[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Rules and Regulations]
[Pages 55838-55841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26862]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300915; FRL-6380-4]
RIN 2070-AB78
Rhizobium Inoculants; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Rhizobium inoculants (pure strains
of Rhizobium spp. bacteria [e.g. Sinorhizobium, Bradyrhizobium &
Rhizobium]; hereinafter referred to as Rhizobium inoculants) 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 establishing this regulation on its own
initiative. EPA submitted a proposed rule under the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of 1996
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Rhizobium inoculants.
DATES: This regulation is effective October 15, 1999. Objections and
requests for hearings, identified by docket control number OPP-300915,
must be received by EPA on or before December 14, 1999.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VIII. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300915 in
the subject line on the first page of your response.
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 (CM #2), 1921 Jefferson Davis Hwy., Arlington,
VA, (703) 308-8699; e-mail: allen.edward@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300915. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 19, 1999 (64 FR 27223) (FRL-6074-3),
EPA issued a proposed rule pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act (FQPA) (Public Law 104-170). This rule was
proposed by EPA on its on initiative. The rule included a summary of
the petition prepared by EPA. There were no comments received in
response to the proposed rule.
The petition requested that 40 CFR 180.1001(c) be amended by
establishing an exemption from the requirement of a tolerance for
residues of Rhizobium inoculants.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(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 and in residential settings, but does not include
occupational exposure. Section
[[Page 55839]]
408(b)(2)(C) requires EPA to give special consideration to exposure of
infants and children to the pesticide chemical residue in establishing
a 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....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
Rhizobium inoculants are discussed in this unit.
The inoculants that are the subject of this exemption are pure
stains of bacteria in the genera Rhizobium, Sinorhizobium or
Bradyrhizobium. 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 resistance genes,
especially those genes with resistance to clincally important
antibiotics. EPA therefore excludes any Rhizobium species with an
intentionally expanded range of antibiotic resistance traits from this
exemption.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
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.
Dietary Exposure
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.
V. Cumulative Effects
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.
VI. Determination of Safety for U.S. Population, Infants and
Children
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
Rhizobium inoculants residues. Accordingly, EPA finds that exempting
Rhizobium inoculants from the requirement of a tolerance will be safe.
EPA believes these bacteria present no dietary risk under any
reasonably foreseeable circumstances.
[[Page 55840]]
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 prenatal 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.
VII. Other Considerations
A. Endocrine Disruptors
The Agency has no information to suggest that Rhizobium inoculants
will adversely affect the immune or endocrine systems. The Agency is
not requiring information on the endocrine effects of this microbial
pesticide at this time; Congress has allowed 3 years after August 3,
1996, for the Agency to implement a screening program with respect to
endocrine effects.
B. International Tolerances
There are no CODEX tolerances or international tolerance exemptions
for Rhizobium inoculants at this time.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need To Do To File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300915 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before December
14, 1999.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request 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
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A. of
this preamble, you should also send a copy of your request to the PIRIB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300915, 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 or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. of this preamble. You
may also send an electronic copy of your request via e-mail to: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 6.1/8.0 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established, resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IX. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. 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). This final rule does not contain any information collections
subject to OMB approval under the Paperwork
[[Page 55841]]
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) (Public Law 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993) and Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), or special
consideration of environmental justice related issues under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994) or require 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). The Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 12612,
entitled Federalism (52 FR 41685, October 30, 1987). This action does
not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(b)(4). This
action directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to publication of this rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 29, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. In section 180.1001, the table in paragraph (c) is amended by
adding alphabetically the following inert ingredient:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Rhizobium inoculants (e.g. ................ All leguminous
Sinorhizobium, Bradyrhizobium & food commodities
Rhizobium).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 99-26862 Filed 10-14-99; 8:45 am]
BILLING CODE 6560-50-F
