[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Proposed Rules]
[Pages 27223-27226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12589]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300838; FRL-6074-3]
RIN 2070-AC18


Rhizobium inoculants; Proposed Exemption from the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish an exemption from the requirement of 
tolerances for residues of Rhizobium inoculants (pure strains of 
Rhizobium spp. bacteria eg. Sinorhizobium, Bradyrhizobium & Rhizobium) 
when used as inert ingredients in pesticide formulations applied to all 
leguminous food commodities. This would not include strains expressing 
rhizobitoxine or strains deliberately altered to expand the range of 
antibiotic resistance. EPA is proposing this regulation on its own 
initiative.
DATES: Written comments should be submitted to EPA on or before July 
19, 1999.

ADDRESSES: By mail, submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit VIII of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by

[[Page 27224]]

EPA without prior notice. The public docket is available for public 
inspection in Rm. 119 at the Virginia address given above, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Edward Allen, Biological 
Pesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number and e-mail: 9th 
Floor, Crystal Mall #2, 1921, Jefferson Davis Hwy., Arlington, VA, 
(703) 308-8699; e-mail:[email protected].

SUPPLEMENTARY INFORMATION: EPA proposes that an exemption from the 
requirement of a tolerance be established for residues of Rhizobium 
inoculants when used as inert ingredients in pesticide formulations 
applied to all leguminous food commodities. EPA is proposing this 
regulation on its own initiative.

I. Electronic Availability

    Electronic copies of this document and other available support 
documents may be obtained on the Internet from the EPA Home Page at the 
``Federal Register--Environmental Documents'' entry for this document 
(http://www.epa.gov/fedrgstr/EPA-PEST/
1999/).

II. Background and Statutory Authority

    New section 408(c)(2)(A)(i) allows EPA to establish an exemption 
from the requirement of a tolerance for a pesticide chemical residue on 
food only if EPA determines that the exemption is ``safe''. 
Section408(c)(2)(A)(ii) defines ``safe'' to mean that `` there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water, but does 
not include occupational exposure. Section 408(c)(2)(B) requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue'' and specifies 
factors EPA is to consider in establishing an exemption.

 III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and 
fattyacids; carriers such as clay and diatomaceous earth; thickeners 
such as carrageenan and modified cellulose; wetting, spreading, and 
dispersing agents; propellants in aerosol dispensers; 
microencapsulating agents; and emulsifiers. The term ``inert'' is not 
intended to imply nontoxicity or lack of chemical activity. Generally, 
EPA has exempted inert ingredients from the requirement of a tolerance 
based on the low toxicity of the individual inert ingredients.

 IV. Risk Assessment and Statutory Findings

     EPA establishes exemptions from the requirement of a tolerance 
only in those cases where it can be clearly demonstrated that the risks 
from aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, EPA considers the toxicity of the inert 
ingredient in conjunction with possible exposure to residues of the 
inert ingredient in food, drinking water, and other non-occupational 
exposures. If EPA is able to determine that a finite tolerance is not 
necessary to ensure that there is a reasonable certainty that no harm 
will result from aggregate exposure to the inert ingredient, an 
exemption from the requirement of a tolerance may be established.

V. Aggregate Risk Assessment and Determination of Safety

     Consistent with section 408(c)(2)(B) of FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of the proposed action. EPA has sufficient data to assess the hazards 
of Rhizobium inoculants in or on all leguminous food commodities. EPA's 
assessment of the dietary exposures and risks associated with 
establishing these tolerances are as follows:
     The data available in the public literature, EPA's Biotechnology 
Science Advisory Committee's reports on genetically engineered 
Rhizobium species and other relevant material have been evaluated. As 
part of the EPA policy statement on inert ingredients published in the 
Federal Register of April 22, 1987 (52 FR 13305), EPA set forth a list 
of studies which would generally be used to evaluate the risks posed by 
the presence of an inert ingredient in a pesticide formulation. 
However, where it can be determined that the inert ingredient will 
present minimal or no risk, EPA generally does not require some or all 
of the listed studies to rule on the proposed tolerance or exemption 
from the requirement of a tolerance for an inert ingredient.

A. Toxicological Profile

     The inoculants that are the subject of this exemption are pure 
stains of bacteria in the genera Rhizobium, Sinorhizobium or 
Bradyrhizobium (hereafter referred to as Rhizobium). Rhizobium species 
are found naturally in soil and are agriculturally important as they 
form a symbiosis with the roots of leguminous plants such as green 
beans, alfalfa and soybeans. This symbiosis is a controlled bacterial 
infection of the root cortical cells and results in root nodules 
formation. These root nodules biologically fix atmospheric nitrogen 
into a form readily useable by plants.
     There are no reports in the literature of these Rhizobium bacteria 
causing disease or injury to man or other animals (USEPA/OPPT ``Risk 
Assessment, Commercialization Request for P-92-403, Sinorhizobium 
(Rhizobium) meliloti RMBPC-2'', May 1997). There are reports of 
Rhizobium bacteria producing a toxin (rhizobitoxine) that can affect 
the growth of legume plants nodulated with these strains. It is 
unlikely that any Rhizobium inoculants that are the subject of this 
exemption would be developed which express rhizobitoxine due to the 
adverse effects they have on the host plant. However, EPA feels it is 
appropriate to exclude Rhizobium strains intentionally developed to 
express rhizobitoxine from this inert clearance because of possible 
additional human exposure to rhizobitoxine.
     EPA believes that any intentional alteration in the range of 
antibiotic resistance of Rhizobium species should be considered for its 
impact on the proliferation of antibiotic resistance traits in 
clinically important pathogenic bacteria. It is common knowledge that 
all bacteria, including these Rhizobium species, have inherent 
resistance to certain antibiotics. It is also known that bacteria, 
especially clinical strains, have developed or acquired antibiotic 
resistance due to widespread use of antibioitcs. The exclusion of 
Rhizobium strains with altered antibiotic resistance from this 
tolerance exemption discourages the use of antibiotic

[[Page 27225]]

resistance genes, especially those genes with resistance to clincally 
important antibiotics. EPA therefore proposes to exclude any Rhizobium 
species with an intentionally expanded range of antibiotic resistance 
traits from this exemption.

B. Exposures and Risks

     1. From food and feed uses, drinking water, and non-dietary 
exposures. For the purposes of assessing the potential dietary exposure 
under this exemption, EPA considered that under this exemption 
Rhizobium inoculants could be present in all raw and processed 
agricultural commodities and drinking water and that non-occupational, 
non-dietary exposure was possible. The intended use pattern as a seed 
or soil inoculant lessens the likelihood of contact with humans other 
than occupational exposure. The likelihood that a soil bacterium such 
as Rhizobium will enter drinking water in significant numbers is remote 
considering the natural filtration of the soil profile as water 
percolates to the water table and the fact that many water supplies are 
treated prior to distribution in municipal systems (USEPA/OPPT, 
Exposure Assessment for Commercialization of a Recombinant Strain of 
Rhizobium meliloti, RMBPC-2, December, 1994). Even if exposure 
occurred, the lack of reports of disease in man or animals indicates 
there is no risk for these exposures. Therefore, EPA concluded that, 
based on this inoculant's use, there are no concerns for risks 
associated with any potential exposure scenarios that are reasonably 
foreseeable.
     2. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance or 
tolerance exemption, the Agency consider ``available information'' 
concerning the cumulative effects of a particular chemical's residues 
and ``other substances that have a common mechanism of toxicity.'' In 
the case of the Rhizobium inoculants, as limited, there is lack of 
toxicity to humans and other animal species as well as no information 
in the literature indicating a cumulative effect with any other 
compound. Therefore, a cumulative risk assessment is not necessary.

C. Aggregate Risks and Determination of Safety for U.S. Population

     Based on this bacteria's toxicological profile, and its 
established use in common agricultural practices, EPA concludes that 
there is a reasonable certainty that no harm to the U.S. population 
will result from aggregate exposure to Rhizobium inoculants. EPA 
believes theses bacteria present no dietary risk under any reasonably 
foreseeable circumstances.

D. Aggregate Risks and Determination of Safety for Infants and Children

     FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre- and postnatal toxicity and the 
completeness of the data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through the use of margin of exposure analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans.
     Due to the low toxicity of these bacteria, EPA has not used a 
safety factor analysis in assessing a risk. For the same reasons the 
additional safety factor is unnecessary.

VI. Other Considerations

     EPA proposes to establish an exemption from the requirement of a 
tolerance without any numerical limitation; therefore, EPA has 
concluded that analytical methods are not required for enforcement 
purposes Rhizobium innoculants. There are no Codex tolerances or 
international tolerance exemptions for Rhizobium innoculants.

VII. Conclusion

    Based on the information and data considered, EPA proposes that an 
exemption from the requirement of a tolerance be established as set 
forth in this document.

VIII. 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 [OPP-300838] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official rulemaking record is located at the Virginia 
address in ``ADDRESSES'' at the beginning of this document.
    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. Comment 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 [OPP-300838]. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This action proposes to establish an exemption from the tolerance 
requirement under FFDCA section 408(e). The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). In addition, this proposed rule does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 
104-4). Nor does it require any special considerations 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).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), the Agency previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides

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the funds necessary to pay the direct compliance costs incurred by 
those governments. If the mandate is unfunded, EPA must provide to OMB 
a description of the extent of EPA's prior consultation with 
representatives of affected State, local, and tribal governments, the 
nature of their concerns, copies of any written communications from the 
governments, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 12875 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of State, local, and tribal governments ``to provide 
meaningful and timely input in the development of regulatory proposals 
containing significant unfunded mandates.''
    Today's proposed rule does not create an unfunded Federal mandate 
on State, local, or tribal governments. The proposed rule does not 
impose any enforceable duties on these entities. Accordingly, the 
requirements of section 1(a) of Executive Order 12875 do not apply to 
this proposed rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the proposed rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural Commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 11, 1999.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 is revised to read as 
follows:
    Authority: 21 U.S.C. 321q, 346a and 371.

    2. In Sec. 180.1001 the tables in paragraphs (c) and (e) are 
amended by adding alphabetically the following inert ingredient:


Sec. 180.1001  Rhizobium inoculants (eg. Sinorhizobium, Bradyrhizobium 
& Rhizobium); Exemption from the requirements of a tolerance.

*    *    *    *    *
    (c) *  *   *

------------------------------------------------------------------------
          Inert ingredient              Limit              Uses
------------------------------------------------------------------------
 
         *        *        *        *        *        *        *
Rhizobium inoculants (eg.                         All leguminous food
 Sinorhizobium, Bradyrhizobium &                   commodities
 Rhizobium).
         *        *        *        *        *        *        *
------------------------------------------------------------------------

*    *    *    *    *
    (e) *  *   *

------------------------------------------------------------------------
          Inert ingredient              Limit              Uses
------------------------------------------------------------------------
 
         *        *        *        *        *        *        *
Rhizobium inoculants (eg.                         All leguminous food
 Sinorhizobium, Bradyrhizobium &                   commodities
 Rhizobium).
         *        *        *        *        *        *        *
------------------------------------------------------------------------


[FR Doc. 99-12589 Filed 5-18-99; 8:45 am]
BILLING CODE 6560-50-F