[Federal Register Volume 60, Number 180 (Monday, September 18, 1995)]
[Proposed Rules]
[Pages 48081-48085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22954]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[FRL-5296-2]
RIN 2060-AF33
Hazardous Air Pollutant List; Proposed Modification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The proposed rule, upon promulgation, will amend the Clean Air
Act (Act) list of hazardous air pollutants (section 112(b)(1), by
removing the compound caprolactam (CAS No. 105-60-2). This action is
being taken in response to a petition to delete the substance
caprolactam which was filed by AlliedSignal, Inc., BASF Corporation,
and DSM Chemicals North America under section 112(b)(3) of the Act. The
EPA is granting the petition by issuance of this proposed rule. The
decision to grant the petition is based on the Agency's examination of
the available information concerning the potential hazards of and
projected exposures to caprolactam. Based on this information, EPA has
made an initial determination that there are adequate data on the
health and environmental effects of caprolactam to determine that
emissions, ambient concentrations, bioacccumulation, or deposition of
the compound are not reasonably anticipated to cause adverse human
health or environmental effects. This determination also takes into
consideration the likelihood of adverse effects in light of the very
limited potential for ambient inhalation exposure.
DATES: Written comments must be received on or before November 2, 1995.
The EPA will hold a public hearing if EPA receives a written request
for such a hearing on or before October 18, 1995. If a hearing is
requested in a timely manner, EPA will keep the record open for thirty
days after such hearing to receive rebuttal or supplementary
information.
ADDRESSES: Submit written comments (duplicate copies preferred) to:
Central Docket Section (A-130), Environmental Protection Agency,
Attention: Docket No. A-94-33, 401 M St. SW., Washington, D.C. 20460.
The docket includes a copy of the original petition, comments submitted
concerning that petition, and additional materials supporting the
proposed rule. The docket may be inspected between 8:00 a.m. and 4:30
p.m. on weekdays at EPA's Central Docket Section, West Tower Lobby,
Gallery 1, Waterside Mall, 401 M St., SW, Washington, D.C. 20460. A
reasonable fee may be charged for copying.
FOR FURTHER INFORMATION 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:
Table of Contents
I. Background
II. Criteria for Delisting
III. Summary of the Petition
IV. EPA Analysis of Petition
A. Hazard Evaluation
B. Exposure Evaluation
C. Human Risk Determination
D. Environmental Effects
V. Proposal to Delete
VI. Interim Relief
VII. Miscellaneous
A. Executive Order 12866
B. Regulatory Flexibility Analysis
C. Unfunded Mandates
I. Background
Section 112 of the 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 promulgate emissions
standards. The listed categories are subject to emission standards
subsequently developed under section 112. The EPA must periodically
review the list of hazardous air pollutants and, where appropriate,
revise this list by rule. In addition, any person may petition EPA
under section 112(b)(3) to modify the list by adding or deleting one or
more substances. A petitioner seeking to delete a substance must
demonstrate that there are 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 human
health or the environment. To sustain this burden, a petitioner must
provide a detailed evaluation of the available data concerning the
substance's potential adverse health and environmental effects, and
estimate the potential exposures through inhalation or other routes
resulting from emissions of the substance.
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), 42 U.S.C., section
7412(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
[[Page 48082]]
effects data. A petition must also provide comprehensive emissions
data, including current peak and annual 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. The EPA found the petition to delete caprolactam to be
complete and published a notice of receipt and request for comments in
the Federal Register on August 26, 1993 (58 FR 45081).
The EPA received ten submissions in response to the request for
comments concerning the caprolactam petition. Eight of these
submissions related to an AlliedSignal facility that emits caprolactam
which is located in Irmo, South Carolina. A number of Irmo residents
reported health problems that they believed were associated with
caprolactam emissions from this plant. The EPA subsequently met with a
local citizens' group, representatives of AlliedSignal, and the South
Carolina Department of Health and Environmental Control to discuss the
citizens' concerns regarding caprolactam emissions from the facility,
and to explore mechanisms which could lead to prompt installation of
additional controls of such emissions.
On March 13, 1995, EPA executed two detailed 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. AlliedSignal agreed
that, if caprolactam is delisted pursuant to this proposal,
AlliedSignal will install emissions controls 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 emissions 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 agreed to establish a citizen advisory panel
concerning the Irmo facility in order to improve communications with
the community and to assure that citizens have an ongoing role in
implementation of the agreed emission reductions.
II. Criteria for Delisting
Section 112(b)(2) of the Act 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 Section 307(b) of the Act.
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.
The 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.
The 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. The 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.
III. Summary of the Petition
The petition to delete caprolactam stated that the petitioners
comprise 100 percent of the U.S. caprolactam producers and caprolactam
by-product ammonium sulfate manufacturers, 88 percent of the Nylon 6
fiber producers, 72 percent of the Nylon 6 plastic producers, and the
only major supplier of Nylon 6 films. The petition contained the
following information:
(A) Identification and location of all facilities producing or
using caprolactam;
(B) Estimated current and future air emissions of caprolactam,
atmospheric modeling and monitoring data supporting the estimation of
peak short-term and annual average ambient concentrations, estimates of
the number people potentially exposed to those concentrations, and
estimated deposition of caprolactam to the land and surface water;
(C) Documentation of a literature search conducted within 6 months
prior to the petition filing, including identification of the data
bases searched, the search strategy, and printed results;
[[Page 48083]]
(D) Printed copies of all human, animal, in vitro, or other
toxicity studies cited in the literature search. In addition, the
petition contained unpublished occupational health data and studies
collected at the AlliedSignal facility in Hopewell, Virginia;
(E) Printed copies of environmental effect data characterizing the
fate of caprolactam when it is released into the atmosphere. This
information includes atmospheric residence time, solubility, phase
distribution, vapor pressure, octanol/water partition coefficient,
particle size, adsorption coefficients, information on atmospheric
transformations, potential degradation or transformation products, and
bioaccumulation potential; and
(F) A list of all support documents in the petition.
IV. EPA Analysis of Petition
A. Hazard Evaluation
The EPA reviewed the discussion of health effects in the petition
and determined that it comprehensively describes the toxicologic and
epidemiologic data concerning caprolactam which is currently available.
There is extensive toxicologic information concerning caprolactam, but
most of the available studies involve ingestion rather than inhalation
of the substance.
The toxicologic information on ingestion of caprolactam includes
long-term bioassays in mice and rats, a three generation reproduction
study in rats, subchronic studies in rats, developmental toxicity
studies in rats and rabbits, and even administration to humans. In
general, the oral studies indicate that caprolactam has low toxicity.
In the available studies, caprolactam was not found to be carcinogenic
or mutagenic. Caprolactam caused neurotoxicity in some acute studies at
high doses. The most sensitive endpoint in the available oral studies
was reduced mean body weight of offspring in a reproductive study in
rats (no observed adverse effect level of 50 mg/kg/day).
The no-observed adverse effect level (NOAEL) for reduced mean body
weight of offspring in the rat study was used by EPA to derive its
current reference dose (RFD) for caprolactam of 0.5 mg/kg/day. The RFD
is defined as an estimate (with uncertainty spanning perhaps an order
of magnitude) of the daily exposure to the human population (including
sensitive subpopulations) that is likely to be without deleterious
effects during a life time. The EPA has assigned a ``high'' confidence
level to the RFD for oral exposure to caprolactam.
The available animal data on inhalation of caprolactam consist of
two acute toxicity studies, one in guinea pigs and the other in rats.
Caprolactam is a highly water soluble solid with a very low vapor
pressure at ambient temperatures. These physical properties make it
difficult to generate stable atmospheres of caprolactam for use in
inhalation toxicity studies and to exclude secondary exposure to
caprolactam by other routes.
Given the present lack of suitable inhalation data, EPA concluded
that derivation of an inhalation reference concentration (RfC) for
caprolactam was infeasible. The petitioners sought to derive an
equivalent human inhalation dose from the oral RFD for caprolactam by
adjusting for human body weight and inhalation rate. The similarity
between the LC50 by the inhalation route and the LD50 by the
oral route in rats does not suggest any important differences in
systemic effects from acute exposures between the two routes. However,
it is inappropriate to utilize an inhalation dose derived from the oral
RFD for all potential adverse effects because caprolactam is a
respiratory irritant. Portal of entry effects preclude use of route-to-
route extrapolation for such a purpose. Moreover, any comparison
between the oral and inhalation routes must consider the possibility of
pharmacokinetic and metabolic differences between the routes.
As noted above, the most sensitive endpoint in the available oral
studies was reduced mean body weight of offspring in a reproductive
toxicity study in rats (no observed adverse effect level of 50 mg/kg/
day). The EPA is reluctant to make quantitative comparisons between the
oral and inhalation routes and EPA has been unable to validate any
general procedures for extrapolation between these routes. Although EPA
considers it questionable to evaluate inhalation risks for many chronic
effects based on oral data, EPA sometimes evaluates the risk of
developmental/reproductive effects by the inhalation route based on an
appropriate oral study. In this instance, the oral NOAEL of 50 mg/kg/
day would be equivalent to approximately 175 mg/m\3\, after adjusting
for a human body weight of 70 kg, 100 percent absorption, and a human
inhalation rate of 20 m\3\/day.
Limited occupational studies of workers with chronic caprolactam
exposure have not found any measurable change in pulmonary function
compared to matched controls. Chronic workplace exposures to
caprolactam in these studies ranged as high as 9,900 g/m\3\
(9.9 mg/m\3\). However, respiratory tract irritation from caprolactam
vapor has been recorded to occur in workers at 46 mg/m\3\. The
recommended worker exposure limit for caprolactam vapor, established to
reduce the potential for irritation, is 23 mg/m\3\ (ACGIH TWA). Both
concentrations are far below the figure of 175 mg/m\3\ extrapolated
above.
B. Exposure Evaluation
The primary use of caprolactam is as the monomer for manufacture of
Nylon 6 fiber, resin, and film. Approximately 83 percent of
domestically-manufactured caprolactam is used in the production of
Nylon 6 fibers, and virtually all of the rest is used to produce Nylon
6 resins and films.
The EPA believes that inhalation is the only important route of
nonoccupational exposure resulting from caprolactam emissions. Dermal
absorption is likely to be insignificant compared to inhalation. The
rapid biodegradation of caprolactam in water as well as the ease of
treatability in sewage treatment systems indicates that humans are
unlikely to be exposed to significant amounts of caprolactam in
drinking water. In addition, caprolactam emitted to the air would be
unlikely to concentrate in food sources.
The EPA source category list identifies three categories of sources
which emit caprolactam: caprolactam manufacturers, ammonium sulfate
manufacturers, and Nylon 6 manufacturers. In their petition, the
petitioners evaluated caprolactam releases by each of these types of
facilities, as well as two additional categories of facilities: Nylon 6
film manufacturers and facilities that heat set Nylon 6 fiber as part
of the manufacture of other products.
The highest annual emissions of caprolactam by an individual
facility reported in the petition were at the AlliedSignal Nylon 6
manufacturing plants in Chesterfield, Virginia (233.5 tons/year), and
Irmo, South Carolina (164.4 tons/year). As noted above, AlliedSignal
has committed to install emission controls at each of these facilities
which will be fully operational well before any controls would be
required based on any standard promulgated under section 112. These
commitments will be implemented through legally enforceable permit
terms and are expected to reduce aggregate caprolactam emissions
(including uncontrolled fugitive emissions) at these facilities by more
than one half, to approximately 111 tons/year and 79 tons/year.
The petitioners presented modeled maximum exposure levels for every
[[Page 48084]]
major source of caprolactam (sources emitting more than 10 tons
annually). The highest estimated caprolactam exposures were for
AlliedSignal's Chesterfield manufacturing facility, at which the
petitioners estimated that the maximum 1-hour concentration would be
1107.8 g/m\3\ and the maximum annual concentration would be
44.7 g/m\3\. After controls are installed at the Chesterfield
and Irmo facilities, the projected maximum 1-hour concentrations will
be 543 g/m\3\ and 482 g/m\3\ respectively, and the
projected maximum annual concentrations will be 19 g/m\3\ and
21 g/m\3\.
Once the agreed emission controls are installed at the AlliedSignal
facilities, the highest modeled caprolactam concentrations will be at
certain of the facilities that heat set Nylon 6 fiber. However, the
annual caprolactam emissions at these facilities will still be less
than the emissions at the AlliedSignal manufacturing facilities, even
after controls have been installed at the AlliedSignal facilities. The
higher modeled concentrations at facilities that heat set Nylon 6 fiber
reflect the more conservative modeling techniques used for these
facilities (the petitioners used ISCST modeling for their own
manufacturing facilities and Tier II screen modeling for other
sources).
C. Human Risk Determination
The maximum modeled concentrations for caprolactam of approximately
1 mg/m \3\ for 1-hour, 0.25 mg/m \3\ for 24-hour, and 0.05 mg/m \3\ for
annual are well below the lowest documented nose and throat irritation
level of 46 mg/m \3\. Moreover, the emission controls which
AlliedSignal has agreed to install at its manufacturing facilities will
significantly reduce the prospect that any person will be exposed to
caprolactam concentrations as great as the maximum estimates presented
in the petition.
As noted above, some citizens living near the AlliedSignal facility
in Irmo, South Carolina, report that they have experienced adverse
health effects in the past which they believe are a result of
caprolactam emissions from that facility. The EPA has discussed these
concerns at length with local citizens, and has made considerable
efforts to assure that prompt and enforceable reductions in caprolactam
emissions are achieved at the Irmo facility. However, EPA cannot
conclude that there is any relation between caprolactam emissions and
the reported health effects based on the information currently
available. In 1993, in response to the concerns of citizens living near
the Irmo facility, the Agency for Toxic Substance and Disease Registry
(ATSDR) conducted a preliminary screening study and recommended that a
full study not be conducted since ``the concentrations of hazardous
substances found in the ambient air sampling were not of health concern
and were not plausibly related to the release of hazardous
substances.'' While the ATSDR investigators acknowledged that hazardous
substances were present in air releases from the facility, they also
stated that the reported symptoms could be associated with naturally
occurring allergens in the local environment.
The available oral toxicology data do not suggest that caprolactam
is appreciably toxic in humans or test animals. The emission controls
which AlliedSignal has agreed to install at its manufacturing plants
should further reduce the prospect for actual exposures as great as the
maximum exposures estimated in the petition. Even though extrapolation
of oral data to the inhalation route of exposure is suspect and
uncertainties remain about portal of entry effects from long-term
exposure, the available information as a whole indicates that adverse
health effects would not be reasonably anticipated in the human
populations located near facilities emitting caprolactam. This
conclusion is reinforced by consideration of the likelihood of adverse
effects given the very limited potential for ambient inhalation
exposure. Based on this information, EPA has made an initial
determination that there are adequate data on the health and
environmental effects of caprolactam to determine that emissions,
ambient concentrations, bioacccumulation, or deposition of caprolactam
are not reasonably anticipated to cause adverse human health effects.
As explained above, the physical properties of caprolactam tend to
make additional inhalation testing difficult to conduct and to
interpret. As a result of discussions with EPA, the petitioners
conducted an inhalation feasibility study and have now agreed to
conduct a 90-day subchronic inhalation study in rats. The variations in
exposure concentrations at the targeted exposure levels in the 90 day
subchronic inhalation study will likely be high. In addition, the
inhalation concentrations generated may not reach the levels which
would cause any of the potential systemic effects predicted by studies
using the oral route but may achieve concentrations that would produce
portal of entry effects.
The EPA anticipates that the results from the 90-day study which
the petitioners have agreed to conduct will not materially alter the
current EPA assessment. Moreover, EPA does not intend to defer final
action in this rulemaking pending submission and analysis of the
results from this inhalation study. If the results of this study
indicate that there are portal of entry effects or systemic effects
from inhalation exposure at levels significantly below those suggested
by the Agency's present assessment, EPA will review any final action
taken in this rulemaking in light of such data.
D. Environmental Effects
In order to delete a substance from the hazardous air pollutant
list, EPA must also evaluate potential environmental effects associated
with emissions of the substance. In the case of caprolactam, the
information in the petition demonstrates that caprolactam will be
rapidly degraded, and is not likely to bioaccumulate, in aquatic
ecosystems. Caprolactam also has low toxicity to fish, invertebrates,
and higher terrestrial plants. Based on this information, EPA has made
an initial determination that there are adequate data on the health and
environmental effects of caprolactam to determine that emissions,
ambient concentrations, bioacccumulation, or deposition of caprolactam
are not reasonably anticipated to cause environmental effects.
V. Proposal to Delete
The EPA hereby proposes to modify the Act list of hazardous air
pollutants (section 112(b)(1), 42 U.S.C. 7412(b)(1)) by deleting the
compound caprolactam (CAS No. 105-60-2).
VI. Interim Relief
Although EPA has proposed to modify the hazardous air pollutant
list by deleting caprolactam, it will remain on the list for most
purposes during the pendency of the rulemaking initiated by this
notice. However, if caprolactam remains on the hazardous air pollutant
list for all purposes during the pendency of the rulemaking to delist
caprolactam, certain facilities which would not otherwise be required
to obtain operating permits under title V of the Act will be required
to prepare and submit applications for operating permits. The EPA has
determined that retention, during the rulemaking to delist caprolactam,
of permit application requirements which will no longer exist after the
delisting process has been completed would result in unnecessary
private and public expenditures on preparation, submission, and
processing of such
[[Page 48085]]
applications, and would yield no environmental benefits.
Because retention of the listing of caprolactam for purposes of
determining the applicability of title V operating permit requirements
during the rulemaking to delist would be burdensome and costly, and
would not effectuate the objectives of the Act, and because it would be
impracticable and contrary to the public interest to defer
administrative relief until after the rulemaking has been completed,
EPA has determined that there is good cause to immediately suspend the
listing of caprolactam for this limited purpose. Accordingly, EPA is
today suspending the listing of caprolactam, for the duration of the
rulemaking to delist caprolactam, for purposes of determining the
applicability of title V permitting requirements. This action provides
sensible regulatory relief for those facilities which manufacture or
utilize Nylon 6 products, and who will not otherwise be subject to
title V requirements once the delisting of caprolactam has been
completed. Any facilities which emit caprolactam but which are
otherwise subject to title V requirements are not affected by this
action, and must satisfy the applicable permitting requirements.
While the proposed rule to delist caprolactam is pending, State
permitting authorities should make any revisions or adjustments in
their title V operating programs necessary to implement today's action
suspending caprolactam from the hazardous air pollutant list for
purposes of determining the applicability of permitting requirements.
In the event that the Agency decides at the conclusion of the
rulemaking not to delete caprolactam from the list, the Agency will
work with affected facilities and State permitting authorities to
assure that any title V requirements resulting solely from that
decision are implemented in a fair and orderly manner.
VII. Miscellaneous
A. Executive Order 12866
Under Executive Order 12866 (58 FR 57735, October 4, 1993), the
Agency must determine whether this regulation, if promulgated, 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 entitlements, 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 entitlements,
grants, user fees, etc. However, since this proposal reflects the
Agency's first decision to grant a petition to modify the hazardous air
pollutant list, EPA has concluded that it might be construed as raising
novel legal or policy issues and has therefore submitted the proposal
for OMB review under Executive Order 12866.
B. Regulatory Flexibility Analysis
Section 603 of the Regulatory Flexibility Act, 5 U.S.C. 603,
requires EPA to prepare and make available for comment an ``initial
regulatory flexibility analysis'' in connection with any rulemaking for
which there is a statutory requirement that a general notice of
proposed rulemaking be published. The ``initial regulatory flexibility
analysis'' describes the effect of the proposed rule on small business
entities. However, section 605(b) of the Act provides that an analysis
not be required when the head of an agency certifies that the rule will
not, if promulgated, have a significant impact on a substantial number
of small entities.
Because adoption of this proposal would reduce regulatory burdens
which would otherwise result from retention of caprolactam on the
hazardous air pollutant list, EPA believes that this rule will have no
adverse effect on small businesses. For the preceding reason, I certify
that this rule will not have a significant economic impact on a
substantial number of small entities.
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
proposal 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 mandate'' 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.
Dated: September 8, 1995.
Carol M. Browner,
Administrator.
[FR Doc. 95-22954 Filed 9-15-95; 8:45 am]
BILLING CODE 6560-50-P
