[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) * * *
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Inert ingredient Limit Uses
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* * * * * * *
Rhizobium inoculants (eg. All leguminous food
Sinorhizobium, Bradyrhizobium & commodities
Rhizobium).
* * * * * * *
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* * * * *
(e) * * *
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Inert ingredient Limit Uses
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* * * * * * *
Rhizobium inoculants (eg. All leguminous food
Sinorhizobium, Bradyrhizobium & commodities
Rhizobium).
* * * * * * *
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[FR Doc. 99-12589 Filed 5-18-99; 8:45 am]
BILLING CODE 6560-50-F