[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