[Code of Federal Regulations]
[Title 29, Volume 6]
[Revised as of July 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 29CFR1910.1048]
[Page 354-380]
TITLE 29--LABOR
CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT
OF LABOR
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS (Continued)--Table of Contents
Subpart Z--Toxic and Hazardous Substances
Sec. 1910.1048 Formaldehyde.
(a) Scope and application. This standard applies to all occupational
exposures to formaldehyde, i.e. from formaldehyde gas, its solutions,
and materials that release formaldehyde.
(b) Definitions. For purposes of this standard, the following
definitions shall apply:
Action level means a concentration of 0.5 part formaldehyde per
million parts of air (0.5 ppm) calculated as an eight (8)-hour time-
weighted average (TWA) concentration.
Assistant Secretary means the Assistant Secretary of Labor for the
Occupational Safety and Health Administration, U.S. Department of Labor,
or designee.
Authorized person means any person required by work duties to be
present in regulated areas, or authorized to do so by the employer, by
this section, or by the OSH Act of 1970.
Director means the Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and Human
Services, or designee.
Emergency is any occurrence, such as but not limited to equipment
failure, rupture of containers, or failure of control equipment that
results in an uncontrolled release of a significant amount of
formaldehyde.
Employee exposure means the exposure to airborne formaldehyde which
would occur without corrections for protection provided by any
respirator that is in use.
Formaldehyde means the chemical substance, HCHO, Chemical Abstracts
Service Registry No. 50-00-0.
(c) Permissible Exposure Limit (PEL)--(1) TWA: The employer shall
assure that no employee is exposed to an airborne concentration of
formaldehyde which exceeds 0.75 parts formaldehyde per million parts of
air (0.75 ppm) as an 8-hour TWA.
(2) Short Term Exposure Limit (STEL): The employer shall assure that
no employee is exposed to an airborne concentration of formaldehyde
which exceeds two parts formaldehyde per million parts of air (2 ppm) as
a 15-minute STEL.
(d) Exposure monitoring--(1) General. (i) Each employer who has a
workplace covered by this standard shall monitor employees to determine
their exposure to formaldehyde.
(ii) Exception. Where the employer documents, using objective data,
that the presence of formaldehyde or formaldehyde-releasing products in
the workplace cannot result in airborne concentrations of formaldehyde
that would cause any employee to be exposed at or above the action level
or the STEL under foreseeable conditions of use, the employer will not
be required to measure employee exposure to formaldehyde.
(iii) When an employee's exposure is determined from representative
sampling, the measurements used shall be representative of the
employee's full shift or short-term exposure to formaldehyde, as
appropriate.
(iv) Representative samples for each job classification in each work
area shall be taken for each shift unless the employer can document with
objective data that exposure levels for a given job classification are
equivalent for different work shifts.
(2) Initial monitoring. The employer shall identify all employees
who may be exposed at or above the action level or at or above the STEL
and accurately determine the exposure of each employee so identified.
(i) Unless the employer chooses to measure the exposure of each
employee potentially exposed to formaldehyde, the employer shall develop
a representative sampling strategy and measure sufficient exposures
within each job classification for each workshift to correctly
characterize and not underestimate the exposure of any employee within
each exposure group.
(ii) The initial monitoring process shall be repeated each time
there is a change in production, equipment, process, personnel, or
control measures which may result in new or additional exposure to
formaldehyde.
(iii) If the employer receives reports of signs or symptoms of
respiratory or dermal conditions associated with formaldehyde exposure,
the employer shall promptly monitor the affected employee's exposure.
(3) Periodic monitoring. (i) The employer shall periodically measure
and accurately determine exposure to
[[Page 355]]
formaldehyde for employees shown by the initial monitoring to be exposed
at or above the action level or at or above the STEL.
(ii) If the last monitoring results reveal employee exposure at or
above the action level, the employer shall repeat monitoring of the
employees at least every 6 months.
(iii) If the last monitoring results reveal employee exposure at or
above the STEL, the employer shall repeat monitoring of the employees at
least once a year under worst conditions.
(4) Termination of monitoring. The employer may discontinue periodic
monitoring for employees if results from two consecutive sampling
periods taken at least 7 days apart show that employee exposure is below
the action level and the STEL. The results must be statistically
representative and consistent with the employer's knowledge of the job
and work operation.
(5) Accuracy of monitoring. Monitoring shall be accurate, at the 95
percent confidence level, to within plus or minus 25 percent for
airborne concentrations of formaldehyde at the TWA and the STEL and to
within plus or minus 35 percent for airborne concentrations of
formaldehyde at the action level.
(6) Employee notification of monitoring results. Within 15 days of
receiving the results of exposure monitoring conducted under this
standard, the employer shall notify the affected employees of these
results. Notification shall be in writing, either by distributing copies
of the results to the employees or by posting the results. If the
employee exposure is over either PEL, the employer shall develop and
implement a written plan to reduce employee exposure to or below both
PELs, and give written notice to employees. The written notice shall
contain a description of the corrective action being taken by the
employer to decrease exposure.
(7) Observation of monitoring. (i) The employer shall provide
affected employees or their designated representatives an opportunity to
observe any monitoring of employee exposure to formaldehyde required by
this standard.
(ii) When observation of the monitoring of employee exposure to
formaldehyde requires entry into an area where the use of protective
clothing or equipment is required, the employer shall provide the
clothing and equipment to the observer, require the observer to use such
clothing and equipment, and assure that the observer complies with all
other applicable safety and health procedures.
(e) Regulated areas. (1) The employer shall establish regulated
areas where the concentration of airborne formaldehyde exceeds either
the TWA or the STEL and post all entrances and accessways with signs
bearing the following information:
DANGER
FORMALDEHYDE
IRRITANT AND POTENTIAL CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
(2) The employer shall limit access to regulated areas to authorized
persons who have been trained to recognize the hazards of formaldehyde.
(3) An employer at a multiemployer worksite who establishes a
regulated area shall communicate the access restrictions and locations
of these areas to other employers with work operations at that worksite.
(f) Methods of compliance--(1) Engineering controls and work
practices. The employer shall institute engineering and work practice
controls to reduce and maintain employee exposures to formaldehyde at or
below the TWA and the STEL.
(2) Exception. Whenever the employer has established that feasible
engineering and work practice controls cannot reduce employee exposure
to or below either of the PELs, the employer shall apply these controls
to reduce employee exposures to the extent feasible and shall supplement
them with respirators which satisfy this standard.
(g) Respiratory protection--(1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
[[Page 356]]
(ii) Work operations, such as maintenance and repair activities or
vessel cleaning, for which the employer establishes that engineering and
work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the PELs.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii), (d)(3)(iii)(B)(1), and (2)), and (f)
through (m).
(ii) If air-purifying chemical-cartridge respirators are used, the
employer must:
(A) Replace the cartridge after three (3) hours of use or at the end
of the workshift, whichever occurs first, unless the cartridge contains
a NIOSH-approved end-of-service-life indicator (ESLI) to show when
breakthrough occurs.
(B) Unless the canister contains a NIOSH-approved ESLI to show when
breakthrough occurs, replace canisters used in atmospheres up to 7.5 ppm
(10xPEL) every four (4) hours and industrial-sized canisters used in
atmospheres up to 75 ppm (100xPEL) every two (2) hours, or at the end of
the workshift, whichever occurs first.
(3) Respirator selection. (i) The employer must select appropriate
respirators from Table 1 in this section.
Table 1--Minimum Requirements for Respiratory Protection Against
Formaldehyde
------------------------------------------------------------------------
Condition of use or
formaldehyde concentration Minimum respirator required \1\
(ppm)
------------------------------------------------------------------------
Up to 7.5 ppm. (10 x PEL).... Full facepiece with cartridges or
canisters specifically approved for
protection against formaldehyde.\2\
Up to 75 ppm. (100 x PEL).... Full-face mask with chin style or chest
or back mounted type, with industrial
size canister specifically approved for
protection against formaldehyde. Type C
supplied air respirator, demand type, or
continuous flow type, with full
facepiece, hood, or helmet.
Above 75 ppm or unknown. Self-contained breathing apparatus (SCBA)
(emergencies). (100 x PEL). with positive pressure full facepiece.
Combination supplied-air, full facepiece
positive pressure respirator with
auxiliary self-contained air supply.
Firefighting................. SCBA with positive pressure in full face-
piece.
Escape....................... SCBA in demand or pressure demand mode.
Full-face mask with chin style or front
or back mounted type industrial size
canister specifically approved for
protection against formaldehyde.
------------------------------------------------------------------------
\1\ Respirators specified for use at higher concentrations may be used
at lower concentrations.
\2\ A half-mask respirator with cartridges specifically approved for
protection against formaldehyde can be substituted for the full
facepiece respirator providing that effective gas-proof goggles are
provided and used in combination with the half-mask respirator.
(ii) The employer must provide a powered air-purifying respirator
adequate to protect against formaldehyde exposure to any employee who
has difficulty using a negative-pressure respirator.
(h) Protective equipment and clothing. Employers shall comply with
the provisions of 29 CFR 1910.132 and 29 CFR 1910.133. When protective
equipment or clothing is provided under these provisions, the employer
shall provide these protective devices at no cost to the employee and
assure that the employee wears them.
(1) Selection. The employer shall select protective clothing and
equipment based upon the form of formaldehyde to be encountered, the
conditions of use, and the hazard to be prevented.
(i) All contact of the eyes and skin with liquids containing 1
percent or more formaldehyde shall be prevented by the use of chemical
protective clothing made of material impervious to formaldehyde and the
use of other personal protective equipment, such as goggles and face
shields, as appropriate to the operation.
(ii) Contact with irritating or sensitizing materials shall be
prevented to the extent necessary to eliminate the hazard.
(iii) Where a face shield is worn, chemical safety goggles are also
required if there is a danger of formaldehyde reaching the area of the
eye.
[[Page 357]]
(iv) Full body protection shall be worn for entry into areas where
concentrations exceed 100 ppm and for emergency reentry into areas of
unknown concentration.
(2) Maintenance of protective equipment and clothing. (i) The
employer shall assure that protective equipment and clothing that has
become contaminated with formaldehyde is cleaned or laundered before its
reuse.
(ii) When ventilating formaldehyde-contaminated clothing and
equipment, the employer shall establish a storage area so that employee
exposure is minimized. Containers for contaminated clothing and
equipment and storage areas shall have labels and signs containing the
following information:
DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
AVOID INHALATION AND SKIN CONTACT
(iii) The employer shall assure that only persons trained to
recognize the hazards of formaldehyde remove the contaminated material
from the storage area for purposes of cleaning, laundering, or disposal.
(iv) The employer shall assure that no employee takes home equipment
or clothing that is contaminated with formaldehyde.
(v) The employer shall repair or replace all required protective
clothing and equipment for each affected employee as necessary to assure
its effectiveness.
(vi) The employer shall inform any person who launders, cleans, or
repairs such clothing or equipment of formaldehyde's potentially harmful
effects and of procedures to safely handle the clothing and equipment.
(i) Hygiene protection. (1) The employer shall provide change rooms,
as described in 29 CFR 1910.141 for employees who are required to change
from work clothing into protective clothing to prevent skin contact with
formaldehyde.
(2) If employees' skin may become spashed with solutions containing
1 percent or greater formaldehyde, for example, because of equipment
failure or improper work practices, the employer shall provide
conveniently located quick drench showers and assure that affected
employees use these facilities immediately.
(3) If there is any possibility that an employee's eyes may be
splashed with solutions containing 0.1 percent or greater formaldehyde,
the employer shall provide acceptable eyewash facilities within the
immediate work area for emergency use.
(j) Housekeeping. For operations involving formaldehyde liquids or
gas, the employer shall conduct a program to detect leaks and spills,
including regular visual inspections.
(1) Preventative maintenance of equipment, including surveys for
leaks, shall be undertaken at regular intervals.
(2) In work areas where spillage may occur, the employer shall make
provisions to contain the spill, to decontaminate the work area, and to
dispose of the waste.
(3) The employer shall assure that all leaks are repaired and spills
are cleaned promptly by employees wearing suitable protective equipment
and trained in proper methods for cleanup and decontamination.
(4) Formaldehyde-contaminated waste and debris resulting from leaks
or spills shall be placed for disposal in sealed containers bearing a
label warning of formaldehyde's presence and of the hazards associated
with formaldehyde.
(k) Emergencies. For each workplace where there is the possibility
of an emergency involving formaldehyde, the employer shall assure
appropriate procedures are adopted to minimize injury and loss of life.
Appropriate procedures shall be implemented in the event of an
emergency.
(l) Medical surveillance--(1) Employees covered. (i) The employer
shall institute medical surveillance programs for all employees exposed
to formaldehyde at concentrations at or exceeding the action level or
exceeding the STEL.
(ii) The employer shall make medical surveillance available for
employees who develop signs and symptoms of overexposure to formaldehyde
and for all employees exposed to formaldehyde in emergencies. When
determining whether an employee may be experiencing signs and symptoms
of possible
[[Page 358]]
overexposure to formaldehyde, the employer may rely on the evidence that
signs and symptoms associated with formaldehyde exposure will occur only
in exceptional circumstances when airborne exposure is less than 0.1 ppm
and when formaldehyde is present in material in concentrations less than
0.1 percent.
(2) Examination by a physician. All medical procedures, including
administration of medical disease questionnaires, shall be performed by
or under the supervision of a licensed physician and shall be provided
without cost to the employee, without loss of pay, and at a reasonable
time and place.
(3) Medical disease questionnaire. The employer shall make the
following medical surveillance available to employees prior to
assignment to a job where formaldehyde exposure is at or above the
action level or above the STEL and annually thereafter. The employer
shall also make the following medical surveillance available promptly
upon determining that an employee is experiencing signs and symptoms
indicative of possible overexposure to formaldehyde.
(i) Administration of a medical disease questionnaire, such as in
appendix D, which is designed to elicit information on work history,
smoking history, any evidence of eye, nose, or throat irritation;
chronic airway problems or hyperreactive airway disease: allergic skin
conditions or dermatitis; and upper or lower respiratory problems.
(ii) A determination by the physician, based on evaluation of the
medical disease questionnaire, of whether a medical examination is
necessary for employees not required to wear respirators to reduce
exposure to formaldehyde.
(4) Medical examinations. Medical examinations shall be given to any
employee who the physician feels, based on information in the medical
disease questionnaire, may be at increased risk from exposure to
formaldehyde and at the time of initial assignment and at least annually
thereafter to all employees required to wear a respirator to reduce
exposure to formaldehyde. The medical examination shall include:
(i) A physical examination with emphasis on evidence of irritation
or sensitization of the skin and respiratory system, shortness of
breath, or irritation of the eyes.
(ii) Laboratory examinations for respirator wearers consisting of
baseline and annual pulmonary function tests. As a minimum, these tests
shall consist of forced vital capacity (FVC), forced expiratory volume
in one second (FEV1), and forced expiratory flow (FEF).
(iii) Any other test which the examining physician deems necessary
to complete the written opinion.
(iv) Counseling of employees having medical conditions that would be
directly or indirectly aggravated by exposure to formaldehyde on the
increased risk of impairment of their health.
(5) Examinations for employees exposed in an emergency. The employer
shall make medical examinations available as soon as possible to all
employees who have been exposed to formaldehyde in an emergency.
(i) The examination shall include a medical and work history with
emphasis on any evidence of upper or lower respiratory problems,
allergic conditions, skin reaction or hypersensitivity, and any evidence
of eye, nose, or throat irritation.
(ii) Other examinations shall consist of those elements considered
appropriate by the examining physician.
(6) Information provided to the physician. The employer shall
provide the following information to the examining physician:
(i) A copy of this standard and appendix A, C, D, and E;
(ii) A description of the affected employee's job duties as they
relate to the employee's exposure to formaldehyde;
(iii) The representative exposure level for the employee's job
assignment;
(iv) Information concerning any personal protective equipment and
respiratory protection used or to be used by the employee; and
(v) Information from previous medical examinations of the affected
employee within the control of the employer.
(vi) In the event of a nonroutine examination because of an
emergency,
[[Page 359]]
the employer shall provide to the physician as soon as possible: A
description of how the emergency occurred and the exposure the victim
may have received.
(7) Physician's written opinion. (i) For each examination required
under this standard, the employer shall obtain a written opinion from
the examining physician. This written opinion shall contain the results
of the medical examination except that it shall not reveal specific
findings or diagnoses unrelated to occupational exposure to
formaldehyde. The written opinion shall include:
(A) The physician's opinion as to whether the employee has any
medical condition that would place the employee at an increased risk of
material impairment of health from exposure to formaldehyde;
(B) Any recommended limitations on the employee's exposure or
changes in the use of personal protective equipment, including
respirators;
(C) A statement that the employee has been informed by the physician
of any medical conditions which would be aggravated by exposure to
formaldehyde, whether these conditions may have resulted from past
formaldehyde exposure or from exposure in an emergency, and whether
there is a need for further examination or treatment.
(ii) The employer shall provide for retention of the results of the
medical examination and tests conducted by the physician.
(iii) The employer shall provide a copy of the physician's written
opinion to the affected employee within 15 days of its receipt.
(8) Medical removal. (i) The provisions of paragraph (l)(8) apply
when an employee reports significant irritation of the mucosa of the
eyes or the upper airways, respiratory sensitization, dermal irritation,
or dermal sensitization attributed to workplace formaldehyde exposure.
Medical removal provisions do not apply in the case of dermal irritation
or dermal sensitization when the product suspected of causing the dermal
condition contains less than 0.05% formaldehyde.
(ii) An employee's report of signs or symptoms of possible
overexposure to formaldehyde shall be evaluated by a physician selected
by the employer pursuant to paragraph (l)(3). If the physician
determines that a medical examination is not necessary under paragraph
(l)(3)(ii), there shall be a two-week evaluation and remediation period
to permit the employer to ascertain whether the signs or symptoms
subside untreated or with the use of creams, gloves, first aid treatment
or personal protective equipment. Industrial hygiene measures that limit
the employee's exposure to formaldehyde may also be implemented during
this period. The employee shall be referred immediately to a physician
prior to expiration of the two-week period if the signs or symptoms
worsen. Earnings, seniority and benefits may not be altered during the
two-week period by virtue of the report.
(iii) If the signs or symptoms have not subsided or been remedied by
the end of the two-week period, or earlier if signs or symptoms warrant,
the employee shall be examined by a physician selected by the employer.
The physician shall presume, absent contrary evidence, that observed
dermal irritation or dermal sensitization are not attributable to
formaldehyde when products to which the affected employee is exposed
contain less than 0.1% formaldehyde.
(iv) Medical examinations shall be conducted in compliance with the
requirements of paragraph (l)(5) (i) and (ii). Additional guidelines for
conducting medical exams are contained in appendix C.
(v) If the physician finds that significant irritation of the mucosa
of the eyes or of the upper airways, respiratory sensitization, dermal
irritation, or dermal sensitization result from workplace formaldehyde
exposure and recommends restrictions or removal, the employer shall
promptly comply with the restrictions or recommendation of removal. In
the event of a recommendation of removal, the employer shall remove the
effected employee from the current formaldehyde exposure and if
possible, transfer the employee to work having no or significantly less
exposure to formaldehyde.
(vi) When an employee is removed pursuant to paragraph (l)(8)(v),
the employer shall transfer the employee to
[[Page 360]]
comparable work for which the employee is qualified or can be trained in
a short period (up to 6 months), where the formaldehyde exposures are as
low as possible, but not higher than the action level. The employeer
shall maintain the employee's current earnings, seniority, and other
benefits. If there is no such work available, the employer shall
maintain the employee's current earnings, seniority and other benefits
until such work becomes available, until the employee is determined to
be unable to return to workplace formaldehyde exposure, until the
employee is determined to be able to return to the original job status,
or for six months, whichever comes first.
(vii) The employer shall arrange for a follow-up medical examination
to take place within six months after the employee is removed pursuant
to this paragraph. This examination shall determine if the employee can
return to the original job status, or if the removal is to be permanent.
The physician shall make a decision within six months of the date the
employee was removed as to whether the employee can be returned to the
original job status, or if the removal is to be permanent.
(viii) An employer's obligation to provide earnings, seniority and
other benefits to a removed employee may be reduced to the extent that
the employee receives compensation for earnings lost during the period
of removal either from a publicly or employer-funded compensation
program or from employment with another employer made possible by virtue
of the employee's removal.
(ix) In making determinations of the formaldehyde content of
materials under this paragraph the employer may rely on objective data.
(9) Multiple physician review. (i) After the employer selects the
initial physician who conducts any medical examination or consultation
to determine whether medical removal or restriction is appropriate, the
employee may designate a second physician to review any findings,
determinations or recommendations of the initial physician and to
conduct such examinations, consultations, and laboratory tests as the
second physician deems necessary and appropriate to evaluate the effects
of formaldehyde exposure and to facilitate this review.
(ii) The employer shall promptly notify an employee of the right to
seek a second medical opinion after each occasion that an initial
physician conducts a medical examination or consultation for the purpose
of medical removal or restriction.
(iii) The employer may condition its participation in, and payment
for, the multiple physician review mechanism upon the employee doing the
following within fifteen (15) days after receipt of the notification of
the right to seek a second medical opinion, or receipt of the initial
physician's written opinion, whichever is later;
(A) The employee informs the employer of the intention to seek a
second medical opinion, and
(B) The employee initiates steps to make an appointment with a
second physician.
(iv) If the findings, determinations or recommendations of the
second physician differ from those of the initial physician, then the
employer and the employee shall assure that efforts are made for the two
physicians to resolve the disagreement. If the two physicians are unable
to quickly resolve their disagreement, then the employer and the
employee through their respective physicians shall designate a third
physician who shall be a specialist in the field at issue:
(A) To review the findings, determinations or recommendations of the
prior physicians; and
(B) To conduct such examinations, consultations, laboratory tests
and discussions with the prior physicians as the third physician deems
necessary to resolve the disagreement of the prior physicians.
(v) In the alternative, the employer and the employee or authorized
employee representative may jointly designate such third physician.
(vi) The employer shall act consistent with the findings,
determinations and recommendations of the third physician, unless the
employer and the employee reach an agreement which is otherwise
consistent with the recommendations of at least one of the three
physicians.
[[Page 361]]
(m) Hazard communication--(1) General. Communication of the hazards
associated with formaldehyde in the workplace shall be governed by the
requirements of paragraph (m). The definitions of 29 CFR 1910.1200(c)
shall apply under this paragraph.
(i) The following shall be subject to the hazard communication
requirements of this paragraph: Formaldehyde gas, all mixtures or
solutions composed of greater than 0.1 percent formaldehyde, and
materials capable of releasing formaldehyde into the air, under
reasonably foreseeable conditions of use, at concentrations reaching or
exceeding 0.1 ppm.
(ii) As a minimum, specific health hazards that the employer shall
address are: Cancer, irritation and sensitization of the skin and
respiratory system, eye and throat irritation, and acute toxicity.
(2) Manufacturers and importers who produce or import formaldehyde
or formaldehyde-containing products shall provide downstream employers
using or handling these products with an objective determination through
the required labels and MSDSs if these items may constitute a health
hazard within the meaning of 29 CFR 1910.1200(d) under normal conditions
of use.
(3) Labels. (i) The employer shall assure that hazard warning labels
complying with the requirements of 29 CFR 1910.1200(f) are affixed to
all containers of materials listed in paragraph (m)(1)(i), except to the
extent that 29 CFR 1910.1200(f) is inconsistent with this paragraph.
(ii) Information on labels. As a minimum, for all materials listed
in paragraph (m)(1)(i) capable of releasing formaldehyde at levels of
0.1 ppm to 0.5 ppm, labels shall identify that the product contains
formaldehyde; list the name and address of the responsible party; and
state that physical and health hazard information is readily available
from the employer and from material safety data sheets.
(iii) For materials listed in paragraph (m)(1)(i) capable of
releasing formaldehyde at levels above 0.5 ppm, labels shall
appropriately address all hazards as defined in 29 CFR 1910.1200(d) and
29 CFR 1910.1200 appendices A and B, including respiratory
sensitization, and shall contain the words ``Potential Cancer Hazard.''
(iv) In making the determinations of anticipated levels of
formaldehyde release, the employer may rely on objective data indicating
the extent of potential formaldehyde release under reasonably
foreseeable conditions of use.
(v) Substitute warning labels. The employer may use warning labels
required by other statutes, regulations, or ordinances which impart the
same information as the warning statements required by this paragraph.
(4) Material safety data sheets. (i) Any employer who uses
formaldehyde-containing materials listed in paragraph (m)(1)(i) shall
comply with the requirements of 29 CFR 1910.1200(g) with regard to the
development and updating of material safety data sheets.
(ii) Manufacturers, importers, and distributors of formaldehyde-
containing materials listed in paragraph (m)(1)(i) shall assure that
material safety data sheets and updated information are provided to all
employers purchasing such materials at the time of the initial shipment
and at the time of the first shipment after a material safety data sheet
is updated.
(5) Written hazard communication program. The employer shall
develop, implement, and maintain at the workplace, a written hazard
communication program for formaldehyde exposures in the workplace, which
at a minimum describes how the requirements specified in this paragraph
for labels and other forms of warning and material safety data sheets,
and paragraph (n) for employee information and training, will be met.
Employers in multi-employer workplaces shall comply with the
requirements of 29 CFR 1910.1200(e)(2).
(n) Employee information and training--(1) Participation. The
employer shall assure that all employees who are assigned to workplaces
where there is exposure to formaldehyde participate in a training
program, except that where the employer can show, using objective data,
that employees are not exposed to formaldehyde at or above 0.1 ppm, the
employer is not required to provide training.
[[Page 362]]
(2) Frequency. Employers shall provide such information and training
to employees at the time of initial assignment, and whenever a new
exposure to formaldehyde is introduced into the work area. The training
shall be repeated at least annually.
(3) Training program. The training program shall be conducted in a
manner which the employee is able to understand and shall include:
(i) A discussion of the contents of this regulation and the contents
of the Material Safety Data Sheet.
(ii) The purpose for and a description of the medical surveillance
program required by this standard, including:
(A) A description of the potential health hazards associated with
exposure to formaldehyde and a description of the signs and symptoms of
exposure to formaldehyde.
(B) Instructions to immediately report to the employer the
development of any adverse signs or symptoms that the employee suspects
is attributable to formaldehyde exposure.
(iii) Description of operations in the work area where formaldehyde
is present and an explanation of the safe work practices appropriate for
limiting exposure to formaldehyde in each job;
(iv) The purpose for, proper use of, and limitations of personal
protective clothing and equipment;
(v) Instructions for the handling of spills, emergencies, and clean-
up procedures;
(vi) An explanation of the importance of engineering and work
practice controls for employee protection and any necessary instruction
in the use of these controls; and
(vii) A review of emergency procedures including the specific duties
or assignments of each employee in the event of an emergency.
(4) Access to training materials. (i) The employer shall inform all
affected employees of the location of written training materials and
shall make these materials readily available, without cost, to the
affected employees.
(ii) The employer shall provide, upon request, all training
materials relating to the employee training program to the Assistant
Secretary and the Director.
(o) Recordkeeping--(1) Exposure measurements. The employer shall
establish and maintain an accurate record of all measurements taken to
monitor employee exposure to formaldehyde. This record shall include:
(i) The date of measurement;
(ii) The operation being monitored;
(iii) The methods of sampling and analysis and evidence of their
accuracy and precision;
(iv) The number, durations, time, and results of samples taken;
(v) The types of protective devices worn; and
(vi) The names, job classifications, social security numbers, and
exposure estimates of the employees whose exposures are represented by
the actual monitoring results.
(2) Exposure determinations. Where the employer has determined that
no monitoring is required under this standard, the employer shall
maintain a record of the objective data relied upon to support the
determination that no employee is exposed to formaldehyde at or above
the action level.
(3) Medical surveillance. The employer shall establish and maintain
an accurate record for each employee subject to medical surveillance
under this standard. This record shall include:
(i) The name and social security number of the employee;
(ii) The physician's written opinion;
(iii) A list of any employee health complaints that may be related
to exposure to formaldehyde; and
(iv) A copy of the medical examination results, including medical
disease questionnaires and results of any medical tests required by the
standard or mandated by the examining physician.
(4) Respirator fit testing. (i) The employer shall establish and
maintain accurate records for employees subject to negative pressure
respirator fit testing required by this standard.
(ii) This record shall include:
(A) A copy of the protocol selected for respirator fit testing.
(B) A copy of the results of any fit testing performed.
(C) The size and manufacturer of the types of respirators available
for selection.
(D) The date of the most recent fit testing, the name and social
security
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number of each tested employee, and the respirator type and facepiece
selected.
(5) Record retention. The employer shall retain records required by
this standard for at least the following periods:
(i) Exposure records and determinations shall be kept for at least
30 years.
(ii) Medical records shall be kept for the duration of employment
plus 30 years.
(iii) Respirator fit testing records shall be kept until replaced by
a more recent record.
(6) Availability of records. (i) Upon request, the employer shall
make all records maintained as a requirement of this standard available
for examination and copying to the Assistant Secretary and the Director.
(ii) The employer shall make employee exposure records, including
estimates made from representative monitoring and available upon request
for examination, and copying to the subject employee, or former
employee, and employee representatives in accordance with 29 CFR 1910.20
(a)-(e) and (g)-(i).
(iii) Employee medical records required by this standard shall be
provided upon request for examination and coying, to the subject
employee or former employee or to anyone having the specific written
consent of the subject employee or former employee in accordance with 29
CFR 1910.20 (a)-(e) and (g)-(i).
(p) Dates--(1) Effective dates--(i) General. This section shall
become effective February 2, 1988, except as noted below.
(ii) Laboratories. This standard shall become effective for anatomy,
histology, and pathology laboratories February 2, 1988, except as noted
in the start-up date section. For all other laboratories, paragraphs (a)
and (c) of this standard shall become effective February 2, 1988, and
paragraphs (b) and (d)-(o) of this standard shall become effective on
September 1, 1988 except as noted in the start-up date section.
(2) Start-up dates--(i) Exposure determinations. Initial monitoring
or objective determinations that no monitoring is required by the
standard shall be completed by 6 months after the effective date of the
standard.
(ii) Medical surveillance. The initial medical surveillance of all
eligible employees shall be completed by 6 months after the effective
date of the standard.
(iii) Emergencies. The emergency procedures required by this
standard shall be implemented by 6 months after the effective date of
the standard.
(iv) Respiratory protection. Respiratory protection as required in
this standard shall be provided as soon as possible and no later than 9
months after the effective date of the standard.
(v) Engineering and work practice controls. Engineering and work
practice controls required by this standard shall be implemented as soon
as possible, but no later than one year after the effective date of the
standard.
(vi) Employee training. Written materials for employee training
shall be updated as soon as possible, but no later than 2 months after
the effective date of the standard.
(3) Start-up dates of amended paragraphs--(i) Respiratory
protection. Respiratory protection required to meet the amended PEL of
0.75 ppm TWA shall be provided as soon as possible but no later than
September 24, 1992.
(ii) Engineering and work practice controls. Engineering and work
practice controls required to meet the amended PEL of 0.75 ppm TWA shall
be implemented as soon as possible, but no later than June 26, 1993.
(iii) Medical removal protection. The medical removal protection
provisions including the multiple physician review mechanism shall be
implemented no later than December 28, 1992.
(iv) Hazard communication. The labeling provisions contained in
amended paragraph (m) of this standard shall be implemented no later
than December 28, 1992. Labeling of containers of formaldehyde products
shall continue to comply with the provisions of 29 CFR 1910.1200 (e)-(j)
until that time.
(v) Training. The periodic training mandated for all employees
exposed to formaldehyde between 0.1 ppm and 0.5 ppm shall begin no later
than August 25, 1992.
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Appendix A to Sec. 1910.1048--Substance Technical Guidelines for
Formalin
The following Substance Technical Guideline for Formalin provides
information on uninhibited formalin solution (37% formaldehyde, no
methanol stabilizer). It is designed to inform employees at the
production level of their rights and duties under the formaldehyde
standard whether their job title defines them as workers or supervisors.
Much of the information provided is general; however, some information
is specific for formalin. When employee exposure to formaldehyde is from
resins capable of releasing formaldehyde, the resin itself and other
impurities or decomposition products may also be toxic, and employers
should include this information as well when informing employees of the
hazards associated with the materials they handle. The precise hazards
associated with exposure to formaldehyde depend both on the form (solid,
liquid, or gas) of the material and the concentration of formaldehyde
present. For example, 37-50 percent solutions of formaldehyde present a
much greater hazard to the skin and eyes from spills or splashes than
solutions containing less than 1 percent formaldehyde. Individual
Substance Technical Guidelines used by the employer for training
employees should be modified to properly give information on the
material actually being used.
Substance Identification
Chemical Name: Formaldehyde
Chemical Family: Aldehyde
Chemical Formula: HCHO
Molecular Weight: 30.03
Chemical Abstracts Service Number (CAS Number): 50-00-0
Synonyms: Formalin; Formic Aldehyde; Paraform; Formol; Formalin
(Methanol-free); Fyde; Formalith; Methanal; Methyl Aldehyde; Methylene
Glycol; Methylene Oxide; Tetraoxymethalene; Oxomethane; Oxymethylene
Components and Contaminants
Percent: 37.0 Formaldehyde
Percent: 63.0 Water
(Note-- Inhibited solutions contain methanol.)
Other Contaminants: Formic acid (alcohol free)
Exposure Limits:
OSHA TWA--0.75 ppm
OSHA STEL--2 ppm
Physical Data
Description: Colorless liquid, pungent odor
Boiling point: 214 deg.F (101 deg.C)
Specific Gravity: 1.08 (H2 O=1 @ 20 deg.C)
pH: 2.8-4.0
Solubility in Water: Miscible
Solvent Solubility: Soluble in alcohol and acetone
Vapor Density: 1.04 (Air=1 @ 20 deg.C)
Odor Threshold: 0.8-1 ppm
Fire and Explosion Hazard
Moderate fire and explosion hazard when exposed to heat or flame.
The flash point of 37% formaldehyde solutions is above normal room
temperature, but the explosion range is very wide, from 7 to 73% by
volume in air.
Reaction of formaldehyde with nitrogen dioxide, nitromethane,
perchloric acid and aniline, or peroxyformic acid yields explosive
compounds.
Flash Point: 185 deg.F (85 deg.C) closed cup
Lower Explosion Limit: 7%
Upper Explosion Limit: 73%
Autoignition Temperature: 806 deg.F (430 deg.C)
Flammability Class (OSHA): III A
Extinguishing Media: Use dry chemical, ``alcohol foam'', carbon
dioxide, or water in flooding amounts as fog. Solid streams may not be
effective. Cool fire-exposed containers with water from side until well
after fire is out.
Use of water spray to flush spills can also dilute the spill to
produce nonflammable mixtures. Water runoff, however, should be
contained for treatment.
National Fire Protection Association Section 325M Designation:
Health: 2--Materials hazardous to health, but areas may be entered
with full-faced mask self-contained breathing apparatus which provides
eye protection.
Flammability: 2--Materials which must be moderately heated before
ignition will occur. Water spray may be used to extinguish the fire
because the material can be cooled below its flash point.
Reactivity: D--Materials which (in themselves) are normally stable
even under fire exposure conditions and which are not reactive with
water. Normal fire fighting procedures may be used.
Reactivity
Stability: Formaldehyde solutions may self-polymerize to form
paraformaldehyde which precipitates.
Incompatibility (Materials to Avoid): Strong oxidizing agents,
caustics, strong alkalies, isocyanates, anhydrides, oxides, and
inorganic acids. Formaldehyde reacts with hydrochloric acid to form the
potent carcinogen, bis-chloromethyl ether. Formaldehyde reacts with
nitrogen dioxide, nitromethane, perchloric acid and aniline, or
peroxyformic acid to yield explosive compounds. A violent reaction
occurs when formaldehyde is mixed with strong oxidizers.
Hazardous Combustion or Decomposition Products: Oxygen from the air
can oxidize
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formaldehyde to formic acid, especially when heated. Formic acid is
corrosive.
Health Hazard Data
Acute Effects of Exposure
Ingestion (Swallowing): Liquids containing 10 to 40% formaldehyde
cause severe irritation and inflammation of the mouth, throat, and
stomach. Severe stomach pains will follow ingestion with possible loss
of consciousness and death. Ingestion of dilute formaldehyde solutions
(0.03-0.04%) may cause discomfort in the stomach and pharynx.
Inhalation (Breathing): Formaldehyde is highly irritating to the
upper respiratory tract and eyes. Concentrations of 0.5 to 2.0 ppm may
irritate the eyes, nose, and throat of some individuals. Concentrations
of 3 to 5 ppm also cause tearing of the eyes and are intolerable to some
persons. Concentrations of 10 to 20 ppm cause difficulty in breathing,
burning of the nose and throat, cough, and heavy tearing of the eyes,
and 25 to 30 ppm causes severe respiratory tract injury leading to
pulmonary edema and pneumonitis. A concentration of 100 ppm is
immediately dangerous to life and health. Deaths from accidental
exposure to high concentrations of formaldehyde have been reported.
Skin (Dermal): Formalin is a severe skin irritant and a sensitizer.
Contact with formalin causes white discoloration, smarting, drying,
cracking, and scaling. Prolonged and repeated contact can cause numbness
and a hardening or tanning of the skin. Previously exposed persons may
react to future exposure with an allergic eczematous dermatitis or
hives.
Eye Contact: Formaldehyde solutions splashed in the eye can cause
injuries ranging from transient discomfort to severe, permanent corneal
clouding and loss of vision. The severity of the effect depends on the
concentration of formaldehyde in the solution and whether or not the
eyes are flushed with water immediately after the accident.
Note.-- The perception of formaldehyde by odor and eye irritation
becomes less sensitive with time as one adapts to formaldehyde. This can
lead to overexposure if a worker is relying on formaldehyde's warning
properties to alert him or her to the potential for exposure.
Acute Animal Toxicity:
Oral, rats: LD50=800 mg/kg
Oral, mouse: LD50=42 mg/kg
Inhalation, rats: LCLo=250 mg/kg
Inhalation, mouse: LCLo=900 mg/kg
Inhalation, rats: LC50=590 mg/kg
Chronic Effects of Exposure
Carcinogenicity: Formaldehyde has the potential to cause cancer in
humans. Repeated and prolonged exposure increases the risk. Various
animal experiments have conclusively shown formaldehyde to be a
carcinogen in rats. In humans, formaldehyde exposure has been associated
with cancers of the lung, nasopharynx and oropharynx, and nasal
passages.
Mutagenicity: Formaldehyde is genotoxic in several in vitro test
systems showing properties of both an initiator and a promoter.
Toxicity: Prolonged or repeated exposure to formaldehyde may result
in respiratory impairment. Rats exposed to formaldehyde at 2 ppm
developed benign nasal tumors and changes of the cell structure in the
nose as well as inflamed mucous membranes of the nose. Structural
changes in the epithelial cells in the human nose have also been
observed. Some persons have developed asthma or bronchitis following
exposure to formaldehyde, most often as the result of an accidental
spill involving a single exposure to a high concentration of
formaldehyde.
Emergency and First Aid Procedures
Ingestion (Swallowing): If the victim is conscious, dilute,
inactivate, or absorb the ingested formaldehyde by giving milk,
activated charcoal, or water. Any organic material will inactivate
formaldehyde. Keep affected person warm and at rest. Get medical
attention immediately. If vomiting occurs, keep head lower than hips.
Inhalation (Breathing): Remove the victim from the exposure area to
fresh air immediately. Where the formaldehyde concentration may be very
high, each rescuer must put on a self-contained breathing apparatus
before attempting to remove the victim, and medical personnel should be
informed of the formaldehyde exposure immediately. If breathing has
stopped, give artificial respiration. Keep the affected person warm and
at rest. Qualified first-aid or medical personnel should administer
oxygen, if available, and maintain the patient's airways and blood
pressure until the victim can be transported to a medical facility. If
exposure results in a highly irritated upper respiratory tract and
coughing continues for more than 10 minutes, the worker should be
hospitalized for observation and treatment.
Skin Contact: Remove contaminated clothing (including shoes)
immediately. Wash the affected area of your body with soap or mild
detergent and large amounts of water until no evidence of the chemical
remains (at least 15 to 20 minutes). If there are chemical burns, get
first aid to cover the area with sterile, dry dressing, and bandages.
Get medical attention if you experience appreciable eye or respiratory
irritation.
Eye Contact: Wash the eyes immediately with large amounts of water
occasionally lifting lower and upper lids, until no evidence of chemical
remains (at least 15 to 20
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minutes). In case of burns, apply sterile bandages loosely without
medication. Get medical attention immediately. If you have experienced
appreciable eye irritation from a splash or excessive exposure, you
should be referred promptly to an opthamologist for evaluation.
Emergency Procedures
Emergencies: If you work in an area where a large amount of
formaldehyde could be released in an accident or from equipment failure,
your employer must develop procedures to be followed in event of an
emergency. You should be trained in your specific duties in the event of
an emergency, and it is important that you clearly understand these
duties. Emergency equipment must be accessible and you should be trained
to use any equipment that you might need. Formaldehyde contaminated
equipment must be cleaned before reuse.
If a spill of appreciable quantity occurs, leave the area quickly
unless you have specific emergency duties. Do not touch spilled
material. Designated persons may stop the leak and shut off ignition
sources if these procedures can be done without risk. Designated persons
should isolate the hazard area and deny entry except for necessary
people protected by suitable protective clothing and respirators
adequate for the exposure. Use water spray to reduce vapors. Do not
smoke, and prohibit all flames or flares in the hazard area.
Special Firefighting Procedures: Learn procedures and
responsibilities in the event of a fire in your workplace. Become
familiar with the appropriate equipment and supplies and their location.
In firefighting, withdraw immediately in case of rising sound from
venting safety device or any discoloration of storage tank due to fire.
Spill, Leak, and Disposal Procedures
Occupational Spill: For small containers, place the leaking
container in a well ventilated area. Take up small spills with absorbent
material and place the waste into properly labeled containers for later
disposal. For larger spills, dike the spill to minimize contamination
and facilitate salvage or disposal. You may be able to neutralize the
spill with sodium hydroxide or sodium sulfite. Your employer must comply
with EPA rules regarding the clean-up of toxic waste and notify state
and local authorities, if required. If the spill is greater than 1,000
lb/day, it is reportable under EPA's Superfund legislation.
Waste Disposal: Your employer must dispose of waste containing
formaldehyde in accordance with applicable local, state, and Federal law
and in a manner that minimizes exposure of employees at the site and of
the clean-up crew.
Monitoring and Measurement Procedures
Monitoring Requirements: If your exposure to formaldehyde exceeds
the 0.5 ppm action level or the 2 ppm STEL, your employer must monitor
your exposure. Your employer need not measure every exposure if a ``high
exposure'' employee can be identified. This person usually spends the
greatest amount of time nearest the process equipment. If you are a
``representative employee'', you will be asked to wear a sampling device
to collect formaldehyde. This device may be a passive badge, a sorbent
tube attached to a pump, or an impinger containing liquid. You should
perform your work as usual, but inform the person who is conducting the
monitoring of any difficulties you are having wearing the device.
Evaluation of 8-hour Exposure: Measurements taken for the purpose of
determining time-weighted average (TWA) exposures are best taken with
samples covering the full shift. Samples collected must be taken from
the employee's breathing zone air.
Short-term Exposure Evaluation: If there are tasks that involve
brief but intense exposure to formaldehyde, employee exposure must be
measured to assure compliance with the STEL. Sample collections are for
brief periods, only 15 minutes, but several samples may be needed to
identify the peak exposure.
Monitoring Techniques: OSHA's only requirement for selecting a
method for sampling and analysis is that the methods used accurately
evaluate the concentration of formaldehyde in employees' breathing
zones. Sampling and analysis may be performed by collection of
formaldehyde on liquid or solid sorbents with subsequent chemical
analysis. Sampling and analysis may also be performed by passive
diffusion monitors and short-term exposure may be measured by
instruments such as real-time continuous monitoring systems and portable
direct reading instruments.
Notification of Results: Your employer must inform you of the
results of exposure monitoring representative of your job. You may be
informed in writing, but posting the results where you have ready access
to them constitutes compliance with the standard.
Protective Equipment and Clothing
[Material impervious to formaldehyde is needed if the employee
handles formaldehyde solutions of 1% or more. Other employees may also
require protective clothing or equipment to prevent dermatitis.]
Respiratory Protection: Use NIOSH-approved full facepiece negative
pressure respirators equipped with approved cartridges or canisters
within the use limitations of these devices. (Present restrictions on
cartridges and canisters do not permit them to be used for a full
workshift.) In all other situations, use positive pressure respirators
such as the
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positive-pressure air purifying respirator or the self-contained
breathing apparatus (SCBA). If you use a negative pressure respirator,
your employer must provide you with fit testing of the respirator at
least once a year in accordance with the procedures outlined in Appendix
E.
Protective Gloves: Wear protective (impervious) gloves provided by
your employer, at no cost, to prevent contact with formalin. Your
employer should select these gloves based on the results of permeation
testing and in accordance with the ACGIH Guidelines for Selection of
Chemical Protective Clothing.
Eye Protection: If you might be splashed in the eyes with formalin,
it is essential that you wear goggles or some other type of complete
protection for the eye. You may also need a face shield if your face is
likely to be splashed with formalin, but you must not substitute face
shields for eye protection. (This section pertains to formaldehyde
solutions of 1% or more.)
Other Protective Equipment: You must wear protective (impervious)
clothing and equipment provided by your employer at no cost to prevent
repeated or prolonged contact with formaldehyde liquids. If you are
required to change into whole-body chemical protective clothing, your
employer must provide a change room for your privacy and for storage of
your normal clothing.
If you are splashed with formaldehyde, use the emergency showers and
eyewash fountains provided by your employer immediately to prevent
serious injury. Report the incident to your supervisor and obtain
necessary medical support.
Entry Into an IDLH Atmosphere
Enter areas where the formaldehyde concentration might be 100 ppm or
more only with complete body protection including a self-contained
breathing apparatus with a full facepiece operated in a positive
pressure mode or a supplied air respirator with full facepiece and
operated in a positive pressure mode. This equipment is essential to
protect your life and health under such extreme conditions.
Engineering Controls
Ventilation is the most widely applied engineering control method
for reducing the concentration of airborne substances in the breathing
zones of workers. There are two distinct types of ventilation.
Local Exhaust: Local exhaust ventilation is designed to capture
airborne contaminants as near to the point of generation as possible. To
protect you, the direction of contaminant flow must always be toward the
local exhaust system inlet and away from you.
General (Mechanical): General dilution ventilation involves
continuous introduction of fresh air into the workroom to mix with the
contaminated air and lower your breathing zone concentration of
formaldehyde. Effectiveness depends on the number of air changes per
hour. Where devices emitting formaldehyde are spread out over a large
area, general dilution ventilation may be the only practical method of
control.
Work Practices: Work practices and administrative procedures are an
important part of a control system. If you are asked to perform a task
in a certain manner to limit your exposure to formaldehyde, it is
extremely important that you follow these procedures.
Medical Surveillance
Medical surveillance helps to protect employees' health. You are
encouraged strongly to participate in the medical surveillance program.
Your employer must make a medical surveillance program available at
no expense to you and at a reasonable time and place if you are exposed
to formaldehyde at concentrations above 0.5 ppm as an 8-hour average or
2 ppm over any 15-minute period. You will be offered medical
surveillance at the time of your initial assignment and once a year
afterward as long as your exposure is at least 0.5 ppm (TWA) or 2 ppm
(STEL). Even if your exposure is below these levels, you should inform
your employer if you have signs and symptoms that you suspect, through
your training, are related to your formaldehyde exposure because you may
need medical surveillance to determine if your health is being impaired
by your exposure.
The surveillance plan includes:
(a) A medical disease questionnaire.
(b) A physical examination if the physician determines this is
necessary.
If you are required to wear a respirator, your employer must offer
you a physical examination and a pulmonary function test every year.
The physician must collect all information needed to determine if
you are at increased risk from your exposure to formaldehyde. At the
physician's discretion, the medical examination may include other tests,
such as a chest x-ray, to make this determination.
After a medical examination the physician will provide your employer
with a written opinion which includes any special protective measures
recommended and any restrictions on your exposure. The physician must
inform you of any medical conditions you have which would be aggravated
by exposure to formaldehyde.
All records from your medical examinations, including disease
surveys, must be retained at your employer's expense.
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Emergencies
If you are exposed to formaldehyde in an emergency and develop signs
or symptoms associated with acute toxicity from formaldehyde exposure,
your employer must provide you with a medical examination as soon as
possible. This medical examination will include all steps necessary to
stabilize your health. You may be kept in the hospital for observation
if your symptoms are severe to ensure that any delayed effects are
recognized and treated.
Appendix B to Sec. 1910.1048--Sampling Strategy and Analytical Methods
for Formaldehyde
To protect the health of employees, exposure measurements must be
unbiased and representative of employee exposure. The proper measurement
of employee exposure requires more than a token commitment on the part
of the employer. OSHA's mandatory requirements establish a baseline;
under the best of circumstances all questions regarding employee
exposure will be answered. Many employers, however, will wish to conduct
more extensive monitoring before undertaking expensive commitments, such
as engineering controls, to assure that the modifications are truly
necessary. The following sampling strategy, which was developed at NIOSH
by Nelson A. Leidel, Kenneth A. Busch, and Jeremiah R. Lynch and
described in NIOSH publication No. 77-173 (Occupational Exposure
Sampling Strategy Manual) will assist the employer in developing a
strategy for determining the exposure of his or her employees.
There is no one correct way to determine employee exposure.
Obviously, measuring the exposure of every employee exposed to
formaldehyde will provide the most information on any given day. Where
few employees are exposed, this may be a practical solution. For most
employers, however, use of the following strategy will give just as much
information at less cost.
Exposure data collected on a single day will not automatically
guarantee the employer that his or her workplace is always in compliance
with the formaldehyde standard. This does not imply, however, that it is
impossible for an employer to be sure that his or her worksite is in
compliance with the standard. Indeed, a properly designed sampling
strategy showing that all employees are exposed below the PELs, at least
with a 95 percent certainty, is compelling evidence that the exposure
limits are being achieved provided that measurements are conducted using
valid sampling strategy and approved analytical methods.
There are two PELs, the TWA concentration and the STEL. Most
employers will find that one of these two limits is more critical in the
control of their operations, and OSHA expects that the employer will
concentrate monitoring efforts on the critical component. If the more
difficult exposure is controlled, this information, along with
calculations to support the assumptions, should be adequate to show that
the other exposure limit is also being achieved.
Sampling Strategy
Determination of the Need for Exposure Measurements
The employer must determine whether employees may be exposed to
concentrations in excess of the action level. This determination becomes
the first step in an employee exposure monitoring program that minimizes
employer sampling burdens while providing adequate employee protection.
If employees may be exposed above the action level, the employer must
measure exposure. Otherwise, an objective determination that employee
exposure is low provides adequate evidence that exposure potential has
been examined.
The employer should examine all available relevant information, eg.
insurance company and trade association data and information from
suppliers or exposure data collected from similar operations. The
employer may also use previously-conducted sampling including area
monitoring. The employer must make a determination relevant to each
operation although this need not be on a separate piece of paper. If the
employer can demonstrate conclusively that no employee is exposed above
the action level or the STEL through the use of objective data, the
employer need proceed no further on employee exposure monitoring until
such time that conditions have changed and the determination is no
longer valid.
If the employer cannot determine that employee exposure is less than
the action level and the STEL, employee exposure monitoring will have to
be conducted.
Workplace Material Survey
The primary purpose of a survey of raw material is to determine if
formaldehyde is being used in the work environment and if so, the
conditions under which formaldehyde is being used.
The first step is to tabulate all situations where formaldehyde is
used in a manner such that it may be released into the workplace
atmosphere or contaminate the skin. This information should be available
through analysis of company records and information on the MSDSs
available through provisions of this standard and the Hazard
Communication standard.
If there is an indication from materials handling records and
accompanying MSDSs that formaldehyde is being used in the following
types of processes or work operations,
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there may be a potential for releasing formaldehyde into the workplace
atmosphere:
(1) Any operation that involves grinding, sanding, sawing, cutting,
crushing, screening, sieving, or any other manipulation of material that
generates formaldehyde-bearing dust
(2) Any processes where there have been employee complaints or
symptoms indicative of exposure to formaldehyde
(3) Any liquid or spray process involving formaldehyde
(4) Any process that uses formaldehyde in preserved tissue
(5) Any process that involves the heating of a formaldehyde-bearing
resin.
Processes and work operations that use formaldehyde in these manners
will probably require further investigation at the worksite to determine
the extent of employee monitoring that should be conducted.
Workplace Observations
To this point, the only intention has been to provide an indication
as to the existence of potentially exposed employees. With this
information, a visit to the workplace is needed to observe work
operations, to identify potential health hazards, and to determine
whether any employees may be exposed to hazardous concentrations of
formaldehyde.
In many circumstances, sources of formaldehyde can be identified
through the sense of smell. However, this method of detection should be
used with caution because of olfactory fatigue.
Employee location in relation to source of formaldehyde is important
in determining if an employee may be significantly exposed to
formaldehyde. In most instances, the closer a worker is to the source,
the higher the probability that a significant exposure will occur.
Other characteristics should be considered. Certain high temperature
operations give rise to higher evaporation rates. Locations of open
doors and windows provide natural ventilation that tend to dilute
formaldehyde emissions. General room ventilation also provides a measure
of control.
Calculation of Potential Exposure Concentrations
By knowing the ventilation rate in a workplace and the quantity of
formaldehyde generated, the employer may be able to determine by
calculation if the PELs might be exceeded. To account for poor mixing of
formaldehyde into the entire room, locations of fans and proximity of
employees to the work operation, the employer must include a safety
factor. If an employee is relatively close to a source, particularly if
he or she is located downwind, a safety factor of 100 may be necessary.
For other situations, a factor of 10 may be acceptable. If the employer
can demonstrate through such calculations that employee exposure does
not exceed the action level or the STEL, the employer may use this
information as objective data to demonstrate compliance with the
standard.
Sampling Strategy
Once the employer determines that there is a possibility of
substantial employee exposure to formaldehyde, the employer is obligated
to measure employee exposure.
The next step is selection of a maximum risk employee. When there
are different processes where employees may be exposed to formaldehyde,
a maximum risk employee should be selected for each work operation.
Selection of the maximum risk employee requires professional
judgment. The best procedure for selecting the maximum risk employee is
to observe employees and select the person closest to the source of
formaldehyde. Employee mobility may affect this selection; eg. if the
closest employee is mobile in his tasks, he may not be the maximum risk
employee. Air movement patterns and differences in work habits will also
affect selection of the maximum risk employee.
When many employees perform essentially the same task, a maximum
risk employee cannot be selected. In this circumstance, it is necessary
to resort to random sampling of the group of workers. The objective is
to select a subgroup of adequate size so that there is a high
probability that the random sample will contain at least one worker with
high exposure if one exists. The number of persons in the group
influences the number that need to be sampled to ensure that at least
one individual from the highest 10 percent exposure group is contained
in the sample. For example, to have 90 percent confidence in the
results, if the group size is 10, nine should be sampled; for 50, only
18 need to be sampled.
If measurement shows exposure to formaldehyde at or above the action
level or the STEL, the employer needs to identify all other employees
who may be exposed at or above the action level or STEL and measure or
otherwise accurately characterize the exposure of these employees.
Whether representative monitoring or random sampling are conducted,
the purpose remains the same--to determine if the exposure of any
employee is above the action level. If the exposure of the most exposed
employee is less than the action level and the STEL, regardless of how
the employee is identified, then it is reasonable to assume that
measurements of exposure of the other employees in that operation would
be below the action level and the STEL.
Exposure Measurements
There is no ``best'' measurement strategy for all situations. Some
elements to consider in developing a strategy are:
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(1) Availability and cost of sampling equipment
(2) Availability and cost of analytic facilities
(3) Availability and cost of personnel to take samples
(4) Location of employees and work operations
(5) Intraday and interday variations in the process
(6) Precision and accuracy of sampling and analytic methods, and
(7) Number of samples needed.
Samples taken for determining compliance with the STEL differ from
those that measure the TWA concentration in important ways. STEL samples
are best taken in a nonrandom fashion using all available knowledge
relating to the area, the individual, and the process to obtain samples
during periods of maximum expected concentrations. At least three
measurements on a shift are generally needed to spot gross errors or
mistakes; however, only the highest value represents the STEL.
If an operation remains constant throughout the workshift, a much
greater number of samples would need to be taken over the 32 discrete
nonoverlapping periods in an 8-hour workshift to verify compliance with
a STEL. If employee exposure is truly uniform throughout the workshift,
however, an employer in compliance with the l ppm TWA would be in
compliance with the 2 ppm STEL, and this determination can probably be
made using objective data.
Need to Repeat the Monitoring Strategy
Interday and intraday fluctuations in employee exposure are mostly
influenced by the physical processes that generate formaldehyde and the
work habits of the employee. Hence, in-plant process variations
influence the employer's determination of whether or not additional
controls need to be imposed. Measurements that employee exposure is low
on a day that is not representative of worst conditions may not provide
sufficient information to determine whether or not additional
engineering controls should be installed to achieve the PELs.
The person responsible for conducting sampling must be aware of
systematic changes which will negate the validity of the sampling
results. Systematic changes in formaldehyde exposure concentration for
an employee can occur due to:
(1) The employee changing patterns of movement in the workplace
(2) Closing of plant doors and windows
(3) Changes in ventilation from season to season
(4) Decreases in ventilation efficiency or abrupt failure of
engineering control equipment
(5) Changes in the production process or work habits of the
employee.
Any of these changes, if they may result in additional exposure that
reaches the next level of action (i.e. 0.5 or 1.0 ppm as an 8-hr average
or 2 ppm over 15 minutes) require the employer to perform additional
monitoring to reassess employee exposure.
A number of methods are suitable for measuring employee exposure to
formaldehyde or for characterizing emissions within the worksite. The
preamble to this standard describes some methods that have been widely
used or subjected to validation testing. A detailed analytical procedure
derived from the OSHA Method 52 for acrolein and formaldehyde is
presented below for informational purposes.
Inclusion of OSHA's method in this appendix in no way implies that
it is the only acceptable way to measure employee exposure to
formaldehyde. Other methods that are free from significant interferences
and that can determine formaldehyde at the permissible exposure limits
within 25 percent of the ``true'' value at the 95 percent
confidence level are also acceptable. Where applicable, the method
shou1d a1so be capab1e of measuring formaldehyde at the action level to
35 percent of the ``true'' value with a 95 percent
confidence level. OSHA encourages emp1oyers to choose methods that will
be best for their individual needs. The employer must exercise caution,
however, in choosing an appropriate method since some techniques suffer
from interferences that are likely to be present in workplaces of
certain industry sectors where formaldehyde is used.
OSHA's Analytical Laboratory Method
Method No: 52
Matrix: Air
Target Concentration: 1 ppm (1.2 mg/m \3\)
Procedures: Air samples are collected by drawing known volumes of air
through sampling tubes containing XAD-2 adsorbent which have been coated
with 2-(hydroxymethyl) piperidine. The samples are desorbed with toluene
and then analyzed by gas chromatography using a nitrogen selective
detector.
Recommended Sampling Rate and Air Volumes: 0.1 L/min and 24 L
Reliable Quantitation Limit:16 ppb (20 g/m\3\)
Standard Error of Estimate at the Target Concentration: 7.3%
Status of the Method: A sampling and analytical method that has been
subjected to the established evaluation procedures of the Organic
Methods Evaluation Branch.
Date: March 1985
1. General Discussion
1.1 Background: The current OSHA method for collecting acrolein
vapor recommends the use of activated 13X molecular sieves. The samples
must be stored in an ice bath during and after sampling and also they
[[Page 371]]
must be analyzed within 48 hours of collection. The current OSHA method
for collecting formaldehyde vapor recommends the use of bubblers
containing 10% methanol in water as the trapping solution.
This work was undertaken to resolve the sample stability problems
associated with acrolein and also to eliminate the need to use bubb1ers
to sample formaldehyde. A goal of this work was to develop and/or to
evaluate a common sampling and analytical procedure for acrolein and
formaldehyde.
NIOSH has developed independent methodologies for acrolein and
formaldehyde which recommend the use of reagent-coated adsorbent tubes
to collect the aldehydes as stable derivatives. The formaldehyde
sampling tubes contain Chromosorb 102 adsorbent coated with N-
benzylethanolamine (BEA) which reacts with formaldehyde vapor to form a
stable oxazolidine compound. The acrolein sampling tubes contain XAD-2
adsorbent coated with 2-(hydroxymethyl)piperidine (2-HMP) which reacts
with acrolein vapor to form a different, stable oxazolidine derivative.
Acrolein does not appear to react with BEA to give a suitable reaction
product. Therefore, the formaldehyde procedure cannot provide a common
method for both aldehydes. However, formaldehyde does react with 2-HMP
to form a very suitable reaction product. It is the quantitative
reaction of acrolein and formaldehyde with 2-HMP that provides the basis
for this evaluation.
This sampling and analytical procedure is very similar to the method
recommended by NIOSH for acrolein. Some changes in the NIOSH methodology
were necessary to permit the simultaneous determination of both
aldehydes and also to accommodate OSHA laboratory equipment and
analytical techniques.
1.2 Limit-defining parameters: The analyte air concentrations
reported in this method are based on the recommended air volume for each
analyte collected separately and a desorption volume of 1 mL. The
amounts are presented as acrolein and/or formaldehyde, even though the
derivatives are the actual species analyzed.
1.2.1 Detection limits of the analytical procedure: The detection
limit of the analytical procedure was 386 pg per injection for
formaldehyde. This was the amount of analyte which gave a peak whose
height was about five times the height of the peak given by the residual
formaldehyde derivative in a typical blank front section of the
recommended sampling tube.
1.2.2 Detection limits of the overall procedure: The detection
limits of the overall procedure were 482 ng per sample (16 ppb or 20
g/m\3\ for formaldehyde). This was the amount of analyte spiked
on the sampling device which allowed recoveries approximately equal to
the detection limit of the analytical procedure.
1.2.3 Reliable quantitation limits: The reliable quantitation limit
was 482 ng per sample (16 ppb or 20 g/m\3\) for formaldehyde.
These were the smallest amounts of analyte which could be quantitated
within the limits of a recovery of at least 75% and a precision
(1.96 SD) of 25% or better.
_______________________________________________________________________
The reliable quantitation limit and detection limits reported in the
method are based upon optimization of the instrument for the smallest
possible amount of analyte. When the target concentration of an analyte
is exceptionally higher than these limits, they may not be attainable at
the routine operating parameters.
_______________________________________________________________________
1.2.4 Sensitivity: The sensitivity of the analytical procedure over
concentration ranges representing 0.4 to 2 times the target
concentration, based on the recommended air volumes, was 7,589 area
units per g/mL for formaldehyde. This value was determined from
the slope of the calibration curve. The sensitivity may vary with the
particular instrument used in the analysis.
1.2.5 Recovery: The recovery of formaldehyde from samples used in
an 18-day storage test remained above 92% when the samples were stored
at ambient temperature. These values were determined from regression
lines which were calculated from the storage data. The recovery of the
analyte from the collection device must be at least 75% following
storage.
1.2.6 Precision (analytical method only): The pooled coefficient of
variation obtained from replicate determinations of analytical standards
over the range of 0.4 to 2 times the target concentration was 0.0052 for
formaldehyde (Section 4.3).
1.2.7 Precision (overall procedure): The precision at the 95%
confidence level for the ambient temperature storage tests was
14.3% for formaldehyde. These values each include an
additional 5% for sampling error. The overall procedure must
provide results at the target concentrations that are 25% at
the 95% confidence level.
1.2.8 Reproducibility: Samples collected from controlled test
atmospheres and a draft copy of this procedure were given to a chemist
unassociated with this evaluation. The formaldehyde samples were
analyzed following 15 days storage. The average recovery was 96.3% and
the standard deviation was 1.7%.
1.3 Advantages:
1.3.1 The sampling and analytical procedures permit the
simultaneous determination of acrolein and formaldehyde.
1.3.2 Samples are stable following storage at ambient temperature
for at least 18 days.
1.4 Disadvantages: None.
[[Page 372]]
2. Sampling Procedure
2.1 Apparatus:
2.1.1 Samples are collected by use of a personal sampling pump that
can be calibrated to within 5% of the recommended 0.1 L/min
sampling rate with the sampling tube in line.
2.1.2 Samples are collected with laboratory prepared sampling
tubes. The sampling tube is constructed of silane treated glass and is
about 8-cm long. The ID is 4 mm and the OD is 6 mm. One end of the tube
is tapered so that a glass wool end plug will hold the contents of the
tube in place during sampling. The other end of the sampling tube is
open to its full 4-mm ID to facilitate packing of the tube. Both ends of
the tube are fire-polished for safety. The tube is packed with a 75-mg
backup section, located nearest the tapered end and a 150-mg sampling
section of pretreated XAD-2 adsorbent which has been coated with 2-HMP.
The two sections of coated adsorbent are separated and retained with
small plugs of silanized glass wool. Following packing, the sampling
tubes are sealed with two \7/32\ inch OD plastic end caps. Instructions
for the pretreatment and the coating of XAD-2 adsorbent are presented in
Section 4 of this method.
2.1.3 Sampling tubes, similar to those recommended in this method,
are marketed by Supelco, Inc. These tubes were not available when this
work was initiated; therefore, they were not evaluated.
2.2 Reagents: None required.
2.3 Technique:
2.3.1 Properly label the sampling tube before sampling and then
remove the plastic end caps.
2.3.2 Attach the sampling tube to the pump using a section of
flexible plastic tubing such that the large, front section of the
sampling tube is exposed directly to the atmosphere. Do not place any
tubing ahead of the sampling tube. The sampling tube should be attached
in the worker's breathing zone in a vertical manner such that it does
not impede work performance.
2.3.3 After sampling for the appropriate time, remove the sampling
tube from the pump and then seal the tube with plastic end caps.
2.3.4 Include at least one blank for each sampling set. The blank
should be handled in the same manner as the samples with the exception
that air is not drawn through it.
2.3.5 List any potential interferences on the sample data sheet.
2.4 Breakthrough:
2.4.1 Breakthrough was defined as the relative amount of analyte
found on a backup sample in relation to the total amount of analyte
collected on the sampling train.
2.4.2 For formaldehyde collected from test atmospheres containing 6
times the PEL, the average 5% breakthrough air volume was 41 L. The
sampling rate was 0.1 L/min and the average mass of formaldehyde
collected was 250 g.
2.5 Desorption Efficiency: No desorption efficiency corrections are
necessary to compute air sample results because analytical standards are
prepared using coated adsorbent. Desorption efficiencies were
determined, however, to investigate the recoveries of the analytes from
the sampling device. The average recovery over the range of 0.4 to 2
times the target concentration, based on the recommended air volumes,
was 96.2% for formaldehyde. Desorption efficiencies were essentially
constant over the ranges studied.
2.6 Recommended Air Volume and Sampling Rate:
2.6.1 The recommended air volume for formaldehyde is 24 L.
2.6.2 The recommended sampling rate is 0.1 L/min.
2.7 Interferences:
2.7.1 Any collected substance that is capable of reacting 2-HMP and
thereby depleting the derivatizing agent is a potential interference.
Chemicals which contain a carbonyl group, such as acetone, may be
capable or reacting with 2-HMP.
2.7.2 There are no other known interferences to the sampling
method.
2.8 Safety Precautions:
2.8.1 Attach the sampling equipment to the worker in such a manner
that it well not interfere with work performance or safety.
2.8.2 Follow all safety practices that apply to the work area being
sampled.
3. Analytical Procedure
3.1 Apparatus:
3.1.1 A gas chromatograph (GC), equipped with a nitrogen selective
detector. A Hewlett-Packard Model 5840A GC fitted with a nitrogen-
phosphorus flame ionization detector (NPD) was used for this evaluation.
Injections were performed using a Hewlett-Packard Model 7671A automatic
sampler.
3.1.2 A GC column capable of resolving the analytes from any
interference. A 6 ft x \1/4\ in OD (2mm ID) glass GC column containing
10% UCON 50-HB-5100 + 2% KOH on 80/100 mesh Chromosorb W-AW was used for
the evaluation. Injections were performed on-column.
3.1.3 Vials, glass 2-mL with Teflon-lined caps.
3.1.4 Volumetric flasks, pipets, and syringes for preparing
standards, making dilutions, and performing injections.
3.2 Reagents:
3.2.1 Toluene and dimethylformamide. Burdick and Jackson solvents
were used in this evaluation.
3.2.2 Helium, hydrogen, and air, GC grade.
3.2.3 Formaldehyde, 37%, by weight, in water. Aldrich Chemical, ACS
Reagent Grade formaldehyde was used in this evaluation.
[[Page 373]]
3.2.4 Amberlite XAD-2 adsorbent coated with 2-(hydroxymethyl--
piperidine (2-HMP), 10% by weight (Section 4).
3.2.5 Desorbing solution with internal standard. This solution was
prepared by adding 20 L of dimethylformamide to 100 mL of
toluene.
3.3 Standard preparation:
3.3.1 Formaldehyde: Prepare stock standards by diluting known
volumes of 37% formaldehyde solution with methanol. A procedure to
determine the formaldehyde content of these standards is presented in
Section 4. A standard containing 7.7 mg/mL formaldehyde was prepared by
diluting 1 mL of the 37% reagent to 50 mL with methanol.
3.3.2 It is recommended that analytical standards be prepared about
16 hours before the air samples are to be analyzed in order to ensure
the complete reaction of the analytes with 2-HMP. However, rate studies
have shown the reaction to be greater than 95% complete after 4 hours.
Therefore, one or two standards can be analyzed after this reduced time
if sample results are outside the concentration range of the prepared
standards.
3.3.3 Place 150-mg portions of coated XAD-2 adsorbent, from the
same lot number as used to collect the air samples, into each of several
glass 2-mL vials. Seal each vial with a Teflon-lined cap.
3.3.4 Prepare fresh analytical standards each day by injecting
appropriate amounts of the diluted analyte directly onto 150-mg portions
of coated adsorbent. It is permissible to inject both acrolein and
formaldehyde on the same adsorbent portion. Allow the standards to stand
at room temperature. A standard, approximately the target levels, was
prepared by injecting 11 L of the acrolein and 12 L of
the formaldehyde stock standards onto a single coated XAD-2 adsorbent
portion.
3.3.5 Prepare a sufficient number of standards to generate the
calibration curves. Analytical standard concentrations should bracket
sample concentrations. Thus, if samples are not in the concentration
range of the prepared standards, additional standards must be prepared
to determine detector response.
3.3.7 Desorb the standards in the same manner as the samples
following the 16-hour reaction time.
3.4 Sample preparation:
3.4.1 Transfer the 150-mg section of the sampling tube to a 2-mL
vial. Place the 75-mg section in a separate vial. If the glass wool
plugs contain a significant number of adsorbent beads, place them with
the appropriate sampling tube section. Discard the glass wool plugs if
they do not contain a significant number of adsorbent beads.
3.4.2 Add 1 mL of desorbing solution to each vial.
3.4.3 Seal the vials with Teflon-lined caps and then allow them to
desorb for one hour. Shake the vials by hand with vigorous force several
times during the desorption time.
3.4.4 Save the used sampling tubes to be cleaned and recycled.
3.5 Analysis:
3.5.1 GC Conditions
Column Temperature:
Bi-level temperature program--First level: 100 to 140 deg.C at 4
deg.C/min following completion of the first level.
Second level: 140 to 180 deg.C at 20 deg.C/min following completion of
the first level.
Isothermal period: Hold column at 180 deg.C until the recorder pen
returns to baseline (usually about 25 min after injection).
Injector temperature: 180 deg.C
Helium flow rate: 30 mL/min (detector response will be reduced if
nitrogen is substituted for helium carrier gas).
Injection volume: 0.8 L
GC column: Six-ft x \1/4\-in OD (2 mm ID) glass GC column containing
10% UCON 50-HB-5100+2% KOH on 80/100 Chromosorb W-AW.
NPD conditions:
Hydrogen flow rate: 3 mL/min
Air flow rate: 50 mL/min
Detector temperature: 275 deg.C
3.5.2 Chromatogram: For an example of a typical chromatogram, see
Figure 4.11 in OSHA Method 52.
3.5.3 Use a suitable method, such as electronic integration, to
measure detector response.
3.5.4 Use an internal standard method to prepare the calibration
curve with several standard solutions of different concentrations.
Prepare the calibration curve daily. Program the integrator to report
results in g/mL.
3.5.5 Bracket sample concentrations with standards.
3.6 Interferences (Analytical)
3.6.1 Any compound with the same general retention time as the
analytes and which also gives a detector response is a potential
interference. Possible interferences should be reported to the
laboratory with submitted samples by the industrial hygienist.
3.6.2 GC parameters (temperature, column, etc.) may be changed to
circumvent interferences.
3.6.3 A useful means of structure designation is GC/MS. It is
recommended this procedure be used to confirm samples whenever possible.
3.6.4 The coated adsorbent usually contains a very small amount of
residual formaldehyde derivative (Section 4.8).
3.7 Calculations:
3.7.1 Results are obtained by use of calibration curves.
Calibration curves are prepared by plotting detector response against
concentration for each standard. The best line through the data points
is determined by curve fitting.
[[Page 374]]
3.7.2 The concentration, in g/mL, for a particular sample
is determined by comparing its detector response to the calibration
curve. If either of the analytes is found on the backup section, it is
added to the amount found on the front section. Blank corrections should
be performed before adding the results together.
3.7.3 The acrolein and/or formaldehyde air concentration can be
expressed using the following equation:
mg/m3=(A)(B)/C
where A=g/mL from 3.7.2, B=desorption volume, and C=L of air
sampled.
No desorption efficiency corrections are required.
3.7.4 The following equation can be used to convert results in mg/
m3 to ppm.
ppm=(mg/m3)(24.45)/MW
where mg/m3=result from 3.7.3, 24.45=molar volume of an ideal
gas at 760 mm Hg and 25 deg.C, MW=molecular weight (30.0).
4. Backup Data
4.1 Backup data on detection limits, reliable quantitation limits,
sensitivity and precision of the analytical method, breakthrough,
desorption efficiency, storage, reproducibility, and generation of test
atmospheres are available in OSHA Method 52, developed by the Organics
Methods Evaluation Branch, OSHA Analytical Laboratory, Salt Lake City,
Utah.
4.2 Procedure to Coat XAD-2 Adsorbent with 2-HMP:
4.2.1 Apparatus: Soxhlet extraction apparatus, rotary evaporation
apparatus, vacuum dessicator, 1-L vacuum flask, 1-L round-bottomed
evaporative flask, 1-L Erlenmeyer flask, 250-mL Buchner funnel with a
coarse fritted disc, etc.
4.2.2 Reagents:
4.2.2.1 Methanol, isooctane, and toluene.
4.2.2.2 2-(Hydroxymethyl)piperidine.
4.2.2.3 Amberlite XAD-2 non-ionic polymeric adsorbent, 20 to 60
mesh, Aldrich Chemical XAD-2 was used in this evaluation.
4.2.3 Procedure: Weigh 125 g of crude XAD-2 adsorbent into a 1-L
Erlenmeyer flask. Add about 200 mL of water to the flask and then swirl
the mixture to wash the adsorbent. Discard any adsorbent that floats to
the top of the water and then filter the mixture using a fritted Buchner
funnel. Air dry the adsorbent for 2 minutes. Transfer the adsorbent back
to the Erlenmeyer flask and then add about 200 mL of methanol to the
flask. Swirl and then filter the mixture as before. Transfer the washed
adsorbent back to the Erlenmeyer flask and then add about 200 mL of
methanol to the flask. Swirl and then filter the mixture as before.
Transfer the washed adsorbent to a 1-L round-bottomed evaporative flask,
add 13 g of 2-HMP and then 200 mL of methanol, swirl the mixture and
then allow it to stand for one hour. Remove the methanol at about 40
deg.C and reduced pressure using a rotary evaporation apparatus.
Transfer the coated adsorbent to a suitable container and store it in a
vacuum desiccator at room temperature overnight. Transfer the coated
adsorbent to a Soxhlet extractor and then extract the material with
toluene for about 24 hours. Discard the contaminated toluene, add
methanol in its place and then continue the Soxhlet extraction for an
additional 4 hours. Transfer the adsorbent to a weighted 1-L round-
bottom evaporative flask and remove the methanol using the rotary
evaporation apparatus. Determine the weight of the adsorbent and then
add an amount of 2-HMP, which is 10% by weight of the adsorbent. Add 200
mL of methanol and then swirl the mixture. Allow the mixture to stand
for one hour. Remove the methanol by rotary evaporation. Transfer the
coated adsorbent to a suitable container and store it in a vacuum
desiccator until all traces of solvents are gone. Typically, this will
take 2-3 days. The coated adsorbent should be protected from
contamination. XAD-2 adsorbent treated in this manner will probably not
contain residual acrolein derivative. However, this adsorbent will often
contain residual formaldehyde derivative levels of about 0.1 g
per 150 mg of adsorbent. If the blank values for a batch of coated
adsorbent are too high, then the batch should be returned to the Soxhlet
extractor, extracted with toluene again and then recoated. This process
can be repeated until the desired blank levels are attained.
The coated adsorbent is now ready to be packed into sampling tubes.
The sampling tubes should be stored in a sealed container to prevent
contamination. Sampling tubes should be stored in the dark at room
temperature. The sampling tubes should be segregated by coated adsorbent
lot number. A sufficient amount of each lot number of coated adsorbent
should be retained to prepare analytical standards for use with air
samples from that lot number.
4.3 A Procedure to Determine Formaldehyde by Acid Titration:
Standardize the 0.1 N HCl solution using sodium carbonate and methyl
orange indicator.
Place 50 mL of 0.1 M sodium sulfite and three drops of
thymophthalein indicator into a 250-mL Erlenmeyer flask. Titrate the
contents of the flask to a colorless endpoint with 0.1 N HCl (usually
one or two drops is sufficient). Transfer 10 mL of the formaldehyde/
methanol solution (prepared in 3.3.1) into the same flask and titrate
the mixture with 0.1 N HCl, again, to a colorless endpoint. The
formaldehyde concentration of the standard may be calculated by the
following equation:
[[Page 375]]
[GRAPHIC] [TIFF OMITTED] TC15NO91.041
This method is based on the quantitative liberation of sodium
hydroxide when formaldehyde reacts with sodium sulfite to form the
formaldehyde-bisulfite addition product. The volume of sample may be
varied depending on the formaldehyde content but the solution to be
titrated must contain excess sodium sulfite. Formaldehyde solutions
containing substantial amounts of acid or base must be neutralized
before analysis.
Appendix C to Sec. 1910.1048--Medical Surveillance--Formaldehyde
I. Health Hazards
The occupational health hazards of formaldehyde are primarily due to
its toxic effects after inhalation, after direct contact with the skin
or eyes by formaldehyde in liquid or vapor form, and after ingestion.
II. Toxicology
A. Acute Effects of Exposure
1. Inhalation (breathing): Formaldehyde is highly irritating to the
upper airways. The concentration of formaldehyde that is immediately
dangerous to life and health is 100 ppm. Concentrations above 50 ppm can
cause severe pulmonary reactions within minutes. These include pulmonary
edema, pneumonia, and bronchial irritation which can result in death.
Concentrations above 5 ppm readily cause lower airway irritation
characterized by cough, chest tightness and wheezing. There is some
controversy regarding whether formaldehyde gas is a pulmonary sensitizer
which can cause occupational asthma in a previously normal individual.
Formaldehyde can produce symptoms of bronchial asthma in humans. The
mechanism may be either sensitization of the individual by exposure to
formaldehyde or direct irritation by formaldehyde in persons with pre-
existing asthma. Upper airway irritation is the most common respiratory
effect reported by workers and can occur over a wide range of
concentrations, most frequently above 1 ppm. However, airway irritation
has occurred in some workers with exposures to formaldehyde as low as
0.1 ppm. Symptoms of upper airway irritation include dry or sore throat,
itching and burning sensations of the nose, and nasal congestion.
Tolerance to this level of exposure may develop within 1-2 hours. This
tolerance can permit workers remaining in an environment of gradually
increasing formaldehyde concentrations to be unaware of their
increasingly hazardous exposure.
2. Eye contact: Concentrations of formaldehyde between 0.05 ppm and
0.5 ppm produce a sensation of irritation in the eyes with burning,
itching, redness, and tearing. Increased rate of blinking and eye
closure generally protects the eye from damage at these low levels, but
these protective mechanisms may interfere with some workers' work
abilities. Tolerance can occur in workers continuously exposed to
concentrations of formaldehyde in this range. Accidental splash injuries
of human eyes to aqueous solutions of formaldehyde (formalin) have
resulted in a wide range of ocular injuries including corneal opacities
and blindness. The severity of the reactions have been directly
dependent on the concentration of formaldehyde in solution and the
amount of time lapsed before emergency and medical intervention.
3. Skin contact: Exposure to formaldehyde solutions can cause
irritation of the skin and allergic contact dermatitis. These skin
diseases and disorders can occur at levels well below those encountered
by many formaldehyde workers. Symptoms include erythema, edema, and
vesiculation or hives. Exposure to liquid formalin or formaldehyde vapor
can provoke skin reactions in sensitized individuals even when airborne
concentrations of formaldehyde are well below 1 ppm.
4. Ingestion: Ingestion of as little as 30 ml of a 37 percent
solution of formaldehyde (formalin) can result in death.
Gastrointestinal toxicity after ingestion is most severe in the stomach
and results in symptoms which can include nausea, vomiting, and servere
abdominal pain. Diverse damage to other organ systems including the
liver, kidney, spleen, pancreas, brain, and central nervous systems can
occur from the acute response to ingestion of formaldehyde.
B. Chronic Effects of Exposure
Long term exposure to formaldehyde has been shown to be associated
with an increased risk of cancer of the nose and accessory sinuses,
nasopharyngeal and oropharyngeal cancer, and lung cancer in humans.
Animal experiments provide conclusive evidence of a causal relationship
between nasal cancer in rats and formaldehyde exposure. Concordant
evidence of carcinogenicity includes DNA binding, genotoxicity in short-
term tests, and cytotoxic changes in the cells of the target organ
suggesting both preneoplastic changes and a dose-rate effect.
Formaldehyde is a complete carcinogen and appears to exert an effect on
at least two stages of the carcinogenic process.
[[Page 376]]
III. Surveillance considerations
A. History
1. Medical and occupational history: Along with its acute irritative
effects, formaldehyde can cause allergic sensitization and cancer. One
of the goals of the work history should be to elicit information on any
prior or additional exposure to formaldehyde in either the occupational
or the non-occupational setting.
2. Respiratory history: As noted above, formaldehyde has recognized
properties as an airway irritant and has been reported by some authors
as a cause of occupational asthma. In addition, formaldehyde has been
associated with cancer of the entire respiratory system of humans. For
these reasons, it is appropriate to include a comprehensive review of
the respiratory system in the medical history. Components of this
history might include questions regarding dyspnea on exertion, shortness
of breath, chronic airway complaints, hyperreactive airway disease,
rhinitis, bronchitis, bronchiolitis, asthma, emphysema, respiratory
allergic reaction, or other preexisting pulmonary disease.
In addition, generalized airway hypersensitivity can result from
exposures to a single sensitizing agent. The examiner should, therefore,
elicit any prior history of exposure to pulmonary irritants, and any
short- or long-term effects of that exposure.
Smoking is known to decrease mucociliary clearance of materials
deposited during respiration in the nose and upper airways. This may
increase a worker's exposure to inhaled materials such as formaldehyde
vapor. In addition, smoking is a potential confounding factor in the
investigation of any chronic respiratory disease, including cancer. For
these reasons, a complete smoking history should be obtained.
3. Skin Disorders: Because of the dermal irritant and sensitizing
effects of formaldehyde, a history of skin disorders should be obtained.
Such a history might include the existence of skin irritation,
previously documented skin sensitivity, and other dermatologic
disorders. Previous exposure to formaldehyde and other dermal
sensitizers should be recorded.
4. History of atopic or allergic diseases: Since formaldehyde can
cause allergic sensitization of the skin and airways, it might be useful
to identify individuals with prior allergen sensitization. A history of
atopic disease and allergies to formaldehyde or any other substances
should also be obtained. It is not definitely known at this time whether
atopic diseases and allergies to formaldehyde or any other substances
should also be obtained. Also it is not definitely known at this time
whether atopic individuals have a greater propensity to develop
formaldehyde sensitivity than the general population, but identification
of these individuals may be useful for ongoing surveillance.
5. Use of disease questionnaires: Comparison of the results from
previous years with present results provides the best method for
detecting a general deterioration in health when toxic signs and
symptoms are measured subjectively. In this way recall bias does not
affect the results of the analysis. Consequently, OSHA has determined
that the findings of the medical and work histories should be kept in a
standardized form for comparison of the year-to-year results.
B. Physical Examination
1. Mucosa of eyes and airways: Because of the irritant effects of
formaldehyde, the examining physician should be alert to evidence of
this irritation. A speculum examination of the nasal mucosa may be
helpful in assessing possible irritation and cytotoxic changes, as may
be indirect inspection of the posterior pharynx by mirror.
2. Pulmonary system: A conventional respiratory examination,
including inspection of the thorax and auscultation and percussion of
the lung fields should be performed as part of the periodic medical
examination. Although routine pulmonary function testing is only
required by the standard once every year for persons who are exposed
over the TWA concentration limit, these tests have an obvious value in
investigating possible respiratory dysfunction and should be used
wherever deemed appropriate by the physician. In cases of alleged
formaldehyde-induced airway disease, other possible causes of pulmonary
disfunction (including exposures to other substances) should be ruled
out. A chest radiograph may be useful in these circumstances. In cases
of suspected airway hypersensitivity or allergy, it may be appropriate
to use bronchial challenge testing with formaldehyde or methacholine to
determine the nature of the disorder. Such testing should be performed
by or under the supervision of a physician experienced in the procedures
involved.
3. Skin: The physician should be alert to evidence of dermal
irritation of sensitization, including reddening and inflammation,
urticaria, blistering, scaling, formation of skin fissures, or other
symptoms. Since the integrity of the skin barrier is compromised by
other dermal diseases, the presence of such disease should be noted.
Skin sensitivity testing carries with it some risk of inducing
sensitivity, and therefore, skin testing for formaldehyde sensitivity
should not be used as a routine screening test. Sensitivity testing may
be indicated in the investigation of a suspected existing sensitivity.
Guidelines for such testing have been prepared by the North American
Contact Dermatitis Group.
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C. Additional Examinations or Tests
The physician may deem it necessary to perform other medical
examinations or tests as indicated. The standard provides a mechanism
whereby these additional investigations are covered under the standard
for occupational exposure to formaldehyde.
D. Emergencies
The examination of workers exposed in an emergency should be
directed at the organ systems most likely to be affected. Much of the
content of the examination will be similar to the periodic examination
unless the patient has received a severe acute exposure requiring
immediate attention to prevent serious consequences. If a severe
overexposure requiring medical intervention or hospitalization has
occurred, the physician must be alert to the possibility of delayed
symptoms. Followup nonroutine examinations may be necessary to assure
the patient's well-being.
E. Employer Obligations
The employer is required to provide the physician with the following
information: A copy of this standard and appendices A, C, D, and E; a
description of the affected employee's duties as they relate to his or
her exposure concentration; an estimate of the employee's exposure
including duration (e.g. 15 hr/wk, three 8-hour shifts, full-time); a
description of any personal protective equipment, including respirators,
used by the employee; and the results of any previous medical
determinations for the affected employee related to formaldehyde
exposure to the extent that this information is within the employer's
control.
F. Physician's Obligations
The standard requires the employer to obtain a written statement
from the physician. This statement must contain the physician's opinion
as to whether the employee has any medical condition which would place
him or her at increased risk of impaired health from exposure to
formaldehyde or use of respirators, as appropriate. The physician must
also state his opinion regarding any restrictions that should be placed
on the employee's exposure to formaldehyde or upon the use of protective
clothing or equipment such as respirators. If the employee wears a
respirator as a result of his or her exposure to formaldehyde, the
physician's opinion must also contain a statement regarding the
suitability of the employee to wear the type of respirator assigned.
Finally, the physician must inform the employer that the employee has
been told the results of the medical examination and of any medical
conditions which require further explanation or treatment. This written
opinion is not to contain any information on specific findings or
diagnoses unrelated to occupational exposure to formaldehyde.
The purpose in requiring the examining physician to supply the
employer with a written opinion is to provide the employer with a
medical basis to assist the employer in placing employees initially, in
assuring that their health is not being inpaired by formaldehyde, and to
assess the employee's ability to use any required protective equipment.
Appendix D to Sec. 1910.1048--Nonmandatory Medical Disease Questionnaire
A. Identification
Plant Name______________________________________________________________
Date____________________________________________________________________
Employee Name___________________________________________________________
S.S. __________________________________________________________________
Job Title_______________________________________________________________
Birthdate:______________________________________________________________
Age:____________________________________________________________________
Sex:____________________________________________________________________
Height:_________________________________________________________________
Weight:_________________________________________________________________
B. Medical History
1. Have you ever been in the hospital as a patient?
Yes {time} No {time}
If yes, what kind of problem were you having?___________________________
_______________________________________________________________________
2. Have you ever had any kind of operation?
Yes {time} No {time}
If yes, what kind?______________________________________________________
_______________________________________________________________________
3. Do you take any kind of medicine regularly?
Yes {time} No {time}
If yes, what kind?______________________________________________________
_______________________________________________________________________
4. Are you allergic to any drugs, foods, or chemicals?
Yes {time} No {time}
If yes, what kind of allergy is it?_____________________________________
_______________________________________________________________________
What causes the allergy?________________________________________________
_______________________________________________________________________
5. Have you ever been told that you have asthma, hayfever, or sinusitis?
Yes {time} No {time}
6. Have you ever been told that you have emphysema, bronchitis, or any
other respiratory problems?
Yes {time} No {time}
7. Have you ever been told you had hepatitis?
Yes {time} No {time}
8. Have you ever been told that you had cirrhosis?
Yes {time} No {time}
[[Page 378]]
9. Have you ever been told that you had cancer?
Yes {time} No {time}
10. Have you ever had arthritis or joint pain?
Yes {time} No {time}
11. Have you ever been told that you had high blood pressure?
Yes {time} No {time}
12. Have you ever had a heart attack or heart trouble?
Yes {time} No {time}
B-1. Medical History Update
1. Have you been in the hospital as a patient any time within the past
year?
Yes {time} No {time}
If so, for what condition?______________________________________________
_______________________________________________________________________
2. Have you been under the care of a physician during the past year?
Yes {time} No {time}
If so, for what condition?______________________________________________
_______________________________________________________________________
3. Is there any change in your breathing since last year?
Yes {time} No {time}
Better?_________________________________________________________________
Worse?__________________________________________________________________
No change?______________________________________________________________
If change, do you know why?_____________________________________________
_______________________________________________________________________
4. Is your general health different this year from last year?
Yes {time} No {time}
If different, in what way?______________________________________________
_______________________________________________________________________
5. Have you in the past year or are you now taking any medication on a
regular basis?
Yes {time} No {time}
Name Rx_________________________________________________________________
Condition being treated_________________________________________________
C. Occupational History
1. How long have you worked for your present employer?
_______________________________________________________________________
2. What jobs have you held with this employer? Include job title and
length of time in each job.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. In each of these jobs, how many hours a day were you exposed to
chemicals?
_______________________________________________________________________
4. What chemicals have you worked with most of the time?
_______________________________________________________________________
5. Have you ever noticed any type of skin rash you feel was related to
your work?
Yes {time} No {time}
6. Have you ever noticed that any kind of chemical makes you cough?
Yes {time} No {time} angle
Wheeze?
Yes {time} No {time}
Become short of breath or cause your chest to become tight?
Yes {time} No {time}
7. Are you exposed to any dust or chemicals at home?
Yes {time} No {time}
If yes, explain:________________________________________________________
_______________________________________________________________________
8. In other jobs, have you ever had exposure to:
Wood dust?
Yes {time} No {time}
Nickel or chromium?
Yes {time} No {time}
Silica (foundry, sand blasting)?
Yes {time} No {time}
Arsenic or asbestos?
Yes {time} No {time}
Organic solvents?
Yes {time} No {time}
Urethane foams?
Yes {time} No {time}
C-1. Occupational History Update
1. Are you working on the same job this year as you were last year?
Yes {time} No {time}
If not, how has your job changed?_______________________________________
_______________________________________________________________________
2. What chemicals are you exposed to on your job?
_______________________________________________________________________
3. How many hours a day are you exposed to chemicals?
_______________________________________________________________________
4. Have you noticed any skin rash within the past year you feel was
related to your work?
Yes {time} No {time}
If so, explain circumstances: __________________________________________
_______________________________________________________________________
5. Have you noticed that any chemical makes you cough, be short of
breath, or wheeze?
Yes {time} No {time}
If so, can you identify it?_____________________________________________
_______________________________________________________________________
D. Miscellaneous
1. Do you smoke?
Yes {time} No {time}
If so, how much and for how long?_______________________________________
_______________________________________________________________________
Pipe____________________________________________________________________
Cigars__________________________________________________________________
Cigarettes______________________________________________________________
2. Do you drink alcohol in any form?
Yes {time} No {time}
If so, how much, how long, and how often? _______________________
_______________________________________________________________________
3. Do you wear glasses or contact lenses?
Yes {time} No {time}
4. Do you get any physical exercise other than that required to do your
job?
[[Page 379]]
Yes {time} No {time}
If so, explain:_________________________________________________________
_______________________________________________________________________
5. Do you have any hobbies or ``side jobs'' that require you to use
chemicals, such as furniture stripping, sand blasting,
insulation or manufacture of urethane foam, furniture, etc?
Yes {time} No {time}
If so, please describe, giving type of business or hobby, chemicals used
and length of exposures.
_______________________________________________________________________
E. Symptoms Questionnaire
1. Do you ever have any shortness of breath?
Yes {time} No {time}
If yes, do you have to rest after climbing several flights of stairs?
Yes {time} No {time}
If yes, if you walk on the level with people your own age, do you walk
slower than they do?
Yes {time} No {time}
If yes, if you walk slower than a normal pace, do you have to limit the
distance that you walk?
Yes {time} No {time}
If yes, do you have to stop and rest while bathing or dressing?
Yes {time} No {time}
2. Do you cough as much as three months out of the year?
Yes {time} No {time}
If yes, have you had this cough for more than two years?
Yes {time} No {time}
If yes, do you ever cough anything up from chest?
Yes {time} No {time}
3. Do you ever have a feeling of smothering, unable to take a deep
breath, or tightness in your chest?
Yes {time} No {time}
If yes, do you notice that this on any particular day of the week?
Yes {time} No {time}
If yes, what day or the week?
Yes {time} No {time}
If yes, do you notice that this occurs at any particular place?
Yes {time} No {time}
If yes, do you notice that this is worse after you have returned to work
after being off for several days?
Yes {time} No {time}
4. Have you ever noticed any wheezing in your chest?
Yes {time} No {time}
If yes, is this only with colds or other infections?
Yes {time} No {time}
Is this caused by exposure to any kind of dust or other material?
Yes {time} No {time}
If yes, what kind?______________________________________________________
5. Have you noticed any burning, tearing, or redness of your eyes when
you are at work?
Yes {time} No {time}
If so, explain circumstances:___________________________________________
_______________________________________________________________________
6. Have you noticed any sore or burning throat or itchy or burning nose
when you are at work?
Yes {time} No {time}
If so, explain circumstances: __________________________________________
_______________________________________________________________________
7. Have you noticed any stuffiness or dryness of your nose?
Yes {time} No {time}
8. Do you ever have swelling of the eyelids or face?
Yes {time} No {time}
9. Have you ever been jaundiced?
Yes {time} No {time}
If yes, was this accompanied by any pain?
Yes {time} No {time}
10. Have you ever had a tendency to bruise easily or bleed excessively?
Yes {time} No {time}
11. Do you have frequent headaches that are not relieved by aspirin or
tylenol?
Yes {time} No {time}
If yes, do they occur at any particular time of the day or week?
Yes {time} No {time}
If yes, when do they occur?_____________________________________________
_______________________________________________________________________
12. Do you have frequent episodes of nervousness or irritability?
Yes {time} No {time}
13. Do you tend to have trouble concentrating or remembering?
Yes {time} No {time}
14. Do you ever feel dizzy, light-headed, excessively drowsy or like you
have been drugged?
Yes {time} No {time}
15. Does your vision ever become blurred?
Yes {time} No {time}
16. Do you have numbness or tingling of the hands or feet or other parts
of your body?
Yes {time} No {time}
17. Have you ever had chronic weakness or fatigue?
Yes {time} No {time}
18. Have you ever had any swelling of your feet or ankles to the point
where you could not wear your shoes?
Yes {time} No {time}
19. Are you bothered by heartburn or indigestion?
Yes {time} No {time}
20. Do you ever have itching, dryness, or peeling and scaling of the
hands?
Yes {time} No {time}
21. Do you ever have a burning sensation in the hands, or reddening of
the skin?
Yes {time} No {time}
22. Do you ever have cracking or bleeding of the skin on your hands?
Yes {time} No {time}
[[Page 380]]
23. Are you under a physician's care?
Yes {time} No {time}
If yes, for what are you being treated?_________________________________
_______________________________________________________________________
24. Do you have any physical complaints today?
Yes {time} No {time}
If yes, explain?________________________________________________________
_______________________________________________________________________
25. Do you have other health conditions not covered by these questions?
Yes {time} No {time}
If yes, explain:________________________________________________________
_______________________________________________________________________
[57 FR 22310, May 27, 1992; 57 FR 27161, June 18, 1992; 61 FR 5508, Feb.
13, 1996; 63 FR 1292, Jan. 8, 1998; 63 FR 20099, Apr. 23, 1998]