
[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
