[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Notices]
[Pages 43141-43143]
[FR Doc No: 2012-17850]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Air Carrier Hazardous Materials Passenger Notification
Requirements: Acceptable Means of Compliance

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting and related information.

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SUMMARY: This notice is to advise interested persons that the Federal
Aviation Administration (FAA), in coordination with the Pipeline and
Hazardous Materials Safety Administration (PHMSA), will conduct a
public meeting to discuss Air Carrier Hazardous Materials Passenger
Notification Requirements and Acceptable Means of Compliance with 49
CFR 175.25. The public meeting, to be held on August 16th, 2012 in
Washington, DC, is intended to provide interested persons with an
opportunity to submit comments and participate in discussions
concerning the acceptability of various means of compliance with
federal hazardous materials regulations.

DATES: August 16th, 2012; from 1 p.m. to 4 p.m.

Meeting Location

    Airlines for America, 1301 Pennsylvania Ave. NW., 11th Floor,
Washington, DC 20004.
    Any person wishing to attend the public meeting (in person or via
telephone) should send an email to<EMAIL_ADDRESS>with
the subject line ``Attendee Information for Passenger Notification
Meeting'' no later than the close of business on August 9th, 2012.
Please include the names and contact information (Organization/Email/
Address/Telephone Number) for any individuals planning to attend, and
indicate whether attendance will be in person or via telephone.
Providing this information will allow us to send you meeting documents
prior to the meeting, assist us in recordkeeping for the meeting,
facilitate the security screening process for entry into the building
on the day of the meeting, and ensure adequate seating space and
telephone conference lines for all attendees.
    We are committed to providing equal access to this meeting for all
participants. If you need alternative formats or other reasonable
accommodations, please call<PHONE_NUMBER> or email: 9-AWA-ASH-ADG-
<EMAIL_ADDRESS>with your request by the close of business on August 9,
2012.
    Attendees will be required to check in with the security desk in
the building lobby, 1st floor. When they get to the 11th floor, a
receptionist will guide them to the meeting room.
    Conference Call Information: Telephone conference capability will
be provided to allow participation from interested individuals who are
unable to attend the meeting in person. To join the telephone
conference, call<PHONE_NUMBER> and enter passcode 981243.
    Prior to the meeting, copies of documents for the Air Carrier
Hazardous Materials Passenger Notification Requirements Public Meeting
and the meeting agenda will be distributed by email to all individuals
who register as participants at the meeting.
    Comment Submission: Stakeholders are encouraged to submit comments
prior to the August 16th, 2012 public meeting by emailing to<EMAIL_ADDRESS>Please mark submissions with the subject line
``Comments for Passenger Notification Public Meeting.'' After the
meeting, all comments received will be posted without change to the
following Web site, including any personal information: http://www.faa.gov/about/office_org/headquarters_offices/ash/ash_programs/hazmat/aircarrier_info/.

FOR FURTHER INFORMATION CONTACT: Kenneth Miller, Federal Aviation
Administration, Office of Hazard Materials Safety (ADG-1), 800
Independence Ave. SW., Washington, DC 20591. Email:
<EMAIL_ADDRESS>Phone:<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION:

I. Background

    49 CFR 175.25 defines requirements for notification at air
passenger facilities of hazardous materials restrictions. One primary
purpose for this rule is to enhance public safety awareness regarding
the carriage of hazardous materials onboard aircraft, either as carry-
on items or in checked baggage. Improved public safety awareness in
this area increases passenger compliance with applicable 49 CFR
requirements, thus enhancing overall aviation safety by reducing the
likelihood of inappropriate items being transported onboard aircraft.
    The Pipeline and Hazardous Materials Safety Administration (PHMSA)
amended 49 CFR 175.25 on January 19, 2011 (76 FR 3382). The amendments
included requirements for passenger notification during ticket purchase
and check-in. The amended rule has an effective date of January 1,
2013. While PHMSA has the primary responsibility for issuing 49 CFR
regulations, the FAA has primary responsibility for overseeing
compliance with these regulations as they pertain to air
transportation. PHMSA and the FAA have received numerous inquiries
regarding specific interpretations of the amended requirements and the
acceptability of certain means of compliance with the revised rules.

II. Purpose of Public Meeting

    The FAA seeks to collaborate with the air passenger transportation
community in defining and implementing a

standard means of compliance with the 49 CFR 175.25 requirements. FAA
envisions this collaboration occurring through the following process:
    Step 1--Initial Public Meeting (the subject of this announcement,
discussed in detail below).
    Step 2--FAA posting for public comment a draft advisory circular
describing one acceptable means of compliance with 49 CFR 175.25. This
means of compliance would be the recommended standard for compliance.
    Step 3--FAA posting of a final advisory circular, including
dispositions to comments received on the draft advisory circular.
    FAA, in coordination with PHMSA, is holding this public meeting to
provide an opportunity for all interested parties to comment on the
FAA's plan for collaboration with the air passenger transportation
community. This meeting is also intended to provide an opportunity for
all interested parties to provide input on the standard means of
compliance for 49 CFR 175.25.
    The FAA and PHMSA also seeks input on the anticipated
implementation timeline for a standard means of compliance with 49 CFR
175.25 requirements, relative to the current effective date for
amendments to 49 CFR 175.25 adopted in 76 FR 3382. Stakeholders are
encouraged to submit questions, comments, recommendations, and other
input in advance. (Please see the Comment Submission section above.)

III. Clarification Questions Regarding 49 CFR 175.25

    In preparation for this public meeting, the FAA and PHMSA are
providing responses below to questions regarding specific
interpretations of the 49 CFR 175.25 rule. The following questions were
submitted to the FAA by the Council on Safe Transportation of Hazardous
Materials (COSTHA).
    Q1. Section 175.25(b)--Ticket Purchase: Is the intent of amendments
to this section adopted in the January 19, 2011 final rule (76 FR 3308;
PHMSA-2009-0126 (HM-215K)) to require a carrier to provide the
permitted and forbidden text or pictorials by Jan 1, 2012 and the
passenger acknowledgement provisions by Jan 1, 2013?
    A1. While Sec.  175.25(b) took effect January 1, 2012, the
passenger acknowledgement portion of the rule is scheduled to take
effect January 1, 2013.
    Q2. Is Ticket Purchase defined anywhere in the regulations within
or beyond the HMR? Not all passengers are issued tickets. For example,
does this section apply to non-revenue or employee travel?
    A2. As defined in 14 CFR 241.03 and for the purpose of this
response, a non-revenue passenger means a person traveling free or
under token charges, except those expressly named in the definition of
revenue passenger; a person traveling at a fare or discount available
only to employees or authorized persons of air carriers or their agents
or only for travel on the business of the carriers; and an infant who
does not occupy a seat.
    Section 175.25(b) notification requirements apply to ticketed
passengers only. However, non-revenue passengers, airline employees
traveling as passengers onboard, and other non-ticketed passengers
remain subject to requirements of the HMR, and actions by non-ticketed
passengers can affect the safety of an air carrier's operation. While
Sec.  175.25 does not define specific notification requirements for
non-ticketed passengers, the FAA and PHMSA solicit input on best
practices for notification of all passengers (ticketed and non-
ticketed) for inclusion in a future FAA advisory circular.
    Q3. Do the requirements of Sec.  175.25 apply to third party travel
sites operated by travel agents and online travel retailers (Orbitz,
Expedia, Travelocity, etc.)? If so, is it the responsibility of the
carrier or the travel agent/retailer to provide the required passenger
notification? The International Civil Aviation Organization Technical
Instructions for the Safe Transport of Dangerous Goods by Air (ICAO
Technical Instructions), at Part 8:1.1.3, states ``Any organization or
enterprise other than an operator (such as a travel agent) * * * should
provide passengers with information about the types of dangerous goods
* * *'' Thus, it appears the ICAO Technical Instructions places the
responsibility to notify passengers in these situations on the third
party provider, and not the carrier.
    A3. The requirements of Sec.  175.25 apply to the aircraft
operator. The aircraft operator is responsible for ensuring that
passengers receive the notifications required by Sec.  175.25,
regardless of whether the ticket is purchased directly from the
aircraft operator or via a third party source. The aircraft operator
can meet its obligations by relying on the notifications provided to
the passenger by a third party, but the aircraft operator is ultimately
responsible for compliance with the rule. PHMSA and FAA solicit input
on best practice arrangements between aircraft operators and third
party travel organizations for inclusion in a future FAA advisory
circular on passenger notification.
    Q4. In a situation where a customer purchases a ticket over the
phone (e.g., by calling a reservation center), what constitutes
compliance with the rule? Do PHMSA and FAA expect a verbal reading of
Sec.  175.25(a)(1) and (2), or would a simplified statement that guides
them to additional information (i.e., carrier Web site) suffice?
    A4. A simplified statement may be acceptable, and may actually be
the preferred means of compliance. The FAA and PHMSA solicit input on
best practices for passenger notification via telephone for inclusion
in a future FAA advisory circular.
    Q5. Is dual acknowledgement (at the time of ticket purchase--
paragraph (b), and time of check-in--paragraph (c)) intentional? If a
passenger acknowledges at the time of ticket purchase, could a record
of that acknowledgement also be used to meet the acknowledgement in
section Sec.  175.25(c)?
    A5. The dual acknowledgement during ticket purchase and check-in is
intentional and required for compliance.
    Q6. In a Rule 240 scenario where a passenger is re-accommodated on
another carrier due to canceled flights or other reasons, would a third
check-in acknowledgement be required?
    A6. Although an aircraft operator may meet its obligations by
relying on notifications provided to the passenger by a third party,
the aircraft operator is ultimately responsible for compliance with the
rule. PHMSA and FAA solicit input on best practice arrangements during
re-accommodation situations for inclusion in a future FAA advisory
circular on passenger notification.
    Q7. In a bulk purchase or charter situation, would a single
individual responding on behalf of their party be acceptable for
compliance with Sec.  175.25(b) and (c)? Would such an acknowledgement
be acceptable for military charters as well?
    A7. Both Sec.  175.25(b) and (c) allow for acknowledgement by a
person acting on the passenger's behalf. While this allows for
acknowledgement by a single individual, PHMSA and FAA solicit input on
best practices for notification of passengers in bulk purchase, charter
flight, or similar situations for inclusion in a future FAA advisory
circular.
    Q8. Is the actual language in Sec.  175.25(a)(1) and (2) required
in all cases? If so, how does a carrier provide notice of additional
materials forbidden beyond those covered in the general language? The
ICAO Technical Instructions do not require specific language but
instead require the carrier

to develop their own language and format.
    A8. The information provided in Sec.  175.25(a)(1) and (2) is
required, but the specific wording used in the HMR is not required.
Further, no part of Sec.  175.25 is intended to prevent aircraft
operators or other individuals from providing additional information to
passengers regarding the safe transport of hazardous materials. The FAA
and PHMSA solicit input on best practices for conveying hazardous
materials safety information, including the information provided in
Sec.  175.25(a)(1) and (2), for inclusion in a future FAA advisory
circular on passenger notification.
    Q9. This rule applies to 14 CFR 129 foreign carriers that operate
from the U.S. Currently, there are 14 types of hazmat listed in the
ICAO Technical Instructions, at 8;1.1, as ``permitted with the approval
of the operator.'' Thus, there may be considerable differences between
each U.S. and foreign airline as to what is ``permitted or forbidden''
by each operator. Note that the ICAO Technical Instructions, at 8;1.1.3
and 8;1.1.4, do not require the types ``permitted'' either--only the
types of hazmat ``forbidden'' needs to be communicated. If a passenger
checks-in with a foreign carrier and then transfers to a domestic
carrier, does the original check in notification satisfy the passenger
notification for the domestic leg as well?
    A9. The aircraft operator may meet their obligations by relying on
notifications provided to the passenger by a third party, but the
aircraft operator is ultimately responsible for compliance with the
rule. The FAA and PHMSA solicit input on best practice arrangements
between foreign and domestic air carriers for inclusion in a future FAA
advisory circular on passenger notification.
    Q10. In the case of remote check-in and boarding, where the
passenger checks in at a remote location and checks baggage as well,
such as a resort, cruise line, or military charter situations, does the
carrier have the responsibility to notify the passenger, or is the
resort, cruise line, or military branch responsible for notification?
Under these scenarios, a non-carrier operation performs the check-in
function. Therefore, the carrier has limited or no contact with the
passenger during the check-in process. An example would include a
military charter originating from a U.S. military installation.
    A10. The requirements of Sec.  175.25 apply to the aircraft
operator. The aircraft operator is responsible for ensuring that
passengers receive the notifications required by Sec.  175.25,
regardless of whether the passenger checks-in directly with the
aircraft operator or via a third party source. Although the aircraft
operator may meet its obligations by relying on notifications provided
to the passenger by a third party, but the aircraft operator is
ultimately responsible for compliance with the rule. PHMSA and FAA
solicit input on best practice arrangements between aircraft operators
and third party organizations for inclusion in a future FAA advisory
circular on passenger notification.
    Q11. Lithium batteries have received a significant amount of
attention by regulatory and enforcement entities over the last 5 years.
Much of this attention is due to incidents involving such batteries,
including incidents occurring in passenger baggage. Yet, the current
language in Sec.  175.25 does not mention lithium batteries. Is it
acceptable for a carrier to develop independent language that conveys
the intent of the language in Sec.  175.25(a)(1) and (2) but varies in
content to address recent incidents or trends? May this language be
used as an alternative to the language contained in Sec.  175.25(a)? We
strongly believe the restrictive language indicated in Sec.  175.25 is
ineffective in communicating hazardous material dangers and
restrictions in passenger baggage to the traveling public.
    A11. The information provided in Sec.  175.25(a)(1) and (2) is
required, but the specific wording used in the HMR is not. Further, no
part of Sec.  175.25 is intended to prevent aircraft operators or other
individuals from providing additional information to passengers
regarding the safe transport of hazardous materials. The FAA fully
supports inclusion of information regarding lithium battery hazards in
passenger notifications. The FAA and PHMSA solicit input on best
practices for conveying hazardous materials safety information,
including the information provided in Sec.  175.25(a)(1) and (2), for
inclusion in a future FAA advisory circular on passenger notification.

    Issued in Washington, DC, on July 17, 2012.
Christopher Glasow,
Director, FAA Office of Hazardous Materials Safety.
[FR Doc. 2012-17850 Filed 7-20-12; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Page 13025]
[FR Doc No: 2022-04799]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-123, OMB Control No. 3235-0105]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
     Form T-3

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for approval.
    Form T-3 (17 CFR 269.3) is an application for qualification of an
indenture under the Trust Indenture Act of 1939 (15 U.S.C. 77aaa et
seq.). The information provided under Form T-3 is used by the
Commission to determine whether to qualify an indenture relating to an
offering of debt securities that is not required to be registered under
the Securities Act of 1933 (15 U.S.C. 77a et seq.). Form T-3 takes
approximately 43 hours per response to prepare and is filed by 11
respondents. We estimate that 25% of the 43 burden hours (11 hours per
response) is prepared by the filer for a total reporting burden of 121
hours (11 hours per response x 11 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by May 9, 2022.
    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 control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: March 2, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-04799 Filed 3-7-22; 8:45 am]
BILLING CODE 8011-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007)

EPA Registration Division contact: [insert name and telephone number
with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Bayer CropScience]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Bayer CropScience] [P. O. Box 12014, 2 T. W. Alexander Drive, 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 by establishing a tolerance for residues of
[Spiromesifen; butanoic acid, 3,3-dimethyl-,
2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester, and
its enol metabolite;
4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one,
calculated as parent compound equivalents] in or on the raw agricultural
commodity [corn, pop grain] at [0.02] parts per million (ppm) and [corn,
pop, stover] at [1.5] 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 the 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. [The uptake and metabolism of spiromesifen in
primary crops is adequately understood. Radiolabeled studies have been
conducted in various plants all showing similar results. The residues of
concern are spiromesifen and its enol metabolite.]

	2. Analytical method. [Adequate analytical methodology using LC/MS/MS
detection is available for enforcement purposes.]

	3. Magnitude of residues. [Magnitude of the residue data were conducted
on pop corn with OPPTS Guideline 860.1500. The data supports
establishing the requested tolerances.]

B. Toxicological Profile

	1. Acute toxicity.  [Oral and dermal LD50 values were >2000 mg/kg bw.
Inhalation LC50 values were >4873 mg/m3 air.  Spiromesifen was not
irritating to rabbit skin or eyes but did cause skin sensitization in
the Magnusson/Kligman maximization test in guinea pigs.  Acute toxicity
studies for spiromesifen support an overall toxicity Category III]

	2. Genotoxicty. [Several genotoxicity tests were conducted to test for
point-mutagenic activity, chromosome aberration in vitro and in vivo,
and for DNA repair.  All tests conducted were negative, indicating no
evidence of mutagenic or genotoxic potential.]

	3. Reproductive and developmental toxicity. [An oral developmental
toxicity study in rat did not reveal any evidence of teratogenic
potential.  The maternal and developmental NOAELs were 10 mg/kg bw/day.
An oral developmental toxicity study in rabbits demonstrated a maternal
NOAEL of 5 mg/kg bw/day, a developmental NOAEL of 35 mg/kg bw/day and
did not reveal any teratogenic potential.  A two-generation study in
rats, with a parental systemic toxicity NOAEL of 3.3 mg/kg bw/day for
males and 4.6 mg/kg bw/day for females (based on the F1 generation), did
not reveal evidence of a primary reproductive toxicity potential.  The
reproductive NOAEL was 36.6 mg/kg bw/day for males and 14.2 mg/kg bw/day
in females.]

	4. Subchronic toxicity. [A subchronic toxicity feeding study with rats
over 90 days demonstrated a NOAEL of 6.3 and 7.7 mg/kg bw/day for males
and females, respectively, based on reduced body weights, effects on the
lipid metabolism (decrease of triglycerides and cholesterol) and thyroid
effects (colloidal alteration, hypertrophy) at the higher dose levels.
A subchronic feeding study in mice over 14 weeks demonstrated a NOAEL of
3.2 and 5.1 mg/kg bw/day based on effects on lipid metabolism (decrease
of cholesterol) and adrenal effects (cytoplasmic eosinophilia).  A
14-week feeding study in dogs demonstrated a NOAEL of 9.2 and 9.3 mg/kg
bw/day based on liver effects (enzyme induction, increased liver weights
and cytoplasmic change) and thyroid effects (decreased T4).]

	5. Chronic toxicity. [A 12-month chronic feeding study in rats
demonstrated a NOAEL of 6.5 and 19.3 mg/kg bw/day for males and females,
respectively.  A 24-month oncogenicity study in rats demonstrated a
NOAEL of 6.1 and 19.5 mg/kg bw/day for males and females, respectively.
An oncogenicity study in the mouse revealed a NOAEL of 3.3 and 3.8 mg/kg
bw/day for males and females, respectively based on macroscopic and
microscopic adrenal effects.  There was no indication in the rat or
mouse for an oncogenic effect of spiromesifen.  A one-year feeding study
with dogs demonstrated a NOAEL of 11.5 and 10.8 mg/kg bw day for males
and females, respectively based on decreased body weights, liver effects
(increased liver weight, hepatocellular cytoplasmic change, vacuoles)
and adrenal effects (increased incidence of small cell types).]

	6. Animal metabolism. [Metabolism and pharmacokinetic studies in the
rat demonstrate that spiromesifen residues are rapidly absorbed,
metabolized and eliminated.  There was no evidence of accumulation of
residues in any tissues or organs.  The primary metabolites are the
enol, which is formed by cleavage of the alkyl ester group, and the
4-hydroxymethyl metabolite.  Several other metabolites are also formed.]

	7. Metabolite toxicology. [In addition to parent, the metabolites of
concern are those containing the enol and 4-hydroxymethyl moieties.
Since both moieties are primary metabolites in mammalian systems
following the oral administration of spiromesifen to rats, the
toxicology data for spiromesifen adequately covers the metabolites.]

	8. Endocrine disruption. [There is no evidence to suggest that
spiromesifen has any primary endocrine disruptive potential.
Reproductive and developmental findings provided no evidence of an
enhanced sensitivity of the young.  All prospective endocrine and
endocrine-related changes which were noted were considered a function of
the chemical's biological mode of action, the degree of exposure, a
response secondary to other changes (e.g. enhanced liver metabolism), an
aging or strain-specific phenomenon, or some combination of these
factors.]

C. Aggregate Exposure

	1. Dietary exposure. [Acute dietary exposure limits for all
populations, including infants and children, are not necessary because
an endpoint of concern attributable to a single exposure (dose) was not
identified from the oral toxicity studies.  In addition, there are no
developmental concerns based on rat and/or rabbit developmental toxicity
studies. For the chronic dietary analysis, the chronic reference dose
(cRfD), of 0.033 mg/kg/day was derived from a parental systemic NOAEL of
3.3 mg/kg/day (based on the F1 generation) in a 2-generation
reproduction toxicity study in rats and the application of an UF of 100.
As the toxicology database is adequate for Food Quality Protection Act
(FQPA) purposes and there are no concerns or residual uncertainties for
pre-/post-natal toxicity, an FQPA safety factor of 1 was applied to the
chronic toxicology values, resulting in a chronic population adjusted
dose (cPAD) of 0.033 mg/kg/day.  As a conservative measure, the cPAD
values were used for all population sub-groups when conducting the
assessments.]

	i. Food. [Assessments were conducted to evaluate the potential risks
due to chronic dietary exposure of the entire U.S. population and
selected population subgroups to residues of spiromesifen and its enol
metabolite.  These assessments cover the established and proposed uses
of spiromesifen on legume vegetables, brassica (head and stem, broccoli
and cabbage; leafy, mustard greens), corn (field), corn (pop), corn
(sweet), cotton, cucurbits (cantaloupe, cucumbers, and summer squash),
fruiting vegetables (peppers and tomatoes), leafy greens (head and leaf
lettuce and spinach), potatoes, strawberries (low growing berries: Crop
Subgroup 13-07-G)  and succulent shelled, edible-podded and dry shelled
beans.  Potential exposure from the rotational crops of alfalfa,
sugarbeets, barley, wheat, and oats are included. These assessments also
include secondary residues in animal tissues resulting from registered
and proposed uses.  Chronic exposure, calculated using DEEM-FCID Version
2.16, for the most exposed subpopulation, Children 1-2 years, equated to
3.3% of the cPAD.  The exposure to the U.S. population equated to 0.9%
of the cPAD. These Tier 3 chronic dietary exposure estimates,
incorporating Bayer CropScience estimates of  percent crop treated, are
well below EPA’s level of concern for the overall U.S. population as
well as the various population subgroups.]

	ii. Drinking Water. [The tolerances requested in pop corn will not
alter potential risks from exposure to residues of spiromesifen or
degradates through drinking water. A Tier II drinking water assessment
for spiromesifen and its enol metabolite was conducted using PRZM/EXAMS
(Pesticide Root Zone Model/Exposure Analysis Modeling System) to
calculate surface water estimated drinking water concentrations (EDWCs).
 The Screening Concentration in Ground Water (SCI-GROW) model was used
to calculate ground water EDWCs. The highest value for a chronic
assessment resulted from the Florida strawberry, surface water scenario.
The EDWC for combined residues of spiromesifen and its enol metabolite,
expressed as parent equivalents, was 5.4 ppb. The chronic EDWC
represents the upper 1-in-10 year mean annual concentration. All EDWCs
values are much lower than the drinking water level of comparison
(DWLOC) value of 326 µg/L (children 1-2 years old) determined for the
chronic scenario. Therefore, the EDWCs do not exceed the Agency’s
level of concern. For the most highly exposed population subgroup,
children 1-2, chronic aggregate dietary exposure (food and water)
calculated using DEEM-FCID Version 2.16 was 3.8% of the cPAD. For the
overall U.S. population, chronic aggregate dietary exposure was 1.2% of
the cPAD. Aggregate exposures are based on an estimated drinking water
concentration of 5.4 µg/L.]

	2. Non-dietary exposure. [There are no indoor or outdoor residential
uses associated with this product.]

D. Cumulative Effects

	[Spiromesifen represents a new class of chemistry, ketoenoles.  There
are no data available to indicate that toxic effects produced by
spiromesifen are a result of a common mechanism and should be cumulated
with those of any other compound. EPA has not made a common mechanism of
toxicity finding as to spiromesifen and any other substances and
spiromesifen does not appear to produce a toxic metabolite produced by
other substances. Bayer will submit information, if necessary, for EPA
to consider concerning any potential cumulative effects of spiromesifen
consistent with the schedule established by EPA at 62 Federal Register
42020 (Aug. 4, 1997) and other EPA publications pursuant to the Food
Quality Protection Act.]

E. Safety Determination

	1. U.S. population. [Based on the exposure assessments described above
and on the completeness and reliability of the toxicity data, it can be
concluded that total aggregate exposure to spiromesifen from all label
uses will utilize less than 2 percent of the RfD for chronic dietary
exposures to the U.S. population and all population subgroups. EPA
generally has no concerns for exposures below 100 percent of the RfD,
because the RfD represents the level at or below which daily aggregate
exposure over a lifetime will not pose appreciable risks to human
health.  Thus, it can be concluded that there is a reasonable certainty
that no harm will result to the U.S. population from aggregate exposure
to spiromesifen residues.]

	2. Infants and children. [The Agency has previously concluded that the
toxicology database is adequate for Food Quality Protection Act (FQPA)
purposes and that there are no concerns or residual uncertainties for
pre-/post-natal toxicity. Therefore, a FQPA factor of 1X was selected.
Available studies include developmental toxicity studies in rats and
rabbits, a two-generation reproductive toxicity study in rats, and acute
and subchronic neurotoxicity studies in rats. In the prenatal
developmental toxicity studies in rats and rabbits and in the
two-generation reproduction study in rats, developmental toxicity to the
offspring occurred at equivalent or higher doses than maternal toxicity.
There are no neurotoxicity concerns based on acute and subchronic
neurotoxicity studies. The most highly exposed population subgroup was
children 1-2 with a total aggregate exposure to spiromesifen from all
label uses utilizing less than 5 percent of the RfD for chronic dietary
exposures. EPA generally has no concerns for exposures below 100 percent
of the RfD, because the RfD represents the level at or below which daily
aggregate exposure over a lifetime will not pose appreciable risks to
human health.  Thus, it can be concluded that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to spiromesifen residues.]

F. International Tolerances

	[Codex maximum residue levels (MRLs) are not yet established  for
spiromesifen.]