percent of urea-formaldehyde resin production in 1977 was consumed by particleboard and plywood manufacturing, where the resin is used as a glue. Urea-formaldehyde resins are also used in decorative laminates, textiles, paper, and foundry sand molds [Ex. 73- 53].
Textile treating to impart wrinkle-resistance to clothing is not a major use of formaldehyde on a strict volume basis. However, apparel manufacture is the sixth largest industry sector in the United States [Exs. 70-2; 70-14]. About 60-85 percent of all apparel fabric is finished with formaldehyde-containing resins, and this use is the major source of widespread exposure to formaldehyde because of the large number of workers potentially exposed.
Formaldehyde destroys bacteria, fungi, molds, and yeast. Its commercial importance as a fungicide is probably its greatest use as a disinfectant [Ex. 70-2]. Because of its bactericidal properties, formaldehyde is used in numerous cosmetic preparations.
Formaldehyde's uses can lead to widespread exposure in downstream industries. For example, when formaldehyde is present in disinfectants, preservatives, and embalming fluid, worker exposure can occur. Although formaldehyde changes into other chemicals when urea-formaldehyde resins and concentrates are produced, decay may occur, causing workers in numerous industries including wood products and apparel manufacture to be exposed to airborne formaldehyde when it offgasses from products manufactured with these resins.
Summary and Explanation of the Proposed Amendments
Paragraph (c) - Permissible Exposure Limits (PELS)
This proposed amendment to the final rule reduces the permissible exposure limit to 0.75 part formaldehyde per million parts of air as an 8-hour time weighted average (0.75 ppm TWA). The basis for proposing this change is the reexamination of the formaldehyde risk assessment that was undertaken in response to the Court remand. In its risk assessment accompanying the promulgation of the standard in 1987, OSHA calculated both the maximum likelihood estimate (MLE) and the upper confidence limit (UCL) for several mathematical models that it concluded best represented the carcinogenic action of formaldehyde. The MLE calculations, which statistically represent the most likely estimate of the risk, indicated that no significant risk remained at the PEL of 1 ppm. However, the UCL figures, which have only a 5% probability of understating the risk, indicated that a significant risk remained at 1 ppm.
OSHA did not accept either the MLE or the UCL as the single best prediction of risk for formaldehyde, but concluded that they defined a range in which the degree of risk was highly uncertain and effectively indeterminable based on the present state of scientific evidence. It was uncertain whether a significant risk remained below 1 ppm. OSHA included ancillary provisions in the standard with the expectation that they would further reduce any residual risk that remained at a PEL of 1 ppm (see discussion at 52 FR 46223-46224).
The Agency has now completed its reconsideration of the record evidence applicable to its original finding that a 1 ppm PEL and ancillary provisions would prevent a significant risk of cancer in workers who are exposed to formaldehyde. OSHA continues to believe that neither the UCL nor the MLE can be used to establish a precise estimate of the remaining risk, but rather believes that they define a continuum within which the risk falls. In choosing where in the continuum to establish the PEL, OSHA has reevaluated its conclusion that the ancillary provisions promulgated on December 4, 1987 would reduce the residual risk that remained at a PEL of 1 ppm. Although OSHA is convinced that the ancillary provisions contribute to risk reduction (52 FR 46253, 46275, 46285, 46287), the Agency is unable to quantify that reduction. OSHA therefore believes it is appropriate to reduce the PEL further in order to increase the certainty that workers are adequately protected. The Agency is proposing that the PEL be reduced to 0.75 ppm TWA, a point within the continuum defined by the MLE and UCL risk estimates. This PEL represents OSHA's best judgment of the exposure limit necessary to eliminate a significant risk of harm to employees. As discussed later, OSHA concludes that this reduction is economically and technologically feasible. With this and the other proposed changes, the standard will provide more cost-effective and comprehensive protection to formaldehyde-exposed workers.
Paragraph (d) - Exposure Monitoring
Exposure monitoring informs the employer as to what the employees' exposures are and whether the employer meets the obligation to keep employee exposures below the PEL. It permits the employer to evaluate the effectiveness of engineering and work practice controls, and identifies the need for additional controls. Exposure monitoring data are part of the information that must be supplied to the physician, and are essential to developing hazard communication programs. The monitoring provisions of the formaldehyde standard contain many of the same elements as the monitoring requirements in other OSHA health standards, including provisions for initial and periodic monitoring; the use of objective data in lieu of initial monitoring; use of representative sampling strategies; termination of monitoring; precision and accuracy of monitoring methods; and employee observation of monitoring and notification of the results. The proposed amendments do not affect these major components, which are described more fully in the preamble to the final standard (52 FR at 46254-46261). The general requirement that the employer monitor employees to determine their exposure to formaldehyde is unchanged, as is the exemption which allows the employer to utilize objective data to determine that measurements are not required for employees exposed below the action level or STEL.
The Agency is proposing a minor amendment to the monitoring provisions of the formaldehyde standard. Specifically, OSHA proposes to delete paragraph (d)(1)(ii)(A) which contains an exception to the general exposure monitoring requirement, since this exemption is rendered redundant and confusing as a result of other proposed amendments. This paragraph exempts employers from monitoring unless there is a "formaldehyde hazard as defined in paragraph (m) or there are employee health complaints possibly associated with formaldehyde exposure." The use of the term "formaldehyde hazard" as defined in paragraph (m) becomes confusing in view of the other proposed amendments to paragraph (m) (discussed below) which would delete the definition of formaldehyde health hazard. Since the definition would be deleted, paragraph (d)(1)(ii)(A) is deleted. The intent of this section, however, is not changed.
The other exception in paragraph (d)(1)(ii)(A) referred to the need to monitor if there are employee health complaints, i.e., reports of signs and symptoms of formaldehyde exposure. This has been removed from paragraph (d)(1)(ii)(A) and added as a new paragraph (d)(2)(iii). This has the effect of stating the requirement positively rather than indirectly as was originally done in paragraph (d)(1)(ii)(A). It is felt that this change clarifies the employer's obligation.
The new paragraph requires employee monitoring if there are reports of signs or symptoms due to formaldehyde exposure, and additionally specifies that monitoring of employees reporting signs or symptoms be done promptly. While the time period represented by "promptly" is not specified, OSHA intends that no more than a few days elapse between the report and the exposure monitoring, unless there are extenuating circumstances. If the concentration is documented to be below the action level or STEL, then under existing paragraph (d)(1)(ii)(B), which is not being changed, objective data may be used to determine the employee's exposure. However, the data used must accurately reflect the affected employee's exposure (see discussion of objective data below.).
Paragraph (l) - Medical Surveillance
(8) - Medical Removal
The final formaldehyde standard promulgated on December 4, 1987 did not include medical removal protection (MRP) provisions. In response to the Court remand on this issue, OSHA has reexamined its reasoning, and carefully reviewed the record. OSHA now concludes that the record, considered as a whole, supports the requirement for MRP. The Agency believes that MRP provisions are important to the success of medical surveillance programs prescribed in the formaldehyde standard. The Agency has particularly relied on such participation in the case of formaldehyde, in that periodic exams were not required at the action level, even though there was some support for this in the record. Instead, effective medical surveillance was accomplished in the final rule through the completion of medical questionnaires, coupled with affected employees' reports of signs and symptoms and medical examinations where necessary. This alternative clearly depends on a high degree of employee participation and cooperation.
OSHA has concluded that the value of MRP in securing employee participation in medical surveillance programs, and the essential nature of these programs, requires that the Agency include MRP here. The other problems with adopting MRP originally cited by OSHA, i.e., nonspecificity and quick resolution of signs and symptoms, do not render MRP inappropriate per se, but rather require that the proposed medical removal provisions should be tailored to reflect the unique properties of formaldehyde. OSHA believes these new MRP provisions will encourage employee cooperation, and address our original concerns.
The proposed amendment specifies those conditions covered by MRP. Conditions which are potentially covered by MRP are limited to those clearly identified in the record as attributable to formaldehyde exposure: significant irritation of the mucosa of the eyes and of the upper airway, respiratory sensitization, dermal irritation, or dermal sensitization (Ex. 42-87, p.175). In the case of dermal irritation and dermal sensitization, and these conditions alone, the medical removal provisions do not apply when the percent of formaldehyde content in the product suspected of causing the dermal condition is below 0.05%. This is because, on the basis of evidence in the record, only those products with higher concentrations have clearly been associated with dermal irritation or dermal sensitization (Ex. 85-56, p.5).
The existing formaldehyde standard requires that employers institute medical surveillance programs for employees exposed to formaldehyde. The purpose of such programs is to identify employees adversely affected by formaldehyde exposure, even if the exposure is below the PEL. In this way, the employee can be treated if necessary, potential causes can be identified, and remedial measures taken.
The medical surveillance program, and all procedures conducted under it, must be supervised by a licensed physician, and provided at no cost to employees. The program consists of screening formaldehyde-exposed employees, with follow-up medical examinations in those instances when the physician feels it necessary. As a minimum, the screening consists of the administration of a questionnaire, which must include a work history, smoking history, and elicit information on a variety of medical conditions associated with formaldehyde exposure. These conditions include eye, nose, or throat irritation, chronic airway problems or hyperreactive airway disease, allergic skin conditions or dermatitis, and upper and lower respiratory problems.
All employees exposed to formaldehyde at or above the action level or STEL must be screened annually, by means of a medical questionnaire. In addition, employees exposed to formaldehyde must be screened with the questionnaire if they develop signs or symptoms of possible formaldehyde-related illness. If the responsible physician, upon evaluating the questionnaire, determines that a medical examination is necessary, the employee must be examined, and given any tests which the physician feels are appropriate.
When the physician has determined that a medical examination is necessary, it must be conducted promptly (as soon as possible, but within a few days at most) and the employer shall promptly comply with any subsequent recommendations for removal or restriction. If an employee reports signs or symptoms, and the physician determines that a medical examination is not immediately necessary, a two-week observation period begins. The purpose of this two-week period is to provide an opportunity for evaluation of the problem and for possible remediation of the condition, or causative factors. This provision is supported by information in the record that many formaldehyde-induced signs and symptoms often resolve themselves within a few hours or days (52 FR 46282). It will permit the employer to see whether signs or symptoms subside spontaneously or with minimal treatment, or to improve working conditions to alleviate the exposure, and the resulting condition, without unnecessary expenditure. If the signs or symptoms have not subsided or been remedied by the end of the two week period, the employee must be examined by the physician. If the signs and symptoms worsen during the two week period, the employee must be examined by the physician as soon as this fact is determined.
Any examination conducted in response to an employee report of signs or symptoms must include a medical and work history and any other element, including tests, which the examining physician deems necessary. The standard does not specify any particular tests. This is due to the variety of conditions associated with formaldehyde exposure which are covered by these provisions. Accordingly, the physician is given broad discretion in selecting any tests appropriate and useful under the circumstances. Any recommendation of restriction or removal must be based on the physician's professional judgment, since there are no specific criteria for evaluating the results that trigger automatic medical removal.
If the examining physician recommends restrictions or removal, these recommendations must be promptly followed as soon as possible (a day or two at most). In the case of removal, transfer alternatives must be considered first. The employee must be moved to a job location with significantly less formaldehyde exposure (about twenty-five percent or greater reduction) and not exceeding the action level. Transfer alternatives include possible job transfers that could be accomplished if the employee were to receive training for a short period of time. OSHA views a short period of time in this context as any period up to 6 months, the maximum period that MRP is available to employees under any circumstance. While the provisions require transfer, if possible, the type of training to be provided by the employer is not specified. OSHA does not intend that special job training programs be established. Job training opportunities such as the employer has afforded employees in the past should be sufficient to meet this requirement.
If there are no transfer alternatives, the employee must still be removed from the formaldehyde exposure for a period of up to six months or until a physician determines that the employee is able to return to work or determines that the employee will not ever be able to return to work.
In addition to effecting actual physical removal, MRP assures that employees are provided with temporary economic protection. When an employee is removed from formaldehyde exposure, through transfer or other means, the employer must maintain the employee's earnings, seniority and benefits. This includes overtime, bonuses, increases and production rate payments the employee would normally receive. This must be continued until the employee is determined to be able to return to the original job, or is determined to be unable to return to any workplace formaldehyde exposure, or for six months, whichever occurs first. If the employee receives any compensation through workers' compensation, or other programs, MRP payments can be reduced by that amount. If the employee obtains other employment, which is made possible by that employee's removal, the employer's obligation is similarly reduced.
The determination as to whether the employee can return to the original job, or is permanently unable to return to formaldehyde exposure is a medical decision, which must be based on a follow-up exam conducted by the employer's chosen physician. When the employee is returned to the original job, any subsequent signs or symptoms that may be reported are subject to another initial evaluation and determination whether an exam is necessary. If there is a determination that no exam is immediately necessary, a two-week period for evaluation and remediation is again initiated, and the employer proceeds from that point as described above.
Generally, when medical removal protection is part of a standard, OSHA usually provides a multiple physician review mechanism to assure successful operation of such programs. The provision of an opportunity for a second medical opinion strengthens and broadens the basis for medical determinations made under the standard. Multiple physician review also assures employee confidence in the soundness of medical determinations which may impact them significantly, and provides employees with a means of addressing judgments in situations where a worker questions the recommendations resulting from a medical exam or consultation. A full discussion of multiple physician review is contained in the preamble to the lead standard (43 FR 52972, 52998) which is applicable here since the proposal's multiple physician review mechanism is similar to that in the lead standard in all respects.
The initial choice of the examining physician is made by the employer. After any examination or consultation concerning medical removal or restriction is made by the employer's chosen physician, the employee must receive a copy of the physician's written opinion within 15 days from the time the employer receives it. The employer must also inform the employee of the right to seek a second medical opinion if the employee does not agree with the employer's physician's opinion. The employee must act within fifteen days from these notifications, or the employer may decline to participate in, or to pay for, any ensuing medical reviews. Otherwise, the multiple physician review mechanism must be provided to the employer without cost to the employee, including lost work time.
In seeking a second opinion, the employee must choose a physician to conduct appropriate examinations and tests, and issue a written opinion concerning the employee's ability to work with formaldehyde. If the two physicians arrive at different conclusions, and quick (a few days at most) resolution is not possible, a third physician, jointly designated by the two physicians or by the employer and employee (or the employee's authorized representative) must be consulted. This third physician must be a specialist in the area of the body affected or the condition (e.g. dermatologist, allergist, pulmonary physician) or must be an occupational physician. The recommendation of the third physician shall be promptly (a few days at most) followed, unless the employer and employee agree to follow any one of the three physicians' recommendations.
These provisions are in many respects similar to and consistent with the MRP mechanism of the lead standard, and a more detailed discussion of how the similar provisions work appears in the lead preamble (43 FR at 52972). For example, both MRP programs base removal decisions on the recommendation of a physician, both programs include wage retention provisions and both programs include a multiple physician review mechanism. To the extent the provisions of the formaldehyde MRP program are similar to those of the lead MRP program, OSHA adopts the legal justification supporting the lead standard, particularly the goal of encouraging employee participation in medical surveillance, in support of the MRP provisions of the formaldehyde standard. OSHA also intends that the provisions of the formaldehyde MRP program which are similar to those in the lead standard will operate and be enforced in a like manner.
Of course, OSHA recognizes that there are important differences between the lead MRP program and the MRP provisions of this standard. For example, formaldehyde MRP is limited to those employees exhibiting signs or symptoms of specified ailments; the formaldehyde MRP program includes a two-week remediation period for those employees not immediately referred to a physician and formaldehyde MRP is not automatically triggered by a feature, such as the blood lead measurements, relied upon in the lead standard. On the issues where the provisions of the formaldehyde MRP program are not consistent with those of the lead MRP program, OSHA expects that the lead standard will offer little enforcement guidance.
Paragraph (m) - Hazard Communication
The hazard communication provisions of the formaldehyde standard contained in paragraph (m) have been the subject of much of the controversy surrounding the formaldehyde standard. In response to a petition from the Formaldehyde Institute, the Agency stayed paragraphs (m)(1)(i) through (m)(4)(ii) (53 FR 50198). In deciding to administratively stay these provisions, OSHA cited the confusion generated by the Agency's attempt to provide a de minimis exemption from the hazard communication requirements. These provisions were also the result of an attempt to address the problem of products which emit or "offgas" formaldehyde, and because of this fact do not fall under the "articles" definition of the generic hazard communication standard, 29 CFR 1910.1200. Having decided these attempts were not successful, the Agency desired to investigate means of clarifying the requirements and improving compliance. One of the alternatives considered was to revoke paragraph (m), and substitute the generic hazard communication standard. This alternative did not really solve the problems that the Agency was trying to address, so upon reconsideration, OSHA has decided to amend paragraph (m) instead. OSHA believes that the hazard communication provisions of this proposal will provide a satisfactory final resolution to this issue. The amended hazard communication provisions of the existing formaldehyde standard discussed below will provide hazard communication requirements that accommodate the unusual properties of formaldehyde, and provide employees who are exposed to this substance with appropriate and adequate warnings.
Generally, hazard communication requirements include the use of labels on containers of the hazardous substance, material safety data sheets (MSDSs) and employee information and training. The labels must include the identity of the hazardous chemicals, appropriate hazard warnings and the name and address of the chemical manufacturers, importer or other responsible party. The employer must retain MSDSs received from the manufacturers or distributor and make them available to employees working with the substance. The material safety data sheets include more extensive information than that on the label, such as the physical and chemical characteristics of the chemicals, the health hazards, the primary routes of entry, the PEL or other recommended exposure limit, whether the substance is listed in the NTP Annual Report on Carcinogens or has been found to be a potential carcinogen by IARC, precautions for safe use and handling, control measures, and emergency and first aid procedures. In addition, the employer must make sure that employees are informed of any operations in their workplace where hazardous chemicals are present, and the location and availability of a written hazard communication program with supporting materials, such as material safety data sheets. Employees must be trained in methods that may be used to detect the presence or the release of a hazardous chemical in their work area, the physical and health hazards of the chemicals in the work area and measures employees can take to protect themselves from these hazards.
In order to clarify the intent of the standard, the text has been simplified. Wood products continue to be covered by the hazard communication requirements of this section. Although the language specifying wood products industry coverage no longer appears in the regulatory language, that industry continues to be covered by the hazard communication requirements of this section, because the exemption in paragraph (b)(6)(ii) of the generic hazard communication standard, 29 CFR 1910.1200, is not referenced and does not apply to this standard. The inclusion of 29 CFR 1910.1200(e)-(j), currently referenced in the stayed provisions would also be deleted. Many of these paragraphs are specifically referenced in other parts of paragraph (m). The one significant provision that is not referenced elsewhere in the standard, 29 CFR 1910.1200(e), written hazard communication programs, has been redrafted specifically for formaldehyde, and added to this proposed revision of paragraph (m).
In this proposed amendment of paragraph (m)(1), the definition of "health hazard" has been deleted, while the purpose of this section, establishing a de minimis threshold or trigger for action at 0.1%, or 0.1 ppm is retained, and explicitly stated. The definition of health hazard is unnecessary and confusing, since 29 CFR 1910.1200(c) contains a definition of "health hazard" which the Agency intends to continue to control along with all other definitions contained in that standard. OSHA intends that the employer's obligations with respect to hazard communication labeling for containers of formaldehyde products will be governed by the formaldehyde standard alone.
The three main elements of hazard communication are labels, material safety data sheets and employee training. The employer is required to use these in assuring that employees are informed of hazards and health effects and know how to protect themselves and reduce risks. The Agency believes that the labeling of products that have some potential to emit formaldehyde, in amounts which range from trivial to considerable, may warrant special consideration and that there may be other acceptable ways to adequately inform employees of hazards in this instance. The Agency has given a great deal of consideration to formaldehyde and hazard communication and finds that this chemical is highly unusual. Many factors distinguish formaldehyde from other chemicals which are regulated under the generic hazard communication standard. Formaldehyde products are unique in their tendency to "off-gas", that is, to release formaldehyde gas from solid materials, such as wood products and textiles. The amount of formaldehyde released is highly variable. It is determined by 1) the amount of formaldehyde entrapped or bound up (measured in "formaldehyde equivalents"), and 2) the rate of decay or release, which decreases over time and is primarily determined by environmental conditions such as temperature and humidity.
To address this problem, OSHA is proposing that, where the potential exposure is low, under 0.5 ppm, the label needs to indicate that formaldehyde may be present, give the name and address of a responsible party and indicate that physical and health hazard information is available from the employer and from MSDSs. Specific hazard information need not appear on the label, only the indication that such information exists, and directions and the location for obtaining such information. Where it cannot be documented that the concentration of formaldehyde will always remain at or below 0.5 ppm under reasonably foreseeable circumstances, the label information must detail all appropriate hazards, including the information that formaldehyde is a potential cancer hazard.
The Agency feels that this "low potential exposure" labeling for solid materials which may offgas formaldehyde strikes a balance, eliminating unnecessary hazard warnings where the potential may not be realized, and giving employees the appropriate warnings, via the label, MSDS's and training (see training discussion below) where there are low level emissions from products which may represent a health risk. This alternative means of accomplishing the goal of effective hazard communication is appropriate here because of the unique properties of formaldehyde, its widespread use and ubiquitous nature. This alternative does not reflect any risk determination or lack thereof. Employers are, of course, free to fully label containers of formaldehyde products in the usual manner without regard to the exposure potential.
The proposed amendments specify that objective data can be used by the employer in determining anticipated levels of formaldehyde release. This is consistent with paragraph (d)(1)(ii)(B), which is discussed above. Objective data consists of information which demonstrates that a particular product or material cannot release formaldehyde in concentrations exceeding the two labeling triggers of at or above 0.1 ppm or above 0.5 ppm, even under reasonably foreseeable conditions. An employer who relies on objective data must establish that the data were obtained under, or are applicable to, workplace conditions closely resembling the processes, type of product or material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations. Changes in the workplace which result in a new or additional formaldehyde exposure may require a new determination, to which the objective data previously used may not be applicable. Examples of information which might be used as objective data include representative personal samples, area samples, historical monitoring data, industry-wide studies, lab test results, and manufacturer's data. A full discussion of objective data is contained in the preamble to the final standard (see 52 FR at 46255-46256).
Paragraph (n) - Employee Information and Training
The proposed amendment would require that employee training would be conducted on an annual basis for all employees exposed to formaldehyde concentrations of 0.1 ppm or greater. The current standard requires initial training for persons exposed at 0.1 ppm or above, but just those exposed at or above the action level or STEL receive annual training. The content of the training remains unchanged, so that training programs already in place in the workplace are not affected by this proposed amendment.
OSHA is proposing this change for a number of reasons.Training is one of the three main elements of hazard communication. The success of risk management programs requires that employees be aware of hazard, work practice and other information essential to understanding the risks associated with their exposure, and the means of reducing that risk. The continued awareness on the part of the employee depends on constant reminders, such as hazard warning labels. Periodic training becomes especially important for formaldehyde, given the importance of the ancillary provisions in reducing risk, and the proposed exemptions to the labeling requirements, which are discussed above. Although employees will have access to material safety data sheets, they are a passive source of information. It is anticipated that training will play a more essential role in employees' awareness of the specific hazards in their workplace, and control measures employed. This is particularly true for illiterate or non-English speaking workers.
Annual training is also important for successful medical surveillance and MRP. These provisions will only be effective if employees know what signs or symptoms are related to the health effects of formaldehyde, if they know how to properly report them to the employer, and if they are periodically encouraged to do so. The record indicates that signs or symptoms are not uncommon in employees exposed to levels of formaldehyde below the action level and the STEL, the levels that currently trigger annual training (52 FR at 46280). It is felt that annual training for employees exposed to lower concentrations of formaldehyde will help assure the continued effectiveness of the ancillary provisions in reducing the risks of formaldehyde exposure. It will also help identify and assist those employees actually suffering health effects, through improving employee cooperation and participation in medical surveillance programs.
Paragraph (p) - Dates
OSHA proposes that employers be given a thirty (30) day period from the time the proposal becomes a final rule in which to generally familiarize themselves with these new provisions. In addition, individual provisions, where appropriate, have delayed start-up dates.
OSHA proposes that employers be given one year to install any additional engineering controls necessary to achieve the new PEL of 0.75 ppm TWA. Many employers will be able to meet this new PEL presently and will not need any more time; with this in mind, this start-up date section requires that compliance be accomplished as quickly as possible, but no later than a year from the effective date of the amendment.
In those cases where respiratory protection is required, such protection must be provided to employees in compliance with paragraph (g) as quickly as possible but no later than 3 months after the effective date of the amendment. It is felt that this extra time may be needed because some employers may have situations where no respiratory protection was needed to meet the PEL of l ppm, while the new PEL of 0.75 ppm may require implementation of respiratory protection programs, at least temporarily until they can achieve compliance with the PEL through the use of engineering controls. Therefore a period of three months may be necessary for these employers to properly select the appropriate respirator to protect their employees and complete fit testing and other necessary elements of an effective respiratory protection program.
The standard's medical surveillance provisions have been in effect for over two years. Employers have already implemented these provisions, including the administration of medical questionnaires to employees reporting signs or symptoms of formaldehyde exposure or employees exposed above the action level or STEL, medical examinations where appropriate and the receipt of physician's written opinions. Employers may need some additional time to implement the medical removal provisions and to ascertain how to adapt them to their particular workplace. The Agency believes that a six month period is appropriate under the circumstances.
Paragraph (m) of the formaldehyde standard as well as the hazard communication standard already impose general hazard communication requirements on employers handling formaldehyde-containing products in their workplaces. The proposed amendments would alter somewhat the labeling requirements for containers of certain products capable of releasing small amounts of formaldehyde. The Agency believes that employers handling formaldehyde products such as those described above may need some additional time to formulate the new labels. Six months is believed to be an appropriate amount of time to accomplish this task in view of the substantial amount of inventory that may be on hand. Moreover, this delayed start-up date would not adversely affect employee health since formaldehyde products would still need to be labeled in the interim in compliance with OSHA's generic hazard communication standard.
The amendments increase the frequency with which employees exposed to formaldehyde between 0.l ppm and 0.5 ppm must receive training. OSHA has decided that a two month start-up period for this provision is appropriate to allow the employer to determine which employees must be trained more frequently. This delayed start-up date is quite generous in view of the fact that the obligation only begins to be effective two months after the effective date of the amendment. Therefore, annual training will not need to be completed for this newly-included group of employees until a year after the anniversary date of their initial training.
Regulatory Impact and Regulatory Flexibility Assessment
Executive Order 12291 (46 FR 13197, 2/19/81) requires that a regulatory analysis be conducted for any rule having major economic consequences on the national economy, individual industries, geographical regions, or levels of government. In addition, the Regulatory Flexibility Act of 1980, 5 U.S.C. 601 et seq., requires OSHA to determine whether a regulation will have a significant impact on a substantial number of small entities.
Consistent with these requirements, OSHA has prepared a Preliminary Regulatory Impact and Regulatory Flexibility Assessment. This regulatory assessment is a supplement to the final Regulatory Impact Analysis (RIA) currently in the docket [Ex. 206].
As described in the 1987 RIA [Ex. 206], OSHA estimates that approximately 2.2 million workers are exposed to formaldehyde at levels of 0.1 ppm or greater. As a result of the introduction of the 1.0 ppm PEL, no workers should currently be exposed at levels above 1.0 ppm. An estimated 84,000 workers are exposed at levels between 0.75 ppm and 1.0 ppm. The balance of about 2.1 million workers are estimated to be exposed at levels between 0.1 and 0.75 ppm. The largest number of exposures currently is in the apparel industry, with an estimated 941,300 exposed workers, with 59,000 of these between 0.75 and 1.0 ppm.
For this analysis, OSHA has assumed that employees exposed between 0.5 and 1.0 ppm are distributed equally across this range; that is one half are currently between 0.75 ppm and 1.0 ppm. As noted in the 1987 RIA [Ex. 206, p. V-3], all employees previously exposed above 1.0 ppm would now be exposed at 0.75 ppm. As noted below, OSHA believes that exposures in textile finishing, laboratories and formaldehyde production are now below 0.75 ppm. The number of affected establishments and employees within the various affected industries is broken down by exposure level in Table I.
As elaborated in the 1987 RIA [Ex. 206, p. VII-1-14], market mechanisms and actions by other governmental bodies have been inadequate in eliminating significant risk to workers from formaldehyde exposure. For this reason, both a lower PEL and annual training for all workers exposed at 0.1 ppm and above are being instituted. In the case of workers leaving employment for medical reasons, workers compensation or unemployment insurance systems can provide income to workers. These systems, however, vary from state to state and do not provide for complete retention of wages and benefits. Without medical removal and wage protection safeguards, workers may continue to suffer acute formaldehyde-related symptoms out of fear of job loss.
The feasibility of a 0.75 ppm PEL was not addressed in the record. Consistent with OSHA's analysis of compliance with the 1.0 ppm PEL, however, OSHA believes a 0.75 ppm PEL is technologically feasible.
In the 1987 RIA, OSHA judged that it was technologically feasible to achieve compliance with a 1.0 ppm PEL [Ex. 206, p. III-2]. At that time, OSHA estimated that those establishments with exposures above 1.0 ppm, in order to comply with a 1.0 ppm PEL, would lower average personal exposures to 75% of the PEL, or 0.75 ppm(1). Those establishments with exposures below 1.0 ppm were judged to be unaffected by the new PEL [Ex. 206, IV-1]. This method of analysis coincided with that of the 1986 Heiden report [Ex. 133], which assigned no costs of engineering controls to establishments with exposures below 1.0 ppm.
(For TABLE I, See printed copy)
Similarly, in this analysis, those establishments with exposures above 0.75 ppm are assumed to lower their exposures to 75% of the new PEL, or 0.56 ppm. These establishments generally had fewer structurally or process-inherent exposure problems than those establishments which had exposures above 1.0 ppm in 1987 [Ex.206, p. IV-19,20,30,32,46,51,52,58, 59,61]. Moreover, the required relative reduction of exposures is less than for those establishments affected by the 1.0 ppm PEL [Ex. 206, p. V-4].
All exposures above 1.0 ppm were projected to drop to 0.75 ppm. OSHA conservatively estimated that 0.75 ppm would be the effective TWA exposure limit firms would strive to reach. It would make little sense to expend money for engineering controls and new processes, only to find that they were inadequate to achieve their intended purpose. Targeting controls to achieve TWA limit lower than the legal limit, provides a critical buffer for unforseen problems that may arise. In order to insure compliance with the 1.0 ppm PEL, exposures were projected to drop to 0.75 ppm or lower.
In the 1987 RIA, OSHA indicated that for some foundries, complying with a PEL of 0.5 ppm would not be feasible [Ex. 206, p. III-2]. The Agency's position was summarized in the Foundry section of the technological feasibility analysis; "OSHA therefore concludes that achieving 0.5 ppm is not feasible by the use of engineering controls." However, OSHA believes that achieving a 0.75 ppm TWA in the foundry industry is technologically feasible. Evidence in the existing record indicates that the majority of foundry employees were exposed to formaldehyde levels of 0.5 ppm or less [Ex. 206, p. II-13, IV-55]. The introduction of engineering controls since the 1987 rule should have moved more employees below 0.75 ppm. OSHA inspection data since the standard took effect indicate that the majority of foundries inspected had exposures below 0.75 ppm [Ex. 301-1]. These data support the conclusion that a PEL of 0.75 ppm is technologically feasible.
Therefore, feasibility is not expected to be a problem for these establishments.
Costs of Compliance
For the purposes of this analysis, it was assumed that (1) establishments are in compliance with the existing OSHA standard and (2) exposure levels have responded as projected in the 1987 RIA.
Consistent with the 1987 RIA, OSHA assumes that only those establishments with exposures between the new PEL of 0.75 ppm and the existing PEL of 1.0 ppm would be affected by the new PEL. These establishments would be expected to lower average exposures to 75% of the new PEL, or 0.56 ppm(2). It is also assumed that employees exposed between 0.5 and 1.0 ppm are evenly distributed within this range(3). Sources available in the record for analyzing the incremental cost of moving from the current 1.0 ppm PEL to a PEL of 0.75 ppm are limited. While a shift to a new technology was postulated in some industries as the only means of achieving compliance with a 0.5 ppm PEL, there was no such prediction made with respect to a 0.75 ppm PEL. Additionally, there was little indication that controls in plants with exposures slightly above 1.0 ppm prior to 1987 were considerably different from those with exposures slightly below 1.0 ppm prior to 1987. For the purposes of this analysis, OSHA projects that the technology necessary to comply with a 0.75 ppm PEL would be generally the same that was used to bring those plants with exposures above 1.0 ppm prior to 1987 into compliance with a 1.0 ppm PEL.
Four additional industries -- textile finishing, apparel manufacturing, formaldehyde production and plastic molding -- are estimated to have potential exposures in excess of 0.5 ppm, but below 1.0 ppm. Both the 1985 Heiden report [Ex. 77-19] and the 1981 Ashford report [Ex. 70-1], examined the costs and impacts of reaching exposure levels below 1.0 ppm for these industry sectors. These studies, along with information from other sources were of particular use in this analysis. The following discussion provides
OSHA's analysis of compliance costs in individual industries.
In the 1987 RIA [Ex. 206, p. IV-54], it was estimated that 1,047 foundries had exposures above 1.0 ppm (first group), and an additional 1,435 had exposures between 0.5 ppm and 1.0 ppm (second group). It was projected that as a result of the 1.0 ppm PEL, average exposures in the first group would be lowered to 0.75 ppm, and that the second group would remain unchanged. OSHA estimates that half of the second group, or 718 foundries, would need to respond to the new PEL of 0.75 ppm. As discussed in the 1987 RIA [Ex. 206, p. IV-53], OSHA found that this group is comprised largely of foundries using the shell core process. To comply with the standard, firms would incur capital costs for local exhaust ventilation of $10,000, with an annual operating cost of $900 per machine, and would have an average of 3 affected machines per plant [Ex. 206, p. IV-52], for a total capital cost of $21,540,000 (718 X 3 X $10,000) and annual operating costs of $1,938,600 (718 X 3 X $900). It is possible that providing controls for only a portion of the machines would reduce exposures sufficiently to achieve compliance with the proposed PEL, but OSHA conservatively assumes that controls on all three would be necessary.
In the 1987 RIA [Ex. 206, p. IV-36] it was estimated that forty hardwood plywood establishments had exposures above 1.0 ppm and would lower exposures to 0.75 ppm as a result of the 1.0 ppm PEL. Sixty-six establishments unaffected by the 1.0 ppm PEL were estimated to have exposures between 0.5 ppm and 1.0 ppm. OSHA estimates that half of these establishments, or 33, would be affected by a 0.75 ppm PEL.
OSHA assumes that plants with exposures between 0.75 ppm and 1.0 ppm have exposure problems similar to those plants which were out of compliance with the 1.0 ppm PEL. These plants were estimated to require fan replacement at an incremental capital cost of $2,000 and an incremental annual operating cost of $100 per plant [Ex. 206, p. IV-34]. The costs to come into compliance with a 0.75 ppm PEL in this industry are therefore estimated to be $66,000 in capital costs and $3,300 in annual operating costs.
In the 1987 RIA, OSHA stated that some plants could comply with a 1.0 ppm PEL with ventilation alone, while others would also need to convert to LEUF resins [Ex. 206, p. IV-30-35]. While it is possible that some or all of the plants discussed in the previous paragraph could achieve compliance with a 0.75 ppm PEL through increased ventilation alone, OSHA conservatively assumes that these plants would also need to convert to LEUF resins to assure compliance. The 1987 RIA noted a gradual shift to low-emitting ureaformaldehyde (LEUF) resins in the hardwood plywood industry [Ex. 206, p. IV-32,35]. However, the establishments with highest formaldehyde exposures currently are also the least likely to have converted. Therefore, due to uncertainty regarding these plants, OSHA is employing the doubly conservative assumption that LEUF resins would be introduced directly as a result of this rule. Using the same method of estimating cost as was used in the 1987 RIA [Ex. 206, p. IV-35], it is estimated that an additional 235 million square feet (MMSF) of board production would need to be converted to LEUF at a cost of $2,750 per MMS, or an annual operating cost of $646,250 ($2,750 X 235). The total costs associated with complying with a 0.75 ppm in the hardwood plywood industry are therefore estimated to be $66,000 in capital costs, $649,550 in annual operating costs.
In the 1987 RIA [Ex. 206, p. IV-24,26] it was estimated that out of 46 plants, 14 had exposures above 1.0 ppm, and would lower exposures to 0.75 ppm as a result of the standard. An additional 16 plants were estimated to have exposures between 0.5 and 1.0 ppm, 8 of which are estimated to have exposures between 0.75 and 1.0 ppm. Assuming these plants would need to employ ventilation similar to those with exposures previously above 1.0 ppm, these plants would need additional ventilation at a capital cost of $215,320 per plant and annual operating costs of $53,830 per plant [Ex. 206, p. IV-21], or a total capital cost of $1,722,560 and a total annual operating cost of $430,640.
Medium Density Fiberboard (MDF)
The 1987 RIA [Ex. 206, p. IV-27,29,31] projected that 9 MDF establishments would lower exposures to 0.75 ppm as a result of the 1.0 ppm PEL. It estimated that 5 additional establishments would have exposures between 0.5 and 1.0 ppm after the standard. It is estimated that approximately half, or 3 of these establishments would be affected by a 0.75 ppm PEL.
In the 1987 RIA it was estimated that the capital costs of lowering exposures to 0.75 ppm through additional ventilation would be $105,534 per plant, with annual operating costs of $63,486. Applying these costs to the 3 affected plants, OSHA estimates the cost of additional ventilation in this industry would be $316,602 in capital costs, and $190,458 in annual operating costs.
In the 1987 RIA, it was estimated that 184 plants had exposures above 1.0 ppm and would lower exposures to 0.75 ppm in response to the 1.0 ppm PEL. These were all facilities that produce both furniture and board ("integrated" plants), that had exposures in their board production operations rather than the furniture operations. There were an additional 2,646 establishments that had exposures estimated between 0.5 and 1.0 ppm, mostly furniture assembly plants with relatively isolated exposures above 0.5 ppm [Ex. 206, p. IV-43-44].
Again it was assumed that one-half, or 1,323 plants, have exposures between 0.75 ppm and 1.0 ppm. However, as noted in the 1987 RIA [Ex. 206, p. IV-44], in many of these plants, the exposure problems were due not to the lack of ventilation but to lack of usage. Poor work practices may be responsible. In this regard, more training, not additional engineering controls, would remedy the exposure problems.
However, to the extent that available ventilation is utilized, there would be an increase in operating costs for these furniture plants. One reasonable basis for estimating these costs is the cost of annual exhaust ventilation employed by Ashford [Ex. 70-1]. The annual operating cost of these systems is estimated to be approximately $864 per year per establishment. OSHA assumes that these additional costs would apply to only half of annual work days, at a cost of $432 annually. Since this cost would be incurred at 1,323 plants, the estimated cost of compliance at these plants would be $571,536 annually.
In approximately 214 plants (one half the integrated plants unaffected by the 1.0 ppm PEL) additional ventilation would likely be necessary to comply with a 0.75 ppm PEL. Based upon the analysis in the 1987 RIA [Ex. 206, p. IV-42], OSHA estimates that capital costs would be $52,000 per plant, or $11,128,000 for all furniture plants. The annual operating costs would be $13,000 per plant, or $2,782,000 for all "integrated" plants, or a total for the industry of $3,443,500.
In its analysis of formaldehyde exposures in laboratories [Ex. 206, p. IV-58-59,61], a clear dichotomy was found between laboratories with functioning fume hoods and good work practices and those without them. High exposure levels were believed to exist in "problem" histology and pathology labs as a result of malfunctioning or misused fume hoods or poor work practices. The record indicated that such controls, as implemented in response to the existing standard, would have largely eliminated exposures above 0.5 ppm [Ex. 128, p. 4,6,9]. Exposures in these laboratories also show significant peak periods or episodes [Ex. 128, p.5]. However, to the extent that laboratories are in compliance with a 2.0 ppm STEL, they should also be in compliance with a 0.75 ppm PEL [Ex. 128, p. 9].
The 1987 RIA indicated, based upon a study of 44 Iowa funeral homes, that TWA exposures were less of a problem than short-term exposures. TWA exposures were estimated to be below 0.5 ppm for all establishments in compliance with the present standard [Ex. 206, p. IV-66]. Annual training for employees exposed between 0.5 and 0.1 ppm should improve work practices and help reduce short term exposures. No engineering controls are thought to be necessary for this.
OSHA's 1987 RIA indicated that 35 plants had partially open production processes and would need to install engineering controls, lowering exposures to 0.75 ppm. The other 62 plants had a closed production process and were not believed to have exposures above 0.5 ppm [Ex. 206, p. IV-70]. No additional engineering control costs are estimated for this industry.
At the time of the 1987 rulemaking, OSHA estimated that there were 685 textile finishing plants with formaldehyde exposures between 0.5 and 1.0 ppm [Ex. 206, p. 78,80]. Approximately half, or 343, are estimated to have exposures between 0.75 and 1.0 ppm.
The Ashford report examined methods [Ex. 70-1] which would be expected to lower exposures in many areas of textile plants. However, the textile industry indicated that as of 1986, they were using the most chemically advanced resins available, and a further reduction of formaldehyde content in cloth would come only at the expense of a significant decrease in fabric quality [Ex. 159].
However, in 1989 OSHA lowered permissible exposure limits (PELs) on about 200 chemicals and instituted PELs for the first time on about 100 others. Since the textile finishing industry uses a large of number of regulated chemicals OSHA believes that engineering controls are being introduced in order to limit chemical exposure generally [54 FR 2816, 1/19/89]. Recent OSHA inspection data have indicated no personal exposures to formaldehyde above 0.5 ppm in this industry [Ex. 301-1]. OSHA therefore believes that all textile finishing plants are currently in compliance with a 0.75 ppm PEL.
In the 1987 RIA, OSHA estimated that 5,737 establishments had exposures between 0.5 and 1.0 ppm. OSHA estimates that approximately half of these, or 2,869 establishments, may have exposures between 0.75 and 1.0 ppm.
The record indicates that exposure problems in the apparel industry are due to the lack of appropriate exhaust ventilation. That is, the workplace is treated like an office or store and air is recirculated rather than exhausted and replaced, allowing formaldehyde concentrations to build [Ex. 78-24, 78-48]. A relatively simple solution to this problem of air stagnation is to install roof exhaust fans. Ashford cited the cost of installing a 2,000 cubic feet per minute (cfm) roof exhaust fan at $1,000, with an increased annual operating cost of $720 [Ex. 70-1, p. 4-19].
However, factoring in inflation for capital equipment costs(4), the capital cost is now estimated to be approximately $1,200, and the incremental annual operating cost $864. OSHA therefore estimates the cost of compliance with the lower PEL in the apparel industry to be $3,442,800 for capital, $2,478,816 in annual operating costs.
The 1987 RIA estimated that approximately 16 out of 49 establishments would have exposures above 0.5 ppm after promulgation of the standard. However, the 1987 RIA indicated no exposures above 0.7 ppm [Ex. 206, p. IV-78].
Ashford [Ex. 70-1] developed formaldehyde production engineering control cost estimates in 1981 and indicated costs of compliance to meet all potential exposure limits. By 1985, Heiden indicated that such plants were already in compliance with a 1.0 ppm PEL [Ex. 77-19]. Therefore, consistent with the above analysis and data, OSHA believes no additional controls would be necessary to achieve compliance with a 0.75 ppm PEL.
Plastic Molding Laminates
In its 1987 RIA, OSHA estimated that approximately 1,000 plants have exposures between 0.5 and 1.0 ppm [Ex. 206, p. IV-75,76]. OSHA estimates that approximately half, or 500 plants, have exposures between 0.75 and 1.0 ppm. Ashford [Ex. 70-1] estimated that there was one molding machine for every four workers, the capital cost for local ventilation was $425 per machine and the annual operating cost was approximately $133 per machine. Given the estimated 5,000 workers exposed between 0.75 and 1.0 ppm, OSHA estimates ventilation would be required for 1,250 machines. Applying the cost adjustment introduced in the apparel section, OSHA now estimates the capital cost would be $510 per machine and the annual operating cost $160. Based upon these unit costs, OSHA estimates $637,500 in capital costs and $200,000 in annual operating costs.
Summary of Engineering Control Costs
OSHA estimates the total capital costs of instituting engineering controls which would be sufficient to comply with a 0.75 ppm PEL to be $38.9 million, with annual operating costs of $9.2 million. The annualized cost(5) of the engineering control capital costs is estimated to be $6.4 million, for a total annualized cost of $15.6 million.
The 1987 price index was used to match unit price assumptions and revenue data used in the 1987 RIA, as they have been used elsewhere in the analysis.
Medical Removal Protection
The medical removal process begins when an employee reports signs and symptoms of possible overexposure to formaldehyde. OSHA previously estimated that 10 percent of workers exposed between 0.1 and 0.5 ppm would report signs and symptoms [Ex. 206, p. IV-11]. These workers would fill out a medical questionnaire, after which a two week evaluation and remediation period would begin. If the symptoms have not subsided after two weeks, the employee would be immediately referred to a physician. The physician might, in turn, recommend transferring the employee to a job with significantly less formaldehyde exposure.
OSHA's medical removal provision is a codified version of plans that already exist in a number of companies [Ex. 159]. Companies with current removal programs have noted that examples where someone had to be placed in another job because of formaldehyde exposure were rare. The former medical director of Burlington Industries reported that "clearly less than ten percent" of those employees completing medical questionnaires required further medical evaluation. He added that only about one percent of these employees had symptoms that were clearly "chemically related" [Tr., p. 160, 5/12/86]. The American Textile Manufacturers Institute stated that "...most companies have a complaint mechanism in place to discover individuals with problems....Corporate medical surveillance programs show absolutely no evidence that contact dermatitis or allergic reaction from formaldehyde is a frequent problem [Ex. 159]." The medical director for the Dan River Clinic, which provides medical examinations for 6,000-12,000 company employees, 25 percent of whom are exposed to formaldehyde in textile operations, at levels between 0.15 and 1.0 ppm, indicated that over a 10 year period he received "no complaints about formaldehyde irritation or formaldehyde induced dermatological problems" [Ex. 159].
There are, however, additional safeguards in the proposed provision that may increase the amount of medical removal. The amended standard would provide for additional training, which would increase employee awareness of the signs and symptoms of formaldehyde exposure, as well as an understanding of their rights under MRP and the proper channels to follow in using it. Additionally, an employee is allowed to appeal the company doctor's decision. Therefore, it is reasonable to expect some increase in the amount of transfer and removal over what is reported currently.
OSHA anticipates that less than 1 percent of the exposed working population would be affected by this provision. The large majority of these cases could be handled by transferring the employee. Only in the case of a very small employer, would an alternate job be unavailable.
OSHA estimates that 10 percent of all employees exposed to formaldehyde would report signs and symptoms that may be related to formaldehyde exposure, but only a small fraction of these would actually need to be moved into other jobs or placed on six-month removal benefits by their employer. Since these employees are already provided medical surveillance under the present standard and a large number of employers presently provide for medical removal in one form or another, the additional burden imposed by this amendment is expected to be small.
However, the potentially significant cost of this provision would be to provide 6 months compensation to employees for whom alternate jobs would not be available. Although the record on medical removal programs in larger companies suggests that alternate jobs are usually available [Ex. 159], the effect of universal medical removal protection on small firms is uncertain. For the purposes of estimating the impact of this provision, OSHA assumes that 10 percent (of the assumed 1 percent of employees who might be removed from their job) cannot be provided alternate employment by their employer and must be provided 6 months compensation. This estimate excludes employees who may find other jobs within 6 months. By these assumptions (10% X 1% removal X 2.2 million exposed X % annual turnover X average annual income X 1.3 fringe benefits X 1/2 year), the cost would be $5.8 million annually.
The existence of current medical removal plans in industry points to the fact that it makes economic sense to have a medical removal program. Workers who suffer adverse health effects from formaldehyde exposure can be moved to positions where they can contribute more productively to a firm's operation. OSHA therefore anticipates offsetting cost savings from this provision in the form of improved productivity, reduced absenteeism and reduced medical care costs.
In the proposed amendment of the existing standard, workers exposed between 0.1 and 0.5 ppm would now be required to receive annual training on the hazards of formaldehyde and ways to avoid them. OSHA estimates the cost of this to be $13.5 million per year.
Based upon the 1987 RIA [Ex. 206, p. I-3], OSHA estimates that there are currently approximately 2 million employees exposed to formaldehyde between 0.1 and 0.5 ppm. OSHA estimates that when current compliance is accounted for, it would take an additional half an hour annually, on average, to provide adequate refresher training specific to formaldehyde for these employees(6). Employing the data and methodology used in the RIA [Ex. 206, p. 15], OSHA estimates the cost of training as follows: Employee training cost: # of employees between 0.1 and 0.5 ppm x (1 + 1/2 turnover rate(7)) x (wage x 1.3 fringe rate) x 1/2 hour Trainer cost in establishments with 20 employees or more: # of employees exposed between 0.1 and 0.5 ppm x (1 + 1/2 turnover rate)/20 x $26(8) x 1/2 hour Trainer cost in establishments with 20 or fewer employees: # of affected establishments x $26 x 1/2 hour
A summary of the compliance costs of these revisions to the Standard for each industry are provided in Table II.
OSHA expects these proposed revisions to the standard to produce quantifiable benefits in the form of reduced cancer incidence due to the lowered PEL and increased training, and reduced acute respiratory irritation due to the institution of medical removal protection. In addition, OSHA expects that the lower PEL and increased training will improve worker productivity through a lessening of irritation and an improved understanding of workplace processes. (For TABLE II, See printed copy)
An estimated 83,818 workers are estimated to be currently exposed at an average formaldehyde concentration of 0.875 ppm (between 0.75 and 1.0 ppm). This exposure is expected to be reduced to an average of 0.5625 ppm after implementation of the 0.75 ppm PEL. The 1987 RIA employed a cancer risk model developed by the Consumer Product Safety Commission based upon rat studies [Ex. 206, p. V-1-5]. Based upon this model, OSHA estimates that from 0.2 to 72 cancers would be avoided over the next 45 years by lowering the PEL from 1 to 0.75 ppm, depending on whether the Maximum Likelihood Estimate (MLE) or the Upper Confidence Limit (UCL) is used in the risk assessment(9). Lowering exposure levels should also bring some decrease in respiratory distress and may result in greater worker productivity, as described further below. OSHA believes that the additional training would also provide health benefits. Annual training insures that the knowledge and appreciation of the hazard and ways to limit exposure through good work practices are reinforced continually.
The Hazard Communication RIA claimed a 20% reduction in all chemical related worker injuries and illnesses as the result of labeling, MSDSs and initial training. With the specific exposure reductions noted in the industry discussion, OSHA expects an additional 5% reduction in formaldehyde-related illnesses and injuries among the workers exposed between 0.1 and 0.5 ppm. Using the same risk model used to project benefits from lowering the PEL, OSHA estimates that, given a 5% risk reduction from annual training, an additional .004 to 79 cancers would be avoided over the next 45 years as a result of annual training(10). In sum, OSHA estimates that lowering the PEL and providing additional training could prevent as many as 151 cancers over the next 45 years, or about 3 per year. However, the lower bound, maximum likelihood estimates of risk, produce only negligible benefits related to the proposed revisions.
In the 1987 RIA, OSHA estimated that 5,911 cases of respiratory distress would be eased by lowering the PEL to 1.0 ppm [Ex. 206, p. V- 9-11]. However, these same symptoms persist at very low exposure levels for a small percentage of the population. These employees would be directly aided by medical removal protection.
OSHA estimates there are 2,163,101 employees exposed to formaldehyde at 0.1 ppm or greater. As estimated in the 1987 RIA, acute respiratory distress debilitates affected workers for half the working year, or 125 days, at a cost of between $5.50 and $23.50(11) per worker per day. As a result of this provision, OSHA estimates that as many as 1% of them may be removed for respiratory distress. The equation for calculating this cost savings would therefore be: # employees X 1% X turnover X $5.50-23.50 per day X 125 days. This would amount to between $4.5 and 19.2 million annually. It should be noted that while this may represent a cost savings to society, such a savings is not enjoyed entirely by employers. In the apparel industry, for example, employees generally work on a piecework basis. Under the current system, the impact of reduced productivity is borne largely by the employee.
Economic Impact and Regulatory Flexibility
An analysis of revenue and profit data provided in the 1987 RIA indicates that the costs to comply (without consideration of cost savings) with these amendments would not have a significant adverse impact on a substantial number of small entities nor on the economy as a whole. In only the fiberboard industry are costs expected to be as much as 0.1% of revenue, and costs are expected to be less than 1% of profits in all but a few industries. The greatest potential impact on profits would be in the hardwood plywood industry, where compliance costs are estimated to equal 5.4% of profits.
Smaller establishments should not be disproportionately impacted. Most of the costs in the hardwood plywood industry are attributed to the introduction of LEUF resins, and these costs are directly proportional to sales. In the furniture industry, most of the engineering control costs would be absorbed by a minority of larger plants. Human resource costs, such as removal protection and training are generally proportional to the number of employees, and therefore would not have a disproportionate impact on small businesses. The requirement to give employees six month removal compensation might be more burdensome to small businesses due to limited availability of alternate jobs, but this should be a particularly rare event. Since the likelihood of encountering such formaldehyde-sensitive employees is directly related to the number of employees in a business, this provision is not expected to substantially impact small entities.
Estimates of average compliance costs per establishment, as a percentage of revenues and profits are provided for all affected industries in Table III.
Environmental Impact Analysis
The National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq., requires OSHA to determine whether this regulatory action would have a significant impact on the environment. These amendments would not increase the amount of formaldehyde found in the general environment and may decrease it as some establishments switch to low-emitting resins. Therefore, the Agency believes that these provisions would not have a significant impact on the environment. No comments made at the public hearing or submitted to the record contradict this conclusion.
OSHA is not seeking OMB clearance under the Paperwork Reduction Act (PRA) of 1980, 44 U.S.C. 3501 et seq. (48 FR 13666) since there are no information collection requirements subject to OMB review under the Paperwork Reduction Act in this formaldehyde proposal.
Federalism and State Plan Applicability
This proposed standard has been reviewed in accordance with Executive Order 12612, 52 FR 41685 (October 30, 1987), regarding Federalism. This Order requires that agencies, to the extent possible, refrain from limiting state policy options, consult with States prior to taking any actions that would restrict State policy options, and take such actions only when there is clear constitutional authority and the presence of a problem of national scope. The Order provides for preemption of State law only if there is a clear Congressional intent for the agency to do so. Any such preemption is to be limited to the extent possible.
Section 18 of the Occupational Safety and Health Act (OSH Act), expresses Congress' clear intent to preempt State laws with respect to which Federal OSHA has promulgated occupational safety or health standards. Under the OSH Act, a State can avoid preemption only if it submits, and obtains Federal approval of, a plan for the development of such standards and their enforcement. Occupational safety and health standards developed by such Plan-States must, among other things, be at least as effective as the Federal standards in providing safe and healthful employment and places of employment.
Those States which have elected to participate under Section 18 of the OSH Act would not be preempted by this regulation and would be able to deal with special, local conditions within the framework provided by this performance-oriented standard while ensuring that their standards are at least as effective as the Federal standard.
The 25 States with their own OSHA-approved occupational safety and health plans must adopt a comparable standard within six months of publication of a final rule. The States are: Alaska, Arizona, California, Connecticut, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, New York, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, Wyoming. For New York and Connecticut, plans cover only state and local government employees. Until such time as a State standard is promulgated, Federal OSHA will provide interim enforcement assistance, as appropriate, in these States.
AUTHORITY and SIGNATURE
Pursuant to the authority of section 4(b)(2), 6(b), and 8(c) of the Occupational Safety and Health Act of 1970 (the Act)(29 U.S.C. 653, 655, 657), the Construction Safety Act (40 U.S.C. 333), the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941), the Secretary of Labor's Order 1-90 (55 FR 9033), 29 CFR Part 1911, 29 CFR Part 1910 is proposed to be amended as set forth below. As with the original standard covering occupational exposure to formaldehyde, this proposed amendment of that standard would also apply to the maritime and construction industries.
List of Subjects in 29 CFR Part 1910
Formaldehyde, Occupational Safety and Health, Chemicals, Cancer. Signed at Washington, D. C. this _______ day of July, 1991.
Gerald F. Scannell
Assistant Secretary of Labor
PART 1910 - [AMENDED]
Part 1910 of Title 29 of the Code Federal Regulations is therefore proposed to be amended as follows:
1.The authority citation for Subpart Z of Part 1910 would be amended to read as follows:
Authority: Secs. 4,6,8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736) or 1-90 (55 FR 9033) as applicable; and 29 CFR Part 1911. Section 1910.1000 Tables Z-1, Z-2, Z-3 also issued under 5 U.S.C. 553 * * * 1910.1048 also issued under 29 U.S.C. 653.
2. Paragraphs (c), (m)(1), (m)(1)(i), (m)(3), (m)(4) and (n) of 29 CFR 1910.1048 would be revised; paragraph (d)(1)(ii)(A) and paragraph (n)(2)(ii) would be revoked; and paragraphs (d)(2)(iii), (l)(8), (l)(9), (m)(5) and (p)(3) would be added to read as follows:
* * * * *
(c) Permissible Exposure Limit (PEL) - (1) TWA: The employer shall assure that no employee is exposed to an airborne concentration of formaldehyde which exceeds 0.75 part formaldehyde per million parts per air (0.75 ppm) as an 8-hour TWA.
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(d) Exposure monitoring - (1) General. * * * (ii) Exception. Where the employer documents, using objective data, that the presence of formaldehyde or formaldehyde-releasing products in the workplace cannot result in airborne concentrations of formaldehyde that would cause any employee to be exposed at or above the action level or the STEL under foreseeable conditions of use, the employer will not be required to measure employee exposure to formaldehyde.
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(2) Initial monitoring. * * * * * (iii) If the employer receives reports of signs or symptoms of respiratory or dermal conditions associated with formaldehyde exposure, the employer shall promptly monitor the affected employee's exposure.
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(l) Medical surveillance. * * * * * (8) Medical removal. (i) The provisions of paragraph (l)(8) apply when an employee reports significant irritation of the mucosa of the eyes or of the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization attributed to workplace formaldehyde exposure. Medical removal provisions do not apply in the case of dermal irritation or dermal sensitization when the product suspected of causing the dermal condition contains less than 0.05% formaldehyde.
(ii) An employee's report of signs or symptoms of possible overexposure to formaldehyde shall be evaluated by a physician selected by the employer pursuant to paragraph (l)(3). If the physician determines that a medical examination is not necessary under paragraph (l)(3)(ii), there shall be a two-week evaluation and remediation period to permit the employer to ascertain whether the signs or symptoms subside untreated or with the use of creams, gloves, first aid treatment or personal protective equipment. Industrial hygiene measures that limit the employee's exposure to formaldehyde may also be implemented during this period. The employee shall be referred immediately to a physician prior to expiration of the two-week period if the signs or symptoms worsen. Earnings, seniority and benefits may not be altered during the two-week period by virtue of the report.
(iii) If the signs or symptoms have not subsided or been remedied by the end of the two-week period, or earlier if signs or symptoms warrant, the employee shall be examined by a physician selected by the employer. The physician shall presume, absent contrary evidence, that observed dermal irritation or dermal sensitization are not attributable to formaldehyde when products to which the affected employee is exposed contain less than 0.1% formaldehyde.
(iv) Medical examinations shall be conducted in compliance with the requirements of paragraph (l)(5)(i) and (ii). Additional guidelines for conducting medical exams are contained in Appendix C.
(v) If the physician finds that significant irritation of the mucosa of the eyes or of the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization result from workplace formaldehyde exposure and recommends restrictions or removal, the employer shall promptly comply with the restrictions or recommendation of removal. In the event of a recommendation of removal, the employer shall remove the affected employee from the current formaldehyde exposure and if possible, transfer the employee to work having no or significantly less exposure to formaldehyde.
(vi) When an employee is removed pursuant to paragraph (l)(8)(v), the employer shall transfer the employee to comparable work for which the employee is qualified or can be trained in a short period (up to 6 months), where the formaldehyde exposures are as low as possible, but not higher than the action level. The employer shall maintain the employee's current earnings, seniority, and other benefits. If there is no such work available, the employer shall maintain the employee's current earnings, seniority and other benefits until such work becomes available, until the employee is determined to be unable to return to workplace formaldehyde exposure, until the employee is determined to be able to return to the original job status, or for six months, whichever comes first.
(vii) The employer shall arrange for a follow-up medical examination to take place within six months after the employee is removed pursuant to this paragraph. This examination shall determine if the employee can return to the original job status, or if the removal is to be permanent. The physician shall make a decision within six months of the date the employee was removed as to whether the employee can be returned to the original job status, or if the removal is to be permanent.
(viii) An employer's obligation to provide earnings, seniority and other benefits to a removed employee may be reduced to the extent that the employee receives compensation for earnings lost during the period of removal either from a publicly or employer-funded compensation program or from employment with another employer made possible by virtue of the employee's removal. (ix) In making determinations of the formaldehyde content of materials under this paragraph the employer may rely on objective data.
(9) Multiple physician review. (i) After the employer selects the initial physician who conducts any medical examination or consultation to determine whether medical removal or restriction is appropriate, the employee may designate a second physician to review any findings, determinations or recommendations of the initial physician and to conduct such examinations, consultations,and laboratory tests as the second physician deems necessary and appropriate to evaluate the effects of formaldehyde exposure and to facilitate this review.
(ii) The employer shall promptly notify an employee of the right to seek a second medical opinion after each occasion that an initial physician conducts a medical examination or consultation for the purpose of medical removal or restriction.
(iii) The employer may condition its participation in, and payment for, the multiple physician review mechanism upon the employee doing the following within fifteen (15) days after receipt of the notification of the right to seek a second medical opinion, or receipt of the initial physician's written opinion, whichever is later;
(A) The employee informs the employer of the intention to seek a second medical opinion, and (B) The employee initiates steps to make an appointment with a second physician.
(iv) If the findings, determinations or recommendations of the second physician differ from those of the initial physician, then the employer and the employee shall assure that efforts are made for the two physicians to resolve the disagreement. If the two physicians are unable to quickly resolve their disagreement, then the employer and the employee through their respective physicians shall designate a third physician who shall be a specialist in the field at issue:
(A) To review the findings, determinations or recommendations of the prior physicians; and
(B) To conduct such examinations, consultations, laboratory tests and discussions with the prior physicians as the third physician deems necessary to resolve the disagreement of the prior physicians.
(v) In the alternative, the employer and the employee or authorized employee representative may jointly designate such third physician.
(vi) The employer shall act consistent with the findings, determinations and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians.
(m) Hazard communication--(1) General. Communication of the hazards associated with formaldehyde in the workplace shall be governed by the requirements of paragraph (m). The definitions of paragraph 29 CFR 1910.1200(c) shall apply under this paragraph.
(i) The following shall be subject to the hazard communication requirements of this paragraph: formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde, and materials capable of releasing formaldehyde into the air, under reasonably foreseeable conditions of use, at concentrations reaching or exceeding 0.1 ppm.
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(3) Labels. (i) The employer shall assure that hazard warning labels complying with the requirements of 29 CFR 1910.1200(f) are affixed to all containers of materials listed in paragraph (m)(1)(i), except to the extent that 29 CFR 1910.1200(f) is inconsistent with this paragraph.
(ii) Information on labels. As a minimum, labels shall identify that the material contains formaldehyde; list the name and address of the responsible party; appropriately warn of all hazards as defined in 29 CFR 1910.1200(d) and 29 CFR 1910.1200 Appendices A and B.
(iii) Exceptions. Employers whose employees handle solid materials which are only covered by this paragraph because the materials are capable of releasing formaldehyde into the air under reasonably foreseeable conditions of use, need only comply with the following:
(A) As a minimum, for those solid materials capable of releasing formaldehyde at levels of 0.1 ppm and above, labels shall identify that the product contains formaldehyde; list the name and address of the responsible party; and state that physical and health hazard information is readily available from the employer and from material safety data sheets.
(B) For those solid materials capable of releasing formaldehyde at levels above 0.5 ppm, labels shall also contain the words "Potential Cancer Hazard" and appropriately address all other hazards as defined in 29 CFR 1910.1200(d) and 29 CFR 1910.1200 Appendices A and B, including respiratory sensitization.
(C) In making the determinations of anticipated levels of formaldehyde release, the employer may rely on objective data indicating the extent of potential formaldehyde release under reasonably foreseeable conditions of use.
(iv) Substitute warning labels. The employer may use warning labels required by other statutes, regulations, or ordinances which impart the same information as the warning statements required by this paragraph.
(4) Material safety data sheets. (i) Any employer who uses formaldehyde-containing materials listed in paragraph (m)(1)(i) shall comply with the requirements of 29 CFR 1910.1200(g) with regard to the development and updating of material safety data sheets.
(ii) Manufacturers, importers, and distributors of formaldehyde-
containing materials listed in paragraph (m)(1)(i) shall assure that material safety data sheets and updated information are provided to all employers purchasing such materials at the time of the initial shipment and at the time of the first shipment after a material safety data sheet is updated.
(5) Written hazard communication program. The employer shall develop, implement, and maintain at the workplace, a written hazard communication program for formaldehyde exposures in the workplace, which at least describes how the requirements specified in this paragraph for labels and other forms of warning and material safety data sheets, and paragraph (n) for employee information and training, will be met. Employers in multi-employer workplaces shall comply with the requirements of 29 CFR 1910.1200(e)(2).
(n) Employee information and training - (1) Participation. The employer shall assure that all employees who are assigned to workplaces where there is exposure to formaldehyde participate in a training program, except that where the employer can show, using objective data, that employees are not exposed to formaldehyde at or above 0.1 ppm, the employer is not required to provide training.
(2) Frequency. Employers shall provide such information and training to employees at the time of initial assignment, and whenever a new exposure to formaldehyde is introduced into the work area. The training shall be repeated at least annually.
* * * * *
* * * * *
(3) Start-up dates of amended paragraphs--(i) Respiratory protection. Respiratory protection required to meet the amended PEL of 0.75 ppm TWA shall be provided as soon as possible but no later than 3 months after the effective date of the amendment.
(ii) Engineering and work practice controls. Engineering and work practice controls required to meet the amended PEL of 0.75 ppm TWA shall be implemented as soon as possible, but no later than one year after the effective date of the amendment.
(iii) Medical removal protection. The medical removal protection provisions including the multiple physician review mechanism shall be implemented within 6 months of the effective date of the amendment.
(iv) Hazard communication. The labeling provisions contained in paragraph (m) of this standard shall be implemented within 6 months of the effective date of the amendment. Labeling of containers of formaldehyde products shall continue to comply with the provisions of 29 CFR l9l0.l200 until that time.
(v) Training. The periodic training mandated for all employees exposed to formaldehyde between 0.l ppm and 0.5 ppm shall begin within 2 months of the effective date of the amendment.
FOOTNOTE (1): The assumption that establishments previously above 1.0 ppm would be reduced to 0.75 ppm in response to the 1.0 ppm PEL was a conservative P + + assumption in two respects. First, as a technological matter, in a number of industries, the engineering controls described in the cost analysis were shown to be capable of lowering exposures by a factor of 10 or more, in many cases to below 0.5 ppm [Ex. 128, p. 6, 15; 1, Chap III]. However, due to difficulties encountered in lowering exposures in some establishments in some industries [Ex. 206, Chap. III], OSHA employed a generic assumption of 0.75 ppm as ther exposure level establishments would reach after implementing costed engineering controls. (Back to text)
FOOTNOTE (2): This is consistent with the assumption made in the RIA of the Standard, in which it was assumed employers would reduce exposures to 0.75 ppm, in order to insure compliance with the 1.0 ppm PEL [Ex. 206, p. V-3]. (Back to text)
FOOTNOTE (3): This is a conservative assumption, as exposure distributions tend to follow a lognormal distribution, with most exposures at relatively low levels, and a relatively small number at higher levels. To the extent this assumption overstates the number of establishments affected by the PEL, then OSHA has overestimated the cost of compliance. (Back to text)
FOOTNOTE (4): Electricity and heating equipment costs (here used as a proxy for ventilation equipment) rose approximately 20% between 1981 and 1987. However, other energy costs, which are also reflected in annual operating costs (e.g., gas heating) generally fell [BLS, Producer Price Indexes, 1987].P + + (Back to text)
FOOTNOTE (5): The annualized cost is derived by applying a cost recovery factor (of 0.163 based on an equipment life expectancy of 10 years and a 10% cost of capital) to any capital costs and adding the annual operating costs. (Back to text)
FOOTNOTE (6): In the 1987 RIA, OSHA estimated that one hour training would be a reasonable estimate of the amount of time required for the annual training in the average establishment [Ex. 206, p. IV-15]. However, the original RIA training costs did not factor in current compliance. In the apparel industry, with almost half of the affected employees, little time would be needed to train employees on these provisions. Moreover, in addition to whatever baseline existed before, the current standard has likely spurred additional training for employees with exposure below 0.5 ppm, in part because some establishments may have chosen to establish training programs for all employees, not just new employees or those exposed above 0.5 ppm. (Back to text)
FOOTNOTE (7): The turnover rate varies by industry [Ex. 206, p. IV-4]. (Back to text)
FOOTNOTE (8): Trainer hourly compensation [Ex. 206, p. IV-15]. (Back to text)
FOOTNOTE (9): Based upon the CPSC five-stage model, the Maximum Likelihood Estimate of Risk (MLE) is expressed as: EP(d)=0.3954763163 x 10(-5) x (dose in ppm)(4) + 0.1597258396 x 10(-5) x (dose in ppm)(5) where EP(d)=the excess probability of cancer attributable to formaldehyde The Upper Confidence Limit (UCL) is approximately linear at low doses and, for the purposes of this analysis, could be expressed as: EP(d)=264 x 10(-5) x (dose in ppm) (Back to text)
FOOTNOTE (10): This was estimated by using the MLE and the UCL, applied to all employees exposed to formaldehyde between 0.5 and 0.1 ppm, assuming an average exposure of 0.3 ppm, and a 5% reduction in risk. (Back to text)
FOOTNOTE (11): As discussed in the 1987 RIA [Ex. 206, p. V-11], this figure was an estimate of the value of reduced work activity as the result of eye, note and throat irritation, coughing, headaches, chest discomfort, changes in lung function, impaired physical performance and exacerbation of asthma. (Back to text)
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