[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Rules and Regulations]
[Pages 35315-35320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15010]


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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: [email protected].
    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: [email protected].

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