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ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
OPP ID: [OPP-2003-0059; FRL-7309-8]
NOTICE: RULES
ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY: Bacillus subtilis var. amyloliquefaciens strain FZB24; Exemption from the Requirement of a Tolerance
DATES: This regulation is effective July 30, 2003. Objections and requests for hearings, identified by docket ID number OPP20030059, must be received on or before September 29, 2003.
DOCUMENT SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus subtilis var.
amyloliquefaciens strain FZB24 on all agricultural commodities when
applied/used in accordance with good agricultural use practices for
plant strengthening, growth enhancement, and plant disease suppression.
Earth BioSciences submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from [[Page 44636]]
the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus subtilis
var. amyloliquefaciens strain FZB24.
SUMMARY: Bacillus subtilis var. amyloliquefaciens (strain FZB24),
SUPPLEMENTAL INFORMATION
I. General InformationA. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to: [sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
[sbull] Antimicrobial pesticides (NAICS 32561)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP20030059. The
official public docket is intended to serve as a repository for
materials (i.e., documents and other information) submitted to the
Agency in connection with this action and/or relied upon by the Agency
in taking this action. Although a part of the official docket, the
public docket does not include Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. The
official public docket is available for public viewing at the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a
beta site currently under development.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ``search,'' then key in the appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of October 22, 2002 (67 FR 32231) (FRL 72757), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(d), as amended by FQPA (Public Law 104170), announcing the filing of a pesticide tolerance petition (PP 2F06453) by Earth BioSciences, 451 Orange St, New Haven, CT 06511. This notice included a summary of the petition prepared by the petitioner Earth BioSciences. There were no comments received in response to the Notice of Filing.
The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus subtilis var. amyloliquefaciens strain FZB24.
Section 408(c)(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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 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 408(b)(2)(C) of the FFDCA 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. . . .'' Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''
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 the 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.
Earth BioSciences, formerly Taensa, Inc., conducted the toxicology
studies required under section 408(d)(2)(A) of the FFDCA to support its
petition for an exemption from the requirement of tolerance for
Bacillus subtilis var. amyloliquefaciens strain FZB24. As illustrated
below, the studies conducted indicate a low mammalian toxicity for
Bacillus subtilis var. amyloliquefaciens strain FZB24. In addition, no
pathogenicity or infectivity was observed in any of the tests conducted
with Bacillus subtilis var. amyloliquefaciens strain FZB24. All toxicology data generated by Earth
[[Page 44637]]
BioSciences have been reviewed by the Biopesticides and Pollution Prevention Division (``BPPD'').
Toxicology data in support of the exemption from the requirement of a tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24 included studies with spores (technical) and with the formulated product (water dispersible powder) as follows:
1. Acute toxicity and/or pathogenicityi. Bacillus subtilis var. amyloliquefaciens strain FZB24 Spores (Technical):
[sbull] Acute oral toxicity/pathogenicity in rats. ``. . . does not
appear to be toxic and/or pathogenic in rats when dosed at 1.3 x
108 cfu.'' BPPD Review of Product Chemistry and Toxicity/
Pathogenicity Data Submitted by Taensa, Inc., for the Registration of
TAE022 and TAE022 WDG, which contains Bacillus subtilis var.
amyloliquefaciens strain FZB24 (Submission No.: S559221; DP Barcode:
254584; Master Record Identification (MRID) No's.: 44758101 through
44758120) (hereinafter referred to as ``BPPD Review December 20, 1999'').
[sbull] Acute dermal toxicity/pathogenicity in rabbits. ``The
severity of irritation persisted 72 hours, and slight irritation
persisted for 10 days, and all resolved by day 11. No deaths observed.
The acute lethal dose (LD
[sbull] Acute pulmonary toxicity/pathogenicity in rats. ``. . .
does not appear to be toxic and/or pathogenic in rats, when dosed at
1.3 x 108 cfu/animal. No total clearance is seen form the
lungs of treated test animals . . . showed a distinct pattern of
clearance from kidney, liver, and spleen.'' (BPPD Review December 20, 1999).
[sbull] Acute intravenous toxicity/pathogenicity in rats. ``. . .
does not appear to be toxic and/or pathogenic in rats, when dosed at
1.7 x 108 cfu/animal.'' (BPPD Review December 20, 1999).
[sbull] Primary eye irritation. ``. . . showed no signs of
persistent irritation into day 21, when dosed at 4.7 x 1010
cfu/right eye/animal.'' (BPPD Review December 20, 1999.) The December
20, 1999 BPPD review indicated Toxicity Category I, but was amended in
a March 7, 2000 review to Toxicity Category II based on a comparison of
test animals showing similar recovery trends and leading to
reversibility within 21 days. Addendum to Toxicity Category for TAE
022, which contains Bacillus subtilis var. amyloliquefaciens Strain
FZB24 (Submission No.: S559221; DP Barcode: 254584; MRID No.: 447581 14).
[sbull] Primary dermal irritation. ``. . . severity of irritations
persisted >72 hours, but resolved by day 11. Dermal irritation = Toxicity II.'' (BPPD Review December 20, 1999).
[sbull] Hypersensitivity testing. ``Based on the submitted data . . . does not appear to be a sensitizer when dosed at 3.6 x
1010 cfu.'' (BPPD Review December 20, 1999).
[sbull] Hypersensitivity incident reporting. ``No recorded or
reported hypersensitivity reaction . . . based on handling MCPA in lab
control setting, equating to 55 person years. . .'' (BPPD Review December 20, 1999).
[sbull] Immune response. ``There is no information to suggest that
Bacillus subtilis var. amyloliquefaciens strain FZB24 has an effect on
the immune system. The submitted toxicity/pathogenicity studies in
rodents indicated that following several routes of exposure, the immune
system is still intact and able to process and clear the active ingredient.'' (BPPD Review December 20, 1999).
[sbull] Potential health effects. ``Based on information given,
there are no apparent negative effects . . . Cited literature on B.
subtilis indicate and/or support the development as a biological control. . .'' (BPPD Review December 20, 1999).
[sbull] Growth parameters. ``. . . is shown to grow at all tested
temperatures (e.g., 30, 34, 37, and 50 [deg]C). The enumeration shows a
low 4.2 x 1011 cfu/g at 37 [deg]C to a high 6.0 x
1011 cfu/g at 34 [deg]C.'' (BPPD Review December 20, 1999).
ii. Bacillus subtilis var. amyloliquefaciens strain FZB24 WDG (Formulation):
[sbull] Acute oral LD
[sbull] Acute dermal LD
[sbull] Primary eye irritation. ``No corneal opacity, and no signs
of irritation by day 7, when dosed . . . at 3.6 x 1010 cfu/
right eye/animal. . . . Toxicity Category III.'' (BPPD Review December 20, 1999).
[sbull] Hypersensitivity. ``Not a sensitizer when dosed at 3.6 x
1010 cfu. No hypersensitivity incidents have been reported.'' (BPPD Review December 20, 1999).
Based on the data generated in accordance with the Tier I data requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III data requirements were not triggered and, therefore, not required in connection with this action.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational 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).
A. Dietary Exposure
Bacillus subtilis var. amyloliquefaciens strain FZB24 is a naturallyoccurring microorganism and widespread in the environment. The low toxicity and nonpathogenicity/infectivity of Bacillus subtilis var. amyloliquefaciens strain FZB24 is demonstrated by the data summarized in this action. The enduse (formulated) product will be applied to all agricultural commodities as a seed treatment and via incorporation, drenching, spraying, dipping, chemigation and hydroponics.
1. Food. While the proposed use pattern may result in dietary exposure with possible residues on all agricultural commodities, negligible risk is expected for the general population, as well as for infants and children. Submitted acute toxicology tests (MRID Numbers 44758108, 44758109, 44758110, 44758111, 44758112, 44758113, 44758114, 44758116, and 45672502) demonstrate that based upon the use sites, use patterns, application method, use rates, low exposure, and minimal risk of toxicity, the potential risks from dietary exposure for both the general population and infants and children are considered low.
2. Drinking water exposure. Although Bacillus subtilis var.
amyloliquefaciens strain FZB24 spores may be found naturally in water,
it is not known as an aquatic bacterium, and therefore is not expected to proliferate in aquatic
[[Page 44638]]
habitats. (Earth BioSciences petition from the requirement of a
tolerance for Bacillus subtilis var.amyloliquefaciens strain FZB24,
dated May 3, 2002.) In addition, the potential for transfer of Bacillus
subtilis var. amyloliquefaciens strain FZB24 to surface or ground water
during runoff associated with intended use applications is considered
minimal to nonexistent, due in part to its percolation through and
resulting capture in soil. Most importantly, though, the risk from
consumption of drinking water containing Bacillus subtilis var.
amyloliquefaciens strain FZB24 is considered minimal as there is no
evidence of adverse effects from oral, dermal, or inhalation exposure
to this microbial agent. (See Unit III.) Accordingly, it is not considered to be a risk to drinking water.
B. Other NonOccupational Exposure
Based on the proposed use patterns, the potential of nondietary exposures to Bacillus subtilis var. amyloliquefaciens strain FZB24 pesticide residues for the general population, including infants and children, is unlikely. Accordingly, the Agency believes that the potential aggregate nonoccupational exposure, derived from dermal and inhalation exposure through the application of Bacillus subtilis var. amyloliquefaciens strain FZB24, should fall well below the currently tested microbial safety levels. (MRID Numbers 44758110, 44758111, 44758112, and 45672502).
1. Dermal exposure. Dermal exposure via the skin is a potential
route of exposure resulting from applications of Bacillus subtilis var.
amyloliquefaciens strain FZB24. Unbroken skin is a natural barrier to
microbial invasion of the human body. Dermal absorption could occur
only if the skin were cut, if the microbe were a pathogen equipped with
mechanisms for entry through or infection of the skin, or if
metabolites were produced that could be dermally absorbed. Acute dermal
toxicity/pathogenicity data resulted in irritation that persisted 72
hours, and slight irritation persisted for 10 days, and all resolved by day 11. No deaths were observed. The acute lethal dose
(LD
2. Inhalation exposure. Inhalation would be an additional potential route of exposure resulting from applications of Bacillus subtilis var. amyloliquefaciens strain FZB24. However, because the pulmonary study showed no adverse effects (MRID Numbers 44758112 and 45672502) the risks anticipated for this route of exposure are considered minimal. V. Cumulative Effects
The Agency has considered available information on the cumulative
effects of such residues and other substances that have a common
mechanism of toxicity. These considerations included the cumulative
effects on infants and children of such residues and other substances
with a common mechanism of toxicity. Because there is no indication of
mammalian toxicity to Bacillus subtilis var. amyloliquefaciens strain
FZB24, the Agency is confident that there will not be cumulative
effects from the residues of this product on all agricultural commodities. (See Unit III.)
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. Bacillus subtilis var. amyloliquefaciens strain FZB24 is a naturally occurring microorganism and Bacillus subtilis var. amyloliquefaciens is widespread in the environment. Based on the very low levels of mammalian toxicity associated with Bacillus subtilis var. amyloliquefaciens strain FZB24, which is demonstrated by the data summarized above, and the history of safe use of B. subtilis, the Agency has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to residues of Bacillus subtilis var. amyloliquefaciens strain FZB24 to the U.S. population. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Accordingly, exempting Bacillus subtilis var. amyloliquefaciens strain FZB24 from the requirement of a tolerance should be considered safe and pose no significant risk.
2. Infants and children. FFDCA section 408(b)(2)(C) provides that
EPA shall apply an additional tenfold margin of exposure (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
on toxicity and exposure unless EPA determines that a different margin
of exposure (safety) will be safe for infants and children. Margins of
exposure (safety) are incorporated into EPA risk assessments either
directly through the use of a margin of exposure analysis or by using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. Here, EPA concludes that the toxicity and
exposure data are sufficiently complete to adequately address the
potential for additional sensitivity of infants and children to
residues of Bacillus subtilis var. amyloliquefaciens strain FZB24 and
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to Bacillus subtilis var.
amyloliquefaciens strain FZB24 residues. Also, for food use of
microbial pesticides, the acute toxicity/pathogenicity studies have
allowed for the conclusion that an exemption from the requirement of a
tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24 is
appropriate and adequate to protect human health, including that of infants and children.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) ``may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the screening program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, Bacillus subtilis var. amyloliquefaciens strain FZB24 may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.
Based on available data, no endocrine systemrelated effects have
been identified with consumption of Bacillus subtilis var.
amyloliquefaciens strain FZB24. It is a naturally occurring bacteria
that is widespread in the environment. To date, there is no evidence to
suggest that Bacillus subtilis var. amyloliquefaciens strain FZB24 [[Page 44639]]
affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.
B. Analytical Method
The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including Bacillus subtilis var. amyloliquefaciens strain FZB24's lack of mammalian toxicity. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purpose for Bacillus subtilis var. amyloliquefaciens strain FZB24. C. Codex Maximum Residue Level
There are no Codex maximum residue levels established for residues of Bacillus subtilis var. amyloliquefaciens strain FZB24.
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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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 written objections and hearing requests with the Hearing Clerk 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 ID number OPP20030059 in the subject line on the first page of your submission. All objections and hearing requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 29, 2003.
1. Filing the request. Your objections 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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 204600001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall
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) 3055697, by email 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, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001.
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, 1200 Pennsylvania Ave., NW., Washington, DC 204600001.
3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., 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.1. Mail your copies, identified by docket ID number OPP20030059, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via email to: oppdocket@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 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. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement for Bacillus subtilis var. amyloliquefaciens strain FZB24
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).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May
[[Page 44640]]
22, 2001). This final 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) (Public Law 1044). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
LowIncome Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). 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
104113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of the FFDCA, such as the exemption from the tolerance
requirement 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. In addition, 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 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the 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.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
X. Congressional Review Act
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 final rule in the Federal Register. This final 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: June 20, 2003.
James Jones,
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. Section 180.1243 is added to subpart D to read as follows:
Sec. 180.1243 Bacillus subtilis var. amyloliquefaciens strain FZB24; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance for residues of
the Bacillus subtilis var. amyloliquefaciens strain FZB24 in or on all
agricultural commodities when applied/used in accordance with label directions.
[FR Doc. 0319134 Filed 72903; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Robyn Rose, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089581; email address: rose.robyn@epa.gov.
Common CFR Searches
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 47 CFR Part 73 26 CFR Part 1 40 CFR Part 180 33 CFR Part 117 50 CFR Part 17 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 44 CFR Part 65 50 CFR Part 660 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 6 CFR Part 5 40 CFR Part 271 47 CFR Part 64 40 CFR Parts 52 and 81 50 CFR Part 665 44 CFR Part 64 10 CFR Part 50 49 CFR Part 571 47 CFR Part 76