U.S. Department of Labor Assistant Secretary for
Occupational Safety and Health Washington, D.C.
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Subject: Enforcement Procedures for Occupational Exposure to Formaldehyde
A. Purpose. This instruction provides uniform inspection procedures and
guidelines to be followed when conducting inspections and issuing citations
for workers potentially exposed to formaldehyde.
B. Scope. This instruction applies OSHA-wide.
C. References.
1. OSHA Instruction STP 2.22A, May 14, 1986, the State Plan
Policies and Procedures Manual.
2. OSHA Instruction CPL 2.45B, June 15, 1989, the Revised Field
Operations Manual (FOM).
3. OSHA Instruction CPL 2-2.20B, February 5, 1990, the OSHA
Technical Manual (OTM).
4. OSHA Instruction ADM l-l.l2B, December 29, 1989, the Integrated
Management Information System (IMIS) Forms Manual.
5. OSHA Instruction CPL 2-2.30, November 14, 1980, 29 CFR
1913.10(b) (6), Authorization of Review of Medical Opinions.
6. OSHA Instruction CPL 2-2.33, February 8, 1982, 29 CFR 1913.10,
Rules of Agency Practice and Procedure Concerning OSHA Access to Employee
Medical Records--Procedures Governing Enforcement Activities.
D. Action. Regional Administrators and Area Directors shall ensure that
the policies and procedures explained in this instruction are implemented.
E. Federal Program Change. This instruction describes a Federal program
change which affects State programs. Each Regional Administrator shall:
OSHA Instruction CPL 2-2.5 NOV 20 1990 Office of Health Compliance Assistance
1. Ensure that a copy of this change is promptly forwarded to each
State designee, using a format consistent with the Plan Change Two-way
Memorandum in Appendix P, OSHA Instruction STP 2.22A, CH-2.
2. Explain the technical content of this change to the State
designee as requested.
3. Ensure that State designees are asked to acknowledge receipt of
this Federal program change in writing to the Regional Administrator as soon
as the State's intention is known, but not later than 70 calendar days after
the date of issuance (10 days for mailing and 60 days for response). This
acknowledgment must include the State's intention to follow OSHA's policies
and procedures described in this instruction, or a description of the State's
alternative policy and/or procedure which is "at least as effective" as the
Federal policy, or of the reasons why the change should not apply to that
State.
4. Ensure that the State designees submit a plan supplement, in
accordance with OSHA Instruction STP 2.22A, Ch-3, as appropriate, following
the established schedule that is agreed upon by the State and Regional
Administrator to submit non FOM/OTM Federal program changes.
a. If a State intends to follow OSHA's policy described in
this instruction, the State must submit either a revised version of this
instruction, adapted as appropriate to reference State law, regulations and
administrative structure, or a cover sheet describing how references in this
instruction correspond to the State's structure. The State's acknowledgment
of the Plan Change Two- way Memorandum may fulfill the plan supplement
requirement if the appropriate documentation is provided.
b. If the State adopts an alternative to Federal guidelines,
the State's submission must
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identify and provide a rationale for all substantial
differences from Federal guidelines in order for OSHA to judge whether a
different State procedure is as effective as comparable Federal
guidelines.
5. Review policies, instructions and guidelines issued by the
State to determine that this change has been communicated to State program
personnel.
F. Background. On December 4, 1987, OSHA revised its standard for
formaldehyde (29 CFR 1910.1048). This reduced the 8-hour time weighted
average (TWA) exposure limit for formaldehyde from 3 parts per million (ppm)
to 1 ppm. The peak allowable exposure of 10 ppm was revoked and the 5 ppm
ceiling was reduced to 2 ppm TWA measured over a 15 minute period (short-term
exposure limit) (STEL). Employers must also conduct exposure monitoring,
offer medical surveillance to exposed employees, and supply protective
equipment and clothing as needed. The employer may need to establish
emergency procedures, provide for clean-up of spills, and install emergency
showers and eyewash facilities. Employee training on the hazards of
formaldehyde and on the formaldehyde standard must be conducted. Training is
reinforced by labels and material safety data sheets (MSDS) required by the
Hazard Communication Standard (HCS)(29 CFR 1910.1200).
1. On March 2, 1988, OSHA announced in the Federal Register the
partial approval by the Office of Management and Budget of information
collection requirements under the formaldehyde standard. All parts of the
standard were approved except for paragraphs (m)(1)(i) through (m)(4)(ii),
concerning hazard communication. In addition, a start-up date for updating
the written materials in the training program was added to paragraph
(p).
2. On November 8, 1988, OSHA announced in the Federal Register
approval of information collection requirements for paragraphs (m)(1)(i)
through (m)(4)(ii). A delayed start-up date was specified for these
provisions along with a clarification of the labeling provisions. In the
interim, OSHA sought
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comments on a petition for administrative stay of the warning
label requirements.
3. On November 22, 1988, OSHA announced in the Federal Register a
further extension of the start-up date for compliance with the newly approved
hazard communication provisions.
4. On December 13, 1988, OSHA announced in the Federal Register an
administrative stay of paragraphs (m)(1)(i) through (m)(4)(ii) for a period
of 9 months. This stay has been extended to December 11, 1990. The effect of
the administrative stay will be the continued enforcement of the Hazard
Communication Standard with respect to formaldehyde.
5. On July 13, 1989, OSHA published in the Federal Register a
corrections and technical amendments notice. Table 1 of paragraph (g),
Respiratory Protection, was modified so that the entry for Type C respirators
specifies pressure demand or continuous flow type, with full facepiece, hood,
or helmet. The notice also clarifies paragraph (g)(2)(ii) by substituting a
performance standard, adequate to protect against formaldehyde exposure"
(based on protection factors), for an erroneous reference to Table 1. Also,
chin style gas masks, approved by NIOSH for formaldehyde exposure, were
incorporated into Table 1. Paragraph (o), Recordkeeping, was amended to
incorporate a reference to 29 CFR 1910.20, the access to medical records
standard.
6. On June 9, 1989, the U.S. Court of Appeals (District of
Columbia circuit) handed down its decision regarding the challenge by the
United Auto Workers (UAW) and Amalgamated Clothing and Textile Workers Union
(ACTWU) to the formaldehyde standard. OSHA was directed to reconsider its
finding of insignificant risk at 1 ppm and its failure to include a
requirement for medical removal protection (MRP). OSHA petitioned the court
to review its decision regarding MRP; this petition was denied on September
22, 1989.
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G. Occupational Exposure to Formaldehyde.
1. Formaldehyde Uses. Formaldehyde is a reactive chemical with
many uses.
a. The major consumers of formaldehyde are the manufacturers
of compressed wood products. Formaldehyde is consumed in resins that are used
as glues in the production of particle board, plywood, and fiberboard. These
wood products in turn are used in the construction, furniture, and mobile
home manufacturing industries.
b. The plastics industry is the second largest use of
formaldehyde-based resins. Molding compounds containing melamine, phenolic,
or acetyl resins are capable of releasing formaldehyde when subjected to heat
and/or pressure in the molding process. The final product, however, contains
little free formaldehyde and has little potential for depolymerization, so
that potential exposure to formaldehyde from use of the plastic product is
minimal. Typical of plastics made from formaldehyde-based resins are lawn
and garden equipment, plumbing fixtures, melamine tableware, and electrical
insulation parts.
c. Formaldehyde-releasing resins are used to add wrinkle-free
and durable press characteristics to synthetic and natural-fiber textiles.
These resins leave residual formaldehyde in the product which can result in
exposure to formaldehyde in the apparel industry. A
dimethyloldihydroxyethyleneurea (DMDHEU)-based resin system is most commonly
used.
d. Formaldehyde-bearing resins are used in the coating
industry primarily as modifiers in alkyd and acrylic coating systems. Urea
formaldehyde resins are used in clear coating for wood furniture, primer
coats for automobiles, baked enamels for appliances, and
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can coatings. Melamine-formaldehyde resins are generally
used where outdoor exposure or contact with detergents require improved
chemical resistance. Melamine-formaldehyde resins also have some application
where corrosion resistance is important.
e. Paper products may be treated with formaldehyde derivatives
(e.g., melamine- or urea- formaldehyde) to add a desired finish or wet-
strength quality. Melamine resins can be inactivated by a high sulfate
concentration, and this problem is overcome by addition of excess
formaldehyde.
f. Formaldehyde is an important constituent of embalming and
preserving fluids because it performs two essential functions--disinfection
and preservation. In mortuaries, embalming fluids may be injected in
concentrated form to preserve the organs in the visceral and thoracic
cavities. Arterial fluids are prepared by diluting the concentrate and are
injected into the arterial system through a hose. Formaldehyde's properties
as a tissue preservative also account for its use in anatomy, histology, and
pathology laboratories.
g. Formaldehyde-based chemicals are used in textile
waterproofing, as accelerators in the production of rubber products, and in
photographic developing. Foundries use formaldehyde-based resins in molds in
the production of ferrous and non-ferrous goods.
h. Formaldehyde is used in the production of industrial
chemicals including pentaerythritol l,4-butenediol, and
trimethyl-o-propane.
i. Some detergents, fertilizers, explosives and abrasive
products are also manufactured with formaldehyde. Because formaldehyde is an
effective bactericide, it is contained in cosmetic products, shampoos, and
hair sprays.
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It is used in the manufacture of some pharmaceutical
products and germicides, and it is used to clean dialysis
equipment.
2. Formaldehyde Exposure.
a. Formaldehyde exposure can occur in three ways:
(1) Exposure to liquid or solid formaldehyde
(paraformaldehyde) and the accompanying vapors;
(2) Exposure to formaldehyde during primary processing of
formaldehyde resins and other chemicals manufactured from formaldehyde;
and
(3) Exposure to formaldehyde released from products that
contain formaldehyde-based resins.
b. Occupational exposures to formaldehyde occur during heat
and/or pressure processing of products made from or including formaldehyde
bearing resins. Examples of such exposures include the pressing of wood
products, extrusion or injection molding of plastics, heat-setting of pleats
on apparel, and casting of molds in foundry processes.
c. Occupational exposures to formaldehyde occur when a
finished product contains residual formaldehyde or when hydrolysis--that is,
the chemical break-down of formaldehyde-containing materials to produce
formaldehyde gas prompted by warm and humid work environments--occurs. The
EPA has described this phenomenon as "pseudoconsumptive use" of formaldehyde;
ie., chemical identity is changed but not irreversibly. Examples of
"Pseudoconsumptive" uses are: (1) ureaformaldehyde resins in fiberboard,
particleboard, plywood, laminates, ureaformaldehyde foams and insulation
products, molding compounds, and protective coatings; (2)
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ureaformaldehyde concentrates used to produce time-release
fertilizers; and (3) hexamethylenetetramine.
3. Operations. Specific operations that cause employee exposure
to formaldehyde include:
a. Formaldehyde transfer operations,
b. Reactor or vessel cleaning,
c. Fugitive emissions in chemical plants,
d. Exposure to articles that have been treated with
formaldehydebased resins before curing,
e. Exposure to articles containing cured resins during transit
from curing operations to storage or further processing,
f. Exposure to stored articles containing cured resins,
and
g. The application of formaldehyde-based resins.
NOTE: Short-term exposures occur during batch operations
such as mixing and during periodic cleaning and maintenance activities.
Concentrated formaldehyde solutions (37% or greater) are often diluted for
sale or use by chemical distributors or end-users, such as hospitals In
addition, short-term exposures occur in mortuaries and laboratories (anatomy,
histology, pathology, environmental testing, and school
biology).
H. Health Effects. Based on the best available evidence in the agency's
record on formaldehyde, OSHA determined that formaldehyde is genetoxic,
showing properties of both a cancer initiator and promoter When inhaled,
formaldehyde is a carcinogen in rats. In humans, formaldehyde exposure has
been associated with cancers of the lung, nasopharynx and oropharynx, and
nasal passages.
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1. Formaldehyde is highly irritating to the upper respiratory
tract and eyes. Concentrations as low as 0.1 to 2 ppm may irritate the eyes,
nose, and throat of some individuals. Concentrations of 3 to 5 ppm cause
tearing of the eyes, and the severity of the effects becomes intolerable to
some persons. Concentrations of 10 to 20 ppm cause difficulty in breathing,
burning of the nose and throat, coughing, and heavy tearing of the eyes.
Concentrations over 25 ppm can cause severe respiratory tract injury that can
lead to pulmonary edema and pneumonitis. A concentration of 100 ppm is
regarded as immediately dangerous to life or health (IDLH) for
formaldehyde.
2. Some persons have developed asthma or bronchitis following
exposure to formaldehyde; usually a single exposure to high concentrations of
formaldehyde as the result of an accidental spill appeared responsible for
the onset of symptoms.
3. Formalin (37% formaldehyde) is a skin irritant and sensitizer.
Formal in solutions splashed in the eye have resulted in blindness. Less
concentrated solutions can also injure the eyes and skin. The severity of
the effect depends on the concentration of formaldehyde in solution and
whether the affected tissue is flushed with water immediately after the
accidental splash. Contact with formalin causes a white discoloration, pain,
drying, cracking, and scaling of the skin. Prolonged and repeated contact
can cause numbness and a hardening or "tanning" of the skin.
4. Previously exposed persons may react to exposure with an
allergic eczematous dermatitis or hives. Employees in industries where there
is direct skin contact with formaldehyde-releasing resins (e.g., textiles)
tend to have a higher than normal incidence of dermatitis. When patch
tested, these persons sometimes show sensitization to formaldehyde.
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I. Clarifications of the Formaldehyde Standard (29 CFR 1910.1048).
1. Paragraph (a) Scope and Application.
a. Formaldehyde refers solely to the chemical defined by
chemical Abstracts Services Registry Number 50-00-0. This chemical is
formaldehyde gas which, per se, is not available commercially. Most
exposures are to formaldehyde gas which is emitted at various concentrations
from numerous products made from formaldehyde-bearing resins. Various
mixtures of formaldehyde, water, and alcohol (sometimes referred to as "
formalin") are also included in CAS #50-00-0. Paraformaldehyde, a solid
polymeric form of formaldehyde, also serves as a source of formaldehyde
gas.
b. The formaldehyde standard applies to all occupational
exposures to formaldehyde. This includes general industry, and by
cross-reference, maritime and construction. The only exceptions to this
coverage occur where the Occupational Safety and Health Act does not give
OSHA jurisdiction over employees. Examples include pesticide applicators who
are covered under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), public employees in States without OSHA-approved occupational safety
and health State plans, and unincorporated businesses with no employees. The
scope of the formaldehyde standard is not affected in most cases by the
laboratory standard. The laboratory standard, 29 CFR 1910.1450, specifically
does not apply to formaldehyde use in histology, pathology, and human or
animal anatomy laboratories; however, if formaldehyde is used in other types
of laboratories which are covered by the laboratory standard the employer
needs to comply with 29 CFR 1910.1450
2. Paragraph (c) Permissible Exposure Limit. Where there are
measurable concentrations of other regulated
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contaminants which affect the same body systems as formaldehyde,
citations should be issued per the FOM, Chapter IV, C.6.c. This manual cites
paragraph 29 CFR 1910.1000(d)(2) of the Air Contaminants standard for use in
cases where there are potential additive and synergistic effects. The Air
Contaminants standard, 29 CFR 1910.1000(d)(2)(i), contains a formula which
has the effect of proportionally reducing the PEL of each regulated toxic
element of the multiple exposure. As an example, if a woodshop worker has an
exposure to wood dust measured at 2.5 mg/m3 TWA, which represents 50% of the
PEL of 5 mg/m3, then the PEL for formaldehyde (1 ppm TWA) would be reduced by
50%, resulting in a PEL for a concurrent formaldehyde exposure of 0.5 ppm.
Paragraph (d) (2)(i) requires employers to meet these adjusted PELs where
there is an exposure to a mixture of air contaminants regulated by Subpart Z.
The body system primarily affected by formaldehyde is the respiratory system
(upper and lower). The immune system may also be affected. (Formaldehyde is
a sensitizer which provokes an IgE (immunoglobulin) mediated response.)
Appendix F contains guidance for calculating the adjusted PELs and SAEs
(sampling and analytical errors). The adjusted PEL should apply only to
enforcement of paragraphs (c), Permissible Exposure Limit and (f), Methods of
compliance. The STEL and AL should not be adjusted for mixtures for
compliance evaluations.
3. Paragraph (d), Exposure Monitoring. Paragraph (d) of the
formaldehyde standard requires employers to determine their employees'
exposure to formaldehyde if any mixture or solution present in the workplace
contains 0.1 percent or more of formaldehyde, or if materials capable of
releasing formaldehyde into the workplace air result in employees being
exposed to formaldehyde at concentrations reaching or exceeding 0.1 ppm. The
CSHO should verify the employee exposure via bulk or air samples.
a. Objective Data. The exposure determination must consist of
actual measurements unless the employer can produce objective data to
document
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that no employee will be exposed to formaldehyde at
concentrations exceeding the 0.5 ppm (TWA) action level (AL), or the 2 ppm
STEL under foreseeable conditions of use. Industry-wide studies or generic
exposure estimates may be a source of objective data; however, the use of
such data must accurately characterize actual employee exposures. For
exposures less than the AL or STEL, area samples may also be used as the
basis for exposure determinations, if they represent those
exposures.
b. Medical Complaints. Regardless of employee exposure level,
if there are employee health complaints, the employer is required to take
action to determine employee exposure.
c. Exception. If mixtures or solutions composed of 0.1
percent or less of formaldehyde are used, employee exposure is below 0.1 ppm,
and there are no employee health complaints then an employer should not be
cited for not monitoring. (See 29 CFR 1910.1048(d)(1)(ii)
(A).)
d. Repeat Monitoring. If there is a change in production,
equipment, process, personnel, or control measures, which may result in a new
or additional exposure to formaldehyde, the initial monitoring shall be
repeated. For example, apparel manufacturers and other producers/users of
formaldehyde resin finished fabrics may need to repeat initial determinations
with different fabric lots.
e. Sampling Methods. As long as the method selected for
sampling and analysis meets the criteria for precision and accuracy set out
in the formaldehyde standard, the employer is free to choose from many
methods available for monitoring exposure to formaldehyde.
(1) Among the methods available are the chromotrophic acid
method which relies on use of a midget impinger, gas
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chromatographic methods which collect formaldehyde in a
specially prepared tube, passive diffusion badges, and handheld
monitors.
(2) Appendix A to this instruction summarizes information
submitted to the formaldehyde docket on passive and direct reading devices
for the measurement of formaldehyde. Limitations, where known, are also
given.
4. Paragraph (h), Protective Equipment and Clothing. This section
addresses the selection and maintenance of protective equipment and clothing,
including aprons, goggles, face shields, and suits. The CSHO should evaluate
potential formaldehyde hazards and use professional judgment in enforcing the
general requirements of 29 CFR 1910.132 and 29 CFR 1910.133, which are
incorporated into the formaldehyde standard by reference. Violations of
these general requirements should be cited under 29 CFR 1910.1048(h). Some
PPE requirements are specified by the formaldehyde standard, and violations
of these requirements should be cited under 29 CFR 1910.1048(h)(1).
a. Solutions containing greater than 1-percent formaldehyde
are damaging to the skin and severely damaging to the eyes. Consequently,
protective equipment adequate to prevent contact with such solutions must be
provided to employees, and the equipment must be kept in good repair and free
of formaldehyde contamination.
b. Some solids that release formaldehyde and solutions that
contain less than 1-percent formaldehyde can also pose a hazard to employees.
Paragraph (h)(1)(iii) requires the employer to provide protective clothing or
equipment, as needed, in accordance with the general standards for protective
equipment and clothing (29 CFR 1910.132 and 29 CFR 1910.133) to prevent
contact
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with irritating or sensitizing materials.
c. Formaldehyde gas poses little hazard from dermal contact,
although there are a few reports in the literature that indicate
sensitization from high airborne concentrations. At the IDLH concentration,
the standard requires whole body protection, essentially equivalent to Level
A protection, to prevent potential sensitization.
d. Butyl and nitrile glove materials provide the greatest
permeation protection. Greater thicknesses of other materials (natural
rubber, PVC, polyethlyene) may be suitable for shorter immersion periods, but
gloves may have to be changed more frequently due to degradation. All these
materials are generally suitable for splash protection. Appendix B to this
instruction summarizes the permeation data available for formaldehyde.
Barrier creams are not regarded as effective protection for formaldehyde,
since there is no data demonstrating their efficacy.
5. Paragraph (i), Hygiene Protection.
a. Emergency Showers. Because of the severe dermal effects
that can occur when employees have skin contact with concentrated solutions
of formaldehyde and because of the relative irreversibility of dermal
sensitization to formaldehyde, the employer is required to provide
conveniently located quick drench showers for employees who become splashed
with solutions of 1 percent or greater formaldehyde as the result of
equipment failure, improper work practices, or other emergencies. Whether or
not the employee is wearing protective clothing does not affect the need for
quick drench showers since the employee must be able to remove PPE splashed
with formaldehyde in a safe manner. The availability
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of emergency showers should also help to lower any
potentially serious inhalation hazard when an employee has been splashed with
a formaldehyde solution.
b. Eye Wash Facilities. Liquid formaldehyde can also cause
severe damage to the eyes. Thus, the standard requires employers to provide
appropriate eye wash facilities within the immediate work area for emergency
use by any employee whose eyes are splashed with solutions containing 0.1
percent or more of formaldehyde.
c. The degree of sophistication of the emergency shower and/or
eyewash station varies with the size of the potential splash. The use of
portable units or hand-held fixtures should be carefully evaluated. Such use
should be limited to small spills (generally less than 8 oz.), provided that
all possible affected body parts can be flushed continuously for 15 minutes.
(For this reason, bottle-type eyewashes are not acceptable.) Appendix C of
this instruction contains specific (nonmandatory) evaluation criteria for
emergency showers and eyewashes.
6. Paragraph (k), Emergencies. Paragraph (k) ensures that the
employer will prepare for any situation where equipment failure, spill or
rupture of containers, or failure of control equipment would result in an
uncontrolled release of formaldehyde that could result in injury or loss of
life. If such circumstances could occur in an accident, the employer must
establish procedures for evacuation and access to emergency medical care,
obtain needed equipment for evacuation and reentry into the area, and
establish procedures for equipment repair, spill cleanup, decontamination,
and waste disposal. Paragraph (k) violations should be grouped with any
applicable violations under 29 CFR 1910.120. The threshold quantity for
formaldehyde for evaluation of catastrophic potential is 500 lbs. (See OSHA
Instruction CPL 2-2.45.)
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a. There is not a specific exposure level that triggers the
emergency provisions. When determining if there is a need to provide for
emergencies, the employer should consider whether employees' lives or health
could be jeopardized in the worst reasonably predictable accident (i.e., the
worst outcome of any possible scenario) unless employees are promptly
evacuated from the area.
b. A 30-minute exposure to 100 ppm is potentially fatal, and
pulmonary edema has been seen after exposures of 50 ppm. These levels can be
generated by relatively small spills (a pint or less), even in ventilated
areas.
7. Paragraph (1), Medical Surveillance.
a. The provisions of paragraph (1) establish an approach to
medical surveillance based on an employee's exposure
potential.
(1) All persons who are required to wear respirators as the
result of their formaldehyde exposure must fill out a medical disease
questionnaire, such as the optional form contained in Appendix D to the
formaldehyde standard, on an annual basis. (Note: The employer is required to
administer the questionnaire, a process which is required to be under the
supervision of a licensed physician, and involves assisting the employee as
necessary to complete the questionnaire.) These persons must then be offered
a physical examination and a pulmonary function test.
(2) All persons who are exposed to formaldehyde at
concentrations between the action level and the 1 ppm TWA limit (but not over
the STEL) must be given the opportunity to participate in a medical
surveillance program on an annual basis by filling out a medical disease
questionnaire. If an
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employee exposed between the action level and the 1 ppm
TWA limit is showing signs and symptoms that may be formaldehyde- related,
the employer must administer to the employee a medical disease questionnaire
without delay. If the physician determines, on the basis of the medical
disease questionnaire, that it is necessary to examine the employee, the
employee would then be sent to the physician for further
examination.
(3) If exposures are less than 0.5 ppm but the employee is
showing signs and symptoms that may be formaldehyde-related, the employee
must be evaluated via a medical disease questionnaire, and further
surveillance would be conducted on the basis of the physician's
determination, as it is for concentrations between 0.5 and 1
ppm.
b. Paragraph (1)(3)(ii) requires the physician to make a
determination, based on evaluation of the medical disease questionnaire, as
to whether additional medical surveillance specified in paragraph (1)(4);
i.e., a medical examination, is necessary to ensure the employee is not being
placed at increased risk of material impairment of health from exposure to
formaldehyde. In some cases, the physician will require additional
information from the medical examinations before a final written opinion can
be given. When the physician does not require additional information to
reach a determination about the employee's health, the determination made in
paragraph (1)(3)(ii) must be provided to the employer in writing, and a copy
given to the employee within 15 days of its receipt by the
employer.
c. Emergencies pose a very different situation from routine
surveillance. If the employer has determined that an emergency situation
could occur, then there must be a prior arrangement
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with a physician or hospital to ensure that any employee
acutely exposed to formaldehyde in an emergency receives proper medical
intervention, as required by paragraph (k). The emergency plan must also
specify what information should be given to emergency care providers, per the
requirements of paragraph (l)(6), and how it is to be
transmitted.
8. Paragraph (m), Hazard Communication. On December 13, 1988,
OSHA announced in the Federal Register an administrative stay of paragraphs
(m)(1)(i) through (m)(4)(ii) of the formaldehyde standard. OSHA has extended
the stay until December 13, 1990.
a. In the interim, OSHA will continue to enforce the HCS with
respect to formaldehyde.
b. Paragraph (m)(1) was not stayed. It reemphasizes that
hazard communication covers formaldehyde exposures occurring in the
manufacture and use of wood products. When applicable, this paragraph shall
be cited along with appropriate violations under the HCS.
9. Paragraph (n), Employee Information and Training.
a. All employees exposed to formaldehyde at concentrations at
or above 0.1 ppm or to solutions containing greater than 0.1 percent or more
of formaldehyde must receive initial training upon hire.
b. All employees exposed at or above the action level or the
STEL must be trained annually.
c. The administrative stay on paragraph (m), Hazard
Communication, does not affect the status of the training requirements under
(n).
(1) Training for formaldehyde conducted after April 4,
1988, must cover all applicable requirements contained in paragraph
(n)(3)
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of the new formaldehyde standard. (See March 2, 1988,
Federal Register, at 53 FR 6628.)
(2) Employees previously trained on formaldehyde's hazards
under the HCS (29 CFR 1910.1200) must be retrained in order to cover
additional information contained in the new formaldehyde
standard.
(3) Retraining and initial training for employees not
previously covered by 29 CFR 1910.1200 must be provided as soon as possible
once the employer has identified that they are exposed to formaldehyde. A
reasonable amount of time should be given the employer to permit
identification of affected employees and to obtain training materials. In no
case should more than 3 months after completion of monitoring be permitted.
(Note that the start-up date for initial monitoring was by August 2,
1988.)
(4) The training provisions of paragraph (n) are to be
cited rather than the HCS information and training requirements if the
employee is covered by (n).
d. Appendix A to the formaldehyde standard provides general
information which is appropriate for a training program. This outline would
need to be supplemented by plant specific information. In addition, the OSHA
hazard recognition training program on formaldehyde may be of assistance to
employers who need to train employees. The program includes information on
the new standard but it is being revised to more fully reflect the changes.
(See OSHA Fact Sheet 89-27.)
10. Paragraph (p), Dates. Since all dates in this section have
passed, all paragraphs are in effect for all industries. Appendix D to this
instruction gives specific effective dates by paragraph.
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11. Supplemental Information. Appendix E to this instruction
summarizes the formaldehyde standard triggering events.
J. Hazard Communication Standard (29 CFR 1910.1200).
(Reserved)
K. Inspection Procedures. The following procedures shall be followed in
addition to the guidance in the FOMH, OTM, and IMIS Forms Manual.
1. Authorization to Review Limited Medical Information.
Appropriately qualified compliance personnel are authorized to review medical
disease questionnaires and medical opinions mandated by the formaldehyde
standard when the limitations and procedures in OSHA Instructions CPL 2-2.30
and CPL 2-2.33 are followed.
a. Qualified compliance personnel are industrial hygienists or
professionals with training in medical disciplines.
b. This authorization is pursuant to 29 CFR
1913.10(b)(6).
2. Recording in the IMIS. In addition to current instructions for
completing the OSHA-1, as found in the IMIS Manual, the following shall be
recorded in Item 42 for all inspections where employee exposure to
formaldehyde is investigated for compliance with 29 CFR 1910.1048 and/or 29
CFR 1910.1200.
Type ID Value
N 16 Form
3. Contested Cases. For contested cases of 29 CFR 1910.1200
involving formaldehyde which the Regional Administrator supports as strong
cases, the Regional Administrator shall expeditiously send a brief memorandum
summarizing the facts to the Director, Directorate of Compliance Programs.
After the information is reviewed at the National Office, the Regional
Administrator will be notified if the
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OSHA Instruction CPL 2-2.52 NOV 20 1990 Office of Health Compliance
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National Office needs applicable portions of the case file
before a recommendation on the case can be rendered.
Gerard F. Scannell Assistant Secretary
DISTRIBUTION: National, Regional, and Area Offices Compliance Officers
State Designees NIOSH Regional Program Directors 7(c)(1) Project Managers
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Appendix A
Passive and Direct Reading Devices (1)
COMPANY: Air Quality Research (415-644-2097). PRODUCT NAME: Passive
Formaldehyde Kit (PF-20). METHOD OF COLLECTION: Bisulfite coated glass fiber
filter. DETECTION: Chromotropic acid. SENSITIVITY: 0.1 ppm for 8 hours; 5
ppm for 15 minutes INTERFERENCES: Low humidity may cause adverse effects.
COMMENTS: Manufacturer claims the PF-20 monitor will operate in a humidity
range of 20 to 90% RH. Face velocities must be greater than 25 cm/s during
sampling.
COMPANY: Assay Technology (415-424-9947). PRODUCT NAME: Chem Chip (TM).
DETECTION: Colorimetric (Furpald procedure). SENSITIVITY: 0.1 ppm for 8
hours; 0.3 ppm for 15 minutes. INTERFERENCES: Other aldehydes but less
interference with higher molecular weights. COMMENTS: Good for the STEL
according to manufacturer's literature. Interferences of other aldehydes
would cause a problem in certain industries such as embalming where
glutaraldehyde may also be present.
COMPANY: Crystal Diagnostic (617-933-4114). PRODUCT NAME: AirScan (TM).
METHOD OF COLLECTION: Chemical reaction. DETECTION: Visible. SENSITIVITY:
0.1 ppm 8 Hr.; STEL (see comments). INTERFERENCES: Possibly humidity but not
definite. COMMENTS: The company states their monitors are sensitive enough
for the STEL if the badge is allowed to develop for several hours. The
results on the humidity interference were inconclusive.
(1) This is a summary of information from the formaldehyde docket on passive
and direct reading devices. It is not a comprehensive list of all available
devices. For further information contact the OSHA Salt Lake City Laboratory
(FTS 588-4270).
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COMPANY: CEA Instrument, Inc. (201-664-2300). PRODUCT NAME: Model 555.
METHOD OF COLLECTION: Direct Reading Instrument. DETECTION: Colorimetric
(pararosaniline). SENSITIVITY: 0.01 ppm continuous reading. INTERFERENCES:
Temperature can cause a problem; other aldehydes. COMMENTS: A review article
states that there is a long equilibration time and calibration must be done
often. Interferences of other aldehydes would cause a problem in certain
industries such as embalming where glutaraldehyde may also be present.
COMPANY: CEA Instruments, Inc. (201-664-2300). PRODUCT NAME: TGM 555.
METHOD OF COLLECTION: Direct Reading Instrument. DETECTION: Colorimetric
(pararosaniline). SENSITIVITY: 0.003 ppm continuous reading. INTERFERENCES:
Temperature can cause a problem; other aldehydes. COMMENTS: Modification of
Model 555. Need to average the continuous readout for STEL. Interferences
of other aldehydes would cause a problem in certain industries such as
embalming where glutaraldehyde may also be present.
COMPANY: Dosimeter Corporation (513-489-8100). PRODUCT NAME: Model F-3.
METHOD OF COLLECTION: Cellulose sponge containing a sorbent DETECTION:
Visual with a comparator badge. SENSITIVITY: 0.03 ppm for 4 hours.
INTERFERENCES: None listed COMMENTS: Manufacturer's stated sensitivity
would make it adequate for STEL.
COMPANY: DuPont. PRODUCT NAME: Pro-Tek C-60 (TM). METHOD OF COLLECTION:
Modified 1% bisulfite. DETECTION: Colorimetric (Chromotropic acid).
SENSITIVITY: 0.12 ppm for 8 hours; 1 ppm for 15 minutes. INTERFERENCES:
Phenol, ethanol and other alcohols but in concentrations 8 times and 15
times, respectively. COMMENTS: Not good for STEL. The interferences of
phenol and ethanol may cause problems in certain industries such as plywood
manufacturing.
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COMPANY: Envirotech Services, Inc. (608-643-4755). PRODUCT NAME: ETS
Dosimeter (TM). METHOD OF COLLECTION: Organic acid on polycarbonate sponge.
DETECTION: Colorimetric (Purpald procedure). SENSITIVITY: 0.1 ppm for 8
hours. INTERFERENCES: Other aldehydes. COMMENTS: Not good for the STEL.
Interferences are other aldehydes which would cause a problem in certain
industries such as embalming where glutaraldehyde may also be present.
COMPANY: Foxboro Analytical (203-853-1616) PRODUCT NAME: Miran-1A. METHOD
OF COLLECTION: Direct Reading Instrument. DETECTION: Infrared
Spectrophotometer. SENSITIVITY: 1 ppm continuous reading. INTERFERENCES:
Any compound which has an absorbance at 3.58 micrometers (C-Ia stretch).
Possibly any aliphatic hydrocarbon may interfere. COMMENTS: Need to average
the continuous readout for STEL or TWA.
COMPANY: MDA Scientific, Inc. PRODUCT NAME: Lion Formaldemeter. METHOD OF
COLLECTION: Direct Reading Instrument. DETECTION: Electrochemical.
SENSITIVITY: 0.3 ppm. INTERFERENCES: Compounds that are easily oxidized
such as methanol, phenol, ethanol and formic acid. COMMENTS: Not useable for
STEL due to the short sampling time (approx. 20 seconds) and the time delay
for the electrochemical cell to return to zero would prevent rapid sequential
measurements.
COMPANY: Sensidyne (813-530-3602). PRODUCT NAME: 91L. METHOD OF
COLLECTION: Detector tube. DETECTION: Visible color indication.
SENSITIVITY: 0.2-5 ppm. INTERFERENCES: Aldehydes, acid gases and ketones.
COMMENTS: The tube has the sensitivity for the STEL but taking a continuous
15-minute sample would be difficult. The number of interferences may lead to
a problem.
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COMPANY: 3M (612-733-8029). PRODUCT NAME: 3721 (TM). METHOD OF COLLECTION:
Bisulfite impregnated pad. DETECTION: Colorimetric (Chromotropic acid).
SENSITIVITY: 0.1 ppm for 8 hours. INTERFERENCES: Manufacturer claims phenol
is not an interference since the monitor has a low collection efficiency for
phenol. COMMENTS: Not good for the STEL. Sampling for longer than 16 hours
in low humidity may make it unusable.
COMPANY: Kem Medical (800-553-0330) PRODUCT NAME: 8510 Vapor-Trak. METHOD
OF COLLECTION: Moistened chemical pad. DETECTION: Colorimetric
(Chromotropic acid). SENSITIVITY: 0.02 ppm (8 hours); 0.64 ppm (15 min).
INTERFERENCES: None listed but colorimetric methods usually have some
interferences. COMMENTS: Manufacturer's material states that humidity should
not be a problem but if it does cause a problem then the exposure would be
underestimated. They do state that 20% RH did not cause a problem. That RH
is probably at room temperature.
COMPANY: Air Technology Labs, Inc. (209-435-3545). PRODUCT NAME: Passive
Bubbler. METHOD OF COLLECTION: 3-methyl-2-benzothiazolinone hydrazone
hydrochloride (MBTH) solution. DETECTION: Colorimetric. SENSITIVITY: 0.2
ppm for 8 hours. 0.8 ppm for 15 minutes. INTERFERENCES: Other aliphatic
aldehydes. COMMENTS: Device is a passive liquid sampler that is independent
of humidity effects.
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Appendix B
Summary of Published Permeation Data
THICK GENERIC MATERIAL BREAKTHROUGH STEADY STATE RATE
COMMENTS (mm) (minutes) (ug/cm2/min)
.28-.60 Nitrile gt 360 to gt1260 .23 Viton(R) gt
960 Chemrel gt 480 Suit Material .08 Silver
Shield gt 360 Glove only .43 Butyl gt
240 to gt 960 gt 240=mixture PE/Tyvek gt 360 to gt 480 .07
PE/EVOH/PE gt 240 35C, Swedish Teflon
gt 180 .05 CPE gt 180
.38-.74 Neoprene 120 to gt 480 lt 90 to lt 900 .16-.46 Natural
Rubber 4 to gt 480 lt 10 to lt 900 .60 Viton(R)/neoprene gt
60
Neo + Nat Rub 35 lt 600 Nitrile-PVC 30
lt 9 .50 PVA 6 to gt 240 Degrades, no water BkTh
for mixtures .15.51 PVC 4 to gt 480 lt 10 to lt
900
________________________
gt = greater than lt = less than B-1
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Appendix C
Nonmandatory Evaluation Criteria for
Emergency Showers and Eyewashes
The criteria for acceptable eyewashes and quick drench showers should be
taken from ANSI Z358.1-1981, which will be revised in the near future. The
National Safety Council Data Sheet 1-686-Rev. 86 contains comparable
criteria, but not identical specifications. Generally, the main criteria for
judging acceptability are:
(1) Initiation: one hand, one action. Once initiated, flow continues,
leaving both hands free.
(2) Location: 15 seconds, 25 feet travel, maximum (for highly concentrated
solutions, 10 seconds, 10 feet maximum). Eyewashes positioned 34"-39" high,
shower approximately 82" high, with 67" high activation (maximum), positioned
23" (maximum) off center from shower head. Location must be clearly marked,
well lighted, and easily accessible; i.e., no obstacles, doorways, or turns.
(3) Water quality: potable, temperature (60-100 degrees F, ideally 90-95
degrees F), pressure (eyewash 30 psi at supply line, shower 30 psi), amount
(eyewash 3 gallons/minute for 15 minutes minimum, showers 30 gallons/minute
for 15 minutes minimum), maintenance (float-away covers or means to prevent
contamination; flush units weekly for a minimum of 3 minutes; bump test
eyewashes daily, showers weekly; full flow testing monthly).
(4) Training: Routine drills advisable. As a minimum, employees must know
the location and proper use of eyewashes and showers (i.e., initiate, remove
contaminated clothing, flush full 15 minutes, etc.).
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Appendix D
Start-up Dates
a. The following provisions were triggered as of February 2, 1988,
(formaldehyde standard paragraphs):
(a) Scope and application.
(b) Definitions.
(c) Permissible Exposure Limit (PEL). The intent was to have
no employees exposed above the PEL by February 2, 1988, (53 FR 46290,
December 4, 1988).
(e) Regulated areas. Signs restricting entry to authorized
personnel must be placed at the entry to all areas where either PEL is
exceeded. An exception is when exposures are over a new PEL but below the
old PEL's and the employer did not have adequate sampling data to comply with
these requirements. Since the start-up date for monitoring was August 2,
1988, (except for laboratories) no exception should be given after this
date.
(g) Respiratory protection. In general, these provisions were
not triggered until November 2, 1988. They could be cited in the interim,
however, if the employer had knowledge for at least 3 months that employees
were exposed above a new PEL.
(h) Protective equipment and clothing.
(i) Hygiene protection.
(j) Housekeeping.
(1) (1)(ii) and (1)(5) Medical surveillance.
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emergency or when employees develop signs and symptoms
of overexposure to formaldehyde. Because any formaldehyde- bearing products
are dermal hazards and because of individual hypersensitivity to
formaldehyde, signs or symptoms of overexposure may occasionally occur even
though airborne levels are below the PELs.
(k) Recordkeeping.
b. The following provisions are scheduled to be in effect as
follows, formaldehyde standard paragraphs:
(d) Exposure monitoring ... August 2, 1988.
(f) Methods of compliance ... February 2, 1989.
(g) Respiratory protection ... As soon as possible but no
later than November 2, 1988.
(k) Emergencies ... August 2, 1988.
(l) Medical surveillance (except (1)(l)(ii) and (1)(5) ...
August 2, 1988.
(n) Employee information and training ... April 4,
1988.
c. Formaldehyde use in histology, pathology, and human or
animal anatomy laboratories (including teaching laboratories) has the same
effective dates as described above. All other laboratories had a delayed
initial effective date of January 1, 1989, except for 29 CFR
l9l0.l048(c)--Permissible exposure limits--which was triggered February 2,
1988. All start-up dates for other laboratories are triggered after the
effective date; e.g., exposure determination is to be completed by 6 months
after January 1, 1989.
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Appendix E
Formaldehyde Standard Triggering Events
Part I. Airborne Levels
A. Below AL and STEL But Above .1 ppm.
1. Exposure Determination. 2. Recordkeeping. 3. Training
(initial). 4. Medical Surveillance for Signs and Symptoms.
B. Above AL or STEL.
1. Initial Monitoring. 2. Periodic Monitoring.
a. At or Above AL ... Every 6 months. b. At or Above STEL
... Once a year.
3. Medical Surveillance. 4. Training (annual). 5.
Applicable provisions in A. above.
C. Above TWA or STEL.
1. Regulated Areas. 2. Methods of Compliance. 3.
Respiratory Protection. 4. Applicable provisions are in A., B.
above.
D. Greater than 100 ppm.
1. Full Body protection. 2. Applicable provisions are in A.,
B., and C. above.
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Part II. Eye or Skin Contact.
A. Greater than or Equal to 1% Formaldehyde Solution.
1. PPE. 2. Hygiene protection.
a. Change Rooms. b. Quick Drench
Shower.
B. Greater than or Equal to 1% Formaldehyde Solution.
1. Eye Wash Facilities. 2. PPE.
C. Irritating or Sensitizing Formaldehyde Materials.
1. PPE. 2. Change Rooms.
Part III. Liquid or Gas.
A. Housekeeping
1. Leak Detection. 2. Preventative Maintenance. 3. Spill
Clean-up.
Part IV. Possibility of Emergency.
A. Emergencies B. Respiratory Protection. C. Medical
Surveillance. D. Training.
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Appendix F
Considering SAEs for Exposure to Mixtures
Often an employee is simultaneously exposed to a variety of chemical
substances in the workplace. Synergistic toxic effects on a target organ are
common for such exposures in many construction and manufacturing processes.
This type of exposure can also occur when impurities are present in single
chemical operations.
New permissible exposure limits (PELs) for mixtures, such as the recent
welding fume standard (5 mg/m3), address the complex problem of synergistic
exposures and their health effects. In addition, the Code of Federal
Regulations (29 CFR 1910.1000) contains a computational approach to assess
exposure to a mixture. This calculation should be used when the components
in the mixture pose a synergistic threat to worker health.
Whether using a single PEL or the mixture calculation, the sampling and
analytical error (SAE) of the individual constituents must be considered
before arriving at a final compliance decision. These SAEs can be pooled and
weighted to give a control limit for the synergistic mixture. To illustrate
this control limit, the following example using the mixture calculation is
shown:
The mixture calculation is expressed as:
Em = C1/L1 + C2/L2) + ..... (Cn/Ln) (1)
Where:
Em = equivalent exposure for the mixture (Em should be 1 for compliance) C
= concentration of a particular substance
L = PEL
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As an example, an exposure to three different but synergistic substances:
Actual Concentration of Material 8-hr Exposure (ppm) 8-hr TWA PEL
(ppm) SAE
Substance 1 500 1000 0.089 Substance 2
80 200 0.11 Substance 3 70
200 0.18
Using equation (1) above:
Em = 500/1000 + 80/200 + 70/200 = 1.25
Since Em is gt 1 an overexposure appears to have occurred; however, the SAE
for each substance also needs to be considered:
Exposure ratio (for each substance) Yn = Cn/Ln
Ratio to total exposure R1 = Y1/Em' ... Rn = Yn/Em
The SAEs (95% confidence) of the substances comprising the mixture can be
pooled by:
RSt = [R1)2 x (SAE1)2 + (R2)2 x (SAE2)2 + ... (Rn)2 x (SAEn)2]1/2
The mixture Control Limit (CL) is equivalent to: 1 + RSt
If Em is gt CL then an overexposure has not been established at the 95%
confidence level; further sampling may be necessary.
If Em is lt 1 and Em is lt CL then overexposure has occurred (95%
confidence).
______________________________
gt = greater than lt = less than
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Using the mixture data above:
Y1 = 500/1000, Y2 = 80/200, Y3 = 70/200
Y1 = 0.5, Y2 = 0.4, Y3 = 0.35
R1 = Y1/Em = 0.4, R2 = 0.32, R3 = 0.28
RSt2 = (0.4)2(0.089)2 + (0.32)2(0.11)2 + (0.28)2(0.18)2
RSt = (RSt2)1/2 = 0.071
CL = 1 + RSt = 1.071
Em = 1.25
Therefore Em is gt CL and an overexposure has occurred within 95% confidence
limits.
_________________________
gt = greater than lt = less than
This calculation is also used when considering a PEL such as the one for
total welding fumes. An executable computer program is available which will
calculate a control limit for any synergistic mixture. The program will run
on any IBM compatible personal computer. For questions contact Rick Cee or
Mike Shulsky from the OSHA Salt Lake City Laboratory.
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