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Bacillus mycoides isolate J; Temporary Exemption from the Requirement of a Tolerance

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[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Rules and Regulations]
[Page 34263-34267]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn06-14]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0303; FRL-8072-3]
 
Bacillus mycoides isolate J; Temporary Exemption from the 
Requirement of a Tolerance

AGENCY:  Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the microbial pesticide 
Bacillus mycoides isolate J on sugar beets when applied/used to control 
Cercospora Leaf Spot (Cercospora beticola) in sugar beets. Montana 
Microbial Products 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 the temporary exemption from 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Bacillus mycoides isolate J. The 
temporary tolerance exemption will expire on December 31, 2007.

DATES: This regulation is effective June 14, 2006. Objections and 
requests for hearings must be received on or before August 14, 2006, 
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-2005-0303. All documents in the 
docket are listed in the index for the docket. 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, Exit Disclaimer or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

[[Page 34264]]

FOR FURTHER INFORMATION CONTACT: Anne Ball, Biopesticides and Pollution 
Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 204607-0001; telephone number: (703) 308-8717; e-mail 
address: ball.anne@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,
Exit Disclaimer 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 pilot e-CFR site at 
http://www.gpoaccess.gov/ecfr. Exit Disclaimer To access the OPPTS Harmonized 
Guidelines referenced in this document, go to the guidelines at 
http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    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. 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-2005-0303 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 August 14, 2006.
    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-2005-0303, by one of the following methods.
    ? Federal eRulemaking Portal: http://www.regulations.gov. Exit Disclaimer 
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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 18, 2006 (71 FR 2932-2933) (FRL-
7755-9), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 5G6983) by Montana Microbial Products, 510 East 
Kent Avenue, Missoula MT 59801. The petition requested that 40 CFR part 
180 be amended by establishing a temporary exemption from the 
requirement of a tolerance for residues of Bacillus mycoides isolate J. 
This notice included a summary of the petition prepared by the 
petitioner Montana Microbial Products. One comment was received in 
response to the notice of filing. The commenter objected to an 
exemption from the requirement of a tolerance. This commenter 
apparently misunderstood the nature of the product which does not 
contain a gene-altered substance. EPA concludes that Bacillus mycoides 
isolate J is ubiquitous in nature and for purposes of this temporary 
tolerance exemption, EPA has determined that it will be safe when used 
in agriculture.
    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. Pursuant to section 408(c)(2)(B), 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), 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 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.

[[Page 34265]]

    An Acute Pulmonary Toxicity/Pathogenicity study (OPPTS 885.3150) in 
rats which were dosed intratracheally with Bacillus mycoides isolate J 
at 1.1 x 108 cfu/animal, was reviewed and found to be 
supplemental because a clear pattern of clearance from all organs was 
not demonstrated during the study's 35-day length. The test substance, 
however, did show a pattern of clearance in some organs. Differential 
heat treatment of tissue samples had suggested that most of the 
recovered organisms were spores. No treated animals died nor were there 
signs in the animals of toxicity or pathogenicity. Given the ubiquitous 
nature of this spore forming bacterium which is found on plants, in 
soil, water, air and decomposing plant tissue, along with the lack of 
mortality of the test animals and the absence of overt signs of 
toxicity or pathogenicity in the animals during the course of this 
pulmonary study, issuance of the Experimental Use Permit (EUP) can be 
justified provided there are instructions for appropriate respiratory 
protection for the applicators specified on the product label.
    The Agency has granted the requests for waivers for the studies 
Primary Eye Irritation ( OPPTS 870.2400) and Primary Dermal Irritation 
(OPPTS 870.2500). The registrant had provided the following rationales 
for the requests with which the EPA agrees:
    1. The inert ingredient in the Bacillus mycoides isolate J end 
product is on the EPA inert list 4A as safe for food use. The 
combination of Bacillus mycoides isolate J spores with this inert would 
not be expected to exacerbate primary ocular and dermal irritation or 
infection.
    2. Personnel who worked with Bacillus mycoides isolate J for 2 to 7 
years showed no eye or dermal exposure effects.
    3. Eye or dermal exposure to Bacillus mycoides isolate J will be 
limited by supervision and protective equipment. If eye or dermal 
exposure did, however, occur, the spores will rinse out of the eye with 
water or wash off the skin with soap and water because spores are 
hydrophilic.
    4. Bacillus mycoides isolate J is not recorded as a human pathogen. 
Due to the ubiquitous presence of Bacillus mycoides isolate J in 
agricultural soils, there has been long term human exposure to Bacillus 
mycoides isolate J in crops and to residual Bacillus mycoides isolate J 
cells or spores in food crops. No toxicity or pathogenicity of Bacillus 
mycoides isolate J in humans had been reported in numerous searched 
citations.
    In connection with the requirement for reporting Hypersensitivity 
Incidents (OPPTS 885.3400), the Registrant has notified the Agency that 
no recorded or reported adverse hypersensitivity reaction to Bacillus 
mycoides isolate J has occurred during the period of 2 years in which 
the substance has been handled in a laboratory setting.
    As stated above, a pattern of complete clearance from all organs 
had not been demonstrated for the acute pulmonary toxicity/
pathogenicity study (OPPTS 885.3150).The requests for waivers on the 
following studies are contingent on demonstrating a pattern of 
clearance of the test organism in the acute pulmonary toxicity/
pathogenicity study, and thus the requests for waivers were not granted.
    ? Acute Oral Toxicity/Pathogenicity (OPPTS 885.3050)
    ? Acute Dermal Toxicity/Pathogenicity (OPPTS 885.3100)
    ? Acute Injection Toxicity/Pathogenicity (OPPTS 885.3200)
    ? Immune Response (OPPTS 885.3550)
    However, as previously stated in this document, the test substance 
for the acute pulmonary toxicity/pathogenicity did show a pattern of 
clearance in some organs. There was no mortality of the test animals, 
nor were there signs in the animals of toxicity or pathogenicity caused 
by this ubiquitous spore-forming bacterium. The issuance of the 
Experimental Use Permit (EUP) can be justified provided there are 
instructions for appropriate respiratory protection for the applicators 
specified on the product label. The basis for this conclusion rests not 
only on the ubiquitous nature of Bacillus mycoides isolate J, the 
absence of mortality, and of overt adverse reactions in the test 
animals, but also on the absence of reported or cited incidents of 
pathogenicity or toxicity in the course of an extensive literature 
search. Therefore, issuance of the Experimental Use Permit (EUP) can be 
justified without the requirement for studies based on OPPTS 885.3050, 
885.3100, 885.3200 and 885.3550, provided there are instructions for 
appropriate respiratory protection for the applicators specified on the 
product label.

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 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

    The proposed EUP is not expected to result in increased dietary 
exposures of Bacillus mycoides isolate J to the general population. The 
quantity of Bacillus mycoides isolate J applied to the beet foliage, 
7.5 x 1011 spores/acre per application, is small compared to 
the natural background levels of Bacillus mycoides isolate J in 
agricultural soils which is reported to typically occur at about 
105 spores per gram. Also, the titer of Bacillus mycoides 
isolate J applied to the foliage declines from 106 spores/
cm2 to between 100 and 1,000 spores/cm2 over a 2-
week period. Because the ordinary consumer encounters only the sugar 
produced from sugar beets, (in which the bacterium is not present), an 
increased dietary exposure is not foreseen.
    There is, in addition, minimal to negligible risk that surface 
water and, thus, drinking water exposure would occur with the proposed 
EUP testing. The proposed test sites are at least one-half mile from 
the nearest surface water. When spray drift or accidental application 
of Bacillus mycoides isolate J over surface water did occur, the 
concentration of Bacillus mycoides isolate J spores in the water had 
been found to be very low. For example an acre dose of Bacillus 
mycoides isolate J, 7.5 x 1011 spores to 100 square meters 
of surface water 1 meter deep, would result in a concentration of 750 
spores per cc of water as noted in the EPA ecological risk assessment 
for Bacillus mycoides isolate J which is based on data submitted by the 
Montana Microbial Products.

B. Other Non-Occupational Exposure

    EPA concludes that dermal or inhalation exposure to the general 
population as a result of this EUP is not likely to occur, based on 
information submitted in pesticide tolerance petition 5G6983 indicating 
that the relevant EUP agricultural sites, which are located in the Red 
River Valley of North Dakota and Minnesota and in eastern Montana, and 
which will not exceed 956 acres, are not accessible to individuals 
other than those conducting this EUP program.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA 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

[[Page 34266]]

common method of toxicity. Because there is no indication of mammalian 
toxicity or pathogenicity resulting from Bacillus mycoides isolate J, 
we conclude that there are no cumulative effects for this bacterium.

VI. Determination of Safety for U.S Population, Infants and Children

    1. U. S. population. The Agency has determined that there is 
reasonable certainty that no harm will result to the U. S. population 
from exposure to residues of Bacillus mycoides isolate J in connection 
with the testing for the proposed EUP program. This determination 
includes all anticipated dietary exposures and other non-occupational 
exposures for which there is reliable information. Oral ingestion of 
the organism is unlikely because consumers will purchase only the sugar 
produced from the sugar beets. This product is not anticipated to 
contain any spores or cells derived from the treatment of the foliage 
of the sugar beets. Data submitted in a pulmonary toxicity/
pathogenicity study revealed no signs of overt toxicity or 
pathogenicity in the test animals. The results of an extensive 
literature search, which included numerous citations of the test 
organism, yielded no reports of its pathogenicity for mammals. There 
will be no access to persons other than participants in the program to 
the test sites for the EUP. The participants in the EUP program are 
required to wear appropriate respiratory protection.
    2. Infants and children. FFDCA section 408(b)(2)(C) 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, also referred to as 
margins of exposure (MOEs), 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 determines that a 
different MOE will be safe for infants and children.
    In this instance, based on all available information, the Agency 
concludes that there is a finding of no toxicity for Bacillus mycoides 
isolate J. Thus there are no threshhold effects of concern to infants 
and children when the microbial is used as a fungicide. Accordingly, 
the Agency concludes that the additional MOE is not necessary to 
protect infants and children, and that not adding any additional MOE 
will be safe for infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient, Bacillus mycoides isolate J is 
not known to exert an influence on the endocrine system.

B. Analytical Method(s)

    Analytic methods for Bacillus mycoides isolate J that are 
sufficient to justify the issuance of an Experimental Use Permit (EUP) 
have been submitted to the Agency.

C. Codex Maximum Residue Level

    No codex maximum residue levels exist for the microbial Bacillus 
mycoides isolate J.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a temporary 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). 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 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 104-4). 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); 
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 104-113, 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 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 (59 FR 22951, 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

[[Page 34267]]

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.

IX. 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 6, 2006.
James Jones,
Director, Office of Pesticide Programs.

? Therefore, 40 CFR chapter I is amended as follows:

PART180--[AMENDED]

? 1. The authority citation for part 180 continues to read as follows:

    Authority : 21 U.S.C. 321(q), 346a and 371.

? 2. Section 180.1269 is added to subpart D to read as follows:

Sec.  180.1269  Bacillus mycoides Isolate J on sugar beets: exemption 
from the requirement of a tolerance.

    Bacillus mycoides isolate J is temporarily exempt from the 
requirement of a tolerance when used as a fungicide for control of 
Cercospora Leaf Spot (Cercospora beticola) on sugar beets. This 
temporary exemption from the requirement of a tolerance expires and is 
revoked on December 31, 2007.

[FR Doc. E6-9282 Filed 6-13-06; 8:45 am]
BILLING CODE 6560-50-S

 
 

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