[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9422]
[[Page Unknown]]
[Federal Register: April 19, 1994]
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DEPARTMENT OF ENERGY
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-211037; FRL-4776-6]
TSCA Section 21 Petition; Response to Citizens' Petition
AGENCY: Environmental Protection Agency (EPA).
ACTION: Response to citizens' petition.
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SUMMARY: On December 22, 1993, the International Union, United
Automobile, Aerospace and Agricultural Implement Workers of America-UAW
(UAW) petitioned EPA under section 21 of the Toxic Substances Control
Act (TSCA), 15 U.S.C. 2620, to issue test rules under section 4 of TSCA
to develop data to aid in the determination of whether machining fluids
pose an unreasonable risk to public health or the environment. This
Notice announces EPA's response to UAW's petition.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-545B, 401
M St., SW., Washington, DC 20460, (202) 554-1404, TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION:
I. Summary of Petition and Response
On December 22, 1993, EPA received a petition under section 21 of
TSCA from UAW. The petitioner subsequently agreed at EPA's request to
extend the statutory deadline for EPA review until April 12, 1993. The
petitioner requested that EPA issue test rules under section 4 of TSCA
to evaluate whether machining fluids pose an unreasonable risk to
public health or the environment. UAW requests the testing because it
believes that although the available epidemiology data is sufficient to
establish the hazards of machining fluids as mixtures, more and better
toxicology data is needed to characterize the health and environmental
risks resulting from exposure to particular components or partial
mixtures of machining fluids.
The petitioner alleges that sufficient evidence exists to establish
that occupational exposure to machining fluids at currently permissible
levels poses a risk of cancer and adverse effects on respiratory
function. UAW says that the information derived from the additional
testing requested, including measurements of environmental release in
the occupational setting, would contribute to refining control
strategies. It asserts that such information would more clearly define
the toxicity of specific components constituting machining fluids and
of different combinations of those components. The petitioner also
believes that additional testing data will provide needed information
regarding workplace exposure to specific components or partial mixtures
of machining fluids.
The petitioner does not identify the specific chemical substances
or chemical mixtures for which testing is requested. UAW states that
the petition applies to all machining fluids, including generic
categories such as straight oils, soluble oils, and synthetic fluids,
and drawing compounds for metal stamping which are similar in
composition to machining fluids. EPA estimates that the UAW petition
potentially applies to hundreds of chemical substances or mixtures of
chemical substances.
The petitioner says that test rules issued in response to the
petition should include, but not be limited to requiring: mutagenicity,
respiratory irritancy, and sensitization bioassays of machining fluid
components, partial combinations and in-use machining fluids;
carcinogenesis bioassays for selected classes of components; chemical
analysis of bulk fluids and aerosols for nitrosamines, bacterial
degradation products (including endotoxin) and higher molecular weight
polynuclear aromatic hydrocarbon formation from use; and health effects
studies. In addition, the petitioner requests test rules requiring
measurement of release to the environment of various machining fluid
components to gauge workplace exposure from airborne machining fluid
components.
On December 9, 1993, UAW petitioned the Occupational Health and
Safety Administration (OSHA) to lower the current OSHA Permissible
Exposure Limit (PEL) for oil mist from machining fluids. The UAW
petition to OSHA includes a request that OSHA approach EPA to determine
the need for test rules for particular ingredients of metalworking
fluids, using authority under TSCA. The UAW petition to OSHA, a copy of
which was filed with the TSCA section 21 petition, is accompanied by a
paper entitled ``Health Effects of Occupational Exposure to Machining
Fluids,'' which contains a summary of selected epidemiological studies
of cancer and respiratory diseases among workers exposed to machining
fluids. In a statement made at the time of the filing, UAW president
Owen Bieber said that additional joint union-company studies are
underway at General Motors, Ford, and Chrysler, and that within a few
years, study sponsors will know far more about, among other things,
what specific ingredients in machining fluids are causing health
problems for workers.
EPA believes that additional testing of machining fluids may be
necessary to adequately characterize the health effects of these fluids
on exposed workers. However, EPA has decided that it is not in a
position at this time to conclude that the requisite section 4 criteria
have been met for the hundreds of chemical substances and mixtures to
which the petition arguably applies. Before deciding to require testing
of machining fluids, EPA will work with OSHA and the National Institute
of Occupational Safety and Health (NIOSH) in a specially convened
Interagency Workgroup to identify specific components of machining
fluids, the combinations in which these chemical substances are used in
the workplace, and the level of workplace exposure to these chemical
substances, and then determine which chemical substances, if any, have
been adequately tested in the past or are currently undergoing testing.
In addition, before imposing testing requirements, EPA must
determine which machining fluid chemicals meet the section 4 standards
for presenting potentially unreasonable risks or evidencing adequate
release or exposure to require testing under TSCA. A more detailed
discussion of these standards is contained in Unit II.A. of this
Notice. EPA anticipates that it will be able to complete the phase of
this process that will result in decisions on whether to initiate
section 4 test rules within 1 year.
Over the last several years, EPA has also taken a number of
additional initiatives as described in Unit IV of this Notice. These
activities help to address potential adverse health effects on workers
exposed to machining fluids.
II. Background
A. Statutory Requirements
Section 21 of TSCA provides that any person may petition EPA to
initiate proceedings for the issuance of rules under sections 4, 6, and
8 of TSCA. A section 21 petition must set forth the facts which the
petitioner believes establish the need for the rules requested. EPA is
required to grant or deny the petition within 90 days. If EPA grants
the petition, the Agency must promptly commence an appropriate
proceeding. If EPA denies the petition, the Agency must publish its
reasons in the Federal Register. Within 60 days of denial, the
petitioner may commence a civil action in a U.S. district court to
compel the initiation of the rulemaking requested in its petition. The
court must, for a petition for a new rule, provide an opportunity for
the petition to be considered de novo. After hearing the evidence, the
court can order EPA to initiate the action requested if the petitioner
has demonstrated, by a preponderance of the evidence, support for
particular conclusions described in section 21. In a challenge to an
EPA denial of a section 21 petition requesting a section 4 rule, the
petitioner would have to demonstrate by a preponderance of the evidence
that information available to the Agency is insufficient to permit a
reasoned evaluation of the effects of a chemical substance or mixture,
and that the chemical substance or mixture either may present an
unreasonable risk of injury or will be produced in substantial amounts
and may result in significant or substantial human exposure or
substantial environmental release, and that testing is necessary to
characterize the risks.
Section 21 does not provide specific direction as to how the Agency
should evaluate a citizen's petition, but merely states that EPA must
grant or deny within 90 days. However, there are standards under
section 4 for issuing regulations, and in determining whether to grant
or deny, EPA must consider whether the requirements for section 4
rulemaking can be met. Under section 4 of TSCA, EPA may issue rules to
require chemical manufacturers and processors to test the chemical
substances and mixtures (chemicals) that they produce. To issue a
section 4 rule on a chemical, EPA must find either that activities
involving the chemical may present an unreasonable risk of injury to
health or the environment, or that the chemical is or will be produced
in substantial quantities and that there is or will be significant or
substantial human exposure to the chemical or that the chemical is or
will be released to the environment in substantial quantities. In
addition, EPA must find that existing data are insufficient to
determine or predict the effects of the chemical and that testing is
necessary to develop that data. EPA must be able to make all of the
above findings to issue a test rule; if EPA believes on the basis of
the information obtained from the petition, and from its investigation
during the 90-day review period, that it cannot make all of the
necessary findings, EPA will deny the section 21 petition.
One of the criteria most relevant to a section 21 petition is
whether testing is necessary. Section 4 expands the concept of
sufficiency provided in the section 21 standards established for the
purposes of district court review, requiring that EPA find that testing
a chemical is necessary to develop the data needed to evaluate the
chemical before it may issue a rule requiring testing of that chemical.
B. Description of Machining Fluid Problems
Machining fluids, also called metalworking fluids, are used to
lubricate and cool industrial equipment and the metal being shaped
during a variety of machining operations. These may include metal
removing operations such as cutting or drilling, metal forming such as
stamping or drawing, or similar operations. In its petition to OSHA,
UAW states that NIOSH estimates that up to 10 million U.S. workers are
routinely exposed to oil mists from machining fluids. Exposure is
primarily occupational; however, there are limited exposure data. There
may be as many as 400 commercial products (EPA, 1992) belonging to one
of four major metalworking fluid types: straight and soluble oils and
semi-synthetic and synthetic fluids. All but the synthetic fluids
contain mineral oil. There are no standard formulations of chemical
components among commercial machining fluids. The following Table 1,
which is illustrative only, indicates the diversity and use patterns of
the generic types of machining fluids and components:
------------------------------------------------------------------------
Straight\1\ Semi-
oil Soluble oil synthetic Synthetic
------------------------------------------------------------------------
Base................
Mineral oil....... X X X
Additive............
Surfactant........ X X
Coupler........... X (X)
Thickener......... X
Detergent......... X X X X
Plasticizer....... (X) X
Anti-Misting...... X
Oiliness Agent.... X
Dispersant........ X
Extreme Pressure.. X X (X)
Passivator........ X
Anti-Foam......... X X X
Alkaline Reserve.. X X X X
Solid Lubricant... X (X)
Odor Mask......... X X X (X)
Corrosion
Inhibitor........ X X X X
Anti-Microbial
Agent............ X X X X
------------------------------------------------------------------------
\1\ The term ``straight oil'' and ``insoluble oil'' may be used
interchangeably.
Notes:
X-Indicates that it is likely that this additive is found in
the fluid.
(X)--Indicates that this additive is occasionally found in the
fluid. Either the additive is in a small percentage of the
formulated products of this type, or there is no advantage to having
the additive in the product.
Sources: Atmenkins, Howell, Luke, Leiter, 1994; Nachtman, 1990.
UAW attached a list of 14 epidemiology studies to its OSHA
petition, along with a general description of the findings of these
studies. Eight studies have been published; the remaining six studies
have not been published and presumably have undergone peer review.
These studies covered several operations including grinding operations
in which inhalation of fine particles of the material being machined
became a concern, as well as exposures in machining operations that did
not involve grinding. The UAW-represented plants in the studies made a
variety of products, using different processes with different machining
fluid compositions and presumably different exposure levels. Taken
together, the studies covered workers in foundry and engine plants
exposed to substances characterized as straight, soluble, and insoluble
oils, synthetic water-based cutting fluids, other synthetic fluids,
cutting oils, metal fumes, abrasives, dusts, oil smoke, coolants,
organic solvents, and nitrosamines. The studies found some evidence of
increased risks of esophageal, rectal, laryngeal and stomach cancer.
However, information regarding the level of exposure was limited or
lacking altogether. For example, only two of the studies provided any
quantitative measurement of exposure and both measures were reflective
of current rather than historical levels to which workers were exposed.
According to UAW, excess stomach cancers were found in seven of the
nine studies conducted at the UAW-represented plants. Of all 14 studies
listed, however, only three studies actually found a statistically
significant increased risk of stomach cancer (Austin et al.,
unpublished; Park et al. 1988; Silverstein et al. 1988). UAW has
commented that it ``believe[s] that there is sufficient evidence to
conclude that exposure to machining fluids poses a risk of occupational
cancer and adverse effects of respiratory health at levels permitted by
the current OSHA Permissible Exposure Limit.'' The epidemiology studies
are consistent with toxicology studies, which have generally shown that
the respiratory tract is sensitive to the effects of machining fluid
exposure. The increased incidence of cancer and respiratory effects in
the epidemiology studies were associated with several types of
machining fluid oils.
III. EPA's Approach to Obtaining Information on Workplace Health
Risks from Exposure to Machining Fluids
EPA agrees with UAW that laboratory work on machining fluids should
be expanded and that additional testing may be needed to more clearly
define the toxicity of specific components of machining fluids and of
different combinations of those components. However, EPA is not at this
time convinced of the necessity to initiate section 4 test rules under
TSCA for all the more than 400 components of machining fluids and the
many hundreds of combinations of those components that are in use
today. EPA believes that before it issues test rules, existing
laboratory data must be reviewed to determine which machining fluid
components have already been tested adequately. EPA believes that it is
important for OSHA and NIOSH to help decide, possibly with additional
input from both unions and industry, which of the hundreds of untested
or inadequately tested machining fluid components or combinations are
most likely to increase health risks to workers because they appear to
have the greatest potential toxicity or are found in the most widely
used machining fluids.
To select machining fluid chemicals for testing in response to this
petition, EPA has recently formed an Interagency Workgroup with
representatives from EPA, OSHA, and NIOSH. This group will review
information regarding the composition of currently-used machining
fluids and existing health effects and exposure data on machining
fluids, and will recommend specific chemicals for testing to the OSHA/
NIOSH/EPA Committee (ONE Committee).
The ONE Committee was established pursuant to a formal Memorandum
of Understanding (MOU) in 1988 to provide a focal point for
coordination and exchange of information on occupational issues
including toxic chemical assessment and regulatory activities of the
three agencies. The Mine Safety and Health Administration (MSHA) was
later added to the Committee.
Following review of the Interagency Workgroup's recommendations for
testing (including monitoring) of specific machining fluid chemical
substances or mixtures, the ONE Committee will refer data needs for
specific chemical substances or mixtures to EPA for development of
proposed test rules. EPA will then undertake to make the necessary
findings under section 4 and develop test rules covering the
recommended substances or mixtures. The identity and number of specific
chemicals referred for testing will depend on the selections of the
Interagency Workgroup, as reviewed by the ONE Committee. EPA has
received letters from OSHA and NIOSH officials expressing their
approval of the Interagency Workgroup's formation, appointing
representatives to serve on the group, and indicating their
understanding that the purpose of the group is to assist in addressing
UAW's concerns regarding occupational health risks associated with
exposure to machining fluids.
Prior to receiving the ONE Committee's referral of data needs the
Interagency Workgroup's recommendations of substances or mixtures for
testing, and Agency review with regard to section 4 criteria, EPA is
not in a position to require testing for the hundreds of combinations
of machining fluid chemical substances (or some subset thereof) which
are currently in use. Specifically, EPA needs to select the chemicals
and combinations that will support the findings required under TSCA
section 4 before EPA can promulgate a test rule. In addition to
evaluating the toxicity of chemicals and mixtures found in machining
fluids, EPA needs to evaluate the potential exposure that occurs during
use. Moreover, thermal and degradation products, and particulates from
the metal work being machined can add to the potentially toxic
exposures. These issues may need further review.
It should also be noted that EPA probably cannot promulgate a TSCA
section 4 test rule for one category of additives mentioned in the
petition. Section 3 of TSCA excludes certain types of chemicals from
the definition of ``chemical substances,'' and therefore from
regulation under TSCA, including chemicals ``manufactured, processed,
or distributed in commerce, for use as pesticides.'' When biocides are
added to machining fluids to act as pesticides, they would not normally
be the subject of a TSCA section 4 rule. However, they are regulated by
EPA under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) 7 U.S.C. 136 et seq. and EPA has authority to require health
and environmental data under FIFRA.
In summary, the Agency recognizes that additional laboratory
testing may be needed to determine the toxicity of inadequately tested
machining fluids. In addition, studies to better characterize worker
exposure to machining fluids may be needed. EPA agrees with UAW that
exposure to toxic machining fluid components and combinations of such
components should be minimized. EPA also agrees with UAW that EPA,
OSHA, and NIOSH should work together to determine the need for TSCA
section 4 rules for particular ingredients and mixtures of metalworking
fluids. EPA has initiated actions that will enable EPA, OSHA and NIOSH
to navigate through the complex and extremely large universe of
machining fluid components and mixtures to select appropriate
substances for testing. The agencies may also seek the assistance of
unions and industry in this effort. EPA believes that consultation with
unions and industry may be particularly useful in handling nomenclature
and product definition issues that must be resolved prior to
promulgating test rules under section 4.
IV. Specific Actions to Address Workplace Exposure to Toxic
Machining Fluid Components
Prior to receiving the December 22, 1993 petition, EPA had
identified machining fluids as a potential source for concern. EPA had
also begun to evaluate the toxicity of these materials.
On June 28, 1990, EPA received a letter from Dr. Franklin Mirer of
UAW indicating UAW's intent to submit a petition under TSCA section 21
requesting TSCA section 4 carcinogenicity testing of cutting oil
components and formulations. In response to this letter and a TSCA
section 8(e) submission, EPA initiated a review of the toxicity of
machining oil components and mixtures under its screening level risk
management process (RM1). After reviewing available data on oil-based
metalworking fluids, EPA concluded on September 9, 1992, that there
were insufficient data at that time to define the agent(s) of concern
for toxicity testing, and EPA presented this conclusion to the ONE
Committee. As a result of this review, EPA decided to group machining
fluid additives by their use (e.g., anti-oxidants, biocides, etc.) into
use clusters for screening with respect to potential human risk,
ecological risk, and pollution prevention. To date, 11 such clusters
have been identified and are under review.
In addition, the following actions were not contemplated by EPA in
response to any UAW initiative. These actions have been taken
previously or are planned unilaterally by EPA to reduce, among other
things, workplace exposure to certain toxic components of machining
fluids.
EPA recently completed an investigation of chlorinated paraffins
and olefins (CP/Os), substances used extensively in cutting fluids.
Chlorinated paraffins (CPs) came to the attention of EPA in 1977, when
the National Toxicology Program (NTP) nominated them for testing.
Earlier that year, an international group of CP manufacturers had
formed a Consortium to test their products for both health and
environmental effects. EPA had discussed the planned testing with the
Consortium and had accepted the Consortium's proposal for voluntary
health and environmental effects testing of CPs. Consequently, EPA at
that time did not propose a section 4(a) rule requiring such health or
environmental effects testing. Following completion of testing by
industry in 1984, EPA tentatively estimated that CPs could pose
potential risks to aquatic life at concentrations at or below the
concentrations that might be expected to occur frequently in the
environment. In addition, NTP, the International Agency for Research on
Cancer, and the State of California had classified short chain CPs as
probable human carcinogens.
In September of 1993, EPA concluded that CP/Os do not present a
general environmental risk, although a few cities with heavy
concentrations of metalworking operations were identified in which CP/O
water concentrations could reach levels of concern to some aquatic
species. The investigation also concluded that CP/Os may pose cancer
risks to specific limited populations, primarily to workers using
metalworking fluids and thus exposed to CP/Os in oil mists. EPA also
concluded that, to a lesser extent, CP/Os also could pose potential
cancer risks to small populations of subsistence fish-eaters in a few
metropolitan areas, and possibly to anyone exposed to dioxin that might
be generated during metalworking operations or when spent fluids are
incinerated. Consequently, EPA is proposing to list CP/Os on the Toxic
Release Inventory (TRI), based primarily on concerns about potential
cancer risks. In addition, EPA has communicated to OSHA the potential
occupational risk to metalworkers at the current PEL.
On May 12, 1993, (58 FR 27944) EPA promulgated a Significant New
Use Rule (SNUR) under TSCA for alkali metal nitrites (AMNs), another
frequent machining fluid additive. EPA has determined that the use of
AMNs as ingredients in machining fluids containing amines may result in
significant exposure to N-nitrosamines and pose a significant cancer
risk to human health. The SNUR applies to any person that manufactures,
imports, or processes AMNs for use as an ingredient in machining fluids
containing amines. Such persons must notify EPA 90 days before
undertaking the activity. This time period gives EPA an opportunity to
evaluate the intended use of the AMNs in question to ensure that
workers are protected from the risks of exposure to N-nitrosamines.
Finally, to address concerns over environmental releases of
machining fluids and components, EPA is planning to propose the Metal
Products and Machinery Phase I Effluent Guideline by November 1994.
This guideline, which is scheduled for promulgation by May 1996, is
intended to cover facilities that manufacture, rebuild or maintain
metal parts, products or machines and that discharge effluent to
surface waters and indirectly to publicly owned treatment facilities.
The phase I guideline will cover the aerospace, aircraft, electronic
equipment, hardware, mobile industrial equipment, ordnance, and
stationary equipment industries. The guideline will regulate discharges
of several pollutants, including some substances that are components of
machining fluids or that constitute machining fluids.
V. Public Record
EPA has established a public record of those documents the Agency
considered in reviewing this petition. The record consists of documents
located in the file designated by docket Number OPPTS-211037, located
at the TSCA Nonconfidential Information Center (NCIC). This Docket is
available for inspection from 12 noon to 4 p.m., Monday through Friday,
except legal holidays, in TSCA NCIC, Rm. E-G102, 401 M St., SW.,
Washington, DC 20460.
List of Subjects
Environmental protection.
Dated: April 12, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 94-9422 Filed 4-18-94;8:45 a.m.]
BILLING CODE 6560-50-F
