[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Rules and Regulations]
[Pages 41365-41369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16803]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300997; FRL-6555-3]
RIN 2070-AB78


Bacillus subtilis Strain QST 713; 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 Bacillus subtilis strain QST 713 in 
or on all raw agricultural commodities when applied/used according to 
label instructions. AgraQuest, Inc. 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 the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of Bacillus 
subtilis strain QST 713.

DATES: This regulation is effective July 5, 2000. Objections and 
requests for hearings, identified by docket control number [OPP-
300997], must be received by EPA, on or before September 5, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
[OPP-300997] in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Susanne Cerrelli, c/o 
Product Manager (PM) 90, Biopesticides and Pollution Prevention 
Division (7511C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8077; and 
e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 41366]]

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300997. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2 (CM #2), 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 26, 1999 (64 FR 20295) (FRL-6074-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a(e), as amended by FQPA (Public Law 104-170) announcing the filing 
of a pesticide tolerance petition by AgraQuest, Inc., 1530 Drew Ave., 
Davis California 95616. This notice included a summary of the petition 
prepared by the petitioner AgraQuest, Inc. 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 strain QST 713.

III. Risk Assessment

    New 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 tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....'' Additionally, section 408(b)(2)(D) 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.

IV. 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.
    A battery of tests determined that QST 713 Technical product is not 
pathogenic and has no significant toxicity. The acute oral toxicity/
pathogenicity, acute pulmonary toxicity/pathogenicity and acute 
intravenous toxicity/pathogenicity studies demonstrated no significant 
toxicity and a lack of pathogenicity. The dermal toxicity and eye 
irritation studies resulted in a Toxicity Category III classification. 
The acute dermal irritation study resulted in a Toxicity Category IV 
classification. Bacillus subtilis strain QST 713 is a ubiquitous 
organism in the environment and there have been no reports of the 
organism affecting the immune system. The submitted toxicity/
pathogenicity studies in rodents with Bacillus subtilis strain QST 713 
indicated that following several routes of exposure, the immune system 
is still intact and able to process and clear the active ingredient. As 
would be expected for any microbial pesticide, QST 713 did elicit a 
very mild delayed hypersensitivity response and is considered a 
potential dermal sensitizer. Further, although it is not known whether 
strain QST 713 does, the species is known to produce the enzyme 
subtilisin which has been reported to produce allergenic or 
hypersensitivity reactions to individuals repeatedly exposed to the 
enzyme in industrial settings. The use of personal protective equipment 
required for applicators and other handlers mitigates the 
hypersensitivity risk by minimizing exposure. No hypersensitivity risk 
is expected for dietary exposure due to the low likelihood that any 
significant residues will occur on treated food.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to

[[Page 41367]]

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. The 
lack of acute oral toxicity/pathogenicity, and the ubiquitous nature of 
the microbial, support the establishment of an exemption from the 
requirement of a tolerance for Bacillus subtilis strain QST 713.
    1. Food. Dietary exposure to the microbial is expected to be 
minimal. In additon, standard practices of washing, peeling, cooking, 
or processing fruits and vegetables will reduce residues of Bacillus 
subtilis strain QST 713 and further minimize dietary exposure. The risk 
posed to adults, infants, and children is likely to be minimal, because 
of the low acute oral toxicity/pathogenicity potential of the microbial 
pesticide.
    2. Drinking water exposure. Oral exposure, at very low levels, may 
occur from ingestion of drinking water. Drinking water is not being 
screened for Bacillus subtilis strain QST 713 as a potential indicator 
of microbial contamination. Both percolation through soil and municipal 
treatment of drinking water would reduce the possibility of exposure to 
the bacterial active ingredient through drinking water. If oral 
exposure should occur through drinking water, the Agency concludes that 
such exposure would present minimal 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 proposed are for agricultural sites. Dermal and 
inhalation exposure is expected to be limited to those who apply or 
handle the pesticide in orchards and farms. Bacillus subtilis presence 
is ubiquitous in the environment and the use of this product is not 
expected to increase dermal or inhalation exposure in non-occupational 
settings.

VI. Cumulative Effects

    No mechanism of toxicity in mammals has been identified for 
Bacillus subtilis strain QST 713. Therefore no cumulative effect with 
other related organisms is anticipated. Because the data available 
demonstrate a low toxicity/pathogenicity potential of the active 
ingredient, the likelihood of adverse dietary effects is expected to be 
minimal.

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

    Based on the acute toxicity information discussed above, 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 strain QST 713. 
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 strain QST 
713 demonstrate a low toxicity/pathogenicity potential. Bacillus 
subtilis is not a human pathogen and has not been implicated in human 
disease, but has been isolated as a rare contaminant from human 
infections. Risk of increased exposure is likely only to exist for 
pesticide applicators and manufacturers of the product. The Agency has 
imposed appropriate risk mitigation measures to protect the workers via 
the use of protective clothing.

VIII. Other Considerations

A. Endocrine Disruptors

    The Agency has no information to suggest that Bacillus subtilis 
strain QST 713 has an effect on the immune and endocrine systems. No 
specific tests have been conducted with Bacillus subtilis strain QST 
713 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 strain QST 
713 is a ubiquitous organism in the environment and there have been no 
reports of the organism affecting endocrine system. Therefore, it is 
unlikely that this organism would have estrogenic or endocrine effects 
because it is practically non-toxic to mammals.

B. Analytical Method(s)

    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 strain QST 713.

C. Codex Maximum Residue Level

    There are no CODEX values for Bacillus subtilis strain QST 713.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300997 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 September 
5, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400,

[[Page 41368]]

Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the 
Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Office of the 
Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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.2. Mail your 
copies, identified by docket number OPP-300997, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork 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 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require OMB review 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 FFDCA section 408(d), such as the exemption 
in this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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 FFDCA section 408(n)(4).

XI. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this 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, 2000.
Joseph J. Merenda, Jr.,
Acting Deputy Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 41369]]

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 180.1209 is added to subpart D to read as follows:


Sec. 180.1209  Bacillus subtilis strain QST 713; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus subtilis strain QST 713 
when used in or on all food commodities.

[FR Doc. 00-16803 Filed 7-3-00; 8:45 am]
BILLING CODE 6560-50-F