[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