16336 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

permit such person at all reasonable

times to have access to and to copy

these records.

(k) Submission of information.

Information submitted to EPA under

this section must be sent in writing to:

TSCA Document Control Officer, (7407),

Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460.

(l) Compliance. (1) A person who

manufactures or imports a new

chemical substance and fails to comply

with any provision of this section is in

violation of section 15 of the Act (15

U.S.C. 2614).

(2) Using for commercial purposes a

chemical substance or mixture which a

person knew or had reason to know was

manufactured, processed, or distributed

in commerce in violation of section 5 of

the Act is a violation of section 15 of the

Act (15 U.S.C. 2614).

(3) Failure or refusal to establish and

maintain records or to permit access to

or copying of records, as required by

this section and section 11 of the Act,

is a violation of section 15 of the Act (15

U.S.C. 2614).

(4) Failure or refusal to permit entry

or inspection as required by section 11

of the Act is a violation of section 15 of

the Act (15 U.S.C. 2614).

(5) Violators may be subject to the

civil and criminal penalties insection 16

of the Act (15 U.S.C. 2615) for each

violation. Persons who submit

materially misleading or false

information in connection with the

requirements of any provision of this

section may be subject to penalties

calculated as if they never filed their

notices.

(6) EPA may seek to enjoin the

manufacture or processing of a chemical

substance in violation of this section or

act to seize any chemical substance

manufactured or processed in violation

of this section or take other actions

under the authority of section 7 of the

Act (15 U.S.C. 2606) or section 17 of the

Act (15 U.S.C. 2616).

(m) Inspections. EPA will conduct

inspections under section 11 ofthe Act

to assure compliance with section 5 and

this section, to verify that information

submitted to EPA under this section is

true and correct, and to audit data

submitted to EPA under this section.

(n) Confidentiality. If a manufacturer

submits information to EPA under this

section which the manufacturer claims

to be confidential business information,

the manufacturer must clearly identify

the information at the time of

submission to EPA by bracketing,

circling, or underlining it and stamping

it with ‘‘CONFIDENTIAL’’ or some other

appropriate designation. Any

information so identified will be treated

in accordance with the procedures in 40

CFR part 2. Any information not

claimed confidential at the time of

submission may be made available to

the public without further notice.

[FR Doc. 95–7712 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F

40 CFR Part 723

[OPTS–50596B; FRL–4923–1]

RIN 2070–AC14

Premanufacture Notification

Exemption; Revision of Exemption for

Chemical Substances Manufactured in

Small Quantities; Low Release and

Exposure Exemption; Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: Section 5(a)(1) of the Toxic

Substances Control Act (TSCA) requires

that persons notify EPA before they

manufacture or import a new chemical

substance for commercial purposes.

Section 5(h)(4) of TSCA authorizes EPA,

upon application and by rule to exempt

the manufacturer or importer of any

new chemical substance from some or

all of the provisions of section 5 if the

Agency determines that the

manufacture, processing, distribution in

commerce, use, or disposal of the

substance will not present an

unreasonable risk of injury to health or

the environment. EPA is amending the

current TSCA section 5(h)(4) limited

exemption defined at 40 CFR 723.50 for

persons who manufacture certain

chemical substances in quantities of

1,000 kilograms or less per year. This

amendment will increase the volume

limit to 10,000 kilograms or less a year.

Also, this amendment adds a new

section 5(h)(4) exemption category for

certain chemical substances with low

environmental releases and human

exposures. This amendment will

significantly reduce administrative

burdens on EPA and industry and will

expedite the Agency review process so

that lower risk chemical substances may

be marketed more quickly. To ensure

that these chemical substances will not

present an unreasonable risk, EPA has

included procedural safeguards,

including a 30–day review, and other

conditions in the exemption.

DATES: This rule is effective May 30,

1995. This rule shall be promulgated for

purposes of judicial review at 1 p.m.

eastern time, on April 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460, Telephone: (202) 554–1404,

TDD: (202) 554–0551.

SUPPLEMENTARY INFORMATION: The

original exemption for chemical

substances manufactured in quantities

of 1,000 kilograms or less per year

became effective on August 26, 1985.

The supporting rationale and

background for that exemption were

published at 50 FR 16477 on April 26,

1985 and 47 FR 33896, August 4, 1982.

This rule was proposed in the Federal

Register on February 8, 1993 (58 FR

7646). Public hearings on this and

related PMN exemptions were held in

Washington, DC. on April 26–28, 1993.

While general background information

is presented here, readers should also

consult the preambles for those notices

for further information on the objectives

and rationale for the rule and the basis

for finding under TSCA section 5(h)(4)

that activities involving the exempt

chemical substances will not present an

unreasonable risk of injury to human

health or the environment.

I. Background

Section 5(a)(1) of TSCA (15 U.S.C.

2604 (a)(1)) requires any person who

intends to manufacture or import a new

chemical substance to notify EPA 90

days before manufacture or importation

begins. Section 5(h)(4) of TSCA (15

U.S.C. 2604(h)(4)) allows the EPA, by

rule, to grant an exemption from any or

all of the requirements of section 5 if

EPA determines that the manufacture,

processing, distribution in commerce,

use, or disposal of a substance will not

present an unreasonable risk of injury to

health or the environment.

II. Final Exemption

A. Summary of the Rule

1. Chemical substances manufactured

at 10,000 kg or less per year.

Manufacturers of all new chemical

substances manufactured in quantities

of 10,000 kilograms or less per year are

eligible to apply for a new category of

exemption. (Note that throughout 40

CFR parts 720, 721, and 723, the term

‘‘manufacturer’’ is defined in TSCA

section 3(8), 15 U.S.C. 2602(8), to

include persons who import the

specified chemical substance; the term

‘‘manufacture’’ is defined to include

importation.) Upon approval,

manufacturers will be permitted to

manufacture up to 10,000 kilograms of

the new chemical substance during
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16337

every 12 month period following the

date of review period expiration without

submitting a full premanufacture notice

(‘‘PMN’’) under section 5(a)(1) of TSCA.

As with the prior exemption for new

chemical substances produced at 1,000

kg or less, new chemical substances will

not be approved under the new

exemption if the Agency believes that

they or their reasonably anticipated

metabolites, environmental

transformation products, byproducts, or

impurities raise a concern for serious

acute or chronic human health effects or

significant environmental effects under

reasonably anticipated conditions of

manufacture, processing, distribution in

commerce, use, or disposal. Any

exemption application will be denied if

the Agency is unable to affirmatively

find that manufacture, processing,

distribution in commerce, use, and

disposal of the exempted substance

pursuant to the exemption will not

present an unreasonable risk of injury to

human health or the environment.

Manufacturers requesting this

exemption must submit notices 30 days

prior to commencement of manufacture

or import. As with the prior exemption,

where manufacturers provide

information on human exposure

controls or environmental release

controls to support the exemption

notice, the manufacturers must maintain

those controls throughout the duration

of the exemption. If EPA identifies a

potential risk from a new chemical

substance, but believes that the risk may

be sufficiently mitigated through

pollution prevention techniques and/or

exposure and release controls, the

Agency may conditionally approve the

exemption pending the manufacturer’s

submission of an amended exemption

notice which includes those or

equivalent techniques or controls. If

there is insufficient time remaining in

the review period to provide the

amended information, manufacturers

may request a temporary suspension of

the review period under 40 CFR

720.75(b). All amended pages of the

exception notice must be received by

the Agency prior to the expiration of the

exemption review period.

Manufacturers are similarly bound to

the uses described in their exemption

notices and may not change the

manufacturing sites identified in their

notices unless they either meet the

conditions specified in paragraph (j)(6)

of the exemption or submit a new

exemption notice.

In accordance with practice under the

superseded 1,000 kilogram exemption,

the Agency will generally perform the

risk assessment under the new

exemption as if the total amount

permissible under the exemption

(10,000 kilograms) were being

produced. However, submitters wishing

their exemptions to be reviewed based

upon annual production volumes lower

than 10,000 kilograms may so indicate

in their exemption notice by marking

the binding box adjacent to the

production volume space on the form.

Submitters who so elect, however, are

bound by their election. Submitters who

subsequently wish to increase their

maximum production volume under the

exemption must submit a new

exemption notice cross-referencing the

original exemption number on the cover

of the notice. If the new exemption is

granted, it will supersede the previous

exemption.

As of the effective date of this rule,

the existing 1,000 kilogram exemption

category will no longer be available for

new exemptions. All exemptions

previously granted under the 1,000

kilogram exemption will remain binding

and effective under the superseded

provisions of 40 CFR 723.50 even

though such provisions will no longer

be contained in the Code of Federal

Regulations. Any modification of the

terms of a previously granted exemption

must be requested via a new exemption

notice. For example, a manufacturer or

importer who was granted an exemption

under the prior 1,000 kilogram per year

or less exemption may submit a new

exemption notice to increase the

production volume up to 10,000

kilograms per year for the same

chemical substance. If such

manufacturer does apply for the 10,000

kilogram exemption, its notice will be

reviewed for unreasonable risk at the

increased production volume. A new

risk assessment will be performed based

on the information submitted in the new

notice. A submitter of a subsequent

10,000 kilogram exemption may

continue to manufacture under the

terms of the 1,000 kilogram exemption

until a regulatory decision is made on

the new exemption notice. If the new

notice is granted, it will supersede the

1,000 kilogram exemption.

2. Low release and exposure

chemicals. In connection with the

Agency’s overall pollution prevention

strategy, EPA is adding a new

exemption category for chemical

substances with low environmental

releases and low human exposures

during their manufacture, distribution

in commerce, processing, use, and

disposal. All manufacturers and

importers of new chemical substances

subject to PMN requirements meeting

the stated release and exposure criteria

are eligible to apply for this low release

and exposure (LoREX) exemption,

regardless of production volume. The

LoREX exemption is intended to

encourage companies to develop

manufacturing, processing, use, and

disposal techniques which minimize

exposures to workers, consumers, the

general public, and the environment.

As with the low volume exemption,

the uses of the new chemical substance

are restricted to those approved in the

exemption notice, and submitters must

maintain any exposure or release

controls throughout the period of the

exemption. Manufacturing sites

identified in the exemption notice are

binding unless specified conditions are

satisfied. (See Comment 3, unit II.B. of

this preamble). EPA believes that these

binding provisions of the LoREX

exemption will, in many instances,

prove to be an effective substitute to

regulation under section 5(e) of TSCA.

Thus, EPA expects this new exemption

category to significantly reduce the

administrative costs presently devoted

to section 5(e) consent order

development and review, and to permit

manufacturers to commence commercial

production of their new products more

quickly, while ensuring against

unreasonable risk of injury to human

health or the environment.

Prospective submitters should be

mindful that the principal focus of the

LoREX exemption is on release and

exposure, not toxicity. Except where

specifically noted in paragraph (c) of the

regulation, EPA will generally be unable

to conduct a thorough review of any

submitted test data within the allotted

review period and may request a

temporary suspension of the review

period if data are submitted. Although

the Agency encourages data

development for new chemical

substances, manufacturers with

submissions which involve extensive

data reviews may, in some cases, be

better served under a PMN review. Such

manufacturers are envouraged to contact

the Pre Notice Communications Staff for

guidance prior to notice submission. To

the extent that the Agency must

undertake extensive detailed

examination of the inherent toxicity of

a given chemical substance, submission

of a PMN may be more appropriate. (Of

course, any toxicity data on the new

chemical substance in the possession or

control of the manufacturer must

accompany the submission whether

necessary for exemption approval or

not).

To satisfy the required section 5(h)(4)

findings of no unreasonable risk, the

exemption notice submitter must first

meet the eligibility criteria listed in

paragraph (c) of the rule indicating that

exposure to the new substance, and
16338 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

hence the risk presented by the

substance, is low. Except as provided

under the surface water and ambient air

criteria, the human exposure side of the

eligibility criteria requires the submitter

to show that there are no exposures to

consumers or the general public

inherent in the proposed manufacturing,

processing, or uses of the substance, and

that any worker exposure which is

likely to occur will be adequately

controlled through use of engineering

controls, work practices, and/or

personal protective equipment.

In terms of environmental releases,

LoREX eligibility criteria for releases to

three environmental media are listed. In

assessing the potential for

environmental release, the submitter is

required to consider all routine releases

from manufacture, processing, and use,

including releases associated with

cleaning of equipment and from

disposal or cleaning of containers and

packaging. For ambient surface water,

submitters must either (1) prevent all

direct and indirect releases of the

exempted substance to surface waters;

or (2) demonstrate that any releases to

water that may occur will result in

surface water concentrations of the

substance that are no greater than 1 part

per billion (ppb) using the surface water

concentration calculation method

described in 40 CFR 721.90 and 721.91.

As stated in paragraph (c)(2)(iii) of the

rule, the Agency may approve of a

surface water concentration level above

1 ppb for a new chemical substance if

the manufacturer supports a request for

a higher concentration with relevant

and scientifically valid data on the new

chemical substance or a close structural

analogue of the substance which

demonstrates that the new substance

will not present an unreasonable risk of

injury to aquatic species or human

health at the higher concentration.

When such data is submitted, the

Agency may request the manufacturer to

temporarily suspend the review period

to permit adequate time to review the

data.

Based on the Agency’s conservative

assumptions for drinking water

exposure estimates, surface water

concentrations of 1 ppb will result in

human drinking water exposures at or

below the 1 mg/year LoREX drinking

water criteria in nearly every case;

therefore, compliance with the drinking

water exposure criteria will be

presumed from compliance with the 1

ppb surface water level. The Agency

reserves the right, however, to require

lower surface water concentrations on a

case-by-case basis when concerns for

carcinogenicity, neurotoxicity, or other

serious chronic effects are raised, or

under conditions where actual drinking

water exposures are likely to

significantly exceed the 1 mg/yr dosage

if the Agency makes the findings in

§723.50(d).

The LoREX eligibility criterion for

maximum annual average ambient air

release concentration from incineration

is 1 μg/m3. This level was derived from

air exposure modeling estimates of

maximum ground level concentrations

from incinerator stacks, using worst case

meteorological data sets. To determine

whether a particular substance meets

the criterion, submitters must calculate

exposure levels using the method

described in §723.50(c)(2). As with

drinking water exposures, the Agency

may require lower air release levels in

individual cases as the Agency makes

the finding in §723.50(d).

For land/groundwater disposal,

LoREX substances must not be disposed

of by landfill or other land disposal

methods unless the submitter

demonstrates that the groundwater

migration potential of the new

substance is negligible. To make such a

demonstration, a submitter must

provide (1) data on the biodegradation

and leaching potential of the new

substance or a close analogue of the

substance, (2) data on the inherent

physical or chemical properties of the

new substance (e.g., solubility in water),

or (3) other data which clearly

establishes that significant releases to

groundwater will not occur. To fulfill

this requirement, EPA suggests the

following core set of tests to establish

groundwater migration potential: (a) An

inherent biodegradability in soil test (40

CFR 796.3400); (b) an anaerobic

biodegradability of organic chemicals

test (40 CFR 796.3140); and (c)

depending on the substance’s chemical

properties, either a sediment and soil

adsorption isotherm test (40 CFR

796.2750) or a soil thin layer

chromatography test (40 CFR 796.2700).

Although the Agency prefers test data

on the specific new chemical substance,

it will consider submitted data on close

structural analogues to the new

chemical substance. EPA strongly

suggests that submitters contact the

TSCA Prenotice Coordinator for

guidance prior to commencement of the

above testing.

Although it is difficult to state in

advance precisely what combinations of

results from the above testing would

clearly establish that the groundwater

migration potential of a chemical

substance is ‘‘negligible’’, some broad

parameters may be given. For example,

manufacturers who perform soil

adsorption testing that result in values

for the logarithm of the soil adsorption

coefficient (‘‘log KOC’’) of their new

chemical substances of 4.5 or greater

will generally be found to have satisfied

the ‘‘negligible groundwater migration

potential’’ standard, unless there is

reason to believe that the substance is

extremely persistent in the

environment. Similarly, biodegradation

test data demonstrating half-lives of

chemical substances of under 1 week, or

complete degradation in under 2 weeks,

would satisfy the LoREX criterion in

most instances. Hydrolysis data

showing that a new chemical substance

hydrolyses at a rapid rate would also

generally be accepted by the Agency.

Chemical substances which do not show

either a 4.5 or greater Log KOC value

alone or a half-life of under 1 week

alone may nonetheless qualify for the

LoREX exemption if the two values in

combination, or together with other

relevant data, support a conclusion that

significant amounts of the substances

will not reach aquifers.

The Agency encourages potential

submitters to consult with the Agency

prior to the initiation of any testing.

Such consultation frequently results in

more relevant data and can often lower

the submitters’ test costs.

Upon approval of a LoREX

exemption, the submitter is bound to

the uses and the exposure and release

controls described in the approved

exemption. The submitter is also bound

to the listed manufacturing sites unless

the conditions described in paragraph

(j)(6) are met. The Agency will deny an

exemption application despite

satisfaction of the LoREX exemption

criteria if EPA makes the findings in

§723.50(d) or if there are issues

concerning exposure or toxicity that

require further review beyond 30 days

under §723.50(h)(1).

B. Discussion of the Public Comments

and the Final Rule

This unit of the preamble summarizes

the major public comments received,

clarifies several areas of confusion

identified by the public comments, and

discusses the differences between the

final rule and the proposal. Readers are

also encouraged to consult the preamble

of the proposed rule (58 FR 7646) for

further explanation of these provisions.

Comment 1—Information reporting

burden. Several commenters suggested

that the information reporting

requirements for both proposed

exemption categories are overly

burdensome and would discourage use

of those exemptions; they believed that,

because of this burden, many potential

applicants would choose to submit full

PMNs rather than use either of these

two exemptions.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16339

Response. The Agency reviewed the

proposed information reporting

requirements and has, to lesson that

burden, revised those requirements in

several areas, as described below.

However, after close examination, EPA

concluded that, in the context of these

two exemption categories, some

additional reporting burden is inevitable

if the exemptions are to be practicable.

This conclusion was based upon several

factors. First, EPA believes that more

information is necessary to support the

TSCA section 5(h)(4) ‘‘will not present

an unreasonable risk’’ finding for the

higher production volume chemical

substances likely to be reviewed under

both the expanded low volume

exemption, and for the new LoREX

exemption category which does not

contain any production volume

limitations for eligibility. Second, in the

Agency’s experience under the prior

low volume exemption (LVE),

resolution of many exemption

applications has been significantly

delayed because additional information

was needed to make regulatory

decisions. Between June 1992 and

January 1993, for example, over 12

percent of the LVE submissions were

suspended during the review period

pending receipt of additional human

exposure, environmental release, worker

protection, and/or environmental

release control information necessary

for the Agency’s risk assessment. The

percentage of submissions delayed for

additional information would likely be

significantly higher for the new highervolume exemptions without some

augmentation of the reporting

requirements. Such delays would be

very costly to both industry, through

lost sales, and to EPA, through higher

administrative expenditures.

One reporting area which several

commenters identified as being

particularly burdensome on

manufacturers was human exposure/

environmental release estimates,

especially estimates for processing and

use sites controlled by others. This

burden was asserted to be especially

acute on manufacturers of small volume

specialty chemical products.

Upon review of these comments, EPA

believes that, if provided with basic

process descriptions for the proposed

manufacturing, processing, and use

operations of a new chemical substance,

EPA can generate adequate exposure

and release estimates for most types of

new chemical substances which may be

manufactured under the new low

volume exemption. This belief is based

on the experience gained from

reviewing TSCA section 5 submissions

for over 25,000 new chemical

substances over the past 16 years.

Therefore, the final rule has been

amended to make information on

human exposures and environmental

releases for low volume exemption

applicants optional if that information is

not known by or readily available to the

manufacturer. Manufacturers should be

aware, however, that EPA-generated

exposure and release estimates will

generally be very conservative due to

the uncertainties over the actual

operating conditions which will be

present at the manufacturing,

processing, and use sites. Therefore, it

will generally be in the applicants’

interest to supply exposure and release

data wherever possible. To assist in

reporting such data under both the low

volume and LoREX exemptions, the

Agency has prepared a draft guidance

document: Guidance for Reporting

Occupational Exposure and

Environmental Release Information

under 40 CFR 723.50. This document

may be obtained through the TSCA

Assistance Information Service at (202)

554–1404; TDD (202) 554–0551; online

service modem (202) 554–5603.

Comment 2— Customer

noncompliance reporting provisions.

Several companies expressed concern

over the provisions in the proposal

which would require exemption holders

to immediately cease distribution of the

exempted substance to any downstream

recipient the holder learns is processing

or using the exempt substance in

violation of use, environmental release,

worker exposure, or other restrictions of

the exemption, and to report such

violations to the Agency. It was

suggested that the Agency adopt the

alternative procedures for dealing with

customer noncompliance now used by

the Agency in its TSCA section 5(e)

consent orders.

Response. The provisions in the

proposal for customer notification of

exemption restrictions and for reporting

customer noncompliance and ceasing

distribution pending EPA’s

investigation into deviations from

exemption conditions are not new; they

were retained from the prior low

volume exemption regulation. (See

existing 40 CFR 723.50(j)). The Agency

has serious concerns over the

environmental and human health risks

which may result from any failures by

downstream recipients to comply with

the requirements of an approved

exemption. Nevertheless, the Agency

appreciates the difficulties which may

flow from a requirement to immediately

cease distribution to noncomplying

customers, regardless of the gravity of

the violation, and believes that the

procedures developed in the section 5

consent order context would be

appropriate in this exemption also.

Therefore, the final rule has been

modified as follows: If a manufacturer

holding an exemption learns that a

direct or indirect customer is processing

or using the exempt substance in

violation of any provisions of the

exemption, the manufacturer must cease

distribution of the substance to the

customer or the customer’s supplier

immediately unless the manufacturer is

able to document each of the following:

(1) That the manufacturer has, within 5

working days, notified the customer in

writing that the customer has failed to

comply with the conditions specified in

§723.50 and the exemption notice; and

(2) that, within 15 working days of

notifying the customer of the

noncompliance, the manufacturer

received from the customer, in writing,

a statement of assurance that the

customer is aware of the terms of

§723.50 and the exemption notice and

will comply with those terms. If, after

receiving a statement of assurance from

a customer, the manufacturer obtains

knowledge that the customer has failed

to comply with any of the conditions

specified in the §723.50 and the

exemption notice, the manufacturer

must immediately cease supplying the

exempted substance to that customer

and must report the failure to comply to

EPA within 15 days of obtaining this

knowledge. Within 30 days of its receipt

of the report, EPA will notify the

manufacturer whether, and under what

conditions, distribution of the new

chemical substance to the customer may

resume.

Comment 3— Changes in

manufacturing site. Several commenters

requested that the Agency consider

providing greater flexibility regarding

changes in manufacturing sites for both

categories of exemptions. They stated

that such unanticipated changes as a

sudden increase in demand or

equipment failure at the original site can

quickly create a need to employ an

alternative manufacturing site on short

notice. In such cases, the proposed

process of obtaining approval for a new

site may preclude the start up of another

manufacturing operation in a timely

fashion.

Response. In response to these

comments, the Agency has added a new

provision to the final rule which

permits applicants to change

manufacturing sites under the following

conditions: First, where the magnitude,

frequency, and duration of exposure of

workers to the chemical substance at the

new manufacturing site is equal to, or

less than, the magnitude, frequency, and

duration of worker exposures to the
16340 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

chemical substance at the

manufacturing sites for which the

Agency performed its risk-assessment

pursuant to the original exemption

notice; and second, where either (1) at

the new manufacturing site, the

manufacturer does not release to surface

waters any of the chemical substance, or

any waste streams containing the

chemical substance; or (2) at the new

manufacturing site, the manufacturer

maintains surface water concentrations

of the chemical substance, resulting

from direct or indirect discharges from

the manufacturing site, at or below 1

ppb, or at or below an alternative

concentration level approved by the

Agency in writing or under the

procedures described at 40 CFR

723.50(c)(2)(iii) of the rule. The surface

water concentrations shall be calculated

using the method described at 40 CFR

721.91 and 721.92.

To meet the first condition described

above regarding worker exposure, a

manufacturer need only maintain

records showing that the new

manufacturing site is employing the

same basic manufacturing technology as

that described in its initial exemption

notice, such that there is not an

appreciable difference in worker

exposures during operations at the new

site compared to the original sites.

Alternatively, a manufacturer could

show that the technology at the new

site, though different, actually decreases

worker exposure levels because of

improved containment equipment,

mechanization of manufacturing

processes, or similar improvements.

The water release conditions may be

satisfied simply by calculating the

surface water concentrations using the

method described at 40 CFR 721.90 and

721.91 and maintaining records of the

calculations. For chemical substances

regulated under either LoREX or the low

volume exemption, the surface water

concentrations must be at or below 1

ppb. If the Agency has approved a

higher concentration level for a

particular LoREX chemical substance

under the procedures described at 40

CFR 723.50(c)(2)(iii), the water

concentration must be at or below that

higher level. The Agency will, upon

request, provide LVE holders with the

water concentration of concern (‘‘COC’’)

used by the Agency in its risk

assessment for the new chemical

substance. LVE holders changing

manufacturing sites must maintain

surface water concentration levels at or

below 1 ppb or the Agency-prescribed

COC, whichever is greater.

All manufacturers who change or add

manufacturing sites pursuant to these

procedures must inform the Agency of

the address of the new sites no later

than 30 days after the commencement of

manufacture at each new site. All other

terms and conditions of the original

exemption will continue in effect.

Comment 4—LoREX eligibility

criteria. Several commenters suggested

that the proposed LoREX eligibility

criteria were too stringent, that very few

chemical substances could meet the

eligibility requirements, and that the

Agency would achieve its streamlining

objectives more directly by establishing

an exemption for site-limited

intermediates.

Response. The Agency largely

disagrees with these comments. As

explained in unit II. A. 2. of this

preamble, EPA believes that the

performance-based eligibility criteria for

the LoREX exemption will be achievable

for a significant number of new

chemical substances, and that, once

manufacturers become more familiar

with the criteria, they will find it to be

much more versatile than a site-limited

intermediate exemption.

As discussed above in this preamble,

the Agency has prepared a draft

guidance document to assist

manufacturers in reporting exposure

and release information under this

exemption. The draft document, entitled

Guidelines for Reporting Occupational

Exposure and Environmental Release

Information under 40 CFR 723.50,

explains in detail the type of

information EPA will need to assess the

potential risks of new chemical

substances manufactured under the

LoREX and low volume exemptions,

and the type of documentation the

Agency believes is adequate to support

an exemption. The document may be

obtained through the TSCA Assistance

Information Service at (202) 554–1404;

TDD (202) 554–0551; online service

modem (202) 554–5603.

As stated throughout the proposal, the

Agency was very interested in

considering any alternative LoREX

criteria which commenters might

suggest. Despite those invitations, very

little comment was offered on the

specific proposed criteria itself.

Nevertheless, the Agency reexamined

the proposed criteria and has decided

that the ambient surface water criteria

could be amended to permit higher

water concentrations in certain cases.

Specifically, EPA determined that it

could permit surface water

concentrations above the standard 1 ppb

if the higher level is supported by

relevant and scientifically valid data on

the new chemical substance or on a

close structural analogue to the new

chemical substance which adequately

demonstrates that the new chemical

substance will not present an

unreasonable risk of injury to aquatic

species or human health at the higher

surface water concentration. Because

scientific review of submitted test data

will often require more than the normal

30–day review period, the Agency may,

on a case-by-case basis, request

manufacturers to temporarily suspend

the review period pending data review.

Comment 5—Revocation provisions.

Several commenters objected to the

proposed provisions regarding

revocation of exemptions after

expiration of the review period. Under

the proposal, the Agency could, based

on new information, notify an

exemption holder that EPA had

determined that the new chemical

substance did not meet the terms of the

exemption and, after providing an

opportunity for the holder to submit

objections, could issue a final

determination revoking the exemption if

it disagreed with the exemption holder’s

objections. Numerous commenters were

very concerned over the potential for

business interruptions and loss of

credibility with customers, and

predicted that many prospective

exemption applicants would choose

submission of a full premanufacture

notification rather than risk revocation

of an exemption under the proposed

provisions. Many suggested that the

Agency reinstate the original notice of

ineligibility provisions contained in the

prior low volume exemption

regulations.

Response. The Agency believes that

manufacturers’ concerns over

unwarranted revocations overstate the

potential for commercial harm coming

to them as a result of these provisions.

In fact, as the Agency stated during

public hearings on the exemption, in the

9 years that the low volume exemption

has been in effect, EPA has yet to invoke

the post-review period revocation

provisions in a single instance.

Moreover, the Agency believes that the

type of information which would

convince it to invoke the revocation

provisions would also convince most

exemption holders to voluntarily

withdraw their exemptions or undertake

appropriate measures to mitigate the

potential risk posed by the new

chemical substance. Nevertheless, the

Agency understands that a perceived

risk of sudden business interruptions by

prospective applicants and their

customers may greatly discourage

utilization of the exemption. In the final

rule, therefore, EPA has reinstated the

post-review period notice of ineligibility

provisions as they were promulgated in

the original low volume exemption.

Those provisions differ from the
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16341

proposed provisions in 2 principal

respects: first, the decision to invoke the

provisions must be made by the

Assistant Administrator for the Office of

Prevention, Pesticides, and Toxic

Substances; and second, if the Assistant

Administrator determines, after a final

determination that the substance does

not meet the terms of the exemption,

that the exemption holder acted with

due diligence and in good faith to meet

the terms of the exemption, the

exemption holder may, if it submits a

PMN for the new chemical substance,

continue to manufacture, process, use,

and distribute the new chemical

substance unless EPA subsequently

takes action under section 5(e) or 5(f) of

TSCA.

Comment 6—User fees. Most

commenters stated that, because

exemption applications are less

burdensome upon the Agency than a

full PMN submissions, the proposed

$2,500 user fee for the exemptions

should be lowered to reflect this

savings.

Response. Although the applications

submitted under these two exemptions

will be less costly, on average, for the

Agency to review than PMN

submissions, the average cost to the

Agency of reviewing an exemption will

still exceed $2,500; however, as a

further incentive for manufacturers to

utilize these exemptions wherever

possible, the Agency has at this time

decided not to impose a user fee

requirement for these exemptions.

III. Rationale for Expanding the Low

Volume Exemption Category

A. Chemical Substances Manufactured

at 10,000 Kilograms or Less Per Year

The basic rationale for expanding the

low volume exemption category from

1,000 kilograms per year to 10,000

kilograms per year is the same as that

for proposing the exemption initially:

chemical substances produced in lower

quantities generally involve

correspondingly lower human

exposures and environmental releases,

and thus generally present less risk than

high volume substances. In the Agency’s

experience reviewing PMN substances

in the 1,000 to 10,000 annual

production range, very few of these

substances present risks of injury to

human health or the environment

significantly greater than the substances

produced under the existing low

volume exemption. Additionally, the

Agency believes that the low volume

exemption has been a very successful

regulatory mechanism as measured by

the level of EPA administrative

resources needed to implement it and

the relative burden it places on

manufacturers. Because of this success,

EPA believes that both its interests and

the interests of industry will be served

by enlarging the portion of new

chemical substances which may be

manufactured under the exemption.

B. Low Release and Exposure (LoREX)

Chemical Substances

In addition to the production volumebased category described above, EPA is

promulgating a new TSCA section

5(h)(4) exemption category based on low

levels of environmental release of and

human exposure to the new chemical

substance. Eligibility is independent of

production volume level.

The Agency believes that the concept

of basing an exemption on low release

and exposure offers several potential

advantages over a more broad volumebased exemption. First, an exposuredriven exemption generally provides a

more direct gauge of the magnitude of

risk presented by a given new chemical

substance. Production volume alone is

only an indirect indicator of exposures

and releases. Secondly, EPA believes

that the existence of a LoREX exemption

will encourage pollution prevention

techniques by rewarding manufacturers

able to meet the low release and

exposure criteria with more timely

regulatory decisions, and in many cases,

with less burdensome regulatory

controls. Such a result would entail

substantial time and resource savings

for both EPA and industry.

1. LoREX criteria. EPA has decided to

set general performance standards for

the LoREX exemption. Persons applying

for exemptions are responsible for

complying with these performance

standards. Section 723.50(c) sets out the

performance standards as ‘‘criteria.’’

Some are absolute, e.g., no releases to

surface waters resulting in water

concentrations above 1 ppb. Others set

a goal but allow compliance to be

achieved without an absolute guarantee

(e.g., no dermal or inhalation worker

exposure) but this result is assumed to

occur if ‘‘adequate’’ controls are used. In

others, a general standard is set, but

EPA can approve a different level for a

specific new chemical substance (e.g.,

no surface water releases resulting in

surface water concentrations above 1

ppb unless a higher concentration is

approved based on data provided by the

applicant in the notice). In all cases,

EPA does not specify how the

exemption applicant is to achieve the

performance standard. In its exemption

notice, the applicant will describe how

it limits exposure with respect to all the

criteria in the exemption. EPA will

evaluate whether these meet the criteria

in §723.50(c)(2). If they do, EPA will

grant the exemption. If the exemption is

granted by EPA, the exemption holder is

responsible for complying with the

standards throughout the period of the

exemption and with any controls or

limitations specified in its exemption

notice.

a. Human exposure. In determining

the appropriate criteria for defining the

types and/or levels of exposure which

should constitute ‘‘low exposure’’ to

humans, EPA considered three distinct

populations: workers, consumers, and

the general population. EPA believes

that, for purposes of this exposure-based

exemption, any direct exposures to

consumers and the general population

would be, in the context of an

abbreviated review period, inconsistent

with the Agency’s statutory obligation

under section 5(h)(4) to affirmatively

find that the exempted substances will

not present an unreasonable risk of

injury to human health. Therefore, the

Agency believes that any consumer and/

or general population exposures (other

than the negligible drinking water and

ambient air exposures discussed later in

this preamble) should automatically

disqualify new chemical substances

from LoREX exemption eligibility.

Exposures to workers may be more

readily monitored and controlled

through engineering controls, workplace

practices, and/or protective equipment

requirements. Therefore, the Agency

believes that it may, consistent with its

section 5(h)(4) obligation, approve a

high percentage of LoREX exemption

notices where appropriate control

measures are instituted in the

workplace.

Workplace exposures may occur

through inhalation or dermal contact.

For dermal exposures, the Agency

believes that the general dermal

exposure requirements used in section

5(e) consent orders and significant new

use rules (SNURs) generally provide

‘‘adequate dermal exposure controls.’’

These include that all workers

reasonably likely to be exposed to

LoREX substances be provided with,

and required to wear, chemical

protective equipment which provides a

barrier to prevent all dermal exposure to

the substance. Chemical protective

clothing used to provide this barrier is

demonstrated to be impervious to the

substance under the expected

conditions of use and duration of

exposure. Such demonstration could be

accomplished under the procedures

described at 40 CFR 721.63(a)(3)(i) - (ii)

of the SNUR provisions by actually

testing the material used to make the

chemical protective clothing and/or by

evaluating the specifications from the
16342 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

manufacturer or supplier of the

chemical protective clothing to establish

that it will be impervious to the

exempted substance alone and in likely

combination with other chemical

substances in the work area.

To provide ‘‘adequate inhalation

exposure controls,’’ submitters of

LoREX exemption notices will (i)

identify the workplace operations where

inhalation exposure is likely to occur;

(2) assess the magnitude, frequency, and

duration of potential exposure; (3)

assess the effectiveness of the various

exposure controls; and (4) select the

method or combination of methods that

will provide workers with the

appropriate protection for the given

workplace. While the Agency strongly

encourages submitters to reduce

workplace exposures at their source,

where feasible, submitters could also

‘‘provide adequate inhalation exposure

controls’’ based on the use of

appropriate respiratory protection

equipment. To achieve adequate

controls, the Agency believes it most

appropriate for a submitter to comply

with the general requirements regarding

respiratory protection used in TSCA

section 5(e) consent orders and SNURS.

These requirements stipulate the use of

respiratory protection in accordance

with the National Institute of

Occupational Safety and Health

(NIOSH) regulations at 30 CFR part 11,

and the Occupational Safety and Health

Administration (OSHA) regulations at

29 CFR 1910.134. (See generally 40 CFR

721.63). Similarly, the inherent physical

or chemical properties of the substance

submitted for an exemption may form

the basis for a conclusion of adequate

exposure controls, as in a nonvolatile

dye manufactured, processed, and used

only in solution, such that inhalation of

particulates will not occur.

b. Environmental release— i. Water

releases. The LoREX water release

eligibility criterion of <1 ppb surface

water concentration was established on

the basis of EPA’s experience in

conducting environmental risk

assessments on PMN substances. The

concentration level must be calculated

by the submitter using the method

described in 40 CFR 721.90 and 721.91.

Based on EPA’s PMN experience,

aquatic toxicity concern levels have

only very rarely been established at

levels below 1 ppb. Thus, EPA is

confident that the vast majority of

LoREX exemption notices satisfying this

criterion will not present an

unreasonable risk of acute or chronic

aquatic toxicity, and that the Agency’s

risk assessment capabilities will identify

those few exemptions which may

require more strict concentration levels

to protect against potential aquatic risks

during the 30–day notice period.

ii. Air releases from incineration. The

LoREX incineration air release

eligibility criterion of < 1 μg/m3, like the

ambient surface water criterion, was

selected on the basis of experience

gained in conducting risk assessments

on over 25,000 new chemical substances

since 1979. At this maximum annual

average concentration, EPA believes

that, using worst case estimates, the

maximum human exposures downwind

from incinerators will be toxicologically

insignificant for most of the chemical

substances it is likely to review under

the LoREX exemption. As noted above,

however, the Agency may require

individual submitters to adhere to lower

incineration release levels for

substances for which chronic toxicity

concerns are raised during the risk

assessment.

The methodology for calculating

maximum annual average concentration

(see subparagraph (c)(2)(iv) of the rule)

was based on computer modeling

similar to that used by the Agency in the

PMN review process. Those interested

in more detail on this methodology

should consult the docket established

for this rulemaking.

Submitters should also be aware that,

although the final rule has not

established generic eligibility criteria for

fugitive air emissions unrelated to

incineration, the Agency will review the

potential for such emissions on a caseby-case basis, and will deny exemptions

if the air emissions reach such levels as

to undermine the Agency’s ability to

conclude that the substances in question

will not present an unreasonable risk.

Based on EPA’s PMN experience,

chemical substances with fugitive air

emissions under 23 kilograms per site

per year are seldom found to present an

unreasonable risk of injury to the

general population. Therefore,

manufacturers submitting a LoREX

exemption notice for substances with

fugitive air emissions below that level

are unlikely to be denied an exemption

on that basis.

iii. Land/groundwater releases. The

final rule excludes from eligibility all

chemical substances which will be

disposed of via landfill unless the

submitter demonstrates to EPA in the

notice that the exempted substance has

negligible ground-water migration

potential. This standard was deemed

most appropriate for this purpose

because the Agency was unable to

develop a broadly applicable method for

estimating groundwater concentrations

of chemical substances based on landfill

disposal volume that would allow

development of a generic criterion.

Given the many variables involved in

making such estimates (e.g., migration

rates, biodegradation rates, sediment/

soil adsorption rates), EPA does not

believe it will be possible to develop a

generic model for estimating

groundwater concentrations for a

significant number of substances with

sufficient reliability to support the

requisite ‘‘will not present an

unreasonable risk’’ finding.

Consequently, the Agency believes that,

in the context of an abbreviated review

period in which in-depth case-by-case

assessments of groundwater leaching

potential are infeasible, prudence

dictates that negligible release be the

primary standard.

However, potential LoREX exemption

submitters with no viable alternatives to

landfill disposal have the option of

demonstrating to the Agency’s

satisfaction that their substance will not

migrate to groundwater. A list of

suggested tests to establish groundwater

migration potential is contained in

Units II.A.2. of this preamble. If such a

demonstration is made, a submitter

would be permitted to landfill excess

quantities of the exempted substance up

to the amounts approved in its

exemption notice. In all cases, however,

the Agency strongly encourages

submitters to strive for total elimination

of releases through employment of the

best available pollution prevention

techniques. (See Unit II.A.2. of this

preamble for further guidance on this

criterion).

IV. Regulatory Analysis

A. Summary of Risk Assessment

1. 10,000 kilogram/year chemical

substances. To assess the risk associated

with raising the ceiling for new

chemical substances eligible for the low

volume exemption from 1,000

kilograms/year to 10,000 kilograms/

year, the Agency relied primarily upon

the risk assessment developed to

support the 1985 final low volume rule,

along with the earlier version used to

support the 1982 proposed low volume

and site-limited intermediate rules.

a. Exposure assessment. The exposure

assessment illustrates that, while low

production volume in itself limits

potential for exposure and

environmental release, manufacture,

processing, and use of new chemical

substances can in some circumstances

result in significant exposures at both

the 1,000 and 10,000 kilogram annual

production levels.

i. Occupational exposure. Based on

PMN data, the number of workers

exposed during manufacturing ranged

from an average of about four for new
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16343

chemical substances manufactured in

quantities of 1,000 kilograms or less per

year to an average of about eight for new

chemical substances manufactured in

quantities of 10,000 kilograms or less

per year. Duration of exposure

associated with manufacture averaged

about 5 hours per day at both

production levels, and the average

number of days of production per year

was 62.

Only a limited number of PMNs

included estimates of workplace

concentration. The average

concentrations associated with

manufacture were most often in the

ranges of 0 to 1 and 1 to 10 mg/m3 for

airborne solids and in the 1 to 10 ppm

range for vapors. EPA’s evaluation of

OSHA data (USEPA, OTS ‘‘Site-Limited

Intermediate Exemption: Occupational

Exposure and Environmental Release

Assessment.’’ March 19, 1982) indicated

a time weighted average (TWA) of 6

ppm, with a maximum value of 72 ppm

for vapors. EPA believes that data

obtained from OSHA monitoring

activities provides more reliable

estimates of workplace concentrations.

EPA’s analysis of processing and use

of low volume chemicals indicated that

the wide variety of possible processing

and use operations can result in a wider

range and higher level of exposures than

is typically associated with

manufacturing operations. The average

number of workers exposed during

processing and use operations exceeded

the average numbers typically exposed

during manufacturing. The number

ranged from an average of 12 workers

for a chemical processed in quantities of

1,000 kilograms or less per year to an

average of 141 workers for chemicals

processed or used in quantities of

10,000 kilograms or less per year.

ii. Consumer exposure. Consumer

exposures were assessed for five use

scenarios: photographic chemicals used

in home darkrooms; spray adhesives;

paints; dyes; and fragrances used in

detergents. The use scenarios, which

reflected actual uses reported in PMNs,

were selected to represent divergent and

potentially significant exposure

situations. In these scenarios, the

individual lifetime average daily

exposures were estimated to range from

0.0016 mg/kg/day for a fragrance in soap

to negligible levels for dyed fabrics.

According to EPA’s analysis, many of

the consumer use scenarios could result

in relatively large numbers of

consumers exposed. The numbers of

consumers potentially exposed at the

10,000 kilogram production level ranged

from 76,000,000 for a fragrance in

shampoo to 98,000 for a spray adhesive.

Because the concentration of a new

chemical substance in a final product

remains constant, the production

volume is likely to affect only the

number of consumers exposed, not the

exposure level to each individual.

Therefore, the number of consumers

exposed at the 10,000 kilogram

production limit is about 10 times the

number that would be exposed at the

1,000 kilogram limit.

b. Environmental release. The Agency

used data derived from PMN

submissions for estimating the likely

magnitude, duration, and frequency of

environmental releases from

manufacturing chemical substances

under the new low volume exemption.

The exposure analysis indicated that the

average quantity released to water is

0.08 percent of the production volume,

with an upper bound of 0.4 percent.

Amounts released to air average 0.03

percent of production volume, with a

0.2 percent upper bound. However,

some processing and industrial uses

result in more substantial release rates,

with a range from 0.3 to 25 percent of

the production volume released to

water. Discharges of a new low volume

chemical substance from a single site

processing 10,000 kilograms of the

substance were estimated to produce

environmental concentrations ranging

from less than 0.0005 to 5.2 ppm in a

receiving stream whose stream dilution

factor was equal to the national median

for streams receiving effluent from

industrial facilities.

In some cases, such as detergent

additives, environmental releases from

consumer uses equaled the total

production volume; however, the actual

magnitude of environmental exposure

was determined to be insignificant due

to the low production volume, the wide

distribution of release, and the small

amount of new chemical substance

typically contained in each consumer

product.

c. Risk under exemption conditions.

There are several elements of the

exemption amendment that will

significantly reduce risks to human

health and the environment.

Chemical substances with

carcinogenic, teratogenic, neurotoxic,

and other chronic effects appear to

present the greatest risks even at

relatively low exposures. The Agency

will deny exemptions for new

substances which may cause such

effects under anticipated conditions of

manufacture, processing, distribution in

commerce, use, or disposal. These

denials will significantly reduce the

likelihood that chemicals that present

such risks would be manufactured

under the amended exemption. If the

exemptions for such substances are

denied, or if their submitters are

required to resubmit their exemption

notices to provide for more stringent

release and exposure controls prior to

approval, the range of potential risks

would be substantially below the high

end of EPA’s estimates.

In addition, under the amended

regulation, EPA would continue to

review all exemption notices during the

30–day review period. This review will

help ensure that manufacturers choose

appropriate safeguards to control risks,

as well as provide a screen to identify

substances that do not qualify for the

exemption.

2. Low exposure/release chemical

substances. The risk associated with a

given substance is a function of both the

inherent toxicity (hazard) of the

substance and the exposure of the

relevant organism to the substance.

Therefore, to the extent that releases and

exposures are maintained below certain

critical levels, potential risks presented

by the substance are minimal. To assess

the potential risk associated with the

LoREX exemption, the Agency

evaluated the exposure and release

criteria in the context of its experience

conducting risk assessments on over

25,000 new chemical substances in the

PMN program over the last 16 years.

Based on this experience, EPA tailored

its LoREX exemption criteria in a

manner to exclude from eligibility

virtually all of the new chemical

substances which the Agency believes

could present potentially significant

human or environmental exposures

under conditions of manufacturing,

processing, and use. For those

substances which meet the eligibility

criteria but may nevertheless present

significant risks due to unusually high

known or predicted toxicity levels, the

Agency will either deny the exemptions

or condition approval upon satisfaction

of stricter exposure and release

requirements.

a. Human exposure. Due to the wide

range of possible consumer and general

population exposures from the universe

of new chemical substances, the Agency

concluded that it could not develop any

meaningful consumer or general

population exposure criteria which

would consistently screen out those

substances which would present

unreasonable risks from direct dermal or

inhalation exposures. Consequently,

EPA has excluded from LoREX

exemption eligibility all new chemical

substances which entail any direct

consumer or general population

exposure (except for negligible drinking

water and ambient air exposures

discussed in Unit IV.A.2.b. of this

preamble). New chemical substances
16344 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

intended for use in consumer paints,

detergents, dyes, and other consumer

products, therefore, would have to be

reviewed by the Agency in a full PMN

or under one of the other applicable

PMN exemptions, unless the chemical

substance is completely reacted,

encapsulated in a polymer matrix, or

otherwise not bioavailable in the final

product.

EPA has substantial experience with

controlling worker exposure to new

chemical substances from reviewing

notices for over 25,000 new substances

under section 5 of TSCA and issuing

several hundred section 5(e) consent

orders and SNURs with worker

protection requirements. EPA believes

that worker exposure to new chemical

substances can be controlled adequately

through the use of appropriate

engineering/process controls and, if

such controls cannot be used, through

use of appropriate personal protective

equipment. EPA has prescribed such

controls and personal protective

equipment in several hundred section

5(e) consent orders and believes that

their proper use reduces worker dermal

and inhalation exposure to new

chemical substances to minimal levels.

Thus, EPA concluded that for workers,

who can be protected adequately from

exposure to new chemical substances, it

would set a goal of no dermal or

inhalation exposure and allow persons

applying for LoREX exemptions to meet

those goals by using ‘‘adequate’’

controls and personal protective

equipment modelled on the sorts of

controls EPA has employed in the

section 5(e) context.

b. Environmental releases. In terms of

environmental releases, there are LoREX

eligibility criteria for releases to three

environmental media. For ambient

surface water, the Agency is requiring

that submitters either (i) prevent all

direct and indirect releases of the

exempted substance to surface waters;

or (ii) demonstrate that any releases to

surface water that may occur will result

in surface water concentrations of the

substance that are no greater than 1 part

per billion (ppb) using the surface water

concentration calculation method

described in 40 CFR 721.90 and 721.91.

Based on Agency worst case

assumptions for drinking water

exposure estimates, surface water

concentrations of 1 ppb will result in

human drinking water exposures at or

below the 1 mg/year LoREX drinking

water criterion in nearly every case;

therefore, compliance with the drinking

water exposure criterion will be

presumed from compliance with the 1

ppb surface water level. The Agency

retains the authority, however, to

require lower surface water

concentrations on a case-by-case basis

when concerns for carcinogenicity,

neurotoxicity, or other serious effects

are raised, or under conditions where

projected drinking water exposures are

likely to significantly exceed the 1 mg/

yr dosage.

The LoREX eligibility criterion for

maximum annual average ambient air

release concentrations from incineration

of the new chemical substance is 1 μg/

m3. This level was derived from air

exposure modeling estimates of

maximum ground level concentrations

from incinerator stacks, using worst case

meteorological data sets. To determine

whether a particular substance meets

the criteria, submitters would calculate

exposure levels using the method

described in §723.50(c)(2)(iv). As with

drinking water exposures, the Agency

may require lower air release levels in

individual cases if concerns for

significant health effects are raised for

the new substance.

For land/groundwater disposal, EPA

is requiring that a LoREX substance not

be disposed of by landfill or other land

disposal methods unless the submitter

demonstrates that the substance will not

migrate to groundwater. (Consult unit

II.A.2. of this preamble for further

information on this criterion.)

Upon approval of a LoREX

exemption, the submitter is bound to

the continuous use of the exposure and

release controls described in the

approved exemption notice, as well as

the listed uses and, unless specified

conditions are met, manufacturing sites.

The Agency will deny an exemption

notice notwithstanding satisfaction of

the exposure-based exemption criteria if

EPA determines that the new substance

may cause serious acute or chronic

effects or significant environmental

effects under anticipated conditions of

manufacture, processing, distribution in

commerce, use, and disposal.

V. Economic Impact

The regulatory impact analysis

estimates the costs and benefits

attributable to the regulation. In this

case, the analysis also contains

estimates for the three additional

amendments to EPA’s TSCA section 5

regulations, namely the Polymer

Amendment, the Procedural

Amendment, and the Non-5(e)

Significant New Use Rule Amendment,

also published today. Because these

regulations are amendments to current

regulations, the costs and benefits are

incremental, estimating the effect of the

amendment with respect to the current

regulation.

The costs and benefits associated with

this amendment are partially quantified;

many of the benefits are unquantified

but are expected to be of significant

importance. Considering only the

quantified costs and benefits, there is a

cost savings in most instances.

Assuming either 1,000, 2,000, or 3,000

annual section 5 submissions, the

savings as compared to the current

regulation are estimated to be:

Annual Number

of Submissions

Annual Cost Savings

($ Million)

Industry Government

1000 ................. 0.2 – 0.4 1.3 – 1.5

2000 ................. 0.4 – 0.7 2.5 – 3.1

3000 ................. 0.5 – 1.1 3.8 – 4.6

This amendment expands the low

volume exemption and establishes the

LoREX exemption. Industry costs

associated with the amendment to the

low volume exemption are reporting

costs and delay costs. Per submission

reporting costs are increased due to the

more comprehensive submission

requirements. Delay costs for those

substances which qualify for the current

exemption are slightly higher, while

delay costs are significantly reduced for

those substances which currently must

submit a full PMN submission but

would qualify for the new exemption.

Delay costs are the costs associated with

the delayed introduction of the

substance into the market due to section

5 regulations.

Industry costs associated with the

LoREX exemption are also reporting

costs and delay costs. Because this

would be a new exemption, all of the

submitters would have originally been

required to submit a full PMN

submission and would be required to

pay a user fee. Also, the reporting

requirements are only slightly more

than current requirements.

Unquantified benefits associated with

this amendment include (1) increased

use of pollution prevention practices by

submitters; (2) a greater emphasis on the

use of low risk chemicals; and (3)

bringing LoREX substance and new

substances manufactured between 1,000

and 10,000 kg per year to market more

quickly. Regarding the third benefit,

most chemical substances eligible for

the exemption will clear review at least

60 days more quickly than if they had

been submitted under a PMN; those

substances that would have been

regulated under section 5(e) will clear

review, on average, 90 to 150 days

sooner.

The Agency’s complete economic

analysis is available in the public record

for this rule (OPPTS–50596B).
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16345

VI. Finding of No Unreasonable Risk

1. Statutory background. Under

section 5(h)(4) of TSCA, EPA is

authorized to exempt the manufacturer

of any new chemical substance from all

or part of the requirements of section 5

if EPA determines that the manufacture,

processing, distribution in commerce,

use, and disposal of the substance will

not present an unreasonable risk of

injury to human health or the

environment. Section 26(c) of TSCA

provides that any action authorized

under TSCA for an individual chemical

substance may be taken for a category of

such substances. Under this regulation,

EPA is exempting two categories of

chemical substances: those with

production volumes less than or equal

to 10,000 kilograms/year, and those

with low human exposure and low

release to the environment. EPA has

determined that these are appropriate

categories under TSCA sections 6(c) and

5(h)(4). For each of these categories, as

discussed below, EPA has made a

finding that new chemical substances

eligible for the exemptions will not

present an unreasonable risk of injury to

human health or the environment when

manufactured, processed, used,

distributed in commerce, or disposed of

under the terms of the exemptions,

including EPA’s 30–day review.

The term ‘‘unreasonable risk’’ is not

defined in TSCA. The legislative

history, however, indicates that

unreasonable risk involves the

balancing of the probability that harm

will occur and the magnitude and

severity of that harm against the effect

of the proposed regulatory action on the

availability to society of the benefits of

the chemical substance.

2. Risks. In making the ‘‘will not

present an unreasonable risk’’ finding

under TSCA section 5(h)(4), EPA first

considered the risk posed by granting

each of the exemptions. Risk is the

combination of the hazard presented by

a chemical substance or category of

chemical substances and the exposure

of humans or the environment to the

substances or category. EPA’s

determination of the reasonableness of

risk involves a consideration of factors

such as environmental effects,

distribution, and fate of the chemical

substance in the environment, disposal

methods, waste water treatment, use of

protective equipment and engineering

controls, use patterns, and market

potential of the chemical substance.

These variables are difficult to quantify

and standardize, thus EPA must

supplement the available data with its

professional judgment.

EPA’s determination that

manufacture, processing, use,

distribution in commerce, and disposal

of these two categories of substances

under the terms of these exemptions

will not present an unreasonable risk of

injury to human health or the

environment is based on consideration

of (i) the limitations on risk that would

result from the safeguards built into the

rule, including Agency review; (ii) the

limitations on risk resulting from the

restriction of the exemptions to the

chemical substances manufactured at

volumes of 10,000 kg/yr or less and to

low release/low exposure chemical

substances; (iii) the benefits to industry

and the public provided by new

chemical substances manufactured

under the exemption; and (iv) the

benefits to the public and the Agency

from the Agency’s enhanced ability to

utilize its limited resources on

reviewing new chemical substances and

uses of higher risk and concern. EPA

recognizes that, even with the

safeguards imposed by this rule, it is not

ensuring that there will be no risk from

new chemical substances manufactured

under the exemption. The statute does

not require zero risk. Rather, it defines

unreasonable risk as a balancing of risk

and benefit. Because of the safeguards in

the amended regulation, the

requirement that the provisions of the

approved exemption are binding on the

submitter, and the restricted nature of

the exemption categories, EPA believes

that risks are not likely to be any greater

than if the full PMN process were

completed. Furthermore, the new

chemical substances provide benefits to

industry and to the public. These

benefits are an important element in the

finding that these substances will not

present an unreasonable risk.

The conditions of these exemptions

are designed to mitigate risk, largely by

the use of: (i) the reviews conducted by

the Agency to assess whether the new

chemical substances may cause chronic

or acute human health or environmental

effects; and (ii) the binding nature of the

provisions of exemption notices,

including the controls placed on

exposure through worker protection

requirements. For the low volume

exemption, EPA determined that risks

would generally be low because low

production volume substances typically

are not expected to result in high

exposure to humans or the environment.

Similarly, the eligibility criteria for the

LoREX exemption directly limit

permissible releases of and exposures to

the exempted substances. In addition to

the general finding of low release/low

exposure, and therefore low risk for

these categories, the restrictions and

safeguards built into the exemptions

will ensure that the risks presented by

the exempt substances are low. For

example, worker protection

requirements and release restrictions

imposed by the terms of the exemptions

will minimize exposure, and therefore,

risk.

a. EPA review. Within the 30–day

review period, EPA is confident that it

can identify the few new chemical

substances under these exemptions that

will pose potential risks which require

more detailed and comprehensive

review. EPA’s abbreviated review plays

an important role in the two exemptions

and in the unreasonable risk finding.

EPA has lengthened the review period

from 21 to 30 days to ensure that staff

resources will be sufficient to review the

exemption notices under the amended

rule. Information to be reviewed include

production volume, hazard information,

descriptions of the manufacturing,

processing, and uses, exposure controls,

releases to the environment, and certain

physical/chemical data which EPA will

assess in making a determination of risk.

During this period, the Agency will

have sufficient time to identify any

issues or problems that will require

more careful analysis, such as that

available in a full PMN review. If EPA

determines that a new chemical

substance is not eligible for an

exemption, manufacture will not begin.

The manufacturer would then be

required to comply with TSCA section

5(a)(1) before the substance could be

manufactured for commercial purposes

by submitting a full PMN to the Agency.

Despite the low risk generally

associated with low volume and low

release/low exposure substances, EPA

recognizes that some substances that

meet the general requirements for these

exemptions, may present risks that are

not appropriate for an exemption, thus

EPA performs a 30–day review of each

exemption notice and can deny

individual exemptions. For example, a

highly toxic chemical substance may

present an unreasonable risk even if

exposure to the substance is low.

Likewise, a low production volume

chemical substance may present an

unreasonable risk if it is hazardous and

is manufactured or processed in a

manner that would result in high

human exposure or high release to the

environment. Thus, although EPA is

making a general finding that these

categories of new chemical substances

will not present an unreasonable risk

under the terms of the exemptions, EPA

will continue to evaluate exemption

notices on a case-by-case basis to

determine if individual substances
16346 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

should be denied an exemption based

on the potential risks presented by those

substances. For a further discussion of

how EPA will determine when to deny

an exemption, see Unit III. of this

notice.

b. New information and EPA

revocation. In addition to these

safeguards, the rule contains several

other provisions that further limit the

possibility that exempted substances

may present unreasonable risks. Most

important, the rule establishes

procedures for revocation of the

exemption if EPA later determines that

the substance may cause serious acute

or chronic human effects or

environmental effects. In addition, EPA

has the authority to require documents

relevant to an exemption from the

manufacturer (in addition to the

information provided in the exemption

notice), and the manufacturer would be

required to submit promptly to EPA any

new data indicating that a substance is

ineligible. These provisions will ensure

that eligibility for and continuation of

the exemption will be determined on

the basis of the best available

information, regardless of when the

information becomes available.

3. Benefits. EPA believes that these

exemptions will allow many

manufacturers to introduce new

chemical substances in commerce much

more rapidly than via the PMN process.

The time and resource savings will also

benefit EPA which will, by utilizing its

limited assets more efficiently, be able

to apply more staff time to reviewing

higher risk chemical substances and

uses.

4. Pollution prevention

considerations. The LoREX exemption

is expected to further the Agency’s

pollution prevention efforts by

encouraging development of

manufacturing processes and

technologies which reduce chemical

releases and exposures at their source.

Such reductions not only limit potential

risks to people and the environment, but

may also produce significant long-term

cost savings to industry through the

recapture and reuse of substances which

would otherwise have been released

into workplaces or the environment.

5. Risk/benefit balance. As discussed

above, EPA has determined that the risk

presented by exempting these two

categories of new chemical substances is

low. At the same time, there are

significant benefits to be achieved by

the exemptions, which encourage

innovation and permit manufacturers to

introduce new chemical substances into

commerce more rapidly. Thus, EPA has

determined that, under the terms of this

rule, the risks associated with low

volume substances and low release/low

exposure substances are outweighed by

the benefits to society of exempting

these substances from full PMN review.

VII. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPPTS–50596B). The record includes

basic information considered by the

Agency in developing this rule. A

public version of the record is available

in the TSCA Nonconfidential

Information Center from 12 noon to 4

p.m., Monday through Friday, except

legal holidays. The TSCA

Nonconfidential Information Center is

located in Rm. NE–B607 (Northeast

Mall), 401 M St., SW., Washington, DC.

VIII. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51835, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to review by the Office of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under section 3(f), the Order defines a

‘‘significant regulatory action’’ as an

action that is likely to (1) have an

annual effect on the economy of $100

million or more, or adversely and

materially affect a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

referred to as ‘‘economically

significant’’) (2) create serious

inconsistency or otherwise interfere

with an action taken or planned by

another agency; (3) materially alter the

budgetary impacts 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 this Executive Order.

Pursuant to Executive Order 12866, it

has been determined that this rule is not

‘‘a significant regulatory action’’ under

section 3(f) of the Order. This action is

therefore not subject to OMB review.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.), the Agency

has determined that this regulatory

action will not impose any adverse

economic impacts on small entities.

EPA believes that, even if all of the

notice submitters were small firms, the

number of small businesses affected by

this action will not be substantial. In

addition, since this action will generally

reduce the existing burden and cost

imposed on notice submitters, the

impact of this action on small entities

should be an overall positive one.

C. Paperwork Reduction Act

The information collection

requirements in this rule have been

approved by the Office of Management

and Budget under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3502 et. seq. and have been assigned

OMB control number 2070–0012. The

public reporting burden for this

collection of information is estimated to

vary from 96 to 116 hours per response,

with an average of 106 hours per

response, including time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

List of Subjects in 40 CFR Part 723

Chemicals, Environmental protection,

Premanufacture notification, Hazardous

materials, Reporting and recordkeeping

requirements.

Dated: March 21, 1995.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I, part 723

is amended as follows:

PART 723 — [AMENDED]

1. The authority citation for part 723

continues to read as follows:

Authority: 15 U.S.C. 2604.

2. By revising §723.50 to read as

follows:

§723.50 Chemical substances

manufactured in quantities of 10,000

kilograms or less per year, and chemical

substances with low environmental

releases and human exposures.

(a) Purpose and scope. (1) This

section grants an exemption from the

premanufacture notice requirements of

section 5(a)(1)(A) of the Toxic

Substances Control Act (15 U.S.C.

2604(a)(1)(A)) for the manufacture of:

(i) Chemical substances manufactured

in quantities of 10,000 kilograms or less

per year.

(ii) Chemical substances with low

environmental releases and human

exposures.

(2) To manufacture a new chemical

substance under the terms of this

exemption a manufacturer must:

(i) Submit a notice of intent to

manufacture 30 days before

manufacture begins, as required under

paragraph (e) of this section.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16347

(ii) Comply with all other provisions

of this section.

(b) Definitions. The following

definitions apply to this subpart.

(1) Act means the Toxic Substances

Control Act (15 U.S.C. 2601 et seq).

(2) Consumer means a private

individual who uses a chemical

substance or any product containing the

chemical substance in or around a

permanent or temporary household or

residence, during recreation, or for any

personal use or enjoyment.

(3) Environment has the same

meaning as in section 3 of the Act (15

U.S.C. 2602).

(4) Environmental transformation

product means any chemical substance

resulting from the action of

environmental processes on a parent

compound that changes the molecular

identity of the parent compound.

(5) Metabolite means a chemical

entity produced by one or more

enzymatic or nonenzymatic reactions as

a result of exposure of an organism to

a chemical substance.

(6) Serious acute effects means human

disease processes or other adverse

effects that have short latency periods

for development, result from short-term

exposure, or are a combination of these

factors and that are likely to result in

death, severe or prolonged

incapacitation, disfigurement, or severe

or prolonged loss of the ability to use a

normal bodily or intellectual function

with a consequent impairment of

normal activities.

(7) Serious chronic effects means

human disease processes or other

adverse effects that have long latency

periods for development, result from

long-term exposure, are long-term

illnesses, or are a combination of these

factors and that are likely to result in

death, severe or prolonged

incapacitation, disfigurement, or severe

or prolonged loss of the ability to use a

normal bodily or intellectual function

with a consequent impairment of

normal activities.

(8) Significant environmental effects

means:

(i) Any irreversible damage to

biological, commercial, or agricultural

resources of importance to society;

(ii) Any reversible damage to

biological, commercial, or agricultural

resources of importance to society if the

damage persists beyond a single

generation of the damaged resource or

beyond a single year; or

(iii) Any known or reasonably

anticipated loss of members of an

endangered or threatened species.

Endangered or threatened species are

those species identified as such by the

Secretary of the Interior in accordance

with the Endangered Species Act, as

amended (16 U.S.C. 1531).

(9) Site means a contiguous property

unit. Property divided only by a public

right-of-way is one site. There may be

more than one manufacturing plant on

a single site.

(10) The terms byproduct, EPA,

importer, impurity, known to or

reasonably ascertainable, manufacture,

manufacturer, new chemical substance,

person, possession or control, and test

data have the same meanings as in

§720.3 of this chapter.

(c) Exemption categories. Except as

provided in paragraph (d) of this

section, this exemption applies to:

(1) Any manufacturer of a new

chemical substance manufactured in

quantities of 10,000 kilograms or less

per year under the terms of this

exemption.

(2) Any manufacturer of a new

chemical substance satisfying all of the

following low environmental release

and low human exposure eligibility

criteria:

(i) Consumers and the general

population. For exposure of consumers

and the general population to the new

chemical substance during all

manufacturing, processing, distribution

in commerce, use, and disposal of the

substance:

(A) No dermal exposure.

(B) No inhalation exposure (except as

described in paragraph (c)(2)(iv) of this

section.

(C) Exposure in drinking water no

greater than a 1 milligram per year

(estimated average dosage resulting from

drinking water exposure in streams from

the maximum allowable concentration

level from ambient surface water

releases established under paragraph

(c)(2)(iii) of this section or a higher

concentration authorized by EPA under

paragraph (c)(2)(iii) of this section).

(ii) Workers. For exposure of workers

to the new chemical substance during

all manufacturing, processing,

distribution in commerce, use and

disposal of the substance:

(A) No dermal exposure (this criterion

is met if adequate dermal exposure

controls are used in accordance with

applicable EPA guidance).

(B) No inhalation exposure (this

criterion is considered to be met if

adequate inhalation exposure controls

are used in accordance with applicable

EPA guidance).

(iii) Ambient surface water. For

ambient surface water releases, no

releases resulting in surface water

concentrations above 1 part per billion,

calculated using the methods prescribed

in §§721.90 and 721.91, unless EPA has

approved a higher surface water

concentration supported by relevant and

scientifically valid data submitted to

EPA in a notice under paragraph (e) of

this section on the substance or a close

structural analogue of the substance

which demonstrates that the new

substance will not present an

unreasonable risk of injury to aquatic

species or human health at the higher

concentration.

(iv) Incineration. For ambient air

releases from incineration, no releases

of the new chemical substance above 1

microgram per cubic meter maximum

annual average concentration,

calculated using the formula:

(kg/day of release after treatment)

multiplied by (number of release days per

year) multiplied by (9.68 × 10-6) micrograms

per cubic meter.

(v) Land or groundwater. For releases

to land or groundwater, no releases to

groundwater, to land, or to a landfill

unless the manufacturer has

demonstrated to EPA’s satisfaction in a

notice under paragraph (e) of this

section that the new substance has

negligible groundwater migration

potential.

(d) Chemical substances that cannot

be manufactured under this exemption.

A new chemical substance cannot be

manufactured under this section,

notwithstanding satisfaction of the

criterion of paragraphs (c)(1) or (c)(2) of

this section, if EPA determines, in

accordance with paragraph (g) of this

section, that the substance, any

reasonably anticipated metabolites,

environmental transformation products,

or byproducts of the substance, or any

reasonably anticipated impurities in the

substance may cause, under anticipated

conditions of manufacture, processing,

distribution in commerce, use, or

disposal of the new chemical substance:

(1) Serious acute (lethal or sublethal)

effects.

(2) Serious chronic (including

carcinogenic and teratogenic) effects.

(3) Significant environmental effects.

(e) Exemption notice. (1) A

manufacturer applying for an exemption

under either paragraph (c)(1) or (c)(2) of

this section must submit an exemption

notice to the EPA at least 30 days before

manufacture of the new chemical

substance begins. The notice must be

sent in writing to: TSCA Document

Control Officer, (7407), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. The

date of submission will be the date on

which the notice is received by the

TSCA Document Control Officer. EPA

will acknowledge the receipt of the

notice by letter. The letter will identify
16348 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

the date on which the review period

begins. The notice shall be submitted

using EPA Form No. 7710–25 (‘‘the

PMN form’’), which may be obtained

from EPA by writing the Environmental

Assistance Division, (7408), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Washington, DC. 20460, or

by calling the TSCA Assistance

Information Service at (202) 554–1404;

TDD (202) 554–0551; online service

modem (202) 554–5603.

(2) The notice shall contain the

information described below, pursuant

to the referenced provisions of §720.45.

(i) Manufacturer identity.

(ii) Chemical identity (§720.45(a)).

(iii) Impurities (§720.45(b)).

(iv) Known synonyms or trade names

(§720.45(c)).

(v) Byproducts (§720.45(d)).

(vi) Production volume (§720.45(e)).

(A) Manufacturers submitting an

exemption application under paragraph

(c)(1) of this section will be assumed to

be manufacturing at an annual

production volume of 10,000 kilograms.

Manufacturers who intend to

manufacture an exempted substance at

annual volumes of less than 10,000

kilograms and wish EPA to conduct its

risk assessment based upon such lesser

annual production level rather than a

10,000–kilograms level, may so specify

by writing the lesser annual production

volume in the appropriate box on the

PMN form and marking the adjacent

binding option box. Manufacturers who

opt to specify annual production levels

below 10,000 kilograms and who mark

the production volume binding option

box shall not manufacture more than the

specific annual amount of the exempted

substance unless a new exemption

notice for a higher (up to 10,000 kgs)

manufacturing volume is submitted and

approved pursuant to this section.

(B) Manufacturers submitting an

exemption under paragraph (c)(2) of this

section shall list the estimated

maximum amount to be manufactured

during the first year of production and

the estimated maximum amount to be

manufactured during any 12–month

period during the first 3 years of

production.

(vii) Description of intended

categories of use. (§720.45(f)).

(viii) For manufacturer-controlled

sites, the manufacturer shall supply

identity of manufacturing sites, process

descriptions, and worker exposure and

environmental release information

(§720.45(g)); for sites not controlled by

the manufacturer, processing and use

operation descriptions, estimated

number of processing and use sites, and

worker exposure/environmental release

information (§720.45(h)). A

manufacturer applying for an exemption

under paragraph (c)(1) of this section

need not provide information on worker

exposure and environmental release

referenced in paragraphs (e)(2)(viii) of

this section if such information is not

known or not readily available to the

manufacturer. To assist in reporting this

information, manufacturers may obtain

a copy of EPA’s Guidance for Reporting

Occupational Exposure and

Environmental Release Information

under 40 CFR 723.50, available from the

Environmental Assistance Division at

the address listed in paragraph (e)(1) of

this section. Where worker exposure

and environmental release information

is not supplied by the manufacturer,

EPA will generally apply ‘‘bounding

estimates’’ (i.e., exposure estimates

higher than those incurred by persons in

the population with the highest

exposure) to account for uncertainties in

actual exposure and release scenarios.

(ix) Type and category of notice. The

manufacturer must clearly indicate on

the first page of the PMN form that the

submission is a ‘‘TSCA section 5(h)(4)

exemption notice,’’ and must indicate

whether the notice is being submitted

under paragraph (c)(1) or (c)(2) of this

section. Manufacturers of chemical

substances that qualify for an exemption

under both paragraph (c)(1) and (c)(2) of

this section may apply for either

exemption, but not both.

(x) Test data (§720.50).

(xi) Certification. In addition to the

certifications required in EPA form

7710–25, the following certifications

shall be included in notices under this

section. The manufacturer must certify

that:

(A) The manufacturer intends to

manufacture or import the new

chemical substance for commercial

purposes, other than in small quantities

solely for research and development,

under the terms of this section.

(B) The manufacturer is familiar with

the terms of this section and will

comply with those terms.

(C) The new chemical substance for

which the notice is submitted meets all

applicable exemption conditions.

(D) For substances manufactured

under paragraph (c)(1) of this section,

the manufacturer intends to commence

manufacture of the exempted substance

for commercial purposes within 1 year

of the date of the expiration of the 30–

day review period.

(xii) Sanitized copy of notice. (A) The

manufacturer must make all claims of

confidentiality in accordance with

paragraph (l) of this section. If any

information is claimed confidential, the

manufacturer must submit a second

copy of the notice, with all information

claimed as confidential deleted, in

accordance with paragraph (l)(3) of this

section.

(B) If the manufacturer does not

provide the second copy, the

submission will be considered

incomplete.

(3) Incomplete notices. If EPA receives

a submission which does not include all

of the information required under this

paragraph (e) of this section, the

submission will be determined to be

incomplete by EPA. When a submission

for a new chemical substance has been

determined to be incomplete, a

manufacturer reapplying for an

exemption for the new chemical

substance must submit a new exemption

notice containing all the information

required under this paragraph (e) of this

section including a certification page

containing an original dated signature;

partial submissions sent to EPA to

supplement notices declared incomplete

will not be accepted. Photocopied pages

from previously submitted exemption

forms will be accepted provided that the

certifications page contains an original

dated signature.

(f) Multiple exemption holders. (1) A

manufacturer who intends to

manufacture a substance for which an

exemption under this section was

previously approved may apply for an

exemption under paragraph (c)(1) or

(c)(2) of this section; however, EPA will

not approve any subsequent exemption

application under paragraph (c)(1) of

this section unless it can determine that

the potential human exposure to, and

environmental release of, the new

chemical substance at the higher

aggregate production volume will not

present an unreasonable risk of injury to

human health or the environment.

(2)(i) If EPA proposes to deny an

exemption application for a substance

for which another manufacturer

currently holds an exemption, and that

proposed denial is based exclusively on

the cumulative human exposure or

environmental release of the substance

which precludes the EPA from

determining that the subsequent

applicant’s activities will not present an

unreasonable risk of injury to human

health or the environment, the EPA will

notify the first exemption holder that it

must, within 21 days of its receipt of

EPA’s notice, either:

(A) Provide a new certification that it

has commenced, or that it will

commence, manufacture of the new

chemical substance under this section

within 1 year of the expiration of its

exemption review period; or

(B) Withdraw its exemption for the

new chemical substance.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16349

(ii) If the first exemption holder does

not respond to the EPA’s notice under

paragraph (f)(2)(i) of this section within

the prescribed time period, EPA shall

issue a notice of ineligibility to the first

exemption holder under the provisions

of paragraph (h)(2) of this section.

(g) Review period. (1) EPA will review

the notice submitted under paragraph

(e) of this section to determine whether

manufacture of the new chemical

substance is eligible for the exemption.

The review period will end 30 days after

receipt of the notice by the TSCA

Document Control Officer. To provide

additional time to address any

unresolved issues concerning an

exemption application, the exemption

applicant may, at any time during the

review period, request a suspension of

the review period pursuant to the

provisions of §720.75(b) of this chapter.

(2) Upon expiration of the 30–day

review period, if EPA has taken no

action, the manufacturer may consider

its exemption approved and begin to

manufacture the new chemical

substance under the terms described in

its notice and in this section.

(h) Notice of ineligibility—(1) During

the review period. If the EPA determines

during the review period that

manufacture of the new chemical

substance does not meet the terms of

this section or that there are issues

concerning toxicity or exposure that

require further review which cannot be

accomplished within the 30–day review

period, EPA will notify the

manufacturer by telephone that the

substance is not eligible. This telephone

notification will subsequently be

confirmed by certified letter that

identifies the reasons for the

ineligibility determination. The

manufacturer may not begin

manufacture of the new chemical

substance without complying with

section 5(a)(1) of the Act or submitting

a new notice under paragraph (e) of this

section that satisfies EPA’s concerns.

(2) After the review period. (i)(A) If at

any time after the review period

specified in paragraph (g) of this section

the Assistant Administrator for the

Office of Prevention, Pesticides, and

Toxic Substances (‘‘the Assistant

Administrator’’) makes a preliminary

determination that manufacture of the

new chemical substance does not meet

the terms of this section, the Assistant

Administrator will notify the

manufacturer by certified letter that EPA

believes that the new chemical

substance does not meet the terms of the

section.

(B) The manufacturer may continue to

manufacture, process, distribute in

commerce, and use the substance after

receiving the notice under paragraph

(h)(2)(i)(A) of this section if the

manufacturer was manufacturing,

processing, distributing in commerce, or

using the substance at the time of the

notification and if the manufacturer

submits objections or an explanation

under paragraph (h)(2)(ii) of this

section. Manufacturers not

manufacturing, processing, distributing

in commerce, or using the substance at

the time of the notification may not

begin manufacture until EPA makes its

final determination under paragraph

(h)(2)(iii) of this section.

(ii) A manufacturer who has received

notice under paragraph (h)(2)(i)(A) of

this section may submit, within 15 days

of receipt of written notification,

detailed objections to the determination

or an explanation of its diligence and

good faith efforts in attempting to

comply with the terms of this section.

(iii) The Assistant Administrator will

consider any objections or explanation

submitted under paragraph (h)(2)(ii) of

this section and will make a final

determination. The Assistant

Administrator will notify the

manufacturer of the final determination

by telephone within 15 days of receipt

of the objections or explanation, and

subsequently by certified letter.

(iv) If the Assistant Administrator

determines that manufacture of the new

chemical substance meets the terms of

this section, the manufacturer may

continue or resume manufacture,

processing, distribution in commerce,

and use in accordance with the terms of

this section.

(v) If the Assistant Administrator

determines that manufacture of the new

chemical substance does not meet the

terms of this section and that the

manufacturer did not act with due

diligence and in good faith to meet the

terms of this section, the manufacturer

must cease any continuing manufacture,

processing, distribution in commerce,

and use of the new chemical substance

within 7 days of the written notification

under paragraph (h)(2)(iii) of this

section. The manufacturer may not

resume manufacture, processing,

distribution in commerce, and use of the

new chemical substance until it submits

a notice under section 5(a)(1) of the Act

and part 720 of this chapter and the

notice review period has ended.

(vi) If the Assistant Administrator

determines that manufacture of the new

chemical substance does not meet the

terms of this section and that the

manufacturer acted with due diligence

and in good faith to meet the terms of

this section, the manufacturer may

continue manufacture, processing,

distribution in commerce, and use of the

new chemical substance if:

(A) It was actually manufacturing,

processing, distributing in commerce, or

using the chemical substance at the time

it received the notification specified in

paragraph (h)(2)(i)(A) of this section.

(B) It submits a notice on the new

chemical substance under section

5(a)(1) of the Act and part 720 of this

chapter within 15 days of receipt of the

written notification under paragraph

(h)(2)(iii) of this section. Such

manufacture, processing, distribution in

commerce, and use may continue unless

EPA takes action under section 5(e) or

5(f) of the Act.

(3) Action under this paragraph does

not preclude action under sections 7,

15, 16, or 17 of the Act.

(i) Additional information. If the

manufacturer of a new chemical

substance under the terms of this

exemption obtains test data or other

information indicating that the new

chemical substance may not qualify

under terms of this section, the

manufacturer must submit these data or

information to EPA within 15 working

days of receipt of the information. If,

during the notice review period

specified in paragraph (g) of this

section, the submitter obtains

possession, control, or knowledge of

new information that materially adds to,

changes, or otherwise makes

significantly more complete the

information included in the notice, the

submitter must send that information to

the address listed on the notice form

within 10 days of receiving the new

information, but no later than 5 days

before the end of the notice review

period. The new submission must

clearly identify the submitter and the

exemption notice to which the new

information is related. If the new

information becomes available during

the last 5 days of the notice review

period, the submitter must immediately

inform its EPA contact for that notice by

telephone.

(j) Changes in manufacturing site, use,

human exposure and environmental

release controls, and certain

manufacturing volumes. (1) Except as

provided in paragraph (j)(6) of this

section, chemical substances

manufactured under this section must

be manufactured at the site or sites

described, for the uses described, and

under the human exposure and

environmental release controls

described in the exemption notice under

paragraph (e) of this section.

(2) Where the manufacturer lists a

specific physical form in which the new

chemical substance will be

manufactured, processed, and/or used,
16350 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

the manufacturer must continue

manufacturing, processing, and/or using

the new chemical substance in either

the same physical form described in the

notice under paragraph (e), or in a

physical form which will not increase

the human exposure to or

environmental release of the new

chemical substance over those

exposures or releases resulting from the

specified physical form (e.g., a

manufacturer which specifies that the

new chemical substance will be

produced in a non-volatile liquid form

generally may not change to a respirable

powder form).

(3) The annual production volume of

chemical substances manufactured

under paragraph (c)(1) of this section for

which the manufacturer designated a

binding annual production volume

pursuant to paragraph (e)(2)(vi) of this

section must not exceed that designated

volume.

(4) Any person who manufactures a

new chemical substance under

paragraph (c)(1) or (c)(2) of this section

must comply with the provisions of this

section, including submission of a new

notice under paragraph (e) of this

section, before:

(i) Manufacturing the new chemical

substance at a site that was not

approved in a previous exemption

notice for the substance, except as

provided in paragraph (j)(6) of this

section.

(ii) Manufacturing the new chemical

substance for a use that was not

approved in a previous exemption

notice for the substance.

(iii) Manufacturing the new chemical

substance without employing the

human exposure and environmental

release controls approved in a previous

exemption notice for the substance.

(iv) Manufacturing the new chemical

substance in a physical form different

than that physical form approved in a

previous exemption notice for the

substance and which form may increase

the human exposure to, or

environmental release of, the new

chemical substance over those

exposures or releases resulting from the

physical form approved in the previous

notice.

(v) Manufacturing the chemical

substance in annual production

volumes above any volume designated

by the manufacturer as binding under

paragraph (e)(2)(vi) of this section in a

previous exemption notice for the

substance.

(5) In an exemption notice informing

EPA of a change in site, use, or worker

protection, or environmental release

controls, the manufacturer is not

required to provide all of the same

information submitted to EPA in a

previous exemption notice for that

chemical substance. The new exemption

notice, however, must indicate the

identity of the new chemical substance;

the manufacturer’s name; the name and

telephone number of a technical

contact; and location of the new site,

new worker protection or environmental

release controls, and new use

information. The notice must also

include the EPA-designated exemption

number assigned to the previous notice

and a new certification by the

manufacturer, as described in paragraph

(e)(2)(xi) of this section.

(6)(i) A manufacturer may, without

submitting a new notice, manufacture

the new chemical substance at a site not

listed in its exemption application

under the following conditions:

(A) the magnitude, frequency, and

duration of exposure of individual

workers to the new chemical substance

at the new manufacturing site is equal

to, or less than, the magnitude,

frequency, and duration of exposure of

the individual workers to the new

chemical substance at the

manufacturing site for which the EPA

performed its original risk-assessment

pursuant to the original exemption

notice; and

(B) Either (1) at the new

manufacturing site, the manufacturer

does not release to surface waters any of

the new chemical substance, or any

waste streams containing the new

chemical substance; or (2) at the new

manufacturing site, the manufacturer

maintains surface water concentrations

of the chemical substance, resulting

from direct or indirect discharges from

the manufacturing site, at or below 1

part per billion, or at or below an

alternative concentration level approved

by the Agency in writing or under the

procedures described in paragraph

(c)(2)(iii) of this section, using the water

concentration calculation method

described at §§721.90 and 721.91.

(ii) The manufacturer shall notify EPA

of any new manufacturing site no later

than 30 days after the commencement of

manufacture of the new chemical

substance under the exemption at the

new manufacturing site as follows:

(A) The notification must contain the

EPA-designated exemption number to

which the notification applies,

manufacturer identity, the street address

of the new manufacturing site, the date

on which manufacture commenced at

the new site, the name and telephone

number of a technical contact at the new

site, any claim of confidentiality, and a

statement that the notification is an

amendment to the original exemption

application under the terms of this

section.

(B) The notification may be submitted

on EPA form 7710–56 ‘‘Notice of

Commencement of Manufacture;’’

however, the manufacturer must add the

statement required under paragraph

(j)(6)(ii)(A) of this section that the

notification is an amendment to the

original exemption.

(C) The notification must contain an

original signature of an authorized

official of the manufacturer.

(k) Customer notification. (1)

Manufacturers of new chemical

substances described in paragraphs

(c)(1) and (c)(2) of this section must

notify processors and industrial users

that the substance can be used only for

the uses specified in the exemption

notice at paragraph (e) of this section.

The manufacturer must also inform

processors and industrial users of any

controls specified in the exemption

notice. The manufacturer may notify

processors and industrial users by

means of a container labeling system,

written notification, or any other

method that adequately informs them of

use restrictions or controls.

(2) A manufacturer of a new chemical

substance described in paragraph (c)(2)

of this section may distribute the

chemical substance only to other

persons who agree in writing to not

further distribute the substance until it

has been reacted, incorporated into an

article, or otherwise rendered into a

physical form or state in which

environmental releases and human

exposures above the eligibility criteria

in paragraph (c)(2) of this section are not

likely to occur.

(3) If the manufacturer learns that a

direct or indirect customer is processing

or using the new substance in violation

of use restrictions or without imposing

prescribed worker protection or

environmental release controls, the

manufacturer must cease distribution of

the substance to the customer or the

customer’s supplier immediately unless

the manufacturer is able to document

each of the following:

(i) That the manufacturer has, within

5 working days, notified the customer in

writing that the customer has failed to

comply with the conditions specified in

this section and the exemption notice

under paragraph (e) of this section.

(ii) That, within 15 working days of

notifying the customer of the

noncompliance, the manufacturer

received from the customer, in writing,

a statement of assurance that the

customer is aware of the terms of this

section and the exemption notice and

will comply with those terms.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16351

(4) If, after receiving a statement of

assurance from a customer under

paragraph (k)(3)(ii) of this section, the

manufacturer obtains knowledge that

the customer has again failed to comply

with any of the conditions specified in

this section or the exemption notice, the

manufacturer shall cease supplying the

new chemical substance to that

customer and shall report the failure to

comply to EPA within 15 days of

obtaining this knowledge. Within 30

days of its receipt of the report, EPA

will notify the manufacturer whether,

and under what conditions, distribution

of the chemical substance to the

customer may resume.

(l) Confidentiality. (1) If the

manufacturer submits information to

EPA under this section which the

manufacturer claims to be confidential

business information, the manufacturer

must clearly identify the information at

the time of submission to EPA by

bracketing, circling, or underlining it

and stamping it with ‘‘CONFIDENTIAL’’

or some other appropriate designation.

Any information so identified will be

treated in accordance with the

procedures in part 2 of this chapter. Any

information not claimed confidential at

the time of submission may be made

available to the public without further

notice.

(2)(i) Any person who asserts a claim

of confidentiality for chemical identity

under this paragraph (l) must provide a

generic chemical name that is only as

generic as necessary to protect the

confidential chemical identity of the

particular chemical substance. The

name should reveal the specific

chemical identity to the maximum

extent possible.

(ii) The generic name provided by the

manufacturer will be subject to EPA

review and approval in accordance with

the procedures specified in

§720.85(b)(6) of this chapter. The

generic name provided by the submitter

or an alternative selected by EPA under

these procedures will be placed on a

public list of substances exempt under

this section.

(3) If any information is claimed

confidential, the manufacturer must

submit a second copy of the notice with

all information claimed as confidential

deleted. EPA will place the second copy

in the public file.

(m) Exemptions granted under

superseded regulations. Manufacturers

holding exemptions granted under the

superseded requirements of this section

(as in effect on May 26, 1995) shall

either continue to comply with those

requirements (including the production

volume limit) or apply for a new

exemption pursuant to this section. EPA

will not accept requests to amend

exemptions granted under the

superseded requirements;

manufacturers wishing to amend such

exemptions must submit a new

exemption under paragraph (e) of this

section. If a new exemption for a new

chemical substance is granted under

this exemption to the manufacturer

holding an exemption under the

superseded requirements, the

exemption under the superseded

requirements for such substance shall be

void.

(n) Recordkeeping. (1) A manufacturer

of a new chemical substance under

paragraph (c) of this section must

maintain the records described in this

paragraph at the manufacturing site or

site of importation for a period of 5

years after date of their preparation.

(2) The records must include the

following to demonstrate compliance

with this section:

(i) Records of annual production

volume and import volume;

(ii) Records documenting complaince

with the applicable requirements and

restrictions of paragraphs (c), (e), (f), (h),

(i), (j), and (k) of this section.

(3) Any person who manufactures a

new chemical substance under the

terms of this section must, upon request

of a duly designated representative of

EPA, permit such person at all

reasonable times to have access to and

to copy records kept under paragraph

(n)(2) of this section.

(4) The manufacturer must submit the

records listed in paragraph (n)(2) of this

section to EPA upon written request.

Manufacturers must provide these

records within 15 working days of

receipt of such request.

(o) Compliance . (1) Failure to comply

with any provision of this section is a

violation of section 15 of the Act (15

U.S.C. 2614).

(2) Submitting materially misleading

or false information in connection with

the requirements of any provision of

this section is a violation of this section

and therefore a violation of section 15

of the Act (15 U.S.C. 2614).

(3) Violators may be subject to the

civil and criminal penalties in section

16 of the Act (15 U.S.C. 2615) for each

violation.

(4) EPA may seek to enjoin the

manufacture or processing of a chemical

substance in violation of this section, or

act to seize any chemical substance

manufactured or processed in violation

of this section, or take other action

under the authority of section 7 of the

Act (15 U.S.C. 2606) or section 17 of the

Act (15 U.S.C. 1616).

[FR Doc. 95–7711 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F