[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Rules and Regulations]
[Page 50553-50556]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au08-4]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-1020; FRL-8378-5]
Bacillus subtilis GB03; 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 microbial pesticide Bacillus
subtilis GB03 in or on all raw agricultural commodities when applied in
accordance with good agricultural practices. Growth Products Ltd.
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 amendment of the existing exemption from the
requirement of a tolerance to cover use in or on all agricultural
commodities and remove the regulatory text specifying ``when applied as
a seed treatment.'' This regulation eliminates the need to establish a
maximum permissible level for residues of Bacillus subtilis GB03 in or
on all raw agricultural commodities.
DATES: This regulation is effective August 27, 2008. Objections and
requests for hearings must be received on or before October 27, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1020. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket identification (ID)
number where indicated and select the ``Submit'' button. Follow the
instructions on the regulations.gov website to view the docket index or
access available documents. All documents in the docket are listed in
the docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
[[Page 50554]]
FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8077; e-mail address: cerrelli.susanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. 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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by 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. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-1020 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 October 27, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-1020, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 2, 2007 (72 FR 62237) (FRL-
8153-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7236) by Growth Products Ltd., P.O. Box 1259, White
Plains, NY 10602. 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 GB03. This notice included
a summary of the petition prepared by the petitioner Growth Products
Ltd. One comment was received in response to this notice expressing
opposition to expanding the number of toxic poisons and expressing
dissatisfaction with the level of safety EPA provides Americans.
Pursuant to its authority under the FFDCA, EPA conducted a
comprehensive assessment of Bacillus subtilis GB03, including a review
of an acute oral toxicity/pathogenicity study in the rat, an acute
dermal toxicity study in the rabbit, an acute pulmonary toxicity/
pathogenicity study in the rat, an acute intravenous toxicity/
pathogenicity study in the rat and a primary eye irritation study in
the rabbit. EPA review of these studies indicated that the active
ingredient was not toxic to test animals when administered via the
oral, dermal, intravenous or pulmonary routes of exposure. The active
ingredient was not infective or pathogenic to test animals when
administered via the oral, pulmonary and intravenous routes. No reports
of hypersensitivity have been recorded from personnel working with this
organism. Based on these data, the Agency has concluded that there is a
reasonable certainty that no harm will result from dietary exposure to
residues of Bacillus subtilis GB03 in or on food and feed. Thus, under
the standard in FFDCA section 408(c)2, an exemption from the
requirement for a tolerance is appropriate.
Section 408(c)(2)(A)(i) of 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 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. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require 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 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
[[Page 50555]]
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.
Toxicological data on the active ingredient has been previously
accepted to support the current exemption from the requirement of a
tolerance for residues (for seed treatment of agricultural commodities)
and various registrations by the manufacturer Bayer CropScience
(formerly Gustafson LLC). Studies on the active ingredient include the
following:
An acceptable acute oral toxicity/pathogenicity study performed on rats
(MRID 41812302) demonstrated the lack of mammalian toxicity at high
levels of exposure to Bacillus subtilis GB03. In this study Bacillus
subtilis GB03 was neither toxic nor infective to rats given an oral
dose of 1.9 x 10\8\ CFU/animal.
An acceptable acute dermal toxicity/pathogenicity study on rabbits
(MRID 41812303) showed no abnormalities in body weight gain during the
study. Desquamation, erythema and edema were observed in the majority
of treated rabbits by day 2, with all signs diminishing by day 15. No
abnormalities were noted in the rabbits at necropsy. Bacillus subtilis
GB03 was not considered toxic when a single 2g (3.6 x 10\9\ CFU)/animal
dose was administered dermally. The dermal toxicity study resulted in a
classification of toxicity category III.
An acceptable acute injection toxicity/pathogenicity study on rats
(MRID 41812305) demonstrated that Bacillus subtilis GB03 was not
infective, pathogenic or toxic for rats when dosed intravenously with
approximately 1.8 x 10\7\ CFU of the test material. Although the
organism was detected in every organ tested, a distinct clearance
pattern was demonstrated. No abnormalities were noted during necropsy.
Based on the submitted data, the test material was not infectious,
pathogenic or toxic to rats.
An acceptable primary eye irritation in rabbits study (MRID 41812306)
demonstrated that Bacillus subtilis GB03 produced a slight to severe
ocular irritation when a single 0.1 g ocular dose was administered.
Ocular irritation dissipated 7 days post dosing. The primary eye
irritation study resulted in a classification of toxicity category III
for this strain of B. subtilis.
An acceptable acute pulmonary toxicity/pathogenicity in rats study
(MRID 41812304) demonstrated that Bacillus subtilis GB03 was neither
toxic, pathogenic nor infective to rats when dosed intratracheally with
approximately 2.84 x 10\8\ CFU of the test material.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA 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).
A. Dietary Exposure
Dietary exposure to the microbial pesticide is likely to occur.
However the lack of acute oral toxicity/pathogenicity and the
ubiquitous nature of the microbe support the establishment of an
exemption from the requirement of a tolerance for Bacillus subtilis
GB03.
1. Food. Dietary exposure to the microbe is expected to be minimal.
The risk posed to adults, infants and children is minimal because of
the low acute oral toxicity/pathogenicity potential of the microbial
pesticide. In addition, standard practices of washing, peeling, cooking
or processing fruits and vegetables reduces residues of Bacillus
subtilis GB03 and further minimizes dietary exposure.
2. Drinking water exposure. Exposure to humans from residues of
Bacillus subtilis GB03 in consumed drinking water would be unlikely.
The proposed and existing use sites of Bacillus subtilis do not include
direct application to aquatic environments. Potential exposure to
surface water would be negligible. The intended use of Bacillus
subtilis GB03 is treatment of growing plants and crops for the purposes
of disease control. The risk of the microorganism passing through the
soil to ground water is minimal to unlikely. Additionally, the bacteria
would not tolerate the conditions water is subjected to in a drinking
water treatment facility (including: chlorination, pH adjustments, and/
or filtration). If oral exposure should occur through drinking water,
the Agency concludes that such exposure would present insignificant
risk due to the lack of acute oral toxicity/pathogenicity and the
ubiquitous nature of the microbe.
B. Other Non-Occupational Exposure
The use sites for these products include residential garden sites,
as well as agricultural sites. Bacillus subtilis is ubiquitous in the
environment. Based on evaluations of the Tier I acute toxicity tests,
the Agency believes that the potential aggregate non-occupational risk
derived from dermal and inhalation exposure through the application of
Bacillus subtilis GB03 is well below the currently tested microbial
safety levels.
V. Cumulative Effects
No mechanism of toxicity in mammals has been identified for
Bacillus subtilis GB03. Therefore, no cumulative effect with other
related organisms is anticipated. Because the available data
demonstrate a low toxicity/pathogenicity potential of the active
ingredient, adverse dietary effects are unlikely.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) as amended by the Food Quality
Protection Act (FQPA) of 1996, provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, FFDCA section 408(b)(2)(C) also 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 database unless EPA determines
that a different margin of safety will be safe for infants and
children.
Based on the acute toxicity information discussed in Unit III, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to the United States population, including
infants and children, to residues of Bacillus subtilis GB03. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because the data available on Bacillus subtilis GB03
demonstrate a low toxicity/pathogenicity potential. Bacillus subtilis
is not a human pathogen and has not been implicated in human disease,
but
[[Page 50556]]
has been isolated as a rare contaminant from human infections. Thus,
there are no threshold effects of concern and, as a result, the
provision requiring an additional margin of safety does not apply.
Further, the considerations of consumption patterns, special
susceptibility, and cumulative effects do not apply to pesticides
without a demonstrated significant adverse effect.
VII. Other Considerations
A. Endocrine Disruptors
The Agency has no information to suggest that Bacillus subtilis
GB03 has an effect on the endocrine system. No specific tests have been
conducted with Bacillus subtilis GB03 to determine such effects.
However, 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.
Bacillus subtilis GB03 is a ubiquitous organism in the environment and
there have been no reports of the organism affecting endocrine systems.
Therefore, it is unlikely that this organism would have estrogenic or
endocrine effects and it is practically non-toxic to mammals.
B. Analytical Method
The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation; therefore, the Agency
has concluded that an analytical method is not required for enforcement
purposes for Bacillus subtilis GB03.
C. Codex Maximum Residue Level
No Codex maximum residue level exists for Bacillus subtilis GB03.
VIII. Conclusions
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to residues of the Bacillus subtilis GB03 in or on all food
and feed commodities. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. The
Agency has arrived at this conclusion because, as discussed above, no
toxicity or pathogenicity to mammals has been observed in test animals.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: August 14, 2008
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1111 is revised to read as follows:
Sec. 180.1111 Bacillus subtilis GB03; exemption from the requirement
of a tolerance.
The biofungicide Bacillus subtilis GB03 is exempted from the
requirement of a tolerance in or on all raw agricultural commodities
when used in accordance with good agricultural practices.
[FR Doc. E8-19860 Filed 8-26-08; 8:45 am]
BILLING CODE 6560-50-S