Hazardous Air Pollutant List; Proposed Modification

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

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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]

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