Efforts of the Department of Health, Education, and Welfare and the Department of Labor to Develop and Issue Health Standards

Published by the Government Accountability Office on 1977-04-27.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                          DCCUHEIT BRESUM
61950   [A1192177]
[Efforts of the Department of Health, Education, and Welfare and
the Department of Lakor to Develop and Issue Health Standards].
April 27, 1977. 22 pp.
Testimony before the House Coamittee on Government Operations:
Manpower and Housing Subcommittee; by Gregory J.  hart,
Director, Human Resources and Development Div.
Issue Area: Consumer and Wcrker Protection: Standards and
    Regulations Adequacy and Timeliness (902).
contact: Human Resources and Develcpment Div.
Budget unction: Health: Prevention and Control of Health
    Problems (553).
organizaticn Concerned: Department of Health, Education, and
     elfare- Department of Labor.
Cvngressional Relevance: House Committee on Government
    Operations: Hanjouer and Housing Subcommittee.
authority: Occupational Safety and Health Act of 1970.
          Occupational health standards are intended to prevent
illness from exposure to toxic substances and harmful physical
agents. lthough workers are exposed to thousands of toxic
substances, hundreds of which say cause cancer, standards have
been established for only 15 substances as of September 30,
1976. The Secretaries of Labor and BHE should estimate, based on
the best available data, the total needs for health standards
and how long it   ill take to complete then with existing fundiag
levels. They should also determine whether and to what extent
additional funds can be used effectively to speed up standards
development and to incre.se efforts to inform, educate, and
train employers and employees concerning toxic substances. If
additional funds can be used more effectively, the Secretary of
Labor should allocate more funds to health standards development
and health information, education, and training activities. The
Secretary of BBE should require that decisions on how such
effort to devote to standards development, as opposed to other
National Institute for Occupational Safety and Health worker
protection programs, be based partly on the ability of the
Occupational Safety and Health Administration to act promptly on
recommended standards. (SC)
        Washington, D.C. 20548

                   FOR RELEASE ON DELIVERY
                   Expected at 9:30 AM EST
                   Wednesday, April 27, 1977
                   Rayburn Building

             STATEMENT OF



              BEFORE TEE



     Madam Chairwoman and members of the Subcommittee,
I am pleased to appear here today to discuss the results

of our review of the efforts of the Department of Labor

and the Department of Health, Education, and Welfare
(HEW) to develop and issue health standards   nder the
Occupational Safety and Health Act of 1970.

     The Congress passed the 1970 act to assure, so far

as possible, safe and healthful working condition   .or

every wrker in the Nation.
     The act authorizes the Secretary of Labor to

establish national occupational sa£fty and health

standards, promote safety and health through employer
and tiployee information and education programs,

and enforce compliance with standards through workplace
inspections with citations and penalties for violations.

The Secretary delegated these responsibilities

to the Occupational Safety and Health Administration

(OSHA) which was created on April 28, 1971.

                       -     -
    The 1970 act created the National Institute for
>'cupational Safety and Health (NIOSH) in HEW to do
occupational safety and health research and related work.

Although NIOSH cannot set standards under the act, one of

its main responsibilities is to provide OSHA with
recommended new or revised standards and scientific
information and criteria for standards.

     Occupational safety standards are to prevent injuries
from mechanical, fire, electrical, nousekeeping, and

other safety hazards.   Occupational health standards are

to prevent illnesses from exposure to toxic substances
and harmful physical agents.    Health standards may

require limits on the amount of dust, fumes, or

particulates from a substance that can be in the air

in the workplace.   Health standards may also require

employers to provide such other measures as protective

clothing, warning labels, and medical examinations.
     Because of the critical need for health standards,
we reviewed health standards development under the act.

                        - 2 -

        It is not known how many of the Nation's estimated
80 million workers are exposed to toxic substances and

other health hazards in their workplaces.     According

to several sources, about 2 million chemical compounds
exist today; information on toxicity may be available for

100,000; about     3,000 known toxic chemicals are commonly

used; and about 500 new substances are introduced each
year.     In 1975, NIOSH published a list identifying

about 1,500 substances as suspected carcinogens, or
cancer-causing agents.

        The Public Health Service estimates that each
year 390,000 new cases of occupational disease appear

and 100,000 workers die from occupational disease.

        Although workers are exposed to thousands of toxic
substances, hundreds of which may cause cancer, standards

had been promulgated under the 1970 act for only 15

substances as of September 30, 1976.     Unless the rate
improves, it will take more than a century to establish
needed standards for substances already identified as

                          - 3 -
hazards.   The problem is   compounded because new

substances, which may warrant standards, are being
introduced faster than standards are being established

on existing substances.     Thus, the bleak occupational

safety and health conditions which the Congress sought
to improve still exist, and may be getting worse.

     The 1970 act became effective in April 1971.

In May 1971 OSHA, as authorized in the act, adopted
standards that had been established under the

Walsh-Healy Act and other Federal laws, and certain

standards that had been developed by consensus groups.
These included exposure limits for about 400 toxic
substances or groups of substances.     It has been

recognized that many of these standards, which consist
solely of exposure limits, need revising       update the

exposure limits and to include work practices, employee

medical examinations, and other measures to help
protect workers.

     NIOSH's recommendations to OSHA for health standards
usually are included in "criteria documents."        These

documents contain scientific data on the effects of
exposure, and other supporting information.

     In 1974 the two agencies started a project--referred

to as the "standards completion project"--to revise most

of the estimated 400 standards adopted by OSHA in May 1971.

The plan was to supplement the exposure limits by adding,
where appropriate, requirements for work practices,
medical examinations, and other measures    Lo   protect
employees from the substances.    NIOSH was to provide
recommendations and support for the revisions, but in
most cases the required NIOSH effort on each substance

was to be far less than the effort usually involved in

developing a criteria document.    NIOSH continued to
develop criteria documents on other substances.

     As of September 30, 1976, NIOSH had submitted
53 criteria documents to OSHA.    The time taken by NIOSH
to complete each of the criteria documents ranged from

1 to 50 months and averaged 22 months.     In April ]977
NIOSH told us that, for 13 documents which it had recently

completed, the average time had been reduced to 14 1/2

     OSHA had issued final standards on only two of the
substances (asbestos and vinyl chloride) covered by the

53 criteria documents completed through September 30, 1976.

                      - 5 -
As of that date, OSHA had had the other 51 documen s

for up to 51 months, or for an average of 18 months.
At least 9 of the documents deal with suspected

carcinogens; many others deal with substances that
may cause other severe and irreversible effects.

According to NIOSH estimates, millions of workers are

exposed to the suspected carcinogens and other dangerous
substances.   For example, NIOSH estimated that 2 million
workers &re exposed to benzene, 1.5 million are exposed

to inorganic arsenic, 175,000 are exposed to hexavalent
chromium, and 80,000 are exposed to chloroform.     These

four substances are among the nine identified by NIOSH

as suspected carcinogens.

     As of September 30, 1976, NIOSH had given OSHA

its recommendations for 203 of the substances or
groups of substances in the special standards completion

project.   Of these, OSHA had had 71 recommendations for

less than 6 months, 65 for 7ito 12 months, 36 for

13 to 18 months, and 31 for more than 18 months.
NIOSH officials said that the hazardous nature of the

substances in the standards completion project warrants
the development of complete standards.   OSHA had not

issued final revised standards on any of the substances
in this project.

     We identified a number of administrative problems

which contributed to delays in completing standards.
     First, neither OSHA nor NIOSH had adequate data

for deciding which of the thousands of toxic substances

should be given priority in developing standards.        The
two agencies have a common goal and face the same
problems, but they have made separate, independent

efforts to get data and set priorities.      They have not
agreed on the type and source of data needed and, in

many cases, have assigned different priorities to the
same substance.     At least six of NIOSH's criteria

documents for recommended standards were not promptly
acted on by OSHA because OSHA considered them to be

low priority.     These covered ultraviolet radiation,

hot environments, inorganic flourides, sodium hydroxide,
xylerne, and zinc oxide.     The six documents were in process
in NIOSH an average of 25 months and, as of September 30, 1976,

had been with OSHA an average of 20 months.

     Another problem was that OSHA did not have an

adequate management information system and controls to
identify and resolve problems which delayed the completion

of standards.     NIOSH has had problems in this area but has
taken corrective actions.      Neither agency could provide

                           - 7 -
us complete information on how long each criteria
document or standard development project was in

process, whether work was delayed beyond expected

completion dates, where in the organizations delays
were occurring, and the problems causing delays.
     Another problem concerned OSHA's limited use

of emergency temporary standards.    Although many

of the NIOSH criteria documents soyr·itted to OSHA

indicated to us that the toxic substances pose grave

danger to workers, OSHA has not issued emergency
temporary standards on most of thesc substances, as

authorized in section 6(c)(1) of the act.    Section 6(c)(1)

requires that OSHA issue an emergency temporary standard

if it determines that employees are exposed to grave
danger because of toxic substances or agents or because

of new hazards, and an emergency standard is needed to

protect employees from the danger.
     After discussing the emergency provisions with us in

October 1976, NIOSH strongly recommended to OSHA that

emergency temporary standards be issued for benzene,
hexavalent chromium, and MOCA, a trade name for one of
14 chemicals covered by an emergency standard which is

now expired.   OSHA does not have written criteria on the

                        - 8 -
conditions under which emergency temporary standards
should be issued, and has not taken the action
recommended by NIOSH.     During discussions with us on
why OSHA had not made more use of the emergency

provisions, OSHA officials raised several issues that

need resolving.

     First, according to one official, OSHA might have
difficulty upholding an emergency temporary standard

unless there is direct evidence of fatalities attributable
to workplace conditions.       According to a January 1974
decision by a U.S. court of appeals, however, such

evidence is not needed.       Second, an OSHA official
told us that OSHA would not use the emergency standard
provisions for any hazards that are already covered

by standards.     In our opinion, this position is
not consistent with the act and its intent.       For example,
at least eight substances identified by NIOSH as

carcinogens are covered by standards that provide
exposure limits not designed to prevent cancer, and

that do not require any other employee protective
measures.   Third, an OSHA official said that OSHA's
legal interpretation that an emergency temporary standard

expires after 6 months has caused reluctance to use the
emergency provision.    In our opinion, the act does not

                          -   9 -
require that an emergency standard expire after 6 months.
Under OSHA's interpretation, unregulated exposure of

workers to a grave danger would be permitted after

6 months merely because OSHA could not meet the
6-month requirement.   Fourth, an OSHA official     said

that requirements should not be included in an
emergency standard unless OSHA had assurance that
industry would be physically able to comply with

such requirements within 6 months.     We believe

that the act contains adequate provisions to allow
industry reasonable time to comply with standards
and that this question should not deter issuance of
standards to protect workers from grave danger.

     Tn January 1977, OSHA announced its intent to propose
regulations under which emergency temporary standards

would be issued for confirmed carcinogens.      If carried

out, this would be a significant step toward establishing
the needed criteria.   AdditioPal criteria are needed

fok substances which, although noncarcinogenic,
pose grave dangers to workers.

     Another problem causing delays concerned OSHA's
approach to developing comprehensive standards that

prescribe exposure limits and various other protective

measures and work practices.      For many of the substances

                       -   10 -
being considered for standards development, NIOSH or
OSHA officials determined that the data compiled by
NIOSH did not adequately support all of the measures
considered desirable for complete protection.           In such
cases, NIO.H has recommended standards based on its view
that workers should be protected promptly with whatever
standards can be supported by the data.           But OSHA, instead
of issuing standards containing the measures that were
supported by the data, delayed issuing standards pending
the development of more or better data.           Delays of
this nature were evident in OSHA's work on standards
       -- MOCA and 13 other carcinogens involved in a
         court decision to partially vacate an OSHA
       -- benzene, which according to NIOSH causes
       -- inorganic arsenic, which NIOSH believes can
         cause cancer;
       -- chloroform, which is also considered by NIOSH
         to be carcinogenic;
       -- and cotton dust, which can cause a serious
         lung disease known       s byssinosis.

                         -   11   -
In our opinion, OSHA's approach in such cases has
not been responsive to the act's intent that standards
be promptly issued based on the best available data
and improved later as more or better data become
     Another cause of delays in completing standards
was the lack of NIOSH or OSHA policies and guidelines on
the evidence needed to support classifying a substance
as a carcinogen for regulatory purposes.        This problem
was evident in the development of standards for cadmium,
beryllium, inorganic lead, benzene, and chloroform.           In
January 1977 OSHA announced that it intended to propose
regulations setting forth criteria for determining
whether and how substances will be identified and
regulated as carcinogens.     The proposed criteria in
the announcement is in line with our views on what
needs to be done.   Because OSHA plans to follow the
rulemaking process, it will take at least 6 months
to establish the criteria.        In view of the importance
of this matter, we believe that OSHA and NIOSH should
immediately apply the criteria.

                       -   12 -
     Limited teamwork by OSHA and NIOSH was another
problem contributing to delays.     Generally, OSHA did
not get involved in NIOSH projects until a draft
criteria document was prepared.     OSHA involvement
in NIOSH decisions to start work on given hazards
would increase the likelihood that OSHA will promptly
act on NIOSH's subsequent recommendations.     Earlier
involvement by OSHA   ould also enable NIOSH to
better consider OSHA's needs in deciding on such
matters as the direction and scope of literature
searches, the issues to be addressed, the desired
protective measures to be included in the standard,
and the evidence to be included in the criteria
document to support the standard.    This could eliminate
or reduce OSHA's problems with NIOSH criteria documents.
HEW told us that NIOSH has attempted to cooperate with OSHA.
     In connection with the need for better teamwork,
a major responsibility of NIOSH is to develop,
compile, and analyze scientific data to be used as
criteria and support for OSHA standards.     However,
OSHA has not placed enough reliance on NIOSH for
doing so.   This results in time-consuming duplication
of much of the NIOSH effort and does not promote a
sense of responsibility and commitment in NIOSH to

                      -   13 -
provide sound, defensible criteria and support for
standards.   OSHA's independent action to resolve problems

with NIOSH's criteria documents relieves NIOSH of its

basic rsponsibility to provide well-supported
recommendations, and does not give NIOSH a basis for
improving future work.

     Another problem affecting the timeliness of

completing standards was the evaluation of inflationary
impact pursuant to Executive Order 11821.    We did not

make an in-depth review to evaluate the quality of
inflationary impact evaluations or to identify specific

ways for reducing the time required for such evaluations.
The long periods of time taken for past evaluations,
about a year on the average, indicate potential for
OSHA to reduce the time for future evaluations.     OSHA

had not evaluated past cases to determine whether or not

the time taken could be reduced.
     Another area needing improvement was NIOSH's

direction and control of its laboratory and field
research activities.     During its first 5 years under

the 1970 act, NIOSH did not insure that its laboratory

and field research was, to the extent practicable,
directed to developirg data needed for recommending

                         - 14 -
standards.   NIOSH headquarters officials recognize
this problem and plan to improve the direction and
control of the research program.


     To improve the timeliness of health standards
development, we are making a number of recommendations
for actions by OSHA and NIOSH on the problems identified

in our review.   A listing of our recommendations

is attached to this statement.     Such actions by themselves,
however, may not be adequate to provide prompt protection
against many of the toxic substances.

     Labor and HEW have not made a thorough assessment
of the total needs for health standards, how long it
will take to produce them with current funding levels, and

whether increased funds could be effectively used to
increase their production.     We believe that such an

assessment is needed to enable the agencies and the

Congress to adequately consider such alternatives as
increasing funds for health standards development and/or
putting more emphasis on informing and educating

employers and workers about toxic substances.

                      - 15 -
     Accordingly, we are recommending that the
Secretaries of Labor and HEW:

     -- Estimate, based on the best available data,
        the total needs for health standards and
        how long it will take to complete them with
        existing funding levels.

     -- Determine whether and to what extent
        additional funds can be used effectively
        to (1) speed up standards development
        and (2) increase efforts to inform, educate,
        and train employers and employees on toxic

We are recommending also that:
     -- If additional funds can be used more effectively,
        the Secretary of Labor allocate more funds to
        health standards development and health
        information, eucation, and training activities.

     -- The Secretary of HEW require that decisions on
        how much effort to devote to standards development,
        as opposed to other NIOSH worker protection
        programs, be based partly on OSHA's ability to
        act promptly on recommended standards.

     On    arch 4, 1977, we gave the Departments of Labor

and HEW a draft report on the results of our review
and asked them for comments.
     By letter dated April 12, 1977, Labor told us that,

because of the recent appointment of a new Assistant

Secretary for Occupational Safety and Health, and the
serious issues which must be considered, the Department
preferred to defer its comments until after our

final report was issued.
                       - 16 -
     3EW commented on the report draft by letter
dated April 12, 1977.    HEW provided extensive
comments and suggestions, but for the most part

did not say specifically whether or not it agreed

with our recommendations.    HEW cited the large number
of substances already covered by its recommendations
to Labor and said that it will have recommended

standards for about 5,000 substances by 1981.

     Madam Chairwoman, this concludes my prepared
statement.   We   ill be pleased to answer any questions

that you or other members of the Subcommittee may have.

                        - 17 -

                 RECOMMENDATIONS BY

1.   OSHA and NIOSH should establish a single program
     for obtaining and using data with which to decide

     on priorities for health standards development.

     The program should be along the lines recommended

     in our August 1976 report.     (Chapter 3)
2.   OSHA and NIOSH should work together to develop

     uniform priorities for substances, industries,
     or industrial processes.     (Chapter 3)

3.   OSHA should establish project planning and reporting

     systems to provide for (1) setting milestone and

     completion dates for each standards development
     project, (2) making regular and periodic reports
     that compare planned and actual progress and
     explain any delays, and (3) maintaining complete

     files on each project.     The system should be

     applied to each recommended standard received

     and to be received from NIOSH, and to any

     standards development effort initiated or tc
     be initiated by OSHA without a recommendation
     from NIOSH.   (Chapter 4)

                       - 18 -
4.   OSHA should define grave danger to include
     exposure of workers to a toxic substance or

     harmful agent which has resulted or can result

     in incurable, irreversible, or fatal harm to
     health.   (Chapter 5)

5.   OSHA should issue emergency temporary standards

     in all cases where they are needed to protect

     employees from grave danger, including any
     such dangers posed by toxic substances or
     harmful agents covered by inadequate standards.

     (Chapter 5)
6.   OSHA should require that emergency temporary
     standards remain in effect until superseded by

     permanent standards.     (Chapter 5)
7.   OSHA should promptly issue emergency temporary or
     permanent standards on toxic substances to require

     needed protection that can be supported by

     available evidence, and should revise and add to

     such standards as more and better evidence becomes
     available.    (Chapter 5)
8.   OSHA and NIOSH should establish and use, in
     consultation with the National Cancer Institute,

     a common policy and guidelines for developing
     and reviewing evidence and deciding whether a

                        -   19 -
     substance should be regulated as a carcinogen.
     The policy and guidelines should be at least as
     stringent, in terms of protecting workers, as
     those applied to substances in the past and

     upheld by Federal court.    (Chapter 6)

9.   OSHA and NIOSH should establish and implement

     an agreement under which:
          -- OSHA will rely on NIOSH to provide the
             scientific information needed to support
             standards. This should include NIOSH
             defending its evidence at public
             hearings and court proceedings.

          -- OSHA will not duplicate literature
             searches and reviews on substances
             covered by NIOSH literature searches
             and reviews.

          -- OSHA will provide its views to NIOSH
             before NIOSH starts a project to
             develop recommended new or revised
             health standards or to update previous
             recommendations, and OSHA will inform
             NIOSH when it disagrees on the priority
             that should be given to the project.

          -- For each project, NIOSH will obtain
             OSHA's views on the direction and
             scope of the literature search, the
             issues to be addressed, the protective
             measures to be considered, and the
             evidence to be sought for support.

          -- OSHA will participate in NIOSH meetings
             to review and discuss draft criteria

          -- OSHA will provide feedback to NIOSH on
             problems that may arise concerning the
             validity of, and scientific evidence
             for, NOSH's recommended standards and
             work with NIOSH in resolving such
             problems. (Chapter 7)
                       - 20 -
10.   OSHA should review and formally report to the
      Secretary of Labor on why inflationary impact
      evaluations have taken so long and whether

      steps can be taken to complete such evaluations
      in less time.   (Chapter 8)
11.   OSHA should decide which substances in the standards

      completion program do not warrant standards and
      expedite the completion of any requ   ed inflationary
      impact evaluations on the remaining substances.

      (Chapter 8)

12.   NIOSH should take the following steps before

      starting research projects:

          -- Identify those substances or hazards on
             which NIOSH has decided to develop or
             update criteria and recommendations for
             standards, and ascertain whether they
             are in line with NIOSH priorities.

          -- Conduct complete literature searches on
             those substances to identify specific
             needs for research in light of existing

          -- Require that each research project be
             directed to fill a specific need identified
             by such literature searches, or an
             explanation be made as to what other
             specific need the project is to fill.

          -- Require that research needed in two
             or more NIOSH esearch branches be
             coordinated so that, to the extent
             practicable, all such research can be
             done simultaneously for input to
             recommended standards and support.
             (Chapter 9)
                        -   21 -
13.   NIOSH should maintain records to readily show

      the results of research and the use made of
      such results.    (Chapter 9)

 4.   OSHA and NIOSH should estimate, based on the
      best available data, the total needs for health
      standards and how long it will take to develop

      them within existing funding levels.     (Chapter 10)

15.   OSHA and NIOSH should determine whether and to
      what extent additional funds can be used to

      speed up standards development and increase
      efforts to inform, educate, and train employers

      and employees on toxic substances.     (Chapter 10)

16.   If additional funds can be used effectively, OSHA
      should allocate a greater portion of its funds
      to health standards development and health
      information, education, and training activities.

      (Chapter 10)

17.   NIOSH decisions on hot much effort to devote to

      standards development, as opposed to other NIOSH
      worker protection programs, should be based partly

      on Labor's ability to promptly act on recommended
      standards.     (Chapter 1)

                           - 22 -