[Federal Register Volume 60, Number 60 (Wednesday, March 29, 1995)]
[Rules and Regulations]
[Pages 16336-16351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7711]
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ENVIRONMENTAL PROTECTION AGENCY
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.
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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
[[Page 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 [[Page 16338]] 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 Sec. 723.50(d).
The LoREX eligibility criterion for maximum annual average ambient
air release concentration from incineration is 1 g/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 Sec. 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 Sec. 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 Sec. 723.50(d) or
if there are issues concerning exposure or toxicity that require
further review beyond 30 days under Sec. 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. [[Page 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 higher-
volume 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
Sec. 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 Sec. 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 Sec. 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
[[Page 16340]] 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 [[Page 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 volume-based 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 volume-based exemption. First, an exposure-driven 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
Sec. 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
[[Page 16342]] 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="">g/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 case-by-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 [[Page 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 [[Page 16344]] 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 g/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
Sec. 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 Cost Savings ($ Million)
Annual Number of ------------------------------------------------
Submissions 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). [[Page 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 [[Page 16346]] 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 Sec. 723.50 to read as follows:
Sec. 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. [[Page 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 Sec. 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 Secs. 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 x 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 [[Page 16348]] 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 Sec. 720.45.
(i) Manufacturer identity.
(ii) Chemical identity (Sec. 720.45(a)).
(iii) Impurities (Sec. 720.45(b)).
(iv) Known synonyms or trade names (Sec. 720.45(c)).
(v) Byproducts (Sec. 720.45(d)).
(vi) Production volume (Sec. 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. (Sec. 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 (Sec. 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 (Sec. 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 (Sec. 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. [[Page 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 Sec. 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, [[Page 16350]] 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 Secs. 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.
[[Page 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 Sec. 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
