[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Proposed Rules]
[Pages 11643-11648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6100]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50630; FRL-5765-6]
RIN 2070-AB27
Sinorhizobium Meliloti Strain RMBPC-2; Proposed Significant New
Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
microorganism
[[Page 11644]]
described as Sinorhizobium meliloti strain RMBPC-2 which is the subject
of premanufacture notice (PMN) P-92-403. This proposal would require
certain persons who intend to manufacture, import, or process this
microorganism for a significant new use to notify EPA at least 90 days
before commencing any manufacturing, importing, or processing
activities 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 use and, if necessary, to prohibit or limit that activity
before it can occur.
DATES: Written comments must be received by EPA by April 9, 1998.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50630. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,
Washington, DC 20460.
Comments and data may also be submitted electronically to:
[email protected]. Follow the instructions under Unit VII. of
this document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each portion. This claim must be
made at the time that the information is submitted to EPA . If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim, and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are
available from the EPA Home Page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/ fedrgstr/).
This proposed SNUR would require persons to notify EPA at least 90
days before commencing the manufacture, import, or processing of the
microorganism identified in PMN P-92-403 for the significant new uses
designated herein. The required notice would provide EPA with
information with which to evaluate an intended use and associated
activities.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use''. EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a significant
new use, 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
chemical substance for that use. Section 26(c) of TSCA authorizes EPA
to take action under section 5(a)(2) of TSCA with respect to a category
of chemical substances. EPA interprets the definition of ``chemical
substance'' under TSCA to include intergeneric microorganisms as stated
in the Federal Register of April 11, 1997 (62 FR 17913) (FRL-5577-2),
June 26, 1986 (51 FR 23324), and December 31, 1984 (49 FR 50886).
Persons subject to this SNUR would comply with the same notice
requirements and EPA regulatory procedures as submitters of
premanufacture notices under section 5(a)(1) of TSCA. In particular,
these requirements include the information submission requirements of
section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1),
(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.
Once EPA receives a SNUR notice, EPA may take regulatory action under
section 5(e), 5(f), 6, or 7 to control the activities for which it has
received a SNUR notice. If EPA does not take action, section 5(g) of
TSCA requires EPA 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.
II. Applicability of General Provisions
General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. On July 27, 1988 (53 FR 28354) and July 27,
1989 (54 FR 31298), EPA promulgated amendments to the general
provisions which apply to this SNUR. In the Federal Register of August
17, 1988 (53 FR 31248), EPA promulgated a ``User Fee Rule'' (40 CFR
part 700) under the authority of TSCA section 26(b). Provisions
requiring persons submitting SNUR notices to submit certain fees to EPA
are discussed in detail in that Federal Register document. Interested
persons should refer to these documents for further information.
III. Background
EPA interprets the definition of ``chemical substance'' under TSCA
to include intergeneric microorganisms. In the Federal Register of
December 31, 1984 (49 FR 50880), EPA published a notice document
entitled ``Proposed Policy Regarding Certain Microbial Products'',
where EPA discussed how reporting requirements of section 5 of TSCA
could be applied to microorganisms. This document was published as part
of another notice document entitled ``Proposal for a Coordinated
Framework for Regulation of Biotechnology'', which was published in the
Federal Register of December 31, 1984 (49 FR 50856) by the Office of
Science and Technology Policy (OSTP). In the Federal Register of June
26, 1986 (51 FR 23313), EPA published a notice document entitled
``Statement of Policy; Microbial Products Subject to the Federal
Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances
Control Act'', in which EPA stated that intergeneric microorganisms
would be considered ``new'' for purposes of section 5 of TSCA. This
document was published as part of another notice document entitled
``Coordinated Framework for Regulation of Biotechnology'', which was
published in the Federal Register of June 26, 1986 (51 FR 23302) by
OSTP. In the Federal Register of April 11, 1997 (62 FR 17910) (FRL-
5577-2) EPA published a final rule entitled ``Microbial Products of
Biotechnology; Final Regulation Under the Toxic Substances Control
Act'', in which EPA reiterated that TSCA applies to intergeneric
microorganisms.
In 1992, Research Seeds, Inc. (the company), located in St. Joseph,
MO, submitted several PMNs to EPA pursuant to section 5(a) of TSCA for
various intergeneric strains of Rhizobium meliloti. Rhizobium meliloti
[[Page 11645]]
has been renamed as Sinorhizobium meliloti. The company conducted
several small and large scale field trials with various of these
strains, including the microorganism which is the subject of PMN P-92-
403. These field trials are subject to a consent order issued by EPA
pursuant to its authority under section 5(e) of TSCA. The consent
order, as amended, limited use by the company of the intergeneric
strains of Rhizobium meliloti, including P-92-403, to specific sites
and only for research and development (R&D) purposes. The consent order
(``the order'') went into effect on April 28, 1992, and was
subsequently modified on June 21, 1993, November 22, 1993, April 4,
1994, and May 4, 1995 to permit additional field trials at different
sites.
On May 26, 1994, Research Seeds, Inc. submitted a request to
commercialize Rhizobium meliloti strain RMBPC-2 (PMN P-92-403). On
January 4, 1995, a subcommittee of the Biotechnology Science Advisory
Committee (BSAC) met to review the Agency's draft risk assessment. The
BSAC submitted its report on March 6, 1995. The Agency's risk
assessment, the report of the BSAC Subcommittee, and other materials
relevant to EPA's review are included in the public docket for this
matter (see Unit VII. of this preamble). The Agency's risk assessment
and the recommendations of the BSAC report are summarized in Unit III.
of this preamble.
On September 16, 1997, EPA modified the order for P-92-403 allowing
limited manufacture, import, and processing for commercial purposes.
The order requires that the company submit a significant new use notice
(SNUN) to EPA at least 90 days before manufacture, processing, or
importation of P-92-403 will exceed a production volume of 500,000
pounds (lbs) during any consecutive 12-month period.
Because the order applies only to the company, once the substance
is on the TSCA Chemical Substances Inventory (maintained by EPA
pursuant to section 8(a) of TSCA), it is no longer a ``new'' chemical
substance subject to PMN requirements. Therefore, any other
manufacturer, importer, or processor may commercialize the
microorganism without restriction unless EPA takes independent action
to regulate the substance. The purpose of this SNUR is to extend the
requirements of the TSCA section 5(e) consent order to all
manufacturers and importers of this particular microorganism.
If the SNUR were to allow several manufacturers or importers to
manufacture or import up to 500,000 lbs of the microorganism during any
consecutive 12-month period without further notification, much more
than 500,000 lbs of the microorganism could be produced in a single
year. Under the terms of such a SNUR the potential would exist for the
microorganism to penetrate the entire market of inoculant on alfalfa
seed without any further notification to EPA. Before allowing any
potential environmental releases of the microorganism above 500,000 lbs
in a 12-month period, EPA wants to evaluate further the need for any
additional testing of Sinorhizobium meliloti strain RMBPC-2 (see Unit
III.D.2. of this preamble). This was the basis for allowing only
limited commercial production under the terms of a TSCA section 5(e)
consent order and proposing this rule.
To ensure that no potential environmental releases of the
microorganism above 500,000 lbs in a 12-month period occur before EPA
receives 90-day notification, EPA is proposing the SNUR as follows: Any
manufacturer or importer who has not previously submitted a
premanufacture notice or significant new use notice for this
microorganism must submit a significant new use notice 90 days before
engaging in any commercial activity, while any manufacturer or importer
who has previously submitted a premanufacture notice or a significant
new use notice for this microorganism must submit a significant new use
notice before manufacturing, importing, or processing greater than a
maximum production volume of 500,000 lbs in any consecutive 12-month
period. If and when EPA receives a significant new use notice for this
microorganism, it will evaluate the need for further environmental
testing based on the information in the notice and all other available
relevant information.
A. Identity of the Microorganism
Rhizobium meliloti was reclassified in 1994 as Sinorhizobium
meliloti (De Lajudie et al., 1994, see Unit IX.1. of this preamble).
The microorganism which is the subject of the consent order
modification is now identified as Sinorhizobium meliloti strain RMBPC-
2. Because only the taxonomic designation of the microorganism has
changed, and not the microorganism itself, Sinorhizobium meliloti
strain RMBPC-2, is identical to that which was the subject of PMN P-92-
403, and continues to be covered by the consent order.
B. Use
The company intends to use the microorganism as an inoculant on
alfalfa seed. The microorganism will initially be sold in a clay-based
carrier directly to farmers for use in coating their own alfalfa seed
prior to planting, and subsequently, if commercially successful, would
be sold to seed processors for use in coating alfalfa seed prior to
sale of the seed to farmers. The company plans to sell strain RMBPC-2
as an alfalfa seed inoculant in all states, as well as for export.
According to the commercialization request submitted by the company to
EPA, the company initially plans to produce no more than 27,000 lbs of
inoculant packaged in individual 8 ounce (oz) bags during the first
year of commercial manufacture. This would be sufficient to treat
approximately 3.2 million lbs of alfalfa seed or approximately 178,000
acres. The bags would be sold directly to farmers who would treat their
own alfalfa seed prior to planting. During the second year of
commercial manufacture, the company plans to produce 54,000 lbs of
inoculant packaged in individual 8 oz bags. This would be sufficient to
treat approximately 6.4 million lbs of seed or approximately 355,000
acres. The company projects that their production of the inoculant
could reach 500,000 lbs by the third year of commercialization.
The following is a summary of the determinations reached on each
major issue addressed in development of the risk assessment for this
microorganism. A complete discussion of each component of the risk
assessment is included in the final document entitled ``Risk
Assessment: Commercialization Request for P-92-403 Sinorhizobium
(Rhizobium) meliloti strain RMBPC-2'', which is included in the public
docket OPPTS-51786 for this matter.
C. Human Health Issues
Concerns about human health effects associated with strain RMBPC-2
relate to three issues: Concern about inherent pathogenicity or
toxicity of naturally-occurring strains of Sinorhizobium meliloti, the
ability of the introduced DNA to impart pathogenic properties to
Sinorhizobium meliloti strain RMBPC-2, and the ability of the
introduced antibiotic resistance genes to transfer to other
microorganisms which are human pathogens.
The BSAC subcommittee stated that ``there is no likelihood that
naturally-occurring members of the species Rhizobium meliloti could
colonize humans or have human pathogenic and/or toxic effects''.
Similarly, the subcommittee concluded that there was no likelihood that
the introduced gene fragments ``could change the behavior of RMBPC-2
with regard to human
[[Page 11646]]
pathogenicity or toxicity'' (Biotechnology Science Advisory Committee,
page 9, 1995, see Unit IX.2. of this preamble). The conclusions of the
BSAC subcommittee and of the risk assessment with respect to each of
these issues are summarized in Unit III.C.1., C.2., and C.3. of this
preamble.
1. Inherent pathogenicity of Sinorhizobium meliloti. Naturally
occurring strains of Sinorhizobium meliloti have been in use in the
United States as commercial seed inoculants for over 100 years. A
thorough search for references to pathogenic effects of these
microorganisms has not disclosed any reports of adverse human health
effects.
2. Pathogenic properties of Sinorhizobium meliloti. The genetic
material introduced into the host strain to produce strain RMBPC-2 is
very well-characterized and contains no sequences encoding for toxin
production or for traits associated with an ability to colonize humans
or cause mammalian pathogenicity.
3. Transfer of antibiotic resistance traits to human pathogens.
There is a very low probability of transfer of the aadA gene, which
encodes for resistance to the antibiotics streptomycin and
spectinomycin, to other microorganisms which are potential human
pathogens. This is due to two reasons: The aadA gene fragment is stably
inserted into the second megaplasmid of Sinorhizobium meliloti.
Megaplasmids are such large genetic segments that they are often
referred to as ``mini-chromosomes''. As such, their ability to transfer
into other microorganisms, even to other closely related species, is
very limited, and Sinorhizobium meliloti does not share habitats with
other microorganisms which are potential human pathogens. As a result,
the physical proximity necessary for gene transfer is not present.
The BSAC subcommittee also concluded that RMBPC-2 satisfied the
criteria developed in 1989 by the BSAC subcommittee on antibiotic
resistance, which had identified criteria for assessing the conditions
under which intergeneric microorganisms containing antibiotic
resistance markers might be approved for commercial use in the
environment. The criteria enumerated in 1989 were that the antibiotic
resistance markers should be located on the chromosome and be non-
transposable and that the antibiotics involved should have limited or
no clinical use. The BSAC subcommittee concluded that in the case of
strain RMBPC-2 these criteria were satisfied because of the low
probability of transfer of the Sinorhizobium meliloti megaplasmid and
because clinical use of both antibiotics was limited and not likely to
increase in the future.
The BSAC subcommittee also noted the very high levels of resistance
to streptomycin and spectinomycin already present in microbial
populations in the environment. The subcommittee noted that other
microorganisms are much more likely sources of resistance genes than
Sinorhizobium meliloti strain RMBPC-2.
D. Environmental Effects Issues
Environmental effects issues are grouped into four major
categories: Survival and dissemination of the microorganisms in the
environment, competitiveness of the microorganisms, effects on yield,
and ability to nodulate non-target plants. Each of these issues is
addressed in Unit III.D.1., D.2., D.3., and D.4. of this preamble.
1. Survival and dissemination of RMBPC-2 in the environment.
Sinorhizobium meliloti strain RMBPC-2 is expected to survive in the
soil once introduced into the environment. Literature studies show that
strains of Sinorhizobium meliloti can persist in low numbers in the
soil for many years and that populations can be stimulated by the
presence of host plants. Data on other intergeneric strains of
Sinorhizobium meliloti closely related to strain RMBPC-2 show that the
microorganisms can persist in the soil at detectable levels in the
absence of plant roots, sometimes for up to 1 year or more after
termination of the field trial.
EPA required collection of monitoring data during the initial field
trials of intergeneric strains of Sinorhizobium meliloti which are
closely related to strain RMBPC-2. Monitoring data on RMBPC-2 was not
specifically collected because this strain was not field tested until
later in the overall field testing program. These data show that there
is very little movement of intergeneric strains of this microorganism
in the soil. Vertical movement of the microorganism was associated with
growth of the alfalfa root system. Population densities of the
microorganism decreased with increasing soil depth. Thus, dissemination
of these microorganisms is limited to the rhizosphere of the associated
host alfalfa plants.
2. Competitiveness of RMBPC-2. Analysis of the data collected on
the competitiveness of strain RMBPC-2, the ability of the strain to
nodulate the roots of alfalfa plants, has shown this strain to be
comparable to other strains derived from the host strain Sinorhizobium
meliloti strain RMBPC-2. The genes affecting the nodulation capability
of Sinorhizobium meliloti were not modified in developing strain RMBPC-
2. The BSAC stated that ``[t]he nodule occupancy data indicate that
RMBPC-2 is similar in competitiveness to other PC-based strains,
indicating that the introduced genes in RMBPC-2 had no major effects on
nodulation competitiveness'' (Biotechnology Science Advisory Committee,
page 8, 1995, see Unit IX.2. of this preamble). Thus, there is no
expected change in either the competitiveness of the microorganism or
in its host range.
The BSAC subcommittee were of divided opinion concerning the need
for additional testing on the persistence, dissemination,
competitiveness, and genetic stability of strain RMBPC-2. In an
appendix to the subcommittee's final report, it was suggested that data
specific to RMBPC-2 be accumulated by reseeding test plots in which the
microorganism had been previously used (Biotechnology Science Advisory
Committee, pages 15 and 18-19, 1995, see Unit IX.2. of this preamble).
This was recommended because ``little or no data were presented on the
behavior of RMBPC-2 itself'' with respect to these characteristics
(Biotechnology Science Advisory Committe, page 15, 1995, see Unit IX.2.
of this preamble).
EPA states in its risk assessment that although data specific to
RMBPC-2 pertaining to some of its environmental characteristics were
not collected, all genetic permutations which contributed to the
construction of strain RMBPC-2 were evaluated by EPA, either during the
early stages of the rhizobia field trials or during testing of strain
RMBPC-2 itself. In addition, genetic modifications to strain RMBPC-2
are not likely to have modified the behavior of the microorganism
compared to that observed with earlier constructs. Moreover, reseeding
the original test plots is no longer possible because all tests have
been terminated and the plots have been returned to normal agricultural
use.
3. Effect on yield of alfalfa plants. Data were also collected and
analyzed relating to the ability of Sinorhizobium meliloti strain
RMBPC-2 to affect the yield of alfalfa plants. These data, encompassing
up to 4 years at some sites, demonstrated that RMBPC-2 is sometimes
able to significantly increase alfalfa yield under conditions of low
nitrogen content of the soil and low indigenous rhizobial populations.
However, the yield increases realized are modest and not outside the
range of yields encountered in commercial alfalfa production using
naturally occurring rhizobial inoculants. The BSAC agreed that,
overall, RMBPC-2
[[Page 11647]]
was shown to perform within the normal range expected of naturally
occurring commercial inoculants. Thus, there were no adverse effects on
alfalfa yield from use of RMBPC-2.
4. Effect on non-target plants. The process of nodulation of
leguminous plants by various strains of Sinorhizobium meliloti is
highly specific. Sinorhizobium meliloti has been reported to
preferentially nodulate various species of alfalfa, sweet clover, and
fenugreek. Collectively, these leguminous species are referred to as
the ``cross-inoculation'' group for Sinorhizobium meliloti. Various
studies have suggested that Sinorhizobium meliloti may also be able to
nodulate certain other leguminous plants outside of its normal cross-
inoculation group such as mesquite.
In considering the potential for Sinorhizobium meliloti to nodulate
leguminous plants other than alfalfa, the BSAC subcommittee was of
divided opinion on whether to recommend additional testing of strain
RMBPC-2. An appendix to the BSAC report described testing which some
members of the subcommittee felt would provide additional assurance
that strain RMBPC-2 would behave as other Sinorhizobium meliloti
inoculants (Biotechnology Science Advisory Committee, pages 15 and 18-
19, 1995, see Unit IX.2. of this preamble). The additional testing
involved greenhouse testing of RMBPC-2 along with other control strains
on various cultivars of sweet clover and several of the major mesquite
species.
EPA addressed these issues in its risk assessment. With respect to
the concern for increased weediness of sweet clover, EPA believes that
there is no incremental hazard if RMBPC-2 were to replace indigenous or
commercial strains of sweet clover inoculants. As noted in the previous
two paragraphs, the ability of RMBPC-2 to nodulate plants within its
cross-inoculation group is comparable to that of other commercial
inoculants, and thus would be unlikely to impart a competitive
advantage to sweet clover plants. In addition, agricultural management
practices in alfalfa fields, which involve mowing alfalfa plants at a
low height, are detrimental to sweet clover growth and would
consequently control sweet clover growth in alfalfa fields, even if the
sweet clover was inoculated by RMBPC-2. Finally, the Agency noted that
nodulation data collected under greenhouse conditions may not
accurately reflect the reality of competitive field conditions.
With respect to mesquite, there is considerable disparity between
the geographic regions of the country in which mesquite and alfalfa are
grown. Thus, there would be little opportunity for strain RMBPC-2 to
come into contact with mesquite plants. In addition, mesquite is
nodulated by a consortium of species and genera of nitrogen-fixing
microorganisms, including various species of Rhizobium and
Bradyrhizobium. As a result, strain RMBPC-2 would need to out-compete
all such species in order to have any observable effect on individual
mesquite plants, which is highly unlikely.
IV. Objectives and Rationale of the Proposed Rule
EPA is issuing this SNUR for a specific microorganism which has
undergone premanufacture review to ensure that:
(1) EPA will receive notice of any company's intent to manufacture,
import, or process the microorganism for a significant new use before
that activity begins.
(2) EPA will have an opportunity to review and evaluate data
submitted in a significant new use notice (SNUN) before the notice
submitter begins manufacturing, importing, or processing the
microorganism for a significant new use.
(3) When necessary to prevent potential unreasonable risks, EPA
will be able to respond to a SNUN by issuing a TSCA section 5(e)
consent order to regulate prospective manufacturers, importers, or
processors of the microorganism before a significant new use of that
substance occurs.
(4) All manufacturers, importers, and processors of the same
microorganism which is subject to a TSCA section 5(e) consent order are
subject to similar requirements.
Issuance of a SNUR for a microorganism does not signify that the
substance is listed on the TSCA Inventory and that its manufacture
would not require a PMN. Manufacturers, importers, and processors are
responsible for ensuring that a new chemical substance subject to a
final SNUR is listed on the TSCA Inventory.
V. Applicability of SNUR to Uses Occurring Before Effective Date of
the Final SNUR
EPA has decided 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
date of proposal, rather than as of the effective date of the rule. If
uses which had commenced between the date of proposal and the effective
date of this rulemaking were considered ongoing, rather than new, any
person could defeat the SNUR by initiating a significant new use before
the effective date. This would make it difficult for EPA to establish
SNUR notice requirements. Thus, persons who begin commercial
manufacture, import, or processing of the microorganism for uses that
would be regulated through this SNUR after the proposal date, would
have to cease any such activity before the effective date of this rule.
To resume their activities, such persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. EPA, not wishing to
unnecessarily disrupt the activities of persons who begin commercial
manufacture, import, or processing for a proposed significant new use
before the effective date of the SNUR, has promulgated provisions to
allow such persons to comply with this proposed SNUR before it is
promulgated. If a person meets the conditions of advance compliance as
codified at Sec. 721.45(h) (53 FR 28354, July 17, 1988), the person is
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of the microorganism between proposal and the effective date
of the SNUR do not meet the conditions of advance compliance, they must
cease that activity before the effective date of the rule. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires.
VI. Economic Analysis
EPA has evaluated the potential costs of establishing significant
new use notice requirements for potential manufacturers, importers, and
processors of the microorganism subject to this rule. EPA's complete
economic analysis is available in the rulemaking record for this
proposed rule (OPPTS-50630).
VII. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-50630 (including comments and data submitted
electronically as described below). In addition, extensive information
for this microorganism can also be found in OPPTS docket number 51786.
This docket contains materials concerning the TSCA section 5(a) review
of P-92-403. A public version of this record,
[[Page 11648]]
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 12 noon to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located in the TSCA
Nonconfidential Information Center Rm. NE-B607, 401 M St., SW.,
Washington, DC.
Electronic comments can be sent directly to EPA at:
[email protected]
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 disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-50630. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
VIII. Regulatory Assessment Requirements
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB). In addition, this action does not impose
any enforceable duty or contain any unfunded mandate as described in
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require
prior consultation with State officials as also specified in Executive
Order 12875, entitled ``Enhancing the Intergovernmental Partnership''
(58 FR 58093, October 28, 1993). Nor does it involve special
considerations of environmental justice related issues as required by
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994), or additional OMB review
in accordance with Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997).
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 rules,
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. 574). This
action does not impose any burden requiring additional OMB approval.
If an entity were to submit a significant new use notice to the
Agency, the annual burden is estimated to average between 30 and 170
hours per response. 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
significant new use notice.
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, OPPE
Regulatory Information Division, U.S. Environmental Protection Agency
(Mail Code 2137), 401 M St., SW., Washington, DC 20460, with a copy to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA''. Please remember to include the OMB
control number in any correspondence, but do not submit any completed
forms to these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously
certified, as a generic matter, that the promulgation of a SNUR does
not have a significant adverse economic impact on a substantial number
of small entities. The Agency's generic certification for promulgation
of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1) and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
IX. References
1. De Lajudie, P. et al. ``Polyphasic Taxonomy of Rhizobia:
Emendation of the Genus Sinorhizobium and Description of Sinorhizobium
meliloti comb. nov., Sinorhizobium saheli sp. nov., and Sinorhizobium
teranga sp. nov.''. Int'l J. of Systematic Bacteriology, October 1994,
pp. 715-733.
2. Final report of the Biotechnology Science Advisory Committee
Subcommittee on Premanufacture Notification; Review of Nitrogen Fixing
Rhizobium meliloti, March 6, 1995.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: February 27, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By adding new Sec. 721.9518 to subpart E to read as follows:
Sec. 721.9518 Sinorhizobium meliloti strain RMBPC-2.
(a) Microorganism and significant new uses subject to reporting.
(1) The microorganism identified as Sinorhizobium meliloti strain
RMBPC-2 (PMN P-92-403) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Commercial activities before submitting a TSCA section 5(a)
notice. For any manufacturer or importer who has not previously
submitted a premanufacture notice or significant new use notice for
this microorganism, the significant new use is any use.
(ii) Commercial activities after submitting a TSCA section 5(a)
notice. For any manufacturer or importer who has previously submitted a
premanufacture notice or a significant new use notice for this
microorganism, the significant new use is manufacture, import, or
processing greater than a maximum production volume of 500,000 lbs in
any consecutive 12-month period.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Persons who must report. Section 721.5 applies to this section
except for Sec. 721.5(a)(2). A person who intends to manufacture or
import this substance for commercial purposes must have submitted a
premanufacture notice or submit a significant new use notice.
(2) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a) and (i) are applicable to manufacturers and importers
of this substance.
(3) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 98-6100 Filed 3-9-98; 8:45 am]
BILLING CODE 6560-50-F