[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Rules and Regulations]
[Pages 29646-29648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14439]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50630A; FRL-5789-5]
RIN 2070-AB27
Sinorhizobium meliloti strain RMBPC-2; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing a significant new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control Act (TSCA) for the
microorganism described as Sinorhizobium meliloti strain RMBPC-2 which
is the subject of premanufacture notice (PMN) P-92-403. This rule will
require 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: This rule is effective July 1, 1998.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-531, 401
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-Hotline@epamail.epa.gov.
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 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 microorganisms as stated in the
Federal Register of April 11, 1997 (62 FR 17910) (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
TSCA section 5(b) and (d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the
[[Page 29647]]
regulations at 40 CFR part 720. Once EPA receives a SNUR notice, EPA
may take regulatory action under TSCA 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 published a proposed SNUR for the microorganism described as
Sinorhizobium meliloti strain RMBPC-2, which is the subject of
premanufacture notice (PMN) P-92-403, in the Federal Register of March
10, 1998 (63 FR 11643) (FRL-5765-6). The background and reasons for the
SNUR are set forth in the preamble to the proposed rule. EPA proposed
the significant new use 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 pounds
(lbs) in any consecutive 12-month period.
The Agency received no public comment concerning the proposed rule.
As a result EPA is issuing the final rule as proposed.
IV. Objectives and Rationale of the 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 microorganism 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 the 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 final
rule (OPPTS-50630A).
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-50630A (including comments and data submitted
electronically). In addition, extensive information for this
microorganism can also be found in OPPTS docket number 51786, which
contains materials concerning the TSCA section 5(a) review of PMN P-92-
403. A public version of this record, including printed, paper versions
of electronic comments, which does not include any information claimed
as Confidential Business Information (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.
VIII. Regulatory Assessment Requirements
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993),
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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 (UMRA)
(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. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a major rule as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 20, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues 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. 98-14439 Filed 5-29-98; 8:45 am]
BILLING CODE 6560-50-F
