Carroll Loye Protocols EMD 003 ( Deer ticks)

004 ( Mosquitoes)

Scott Carroll, Ph. D.

Director Carroll Loye Biological Research Davis, CA TITLE: TEST OF PERSONAL INSECT REPELLENTS PROTOCOL NUMBER: C L  001 TABLE OF CONTENTS Protocol ( as required by California EPA) 1 Experimental Subject's Bill of Rights 12 Concise CV of Study Director 13 Protocol Approval Signature 14 EFFICACY TEST PROTOCOL PLEASE NOTE: This protocol is privileged and confidential, and is for the sole use of Dr. Scott Carroll, his agents and associates.

TABLE OF CONTENTS Protocol 1 Protocol Approval Signatures 12 Appendix: Test Material Formulations 13 1 TITLE: TEST OF PERSONAL INSECT REPELLENTS History

US EPA protocol review a courtesy

Cal EPA review mandatory  discursive, " template" protocol required ( 001)

 EPA personnel as co PI  approved annually  approved by UCSF Medical School IRB Present

UCSF bows out

Cal EPA begins by study review

Cal EPA suggests FL based ` IIRB'

SPC divides studies by target pest as US EPA asks for protocols for HSRB

C L 001 is artifact  C L  001: recruitment

Source( s): Participants are recruited by verbal networking through our academic and personal communities of friends, neighbors and scientists in Davis California. Individuals are recruited from the community specifically for each study. Studies are not conducted with individuals from particular employers or agencies. Students in PI's laboratory who depend on him directly for employment or scholastically are not eligible to participate. C L  001: recruitment 2

Initial Contact Method: Initial contact is through word of mouth and telephone contact of individuals in our Volunteer Data Base.

Follow up Contact Method: Telephone interview, personal interview with the Study Director conducted at the Carroll Loye Biological Research Offices. C L  001: safety

18 point explication of practices that promote subject comfort and safety Informed Consent Form

Research Related Injuries

Nature and Purpose

Subject Selection

Study Duration

Study Procedures

Study Design

Screening Visit

Procedures ICF 2

Restrictions

Risk/ Discomforts

Measures will be implemented to remove mosquitoes before they have an opportunity to bite.

Pregnancy risks

Unknown / Unforeseeable Risks ICF 3

You DO NOT waive your legal rights by signing this form.

Right to Withdraw or Removal from the Study

Treatment Alternative

Benefits

Offer to any Questions about this Study

Costs and Reimbursement

Confidentiality Inclusion

9.1.1 Inclusion criteria:

<IP_ADDRESS> Age: At least 18 yrs

<IP_ADDRESS> Sex: Male/ female

<IP_ADDRESS> Race: Any race

<IP_ADDRESS> Written consent ( see 9.4, below) Exclusion 1 9.1.2 Exclusion criteria:

<IP_ADDRESS> Known to be to be hypersensitive to mosquito bites.

<IP_ADDRESS> Known to be to be sensitive to any of the test product ingredients.

<IP_ADDRESS> Poor physical condition.

<IP_ADDRESS> Unwilling to submit to brief query about personal condition.

<IP_ADDRESS> Not able to write, and speak English at approximately the University of California college level. Exclusion 2

<IP_ADDRESS> Unwilling to refrain from use of perfumed products, alcoholic beverages or smoking after 9 PM the evening preceding the test and throughout the test.

<IP_ADDRESS> Known to be pregnant or lactating. Pregnancy will be self checked by each female volunteer on the morning of the repellent test using an OTC test kit provided by the Study Director. Results of each such test will be immediately verified by direct inspection by a female technician trained to make that assessment. Only volunteers scored as nonpregnant will be allowed to participate. Consenting procedures 1

We contact subjects who participated in previous Carroll

Loye repellent efficacy tests by selecting them from our Volunteer Database. At that time interested individuals often ask if one or more of their lab mates or acquaintances can participate as well. All such potential participants are screened or re screened for suitability for each test in a private, one on one conversation held at the office of the Principal Investigator ( PI). The Exclusion Criteria ( section 9.1.2) are exercised by asking each candidate to address them in the interview with the PI. It is explained that pregnancy will be assessed directly in on the test day. The PI encourages candidates to ask questions and ask for clarification at any time during the interview and in all activities that follow. Consenting procedures 2

To candidates that pass screening the PI describes the test purpose in plain language ( in English), and the procedures and comportment to be followed are described in detail. Candidates are then asked if they would like to retire from consideration at that point. If they wish to remain in consideration, it is explained and emphasized that they may withdraw from the test at any time during the test without penalty to their compensation. Candidates are given copies of the State of California Department of Pesticide Regulation ` Experimental Subjects' Bill of Rights' to read as the PI reads it aloud. They are also given a copy of the IRB approved consent form to read as the PI reads it aloud. The amount and form of compensation is described. Consenting procedures 3

They are again encouraged to ask any questions they have about the test, which may include understanding its purpose more fully, understanding risks and discomforts more fully, and understanding treatment and compensation for injury more fully.

While the majority of our subjects have worked with us on an occasional basis for a number of years, we encourage them to personally evaluate their interests and concerns about participation seriously each time. Consenting procedures 4

We ask them not to sign on immediately but to give the situation due consideration ( normally at least one day,

sometimes less for those who have participated in multiple prior studies). Because most of the volunteers are researchers and/ or have advanced degrees in life sciences, we regard their motivations and decisions to participate as being unusually well considered and well informed. Accordingly, we normally accept their decisions to participate if they so choose following due consideration. Nonetheless, the PI retains the final right to refuse participation to any candidate.


[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Notices]
[Pages 14699-14700]
[FR Doc No: 2014-05766]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC14-65-000.
    Applicants: Desert View Power, Inc., Eel River Power LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers, Expedited Action and
Shortened Comment Period of Desert View Power, Inc., et al.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5158.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: EC14-66-000.
    Applicants: Scrubgrass Generating Company, L.P.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of
Scrubgrass Generating Company, L.P.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5082.
    Comments Due: 5 p.m. ET 3/28/14.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-5-003; ER11-6-002; ER13-131-002; ER14-479-001;
ER14-950-001.
    Applicants: Great Bay Energy I LLC, Great Bay Energy IV, LLC, Great
Bay Energy LLC, Great Bay Energy V, LLC, Great Bay Energy VI, LLC,
Great Bay Energy, LLC.
    Description: Notice of Non-Material Change in Status of the Great
Bay Energy Companies.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5160.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: ER14-836-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-03-07--SA 2622 Courtenay & OTP (J262-3) E&P
Compliance Filing to be effective 12/27/2013.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5023.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-846-001.
    Applicants: Northern States Power Company, a Minnesota corporation,
Northern States Power Company, a Wisconsin corporation.
    Description: 20140306-Theoretical Reserve Update to be effective 1/
1/2013.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5153.
    Comments Due: 5 p.m. ET 3/20/14.

    Docket Numbers: ER14-998-001.
    Applicants: Richland-Stryker Generation LLC.
    Description: Amendment to 3 to be effective 3/8/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5146.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1341-001.
    Applicants: Solea Energy, LLC.
    Description: Amended MBR Filing to be effective 3/1/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5123.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1438-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3764; Queue No. Y3-029
to be effective 2/4/2014.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5134.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: ER14-1439-000.
    Applicants: TrailStone Power, LLC.
    Description: TrailStone MBR filing to be effective 3/7/2014.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5147.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: ER14-1440-000.
    Applicants: California Independent System Operator Corporation.
    Description: Petition for Limited Waiver of Tariff Provisions and
Expedited Commission Action to be effective N/A.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5152.
    Comments Due: 5 p.m. ET 3/13/14.

    Docket Numbers: ER14-1441-000.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: PASNY Tariff Amendment to be effective 3/1/2014.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5154.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: ER14-1442-000.
    Applicants: California Independent System Operator Corporation.
    Description: Petition for Tariff Waiver and Next-Day Action to be
effective N/A.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5155.
    Comments Due: 5 p.m. ET 3/11/14.

    Docket Numbers: ER14-1443-000.
    Applicants: Southern California Edison Company.
    Description: Amended SGIA and Distribution Service Agreement With
SCE's GPS to be effective 5/7/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5002.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1444-000.
    Applicants: Southern California Edison Company.
    Description: LGIA with Palmdale Energy, LLC to be effective 3/8/
2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5005.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1445-000.
    Applicants: Dunkirk Power LLC.
    Description: Requests of Dunkirk Power LLC for Limited Tariff
Waiver, Extension Under the Tariff and Commission Action by July 2,
2014.
    Filed Date: 3/6/14.
    Accession Number: 20140306-5161.
    Comments Due: 5 p.m. ET 3/27/14.

    Docket Numbers: ER14-1446-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-03-07--SA 2037 Ameren-Wabash Valley (Citizens)
WDS Agreement to be effective 1/1/2014.

    Filed Date: 3/7/14.
    Accession Number: 20140307-5062.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1447-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2809 Cimarron Wind Energy & Sunflower Meter Agent
Agreement to be effective 3/1/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5087.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1448-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Rev. to Security Agreement as an Exhibit to FAP to be
effective 3/7/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5088.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1449-000.
    Applicants: Arizona Public Service Company.
    Description: Service Agreement No. 330, LGIA With Copper Mountain
Solar 3, LLC to be effective 2/10/2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5104.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1450-000.
    Applicants: Indigo Generation LLC.
    Description: Order No. 784 Compliance Filing to be effective 3/8/
2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5127.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1451-000.
    Applicants: Larkspur Energy LLC.
    Description: Order No. 784 Compliance Filing to be effective 3/8/
2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5128.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1452-000.
    Applicants: Wildflower Energy LP.
    Description: Order No. 784 Compliance Filing to be effective 3/8/
2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5129.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1453-000.
    Applicants: Mariposa Energy, LLC.
    Description: Order No. 784 Compliance Filing to be effective 3/8/
2014.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5132.
    Comments Due: 5 p.m. ET 3/28/14.

    Docket Numbers: ER14-1454-000.
    Applicants: RC Cape May Holdings, LLC.
    Description: Request for Waiver of Must-Offer Requirement of RC
Cape May Holdings, LLC.
    Filed Date: 3/7/14.
    Accession Number: 20140307-5168.
    Comments Due: 5 p.m. ET 3/28/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 7, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-05766 Filed 3-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Page 47380]
[FR Doc No: 2016-17221]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14789-000]

Lock+ Hydro Friends Fund IV, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On June 27, 2016, the Lock+ Hydro Friends Fund IV, LLC filed an
application for a preliminary permit under section 4(f) of the Federal
Power Act proposing to study the feasibility of the proposed
Mississippi River Lock and Dam 26 Project No. 14789-000, to be located
at the existing Mississippi River Lock and Dam No. 26 on the
Mississippi River, near the City of West Alston, in St. Charles County,
Missouri and the City of Alton, in Madison County, Illinois. The
Mississippi River Lock and Dam No. 26 is owned by the United States
government and operated by the U.S. Army Corps of Engineers.
    The proposed project would consist of: (1) A new 750-foot-long by
22-foot-wide by 66-foot-high steel frame modular hydropower system
containing fifty 1.5-megawatt (MW) hydropower turbines for a total
combined generating capacity of 75 MW; (2) a new 550-foot-long by 750-
foot-wide tailrace; (3) a new 50-foot by 100-foot switchyard; (4) a new
5.2-mile-long, 69-kilovolt (kV) or 115 kV transmission line; and (5)
appurtenant facilities. The project would have an estimated annual
generation of 427,050 megawatt-hours.
    Applicant Contact: Mr. Wayne F. Krouse, P.O. Box 43796, Birmingham,
AL 35243; telephone<PHONE_NUMBER>, extension 709.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. The Commission strongly encourages electronic filing.
Please file comments, motions to intervene, notices of intent, and
competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14789-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14789) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: July 15, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-17221 Filed 7-20-16; 8:45 am]
 BILLING CODE 6717-01-P


FILE NAME:  biopetit.wpt   (1/1/2005) (xml)

Number: P4

ATTENTION:

All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

                All text in blue font (instructions for preparing the
document), should be removed prior to sending the document to the
Federal Register Staff.  Instructional text and prompts in green font
should also be removed.

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING TEMPLATE FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL
REGISTER

(1/1/2005)

EPA Biopesticides and Pollution Prevention Division contact: [insert
name and telephone number with area code]

INSTRUCTIONS: Use this template in preparing your notice of filing for
your company’s pesticide petition.  In cases where the outline element
does not apply,  insert “NA-Remove” and maintain the outline.  The
comment balloons appearing in the left margin contain Government
Printing Office (GPO) typesetting codes which expedite the Federal
Register (FR) publication process at EPA for the FR document containing
your company’s pesticide petition. In the template, do not remove or
alter the comment balloons; change the margins, font, or format; or use
the WordPerfect comment function.  Follow the instructions that appear
italicized, color coded, and bracketed.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
TEMPLATE:

Bayer CropScience LP

	EPA has received a pesticide petition [insert petition number] from
Bayer CropScience LP, 2 T.W. Alexander Dr. Research Triangle Park, NC
27709, proposing pursuant to section 408(d) of the Federal  Food, Drug,
and Cosmetic Act (FFDCA),  21 U.S.C. 346a(d), to amend 40 CFR part 180
to establish an exemption from the requirement of a tolerance for the
plant-pesticide Cry2Ae in or on all plants

    The petitioner’s summary of the pesticide petition is printed
below as required by section 408(d) (3) of the Federal Food Drug and
Cosmetic Act.  The summary of the petition was prepared by Bayer
CropScience and represents the view of the petitioner.  The petition
summary announces the availability of a description of the analytical
methods available to the EPA for the detection and measurement of the
pesticide chemical residues or an explanation of why no such method is
needed.

This notice of filing summarizes the information submitted and cited by
Bayer CropScience LP in support of a request for a temporary exemption
from the requirement of a tolerance for the Bacillus thuringiensis
Cry2Ae protein and the genetic material necessary for its production in
cotton.

.  The Bacillus thuringiensis Cry2Ae protein has been incorporated into
cotton plants to provide control of lepidopteran insect pests such as
cotton bollworm and tobacco budworm.  Cry2Ae transformed plants are
derived from transformation events GHB714 and GHB119 that contain the
Cry2Ae protein via Agrobacterium mediated transformation.  The Cry2Ae
protein is highly specific to the targeted lepidopteran species, and is
non-toxic to mammalian species.  The Cry2Ae technology provides
producers with efficacious control of lepidopteran pest species in a
safe and efficient manner.

.   No analytical method is included because this petition requests a
temporary exemption from the requirement for a tolerance.

	Bacillus thuringiensis proteins have been used as safe and effective
pest control agents in microbial formulations for almost 40 years.
There have been over 150 registered microbial Bacillus thuringiensis
products in the United States for use in agriculture, forestry, and
vector control.  The numerous toxicology studies conducted with these
microbial products show no significant adverse effects, and demonstrate
that the products are practically non-toxic to mammals.  An exemption
from the requirement of a tolerance has been in place for these products
since at least 1971 (40 CFR 180.1011).

	Toxicology studies conducted to determine the toxicity of the Cry2Ae
protein demonstrated that the protein is not toxic to mammals.  In an
acute toxicity study in mice, high doses of Cry2Ae protein revealed no
adverse effects.  In an in vitro study, the Cry2Ae protein was rapidly
and completely degraded in simulated gastric fluid in the presence of
pepsin at pH 1.2 with no residual protein visible after 2 minutes of
incubation.  This indicates that the protein is highly susceptible to
digestion in the human digestive tract and that the potential for
adverse health effects from acute or chronic exposure is virtually
nonexistent.

	Proteins in general are not known to be chronic toxicants or
carcinogens. A search of relevant databases indicated that the amino
acid sequence of the Cry2Ae protein exhibits no significant homology to
the sequences of known protein toxins.  In addition, there was no
homology with sequences of known allergens and Cry2Ae was not
glycosylated in planta.  Therefore, the Cry2Ae protein is highly
unlikely to exhibit an allergic response.

	The genetic material necessary for the production of the Cry2Ae protein
are nucleic acids (DNA) which are common to all forms of plant and
animal life. There are no known instances of where nucleic acids have
caused toxic effects as a result of dietary exposure.

	Collectively, the available data on the Cry2Ae protein along with a
proven safe use of microbial Bacillus thuringiensis products establishes
the safety of the Cry2Ae protein and the genetic material necessary for
its production in all plants.

	Bacillus thuringiensis proteins are known to have a high degree of
insect specificity to lepidopteran species via binding to specific
receptors in the insect gut.  There are no receptors for these proteins
in mammalian species and therefore, these proteins are not toxic to
humans, wildlife, or beneficial insects, and readily break down in the
acidic environment of the digestive system.  The level of Cry2Ae protein
expressed in planta is very low, and is contained within the plant
making any route of exposure other than ingestion very unlikely.  While
dietary exposures may occur at low levels through consumption of raw
agricultural commodities, significant exposure to the Cry2Ae protein is
unlikely.  Since the Cry2Ae protein is contained within the plant
structure, it is highly unlikely that there would be opportunity for the
Cry2Ae protein to be introduced to drinking water or through physical or
other forms of contact in which a traditional pesticide may be
introduced into the body.  In summary, the potential for aggregate
exposure to the Cry2Ae protein is highly unlikely.

	Common modes of toxicity are not relevant to consideration of the
cumulative exposure to the Cry2Ae protein.  The Cry2Ae protein readily
breaks down during digestion, and has demonstrated a lack of mammalian
toxicity.  Furthermore, Bacillus thuringiensis proteins are known to
have very specific modes of action which do not affect humans, such that
the biological effects of the Cry2Ae protein do not appear to be
cumulative with any other known compounds.

. Considering the minute quantities of protein expressed within the
plant, the non-toxic nature of the Cry2Ae protein and Bacillus
thuringiensis proteins in general, the high degree of digestibility, the
lack of non-dietary exposure, and the lack of allergenic potential, BCS
concludes that the risk posed by Cry2Ae protein to the U.S. population
is insignificant.

.  Non-dietary exposure to infants and children is not anticipated, due
to the proposed use pattern of the Cry2Ae protein.  Due to the lack of
toxicity of the product on mammals, the lack of allergenic potential,
and the high degree of digestibility of the Cry2Ae protein, it is not
anticipated to pose any harm to infants and children from dietary
exposure.

Cry2Ae is a pesticidal protein derived from a source not known to exert
an influence on the immune or endocrine system.  Given the
characteristics of the Cry2Ae protein as described above, the potential
for effects on the immune or endocrine systems is highly unlikely.

There are no existing tolerances or exemptions from the requirement of a
tolerance for the Cry2Ae protein granted to Bayer CropScience.

	No maximum residue levels have been established for the Cry2Ae protein
under the Codex Alimentarius.

 PAGE  3

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[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6703-6704]
[FR Doc No: 2015-02459]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OARM-2011-0748; FRL-9922-61-OARM]

Proposed Information Collection Request; Comment Request; Monthly
Progress Reports (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Monthly Progress Reports
(Renewal)'' to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through May 31, 2015.
An Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before April 7, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OARM-
2011-0748, online using http://www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC
20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy Training and
Oversight Division, Office of Acquisition Management, (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number: 202-564-

4522; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This notice is a proposed extension of EPA ICR No.
1039.14, OMB Control No. 2030-0005, which is approved through May 31,
2015. Appropriate Government surveillance of contractor performance is
required to give reasonable assurance that efficient methods and
effective cost controls are being used for various cost-reimbursable
and fixed-rate contracts. Per 48 CFR 1552.211 regulations, on a monthly
basis, the Agency requires contractors to provide the Contracting
Officer's Representative (COR) with a report detailing: (a) What was
accomplished on the contract for that period, (b) expenditures for the
same period of time, and (c) what is expected to be accomplished on the
contract for the next month. Responses to the information collection
are mandatory for contractors and are required for the contractors to
receive monthly payments.
    Form numbers: 1900-68.
    Respondents/affected entities: Private sector.
    Respondent's obligation to respond: Mandatory per 48 CFR 1552.211.
    Estimated number of respondents: 203.
    Frequency of response: Monthly.
    Total estimated burden: 60,900 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $5,391,258 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: Please note: the revised estimates and burden
numbers are included in the Supporting Statement that will be added to
Docket ID No. EPA-HQ-OARM-2011-0748 for public review and comment.
There may be a decrease in the number of hours in total estimated
respondent burden down from 60,900 hours, as collection activities may
decrease with improved tracking software and overall efficiency.

    Dated: January 28, 2015.
John R. Bashista,
Director, Office of Acquisition Management.
[FR Doc. 2015-02459 Filed 2-5-15; 8:45 am]
BILLING CODE 6560-50-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: William Cutchin;<PHONE_NUMBER>

TEMPLATE:

Bayer CropScience

3F8182

	EPA has received a pesticide petition (3F8182) from  Bayer CropScience
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing the tolerances for residues of aluminum
tris(O-ethylphosphonate) in or on the raw agricultural commodity
Pepper/Eggplant, subgroup 8-10B, at 0.01 parts per million (ppm) and
Non-bell (chili) pepper dried fruits at 0.01 parts per million (ppm).
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.   SEQ CHAPTER \h \r 1 The metabolism of fosetyl-al
in plants is adequately understood. Adequate data on the nature of the
residues in plants, including identification of major metabolites and
degradates of fosetyl-al, are available. Radiolabeled studies on the
uptake, translocation and metabolism in plants show that the chemical
proceeds through hydrolytic cleavage of the ethyl ester. The major
residues are fosetyl-al, phosphorus acid, and ethanol. The  tolerances
are established for the parent only, that is fosetyl-al as specified in
40 CFR 180.415.

	2. Analytical method.   SEQ CHAPTER \h \r 1 An enforcement method for
plant commodities has been validated on various commodities.  It has
undergone successful EPA validation and has been submitted for inclusion
in PAM II.  The animal method has also been approved as an adequate
enforcement method.>

	3. Magnitude of residues. Magnitude of residue data in/on bell and
non-bell (chili) pepper fresh fruits and non-bell (chili) pepper dried
fruits were determined from fourteen field trials conducted in Mexico (6
trials), Peru (3 trials) and California (5 trials).  Prior to
transplant, all seedlings were grown in greenhouse trays and received
three foliar spray applications ranging from 8.09 to 8.69 lbs
fosetyl-al/A/application (9.07 to 9.74 Kg fosetyl-al/A/application) with
a 10-day treatment interval.  Total foliar application rates ranged from
24.5 to 25.4 lbs fosetyl-al/A (27.5 to 28.4 Kg fosetyl-al/A).  Following
transplant of the previously treated seedlings, plants received either 3
drench applications or 3 chemigation applications ranging from 0.83 to
0.84 lb fosetyl-al/A/application (0.93 to 0.94 Kg
fosetyl-al/ha/application) with a 10 day treatment interval and 5-day
PHI.  Total combined seasonal application rates for both treatment
regimens (foliar + drench and foliar + chemigation) ranged from 27.0 to
27.8 lbs fosetyl-al/A (30.3 to 31.2 Kg fosetyl-al/ha).  Duplicate
composite samples of bell and non-bell pepper, fresh fruits were
collected from the treated plots at 4- to 5-day pre-harvest intervals
(PHIs).  In the non-bell/chili pepper trials, samples of fresh non-bell
peppers to be dried were collected at the same intervals as samples for
fresh non-bell peppers.  These samples were allowed to dry either
outside, inside at room temperature, or in a low-temperature drying oven
for 7 to 20 days, according to typical local agricultural practices.
Six of the trials were conducted as decline trials with fresh fruit
samples collected at 0, 2, 4, 5, 7 and 9 to 10 days.

Residue values for dried non-bell (chili) peppers were calculated by
multiplying residue values measured in fresh non-bell (chili) peppers by
a processing factor determined from the dry weight of each of the
respective non-bell chili pepper samples.  Fosetyl residues, quantitated
as fosetyl-al only, in bell pepper, fresh fruits, non-bell (chili)
pepper, fresh fruits and non-bell (chili) pepper, dried fruits were
<0.01 ppm.

B. Toxicological Profile

	1. Acute toxicity.    SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 A
complete battery of acute toxicity studies for fosetyl-Al technical has
been conducted.  The lethal dose LD50 from the acute oral rat is
5.4 g/kg and the LD50 from an acute dermal rabbit study is >2 g/kg.
The

LC50 for a rat inhalation study is >1.73 mg/L.  The acute oral rat and
primary dermal irritation studies indicate category IV toxicity.  A
guinea pig dermal sensitization study shows fosetyl-Al is not a skin
sensitizer. The primary eye irritation study in rabbits shows fosetyl-Al
to be an eye irritant with Category I toxicity.

	2. Genotoxicty.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Fosetyl-Al
is neither mutagenic nor genotoxic.  The genetic toxicity potential of
fosetyl-Al was assessed in several assays.  Eight mutagenicity tests
performed with fosetyl-Al were negative.  The tests included two Ames
assays with S. typhimurum, two phase induction assays using E. coli, two
micronucleus

studies in mice, one DNA repair assay using E. coli and one mutation
assay in Saccharomyces cereviseae.

	3. Reproductive and developmental toxicity. Fosetyl-Al is not a
reproductive toxicant and shows no evidence of estrogertic or androgenic
related effects.

a. 	In a three generation reproduction study, fosetyl-Al was
administered to rats at dietary levels of 0, 6,000, 12,000 or 24,000
ppm.  No adverse effects on reproductive performance or pup survival
were observed in any dose group.  The lowest-observed adverse effect
level (LOAEL) was established at 12,000 ppm based on effects on animal
weights and urinary tract changes.  The no-observed adverse effect level
(NOAEL) for all effects was 6,000 ppm.

b.	A teratology study in rats dosed via oral gavage at 500, 1,000 or
4,000 mg/kg/day showed a developmental NOAEL of 1,000 mg/kg.  At
4,000 mg/kg, there was maternal toxicity as evidenced by effects on
animal weights, maternal deaths, increased resorptions and delayed fetal
ossification.

c.	A rabbit teratology study showed no toxic effects at oral doses up to
500 mg/kg.  Effects of fosetyl-Al on fetal development were observed
only in the rat at a dose producing severe maternal toxicity.  In the
absence of maternal toxicity, no adverse effects on fetal development
were observed, i.e. at 1000 mg/kg/day in rats or at 500 mg/kg/day in
rabbits.>

	4. Subchronic toxicity.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1  In
subchronic studies, no significant toxicity was observed even at doses
exceeding the limit of 1000 mg/kg/day.

a. 	A 21-day dermal study in rabbits showed mild to moderate skin
irritation and a NOAEL of 1.5 g/kg/day.

b.	A 90-day feeding study in rats showed a NOAEL of >5000 ppm; the LOAEL
was 25,000 ppm with extramedullary hematopoiesis in the spleen.

c.	A 90-day dog feeding study showed a NOAEL of 10,000 ppm and a LOAEL
at 50,000 ppm, at which the test animals had a lower serum potassium
level than untreated animal.>

	5. Chronic toxicity. Chronic toxicity studies have been conducted in
dogs and rats:

a.	Dog: Fosetyl-Al was fed to dogs for two years at concentrations qf 0,
10,000, 20,000, and 40,000 ppm.  The NOAEL was 10,000 ppm, equivalent to
250 mg/kg/day. The NOAEL was 20,000 ppm bused on a slight degenerative
effect on the testes. These testicular changes, as well as a few
scattered clinical changes, were seen in the high dose dogs.  No effects
were observed in the urinary tract.

b.	Rat: Fosetyl-Al was administered via admixture in the diet to CD rats
at target levels of 0, 2,000, 8,000, and 30,000/40,000 ppm for
approximately two years. Based on these levels, respective doses were
100, 400 and 2000/1500 mg/kg/day. After two weeks at 40,000 ppm, this
dietary level was reduced to 30,000 ppm due to the occurrence of red
coloration of the urine and a decrease in body weight gain. Although
these findings were no longer apparent after Week 2, analytical
verification of dietary levels revealed that the highest dietary level
ranged from approximately 38,000 to 61,000 ppm during the first 32 weeks
of the study.  No significant differences in body weight or food
consumption were noted at 2,000 or 8,000 ppm.  No biologically
significant differences were observed in ophthalmoscopy, hematology,
clinical chemistry or urinalysis for treated and control animnls.
Calculi in the urinary bladder were observed for several male and female
rats in the high dose group.  Non-neoplastic findings consisted of
epithelial hyperplasia and inflammation in the urinary bladders of males
at 30,000/40,000 ppm.  Increased incidences of hydronephrosis,
inflammation, and epithelial hyperplasia in the kidney were also
observed in males from the high dose group. Females from the same group
exhibited increased incidences qf epithelial hyperplasia in the urinary
bladder and hydronephrosis in the kidney.  The NOAEL in the chronic rat
study was 8,000 ppm (400 mg/kg/day).  The lowest NOAEL for chronic
effects of fosetyl-Al is 10,000 ppm (250 mg/kg/day) based on the dog
study. This NOAEL is based on minor changes at 20,000 ppm.  In the rat,
calculi in the urinary bladder and related histopathological changes in
the bladder and kidneys of males and females were observed at
30,000/40,000 ppm.

	6. Chronic Toxicity and Carcinogenicity Long-term feeding studies were
conducted with technical grade fosetyl-al in mice and rats and with
monosodium phosphite, the primary urinary metabolite of fosetyl-al, in
rats. These studies, in addition to a mechanistic study in rats, are
described below:

a.	Rat.  Fosetyl-al was administered via admixture in the diet to CD
rats at target levels of 0, 2,000, 8,000, and 30,000/40,000 ppm for
approximately 2 years. After 2 weeks at 40,000 ppm, this dietary level
was reduced to 30,000 ppm due to the occurrence of red coloration of the
urine and a decrease in body weight gain. Although, these findings were
no longer apparent after week 2, analytical verification of dietary
levels revealed that the highest dietary level ranged from approximately
38,000 to 61,000 ppm during the first 32 weeks of the study.  Calculi in
the urinary bladder were observed for several male and female rats at
30,000/40,000 ppm.  Microscopic examination revealed transitional cell
carcinomas and papillomas in the urinary bladders of high dose males.
In addition, a statistically significant increase in adrenal
pheochromocytomas (benign and malignant combined) was observed in males
at 8,000 and 30,000/40,000 ppm.  The adrenal slides were independently
reread by two consulting pathologists who found no significant
dose-related increases in the incidence of pheochromocytomas or
hyperplasia.  The NOAEL for fosetyl-al in the chronic rat study was
8,000 ppm.

A subsequent mechanistic study in rats conducted with dietary levels of
8,000, 30,000 and 50,000 ppm demonstrated that the massive doses of
30,000 and 50,000 ppm fosetyl-al alter calcium/phosphorous homeostasis
resulting in severe acute renal injury, similar to that observed in the
chromic rat study, and the formation of calculi in kidneys, ureters, and
bladder. Under  conditions of chronic exposure, these effects could lead
to the formation of bladder tumors as seen in the chronic rat study. At
8,000 ppm, no evidence of renal injury was observed, a result consistent
with the absence of bladder tumors. Thus, the bladder tumors induced by
fosetyl-al were the result of acute renal injury followed by a chronic
toxic reaction rather than a true carcinogenic effect.  An
carcinogenicity study in rats was conducted with monosodium phosphite
administered via dietary mixture at levels of 2,000, 8,000, and 32,000
ppm. No evidence of carcinogenicity was observed in this study.

b.	Mouse.  A 2-year feeding/carcinogenicity study was conducted in mice
fed diets containing fosetyl-al at 0, 2,500, 10,000, or 20,000/30,000
ppm. The 20,000 ppm dose was increased to 30,000 ppm during week 19 of
the study. The NOAEL for all effects was 20,000/30,000 ppm (3,000/4,500
mg/kg/day).  There were no carcinogenic effects observed under the
conditions of this study.

c.	EPA's Carcinogenicity Peer Review Committee (CPRC) concluded in their
report of June 29, 1993 that the pesticidal use of fosetyl-al is
unlikely to pose a carcinogenic hazard for humans given that: (a) Tumors
develop in rats under extreme conditions that are unlikely to be
achieved other than under laboratory conditions (at a dose in excess of
the EPA dose limit for carcinogenicity studies); (b) tumors in rats are
believed to develop only at doses that produce stones; (c) human dietary
exposure to fosetyl-al is only about one-500,000th of the NOAEL for
stone formation in the rat (the most sensitive experimental model); and
(d) the dose of fosetyl-al which can be absorbed dermally by applicators
is also probably too low to result in stone formation. Therefore, a
cancer dietary exposure analysis for fosetyl-al is not performed.

7. Animal metabolism.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Rat
metabolism studies showed that most of the radiolabel rapidly appeared
in exhaled carbon dioxide. There was also some radiolabel excreted in
the urine as phosphite, along with a smaller amount as the unchanged
parent compound. It appears that fosetyl-al is essentially completely
absorbed after ingestion and extensively hydrolyzed to carbon dioxide
which is exhaled. The phosphite is excreted in the urine without further
oxidation to phosphate. Aluminum does not appear to be absorbed to a
significant extent from the gastrointestinal tract.

	8. Metabolite toxicology. There are no metabolites of toxicological
concern. The tolerances are established for the parent only, that is
fosetyl-al.

	9. Endocrine disruption. No evidence of estrogenic or androgenic
effects were noted in any study with fosetyl-al. No adverse effects on
mating or fertility indices and gestation, live birth, or weaning
indices were noted in a three-generation rat reproduction study at doses
well above EPA's limit of 1,000 mg/kg/day. Therefore, Bayer CropScience
concludes that fosetyl-al does not have any effect on the endocrine
system.

C. Aggregate Exposure

	1. Dietary exposure.   SEQ CHAPTER \h \r 1 For all currently registered
and proposed uses of fosetyl-al, acute and chronic food exposure for
various subgroups of the U.S. population were estimated using the
Dietary Exposure Evaluation Model with the Food Commodity Intake
Database (DEEM-FCID) software Version 3.14. The DEEM analysis evaluated
the individual food consumption as reported by respondents in the
USDA’s National Health and Nutrition Examination Survey (NHANES) from
2003 to 2008 nationwide continuing surveys of food intake by
individuals.  A Tier 1 dietary assessment was evaluated based on
established tolerances for all registered uses and 100% crop treated.
For the proposed use on Bell Peppers and Non-Bell Peppers, the proposed
tolerance of 0.01 ppm was used in this assessment.

For acute risk, EPA found no appropriate endpoint attributable to a
single dose exposure was identified in oral acute toxicity studies.
Therefore, an acute RfD was not established and there was no expectation
of acute risk.  For chronic risk, EPA established the chronic reference
dose (RfD) for fosetyl-al at 2.5 mg/kg/day.  This reference dose (RfD)
is based on a NOAEL of 250 mg/kg/day from a 2-year feeding study in dogs
and the use of a 100 fold safety factor to account for interspecies and
intraspecies differences.  Since no dermal or systemic toxicity was seen
at the limit dose following repeated dermal applications in the 21-day
toxicity study using rats, no endpoint value was calculated for short
and intermediate-term exposure and risk. The Agency has concluded that
fosetyl-al is unlikely to pose a carcinogenic hazard to humans.
Therefore, a cancer exposure and risk assessment is not appropriate.>

<	i. Food. For food, Tier 1 acute and chronic dietary exposure
assessments were performed. Acute exposure was not required since there
was no acute reference dose established for this endpoint.  The chronic
exposure to fosetyl-al from food utilizes 4% of the chronic population
adjusted dose (cPAD) for the U.S. population, 5% of the cPAD for
infants, and 12% of the cPAD for children 1-2 years old, the
subpopulation at greatest exposure.  Based on the results of this
conservative analysis, exposure to fosetyl-al residues from the proposed
uses is expected to be minimal.  Bayer CropScience concludes that
dietary exposure to fosetyl-al resulting from the currently registered
uses and the proposed use of the product will be well below the Agency's
level of concern.>

<	ii. Drinking water. The potential for ground water and/or surface
water contamination by fosetyl-al and its degradates is expected to be
very low, in most cases, due to the rapid degradation of the compound in
soil to non-toxic degradates under both aerobic and anaerobic
conditions.  Ground water estimations were based on “maximum
loading” conditions using the SCI-GROW2 screening level model.  The
estimated ground water concentration was 0.006 ppb for all uses.
Surface water estimations were based on environmental fate data and
pesticide label application using the FIRST model.  The estimated
surface water concentrations were 0.0086 ppb (peak) and 0.00003 ppb
(annual mean) for proposed uses.

	2. Non-dietary exposure.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1
Fosetyl-al is currently registered for residential use on turf and
ornamental plants. Chronic exposure is not expected for residential
uses. There is also no expectation of acute risk. No appropriate
endpoint attributable to a single dose exposure was identified in oral
toxicity studies and consequently, an acute RfD cannot be calculated. No
endpoint value is calculable for short- and intermediate-term exposure
and a risk analysis cannot be performed

since no dermal or systemic toxicity was seen at the limit dose
following repeated dermal applications in the 21-day toxicity study
using rats. The Agency has previously concluded that fosetyl-al is
unlikely to pose a carcinogenic hazard to human. Therefore, a cancer
exposure and risk assessment is not appropriate. Thus, Bayer CropScience
concludes that the ornamental and turf uses do not add significantly to
the aggregate exposure for fosetyl-al.

D. Cumulative Effects.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1
Effects associated with fosetyl-al are unlikely to be cumulative with
any other compound. The formation of calculi and bladder tumors in rats
is the only significant toxicological effect observed with fosetyl-al.
These effects were observed in rat only at a dose which not only exceeds
estimated human exposure by several orders of magnitude but is in excess
of the OPP dose limit for carcinogenicity studies.  Therefore, an
aggregate assessment based on common mechanisms of toxicity is not
appropriate as exposure to humans will be well below

the levels producing calculi and bladder tumors in rats. Further,
considering the rapid elimination of fosetyl-al in the rat metabolism
study, any effects associated with fosetyl-al are unlikely to be
cumulative with any other compound. Based on these reasons, only the
potential risks of fosetyl-al are considered in the exposure

assessment.

E. Safety Determination

	1. U.S. population.   SEQ CHAPTER \h \r 1 Chronic risk estimates
associated with exposure to fosetyl-al in food and water are expected to
be well below the Agency's level of concern.  The Tier I chronic
exposure analysis performed for all currently registered and proposed
food uses show that exposure to fosetyl-al utilizes 4% of the cPAD for
the U.S. population, 5% of the cPAD for infants, and 12% of the cPAD for
children

1-2 years old, the subpopulation at greatest exposure.  This analysis
was conducted assuming 100% crop treated and tolerance level residue
values for all crops.  The contribution of fosetyl-al residues in
surface water and ground water to chronic aggregate exposure was
minimal.  Therefore, Bayer CropScience concludes that even when
considering the potential incremental risk resulting from the proposed
use on bell and non-bell peppers, there is a reasonable certainty that
no harm will result from aggregate exposure to fosetyl-al residues.

	2. Infants and children.   SEQ CHAPTER \h \r 1 Infants and children.
No indication of increased susceptibility of rat or rabbit fetuses to in
utero and/or postnatal exposure was noted in the developmental and
reproductive toxicity studies.  The Agency has previously determined
that no additional safety factor to protect infants and children is
necessary for this product.  Using the conservative assumptions
described in the exposure section above, aggregate exposure to
fosetyl-al from currently registered food uses will utilize 5% of cRfD
for infants, and up to 12% of the cRfD for children 1-2 years old, the
subpopulation at greatest exposure.  Even when considering the potential
incremental dietary risk resulting from the proposed use on bell and
non-bell peppers, the potential for exposure to residues in drinking
water and from non-dietary, non-occupational exposure, the aggregate
exposure to fosetyl-al is expected to be well below the level of
concern. Bayer CropScience concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to fosetyl-al residues.

F. International Tolerances

No maximum residue limits (MRLs) have been established for residues of
fosetyl-al in or on bell or non-bell peppers by the Codex Alimentarius
Commission (CODEX).

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