[Federal Register: June 13, 2003 (Volume 68, Number 114)]
[Rules and Regulations]
[Page 35315-35320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn03-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 725
[OPPT-2002-0041; FRL-7200-3]
RIN 2070-AD43
Burkholderia Cepacia Complex; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing a significant new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control Act (TSCA) for Burkholderia
cepacia complex (Bcc), a group of naturally-occurring microorganisms.
Bcc microorganisms, when encountered in sufficient numbers through an
appropriate route of exposure by a member of a sensitive population,
such as a cystic fibrosis (CF) patient, have the potential to cause a
severe infection, resulting in significantly increased rates of
mortality. This rule would require persons who intend to manufacture,
import, or process any individual member of Bcc for a significant new
use to notify EPA at least 90 days before commencing the manufacturing
(including import) or processing of Bcc for a use designated by this
SNUR as a significant new use. The required notice would provide EPA
with the opportunity to evaluate the intended new use and associated
activities and, if necessary, to prohibit or limit that activity before
it occurs.
DATES: This final rule is effective on August 12, 2003.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov. For technical information contact: James Alwood, Chemical Control
Division, Office of Pollution Prevention and Toxics (7405M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail
address: alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
(including import), process, or use products that contain living
microorganisms subject to jurisdiction under TSCA, especially if you
know that your products contain or may contain members of Bcc.
Potentially affected entities may include, but are not limited to:
[sbull] Chemical manufacturers (NAICS 325), e.g., Persons
manufacturing, importing, or processing products for commercial
purposes containing Bcc for biofertilizers; biosensors; biotechnology
reagents; commodity or specialty chemical production; energy
applications; and other TSCA uses.
[sbull] Waste management and remediation (NAICS 562), e.g., Waste
treatment or pollutant degradation.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the list of substances excluded by TSCA section
(3)(2)(B), and the applicability provisions in 40 CFR 725.105(c) for
SNUR related obligations. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPPT-2002-0041. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The EPA Docket Center Reading
Room telephone number is (202) 566-1744 and the telephone number for
the OPPT Docket, which is located in EPA Docket Center, is (202) 566-
0280.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. The OPPTS harmonized test
guideline referenced in this document is available at http:/www.epa.gov/opptsfrs/home/guidelin.htm.
A frequently updated electronic
version of 40 CFR part 725 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr725_00.html
, a beta site currently
under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket identification number.
II. Background
A. What Action is the Agency Taking?
This SNUR will require persons to notify EPA at least 90 days
before commencing the manufacture, import, or processing of any member
of Bcc, a group of naturally occurring microorganisms, for any use
other than research and development in the degradation of chemicals via
injection into subsurface groundwater.
[[Page 35316]]
B. What is the Agency's Authority for Taking this Action?
TSCA section 5(a)(2) authorizes EPA to determine that a use of a
chemical substance is a ``significant new use.'' See also, 40 CFR part
725, subparts L-M. EPA must make this determination by rule after
considering all relevant factors, including those listed in section
5(a)(2) of TSCA. Section 5(a)(2) of TSCA lists the following as
potentially relevant factors for EPA to consider:
(A) the projected volume of manufacturing and processing of a
chemical substance,
(B) the extent to which a use changes the type or form of
exposure to human beings or the environment to a chemical substance,
(C) the extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a
chemical substance, and
(D) the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
a chemical substance.
Once EPA promulgates a rule designating ``significant new uses''
for a given chemical substance, section 5(a)(1)(B) of TSCA requires
persons to submit a notice to EPA at least 90 days before they
manufacture, import, or process the substance for that use. The
mechanism for reporting under this requirement is established under 40
CFR 725.105(c).
EPA has interpreted the TSCA section 3(2) definition of ``chemical
substance '' as authorizing EPA to regulate microorganisms under TSCA.
See the Federal Register of April 11, 1997 (62 FR 17910 and 17913)
(FRL-5577-2). Microorganisms that are not intergeneric are implicitly
included on the TSCA Inventory, which would include naturally-occurring
microorganisms such as Bcc (40 CFR 725.8(b)). Thus, such microorganisms
are only subject to TSCA section 5 notification requirements upon
promulgation of a SNUR, pursuant to TSCA section 5(a)(2).
C. Which General Provisions Apply?
General provisions for SNURs appear under subpart L of 40 CFR part
725. These provisions describe persons subject to the rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. Persons subject to this SNUR must comply with the same notice
requirements and EPA regulatory procedures as submitters of Microbial
Commercial Activity Notices (MCANs) or TSCA Experimental Release
Applications(TERAs) under section 5(a)(1)(A) of TSCA. In particular,
these requirements include the information submission requirements of
TSCA section 5(b) and 5(d)(1), the conditions necessary to qualify for
the exemptions under TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5),
as codified in the regulations at 40 CFR part 725. In contrast to the
provisions of 40 CFR part 721, under 40 CFR part 725, EPA has adopted a
narrow interpretation of the TSCA section 5(h)(3) exemption for small
quantities used in research. Under 40 CFR 725.3, EPA has defined small
quantities solely for research and development as ``quantities of a
microorganism manufactured, imported, or processed or proposed to be
manufactured, imported, or processed solely for research and
development that meet the requirements of Sec. 725.234.'' Any other
research and development activity of a microorganism subject to a SNUR
must comply with the section 5(a)(1)(A) notification requirements
unless that activity has been excluded from coverage under the SNUR.
See 40 CFR 725.3, subparts E and F of 40 CFR part 725, and the Federal
Register of April 11, 1997 (62 FR 17921-17926).
Once EPA receives an MCAN or TERA, EPA may take regulatory action
under TSCA section 5(e), 5(f), 6, or 7 to control the activities on
which it has received the MCAN or TERA. If EPA does not take action,
EPA is required under TSCA section 5(g) to explain in the Federal
Register its reasons for not taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret TSCA section 12(b) appear
at 40 CFR part 707. Persons who intend to import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Such persons must certify that they are in
compliance with SNUR requirements. The EPA policy addressing the import
certification appears at 40 CFR part 707.
III. Summary of the Final Rule
A. Final Rule
On July 31, 2001, the Cystic Fibrosis Foundation (CFF) submitted a
petition under section 21 of TSCA which requested EPA to ``establish
regulations prohibiting the manufacture, processing, distribution in
commerce, use, and improper disposal of bacterial species within the
Burkholderia cepacia complex.'' On November 6, 2001 (66 FR 56105) (FRL-
6808-7), EPA published in the Federal Register a notice denying that
petition. EPA also stated in the notice that it intended to issue a
SNUR for Bcc. On January 9, 2002 (67 FR 1179) (FRL-6809-2) EPA proposed
a SNUR for Bcc, where the significant new use for Bcc was designated as
any use other than research and development in the degradation of
chemicals via injection into subsurface groundwater. EPA received
comments regarding the proposed SNUR only from CFF. EPA's response to
those comments is contained in the next paragraph. No one identified
any other ongoing commercial uses of Bcc other than those identified by
EPA. In addition, no new data were submitted or identified that would
change EPA's findings regarding the SNUR for Bcc. Therefore, EPA is
issuing the SNUR as proposed. This final rule requires persons who
intend to manufacture, import, or process Bcc for any use other than
research and development in the degradation of chemicals via injection
into subsurface groundwater notify EPA at least 90 days before
commencing such activity.
B. Response to Comments
As noted earlier, the only comments submitted on the proposed SNUR
were from CFF. CFF did not challenge or object to any of the provisions
proposed by the Agency in the proposed SNUR, but instead suggested that
the final rule should be expanded beyond what was proposed in two ways.
First, CFF stated that EPA should designate as a significant new use
all research and development activities that result in potential
environmental release of Bcc. Second, CFF stated that EPA should
require manufacturers of microoganisms that may contain Bcc to test
their products for the presence of Bcc. Leaving aside the fact that
these comments go beyond the scope of the proposed SNUR, the changes
proposed by CFF are not appropriate for inclusion in a Significant New
Use Rule under section 5 of TSCA.
As to CFF's first comment, CFF asks the Agency to require
notification even for ``research and development in the degradation of
chemicals via injection into subsurface groundwater.'' In the proposed
SNUR, EPA identified ``research and development in the degradation of
chemicals via injection into subsurface groundwater'' as an existing
use. CFF did not present any information to suggest that this
particular use is not an existing use, or that new research and
development activities would be significantly different in kind or
quantity than existing activities. Under the
[[Page 35317]]
circumstances, the Agency continues to believe that the particular
research and development activities excluded from the proposed SNUR
constitute an ongoing use of Bcc, and therefore do not constitute a
``significant new use'' for purposes of section 5(a)(2) of TSCA. Only
significant new uses may be included in a Significant New Use Rule.
As to CFF's request that the SNUR require manufacturers of
microorganisms to test their products to determine whether they contain
Bcc. EPA concurs that manufacturers of microorganisms are responsible
for knowing whether their products contain Bcc and EPA encourages
manufacturers to test their products if they are uncertain whether the
products contain Bcc. EPA's regulations exempt ``chemical'' impurities
from SNUR reporting requirements (40 CFR 721.45(d)), but those
regulations do not provide a similar exemption for ``microorganisms''
produced as impurities (see 40 CFR 725.912). When this SNUR becomes a
final effective rule, all commercial uses of Bcc, except research and
development in the degradation of chemicals via injection into
subsurface groundwater, will require notification to EPA at least 90
days before commencing the manufacturing (including import) or
processing of Bcc. Any manufacturer, importer, or processor of
microorganisms that actually contain Bcc, even if the Bcc is present
unintentionally as an impurity, will be required to submit a
notification before commencing activities subject to this final SNUR.
However, the Agency does not believe that a requirement to test
products is appropriate for inclusion in a SNUR under section 5 of
TSCA.
If a manufacturer, importer, or processor does decide to test its
products, the Agency encourages conformity with OPPTS Product Analysis
Test Guideline 885.1100 for product identity. Because identification of
members of the Bcc may be difficult due to complexities of the taxonomy
of this group, EPA believes it advisable to consult experts in this
matter prior to testing. EPA encourages any manufacturer, importer, or
processor considering such testing to consult the Agency for further
guidance or questions.
IV. Objectives and Rationale of the Rule
In determining what would constitute a significant new use for the
microorganisms that are the subject of this SNUR, EPA considered
relevant information on the toxicity of the microorganisms, likely
exposures associated with potential uses, information provided by
industry sources, and the relevant factors listed in TSCA section
5(a)(2) and Unit II.B. Based on these considerations, EPA has
determined that all uses other than research and development in the
degradation of chemicals via injection into subsurface groundwater, are
significant new uses.
EPA's considerations under each of the relevant factors are
discussed below:
1. Projected volume of manufacturing and processing of a chemical
substance. At present there is little manufacturing and processing of
Bcc, so almost all exposure to Bcc today is from its presence in the
natural environment. Any new use of Bcc could result in a significant
increase in manufacturing and processing of the compound, and of
exposure to it. Microorganisms may reproduce and increase beyond the
number initially introduced and may spread beyond the site of
manufacture or processing. Thus, what begins as a small localized
population of microorganisms may become a large widespread population
which could contribute to increased exposure potential for Bcc beyond
that which occurs naturally. These facts complicate the Agency's
ability to project the potential volume and processing of Bcc. However,
Bcc is typically found in the environment in soils at a concentration
of 10\2\ to 10\4\ colony forming units (cfu)/g. Manufacture of Bcc
would result in production of batches of 10\16\ cfu of Bcc. Depending
on the type and duration of use these batches could be even larger.
(See Reference 16, 67 FR 1185, January 9, 2002 (FRL-6809-2))
2. Extent to which a use changes the type or form of exposure to
human beings or the environment to a chemical substance. Currently,
human beings are exposed to Bcc because of its presence in soil, where
it is found at concentrations significantly lower than might be seen if
it is cultivated for commercial use. In addition to the fact that these
uses would likely involve much higher concentrations of Bcc than are
naturally found in the environment, some of the potential uses
identified for Bcc, including bioremediation (degradation of toxic
chemicals), degradation of grease in drains, turf management, and
specialty chemicals production, could also significantly increase
direct dermal and inhalation exposures of Bcc to human beings and
release of Bcc to the environment. (See Reference 16, 67 FR 1185,
January 9, 2002). This would be especially true for individuals
involved directly in or near the manufacturing or application of
formulations containing Bcc. These are types and forms of exposures to
which human beings and the environment are exposed on a limited basis
during field studies of Bcc in the biodegradation of chlorinated
solvents in groundwater.
3. Extent to which a use changes the magnitude and duration of
exposure to human beings or the environment to a chemical substance.
Currently, human beings are exposed to Bcc because of its presence in
soil, where it is found at concentrations significantly lower than
might be seen if it is cultivated for commercial use. In addition to
the fact that these uses would likely involve much higher
concentrations of Bcc than are naturally found in the environment, some
of the potential uses identified for Bcc, including bioremediation
(degradation of toxic chemicals), degradation of grease in drains, turf
management, and specialty chemicals production, could also
significantly increase direct dermal and inhalation exposures of Bcc to
human beings and release of Bcc to the environment. Releases from
typical manufacturing could result in releases to surface waters of
10\9\ to 10\13\ cfu in water and 10\5\ cfu in the air. Inhalation
exposures of 450 cfu and dermal exposures of 10\11\ cfu to exposed
workers could also result from typical manufacturing. (See Reference
16, 67 FR 1185, January 9, 2002) Exposures from various uses would be
the same or higher depending on the method of application. For example,
if spray-applied, the potential for inhalation exposure would be higher
due to potential inhalation of mist. All Bcc produced for uses such as
bioremediation (degradation of toxic chemicals), degradation of grease
in drains, and turf management would eventually be released to the
environment. New uses could also significantly increase the duration of
exposure. Use in bioremediation for research and development could be
limited to a few days/yr. In instances where manufacturing and
application of formulations containing Bcc are repeated or continuous
this increased level of exposure could occur on a daily basis
throughout the year. In addition, repeated or continuous applications
of formulations containing Bcc at the same location would increase the
likelihood that a small localized population could become a larger and
more widespread population. All of these factors would contribute to a
change in the magnitude and duration of exposure to which human beings
and the environment are not currently exposed.
4. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance. EPA has not currently identified any
[[Page 35318]]
general commercial use of Bcc. EPA has identified field studies of Bcc
in the biodegradation of chlorinated solvents in groundwater. (See
Reference 15, 67 FR 1185, January 9, 2002) EPA expects only limited
exposures from the identified field studies of Bcc as only technically
qualified individuals are growing and injecting Bcc directly into
groundwater. Other potential uses identified for Bcc which include
bioremediation (degradation of toxic chemicals), degradation of grease
in drains, turf management, and specialty chemicals production, could
significantly increase dermal and inhalation exposures of Bcc to human
beings as well as releases to the environment. Currently, there are no
exposures to human beings and no releases to the environment from these
uses. In most cases these exposures would be higher than typically
found in nature and more likely to be encountered by a member of a
sensitive population.
EPA wants to achieve the following objectives with regard to the
significant new uses that are designated in this rule. EPA wants to
ensure that:
[sbull] EPA will receive notice of any company's intent to
manufacture, import, or process Bcc for a significant new use before
that activity begins.
[sbull] EPA will have an opportunity to review and evaluate data
submitted in an MCAN or TERA before the notice submitter begins
manufacturing, importing, or processing Bcc for a significant new use.
[sbull] EPA would be able to regulate prospective manufacturers,
importers, or processors of Bcc before a significant new use occurs,
provided such regulation is warranted pursuant to TSCA section 5(e) or
section (5)(f).
V. Alternatives
Before issuing this SNUR, EPA considered the following alternative
regulatory actions for Bcc. In addition, EPA determined that Bcc is
currently not subject to Federal notification requirements.
1. Promulgate a TSCA section 8(a) reporting rule for Bcc. Under a
TSCA section 8(a) rule, EPA could require any person to report
information to the Agency when they intend to manufacture or import
Bcc. However, the use of TSCA section 8(a) rather than the SNUR
authority, would not provide the opportunity for EPA to review human
and environmental hazards and exposures associated with the new uses of
these substances and, if necessary, to take immediate regulatory action
under TSCA section 5(e) or section 5(f) to prohibit or limit the
activity before it begins. In addition, EPA may not receive important
information from small businesses, because those firms generally are
exempt from TSCA section 8(a) reporting requirements. In view of EPA's
concerns about Bcc and its interest in having the opportunity to review
these substances and regulate them as appropriate, pending the
development of exposure and/or hazard information should a significant
new use be initiated, the Agency believes that a TSCA section 8(a) rule
for Bcc would not meet all of EPA's regulatory objectives.
2. Regulate Bcc under TSCA section 6. EPA must regulate under TSCA
section 6 if there is a reasonable basis to conclude that the
manufacture, import, processing, distribution in commerce, use, or
disposal of a chemical substance or mixture ``presents or will
present'' an unreasonable risk of injury to human health or the
environment. Based on EPA's findings that there is currently no general
commercial use of Bcc, EPA concluded that risk management action under
TSCA section 6 is not necessary at this time. This SNUR will allow the
Agency to address the potential risks associated with any intended
significant new use of Bcc.
VI. Test Data and Other Information
EPA recognizes that section 5 of TSCA does not require the
development of any particular test data before submission of a MCAN or
TSCA Experimental Release Application (TERA). Persons are required only
to submit test data in their possession or control and to describe any
other data known to or reasonably ascertainable by them (15 U.S.C.
2604(d); 40 CFR 725.160).
However, in view of the potential health risks posed by the
significant new uses of Bcc, EPA requests that potential MCAN or TERA
submitters include data that would permit a reasoned evaluation of
risks posed by Bcc when used for an intended significant new use. EPA
also requests that potential MCAN or TERA submitters include data that
demonstrate that the bacteria which would be the subject of the MCAN or
TERA are in fact in the Bcc. EPA encourages persons to consult with the
Agency before submitting an MCAN or TERA for Bcc. As part of this
optional pre-notice consultation, EPA will discuss specific data it
believes are necessary to evaluate a significant new use of Bcc. EPA
urges MCAN or TERA submitters to provide detailed information on human
and environmental exposures that would result or could reasonably be
anticipated to result from the significant new uses of Bcc. In
addition, EPA encourages persons to submit information on risks posed
by Bcc compared to risks posed by possible substitutes. An MCAN or TERA
submitted without sufficient data to reasonably evaluate risks posed by
a significant new use of Bcc may increase the likelihood that EPA will
take action under TSCA section 5(e).
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
EPA believes that the intent of section 5(a)(1)(B) of TSCA is best
served by designating a use as a significant new use as of the proposal
date of the SNUR, rather than as of the effective date of the final
rule. If uses begun after publication of the proposed SNUR were
considered to be ongoing, rather than new, it would be difficult for
EPA to establish notification requirements, because any person could
defeat the SNUR by initiating the proposed significant new use before
the proposed rule became final, and then argue that the use was
ongoing.
Any person who, after publication of the proposed SNUR, began
commercial manufacture, import, or processing of Bcc, for the
significant new use in this SNUR, must stop such activity before the
effective date of the final rule. To resume commercial manufacture,
import or processing of Bcc, those persons will have to meet all
applicable MCAN or TERA requirements and wait until the notice review
period, including all extensions, expires before engaging in any
commercial manufacture, import, or processing of Bcc for a significant
new use. If, however, persons who began commercial manufacture or
import of Bcc for a significant new use between the proposal and the
effective date of the final SNUR met the conditions of advance
compliance as codified at 40 CFR 725.912, those persons would be
considered to have met the requirements of the final SNUR for those
activities.
VIII. Economic Considerations
EPA has evaluated the potential costs of establishing a SNUR for
potential manufacturers, importers, and processors of Bcc. These
potential costs are related to the submission of MCANs, TERAs, and the
export notification requirements of TSCA section 12(b). EPA notes that,
the costs of submission of MCANs or TERAs will not be incurred by any
company unless that company decides to pursue a significant new use as
defined in this SNUR. The
[[Page 35319]]
Agency's economic analysis is available in the public docket for this
rule.
A. MCANs and TERAs
Because of uncertainties related to predicting the number of MCANs
or TERAs that will be submitted as a result of this SNUR, EPA is unable
to calculate the total annual cost of compliance with the final rule.
However, EPA estimates that the cost for preparation and submission of
an MCAN ranges from approximately $7,582 to $42,736, which includes the
$2,500 user fee required by the Agency. EPA notes that small businesses
with annual sales of less than $40 million are subject to a reduced
user fee of $100. The cost of a TERA is estimated to range from $6,905
to $73,562.
Based on past experience with SNURs and the low number of
Significant New Use Notices (SNUNs) which are submitted on an annual
basis, EPA believes that there would be few, if any, MCANs or TERAs
submitted as a result of this SNUR. Furthermore, no company is required
to submit an MCAN or TERA for Bcc unless the company decides to begin
manufacture, import, or processing of Bcc for any use other than
research and development in the degradation of chemicals via injection
into subsurface groundwater. As a result, EPA expects that companies
would be able to determine if the burden of submitting an MCAN or TERA
would be likely to create significant adverse economic impacts for the
company prior to incurring MCAN/TERA-related costs.
B. Export Notification
As noted in Unit II.C., persons who intend to export a
microorganism identified in a proposed or final SNUR are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)). These provisions require that a company notify EPA of the
first shipment to a particular country of an affected microorganism.
The estimated cost of the TSCA section 12(b)(1) export notification,
which would be required for the first export to a particular country of
a microorganism subject to this rule, is estimated to be $158.35 for
the first time that an exporter must comply with TSCA section 12(b)(1)
export notification requirements, and $14.43 for each subsequent export
notification submitted by that exporter.
EPA is unable to estimate the total number of TSCA section 12(b)
notifications that will be received as a result of this SNUR, or the
total number of companies that will file these notices. However, EPA
expects that the total cost of complying with the export notification
provisions of TSCA section 12(b) will be limited based on historical
experience with TSCA section 12(b) notifications and the fact that no
companies have currently been identified that currently market Bcc
commercially. If companies were to manufacture the microorganisms
covered by this SNUR for export only, these companies would incur costs
associated with export notification even if these companies decided to
forgo any domestic significant new use. EPA is not aware of any
companies in this situation, and expects that any potential impact
would be limited to the small burden of export notification.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that SNURs are not a ``significant
regulatory action'' subject to review by OMB, because they do not meet
the criteria in section 3(f) of the Executive Order.
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rule
and in addition to its display on any related collection instrument,
are listed 40 CFR part 9.
The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 1188.06). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit
an MCAN or TERA to the Agency, the annual burden is estimated to
average between 98.96 and 118.92 hours per response at an estimated
reporting cost between $5,957 and $7,192 per MCAN. This burden estimate
includes the time needed to review instructions, search existing data
sources, gather and maintain the data needed, and complete, review and
submit the required MCAN or TERA. This burden estimate does not include
the $2,500 user fee submission of an MCAN ($100 for businesses with
less than $40 million in annual sales).
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director, OP
Regulatory Information Division (2137), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR applies to any person (including small
or large entities) who intends to engage in any activity described in
the rule as a ``significant new use.'' By definition of the word
``new,'' and based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activity. Since a SNUR only requires that any person who intends to
engage in such activity in the future must first notify EPA by
submitting an MCAN or TERA, no economic impact will even occur until
someone decides to engage in those activities. Although some small
entities may decide to conduct such activities in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
over 1000 SNURs, the Agency receives fewer than 10 SNUNs per year. Of
those SNUNs submitted, none appear to be from small entities in
response to any SNUR. In addition, the estimated reporting cost for
submission of an MCAN or TERA (see Unit VIII.A.) are minimal regardless
of the size of the firm. Therefore, EPA believes that the potential
economic impact of complying with this SNUR is not expected to be
significant or adversely impact a substantial number of small entities.
This rationale has been provided to the Chief Counsel for Advocacy of
the Small Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with SNURs, State, local, and tribal
governments have not been impacted by these rulemakings, and EPA does
not
[[Page 35320]]
have any reasons to believe that any State, local, or tribal government
will be impacted by this rulemaking. As such, EPA has determined that
this regulatory action does not impose any enforceable duty, contain
any unfunded mandate, or otherwise have any effect on small governments
subject to the requirements of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
E. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
This rule does not have tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This does
not significantly or uniquely affect the communities of Indian tribal
governments, nor does it involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000), which took effect on January 6, 2001
do not apply to this rule.
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
K. Executive Order 12630: Governmental Actions and Interference with
Constitutionally Protected Property Rights
EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 15, 1988), by examining the takings
implications of this rule in accordance with the ``Attorney General's
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings'' issued under the Executive Order.
L. Executive Order 12988: Civil Justice Reform
In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
M. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 725
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 6, 2003.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR part 725 is amended as follows:
PART 725--[AMENDED]
0
1. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
2. By adding new Sec. 725.1075 to subpart M to read as follows:
Sec. 725.1075 Burkholderia cepacia complex.
(a) Microorganism and significant new uses subject to reporting.
(1) The microorganisms identified as the Burkholderia cepacia complex
defined as containing the following nine species, Burkholderia cepacia,
Burkholderia multivorans, Burkholderia stabilis, Burkholderia
vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia,
Burkholderia cepacia genomovar VIII (Burkholderia anthina), and
Burkholderia cepacia genomovars III and VI are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new use is any use other than research and
development in the degradation of chemicals via injection into
subsurface groundwater.
(b) [Reserved]
[FR Doc. 03-15010 Filed 6-12-03; 8:45 am]
BILLING CODE 6560-50-S