[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-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 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),

[[Page 29648]]

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