[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Proposed Rules]
[Pages 1179-1186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-513]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 725

[OPPTS-50645; FRL-6809-2]
RIN 2070-AD43


Burkholderia Cepacia Complex; Proposed Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing 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 proposed rule would require persons 
who intend to manufacture, import, or process 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: Comments, identified by docket control number OPPTS-50645, must 
be received on or before March 11, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPPTS-50645 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Office of Program Management and 
Evaluation, Office of Pollution Prevention and Toxics (7401), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; 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; 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 Bcc. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Chemical manufacturers            325                 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
Waste management and remediation  562                 Waste treatment or
                                                       pollutant
                                                       degradation
------------------------------------------------------------------------


[[Page 1180]]

    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 the table in this unit 
could also be affected. To determine whether you or your business is 
affected by this action, you should carefully examine the list of 
substances excluded by TSCA section (3)(2)(B), and the applicability 
provisions at 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 Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50645. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, North 
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. 
The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-50645 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in EPA East Building Rm. 6428, 1201 Constitution 
Ave., NW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the DCO is (202) 564-8930.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments and data will also be accepted on standard disks in 
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPPTS-50645. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the technical person identified under FOR FURTHER 
INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Action is the Agency Taking?

    This proposed rule would require persons to notify EPA at least 90 
days before commencing the manufacture, import, or processing 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.

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

[[Page 1181]]

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 proposed rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the proposed 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) 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, 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 notice. 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 Proposed Rule

    On July 31, 2001, The Cystic Fibrosis Foundation 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.'' The Bcc was defined by the petitioner 
as nine species including B. cepacia, B. multivorans, B. stabilis, B. 
vietnamiensis, B. ambifaria, B. pyrrocinia, and three as yet unnamed 
species referred to as B. cepacia genomovars III, VI, and VIII. The 
petitioner stated that ``exposure of individuals with CF to Bcc 
frequently results in life-threatening infections'' and ``these actions 
are necessary to address the significant threat that these 
microorganisms pose to individuals with CF and other diseases that 
compromise the immune system.'' 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.
    It is well established that when encountered in sufficient numbers 
through an appropriate route of exposure by a member of a sensitive 
population, such as a CF patient, Bcc has the potential to cause a 
severe infection, resulting in significantly increased rates of 
mortality. There is also the possibility of increased exposure from 
several potential commercial uses especially for bioremediation where 
EPA has identified environmental research and development of Bcc that 
has already occurred. EPA believes that there is currently no general 
commercial use of Bcc. Therefore, EPA is proposing to designate any use 
of Bcc other than research and development in the degradation of 
chemicals via injection into subsurface groundwater as a significant 
new use.
    This proposed rule, when finalized, would require persons, who 
intend to manufacture, import, or process Bcc for a significant new use 
to notify EPA, through submission of an MCAN or TSCA Experimental 
Release Application (TERA), at least 90 days before commencing the 
manufacture or importation of any of these microorganisms for any use 
other than research and development in the degradation of chemicals via 
injection into subsurface groundwater. The required notice would 
provide EPA with the opportunity to evaluate the intended use, and, if 
necessary, to prohibit or limit that use before it occurs.

IV. Hazard and Exposure of Bcc

A. Defining Bcc

    B. cepacia complex is comprised of former Pseudomonas species (P. 
cepacia and P. pyrrocinia), existing Burkholderia species newly allied 
with Bcc (B. vietnamiensis), newly named Burkholderia species split off 
from Burkholderia cepacia (B. multivorans, B. stabilis, and B. 
ambifaria), and the three as yet unnamed genomovars (genomovars III, 
VI, and VIII). Of these nine components, only seven appear generally 
accepted as members of the Bcc in the current literature. Most current 
literature and reports refer to seven genomovars/species in the Bcc. 
One of these components, B. pyrrocinia had not been universally 
associated with Bcc until recently, but new information appears to move 
B. pyrrocinia from a unique species to part of a new genomovar of the 
Bcc. Additionally, recent information indicates that a publication is 
in

[[Page 1182]]

preparation which will establish a new genomovar (VIII). Acceptance of 
these two additional genomovars may be a function of the time needed 
for common usage by the research community (Ref. 1).
    For purposes of this proposed rule EPA is defining Bcc as including 
all nine species. EPA is also proposing to use the provisional name, 
Burkholderia cepacia genomovars III, VI, and VIII, for the three 
unnamed genomovars, in the codified text and to replace these names 
with species designations via an administrative amendment when the 
species names are accepted by the scientific community. If in the 
future the composition of the Bcc is modified to include new species 
equivalents, or existing Bcc members are removed from that group, EPA 
will consider whether an additional rulemaking is warranted to revise 
the definition of Bcc in this proposed rule.

B. Bcc Hazard Assessment

    Although B. cepacia is not a frank pathogen for humans, it is an 
important opportunistic pathogen for patients with CF and other 
diseases resulting in immune defects (Refs. 2 and 3). CF is an 
autosomal recessive disorder resulting in the dysfunction of the cystic 
fibrosis transmembrane regulator (CFTR), that actively transports 
chloride ions across the plasma membrane of mammalian cells (Ref. 3). 
This defect results in high salt concentrations in epithelial 
secretions and a production of a thick mucus within the airways of the 
CF lung. The airway mucus impairs normal mucocilliary clearance 
mechanisms, thus promoting infection with a variety of microbial 
pathogens.
    CF patients suffer from a variety of health problems including 
infection, intestinal obstruction, pancreatic insufficiency, 
reproductive problems, and malnutrition (Ref. 4). These result in 
symptoms such as gastrointestinal pain, diarrhea, fatigue, weight loss, 
and wheezing. These problems are the result of mutations in the CFTR 
gene (Ref. 5). There have been more than 600 different mutations of 
this gene documented (Ref. 6). Different mutations have resulted in 
different phenotypes of the disease. Thus, CF is not an ``all or none'' 
disease, and the spectrum of CF disease can vary from very mild to very 
severe (Ref. 7).
    Bacterial colonization and associated inflammation are the major 
causes of morbidity and mortality in patients with CF (Ref. 3). 
Surprisingly, the spectrum of bacteria that are routinely isolated from 
CF sputum is narrow (Ref. 3). Characteristically, infant CF patients 
are infected with Staphylococcus aureus and Haemophilus influenzae. In 
adolescent and adult CF patients, the prevalence of pulmonary infection 
with Pseudomonas aeruginosa (80-90% in most CF adults) exceeds that of 
all other pathogens. Other organisms isolated from CF patients include 
Stenotrophomonas maltophilia, Alcaligenes xylosoxidans, Aspergillus 
species, Ralstonia pickettii, and Bordetella.
    Although Pseudomonas aeruginosa is the dominant pathogen for the CF 
patient, B. cepacia has been isolated with increasing frequency over 
the last 15 years (Ref. 3). According to the Cystic Fibrosis 
Foundation, 3.5% of all people with CF receiving care at CF Foundation-
accredited Care Centers in 1988 were infected with B. cepacia. An adult 
CF infection rate of 6% has been reported (Ref. 6). The clinical 
outcome for CF patients can vary considerably. Some patients have only 
transient infection or are chronically infected without impact. 
Infection in other patients results in a more rapid deterioration of 
lung function. In about 20% of CF patients infected with B. cepacia, 
colonization results in the so-called ``cepacia syndrome,'' which is 
characterized by fever, pneumonia, and ultimately a fatal clinical 
decline.
    B. cepacia causes pulmonary infections in CF patients. Respiratory 
tract infections, in general, are mainly caused by invasion of the 
mucus membranes lining the respiratory tract (Ref. 8). Thus, inhalation 
exposure would be the most relevant route of exposure for B. cepacia 
risk assessment. The level of exposure needed to cause infection is not 
known (Ref. 9).
    B. cepacia is a pathogen in other immunocompromised patients as 
well. For example, patients with chronic granulomatous disease (CGD) 
are at a high risk of invasive B. cepacia infection (Ref. 10). This can 
result in fatal pneumonia in these patients. CGD is an inherited 
disorder of the immune system that leaves patients vulnerable to 
bacterial and fungal infections.
    The virulence factors that allow B. cepacia to cause disease are 
only beginning to be defined (Ref. 11). Several virulence factors have 
been proposed for B. cepacia infecting CF patients. These include B. 
cepacia lipopolysaccharide catalase, a hemolysin, lipases, proteases, 
siderophores, and a so-called giant cable pilus. However, it is 
difficult to determine if the virulence traits identified actually 
contribute to pathogenicity in CF patients. This is partly due to 
animal models that do not reproduce the human CF phenotype with high 
fidelity.
    Ascertaining the virulence factors important for B. cepacia 
infection would help in determining the relative pathogenicity of each 
distinct B. cepacia genomovar. Formerly a member of the genus 
Pseudomonas, B. cepacia is now known to be a complex of bacteria (B. 
cepacia complex) consisting of nine distinct species or genomovars 
(Ref. 3). Currently, it is not known if all genomovars of the B. 
cepacia complex are human pathogens. Based on analyses of isolates 
associated with human disease, genomovar III appears to be the most 
pathogenic for CF patients (Ref. 11). Some of the other genomovars are 
only rarely encountered in a clinical setting, and their ability to 
cause disease in CF patients is unknown. Thus far, however, no B. 
cepacia strains can currently be determined to be free from the 
potential to cause disease in CF patients (Ref. 12).
    Ascertaining the virulence factors important for B. cepacia 
infection would also help in determining the source of all the 
infections that cause disease in CF patients. For example, epidemic 
transmission of B. cepacia is most commonly seen with genomovar III 
(Ref. 11). However, CF patients can also be infected by non-epidemic 
strains of B. cepacia (Refs. 2, 4, and 11). The source of all the 
infections that cause disease in CF patients is unknown. Potential 
infection sources could include: a) humans, b) hospital/treatment 
centers (nosocomial), c) food, or d) the environment (soil, water, 
plants). Thus far, only patient to patient transmission has been 
demonstrated to be an infection source (Ref. 13). Importantly, 
environmental isolates of B. cepacia cannot thus far be distinguished 
from human pathogenic strains (Ref. 11).
    The therapy for B. cepacia remains a challenge (Ref. 11). B. 
cepacia is highly resistant to antibiotic drugs, and there is poor 
penetration of antibiotics into respiratory secretions. There have been 
reports of bacterial isolates for which no single anti-bacterial agent 
is effective in vitro. According to one author (Ref. 14), the most 
effective reagents appear to be carbapenems, extended-spectrum 
-lactam drugs, and trimethoprim-sulfamethoxazole.

C. Potential Uses of Bcc

    Studies suggest that Bcc microorganisms may be useful in a variety 
of TSCA applications, including bioremediation (degradation of toxic 
chemicals, as well as degradation of grease in drains), turf 
management, and specialty chemicals production. In order to gauge the 
scope of commercial use of Bcc, EPA conducted a survey of over

[[Page 1183]]

100 firms, associations, and researchers. In sum, EPA was able to 
discover no evidence that Bcc is contained in a commercial product 
currently available for use in the U.S. The only potential TSCA uses of 
Bcc for which information is available are field studies of Bcc in the 
biodegradation of chlorinated solvents in groundwater. Specifically, 
one company has injected a strain of Bcc into aquifers in New Jersey to 
demonstrate its ability to degrade trichloroethylene, and a consulting 
firm carried out a pilot study in Wichita, Kansas to verify the 
effectiveness and overall feasibility of injecting Burkholderia cepacia 
PR1301 into groundwater to degrade chlorinated aliphatic 
hydrocarbons. The conclusion to the pilot study report suggests that 
the use of Burkholderia cepacia PR1301 was quite successful 
and should reduce clean-up time and costs at many other sites. However, 
none of these strains is currently available for general commercial 
use.
    No companies indicated that Bcc was currently used for the 
degradation of grease (typically in drain cleaners) or for turf 
management (typically in thatch reduction), although researchers and 
firms cautioned that even the companies that produce such products may 
be unaware of the presence of Bcc.
    One respondent indicated that lipases harvested from Bcc are used 
in the production of specialty chemicals. One company web site lists 
seven lipases derived from Bcc species available for sale under their 
brand names. However, when this company was contacted, it indicated 
that it imports the lipases from an overseas firm and does not work 
with Bcc microorganisms. No more information was available.
    Many respondents indicated a knowledge of Bcc and its possible 
applications, but very few had any knowledge that it was actually being 
used. Some contacts indicated that Bcc's potential for opportunistic 
pathogenicity had led them to disregard it for use in their products. 
Thus, the information available to EPA indicates that the only existing 
TSCA use of Bcc in the U.S. are the demonstration studies of its 
effectiveness in degrading chlorinated solvents in groundwater. EPA 
considers these studies to fall under the description of research and 
development (Ref. 15).

D. Exposures

    Bcc is a naturally occurring microorganism which is found in a wide 
range of habitats but especially in high populations in the soil. While 
Bcc is not known to be in general commercial use at this time, the 
potential uses identified could give rise to exposures in different 
ways. To produce microorganisms on a commercial scale, they first are 
cultured in large commercial fermentation facilities to obtain adequate 
amounts for a potential use. If used for specialty chemical manufacture 
the microorganisms are cultured first then killed after harvesting the 
chemical substance to be manufactured. EPA has identified potential 
dermal and inhalation exposures as well as environmental release from 
manufacture of microorganisms. These exposures could occur for any 
potential use of microorganisms. Sources of potential environmental 
release include exhaust gas from the fermentor and wastes from cleanup 
of equipment. Potential exposures result from laboratory propogation of 
cells, sampling, equipment cleaning/maintenance, and from cell 
recovery. Estimates of potential inhalation exposure were derived from 
area monitoring data in fermentation facilities. Estimates of potential 
dermal exposure were derived from laboratory experiments involving 
liquids which measured the retention on the hands for various types of 
exposures.
    In addition to exposure from fermentation, there is also potential 
for dermal and inhalation exposures as well as environmental release 
from uses in bioremediation, turf builders, and drain cleaners. The 
primary source of potential release and dermal exposure is from the 
intended injection or application of the material. Application of turf 
builders would be spray applications resulting in increased inhalation 
exposures. Other release sources include air releases from off-gassing 
of aerated shipping containers and residue left in the shipping 
containers. Exposure to bioaerosols may occur from the aerated shipping 
containers. Although there is no evidence that Bcc specifically is used 
in the turf building or drain cleaning applications, there are 
commercially available products that contain microbials. (Ref. 16)

V. Objectives and Rationale of the Proposed Rule

    In determining what would constitute a significant new use for the 
microorganisms that are the subject of this proposed 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. of this document. 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. Microorganisms may reproduce and increase beyond the number 
initially introduced and may spread beyond the site of manufacture or 
use. 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.
    2. Extent to which a use changes the type, form, magnitude, and 
duration of exposure to human beings or the environment to a chemical 
substance. EPA has not currently identified any general commercial use 
of Bcc. EPA has identified field studies of Bcc in the biodegradation 
of chlorinated solvents in groundwater. All other research and 
development activities, other than such field studies involving 
injection into groundwater, that do not meet the definition of small 
quantities for research and development would require reporting under 
40 CFR 725.105(c) if included in a final SNUR. EPA is specifically 
soliciting comments on whether all other research and development 
activities should be captured under the SNUR or whether the SNUR should 
be limited to general commercial use of Bcc.
    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. The potential uses 
identified in Unit IV.C. of this document, which include bioremediation 
(degradation of toxic chemicals, as well as degradation of grease in 
drains), turf management, and specialty chemicals production, could 
significantly increase dermal and inhalation exposures of Bcc to 
humans. In some cases these exposures could be higher than typically 
found in nature and more likely to be encountered by a member of a 
sensitive population. These exposures would significantly increase the 
type, form, magnitude, and duration of exposures to human beings from 
known uses of Bcc.
    EPA wants to achieve the following objectives with regard to the 
significant new uses that are designated in this proposed rule. EPA 
wants to ensure that:

[[Page 1184]]

    1. EPA will receive notice of any company's intent to manufacture, 
import, or process Bcc for a significant new use before that activity 
begins.
    2. EPA will have an opportunity to review and evaluate data 
submitted in an MCAN before the notice submitter begins manufacturing, 
importing, or processing Bcc for a significant new use.
    3. 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 (f).

VI. Alternatives

    Before proposing 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 proposed SNUR would 
allow the Agency to address the potential risks associated with any 
intended significant new use of Bcc. If EPA is notified of any 
additional existing commercial uses, EPA may reconsider the decision 
and pursue additional regulatory action as appropriate.

VII. 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 
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).

VIII. Applicability of Proposed 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.
    Persons who begin commercial manufacture, import, or processing of 
Bcc, for the significant new use in this proposed SNUR, after the 
proposal has been published must stop that 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 begin commercial manufacture or 
import of Bcc for a significant new use between the proposal and the 
effective date of the final SNUR meet 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.

IX. 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 proposed SNUR.

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 proposed 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 (Ref. 17).
    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

[[Page 1185]]

begin manufacture or importation of Bcc. 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. of this document, 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 proposed 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 
(Ref. 17).
    EPA is unable to estimate the total number of TSCA section 12(b) 
notifications that will be received as a result of this proposed 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 proposed 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.

X. References

    These references have been placed in the official record that was 
established under docket control number OPPTS-50645 for this document 
as indicated in Unit I.B.2. of this document.
    1. Risk Assessment for TSCA Section 21 Petition on Bacteria in the 
Burkholderia cepacia complex, USEPA, November 2001.
    2. Mohr, C.D., Tomich, M., and Herfst, C.A., Microbes and 
Infection, 3, 2001, 425.
    3. Hutchison, M. L., and Govan, J. R. W, Microbes and Infection, 1, 
1999, 1005.
    4. Buchwald, M.., Clin Invest Med 1996; 19 (5): 304.
    5. Mickle, JE.and Cutting, G.G., Clin.Chest Med. 19, 1998, 443.
    6. do Pico, Guillermo A., http://www.chestnet.org/education/pccu/vol12/lesson20.html
    7. Bush, A., and Wallis, C., Ped. Pulmonology 30, 2000, 139.
    8. Davies, S.S., Advanced Drug Delivery Reviews 51, 2001, 21.
    9. FIFRA SAP Report # 99-04, Sept. 30, 1999.
    10. Geiszt, M., Kapus, A., and Legeti, E., J. Leukocyte Biology 69, 
2001, 191.
    11. Parke, J. L., Gurian-Sherman, D., Ann. Rev. Phytopath. 39, 
2001, 225.
    12. FIFRA SAP report (1999). Risk Assessment of Burkholderia 
cepacia - based biopesticides and other bacteria related to 
opportunistic human infections.
    13. Speert, D. P., Infect. Med., 18, 2001,49.
    14. Parke, J.J., The Plant Health Instructor, 10, 2000, 1094.
    15. Commercial Uses of Burkholderia cepacia complex, USEPA, October 
2001.
    16. Assessment of Potential Worker Exposure and Environmental 
Releases From Commercial Uses of Burkholderia cepacia complex, USEPA, 
October 2001.
    17. Economic Analysis to Support the Proposed SNUR for Burkholderia 
cepacia complex, USEPA, October 15, 2001.

XI. Regulatory Assessment Requirements

    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 proposed or final 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.
    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and tribal governments have not been impacted by these 
rulemakings, and EPA does not 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) (Pub. L. 104-4).
    This proposed 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 proposed rule. Nor will this 
action 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).
    In issuing this proposed 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).
    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 proposed 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.
    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).
    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.
    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), Pub. L. 104-113, section

[[Page 1186]]

12(d) (15 U.S.C. 272 note), does not apply to this action.
    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 proposed 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, 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 900 SNURs, the 
Agency has received fewer than 25 SNUNs. 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 IX.A. of this document) are minimal regardless of the size of the 
firm. Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR are 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.
    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 in 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. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.
    This proposed 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.

List of Subjects in 40 CFR Part 725

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: December 21, 2001.
William H. Sanders, III
Office Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 725 be amended as 
follows:

PART 725--[AMENDED]

    1. The authority citation for part 725 would continue to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

    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, and 
Burkholderia cepacia genomovars III, VI, and VIII 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. 02-513 Filed 1-8-02; 8:45 am]
BILLING CODE 6560-50-S