30816 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations

information collection burden estimates

made previously. The change to the

implementation plan requirements

merely extends the date for submission

of plans from existing sources. These

changes do not impose new

requirements. Consequently, the ICR has

not been revised.

B. Executive Order 12866 Review

Under Executive Order 12866, the

EPA must determine whether the

proposed regulatory action is ‘‘not

significant’’ and therefore, subject to

OMB review and the requirements of

the executive order. The Order defines

‘‘significant’’ regulatory action as one

that is likely to lead to 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 in

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.

The Shipbuilding NESHAP

promulgated on December 15, 1995 was

determined to not be a ‘‘significant

regulatory action’’ under Executive

Order 12866. Therefore, a regulatory

impact analysis was not prepared. The

amendments issued today extend dates

for submittal of implementation plans

and the compliance date and remove the

requirement for approval of

implementation plans. These changes

do not add any additional control

requirements or costs. Therefore, this

regulatory action does not affect the

previous decision and is not considered

to be significant.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980

requires the identification of potentially

adverse impacts of Federal regulations

upon small business entities. The Act

specifically requires the completion of a

Regulatory Flexibility Analysis in those

instances where small business impacts

are possible. Because this rulemaking

imposes no adverse economic impacts,

a Regulatory Flexibility Analysis has not

been prepared. Pursuant to Section

605(b) of the Regulatory Flexibility Act,

5 U.S.C. 605(b), the Administrator

certifies that this rule will not have a

significant economic impact on a

substantial number of small entities.

D. Submission to Congress and the

General Accounting Office

Under section 801(a)(1)(A) of the

Administrative Procedures Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996, EPA submitted a report containing

this rule and other required information

to the U.S. Senate, the U.S. House of

Representatives and the Comptroller

General of the General Accounting

Office prior to publication of the rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by section

804(2) of the APA as amended.

E. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995, the EPA

must prepare a budgetary impact

statement to accompany any proposed

or final rule that includes a Federal

mandate that may result in estimated

costs to State, local, or tribal

governments in the aggregate; or to the

private sector, of $100 million or more.

Under Section 205, the EPA must select

the least costly, most cost-effective or

least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires the

EPA to establish a plan for informing

and advising any small governments

that may be significantly or uniquely

impacted by the rule.

The EPA has determined that the

action promulgated today does not

include a Federal mandate that may

result in estimated costs of $100 million

or more to either State, local, or tribal

governments in the aggregate, or to the

private sector. Therefore, the

requirements of the Unfunded Mandates

Reform Act do not apply to this action.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Hazardous

substances, Reporting and

recordkeeping requirements.

Dated: June 7, 1996.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I, part 63,

subpart II, of the Code of Federal

Regulations is amended as follows:

PART 63—[AMENDED]

1. The authority citation for part 63

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

Subpart II—National Emission

Standards for Shipbuilding and Ship

Repair (Surface Coating)

2. Section 63.784 is amended by

revising paragraph (a) to read as follows:

§ 63.784 Compliance dates.

(a) Each owner or operator of an

existing affected source shall comply

within two years after the effective date

of this subpart.

* * * * *

3. Section 63.787 is amended by

revising paragraphs (b)(1)(ii) and (b)(4)

and by removing and reserving

paragraph (b)(2) to read as follows:

§ 63.787 Notification requirements.

* * * * *

(b) * * *

(1) * * *

(ii) Not later than one year after the

effective date of this subpart, submit the

implementation plan to the

Administrator along with the

notification required by § 63.9(b)(2) or

(b)(5) of subpart A, as applicable.

(2) [Reserved]

* * * * *

(4) Major sources that intend to

become area sources by the compliance

date. Existing major sources that intend

to become area sources by the December

16, 1997 compliance date may choose to

submit, in lieu of the implementation

plan required under paragraph (b)(1) of

this section, a statement that, by the

compliance date, the major source

intends to obtain and comply with

federally enforceable limits on their

potential to emit which make the

facility an area source.

* * * * *

[FR Doc. 96–15439 Filed 6–17–96; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 63

[AD–FRL–5520–5]

RIN 2060–AF33

Hazardous Air Pollutant List;

Modification

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is amending the list

of hazardous air pollutants in Clean Air

Act Section 112(b)(1) by removing the

compound caprolactam (CAS No. 105–

60–2). This rulemaking was initiated in

response to a petition to delete the

substance caprolactam which was filed

by AlliedSignal, Inc., BASF

Corporation, and DSM Chemicals North
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations 30817

America under section 112(b)(3) of the

Act. Based on the available information

concerning the potential hazards of and

projected exposures to caprolactam,

EPA has made a determination pursuant

to Clean Air Act Section 112(b)(3)(C)

that there are adequate data on the

health and environmental effects of

caprolactam to determine that

emissions, ambient concentrations,

bioaccumulation, or deposition of the

compound may not be reasonably

anticipated to cause adverse human

health or environmental effects.

Although EPA acknowledges that there

are scientific uncertainties in its

analysis of the potential effects of

ambient caprolactam exposures, EPA

does not regard any of these

uncertainties to be sufficiently material

to preclude this determination.

DATES: This final rule will be effective

on June 18, 1996. Because this final rule

is based on a determination of

nationwide scope and effect, any

petition for judicial review of this rule

may be filed only in the United States

Court of Appeals for the District of

Columbia and must be filed no later

than August 19, 1996.

ADDRESSES: The administrative record

supporting this final rule is collected in

Docket Number A–94–33. All

documents in that docket, including a

complete copy of the original petition,

all comments on the proposed rule, and

a transcript of the public hearing, may

be examined between 8:00 A.M. and

4:30 P.M. on business days at the EPA

Central Docket Section, Waterside Mall,

401 M St., SW, Washington, D.C. 20460.

FOR FURTHER INFORMATION CONTACT: For

specific information concerning this

final rule, contact Dr. Nancy B. Pate,

Office of Air Quality Planning and

Standards (MD–12), U.S. EPA, Research

Triangle Park, NC 27711, telephone

(919) 541–5347.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. The Delisting Process

Section 112 of the Clean Air Act

contains a mandate for EPA to evaluate

and control emissions of hazardous air

pollutants. Section 112(b)(1) includes an

initial list of hazardous air pollutants

that is composed of specific chemical

compounds and compound classes to be

used to identify source categories for

which the EPA will subsequently

promulgate emissions standards.

Clean Air Act Section 112(b)(2)

requires EPA to make periodic revisions

to the initial list of hazardous air

pollutants set forth in Section 112(b)(1)

and outlines criteria to be applied in

deciding whether to add or delete

particular substances. Section 112(b)(2)

identifies pollutants that should be

listed as:

* * * pollutants which present, or may

present, through inhalation or other routes of

exposure, a threat of adverse human health

effects (including, but not limited to,

substances which are known to be, or may

reasonably be anticipated to be, carcinogenic,

mutagenic, teratogenic, neurotoxic, which

cause reproductive dysfunction, or which are

acutely or chronically toxic) or adverse

environmental effects whether through

ambient concentrations, bioaccumulation,

deposition, or otherwise * * *

To assist EPA in making judgments

about whether a pollutant causes an

adverse environmental effect, Section

112(a)(7) defines an ‘‘adverse

environmental effect’’ as:

* * * any significant and widespread

adverse effect, which may reasonably be

anticipated, to wildlife, aquatic life, or other

natural resources, including adverse impacts

on populations of endangered or threatened

species or significant degradation of

environmental quality over broad areas.

Section 112(b)(3) establishes general

requirements for petitioning EPA to

modify the hazardous air pollutant list

by adding or deleting a substance.

Although the Administrator may add or

delete a substance on his own initiative,

the burden is on a petitioner to include

sufficient information to support the

requested addition or deletion under the

substantive criteria set forth in Sections

112(b)(3) (B) and (C). The Administrator

must either grant or deny a petition

within 18 months of receipt. If the

Administrator decides to grant a

petition, the Agency publishes a written

explanation of the Administrator’s

decision, along with a proposed rule to

add or delete the substance. If the

Administrator decides to deny the

petition, the Agency publishes a written

explanation of the basis for denial. A

decision to deny a petition is final

Agency action subject to review in the

D.C. Circuit Court of Appeals under

Clean Air Act Section 307(b).

To promulgate a final rule deleting a

substance from the hazardous air

pollutant list, Section 112(b)(3)(C)

provides that the Administrator must

determine that:

* * * there is adequate data on the health

and environmental effects of the substance to

determine that emissions, ambient

concentrations, bioaccumulation, or

deposition of the substance may not

reasonably be anticipated to cause any

adverse effects to the human health or

adverse environmental effects.

EPA will grant a petition to delete a

substance, and publish a proposed rule

to delete that substance, if it makes an

initial determination that this criterion

has been met. After affording an

opportunity for comment and for a

hearing, EPA will make a final

determination whether the criterion has

been met.

EPA does not interpret Section

112(b)(3)(C) to require absolute certainty

that a pollutant will not cause adverse

effects on human health or the

environment before it may be deleted

from the list. The use of the terms

‘‘adequate’’ and ‘‘reasonably’’ indicate

that the Agency must weigh the

potential uncertainties and their likely

significance. Uncertainties concerning

the risk of adverse health or

environmental effects may be mitigated

if EPA can determine that projected

exposures are sufficiently low to

provide reasonable assurance that such

adverse effects will not occur. Similarly,

uncertainties concerning the magnitude

of projected exposures may be mitigated

if EPA can determine that the levels

which might cause adverse health or

environmental effects are sufficiently

high to provide reasonable assurance

that exposures will not reach harmful

levels. However, the burden remains on

a petitioner to resolve any critical

uncertainties associated with missing

information. EPA will not grant a

petition to delete a substance if there are

major uncertainties which need to be

addressed before EPA would have

sufficient information to make the

requisite determination.

B. The Present Petition and Rulemaking

On July 19, 1993, EPA received a

petition from AlliedSignal, Inc., BASF

Corporation, and DSM Chemicals North

America, Inc. (‘‘petitioners’’) to delete

caprolactam (CAS No. 105–60–2) from

the hazardous air pollutant list in

Section 112(b)(1). Following receipt of

the petition, EPA conducted a

preliminary evaluation to determine

whether the petition was complete

according to Agency criteria. To be

deemed complete, a petition must

consider all available health and

environmental effects data. A petition

must also provide emissions data

sufficient to assess peak and average

emissions for each source, and must

estimate the resultant exposures of

people living in the vicinity of the

source. In addition, a petition must

address the environmental impacts

associated with emissions to the

ambient air and impacts associated with

the subsequent cross-media transport of

those emissions. EPA found the petition

to delete caprolactam to be complete

and published a notice of receipt and

request for comments in the Federal
30818 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations

Register on August 26, 1993 (58 FR

45081).

After evaluating submissions received

by EPA in response to the notice of

receipt, which included concerns

expressed by citizens concerning

emissions of caprolactam by the

AlliedSignal facility in Irmo, South

Carolina, EPA entered into discussions

with AlliedSignal to determine what

could be done to address these

concerns. On March 13, 1995, EPA

executed two detailed emission

reduction agreements with AlliedSignal

concerning the Irmo manufacturing

facility and another facility located in

Chesterfield, Virginia, copies of which

are included in the public docket for

this rulemaking. Under these

agreements, AlliedSignal is installing

emission controls for caprolactam

which EPA believes are equivalent to

the controls which would have been

required had EPA issued a standard to

control these sources under Section 112.

The agreed emission controls will be

incorporated in federally enforceable

operating permits for the affected

facilities, and will be in place years

earlier than controls would have

otherwise been required. In addition,

AlliedSignal has established a citizen

advisory panel concerning the Irmo

facility, which EPA is hopeful will

improve communications with the

community and provide citizens an

ongoing role in implementation of the

agreed emission reductions.

On September 8, 1995, based on a

comprehensive review of the data

provided in the petition and otherwise

provided to EPA, the Agency made an

initial determination that the statutory

criterion for deletion of caprolactam

from the hazardous air pollutant list had

been met. EPA therefore granted the

petition by AlliedSignal, Inc., BASF

Corporation, and DSM Chemicals and

issued a proposed rule to delist

caprolactam. (60 FR 48081, September

18, 1995).

EPA received a total of 19 comments

on the September 18, 1995 proposed

rule. EPA subsequently granted a

request by a citizen’s group concerned

about emissions from the AlliedSignal

Irmo, SC facility to extend the comment

period until November 2, 1995. (60 FR

58589, November 28, 1995). EPA

conducted this delisting rulemaking

pursuant to the procedures established

by Clean Air Act Section 307(d).

Accordingly, as provided by Section

307(d)(5), EPA held a public hearing

concerning the proposed rule in Irmo,

SC on December 7, 1995. A transcript of

the hearing is included in the public

docket for this rulemaking. Pursuant to

Section 307(d)(5), EPA kept the record

of this rulemaking open for thirty days

after the December 7, 1995 hearing to

receive rebuttal and supplementary

information.

II. Adverse Comments and EPA

Responses

A. Overview

Of the 19 written comments which

were received concerning the proposed

delisting of caprolactam, seven

commenters supported and seven

commenters opposed delisting. Other

commenters expressed concerns

regarding particular elements of the

Agency’s assessment, but did not

expressly support or oppose the

proposal. Many of the persons who

made statements at the public hearing

held on December 7, 1995 in Irmo, SC

expressed opposition to the proposed

delisting, in most cases because of a

belief that emissions by AlliedSignal’s

Irmo facility were the cause of adverse

health effects in their homes or

community. Many of the commenters

opposing the delisting of caprolactam

were members or representatives of

People United for a Responsible

Environment (PURE), a citizen’s group

located in the Irmo-St. Andrews area of

Columbia, SC.

EPA has considered carefully all of

the comments both supporting and

opposing the proposed delisting,

focussing in particular on those

comments which suggested potential

deficiencies in the substantive rationale

upon which EPA based its initial

determination that the criterion in Clean

Air Act Section 112(b)(3)(C) had been

met. A summary of the comments and

the EPA responses to them has been

included in the docket for this

proceeding. In this notice, EPA will

discuss adverse comments which it

received and its response to them.

B. Toxicity Data

Opponents of delisting commented

that EPA should place greater emphasis

on the findings in several Eastern

European studies, which reported

adverse reproductive effects in animals

and exposed workers following

inhalation of caprolactam.

Unfortunately, there are numerous

methodologic problems with the

manner in which the cited studies were

performed and documented which

severely limit their value for risk

assessment. Well-designed, documented

and conducted animal studies do

indicate that the most sensitive chronic

health effect endpoint associated with

caprolactam exposure is reduced mean

fetal body weight (noted in a rodent

reproductive study). However, since the

reported results in these Eastern

European studies cannot be readily

reconciled with subsequent studies,

EPA does not believe that these studies

warrant any change in its risk

assessment for caprolactam.

Opponents of delisting also have

argued that the available animal data on

inhalation of caprolactam is inadequate

to support the Agency’s conclusions,

and that EPA should wait for the results

from the subchronic rat inhalation study

of caprolactam which AlliedSignal is

currently performing before taking final

action in this rulemaking. EPA agrees

that the available animal data on

inhalation of caprolactam is very

limited in comparison to the large

number of studies of caprolactam

ingestion. This is largely because the

physical properties of the substance

make it difficult to generate stable

atmospheres of caprolactam at levels

which would be toxicologically

significant and to control for possible

secondary exposure to caprolactam by

the oral route. However, EPA believes

that the commenters who assert that

EPA should wait to take action until

after the current subchronic inhalation

study has been completed

misunderstand the study’s purpose and

likely significance.

Based on the currently available

human and animal data, the most

sensitive effect of inhalation exposure to

caprolactam is irritation of the eye,

nose, and throat. In a limited but

reliable occupational study of workers

exposed to airborne caprolactam over

nearly two decades, irritant effects in

the nose and throat were observed in

some workers at all levels above 46 mg/

m3, and no distress was noted among

workers at concentrations ranging up to

32 mg/m3. This approximate no

observed effect level of 32 mg/m3 for

acute irritation by caprolactam in

humans is consistent with one animal

study, in which brief exposure to

caprolactam levels up to 26 mg/m3 did

not elicit any of the physiologic

responses typical of irritants.

EPA believes that projected exposures

of the general population to a substance

in the ambient air at concentrations

which result in acute irritation can be

an appropriate basis for inclusion of that

substance on the list of hazardous air

pollutants. However, in the case of

caprolactam, the highest modeled onehour caprolactam concentration near

any facility based on reported emissions

was approximately 1 mg/m3, well below

the lowest documented irritation level

of 46 mg/m3.

The target exposure levels in the

subchronic inhalation study being

conducted by AlliedSignal are 25, 75,
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations 30819

and 250 mg/m3. The new inhalation

study will provide additional

information on potential adverse effects

on the respiratory tract, as well as any

adverse systemic effects, associated with

sustained inhalation of caprolactam.

Although EPA is reluctant to make

quantitative comparisons between the

oral and inhalation routes, EPA has

previously calculated that the oral

NOAEL (No Observed Adverse Effect

Level) for reproductive effects of 50 mg/

kg/day would be approximately

equivalent to 175 mg/m3, after adjusting

for a human body weight of 70 kg, 100

percent absorption, and a human

inhalation rate of 20 m3/day. EPA

considers it probable that the new

inhalation study will permit better

quantification of the dose-response

relationship for potential portal of entry

effects, but it is less clear whether even

the highest concentration achieved by

the new study will be sufficient to cause

any of the systemic effects observed in

previous oral studies.

The purpose of the new inhalation

study is to enable a more precise

quantitative dose response assessment

for the inhalation effects of caprolactam

exposure. While the study may be quite

useful in this respect, EPA considers it

unlikely that the study will change the

more general conclusions of the risk

assessment on which this final rule is

based. In other words, EPA does not

consider the uncertainties the new

study is designed to address to be

material to the overall risk

determination underlying today’s

action.

Even if the new study were to detect

portal of entry effects in rats following

repeated exposure at the lowest target

concentration of 25 mg/m3, this would

probably have greater significance in an

occupational context than in assessing

the risks associated with ambient

exposures. The new study will expose

animals to this concentration for 13

weeks. The maximum modeled ambient

caprolactam concentration for a 24-hour

period is 0.25 mg/m3, two orders of

magnitude below the lowest target

concentration in the new study. (The

maximum modeled ambient

concentration on an annual basis is 0.05

mg/m3.)

Given the animal and human data

already available, EPA considers it quite

improbable that the new study will

detect adverse systemic effects at the

lower exposure levels. However, in the

event that such effects are observed,

EPA will review today’s action in light

of such data.

EPA wishes to stress that its decision

that there is no need to wait for

submission of the new inhalation study

is based on the Agency’s conclusion that

the present data are already adequate to

support the requisite statutory

determination. EPA does not agree with

the argument made by AlliedSignal in

its comments that previous EPA

delisting actions under Section 313 of

the Emergency Planning and

Community Right-to-Know Act (EPCRA)

provide precedent that would enable

EPA to proceed with delisting under

Clean Air Act Section 112 when

research which is clearly material to its

risk assessment is still underway.

Unlike Clean Air Act Section

112(b)(3)(C), which requires EPA to

determine that currently available data

are adequate to support a determination

that a substance may not reasonably be

expected to cause adverse effects,

EPCRA Section 313(d)(3) provides that

a chemical may be deleted if there is not

sufficient evidence to establish that it

causes certain adverse effects.

C. Human Effects Information

In comments submitted by PURE and

statements by individual citizens at the

public hearing, many commenters

asserted their belief that there is a

relation between various adverse human

health effects and caprolactam

emissions by the AlliedSignal Irmo

facility. The effects described include

headaches, allergies, sinus problems,

respiratory disorders, multiple chemical

sensitivity, chronic fatigue syndrome,

various digestive disorders, neurologic

disorders, and several types of cancer.

Although reports of irritation of the

upper respiratory tract are qualitatively

similar to the effects observed at far

higher concentrations in occupational

studies, EPA is not aware of any

evidence which would indicate a

relation between the occurrence of these

common disorders in the general

population and caprolactam exposure.

EPA is also unaware of any evidence

which would support the claimed

relationship between caprolactam

exposure and the other specific diseases

which were mentioned. In the absence

of any reliable epidemiologic or clinical

information, or any other collateral

evidence which would suggest the

biological plausibility of the described

effects, EPA cannot justify affording any

weight to such anecdotal evidence in its

risk assessment.

The purported relationship between

caprolactam exposure and the

symptoms of multiple chemical

sensitivity (MCS) requires separate

discussion. There is at present no

medical consensus concerning the

definition or the nature of this disorder.

EPA is aware that some individuals and

their physicians report they are

unusually sensitive to multiple

chemicals to which the general

population is commonly exposed

without ill effect. One person who

spoke at the public hearing asserted that

she is so sensitive to chemicals that she

cannot use a dishwashing machine in

her home. While EPA recognizes the

formidable challenges and problems

which may be faced by such individuals

as they attempt to function in modern

industrial society, such unusual and

extreme sensitivity is not among the

effects that EPA was directed to

consider in identifying and listing

hazardous air pollutants.

EPA is aware that a number of

individuals in the Irmo-St. Andrews

area have firmly concluded that

caprolactam is the cause of health

problems which they or their families

have experienced. EPA accepts the

concern and personal sincerity of these

individuals’ beliefs, but is not aware of

any scientific evidence which would

support them. EPA acknowledges the

disappointment its decision to delist

will cause these individuals, but

respectfully suggests that the

substantive changes at the Irmo facility

have more practical significance to them

than the plausibility of the claimed

effects. EPA has taken steps which

assure that there will be Federally

enforceable reductions of caprolactam

emissions at the Irmo facility equivalent

to those which would have been

required had caprolactam remained on

the list of hazardous air pollutants, and

that such reductions will be in place

years before they would otherwise have

been required.

The Agency for Toxic Substances and

Disease Registry (ATSDR) commented

on the EPA discussion of an ATSDR

report in the proposed rule. ATSDR

noted that EPA had called the report a

‘‘preliminary screening study,’’ although

the ATSDR reviewed only the available

literature, environmental monitoring

data, and written and verbal reports of

health concerns from individuals, and

no health screening was performed on

individuals. ATSDR also noted that the

proposed rule had misquoted the

ATSDR report, and that its conclusions

concerning the Irmo Facility should not

be generalized or applied to other

facilities.

The use by EPA of the term

‘‘preliminary screening study’’ was not

intended to imply that any health

screening had been performed by

ATSDR, and EPA regrets any confusion

this phrase may have caused. In its

report, ATSDR did reach conclusions

regarding the Irmo facility which are

consistent with the EPA analysis, but

the determination by EPA that the
30820 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations

statutory criterion for delisting has been

met is not predicated on the ATSDR

conclusions. As far as the quotation

from the ATSDR report in the proposed

rule, the omission of several words was

inadvertent. The correct quotation is:

‘‘* * * the concentration of hazardous

substances found in ambient air sampling

were not of health concern and the

community health concerns were not

plausibly related to the release of hazardous

substances.’’ (correction italicized)

Finally, although the determination

by EPA that caprolactam meets the

statutory criterion for delisting is

generic in nature, EPA never intended

to generalize the ATSDR findings to

other facilities or the communities in

which they are located.

One frequent comment by the

residents in the Irmo-St. Andrews area

was that EPA should study the residents

of that area before proceeding to delist

caprolactam. EPA has carefully

evaluated the feasibility and scientific

value of an epidemiologic study and has

determined that it would neither be

practical or informative. In its

evaluation, EPA utilized five criteria for

determining the feasibility of

community environmental studies

suggested by Bender, et al., in a 1990

article in the American Journal of

Epidemiology. A memorandum

summarizing this EPA evaluation has

been included in the docket.

The EPA evaluation makes it clear

that a meaningful study of persons

exposed to caprolactam emissions from

the Irmo facility cannot be conducted.

Key problems with such a study include

the selection of biologically plausible

health effects in the exposed

population, the identification and

measurement of other factors which

might contribute to these health effects,

and the lack of adequate statistical

power to detect differences between

exposed and unexposed populations.

As noted above, it is difficult to

identify the specific health effects

which would be the focus of such a

study. If there were an unusual cluster

of a single rare disease in the

community, a credible allegation of a

potential relation between that disease

and caprolactam exposure, and all

persons with that disease from an

identified population including exposed

individuals could be examined, a casecontrol study might be practicable.

However, none of these factors are

present here.

A cohort study of an exposed

population (such as students at a nearby

elementary school) would also be

impractical. The non-specific

complaints in the upper respiratory tract

which are most frequently asserted by

residents to be potentially related to

caprolactam exposure have a very high

incidence in any population. Such

upper respiratory complaints can be

caused by other pollutants, allergens,

and infectious agents, and it would be

difficult if not impossible to adequately

control for these confounding factors in

the study and control populations.

Finally, the size of any potentially

exposed valid study population that

could be identified would probably not

be large enough to provide sufficient

statistical power to detect significant

differences even if they do exist.

EPA realizes that there is a perception

by many concerned citizens that any

hypothetical relation between actual

exposures and actual health effects can

be scientifically studied. Unfortunately,

this is not the case. Given the currently

available information and the analytic

tools provided by current science, EPA

sees little or no utility to an

epidemiologic study of caprolactam

exposure in the Irmo-St. Andrews area.

This is similar to the conclusion

reached by ATSDR in its report.

D. Exposure Information

One commenter stated that the

exposure estimates by the petitioners

and by EPA were incomplete because

they did not consider caprolactam

emissions from hot mix asphalt (HMA)

plants. The commenter estimated that

caprolactam emissions from individual

HMA plants could exceed the major

source threshold of 10 tons per year,

and that total caprolactam emissions

from such facilities could be as high as

18,000 tons per year. Caprolactam is an

ingredient in liquid anti-stripping

agents containing

bis(hexamethylene)triamine (BHMT),

which are used in some HMA plants.

Prior to submission of this comment,

EPA was unaware of HMA plants as a

potential source of caprolactam

emissions. If the commenter’s estimates

of emissions from HMA plants were

determined to be correct, it was clear

that the failure of the petitioners to

address such emissions in their petition

had been a significant omission.

AlliedSignal investigated emissions of

caprolactam from HMA plants and

submitted comments summarizing its

findings. Although the commenter had

estimated based on a material safety

data sheet for one anti-stripping agent

that caprolactam levels in such products

are 5%, the actual level of caprolactam

found in this product by AlliedSignal

was .38%. In nine such products tested

by AlliedSignal, the average

caprolactam level was .79%, and the

highest level found was 1.8%. Based on

other assumptions suggested by the

original commenter, AlliedSignal

estimated that worst-case emissions

from an HMA plant using a liquid antistripping agent containing the

maximum caprolactam level of 1.8%

would be 3.6 tons per year. AlliedSignal

noted that not all HMA plants use liquid

anti-stripping agents, and not all such

agents contain BHMT (and thus

caprolactam). Based on estimates of the

total quantity of liquid anti-stripping

agents produced annually, and the

percentage of such agents containing

BHMT, AlliedSignal concluded that no

more than 27 tons/year of caprolactam

is emitted from all HMA plants.

EPA considers the estimates by

AlliedSignal of caprolactam emissions

by HMA plants to be reasonable based

on the information provided. Based on

these estimates, no single HMA plant

would constitute a major source of

caprolactam. Because the estimated

emissions from plants in the HMA

source category are lower than reported

emissions from the other source

categories evaluated in the original

petition, EPA does not believe that

emissions from such sources would

affect its conclusion that the statutory

criterion for delisting has been met.

Several commenters expressed doubt

as to the reliability of the exposure

modeling on which the caprolactam

delisting petition and the EPA risk

assessment are based. In general, EPA

believes that the exposure models

utilized by the petitioners produce

conservative results. Although actual

ambient monitoring data around

facilities emitting caprolactam is very

limited, AlliedSignal submitted

information indicating that actual

measurements of ambient caprolactam

levels at a monitoring station near its

Irmo facility operated by the State of

South Carolina Department of Health

and Environmental Control were

generally less than the concentrations

for that location which were predicted

by modeling.

Several commenters expressed

concern that the EPA conclusions

regarding the adverse effects of current

caprolactam emissions do not assure

that new sources with greater

caprolactam emissions than those

identified in the petition will not

emerge in the future. A related concern

was that the agreements with

AlliedSignal regarding control of

caprolactam emissions at its

manufacturing facilities will not affect

emissions at future facilities.

EPA does not interpret Section

112(b)(3)(C) to require consideration of

hypothetical emissions from facilities

that might be constructed in the future.
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations 30821

The logical consequence of such an

expansive construction would be that

no substance could ever be delisted, due

to the hypothetical possibility of some

future facility with emissions large

enough to cause adverse effects. In the

event that some future facility has

uncontrolled caprolactam emissions

great enough to change the conclusions

of the present EPA risk assessment, EPA

can revisit its decision to delist

caprolactam at that time.

EPA readily acknowledges that the

agreements with AlliedSignal do not

apply to other caprolactam emitting

facilities, either those presently in

existence or those which might be

constructed in the future. Although EPA

has been unable to establish any link

between caprolactam emissions at the

Irmo facility and health effects in that

community, EPA negotiated an

agreement with AlliedSignal concerning

installation of additional emission

controls in order to alleviate the stated

concerns of the residents in that

community. EPA also reached

agreement with AlliedSignal concerning

control of emissions at its Chesterfield,

VA manufacturing facility because that

facility had large uncontrolled

caprolactam emissions analogous to

those at the Irmo facility. While EPA

does not consider the Federally

enforceable reductions in caprolactam

emissions at either of these facilities to

be essential to meet the statutory criteria

for delisting, these reductions do

provide substantial additional assurance

that adverse human health effects will

not occur. Moreover, the agreed

reductions will be in place well before

any mandatory emission reductions

which would have resulted from the

continued listing of caprolactam as a

hazardous air pollutant.

E. Emission Reductions by AlliedSignal

Several commenters from the Irmo-St.

Andrews area expressed doubt

concerning the enforceability of the

caprolactam reductions at the Irmo

facility which have been agreed to by

AlliedSignal. Such comments are

simply erroneous. AlliedSignal has

unequivocally agreed that the key terms

and conditions which assure such

reductions will be incorporated into the

Federally enforceable Title V operating

permit for the Irmo facility. This is the

same permit which would have been

utilized to enforce any emission

standard controlling caprolactam

emissions from this facility adopted

pursuant to Clean Air Act Section 112.

In its comments, PURE argued that

EPA should not presume that the

emission reductions to be achieved by

AlliedSignal at the Irmo facility are

equivalent to the reductions which

would be required by a Maximum

Achievable Control Technology (MACT)

standard issued under Section 112,

because EPA has not gone through the

steps which would be necessary to

determine what MACT would be. Since

any MACT standard issued for the

source category including the

AlliedSignal Irmo facility would not be

issued until years from now, EPA

cannot say with precision what such a

standard would ultimately require.

However, EPA has determined that the

emissions control technology being

installed at the AlliedSignal Irmo and

Chesterfield facilities is likely to

perform at least as well as that which

has been demonstrated at other wellcontrolled facilities.

EPA bases its conclusions concerning

the effectiveness of emission controls

being installed at the AlliedSignal

facilities on the emission and

production information contained in the

petition and produced by the petitioners

during the rulemaking, and on visits by

EPA to several operating Nylon 6

production facilities, including the

AlliedSignal Irmo facility and the BASF

Clemson facility. (PURE representatives

have cited BASF as a company which

does a good job of controlling its

caprolactam emissions.) EPA has

evaluated each of six Nylon 6

production facilities to determine the

ratio of the amount of caprolactam

emitted to the amount of Nylon 6 fiber

production. The ratio of emissions to

production at the AlliedSignal Irmo and

Chesterfield facilities after all required

controls have been installed will be less

than the present ratio of emissions to

production at all other facilities except

the BASF Anderson plant, which has

lower emissions because it spins Nylon

6 fiber but receives polymerized

caprolactam from another site. Although

the analysis underlying a MACT

standard would be more detailed, and

would likely involve separate analysis

of caprolactam emissions for

polymerization, depolymerization, and

spinning operations, EPA considers it

improbable that a MACT standard based

on presently demonstrated technologies

would require greater control of

caprolactam emissions at the

AlliedSignal facilities than is required

by the agreements AlliedSignal has

executed.

Several commenters complained that

the agreement between EPA and

AlliedSignal does not adequately

regulate emergency releases from the

plant. Under general MACT provisions,

releases during periods of upset and

abnormal operation are not considered

in determining compliance with MACT

standards. Thus, the implicit

assumption that a MACT standard

would regulate emergency releases more

stringently than the agreement is

mistaken. In addition, the commenters

appear to overestimate the significance

of such releases. Figures provided by

AlliedSignal indicate that additional

caprolactam emissions associated with

scheduled maintenance and

unscheduled malfunctions of emission

control equipment at the Irmo facility

represent less than one percent of the

total caprolactam emissions by that

facility.

The agreement concerning the

AlliedSignal Irmo facility does contain

provisions which require expeditious

reporting of any emission control

equipment upset or malfunction, as well

as any emergency releases, to the South

Carolina Department of Health and

Environmental Control. The agreement

also requires prompt repair of any

malfunctioning emission control

equipment, and installation of pressure

control devices on those emission

points most susceptible to emergency

releases.

F. Delisting Criteria

In its comments, PURE asserted that

EPA is required to consider

occupational exposures in deciding

whether to delist caprolactam. EPA

firmly disagrees with this comment. The

language of Section 112(b)(3)(C) refers to

‘‘emissions, ambient concentrations,

bioaccumulation, or deposition of the

substance.’’ Nothing in this language

suggests that EPA should consider

worker exposures in its delisting

assessment. Moreover, it would be

illogical to assume that worker

exposures should be considered in

deciding whether to delist when

continued listing would not itself lead

to any requirement that occupational

exposures be controlled.

In its comments, PURE also argued

that the proposed delisting would be

unlawful because it assumes future

compliance by AlliedSignal with the

agreed emission reductions, thereby

circumventing the purposes of the Clean

Air Act. It could be argued that

consideration of future emission

reductions in a decision to delist a

substance from the list of hazardous air

pollutants is a reasonable construction

of Section 112(b)(3)(C) consistent with

the purposes of the Clean Air Act, so

long as such reductions will be as

enforceable as those which might be

required by a MACT standard and will

be in place before any MACT standard

could be issued. However, in this

instance it was not necessary to resolve

this question. EPA has determined that
30822 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations

the petitioners have satisfied the

statutory criterion for delisting in

Section 112(b)(3)(C) based on the

emissions reported in the delisting

petition. The agreements by

AlliedSignal requiring enforceable

reductions in caprolactam emissions at

its facilities provide additional

assurance that the agency’s

determination is correct, but are not an

essential element in the risk assessment

on which that determination is based.

III. Final Rule

A. Rationale for Action

The detailed factual rationale

supporting the Agency’s initial

determination that the criterion in Clean

Air Act Section 112(b)(3)(C) had been

met is set forth in the proposed rule

published in the Federal Register on

September 18, 1995 (60 FR 48081). As

is apparent from the discussion above,

although EPA has done substantial

additional analysis pursuant to the

comments submitted during the

subsequent rulemaking, none of those

comments have caused EPA to revise

the basic scientific analysis on which

that initial determination was

predicated. EPA hereby incorporates in

its rationale for this final rule the

substantive assessment of potential

hazards, projected exposures, human

risk, and environmental effects set forth

in the proposed rule to delist

caprolactam. Based on that assessment,

the Agency’s evaluation of the

comments and additional information

submitted during the rulemaking (as

summarized above), and on the other

materials which have been incorporated

in the public docket for this rulemaking,

EPA has made a determination that

there is adequate data on the health and

environmental effects of caprolactam to

determine that emissions, ambient

concentrations, bioaccumulation or

deposition of caprolactam may not

reasonably be anticipated to cause any

adverse effects to human health or

adverse environmental effects. On that

basis, caprolactam is hereby deleted

from the list of hazardous air pollutants

set forth in Clean Air Act Section

112(b)(1). This deletion shall be final on

the effective date of this rule.

B. Implementation

Although EPA intends in the future to

conduct a rulemaking to codify the

hazardous air pollutant list set forth in

Clean Air Act Section 112(b)(1) and to

correct various technical errors in the

statutory list which have been identified

since 1990, the list is at present

uncodified. Therefore, today’s rule does

not revise the text of any existing

provision of the Code of Federal

Regulations. However, on the effective

date of this rule, caprolactam will be

deleted for all purposes from the list set

forth in Section 112(b)(1). To avoid

confusion concerning the status of

caprolactam, pending the rulemaking

which will codify and correct the list set

forth in Section 112(b)(1), EPA will add

to the Code of Federal Regulations a

brief provision confirming that

caprolactam has been deleted from the

list.

EPA included in the proposed rule to

delist caprolactam a provision providing

immediate relief, on an interim basis,

for certain facilities which might

otherwise have been required to apply

for Title V operating permits based

solely on the continued inclusion of

caprolactam on the list of hazardous air

pollutants. That provision suspended

the listing of caprolactam, for the

duration of this rulemaking, solely for

the limited purpose of determining the

applicability of Title V permitting

requirements. The interim relief

provided in the proposed rule is no

longer necessary and will expire by its

own terms on the effective date of this

final rule.

C. Effective Date

This final rule will be effective on

June 18, 1996, the date it is published

in the Federal Register. Although

Section 553(d) of the Administrative

Procedure Act, 5 U.S.C. 553(d), provides

that substantive rules must be published

at least 30 days prior to their effective

date, this requirement does not apply to

this rule. First, this rule was

promulgated pursuant to Clean Air Act

Section 307(d), and that provision

expressly states that the provisions of

Section 553 do not apply to this action.

Second, even under Section 553, the

requirement that a rule be published 30

days prior to its effective date does not

apply to a rule

‘‘which grants or recognizes an exemption or

relieves a restriction.’’

D. Judicial Review

This final rule deleting caprolactam

from the list of hazardous air pollutants

in Clean Air Act Section 112(b)(1) is

based on a determination of nationwide

scope and effect. A petition for judicial

review of this final rule may be filed

solely in the United States Court of

Appeals for the District of Columbia.

Any such petition for judicial review of

this rule must be filed no later than

August 19, 1996. In any resulting action,

no objection can be made which was not

raised with reasonable specificity

during the period for public comment

(including the public hearing).

IV. Miscellaneous

A. Executive Order 12866

Under Executive Order 12866 (58 FR

57735, October 4, 1993), EPA must

determine whether this rule is

‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget under the Executive Order. The

Order defines ‘‘significant regulatory

action’’ as one that is likely to result in

a rule that may:

1. Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities;

2. Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

3. Materially alter the budgetary

impact of entitlement, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

4. Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

This action will not result in an

annual effect on the economy of $100

million or another adverse economic

impact, does not create a serious

inconsistency or interfere with another

agency’s action, and does not materially

alter the budgetary impacts of

entitlement, grants, user fees, etc. While

States may lose Title 5 permit fees as a

direct result of this rule, the number of

affected facilities is not believed to be

significant. However, since this action is

the Agency’s first decision to modify the

hazardous air pollutant list, EPA

believes that it could be construed as

raising novel legal or policy issues and

has therefore submitted this rule for

OMB review under Executive Order

12866.

B. Regulatory Flexibility Analysis

EPA has determined that it is not

necessary to prepare a regulatory

flexibility analysis in connection with

this final rule. This rule will reduce

regulatory burdens on small businesses

which would otherwise be associated

with retention of caprolactam on the list

of hazardous air pollutants. EPA has

determined that this rule will have no

adverse effect on small businesses.

Accordingly, this rule will not have ‘‘a

significant impact on a substantial

number of small entities,’’ as that phrase

is utilized in Section 605(b) of the

Regulatory Flexibility Act, as amended.
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Rules and Regulations 30823

C. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995, EPA

must prepare a written statement to

accompany any rules that have ‘‘Federal

mandates’’ that may result in the

expenditure by the private sector of

$100 million or more in any one year.

Under Section 205, EPA must select the

most cost-effective and least

burdensome alternative that achieves

the objective of such a rule and that is

consistent with statutory requirements.

Section 203 requires EPA to establish a

plan for informing and advising small

governments that may be significantly

and uniquely affected by the rule.

The Unfunded Mandates Act defines

a ‘‘Federal private sector mandate’’ for

regulatory purposes as one that, among

other things, ‘‘would impose an

enforceable duty upon the private

sector.’’ This final rule to modify the

hazardous air pollutant list to delete

caprolactam is deregulatory in nature

and does not impose any enforceable

duties upon the private sector.

Therefore, this rulemaking is not a

‘‘Federal private sector mandat’’ and is

not subject to the requirements of

Section 202 or Section 205 of the

Unfunded Mandates Act. As to Section

203, EPA finds that small governments

will not be significantly and uniquely

affected by this rulemaking.

D. Submission to Congress and the

General Accounting Office

Under section 801(a)(1)(A) of the

Administrative Procedures Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996, EPA submitted a report containing

this rule and other required information

to the U.S. Senate, the U.S. House of

Representatives and the Comptroller

General of the General Accounting

Office prior to publication of the rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by section

804(2) of the APA as amended.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Hazardous

substances.

Dated: June 7, 1996.

Carol M. Browner,

Administrator.

40 CFR part 63 is amended as follows:

PART 63—NATIONAL EMISSION

STANDARDS FOR HAZARDOUS AIR

POLLUTANTS FOR SOURCE

CATEGORIES

1. The authority citation for part 63

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart C—[Amended]

2. Subpart C is amended by adding

§ 63.60 and adding and reserving

§§ 63.61 through 63.69 to read as

follows:

§ 63.60 Deletion of caprolactam from the

list of hazardous air pollutants.

The substance caprolactam (CAS

number 105602) is deleted from the list

of hazardous air pollutants established

by 42 U.S.C. 7412(b)(1).

§§ 63.61–63.69 [Reserved]

[FR Doc. 96–15445 Filed 6–17–96; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF ENERGY

48 CFR Parts 911, 952, and 970

RIN 1991–AB27

Acquisition Regulation; Technical

Amendments

AGENCY: Department of Energy.

ACTION: Correction to final rule.

SUMMARY: This notice corrects errors

appearing in the final rule published at

61 FR 21975 on May 13, 1996. The rule

made technical amendments to the

Department of Energy Acquisition

Regulation (DEAR) to conform to

changes made in the Federal

Acquisition Regulation (FAR) as a result

of the Federal Acquisition Streamlining

Act of 1994.

EFFECTIVE DATE: June 12, 1996.

FOR FURTHER INFORMATION CONTACT:

Richard B. Langston, Office of Policy

(HR–51), Office of the Deputy Assistant

Secretary for Procurement and

Assistance Management, Department of

Energy, 1000 Independence Avenue,

SW., Washington, D.C. 20585 (202) 586–

8247.

SUPPLEMENTARY INFORMATION:

Need for Correction

As published, the rule contained

errors which could be confusing to the

reader and need correction.

Correction of Publication

Accordingly, the final rule published

on May 13, 1996, which was the subject

of FR Doc. 96–11918 is corrected as

follows:

911.600 [Corrected]

1. At page 21976, in subpart 911.600,

at the bottom of the center column, the

reference to ‘‘FAR subpart 911.6’’ is

corrected to read ‘‘FAR subpart 11.6.’’

952.211 [Corrected]

2. At page 21977, second column,

insert amendment 18.d to read as

follows:

18.d In newly redesignated sections

952.211–70, including its Alternate I,

and 952.211–71, including its Alternate

I, the date ‘‘JUNE 1987’’ following the

clause heading is revised to read ‘‘JUN

1996.’’ In newly redesignated section

952.211–72, the date ‘‘MAY 1987’’

following the clause heading is revised

to read ‘‘JUN 1996.’’ In newly

redesignated 952.211–73, the date ‘‘APR

1987’’ following the clause heading is

revised to read ‘‘JUN 1996.’’

952.226 [Corrected]

3. At page 21977, second column,

insert amendment 19.a to read as

follows:

19.a At sections 952.226–70,

952.226–71, 952.226–72, and 952.226–

73, the date ‘‘May 1995’’ following the

clause heading is revised to read ‘‘JUN

1996.’’

952.250–70 [Corrected]

4. At page 21977, second column,

insert amendment 20.a to read as

follows:

20.a At section 952.250–70, the date

‘‘JAN 1992’’ following the clause

heading is revised to read ‘‘JUN 1996.’’

970.5204–9 [Corrected]

5. At page 21977, second column,

insert amendment 23.a to read as

follows:

23.a At section 970.5204–9, the date

‘‘APR 1984’’ following the clause

heading is revised to read ‘‘JUN 1996.’’

6. At page 21977, third column, at

970.5204–9, the date ‘‘APR 1996’’

following the clause heading is

corrected to read ‘‘JUN 1996.’’

970.5204–13 [Corrected]

7. At page 21977, third column, insert

amendment 24.a to read as follows:

24.a At 970.5204–13, the date ‘‘SEPT

1991’’ following the clause heading is

revised to read ‘‘JUN 1996.’’

970.5204–14 [Corrected]

8. At page 21978, first column, insert

amendment 25.a to read as follows:

25.a At 970.5204–14, the date ‘‘OCT

1990’’ following the clause heading is

revised to ‘‘JUN 1996.’’

970.5204–44 [Corrected]

9. At page 21978, first column, insert

amendment 26.a to read as follows:

26.a At 970.5204–44, the date ‘‘Oct

1995’’ following the clause heading is

revised to ‘‘JUN 1996.’’