Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Formaldehyde|
| Title:||Section 4 - IV. Summary and Explanation of the Final Amendments|
IV. Summary and Explanation of the Final Amendments
The final amendments to the formaldehyde standard in response to the Court remand and related issues are generally unchanged from OSHA's proposal published July 15, 1991, with only a few exceptions. As explained below, the most significant change is in the hazard communication provisions, paragraph (m).
A total of 34 comments were received. Most comments supported the amendments as proposed.
This preamble describes the specific points raised by commenters and the resolution of the issues involved.
Paragraph (c) - Permissible Exposure Limit (PEL)
This amendment to the final rule reduces the permissible exposure limit to 0.75 parts formaldehyde per million parts of air as an 8-hour time weighted average (0.75 ppm TWA). The basis for 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 percent 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. Since 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).
As instructed by the Court, the Agency reconsidered 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 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. The Court criticized OSHA's reliance on the ancillary provisions to reduce risk because OSHA could not quantify the extent of exposure reduction, and hence risk reduction, these provisions would produce. 878 F.2d at 396. Although OSHA is convinced that the ancillary provisions contribute to risk reduction (52 FR 46253, 46275, 46285, 46287), the Agency is still unable to quantify that reduction. OSHA therefore believes it cannot rely on the ancillary provisions to reduce risk and that it is appropriate to reduce the PEL further in order to increase the certainty that workers are adequately protected. The Agency has determined that the PEL should 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, along with the ancillary provisions, necessary to eliminate a significant risk of harm to employees.
Of the commenters who responded to the proposed amendments, only six addressed this issue specifically. Of these comments, five (Ex. 304-3, 304-14, 304-15, 304-24, and 304-27) ranged from expressing positive or conditional support to providing recommendations that would, in the commenters' estimation, strengthen the evidence for adopting the 0.75 ppm level.
The comment submitted by the Society of the Plastics Industry (Ex. 304-3) expressed unconditional support for the lower PEL. However, the National Electrical Manufacturers Association (Ex. 304-14), while supporting the lower PEL, cautioned against further reduction. Similarly, Monsanto (Ex. 304-15) supported the proposed PEL.
While not disagreeing with a PEL of 0.75 ppm, Du Pont (Ex. 304-24) suggested that OSHA supplement the cancer incidence information by incorporating risk data compiled by Casanova and Heck, and published by the Chemical Industry Institute of Toxicology (CIIT), which utilized pharmacokinetic modeling. OSHA considered these types of studies in preparing the risk assessment for the 1987 final standard for formaldehyde. The Agency's reasons for not including these types of studies are discussed in the preamble to the 1987 final standard (52 FR 46225) and remain the same. Moreover, since Du Pont does not claim that these data would justify a different PEL than 0.75 ppm, OSHA does not believe it is necessary or appropriate to reopen the rulemaking record at this stage of the proceedings to include them.
In a related comment, Duke Power (Ex. 304-24) suggested that factors other than carcinogenicity, e.g, irritant properties, should be used to justify the reduction of the PEL. OSHA agrees that irritant effects are involved and that lowering the PEL will reduce incidences of these effects. Reducing the PEL below 1 ppm will reduce the residual irritant risk that remains at 1 ppm.
Only one comment, submitted by an individual worker, (Ex. 304-1) opposed the proposed action to lower the PEL, but offered no substantive information to support its opposition.
OSHA believes that the comments support the reduction in the PEL effected by this amendment. OSHA further concludes that this reduction in the PEL is economically and technologically feasible. See the discussion under Regulatory Impact and Regulatory Flexibility Assessment later in this preamble.
Paragraph (d) - Exposure Monitoring
Exposure monitoring informs the employer of the levels of formaldehyde to which employees are exposed. Such information is essential to determining whether the employer meets the obligation to keep employee exposures below the PEL and STEL and the obligations imposed by the standard when exposures exceed the action level. 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 under the standard's medical surveillance provisions.
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 final 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.
A technical amendment was proposed for the monitoring provisions of the formaldehyde standard which is implemented in the final amendments. Specifically, paragraph (d)(1)(ii)(A), which contained an exception to the general exposure monitoring requirement, is deleted, since it related to the definition of formaldehyde health hazard which had been included in paragraph (m)(1)(i) but which is also being deleted in this final rule. The intent of this section, however, is not changed.
The other exception in paragraph (d)(1)(ii)(A) which made reference to the need to monitor if there are employee health complaints, i.e., reports of signs and symptoms of formaldehyde exposures, 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 in order to provide employers some flexibility, OSHA intends that no more than a few days elapse between the report and the exposure monitoring, unless there are extenuating circumstances.
Duke Power (Ex. 304-24) suggested that "a few days" may not allow sufficient time for some employers to conduct monitoring, particularly those who would need to hire outside consultants to conduct the monitoring. OSHA believes that in the event this situation arises it would constitute extenuating circumstances and would be permissible, provided the employer can prove his or her diligence in attempting to meet the requirement.
Under existing paragraph (d)(1)(ii)(B), which is not being changed, objective data may be used to determine that the employee's exposure cannot exceed the action level or STEL. However, the data used must accurately reflect the affected employee's exposure (see discussion of objective data below.).
A related comment submitted by Owens Corning Fiberglas (Ex. L304-31) pointed out that sampling methods were not specified relative to determining if concentrations exceed levels which would require labeling and training. Neither the proposal nor the final amendments require sampling in such cases but allow the use of objective data which would indicate the potential formaldehyde release under reasonably foreseeable conditions of use. Thus, the standard does not actually pose the difficulty which is perceived by this commenter.
Paragraph (g) - Respiratory Protection
Issues related to respiratory protection were not part of the proposed amendments. However, two comments were submitted that were a logical outgrowth of the proposal to reduce the PEL. Wilson Safety Products (Ex. 304-12) pointed out that Table 1 of the 1987 standard (52 FR 46293), "Minimum Requirements for Respiratory Protection Against Formaldehyde," should be corrected to reflect the change in the PEL from 1 ppm to 0.75 ppm. OSHA agrees and has accordingly reproduced the table with the necessary corrections in paragraph (g). Footnote "(2)" regarding the use of half-mask respirators is retained. In addition, a technical correction has been made to paragraph (g)(3)(iv) to reflect the change in the PEL. This paragraph addresses the required frequency of replacement for canisters in atmospheres up to 10 times the PEL and 100 times the PEL, respectively. The allowable concentrations are changed from 10 ppm to 7.5 ppm and from 100 ppm to 75 ppm to reflect the 0.75 permissible exposure limit.
ISEA (Ex. 304-21) observed that the proposed amendments did not discuss the relative merits of engineering controls and respirators to protect against airborne formaldehyde. ISEA suggested that before OSHA prescribes engineering controls in lieu of respirators as the primary means of complying with the new PEL for formaldehyde, it should complete its ongoing rulemaking on Methods of Compliance. (See 54 FR 23991, 6/5/89).
The methods of compliance section of the formaldehyde standard was not challenged before the D.C. Circuit and OSHA did not propose to reconsider it when it proposed the amendments now under consideration. The formaldehyde record was reopened only to resolve the remand issues and the outstanding issues related to the hazard communication provisions. Moreover, the Methods of Compliance rulemaking proposed to amend only the Air Contaminants standard (29 CFR 1910.1000) and the Respiratory Protection standard (29 CFR 1910.134). Since that rulemaking does not propose to amend substance-specific standards such as the formaldehyde standard, it provides no basis to defer action on these proposed amendments.
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. On reconsideration, the Agency has concluded that MRP provisions can contribute to the success of the medical surveillance programs prescribed in the formaldehyde standard. Unlike some other substance-specific standards, the formaldehyde standard does not provide for periodic medical examinations for employees exposed at or above the action level. Instead, medical surveillance is accomplished in the final rule through the completion of annual medical questionnaires, coupled with affected employees' reports of signs and symptoms and medical examinations where necessary. This alternative depends on a high degree of employee participation and cooperation to determine if employee health is being impaired by formaldehyde exposure. OSHA believes these new MRP provisions will encourage employee participation in the standard's medical surveillance program and avoid the problems associated with nonspecificity and quick resolution of signs and symptoms that originally concerned the agency (see 52 FR 46282).
The final amendments specify those conditions covered by MRP. Conditions which are potentially covered by MRP are limited to 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 percent. 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, a 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 hyperactive 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.
If, in the examining physician's professional judgment, restrictions or removal are needed to alleviate the employee's symptoms of formaldehyde exposure, the physician's recommendations must be 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), which cannot exceed 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 either that the employee is able to return to work or 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's removal permits the employee to obtain other employment, 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 as to 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.
When medical removal protection is part of a standard, OSHA usually provides a multiple physician review mechanism to assure successful operation of such programs. Multiple physician review provides an employee with an opportunity for a second medical opinion in a situation where a worker questions the recommendations resulting from a medical exam or consultation performed by a physician chosen by the employer. By doing so, it assures employee confidence in the soundness of medical determinations which may impact them significantly. As employee confidence is necessary to assure that employees will cooperate with the standard's medical surveillance provisions, multiple physician review is an integral component of the standard. 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 multiple physician review mechanism provided by these final amendments 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 by the employer without cost to the employee, including lost work time.
In seeking a second opinion, the employee may 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 in question (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.
The MRP 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 (although removal under the lead standard is also required if an employee's blood lead level exceeds a certain value), 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 laboratory result, 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.
The Agency received a number of comments in connection with various aspects of the proposed MRP provision. Three commenters, Honeywell, Amoco Corporation, and Duke Power (Exs. 304-2, 304-18 and 304-24, respectively) raised the question as to whether the provision was intended to apply to office environments where employees may potentially be adversely affected by the off-gassing of formaldehyde from building materials and furnishings. OSHA believes that paragraph (a), scope and application, of the final standard indicates the Agency's intent to include all occupational exposures to formaldehyde under the standard, without regard to workplace environment. In particular, the standard's application to materials that release formaldehyde is relevant to offices and similar workplaces where formaldehyde exposures primarily result from off-gassing of building materials and furnishings. OSHA believes that to the extent that an employee in any occupational setting is exposed to formaldehyde at concentrations high enough to induce signs and symptoms of formaldehyde-related illness, that person should be protected by the MRP provisions of this standard. However, since formaldehyde exposures in offices are low, OSHA would expect MRP to affect employees in such environments only in exceptional cases.
MRP is directed toward employees suffering significant irritant effects attributable to formaldehyde exposures who, in the examining physician's judgment, will benefit from restriction or removal from work areas where formaldehyde is present. The MRP provisions are not designed to cover employees who have been determined to be permanently sensitized to formaldehyde. However, while that determination is being made, OSHA would expect that such employees receive MRP benefits. Sensitized employees often can resume work in areas with lower formaldehyde exposure without suffering adverse effects. The provision exempts from coverage dermal conditions (irritation or sensitization) caused by exposure to products containing less than 0.05 percent formaldehyde.
The commenters identified above also recommended that OSHA provide a cut-off level for airborne concentrations of formaldehyde below which the MRP provisions would not apply, e.g. 0.1 or 0.5 ppm. Because of the nature of the hazard presented by formaldehyde and the variation in individual susceptibility to its effects, OSHA does not believe that there is sufficient justification in the record to establish such a level. Moreover, OSHA does not feel that such a level is necessary, given the checks and balances built into the MRP provisions. For example, administration of the medical questionnaire precedes any action connected with MRP. On the basis of the employee's responses, the examining physician can make a determination regarding the need for medical examinations. If the physician decides that medical examinations are not immediately necessary, the employee begins a 2-week observation period. During this time the medical condition may be resolved either spontaneously or through remedial action such as removal of the formaldehyde source, a reduction in the exposure level or the intervention of minimal medical treatment. OSHA believes that this approach will allow employers an opportunity to resolve many employee medical problems associated with exposure to formaldehyde before medical removal would become necessary.
A comment submitted by ARCO Alaska, Inc. (Ex. 304-4) suggested that medical removal be triggered by "objective clinical evidence" rather than an employee's complaint of signs or symptoms of sensory irritation. ARCO Alaska requested that the standard permit the examining physician leeway to rely on evidence derived from a physical exam. OSHA believes that the proposed amendments already accommodate the concern expressed by the commenter. The MRP provisions do not preclude the examining physician from performing any type of medical exam that he or she feels is appropriate in reaching a decision as to whether the signs and symptoms presented by an employee are related to that employee's exposure to formaldehyde. The physician must first administer the medical questionnaire to employees exhibiting signs and symptoms of formaldehyde exposure. Following this, the physician is given broad discretion in selecting appropriate and useful medical tests.
In a related comment, the Amoco Corporation (Ex.304-18) recommended that OSHA require the examining physician to be one who specializes in occupational medicine. OSHA notes that the initial choice of an examining physician rests with the employer, and the standard does not preclude the employer from choosing a physician licensed in occupational medicine. However, as in previous rulemakings, the Agency does not feel that requiring physicians to be specialists in occupational medicine is practical or feasible, given the limited number of such physicians. (The number of occupational physicians is estimated to be around 5,000 according to the Institute of Occupational Medicine.) Also, OSHA believes that many licensed physicians who are not specialists in occupational medicine are fully qualified to make the medical determinations required under the MRP provisions. The final amendment does require that if a third physician is consulted with respect to the MRP provisions, this physician must be specialized in the area of the body affected or condition (e. g. dermatologist, allergist) or be an occupational physician. OSHA believes that this will not overly tax the number of occupational physicians available and will reserve the requirement to use one to those instances where there is a difference in professional opinion, the resolution of which might benefit from a physician trained in occupational medicine.
Additional comments were received regarding the economic protection clause of the MRP provisions. For example, the Amoco Corporation (Ex. 304-18) stated: "Worker protections such as these have traditionally been considered the province of labor relations and, in our opinion should remain so." OSHA notes that MRP is not a labor-relations provision but a mechanism to protect worker health. In promulgating the lead standard, (see 43 FR 52973, November 14, 1978), convincing evidence was presented that pointed out the painful dilemma confronting many lead-exposed workers. For example, a worker could participate in the medical surveillance program and risk losing his or her job if abnormal medical findings were revealed that could be linked to occupational exposure to lead. On the other hand, a worker could resist participation in the medical surveillance program and thus lose the benefits that medical surveillance is designed to provide. To obviate the need for employees to have to make such decisions, OSHA required employers to protect employee benefits in the event a job transfer or removal became necessary. OSHA is not aware of evidence in the formaldehyde record that suggests that the situation is different regarding formaldehyde workers. OSHA believes that formaldehyde workers need similar assurance that wages, seniority and other attendant benefits will be retained to secure their participation in medical surveillance.
The Photo Marketing Association International (L304-29) asserted: "[T]o the extent the allergic reaction prevents the employee from working or causes other injury, the employee has a remedy through the state worker's compensation laws." As noted earlier in this preamble discussion, where an employee has been determined to be unable to work in areas where formaldehyde is present due to permanent sensitization to the substance, the MRP provisions cease to apply. MRP is designed to bridge the short period while a symptomatic employee is waiting to recover or is being trained to do another job with lower formaldehyde exposure. Where an employee cannot work with formaldehyde and there is no other job available, the employee will need to rely on worker's compensation. In cases where employees are covered by MRP, if the employee receives any compensation through worker's compensation or other programs, the MRP payments can be reduced by that amount. However, in cases where the medical condition is reversible, OSHA believes that MRP is an appropriate measure for the reasons discussed above. The comment submitted by the Photo Marketing Association International goes on to urge OSHA to either delete the requirement of maintaining the affected employee's benefits or to exempt small businesses from these requirements. OSHA does not feel there is justification for an exemption for small businesses; the harm that may be inflicted on an employee will not differ with the size of the business and there is no evidence in the record to show that the MRP provisions would cause an unacceptable or infeasible burden on small businesses. The costs and benefits of MRP are addressed in the Regulatory Impact Analysis.
Organization Resources Counselors, Inc. (Ex. L304-19) raised objection to the requirement for a second medical opinion if the first medical opinion recommended that the employee be restricted rather than removed. ORC believed that a second opinion was not necessary in such a situation because the employee's compensation and benefits would not be at risk. This comment misconceives the purpose of multiple physician review. That purpose is to assure that a second medical opinion can be sought by an employee who is dissatisfied with the recommendations of the physician chosen by the employer. OSHA believes that this provision is essential to assure that employees have confidence in the soundness of medical determinations that affect them. If an employee is suffering sensory irritation from formaldehyde and the employer's physician recommends restriction rather than removal, the employee may believe that this recommendation will not adequately address his or her symptoms and seek a second medical opinion, which might recommend removal. Thus, even if the first physician recommends restriction, the outcome of the multiple physician review process may be removal.
The Department of Veteran Affairs (Ex. 304-23) asked that OSHA specify the frequency and duration of the symptoms reported by the employee before medical removal would apply. OSHA believes this approach to be unrealistic. As the provision is written, restriction or removal of an employee is based on the physician's professional judgment. While frequency of symptoms may enter into the physician's decision with respect to determining the appropriate course of action, other factors such as the severity of symptoms as well as the employee's general state of health will also enter into this decision. Therefore OSHA does not feel that frequency should be mandated by this amendment.
Paragraph (m) - Hazard Communication
Generally, hazard communication requirements are governed by OSHA's generic Hazard Communication standard (HCS), 29 CFR 1910.1200. The HCS requires 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 manufacturer, importer or other responsible party. The employer must retain MSDSs received from the manufacturer 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 MSDSs. 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.
The formaldehyde standard contained specific hazard communications provisions in paragraph (m) that supplemented the requirements of the generic HCS in an attempt to accommodate the unique properties of formaldehyde. Those provisions have been the subject of much of the controversy surrounding the formaldehyde standard. In brief, the hazard communication provisions of the formaldehyde standard applied to formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm. Employers were required, as a minimum, to address the following hazards: cancer, irritation, and sensitization of the skin and respiratory system, eye and throat irritation and acute toxicity. Manufacturers and importers of formaldehyde were required to provide downstream employers with an objective determination through labels and material safety data sheets if the items were considered to constitute a health hazard in accordance with the HCS under normal conditions of use. The labels were to comply with the requirements of the HCS, 29 CFR 1910.1200(f). As a minimum, the labels were required to identify the hazardous material; identify the responsible party; contain the language, "Potential Cancer Hazard;" and warn of all other hazards as defined in Appendices A and B of 29 CFR 1910.1200. Material safety data sheets were to be developed in accordance with paragraph (g) of the HCS.
The "de minimis exemption," which exempted materials capable of releasing formaldehyde in concentrations less than 0.1 ppm from hazard communication requirements, was an attempt to address the problem of products which emit or "offgas" formaldehyde, and because of this fact do not fall under the "articles" exemption of the generic HCS. The de minimis exemption, contained in paragraph (m)(1)(i), proved confusing and controversial, because it implied, contrary to other provisions of the standard, that any exposure above 0.1 ppm constituted a health hazard. The provision prompted a petition from the Formaldehyde Institute, which OSHA granted, to stay paragraphs (m)(1)(i) through (m)(4)(ii) (53 FR 50198). Having decided that its attempt to provide a workable de minimis exemption was not successful, the Agency desired to investigate means of clarifying the requirement and improving compliance. Upon reconsideration, OSHA proposed to amend paragraph (m). The proposed amendments were designed to provide hazard communication provisions that accommodate the unusual properties of formaldehyde and provide appropriate worker protection without undue burden on employers.
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. (56 FR at 3207, 7/15/91).
The following summarizes the changes in brief: Wood products continue to be covered under the hazard communication provisions of the formaldehyde standard; references to the generic Hazard Communication Standard in the stayed paragraphs of the formaldehyde standard (m)(1)(i) through (m)(4) were deleted; the definition of "health hazard" was deleted but trigger levels for action (0.1 percent or 0.1 ppm) were retained.
In developing the proposed amendments the Agency gave a great deal of consideration to finding acceptable means to apply hazard communication provisions in the formaldehyde standard given the known unique properties of the chemical. In particular, formaldehyde's ability to "offgas," that is, to release formaldehyde gas from solid materials such as wood products and textiles distinguishes it from other chemicals for which the generic Hazard Communication Standard can readily apply. Solid materials capable of emitting formaldehyde do not neatly fall within the "article" exemption of the generic standard. An "article" as defined at 29 CFR 1910.1200 (c) means a manufactured item (i) which is formed to a specific shape or design during manufacture; (ii) which has an end function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which does not release, or otherwise result in exposure to, a hazardous chemical, under normal conditions of use. An article is not considered to release a hazardous chemical if only a few molecules or a trace amount are emitted. (See 52 FR at 31865, August 24, 1987). With regard to formaldehyde, the amount of the chemical that is emitted is highly variable, depending on the amount of the chemical bound up in the material and the rate of decay or release which decreases over time. The rate of release is influenced by environmental factors such as temperature and humidity. Therefore to apply the generic hazard communication provisions without qualification would, in effect, require comprehensive labeling for all products capable of emitting more than a few molecules of formaldehyde without due consideration to other relevant factors.
To address this problem, OSHA proposed that, where the potential exposure is 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 would be required to detail all appropriate hazards, including the information that formaldehyde is a potential cancer hazard.
The Agency felt that this "low potential exposure" labeling for solid materials which may offgas formaldehyde struck a balance, eliminating unnecessary hazard warnings where the potential may not be realized, and giving employees the appropriate warnings, via the label, MSDSs and training where there are low level emissions from products which may represent a health risk.
A considerable number of comments were received that questioned the Agency's proposed approach which, according to the commenters, established an artificial distinction between formaldehyde exposures from solid materials and other physical forms of formaldehyde. For example, in its comment the Association of Nonwoven Fabrics Industry stated:
To the best of our knowledge, OSHA has provided no evidence documenting that the health hazard of exposure to 0.1 - 0.5 ppm of formaldehyde from a solid material can be distinguished by the exposed individual to an equal exposure of 0.1 - 0.5 ppm of formaldehyde from another source. (Ex. 304-9).
A similar comment was submitted by the Industrial Coatings Group, Inc. With respect to labeling, the comment stated:
A distinction is drawn between solids and other materials for no apparent reason. Since the issue is the potential emission of a chemical, and since the property under discussion is the amount of formaldehyde capable of being released (not what form it is in) it seems peculiar to make a distinction based on the phase of the emission source. (Ex. 304-22).
Several other commenters supported the above view. (Exs. 304-8, 304-8, L304-19, L304-25, 304-27, and L304-34).
OSHA has therefore reevaluated the options with respect to hazard communication and agrees that the distinction between solids and other forms of formaldehyde is not appropriate. OSHA has concluded that labeling requirements should apply uniformly to all forms of formaldehyde. Specifically, where it is determined through monitoring or the use of objective data that employee exposures will not exceed levels above 0.5 ppm, the hazard warning label shall include the following information: the material or mixture contains formaldehyde; the name and address of the responsible party; and a statement that physical and health hazard information is readily available from the employer and from material safety data sheets. Where it cannot be documented that the concentration will always remain at or below 0.5 ppm under reasonably foreseeable conditions, the label information must detail all appropriate hazards, including information that formaldehyde is a potential cancer hazard. Formaldehyde-containing products incapable of causing exposures at or above 0.1 ppm or mixtures and solutions containing less than 0.1 percent formaldehyde will not be subject to any hazard communication requirements.
This provision should not be construed as precedential for other rulemakings. Formaldehyde has unique properties and uses which make it necessary to distinguish its handling from that of the generic labeling requirements of the Hazard Communication Standard. The importance and effectiveness of the Hazard Communication Standard itself should in no way be diminished by the approach taken in these final amendments concerning formaldehyde.
OSHA notes that the foregoing should resolve other questions concerning the labeling requirements as proposed. For example, the BF Goodrich Company (Ex. 304-17) asked for a definition of "materials" and "solid materials" if OSHA continued to make such distinctions in the context of labeling requirements. OSHA believes that the final amendments clarify the fact that all physical forms of formaldehyde will be subject to identical labeling requirements as prescribed in paragraphs (m)(1)(ii) and (m)(1)(iii) and therefore such definitions are unnecessary.
The Shipbuilders Council of America (Ex. 304-7) and Newport News Shipbuilding (Ex. 304-33) recommended that OSHA allow employers the option of posting signs in work areas affected by formaldehyde off-gassing in lieu of labeling, where such conditions are transient and short-lived. The source of the off-gassing or conditions of use of formaldehyde were not apparent from the comment. However, paragraph (f) of the Hazard Communication Standard, referenced in this section, provides for the use of signs in situations where it is impractical to affix labels. Specifically, paragraph (f)(6) of the Hazard Communication Standard allows employers to use signs, placards, process sheets, etc. in lieu of affixing labels to individual process containers as long as the alternative method conveys the identity of the hazardous chemical and appropriate hazard warning. OSHA believes that it is reasonable to allow the use of signs in work areas where employees may be incidentally exposed to formaldehyde for brief periods of time as long as the appropriate hazard warning is noted and employees are trained regarding the significance of information on the sign.
Updike, Kelly & Spellacy (Ex. 304-5) suggested that the labeling provisions should apply only to products produced 6 months or more after the effective date to eliminate the need for employers to repackage and relabel any existing inventory to meet the requirements of the provision. OSHA notes that labeling has already been an ongoing obligation under the generic Hazard Communication standard. Consequently, the labels prepared in order to comply with the generic HCS will automatically be in compliance with this standard and therefore there is no need for repackaging or relabeling products by manufacturers, importers or employers.
The Amoco Corporation (Ex. 304-18) questioned whether manufacturers could anticipate a product's reasonably foreseeable conditions of use for labeling purposes. The comment asked for guidance on a number of points with respect to how the manufacturer or importer should calculate the rate of emission for labeling purposes.
The labeling requirement is intended to apply to the maximum potential emission under foreseeable conditions of use. It is the responsibility of the manufacturer and/or importer to establish what that value is and label accordingly. OSHA noted in the original rulemaking that it could be difficult for the manufacturer or importer to make this determination (52 FR at 46285), but OSHA nevertheless believes that this approach best provides for employees to have comprehensive hazard information without unnecessary burden to employers. If manufacturers or importers are uncertain over whether labeling is required under certain circumstances, they can assure compliance by labeling in accordance with conservative assumptions as to emission levels. OSHA therefore does not believe it is necessary or appropriate to give specific guidance on calculating emission rates beyond the "reasonably foreseeable conditions of use" language in the standard.
Finally, a considerable number of commenters (See Exs. 304-3, 304-7, 304-9, 304-11, 304-15, 304-17, L304-19, 304-24, L304-25, 304-27, L304-28 and 304-32) asked for clarification on whether the levels that trigger the labeling and training provisions are intended to be based on instantaneous exposures, short term exposures, or 8-hour time-weighted averages. OSHA intends for these levels to mean 8-hour time-weighted averages.
The proposed amendments to the formaldehyde standard specified that objective data could be used by the employer in determining anticipated levels of formaldehyde release. This provision remains unchanged in the final amendments and 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 0.1 ppm or above 0.5 ppm under reasonably foreseeable conditions. 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 1987 final standard (see 52 FR at 46255-46256).
Paragraph (n) - Employee Information and Training
The final amendments require that employee training be conducted on an annual basis for all employees exposed to formaldehyde concentrations of 0.1 ppm or greater. The 1987 final standard requires initial training for persons exposed at 0.1 ppm or above, but annual training is only required for those exposed at or above the action level or STEL. The content of the training is not affected by this final amendment.
OSHA has determined that training for employees exposed to lower concentrations of formaldehyde is necessary 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 exemptions to the labeling requirements, which are discussed above. Although employees will have access to material safety data sheets, MSDSs 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 (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.
Several comments were submitted concerning the employee information and training provision. The Food and Allied Service Trades (304-6) suggested that OSHA strengthen the training program for workers exposed to formaldehyde and recommended several subject areas that should be included. This was not an issue for consideration in the proposed amendments, and OSHA has no evidence that the training provisions of the final formaldehyde standard issued in 1987 are not sufficient. The intent of paragraph (n) as contained in the proposed amendments was to clarify when training is to be conducted for employees exposed to formaldehyde and the frequency of such training. The final amendment requires annual training for all formaldehyde-exposed workers at levels at or above 0.1 ppm.
The Shipbuilders Council of America (Ex. 304-7) and Newport News Shipbuilding (Ex. 304-33) asked OSHA to extend to the start-up date for training by an additional four months beyond the proposed effective date to coincide with the 6 months allowed for the labeling provisions. The commenters' reasoning was that much of the requirement for training would be based on the presence of the manufacturer's label. OSHA agrees that warning labels must be covered under training. However, labeling is broadly required under the HCS and there is no need to delay training simply because the content of the labels may change. In other words, labels conforming to the Hazard Communication Standard will also comply with those required by this amended standard. As labels or other information change, the training, which must be conducted annually, can be modified as needed. Therefore, OSHA feels that the time allocated for the implementation of initial training is appropriate.
The other concerns regarding the training provisions dealt with requests that the 0.1 ppm trigger level that initiates training be specified as an 8-hour TWA. As discussed earlier in this preamble, OSHA interprets the 0.1 ppm trigger to be an 8-hour TWA.
Paragraph (p) - Dates
The final amendments become effective 30 days following publication in the Federal Register. This period enables employers to familiarize themselves with these new provisions. In addition, individual provisions, where appropriate, have delayed start-up dates.
Employers will 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 is considered 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 final 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 to the final standard increase the frequency with which employees exposed to formaldehyde between 0.l ppm and 0.5 ppm must receive training. Following initial training, such employees must receive training annually. OSHA has concluded 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.
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