[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]


=======================================================================
-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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