[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Rules and Regulations]
[Pages 30816-30823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15445]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AD-FRL-5520-5]
RIN 2060-AF33
Hazardous Air Pollutant List; Modification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The EPA is amending the list of hazardous air pollutants in
Clean Air Act Section 112(b)(1) by removing the compound caprolactam
(CAS No. 105-60-2). This rulemaking was initiated in response to a
petition to delete the substance caprolactam which was filed by
AlliedSignal, Inc., BASF Corporation, and DSM Chemicals North
[[Page 30817]]
America under section 112(b)(3) of the Act. Based on the available
information concerning the potential hazards of and projected exposures
to caprolactam, EPA has made a determination pursuant to Clean Air Act
Section 112(b)(3)(C) that there are adequate data on the health and
environmental effects of caprolactam to determine that emissions,
ambient concentrations, bioaccumulation, or deposition of the compound
may not be reasonably anticipated to cause adverse human health or
environmental effects. Although EPA acknowledges that there are
scientific uncertainties in its analysis of the potential effects of
ambient caprolactam exposures, EPA does not regard any of these
uncertainties to be sufficiently material to preclude this
determination.
DATES: This final rule will be effective on June 18, 1996. Because this
final rule is based on a determination of nationwide scope and effect,
any petition for judicial review of this rule may be filed only in the
United States Court of Appeals for the District of Columbia and must be
filed no later than August 19, 1996.
ADDRESSES: The administrative record supporting this final rule is
collected in Docket Number A-94-33. All documents in that docket,
including a complete copy of the original petition, all comments on the
proposed rule, and a transcript of the public hearing, may be examined
between 8:00 A.M. and 4:30 P.M. on business days at the EPA Central
Docket Section, Waterside Mall, 401 M St., SW, Washington, D.C. 20460.
FOR FURTHER INFORMATION CONTACT: For specific information concerning
this final rule, contact Dr. Nancy B. Pate, Office of Air Quality
Planning and Standards (MD-12), U.S. EPA, Research Triangle Park, NC
27711, telephone (919) 541-5347.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. The Delisting Process
Section 112 of the Clean Air Act contains a mandate for EPA to
evaluate and control emissions of hazardous air pollutants. Section
112(b)(1) includes an initial list of hazardous air pollutants that is
composed of specific chemical compounds and compound classes to be used
to identify source categories for which the EPA will subsequently
promulgate emissions standards.
Clean Air Act Section 112(b)(2) requires EPA to make periodic
revisions to the initial list of hazardous air pollutants set forth in
Section 112(b)(1) and outlines criteria to be applied in deciding
whether to add or delete particular substances. Section 112(b)(2)
identifies pollutants that should be listed as:
* * * pollutants which present, or may present, through inhalation
or other routes of exposure, a threat of adverse human health
effects (including, but not limited to, substances which are known
to be, or may reasonably be anticipated to be, carcinogenic,
mutagenic, teratogenic, neurotoxic, which cause reproductive
dysfunction, or which are acutely or chronically toxic) or adverse
environmental effects whether through ambient concentrations,
bioaccumulation, deposition, or otherwise * * *
To assist EPA in making judgments about whether a pollutant causes
an adverse environmental effect, Section 112(a)(7) defines an ``adverse
environmental effect'' as:
* * * any significant and widespread adverse effect, which may
reasonably be anticipated, to wildlife, aquatic life, or other
natural resources, including adverse impacts on populations of
endangered or threatened species or significant degradation of
environmental quality over broad areas.
Section 112(b)(3) establishes general requirements for petitioning
EPA to modify the hazardous air pollutant list by adding or deleting a
substance. Although the Administrator may add or delete a substance on
his own initiative, the burden is on a petitioner to include sufficient
information to support the requested addition or deletion under the
substantive criteria set forth in Sections 112(b)(3) (B) and (C). The
Administrator must either grant or deny a petition within 18 months of
receipt. If the Administrator decides to grant a petition, the Agency
publishes a written explanation of the Administrator's decision, along
with a proposed rule to add or delete the substance. If the
Administrator decides to deny the petition, the Agency publishes a
written explanation of the basis for denial. A decision to deny a
petition is final Agency action subject to review in the D.C. Circuit
Court of Appeals under Clean Air Act Section 307(b).
To promulgate a final rule deleting a substance from the hazardous
air pollutant list, Section 112(b)(3)(C) provides that the
Administrator must determine that:
* * * there is adequate data on the health and environmental effects
of the substance to determine that emissions, ambient
concentrations, bioaccumulation, or deposition of the substance may
not reasonably be anticipated to cause any adverse effects to the
human health or adverse environmental effects.
EPA will grant a petition to delete a substance, and publish a proposed
rule to delete that substance, if it makes an initial determination
that this criterion has been met. After affording an opportunity for
comment and for a hearing, EPA will make a final determination whether
the criterion has been met.
EPA does not interpret Section 112(b)(3)(C) to require absolute
certainty that a pollutant will not cause adverse effects on human
health or the environment before it may be deleted from the list. The
use of the terms ``adequate'' and ``reasonably'' indicate that the
Agency must weigh the potential uncertainties and their likely
significance. Uncertainties concerning the risk of adverse health or
environmental effects may be mitigated if EPA can determine that
projected exposures are sufficiently low to provide reasonable
assurance that such adverse effects will not occur. Similarly,
uncertainties concerning the magnitude of projected exposures may be
mitigated if EPA can determine that the levels which might cause
adverse health or environmental effects are sufficiently high to
provide reasonable assurance that exposures will not reach harmful
levels. However, the burden remains on a petitioner to resolve any
critical uncertainties associated with missing information. EPA will
not grant a petition to delete a substance if there are major
uncertainties which need to be addressed before EPA would have
sufficient information to make the requisite determination.
B. The Present Petition and Rulemaking
On July 19, 1993, EPA received a petition from AlliedSignal, Inc.,
BASF Corporation, and DSM Chemicals North America, Inc.
(``petitioners'') to delete caprolactam (CAS No. 105-60-2) from the
hazardous air pollutant list in Section 112(b)(1). Following receipt of
the petition, EPA conducted a preliminary evaluation to determine
whether the petition was complete according to Agency criteria. To be
deemed complete, a petition must consider all available health and
environmental effects data. A petition must also provide emissions data
sufficient to assess peak and average emissions for each source, and
must estimate the resultant exposures of people living in the vicinity
of the source. In addition, a petition must address the environmental
impacts associated with emissions to the ambient air and impacts
associated with the subsequent cross-media transport of those
emissions. EPA found the petition to delete caprolactam to be complete
and published a notice of receipt and request for comments in the
Federal
[[Page 30818]]
Register on August 26, 1993 (58 FR 45081).
After evaluating submissions received by EPA in response to the
notice of receipt, which included concerns expressed by citizens
concerning emissions of caprolactam by the AlliedSignal facility in
Irmo, South Carolina, EPA entered into discussions with AlliedSignal to
determine what could be done to address these concerns. On March 13,
1995, EPA executed two detailed emission reduction agreements with
AlliedSignal concerning the Irmo manufacturing facility and another
facility located in Chesterfield, Virginia, copies of which are
included in the public docket for this rulemaking. Under these
agreements, AlliedSignal is installing emission controls for
caprolactam which EPA believes are equivalent to the controls which
would have been required had EPA issued a standard to control these
sources under Section 112. The agreed emission controls will be
incorporated in federally enforceable operating permits for the
affected facilities, and will be in place years earlier than controls
would have otherwise been required. In addition, AlliedSignal has
established a citizen advisory panel concerning the Irmo facility,
which EPA is hopeful will improve communications with the community and
provide citizens an ongoing role in implementation of the agreed
emission reductions.
On September 8, 1995, based on a comprehensive review of the data
provided in the petition and otherwise provided to EPA, the Agency made
an initial determination that the statutory criterion for deletion of
caprolactam from the hazardous air pollutant list had been met. EPA
therefore granted the petition by AlliedSignal, Inc., BASF Corporation,
and DSM Chemicals and issued a proposed rule to delist caprolactam. (60
FR 48081, September 18, 1995).
EPA received a total of 19 comments on the September 18, 1995
proposed rule. EPA subsequently granted a request by a citizen's group
concerned about emissions from the AlliedSignal Irmo, SC facility to
extend the comment period until November 2, 1995. (60 FR 58589,
November 28, 1995). EPA conducted this delisting rulemaking pursuant to
the procedures established by Clean Air Act Section 307(d).
Accordingly, as provided by Section 307(d)(5), EPA held a public
hearing concerning the proposed rule in Irmo, SC on December 7, 1995. A
transcript of the hearing is included in the public docket for this
rulemaking. Pursuant to Section 307(d)(5), EPA kept the record of this
rulemaking open for thirty days after the December 7, 1995 hearing to
receive rebuttal and supplementary information.
II. Adverse Comments and EPA Responses
A. Overview
Of the 19 written comments which were received concerning the
proposed delisting of caprolactam, seven commenters supported and seven
commenters opposed delisting. Other commenters expressed concerns
regarding particular elements of the Agency's assessment, but did not
expressly support or oppose the proposal. Many of the persons who made
statements at the public hearing held on December 7, 1995 in Irmo, SC
expressed opposition to the proposed delisting, in most cases because
of a belief that emissions by AlliedSignal's Irmo facility were the
cause of adverse health effects in their homes or community. Many of
the commenters opposing the delisting of caprolactam were members or
representatives of People United for a Responsible Environment (PURE),
a citizen's group located in the Irmo-St. Andrews area of Columbia, SC.
EPA has considered carefully all of the comments both supporting
and opposing the proposed delisting, focussing in particular on those
comments which suggested potential deficiencies in the substantive
rationale upon which EPA based its initial determination that the
criterion in Clean Air Act Section 112(b)(3)(C) had been met. A summary
of the comments and the EPA responses to them has been included in the
docket for this proceeding. In this notice, EPA will discuss adverse
comments which it received and its response to them.
B. Toxicity Data
Opponents of delisting commented that EPA should place greater
emphasis on the findings in several Eastern European studies, which
reported adverse reproductive effects in animals and exposed workers
following inhalation of caprolactam. Unfortunately, there are numerous
methodologic problems with the manner in which the cited studies were
performed and documented which severely limit their value for risk
assessment. Well-designed, documented and conducted animal studies do
indicate that the most sensitive chronic health effect endpoint
associated with caprolactam exposure is reduced mean fetal body weight
(noted in a rodent reproductive study). However, since the reported
results in these Eastern European studies cannot be readily reconciled
with subsequent studies, EPA does not believe that these studies
warrant any change in its risk assessment for caprolactam.
Opponents of delisting also have argued that the available animal
data on inhalation of caprolactam is inadequate to support the Agency's
conclusions, and that EPA should wait for the results from the
subchronic rat inhalation study of caprolactam which AlliedSignal is
currently performing before taking final action in this rulemaking. EPA
agrees that the available animal data on inhalation of caprolactam is
very limited in comparison to the large number of studies of
caprolactam ingestion. This is largely because the physical properties
of the substance make it difficult to generate stable atmospheres of
caprolactam at levels which would be toxicologically significant and to
control for possible secondary exposure to caprolactam by the oral
route. However, EPA believes that the commenters who assert that EPA
should wait to take action until after the current subchronic
inhalation study has been completed misunderstand the study's purpose
and likely significance.
Based on the currently available human and animal data, the most
sensitive effect of inhalation exposure to caprolactam is irritation of
the eye, nose, and throat. In a limited but reliable occupational study
of workers exposed to airborne caprolactam over nearly two decades,
irritant effects in the nose and throat were observed in some workers
at all levels above 46 mg/m3, and no distress was noted among
workers at concentrations ranging up to 32 mg/m3. This approximate
no observed effect level of 32 mg/m3 for acute irritation by
caprolactam in humans is consistent with one animal study, in which
brief exposure to caprolactam levels up to 26 mg/m3 did not elicit
any of the physiologic responses typical of irritants.
EPA believes that projected exposures of the general population to
a substance in the ambient air at concentrations which result in acute
irritation can be an appropriate basis for inclusion of that substance
on the list of hazardous air pollutants. However, in the case of
caprolactam, the highest modeled one-hour caprolactam concentration
near any facility based on reported emissions was approximately 1 mg/
m3, well below the lowest documented irritation level of 46 mg/
m3.
The target exposure levels in the subchronic inhalation study being
conducted by AlliedSignal are 25, 75,
[[Page 30819]]
and 250 mg/m3. The new inhalation study will provide additional
information on potential adverse effects on the respiratory tract, as
well as any adverse systemic effects, associated with sustained
inhalation of caprolactam. Although EPA is reluctant to make
quantitative comparisons between the oral and inhalation routes, EPA
has previously calculated that the oral NOAEL (No Observed Adverse
Effect Level) for reproductive effects of 50 mg/kg/day would be
approximately equivalent to 175 mg/m3, after adjusting for a human
body weight of 70 kg, 100 percent absorption, and a human inhalation
rate of 20 m3/day. EPA considers it probable that the new
inhalation study will permit better quantification of the dose-response
relationship for potential portal of entry effects, but it is less
clear whether even the highest concentration achieved by the new study
will be sufficient to cause any of the systemic effects observed in
previous oral studies.
The purpose of the new inhalation study is to enable a more precise
quantitative dose response assessment for the inhalation effects of
caprolactam exposure. While the study may be quite useful in this
respect, EPA considers it unlikely that the study will change the more
general conclusions of the risk assessment on which this final rule is
based. In other words, EPA does not consider the uncertainties the new
study is designed to address to be material to the overall risk
determination underlying today's action.
Even if the new study were to detect portal of entry effects in
rats following repeated exposure at the lowest target concentration of
25 mg/m3, this would probably have greater significance in an
occupational context than in assessing the risks associated with
ambient exposures. The new study will expose animals to this
concentration for 13 weeks. The maximum modeled ambient caprolactam
concentration for a 24-hour period is 0.25 mg/m3, two orders of
magnitude below the lowest target concentration in the new study. (The
maximum modeled ambient concentration on an annual basis is 0.05 mg/
m3.)
Given the animal and human data already available, EPA considers it
quite improbable that the new study will detect adverse systemic
effects at the lower exposure levels. However, in the event that such
effects are observed, EPA will review today's action in light of such
data.
EPA wishes to stress that its decision that there is no need to
wait for submission of the new inhalation study is based on the
Agency's conclusion that the present data are already adequate to
support the requisite statutory determination. EPA does not agree with
the argument made by AlliedSignal in its comments that previous EPA
delisting actions under Section 313 of the Emergency Planning and
Community Right-to-Know Act (EPCRA) provide precedent that would enable
EPA to proceed with delisting under Clean Air Act Section 112 when
research which is clearly material to its risk assessment is still
underway. Unlike Clean Air Act Section 112(b)(3)(C), which requires EPA
to determine that currently available data are adequate to support a
determination that a substance may not reasonably be expected to cause
adverse effects, EPCRA Section 313(d)(3) provides that a chemical may
be deleted if there is not sufficient evidence to establish that it
causes certain adverse effects.
C. Human Effects Information
In comments submitted by PURE and statements by individual citizens
at the public hearing, many commenters asserted their belief that there
is a relation between various adverse human health effects and
caprolactam emissions by the AlliedSignal Irmo facility. The effects
described include headaches, allergies, sinus problems, respiratory
disorders, multiple chemical sensitivity, chronic fatigue syndrome,
various digestive disorders, neurologic disorders, and several types of
cancer. Although reports of irritation of the upper respiratory tract
are qualitatively similar to the effects observed at far higher
concentrations in occupational studies, EPA is not aware of any
evidence which would indicate a relation between the occurrence of
these common disorders in the general population and caprolactam
exposure. EPA is also unaware of any evidence which would support the
claimed relationship between caprolactam exposure and the other
specific diseases which were mentioned. In the absence of any reliable
epidemiologic or clinical information, or any other collateral evidence
which would suggest the biological plausibility of the described
effects, EPA cannot justify affording any weight to such anecdotal
evidence in its risk assessment.
The purported relationship between caprolactam exposure and the
symptoms of multiple chemical sensitivity (MCS) requires separate
discussion. There is at present no medical consensus concerning the
definition or the nature of this disorder. EPA is aware that some
individuals and their physicians report they are unusually sensitive to
multiple chemicals to which the general population is commonly exposed
without ill effect. One person who spoke at the public hearing asserted
that she is so sensitive to chemicals that she cannot use a dishwashing
machine in her home. While EPA recognizes the formidable challenges and
problems which may be faced by such individuals as they attempt to
function in modern industrial society, such unusual and extreme
sensitivity is not among the effects that EPA was directed to consider
in identifying and listing hazardous air pollutants.
EPA is aware that a number of individuals in the Irmo-St. Andrews
area have firmly concluded that caprolactam is the cause of health
problems which they or their families have experienced. EPA accepts the
concern and personal sincerity of these individuals' beliefs, but is
not aware of any scientific evidence which would support them. EPA
acknowledges the disappointment its decision to delist will cause these
individuals, but respectfully suggests that the substantive changes at
the Irmo facility have more practical significance to them than the
plausibility of the claimed effects. EPA has taken steps which assure
that there will be Federally enforceable reductions of caprolactam
emissions at the Irmo facility equivalent to those which would have
been required had caprolactam remained on the list of hazardous air
pollutants, and that such reductions will be in place years before they
would otherwise have been required.
The Agency for Toxic Substances and Disease Registry (ATSDR)
commented on the EPA discussion of an ATSDR report in the proposed
rule. ATSDR noted that EPA had called the report a ``preliminary
screening study,'' although the ATSDR reviewed only the available
literature, environmental monitoring data, and written and verbal
reports of health concerns from individuals, and no health screening
was performed on individuals. ATSDR also noted that the proposed rule
had misquoted the ATSDR report, and that its conclusions concerning the
Irmo Facility should not be generalized or applied to other facilities.
The use by EPA of the term ``preliminary screening study'' was not
intended to imply that any health screening had been performed by
ATSDR, and EPA regrets any confusion this phrase may have caused. In
its report, ATSDR did reach conclusions regarding the Irmo facility
which are consistent with the EPA analysis, but the determination by
EPA that the
[[Page 30820]]
statutory criterion for delisting has been met is not predicated on the
ATSDR conclusions. As far as the quotation from the ATSDR report in the
proposed rule, the omission of several words was inadvertent. The
correct quotation is:
``* * * the concentration of hazardous substances found in
ambient air sampling were not of health concern and the community
health concerns were not plausibly related to the release of
hazardous substances.'' (correction italicized)
Finally, although the determination by EPA that caprolactam meets
the statutory criterion for delisting is generic in nature, EPA never
intended to generalize the ATSDR findings to other facilities or the
communities in which they are located.
One frequent comment by the residents in the Irmo-St. Andrews area
was that EPA should study the residents of that area before proceeding
to delist caprolactam. EPA has carefully evaluated the feasibility and
scientific value of an epidemiologic study and has determined that it
would neither be practical or informative. In its evaluation, EPA
utilized five criteria for determining the feasibility of community
environmental studies suggested by Bender, et al., in a 1990 article in
the American Journal of Epidemiology. A memorandum summarizing this EPA
evaluation has been included in the docket.
The EPA evaluation makes it clear that a meaningful study of
persons exposed to caprolactam emissions from the Irmo facility cannot
be conducted. Key problems with such a study include the selection of
biologically plausible health effects in the exposed population, the
identification and measurement of other factors which might contribute
to these health effects, and the lack of adequate statistical power to
detect differences between exposed and unexposed populations.
As noted above, it is difficult to identify the specific health
effects which would be the focus of such a study. If there were an
unusual cluster of a single rare disease in the community, a credible
allegation of a potential relation between that disease and caprolactam
exposure, and all persons with that disease from an identified
population including exposed individuals could be examined, a case-
control study might be practicable. However, none of these factors are
present here.
A cohort study of an exposed population (such as students at a
nearby elementary school) would also be impractical. The non-specific
complaints in the upper respiratory tract which are most frequently
asserted by residents to be potentially related to caprolactam exposure
have a very high incidence in any population. Such upper respiratory
complaints can be caused by other pollutants, allergens, and infectious
agents, and it would be difficult if not impossible to adequately
control for these confounding factors in the study and control
populations. Finally, the size of any potentially exposed valid study
population that could be identified would probably not be large enough
to provide sufficient statistical power to detect significant
differences even if they do exist.
EPA realizes that there is a perception by many concerned citizens
that any hypothetical relation between actual exposures and actual
health effects can be scientifically studied. Unfortunately, this is
not the case. Given the currently available information and the
analytic tools provided by current science, EPA sees little or no
utility to an epidemiologic study of caprolactam exposure in the Irmo-
St. Andrews area. This is similar to the conclusion reached by ATSDR in
its report.
D. Exposure Information
One commenter stated that the exposure estimates by the petitioners
and by EPA were incomplete because they did not consider caprolactam
emissions from hot mix asphalt (HMA) plants. The commenter estimated
that caprolactam emissions from individual HMA plants could exceed the
major source threshold of 10 tons per year, and that total caprolactam
emissions from such facilities could be as high as 18,000 tons per
year. Caprolactam is an ingredient in liquid anti-stripping agents
containing bis(hexamethylene)triamine (BHMT), which are used in some
HMA plants.
Prior to submission of this comment, EPA was unaware of HMA plants
as a potential source of caprolactam emissions. If the commenter's
estimates of emissions from HMA plants were determined to be correct,
it was clear that the failure of the petitioners to address such
emissions in their petition had been a significant omission.
AlliedSignal investigated emissions of caprolactam from HMA plants
and submitted comments summarizing its findings. Although the commenter
had estimated based on a material safety data sheet for one anti-
stripping agent that caprolactam levels in such products are 5%, the
actual level of caprolactam found in this product by AlliedSignal was
.38%. In nine such products tested by AlliedSignal, the average
caprolactam level was .79%, and the highest level found was 1.8%. Based
on other assumptions suggested by the original commenter, AlliedSignal
estimated that worst-case emissions from an HMA plant using a liquid
anti-stripping agent containing the maximum caprolactam level of 1.8%
would be 3.6 tons per year. AlliedSignal noted that not all HMA plants
use liquid anti-stripping agents, and not all such agents contain BHMT
(and thus caprolactam). Based on estimates of the total quantity of
liquid anti-stripping agents produced annually, and the percentage of
such agents containing BHMT, AlliedSignal concluded that no more than
27 tons/year of caprolactam is emitted from all HMA plants.
EPA considers the estimates by AlliedSignal of caprolactam
emissions by HMA plants to be reasonable based on the information
provided. Based on these estimates, no single HMA plant would
constitute a major source of caprolactam. Because the estimated
emissions from plants in the HMA source category are lower than
reported emissions from the other source categories evaluated in the
original petition, EPA does not believe that emissions from such
sources would affect its conclusion that the statutory criterion for
delisting has been met.
Several commenters expressed doubt as to the reliability of the
exposure modeling on which the caprolactam delisting petition and the
EPA risk assessment are based. In general, EPA believes that the
exposure models utilized by the petitioners produce conservative
results. Although actual ambient monitoring data around facilities
emitting caprolactam is very limited, AlliedSignal submitted
information indicating that actual measurements of ambient caprolactam
levels at a monitoring station near its Irmo facility operated by the
State of South Carolina Department of Health and Environmental Control
were generally less than the concentrations for that location which
were predicted by modeling.
Several commenters expressed concern that the EPA conclusions
regarding the adverse effects of current caprolactam emissions do not
assure that new sources with greater caprolactam emissions than those
identified in the petition will not emerge in the future. A related
concern was that the agreements with AlliedSignal regarding control of
caprolactam emissions at its manufacturing facilities will not affect
emissions at future facilities.
EPA does not interpret Section 112(b)(3)(C) to require
consideration of hypothetical emissions from facilities that might be
constructed in the future.
[[Page 30821]]
The logical consequence of such an expansive construction would be that
no substance could ever be delisted, due to the hypothetical
possibility of some future facility with emissions large enough to
cause adverse effects. In the event that some future facility has
uncontrolled caprolactam emissions great enough to change the
conclusions of the present EPA risk assessment, EPA can revisit its
decision to delist caprolactam at that time.
EPA readily acknowledges that the agreements with AlliedSignal do
not apply to other caprolactam emitting facilities, either those
presently in existence or those which might be constructed in the
future. Although EPA has been unable to establish any link between
caprolactam emissions at the Irmo facility and health effects in that
community, EPA negotiated an agreement with AlliedSignal concerning
installation of additional emission controls in order to alleviate the
stated concerns of the residents in that community. EPA also reached
agreement with AlliedSignal concerning control of emissions at its
Chesterfield, VA manufacturing facility because that facility had large
uncontrolled caprolactam emissions analogous to those at the Irmo
facility. While EPA does not consider the Federally enforceable
reductions in caprolactam emissions at either of these facilities to be
essential to meet the statutory criteria for delisting, these
reductions do provide substantial additional assurance that adverse
human health effects will not occur. Moreover, the agreed reductions
will be in place well before any mandatory emission reductions which
would have resulted from the continued listing of caprolactam as a
hazardous air pollutant.
E. Emission Reductions by AlliedSignal
Several commenters from the Irmo-St. Andrews area expressed doubt
concerning the enforceability of the caprolactam reductions at the Irmo
facility which have been agreed to by AlliedSignal. Such comments are
simply erroneous. AlliedSignal has unequivocally agreed that the key
terms and conditions which assure such reductions will be incorporated
into the Federally enforceable Title V operating permit for the Irmo
facility. This is the same permit which would have been utilized to
enforce any emission standard controlling caprolactam emissions from
this facility adopted pursuant to Clean Air Act Section 112.
In its comments, PURE argued that EPA should not presume that the
emission reductions to be achieved by AlliedSignal at the Irmo facility
are equivalent to the reductions which would be required by a Maximum
Achievable Control Technology (MACT) standard issued under Section 112,
because EPA has not gone through the steps which would be necessary to
determine what MACT would be. Since any MACT standard issued for the
source category including the AlliedSignal Irmo facility would not be
issued until years from now, EPA cannot say with precision what such a
standard would ultimately require. However, EPA has determined that the
emissions control technology being installed at the AlliedSignal Irmo
and Chesterfield facilities is likely to perform at least as well as
that which has been demonstrated at other well-controlled facilities.
EPA bases its conclusions concerning the effectiveness of emission
controls being installed at the AlliedSignal facilities on the emission
and production information contained in the petition and produced by
the petitioners during the rulemaking, and on visits by EPA to several
operating Nylon 6 production facilities, including the AlliedSignal
Irmo facility and the BASF Clemson facility. (PURE representatives have
cited BASF as a company which does a good job of controlling its
caprolactam emissions.) EPA has evaluated each of six Nylon 6
production facilities to determine the ratio of the amount of
caprolactam emitted to the amount of Nylon 6 fiber production. The
ratio of emissions to production at the AlliedSignal Irmo and
Chesterfield facilities after all required controls have been installed
will be less than the present ratio of emissions to production at all
other facilities except the BASF Anderson plant, which has lower
emissions because it spins Nylon 6 fiber but receives polymerized
caprolactam from another site. Although the analysis underlying a MACT
standard would be more detailed, and would likely involve separate
analysis of caprolactam emissions for polymerization, depolymerization,
and spinning operations, EPA considers it improbable that a MACT
standard based on presently demonstrated technologies would require
greater control of caprolactam emissions at the AlliedSignal facilities
than is required by the agreements AlliedSignal has executed.
Several commenters complained that the agreement between EPA and
AlliedSignal does not adequately regulate emergency releases from the
plant. Under general MACT provisions, releases during periods of upset
and abnormal operation are not considered in determining compliance
with MACT standards. Thus, the implicit assumption that a MACT standard
would regulate emergency releases more stringently than the agreement
is mistaken. In addition, the commenters appear to overestimate the
significance of such releases. Figures provided by AlliedSignal
indicate that additional caprolactam emissions associated with
scheduled maintenance and unscheduled malfunctions of emission control
equipment at the Irmo facility represent less than one percent of the
total caprolactam emissions by that facility.
The agreement concerning the AlliedSignal Irmo facility does
contain provisions which require expeditious reporting of any emission
control equipment upset or malfunction, as well as any emergency
releases, to the South Carolina Department of Health and Environmental
Control. The agreement also requires prompt repair of any
malfunctioning emission control equipment, and installation of pressure
control devices on those emission points most susceptible to emergency
releases.
F. Delisting Criteria
In its comments, PURE asserted that EPA is required to consider
occupational exposures in deciding whether to delist caprolactam. EPA
firmly disagrees with this comment. The language of Section
112(b)(3)(C) refers to ``emissions, ambient concentrations,
bioaccumulation, or deposition of the substance.'' Nothing in this
language suggests that EPA should consider worker exposures in its
delisting assessment. Moreover, it would be illogical to assume that
worker exposures should be considered in deciding whether to delist
when continued listing would not itself lead to any requirement that
occupational exposures be controlled.
In its comments, PURE also argued that the proposed delisting would
be unlawful because it assumes future compliance by AlliedSignal with
the agreed emission reductions, thereby circumventing the purposes of
the Clean Air Act. It could be argued that consideration of future
emission reductions in a decision to delist a substance from the list
of hazardous air pollutants is a reasonable construction of Section
112(b)(3)(C) consistent with the purposes of the Clean Air Act, so long
as such reductions will be as enforceable as those which might be
required by a MACT standard and will be in place before any MACT
standard could be issued. However, in this instance it was not
necessary to resolve this question. EPA has determined that
[[Page 30822]]
the petitioners have satisfied the statutory criterion for delisting in
Section 112(b)(3)(C) based on the emissions reported in the delisting
petition. The agreements by AlliedSignal requiring enforceable
reductions in caprolactam emissions at its facilities provide
additional assurance that the agency's determination is correct, but
are not an essential element in the risk assessment on which that
determination is based.
III. Final Rule
A. Rationale for Action
The detailed factual rationale supporting the Agency's initial
determination that the criterion in Clean Air Act Section 112(b)(3)(C)
had been met is set forth in the proposed rule published in the Federal
Register on September 18, 1995 (60 FR 48081). As is apparent from the
discussion above, although EPA has done substantial additional analysis
pursuant to the comments submitted during the subsequent rulemaking,
none of those comments have caused EPA to revise the basic scientific
analysis on which that initial determination was predicated. EPA hereby
incorporates in its rationale for this final rule the substantive
assessment of potential hazards, projected exposures, human risk, and
environmental effects set forth in the proposed rule to delist
caprolactam. Based on that assessment, the Agency's evaluation of the
comments and additional information submitted during the rulemaking (as
summarized above), and on the other materials which have been
incorporated in the public docket for this rulemaking, EPA has made a
determination that there is adequate data on the health and
environmental effects of caprolactam to determine that emissions,
ambient concentrations, bioaccumulation or deposition of caprolactam
may not reasonably be anticipated to cause any adverse effects to human
health or adverse environmental effects. On that basis, caprolactam is
hereby deleted from the list of hazardous air pollutants set forth in
Clean Air Act Section 112(b)(1). This deletion shall be final on the
effective date of this rule.
B. Implementation
Although EPA intends in the future to conduct a rulemaking to
codify the hazardous air pollutant list set forth in Clean Air Act
Section 112(b)(1) and to correct various technical errors in the
statutory list which have been identified since 1990, the list is at
present uncodified. Therefore, today's rule does not revise the text of
any existing provision of the Code of Federal Regulations. However, on
the effective date of this rule, caprolactam will be deleted for all
purposes from the list set forth in Section 112(b)(1). To avoid
confusion concerning the status of caprolactam, pending the rulemaking
which will codify and correct the list set forth in Section 112(b)(1),
EPA will add to the Code of Federal Regulations a brief provision
confirming that caprolactam has been deleted from the list.
EPA included in the proposed rule to delist caprolactam a provision
providing immediate relief, on an interim basis, for certain facilities
which might otherwise have been required to apply for Title V operating
permits based solely on the continued inclusion of caprolactam on the
list of hazardous air pollutants. That provision suspended the listing
of caprolactam, for the duration of this rulemaking, solely for the
limited purpose of determining the applicability of Title V permitting
requirements. The interim relief provided in the proposed rule is no
longer necessary and will expire by its own terms on the effective date
of this final rule.
C. Effective Date
This final rule will be effective on June 18, 1996, the date it is
published in the Federal Register. Although Section 553(d) of the
Administrative Procedure Act, 5 U.S.C. 553(d), provides that
substantive rules must be published at least 30 days prior to their
effective date, this requirement does not apply to this rule. First,
this rule was promulgated pursuant to Clean Air Act Section 307(d), and
that provision expressly states that the provisions of Section 553 do
not apply to this action. Second, even under Section 553, the
requirement that a rule be published 30 days prior to its effective
date does not apply to a rule
``which grants or recognizes an exemption or relieves a
restriction.''
D. Judicial Review
This final rule deleting caprolactam from the list of hazardous air
pollutants in Clean Air Act Section 112(b)(1) is based on a
determination of nationwide scope and effect. A petition for judicial
review of this final rule may be filed solely in the United States
Court of Appeals for the District of Columbia. Any such petition for
judicial review of this rule must be filed no later than August 19,
1996. In any resulting action, no objection can be made which was not
raised with reasonable specificity during the period for public comment
(including the public hearing).
IV. Miscellaneous
A. Executive Order 12866
Under Executive Order 12866 (58 FR 57735, October 4, 1993), EPA
must determine whether this rule is ``significant'' and therefore
subject to review by the Office of Management and Budget under the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
1. Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or tribal governments or communities;
2. Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
3. Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
4. Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
This action will not result in an annual effect on the economy of
$100 million or another adverse economic impact, does not create a
serious inconsistency or interfere with another agency's action, and
does not materially alter the budgetary impacts of entitlement, grants,
user fees, etc. While States may lose Title 5 permit fees as a direct
result of this rule, the number of affected facilities is not believed
to be significant. However, since this action is the Agency's first
decision to modify the hazardous air pollutant list, EPA believes that
it could be construed as raising novel legal or policy issues and has
therefore submitted this rule for OMB review under Executive Order
12866.
B. Regulatory Flexibility Analysis
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. This rule will
reduce regulatory burdens on small businesses which would otherwise be
associated with retention of caprolactam on the list of hazardous air
pollutants. EPA has determined that this rule will have no adverse
effect on small businesses. Accordingly, this rule will not have ``a
significant impact on a substantial number of small entities,'' as that
phrase is utilized in Section 605(b) of the Regulatory Flexibility Act,
as amended.
[[Page 30823]]
C. Unfunded Mandates
Under Section 202 of the Unfunded Mandates Reform Act of 1995, EPA
must prepare a written statement to accompany any rules that have
``Federal mandates'' that may result in the expenditure by the private
sector of $100 million or more in any one year. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objective of such a rule and that is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising small governments that may be significantly
and uniquely affected by the rule.
The Unfunded Mandates Act defines a ``Federal private sector
mandate'' for regulatory purposes as one that, among other things,
``would impose an enforceable duty upon the private sector.'' This
final rule to modify the hazardous air pollutant list to delete
caprolactam is deregulatory in nature and does not impose any
enforceable duties upon the private sector. Therefore, this rulemaking
is not a ``Federal private sector mandat'' and is not subject to the
requirements of Section 202 or Section 205 of the Unfunded Mandates
Act. As to Section 203, EPA finds that small governments will not be
significantly and uniquely affected by this rulemaking.
D. Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances.
Dated: June 7, 1996.
Carol M. Browner,
Administrator.
40 CFR part 63 is amended as follows:
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart C--[Amended]
2. Subpart C is amended by adding Sec. 63.60 and adding and
reserving Secs. 63.61 through 63.69 to read as follows:
Sec. 63.60 Deletion of caprolactam from the list of hazardous air
pollutants.
The substance caprolactam (CAS number 105602) is deleted from the
list of hazardous air pollutants established by 42 U.S.C. 7412(b)(1).
Secs. 63.61-63.69 [Reserved]
[FR Doc. 96-15445 Filed 6-17-96; 8:45 am]
BILLING CODE 6560-50-P
