[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]


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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.

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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: [email protected].

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 [email protected], 
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: opp-
[email protected]. 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).
 
         *        *        *        *        *        *        *
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[FR Doc. 99-26862 Filed 10-14-99; 8:45 am]
BILLING CODE 6560-50-F