In response to a motion for reconsideration by the United Auto
Workers (UAW), the Halogenated Solvents Industry Alliance, Inc., and
others, the Agency is proposing to add paragraphs (j)(9)(i) (A) and
(B), (j)(10), (j)(11), (j)(12), (j)(13), and (j)(14), dealing with
medical removal protection, medical removal protection benefits,
voluntary removal or restriction of an employee, and multiple health
care professional review to the MC standard.
Respondents: The respondents are employers whose employees have
occupational exposure to MC, Chemical Abstracts Service Registry Number
75-09-2, in general industry, construction and shipyard employment,
approximately 92,000 respondents.
Estimate of Burden Hours: OSHA estimates that the total burden for
the proposed MC collection of information provision will be 619 burden hours.
Estimate of Costs: OSHA estimates that the total cost for the first
year will be $60,515 for the collection of information provision.
Interested parties are requested to send comments regarding this
information collection to the Office of Information and Regulatory
Affairs, Attn. OSHA Desk officer, OMB New Executive Office Building,
725 17th Street, NW, Room 10235, Washington, DC 20503. Commenters are
encouraged to send a copy of their comments on the collection of
information to OSHA along with their other comments.
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
approval of the final information collection request: They will also
become a matter of public record. Copies of the referenced information
collection request are available for inspection and copying in the OSHA
Docket office and will be mailed immediately to any person who requests
copies by telephoning Adrian Corsey at (202) 219-7075 extension 105.
For electronic copies of the MC information collection request, contact
OSHA's WebPage on the Internet at osha.gov and click on
''Federal Register Notices''. Then click on ''Type of Publication'',
then ''Notices'', and lastly ''1998''. Copies of the request are also
available at the OMB docket office. I. Background
On January 10, 1997, OSHA issued a standard regulating occupational
exposure to methylene chloride (MC). 62 FR 1494. The standard was
designed to reduce both the risk that worker exposure to MC will cause
cancer and the risk that MC will cause or aggravate certain other
adverse health effects. The standard reduced the prior 8-hour time-
weighted-average permissible exposure limit (8-hour TWA PEL) to MC from
500 parts per million (ppm) to 25 ppm. It also set a short term
exposure limit (STEL) of 125 ppm averaged over a 15 minute period.
The 8-hour TWA PEL was set at 25 ppm to reduce, to the extent
feasible, the risk that workers exposed to MC would contract cancer.
Data showing that MC exposure presents a risk of cancer included animal
bioassay data, studies detailing the metabolism of MC to carcinogenic
products in humans, and epidemiological studies suggesting an elevated
risk of biliary cancer and astrocytic brain cancer in MC-exposed
workers. The agency used a physiologically-based pharmacokinetic
[[Page 24503]]
(PBPK) model to estimate the cancer risk. OSHA's final risk assessment
estimated that, at the prior 8-hour TWA PEL of 500 ppm (a level that
the Agency found was considerably higher than the level at which most
affected workers were currently exposed, see 62 FR 1565), lifetime
occupational exposure to MC could result in approximately 125 cancer
deaths per 1000 exposed workers. 62 FR 1563, Table VII. At the new 8-
hour TWA PEL of 25 ppm, OSHA estimated that the excess cancer risk
would be reduced to approximately 3.6 deaths per 1000 workers. Id. OSHA
concluded that a significant risk to workers remains at an exposure
level of 25 ppm but set the 8-hour TWA PEL at that level because it was
the lowest level for which OSHA could document feasibility across all
the affected application groups. 62 FR 1575.
The STEL was set at 125 ppm to minimize the adverse health effects
caused by acute exposure to MC. Central nervous system (CNS) depression
has been observed at MC concentrations as low as 175 ppm. CNS
depression is characterized by fatigue, difficulty in maintaining
concentration, dizziness, and headaches. These consequences of MC
exposure constitute material impairments of health and, by reducing
workers' coordination and concentration, can lead to workplace
accidents. Also, MC is metabolized to carbon monoxide (CO) and
therefore causes health impairment similar to that caused by direct
exposure to CO. Carbon monoxide blocks the oxygen binding site on
hemoglobin, producing carboxyhemoglobin, or COHb. Elevated COHb levels
reduce the supply to oxygen to the heart and can aggravate pre-existing
heart disease and lead to heart attacks. Physical exertion increases
the concentration of COHb in MC-exposed workers and thus increases the
risk of a heart attack, particularly to persons with silent or
symptomatic cardiac disease, who may be susceptible to very small
increases in COHb due to an already impaired blood supply to the heart.
The liver and skin are also susceptible to acute effects from MC
exposure. Chlorinated hydrocarbons as a class (of which MC is a member)
are generally toxic to the liver. However, animal studies indicate that
MC is among the least hepatotoxic of this class of compounds. The
limited amount of human data that are available is inconclusive but
supports the hypothesis that MC is toxic to the liver. 62 FR at 1515.
Prolonged skin contact with MC also causes irritation and skin burns.
62 FR at 1609.
Employers must achieve the 8-hour TWA PEL and the STEL, to the
extend feasible, by engineering and work practice controls. If such
controls are unable to achieve the exposure limits, and during the time
they are being implemented, employers must provide, at no cost to
employees, and ensure that employees use, appropriate respirators. The
standard does not permit the use of air-purifying respirators to
protect against MC exposure because MC 1uickly penetrates all currently
available organic vapor cartridges, rendering air-purifying respirators
ineffective after a relatively brief period of time. Therefore, when
respiratory protection is required, the standard provides that
atomsphere-supplying respirators must be used.
The standard requires employers to provide medical surveillance to
employees who are exposed to MC either (1) at or above the action level
on 30 or more days per year or at or above the 8-hour TWA PEL or STEL
on 10 or more days per year; (2) at or above the 8-hour TWL Pel or STEL
for any time period where an employee who has been identified by a
physician or other licensed health care professional as being at risk
from cardiac disease or from some other serious MC-related health
condition requests inclusion in the medical surveillance program; or
(3) during an emergency. The medical surveillance must include a
comprehensive medical and work history that emphasizes neurological
symptoms, skin conditions, history of hematologic or liver disease,
signs or symptoms suggestive of heart disease (angina, coronary artery
disease), risk factors for cardiac disease, MC exposures, and work
practices and personal protective equipment used during such exposures.
The standard's medical surveillance procedures focus on MC's
noncarcinogenic health effects because a medical surveillance program
cannot detect cancer at a preneoplastic state. 62 FR at 1589. However,
the standard's medical surveillance provisions can lead to early
detection of cancer and to higher survival rates from early treatment.
OSHA found that the standard was both technologically and
economically feasible in all of the industrial applications that use
MC. However, the Agency recognizes that larger employers are better
able than smaller ones to absorb or pass through the costs associated
with compliance with the standard. To avoid placing an undue economic
burden on small businesses, OSHA provided for later startup dates for
small employers. Larger employers were given until April 10, 1998 (one
year after the standard's effective date) to complete installation of
engineering controls to achieve the PEL and STEL, while employers with
fewer than 20 employees were given a total of three years, or until
April 10, 2000, to do so. Employers with fewer than 20 employees were
also given more time than larger employers to comply with the other
provisions of the standard. In addition, intermediate startup dates
were established for polyurethane foam manufacturers with 20-99
employees because OSHA anticipated that firms in that group could have
somewhat higher capital expenditures to meet the requirements of the standard.
II. The Motion for Reconsideration
The motion filed by the parties asks OSHA to reconsider two aspects
of the standard: (1) The agency's decision not to include medical
removal protection benefits in the medical surveillance provisions of
the standard; and (2) the start-up dates for engineering controls and
for use of respirators to achieve the 8-hour TWA PEL for employers
using MC in certain specific applications. Those applications are:
Polyurethane foam manufacturing; Foam fabrication;
Furniture refinishing; General aviation aircraft stripping;
Formulation of products containing methylene chloride;
Boat building and repair; Recreational vehicle manufacture;
Van conversion; Upholstery; and
Use of methylene chloride in construction work for
restoration and preservation of buildings, painting and paint removal,
cabinet making and/or floor refinishing and resurfacing.
The motion requests that the standard's current final engineering
control startup date of April 10, 2000, which now applies to employers
with fewer than 20 employees, be applied also to employers in the
specified application groups with 20-49 employees and to foam
fabricators with 20-149 employees. (In referring to an employer's
number of employees, the parties to the motion explain that they intend
for the number of employees to refer to the total number or workers
employed by the particular employer, not the number who work at a
particular facility or the number that use methylene chloride in their
work.) The motion requests shorter extensions of the engineering
control dates for larger employers in these application groups. The
parties further request that respirator use to achieve the 8-hour TWA
PEL not be required before the [[Page 24504]]
engineering control startup dates for the employers covered by the motion.
In evaluating the motion, OSHA notes that the parties are not
seeking to modify the fundamental protections provided to workers by
the standard. They are not challenging the 8-hour TWA PEL or the STEL
or the requirement that those limits be met, to the extent feasible,
through engineering and work practice controls. Nor are the parties
seeking modifications of the provisions in the standard for regulated
areas, protective work clothing and equipment, hygiene facilities,
hazard communication, employee information and training, and
recordkeeping. Moreover, the extensions of the startup dates that they
seek would not change the standard's current final compliance deadline
of April 10, 2000 but would merely give additional employers the
benefit of that startup date. The parties suggest that their proposed
changes to startup dates will enhance long-term worker protection by
enabling employers to use their resources effectively and efficiently
in developing permanent engineering solutions to reduce MC exposures in
their workplaces. The parties' proposed addition to the medical
surveillance provisions of the standard--a provision for medical
removal protection benefits--is also designed to enhance worker
protection by encouraging worker participation in medical surveillance.
Thus, the parties believe that the amendments they seek will promote
worker protection while minimizing employers' compliance burdens.
III. Medical Removal Protection Benefits
OSHA set the permissible exposure limits for methylene chloride to
eliminate significant risk, to the extent feasible, to workers exposed
to MC. However, individuals vary in their response to chemical
exposures. Some may see their health impaired, or preexisting medical
conditions aggravated, at an exposure level that does not provoke such
effects in most workers. Medical surveillance can identify those
workers who exhibit signs or symptoms of illnesses that could be
aggravated by exposure to a toxic substance and lead to treatment or
reduction in exposure. OSHA has therefore provided for medical
surveillance whenever it has issued a new standard for a single toxic
substance. Medical surveillance can result in a medical opinion that
particular workers should be removed from their present jobs have their
work activities otherwise restricted. This can lead to concern among
workers that participation in medical surveillance could cost them
their jobs. A worker who fear that medical surveillance may endanger
his or her livelihood may be reluctant to consent to medical tests or
to provide complete and accurate information during a medical
examination. If employees whose health could be significantly impaired
by continued MC exposure withhold their full cooperation, they might
continue to be exposed to MC without being aware that such exposure
poses a risk to their health. To avoid having the potential loss of a
job act as a disincentive to workers participating in the standard's
medical surveillance program, OSHA has, in certain of its toxic
chemical standards, provided for medical removal protection benefits
(MRPB). MRPB provisions require that an employer who must remove an
employee from continued exposure to a chemical or otherwise restrict an
employee's exposure to that chemical must maintain the employee's
earnings and other employment rights and benefits for a specified time.
When it has included MRPB provisions in earlier standards, OSHA has
delineated as specifically as possible the medical conditions that
trigger removal. Where possible, the Agency has specified objective
removal criteria. For example, the lead standard (29 CFR 1910.1025)
requires that an employee be removed from exposure above the action
level when an employee's blood lead concentration exceeds a certain
value. Similarly, the cadmium standard (29 CFR 1910.1047) lists
objective biological monitoring criteria that trigger medical removal.
OSHA has also, however, recognized that medical removal is
sometimes appropriate without regard to specific biological markers
when, in the judgment of a physician or other licenses health care
professional, removal is necessary to protect the health of the
employee. Thus, in addition to objective removal criteria, the lead and
cadmium standards provide for medical removal based on the discretion
of a health care professional. The lead standard requires medical
removal ''on each occasion that a final medical determination results
in a medical finding, determination, or opinion that the employee has a
detected medical condition which places the employee at increased risk
of material impairment to health from exposure to lead.'' Under the
cadmium standard, an employee must be removed if a written medical
opinion determines that removal is justified by ''biological monitoring
results, inability to wear a respirator, evidence of illness, other
signs or symptoms of cadmium-related dysfunction or disease, or any
other reason deemed medically sufficient * * *.'' The formaldehyde
standard (29 CFR 1910.1048) contains no objective criteria for medical
removal but provides for removal ''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.''
In the proposed MC rule, OSHA solicited comment on whether it
should provide for medical removal protection benefits in the final
rule. 56 FR at 57043 (Nov. 7, 1991). A number of commenters urged the
Agency to do so on the basis that MRPB would encourage employee
participation in medical surveillance. In the final rule, OSHA found,
as it had in the earlier standards discussed above, that MRPB would
increase employee participation in medical surveillance. However, the
Agency declined to include such a provision in the standard because it
did not believe it could offer substantive guidance to medical
professionals as to when it would be appropriate to remove an employee
from further MC exposure or to return a removed employee to the
workplace. 62 FR at 1595.
The parties to the motion for reconsideration believe they have
drafted a provision that is narrowly tailored to diseases that MC
exposure may aggravate and that limits the scope of the provision in a
way that avoids any undue economic burden on small employers. Under
their proposal, MRPB would be required only when a physician or other
licensed health care professional (PLHCP) determines that the
employee's exposure to MC would contribute to or aggravate the
employee's existing cardiac, hepatic, neurological (including stroke),
or skin disease. The parties note that the heart, liver, central
nervous system, and skin are the organs and systems that OSHA
identified in the standard as being particularly susceptible to MC-
induced noncarcinogenic health effects. They believe that physicians
and other licensed health care professionals will be able to render an
informed judgment as to whether MC exposure will contribute to or
aggravate an existing disease affecting these systems or organs.
The parties further propose, in paragraph (j)(10), that the
standard require the PLHCP to presume that MC exposure below the 8-hour TWA PEL
[[Page 24505]]
will not aggravate an existing disease of the heart, liver, central
nervous system, or skin. Under the proposal, a PLHCP who recommends
removal of an employee who is exposed below the 8-hour TWA PEL must
cite specific medical evidence to support the recommendation. Absent
such evidence, the employer need not remove the employee.
When a medical determination indicates removal, the parties'
proposal requires the employer to either transfer the employee to
comparable work where MC exposures are below the action level or remove
the employee from MC exposure. For each employee thus removed or
transferred, the employer must maintain the employee's earnings,
seniority, and other employment rights and benefits for up to six
months. The employer may cease paying MRP benefits before the end of
the six-month period upon receipt of a medical determination that the
employee's exposure to MC will no longer aggravate any existing
cardiac, hepatic, neurological, or dermal disease, or upon receipt of a
medical determination concluding that the employee can never return to
MC exposure above the action level.
The parties also propose inclusion of provisions that OSHA has
routinely included in previous standards that provided for MRPB. These
provisions (1) allow an employer to condition an employee's receipt of
MRPB on participation in follow-up medical surveillance; (2) provide
for a diminution of MRP benefits to offset any workers' compensation
indemnity payments the employee receives for the same period of time;
(3) provide an offset of such benefits against compensation from a
publicly or employer-funded compensation program or income the employee
receives from other employment that is made possible by virtue of the
employee's removal, and (4) require the employer to pay MRP benefits if
it voluntarily removes or restricts an employee due to the effects of
MC exposure on the employee's medical condition.
The current standard provides for the employer to select the PLHCP
who conducts medical surveillance. Under the parties' proposal, the
health care professional selected by the employer would make the
medical determination whether to recommend that an employee be removed.
The parties also, propose to include a provision that allows employees
the option to have the recommendation of the employer-selected health
care professional reviewed by a health care professional or the
employee's choice. If the two health care professionals disagree, they
jointly designate a third, who must be a specialist in the field at
issue and whose written opinion is the definitive medical determination
under the standard. The parties note that, in previous standards that
have provided for MRPB, OSHA has included similar provisions for multi-
step review to strengthen the basis for medical removal determinations
and to increase employee confidence in those determinations.
The parties have also recommended a provision designed to avoid an
undue burden that could result if a small business would need to
provide medical removal protection benefits to more than one employee
at the same time. Paragraph (j)(11)(i)(B) of their proposal states that
if the employer receives a recommendation for medical removal of an
additional employee and comparable work that does not involve exposure
to MC at or above the action level is not available, the employer need
not remove the additional employee if the employer can demonstrate that
removal and the costs of MRP benefits to that employee, considering
feasibility in relation to the size of the employer's business and the
other requirements of this standard, make further reliance on MRP an
inappropriate remedy. In such a case, the employer may retain the
additional employee in the existence job until transfer or removal
becomes appropriate, provided: (i) The employer or the PLHCP informs
the additional employee of the risk to the employee's health from
continued MC exposure; and (ii) the employer ensures that the employee
receives medical surveillance, including a physical examination, at
least every 60 days.
OSHA has carefully considered the parties' proposal in light of its
earlier concern that a MRPB provision must provide sufficient guidance
to licensed health care professionals as to when medical removal is
indicated. OSHA concludes that the MRPB provision recommended by the
parties delineates with sufficient specificity the circumstances that
can trigger medical removal protection benefits. First, the provision
requires MRPB only if the PLHCP finds that the employee has an
identifiable disease of one or more specific organs that are known to
be susceptible to MC exposure. Second, by providing for a rebuttable
presumption that such a disease will not be aggravated by exposure to
MC below the 8-hour TWA PEL, the parties' proposal ensures that the
physician or other health care professional will take into account the
level of methylene chloride to which the worker is exposed. OSHA
believes that, with these constraints, the parties' proposal will
improve employee confidence and participation in medical surveillance
while providing adequate guidance to the physicians and other licensed
health care professionals who will be conducting medical surveillance
and making recommendations for medical removal under the standard.
OSHA also believes that the ancillary provisions of the MRPB
program recommended by the parties are appropriate. The parties have
patterned their recommendation on the existing OSHA standards that
provide for MRPB. OSHA agrees that provisions it has routinely included
as part of a MRPB program, including those providing for a multi-step
review process, should be included in the methylene chloride standard.
OSHA continues to believe that multi-step review is vital to ensuring
employee confidence in medical removal determinations and is a
necessary part of any standard that provides for medical removal
protection benefits.
The one provision in the parties' proposal with no direct
counterpart in earlier standards that provide for MRPB is the provision
in proposed paragraph (j)(11)(i)(B) that would allow an employer who
has already removed one or more employees under paragraph (j)(11) to
retain an additional employee in the existing job despite a removal
recommendation if removal would result in undue economic burden. In
such a situation, the parties propose that the employer must provide
enhanced medical surveillance to the employee and must ensure that the
employee who is not removed is fully informed of the health risk
presented by continued MC exposure.
OSHA agrees with the parties that, in the limited circumstances
specified in this provision, it is appropriate to allow an employer to
retain an employee in his or her present job, even when the PLHCP has
recommended removal, provided the employer ensures that the employee
receives the more frequent medical surveillance specified in the
proposed provision and is fully aware of the health risk. Frequent
medical surveillance and full information will enable the employer and
employee to take steps to minimize the risk under exiting workplace
conditions, by, for example, implementing those controls that are in
place and strictly following work practices that are designed to
minimize the employee's MC exposure. Thus, the parties' proposal
provides additional protection to those workers who would be retained
in their current jobs under paragraph (j)(11)(i)(B). [[Page 24506]]
IV. Extensions of Startup Dates
The motion for reconsideration requests that the standard's current
final engineering control startup date of April 10, 2000, which is
limited in the final standard to employers with fewer than 20
employees, also apply to employers in the specified application groups
who have 20-49 employees and to foam fabricators who have 20-149
employees. According to the parties employers in these application
groups and size categories, like those with fewer than 20 employees,
have limited resources with which to develop and implement engineering
controls and will be able to use those resources more efficiently if
given additional time to develop and install effective controls and to
take advantage of the compliance assistance that OSHA plans to offer.
The motion requests shorter extensions of the engineering control dates
for larger employers in these application groups.
The parties further request that respirator use to achieve the 8-
hour TWA PEL (currently required by Aug. 31, 1998 under a partial stay
issued by OSHA on Dec. 18, 1997, 62 FR 66275) not be required before
the engineering control startup dates for those employers covered by
the motion. They contend that workers would be better protected if
these employers can concentrate their limited resources on implementing
effective engineering controls rather than diverting part of those
resources to interim and expensive respiratory protection that would no
longer be needed a short time later, once full compliance with the 8-
hour TWA PEL and STEL is achieved by engineering controls.
The following chart shows the startup dates requested by the motion
for reconsideration. Where the startup date for a provision has already
passed, the chart lists that provision as being ''in effect.'' For the
reasons discussed below, OSHA is now proposing to adopt the startup
dates requested by the parties to the motion. |
