 United States Environmental Protection Agency Washington, DC 20460 Thirty (30)-Day Adverse Incident Written Report for The Pesticide General Permit (PGP) For Discharges from the Application of Pesticides Form Approved OMB No. 2040-0004 This form is for Operators required to submit a written report of any reportable adverse incidents to the appropriate EPA Regional office and to the state lead agency for pesticide regulation. Where multiple Operators are authorized for a discharge that results in an adverse incident, reporting by any one of the Operators constitutes compliance for all of the Operators, provided a copy of this report is also provided to all of the other authorized Operators within 30 days of the reportable adverse incident. A. Reportable Adverse Incident Is the adverse incident reportable?  Reporting of adverse incidents is not required under the PGP in the following situations: (a) An Operator is aware of facts that indicate that the adverse incident was not related to toxic effects or exposure from the pesticide application; (b) An Operator has been notified by EPA, and retains such notification, that the reporting requirement has been waived for this incident or category of incidents; (c) An Operator receives information of an adverse incident, but that information is clearly erroneous; or (d) An adverse incident occurs to pests that are similar in kind to potential target pests identified on the FIFRA label.   	Yes. You must complete this report and submit it to the appropriate EPA Regional office and to the state lead agency for pesticide regulation.   	No. STOP. You are not required to complete this report. However, you may consider using this form to document the incident and your rationale for why reporting of the adverse incident is not required. This information may be useful to support your rationale should you be questioned on such.  B. Information from the 24-Hour Adverse Incident Notification When an Operator observes or is otherwise made aware of an adverse incident, which may have resulted from a discharge from a pesticide application, the Operator must immediately notify the appropriate EPA Incident Reporting Contact, as identified at https://www.epa.gov/npdes/pesticide-permitting. This notification must be made by telephone within 24 hours of the Operator becoming aware of the adverse incident. Operators must include in the written report the information provided to EPA in the 24-hour adverse incident notification (PGP Part <IP_ADDRESS>). Attach additional information if necessary.  1.	Caller's Contact Information: a.	Name:

b.	Telephone Number:

 -

 -

Ext

2.	Operator Information: a.	Operator Name:

b.		Mailing Address:      Street:

     City:

State:

 ZIP Code:

 -

3.	NOI NPDES Permit Tracking Number:

  (Enter "NA" if not applicable) 4.	Contact person, if different than the person providing the 24-hour notice under item 1 above:  a.	Name:

b.	Telephone Number:

 -

 -

Ext

   5.	Describe how and when the Operator became aware of the adverse incident: 	 	 	 	    6.	Describe the location of the adverse incident: 	 	 	    7.	Describe the adverse incident identified and the pesticide product, including EPA pesticide registration number in item 7a below, for each product applied in the area of the adverse incident: 	 	 	 	 	 	 a. EPA Pesticide Registration Number:  EPA Pesticide Registration Number:

                                           8.	Describe any steps the Operator has taken or will take to correct, repair, remedy, clean up, or otherwise address any adverse effects: 	 	 	 	 	 	 	    9.	Identify any other Operators authorized for coverage under this permit for discharges from the pesticide application activities that resulted in the adverse incident and if so, provide details of your notification of those other Operator(s): 	 	 	 	 	 C. Date and Time the Operator Notified EPA of the Adverse Incident 1.	Date EPA was contacted:

/

/

  2.	Time EPA was contacted:	 3.	Name and/or title of the person the Operator spoke with at EPA:                                                                         a. Name:

                                                                      b. Title:

   4.	Instructions received from EPA:

D. Other Information Required in the Thirty (30) Day Adverse Incident Report Please attach additional information if necessary.    1. 	Location of incident, including the names of any waters affected and appearance of those waters (sheen, color, clarity, etc.): 	 	 	    2.	Describe the circumstances of the adverse incident including species affected, estimated number of affected individuals, and approximate size of dead or distressed organisms: 	 	 	    3.	Describe the magnitude and scope of the affected area (e.g. aquatic square area or total stream distance affected): 	 	 	    4.	Provide the pesticide application rate, intended use site (e.g., on the bank, above waters, or directly to water), method of application, and the name of pesticide product and EPA pesticide registration number (EPA Reg. No.).     Pesticide  application rate:                                                                                Pesticide  application rate:

   Intended use site:

Intended use site:

   Method of application:

Method of application:

   Pesticide Product:

Pesticide Product:

   EPA Reg. No.:

EPA Reg. No.:

   5.	Describe the habitat and the circumstances under which the adverse incident occurred (including any available ambient water data for  pesticides applied): 	 	 	    6.	Provide an indication of which laboratory test(s), if any, were performed, and when. (Note: A summary of the test results must be provided within 5 days after they become available, if not available at the time of submission of this report.): 	 	 	 	    7.	Describe the actions to be taken to prevent recurrence of adverse incidents:

E. Certification I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gathered and evaluated the information submitted. On the basis of my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations.   Printed Name:

Title:

E-Mail:

  Signature/Responsible Official:

                                                                          Date:

/

/

Adverse Incident Report Preparer (Complete if Adverse Incident Report was prepared by someone other than the certifier) Preparer Name:

Organization:

Phone:

 -

 -

Ext

                                                                          Date:

/

/

E-Mail:

       Instructions for Completing and Submitting the Thirty (30) Day Adverse Incident Written Report for the Pesticide General Permit (PGP) for Discharges from the Application of Pesticides

Who Must Submit a 30-day Adverse Incident Report? All Operators who observe or are otherwise made aware of a reportable adverse incident pursuant to Part 6.4 of the permit must submit on adverse incident report. However, even for those identified adverse incidents for which the Operator is not required to report, EPA recommends that Operators consider using this form to document the incident and the rationale for why reporting of the adverse incident is not required. This information may be useful to support a rationale should this determination be questioned. An adverse incident, as defined in the Appendix A of the permit, is an unusual or unexpected incident that an Operator has observed upon inspection or of which the Operator otherwise became aware, in which: (1) there is evidence that a person or non-target organism has likely been exposed to a pesticide residue, and (2) the person or non-target organism suffered a toxic or adverse effect. See Appendix A of the permit, for the complete definition of adverse incident. Where multiple Operators are authorized for a discharge that results in an adverse incident, notification and reporting by any one of the Operators constitutes compliance for all of the Operators, provided a copy of the written report required in Part 6.4.2 of the permit is also provided to all of the other authorized Operators within 30 days of the reportable adverse incident. When to File the Adverse Incident Report Operators must provide a written report of any reportable adverse incidents to the appropriate EPA Regional office and to the state lead agency for pesticide regulation within 30 days of the adverse incident pursuant to Part <IP_ADDRESS> of the permit. Where to File the 30-day Adverse Incident Report The Operator must immediately notify the appropriate EPA Incident Reporting Contact, as identified at https://www.epa.gov/npdes/pesticide-permitting, of the adverse incident within 24 hours. The Operator(s) must provide a written report of the adverse incident to the appropriate EPA Regional office at the address listed in Part 8 of the permit and to the state lead agency for pesticide regulation (see http://npic.orst.edu/state1.htm). If an Operator becomes aware of an adverse incident affecting a federally listed threatened or endangered species or federally designated critical habitats which may have resulted from a discharge from the Operator's pesticide application, the Operator must immediately notify the National Marine Fisheries Service (NMFS) in the case of an anadromous or marine species, (see http://www.nmfs.noaa.gov) or the United States Fish and Wildlife Service (FWS) in the case of a terrestrial or freshwater species (see http://www.fws.gov). Completing the 30-day Adverse Incident Report To complete this form, type or print in uppercase letters in the appropriate areas only. Please make sure you complete all questions. Make sure you make a photocopy for your records before you send the completed original form to the appropriate EPA Regional office. Section A. Reportable Adverse Incident The Operator is required to submit this Adverse Incident Report if the adverse incident is reportable. Check yes if the adverse incident is reportable. If an Adverse Incident Report is not required, check no. No further action is needed on this form. Reporting of adverse incidents is not required under the PGP in the following situations: a.	An Operator is aware of facts that indicate that the adverse incident was not related to toxic effects or exposure from the pesticide application; b.	An Operator has been notified by EPA, and retains such notification, that the reporting requirement has been waived for this incident or category of incidents; c.	An Operator receives information notifying the Operator of an adverse incident, but that information is clearly erroneous; or d.	An adverse incident occurs to pests that are similar in kind to potential target pests identified on the FIFRA label. Section B. Information from the 24-hour Adverse Incident Notification 1.	Provide contact information for the person who called EPA to report the adverse incident.    a.	Enter the legal name of the caller.    b.	Enter the phone number of the caller. 2.	Provide the Operator's contact information.    a.	Enter the legal name of the Operator.    b.	Enter the mailing address of the Operator. 3.	If an NOI was filed as required in Part 1.2 of the permit, enter the NPDES Permit Tracking Number assigned by NeT or the EPA's Pesticides Processing Center. You can find the tracking number assigned to your NOI using EPA's NPDES eReporting Tool (NeT). If no NOI submitted, enter "NA" for not applicable. 4.	Provide information for a contact person, if different than the person who called EPA to report the adverse incident.    a. 	Enter the legal name of the contact person.    b. 	Enter the phone number of the contact person. 5.	Provide a description of how and when the Operator became aware of the adverse incident. 6.	Provide a description of the location of the adverse incident. 7.	Provide a description of the adverse incident and the pesticide product used in the adverse incident. Include the EPA pesticide registration number for each product applied in the area of the adverse incident. Attach additional pages if necessary. 8.	Provide a description of any steps the Operator has taken to correct, repair, remedy, clean up or otherwise address the adverse effects of the incident. 9.	Identify any other Operators authorized for coverage under the permit for discharges from the pesticide application activities that resulted in the adverse incident. If other Operators are authorized under this permit, provide details of your notification of those other Operator(s). Section C. Date and Time the Operator Notified EPA of the Adverse Incident 1. 	Enter the date that EPA was contacted to report the adverse incident. 2. 	Enter the time EPA was contacted to report the adverse incident. 3.  Provide the legal name and title of the person contacted at EPA. 4. 	Provide a description of the instructions received by EPA. Section D. Other Information Required in the Thirty (30) Day Adverse Incident Report 1.	Enter the location of the adverse incident and include the names of any waters affected. Please include the appearance of those waters (sheen, color, clarity, etc.). 2.	Provide a description of the circumstances of the adverse incident including species affected, estimated number of affected individuals and approximate size of dead or distressed organisms. 3.	Provide a description of the magnitude and scope of the affected area. Include aquatic square area or total stream distance affected, if possible. 4.	Provide the pesticide application rate, intended use site (e.g., on the bank, above waters, or directly to water), method of application, and the name of pesticide product and EPA pesticide registration number. 5.	Provide a description of the habitat and the circumstances under which the adverse incident occurred (including any available ambient water data for pesticides applied). 6.	Indicate which laboratory test(s) were performed and when, if laboratory tests were performed. The summary of the test results must be provided within 5 days after they become available, if not available at the time of submission of this report. 7.	Provide a description of the actions to be taken to prevent recurrence of adverse incidents. Section E. Certification Enter the certifier's printed name and title. Sign and date the form. For more information about the certification statement and signature, see 40 CFR 122.41(k). (CAUTION: An unsigned or undated form will not be accepted.) Federal statutes provide for severe penalties for submitting false information. Federal regulations require this application to be signed as follows: For a corporation: by a responsible corporate officer, which means: (i)	president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation, or (ii)	 the manager of one or more manufacturing, production, or operating facilities, provided the manager is authorized to make management decisions that govern the operation of the regulated activity including having the explicit or implicit duty of making major capital investment recommendations, and initiating and directing other comprehensive measures to assure long-term environmental compliance with environmental laws and regulations; the manager can ensure that the necessary systems are established or actions taken to gather complete and accurate information for permit application requirements; and where authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures; For a partnership or sole proprietorship: by a general partner or the proprietor; or For a municipal, state, federal, or other public facility: by either a principal executive or ranking elected official. If the report was prepared by someone other than the certifier (for example, if the report was prepared by a consultant for the certifier's signature), include the name, organization, phone number and e-mail address of the report preparer and the date that the report was prepared. Paperwork Reduction Act Notice The public reporting and recordkeeping burden for this collection of information is estimated to average 4 hours or 240 minutes per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed Adverse Incident Report to this address.


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

<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 and brackets, i.e., “[insert
company name],” with the information specific to your action.>

<TEMPLATE:>

<[Dow AgroSciences]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number]) from
[Dow AgroSciences], [9330 Zionsville Road, Indianapolis, IN, 46268]
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.>

)>

<	1. by establishing a tolerance for residues of>

	[isoxaben] in or on the raw agricultural commodity [grape; grape,
juice; and grape, raisin] at [0.01] parts per million (ppm); in or on
the raw agricultural commodity [nut, tree, group and pistachio] at
[0.03] parts per million (ppm); in or on the raw agricultural commodity
[almond, hulls] at [0.35] parts per million (ppm); AND

<

	2. to request a waiver for the requirement of a tolerance for
[isoxaben] in or on the raw agricultural commodity [cattle, meat
byproducts; meat and milk].

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: [The nature of the residue in plants (grapes and
cereals) has been determined using radiolabeled isoxaben and is
adequately understood for the purposes of these tolerances.  The results
of the plant and animal metabolism studies and toxicity testing indicate
that the total toxic residue to be regulated is isoxaben.]

>

<	2. Analytical method. [There is a practical method (liquid
chromatography with positive ion atmospheric pressure chemical
ionization tandem mass spectrometry (LC/MS/MS)) for detection of
isoxaben residues.  The limit of detection (LOD) and limit of
quantitation (LOQ) are 0.003 µg/g and 0.01 µg/g, respectively and are
suitable for detecting and measuring levels of isoxaben in or on food
and allows monitoring of food with residues at or above the level set
for these tolerances.  The method has an independent laboratory
validation.]>

<	3. Magnitude of residues. [The proposed tolerances for isoxaben are
supported by MOR trials conducted in grapes, almonds and pecans.  The
magnitude of residues of isoxaben were determined following a single
maximum application of Gallery* 75 DF herbicide which is a water
dispersible granular.  A similar design was used in all three studies so
that one trial in each study was a decline trial and also each trial had
one control plot and two treated plots.  Applications were made to the
orchard or vineyard floor and resulting residues in the portions of the
plants consumed by humans are predominantly below the LOD and all but
two individual values were below the LOQ.  The farming practices and
environmental conditions were typical of those used in the production of
these crops.  For grapes, 12 trials were conducted in Washington,
California and New York; all residue values were below the LOQ in grapes
and ranged from no detects (ND) to 0.0085 ppm.  No concentration of
residues was measured upon processing to raisins or juice.  For the five
almond trials conducted in California, residue values ranged from no
detects to 0.015 ppm in the nutmeat and 0.0073 to 0.30 ppm in the hulls.
 For pecans, five trials were conducted in Georgia, Louisiana and Texas;
all residue values were non-detects, with the exception of one value;
that residue was just above the LOD at 0.0031 ppm.]>

<B. Toxicological Profile>

<	1. Acute toxicity.  [Isoxaben is not considered acutely toxic via
ingestion, inhalation or dermal exposure.  The acute oral LD50 for
isoxaben is >5000 mg/kg-bw in the rat, mouse and dogs; acute dermal LD50
in rabbit >2000 mg/kg-bw; the 4-hr inhalation LC50 for rats was 2.93
mg/L air.  No skin sensitization has been observed.  Isoxaben does not
produce significant eye or skin irritation.  No acute endpoint has been
established for further risk assessment.  In addition, all current
end-use product labels for both dry flowables and fertilizer
formulations carry the lowest signal word of “Caution”. ]>

<	2. Genotoxicity: [Isoxaben yielded negative results in a battery of in
vitro and in vivo tests for mutagenicity and other forms of
genotoxicity.  Initially, the micronucleus assays in mice gave a weakly
positive result but findings were not deemed to be dose-related> and
were of questionable biological significance.  A more recent mouse bone
marrow micronucleus test gave negative results and isoxaben showed no
genotoxic potential.]

<	3. Reproductive and developmental toxicity. [The teratogenic potential
of isoxaben has been tested in rats and rabbits.  Based on the rabbit
study, a NOEL of 1000 mg/kg/day is assigned for developmental toxicity
and 320 mg/kg/day for maternal toxicity.  >A three generation study in
rats with doses at 0, 40, 200, or 1000 mg/kg/day resulted in maternal
and paternal toxicity in the higher doses; effects were also observed on
prenatal and postnatal development in the high dose group.  The NOEL for
maternal and paternal toxicity was 40 and 200 mg/kg/day respectively.
The NOEL for development offspring was 200 mg/kg/day and for
reproduction was 1000 mg/kg/day.  No increased sensitivity for the young
is observed.]

<	4. Subchronic toxicity. [Several 90-day feeding studies have been
conducted in rats, mice and dogs.  The NOAEL threshold is established
for rats at > 94 mg/kg bw/day.  In mice, the NOEL is 15.5 mg/kg bw /day
and the NOEL for dogs is 110 mg/kg/day.  Result thresholds were based on
increased liver weight and/or increased hepatic p-nitroanisole
0-demethylase activity.  A 28-day dermal study in rabbits found
technical isoxaben to be non-irritating at 1000 mg/kg bw/day and no
evidence of systemic toxicity was observed.>

<	5. Chronic toxicity. [EPA has established the reference dose (RfD) for
isoxaben at 0.05 mg/kg/day for chronic risk assessment.  Studies in
dogs, rats and mice were reviewed and the resulting cRfD is
conservatively based on the 2-year rat feeding study in rats with a NOEL
of 5 mg/kg/day and applied uncertainty factor of 100 for both
interspecies extrapolation (10x) and intraspecies variability (10x).
The critical effects associated with the threshold were increased BUN,
decreased serum AP (alkyl phosphatase) and AST (aspartate
aminotransferase); decreased food consumption efficiency; increased
heart/body weight.

Oncology data for both rats and mice is available.  Isoxaben is
currently classified as a Group C compound by the OPP Peer Review
committee on the basis of a statistically significant increase in benign
liver tumors in mice.  Estimates of human dietary oncogenic risk were
based on the agency’s previously established Q* value of 2.3x10-3
(mg/kg-day)-1.]>

<	6. Animal metabolism. [Isoxaben has been shown to be readily and
rapidly absorbed when orally administered, but also rapidly excreted
from tissues: total urinary and fecal excretion ranging from 70 to 100%
has been observed in series of studies and timeframes.  Two tissue
distribution studies in rats with single doses of 14C labeled isoxaben
investigated the distribution of the absorbed dose; both found the
highest levels in the GI tract congruent with the understanding of the
rapid fecal excretion.  About 10% of absorbed dose converted to 15 or
more metabolites excreted in the urine.  For dermal exposure: a dermal
absorption value of 11% has been observed.  Supplemental data from some
bovine NOR work demonstrates any meat or fat residues of isoxaben in
cattle would be constituted primarily of degradates and <10% of the
parent isoxaben.  Based on the understanding of metabolism in both rats
and the cow, the low potential dietary burden to cattle from almond
hulls should result in residues below the current limit of detection in
milk and fat.  Based on this information, a waiver from animal product
tolerances (cattle, meat byproducts; meat and milk) is sought.]>

<	7. Metabolite toxicology. [The residue of concern for tolerance
purposes has already been established as the parent material isoxaben.
Thus, there is no need to address metabolite toxicity.]>

<	8. Endocrine disruption. [No reference of isoxaben as an endocrine
disruptor was found in a web search, nor do any of the existing toxicity
studies suggest that endocrine modulation is a concern for isoxaben. ]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [The dietary assessment model DEEM-FCID version
2.16 was employed to assess chronic dietary risk.  DEEM estimates US
consumption patterns based on the Continuing Survey of Food Intake by
Individuals (CSFII) and EPA/USDA translation recipes from August 2002.
A DEEM residue file for a Tier I Dietary assessment was prepared using
proposed tolerance values plus water values from the Tier I screening
models.  DEEM was used to assess percent of chronic RfD for
subpopulations and also lifetime cancer risk using the cRfD of 0.05
mg/kg/day and a Q* values of 0.0023 (mg/kg/day)-1, respectively.  An
acute endpoint was not identified for acute dietary exposure and risk
assessment, therefore, an acute dietary exposure assessment was not
performed.]>

<	i. Food. [A Tier I dietary assessment for use on grapes and nuts
employed the proposed tolerance values for grapes, grape juice, raisins,
all nuts in crop grouping 14 including pistachio with no adjustment for
percent crop treated.  MOR trials in grapes showed no concentration in
grape juice or raisins and therefore proposed tolerances for these
processed commodities are the same as for grapes; no processing factors
were included in the DEEM assessment.  The use of a tolerance level and
100% of crop treated clearly results in an overestimate of human
exposure and results in a conservative dietary assessment.]>

<	ii. Drinking water. [Assessment for potential exposure via water has
been conducted using the EPA's Office of Pesticide Programs guidance
document for appropriate environmental fate input values to the Tier I
aquatic exposure models SCI-GROW and FIRST.  Based on residential uses
with three 1 lb/A applications, 60 days apart, the resulting Tier I
output from SCI-GROW is a groundwater calculation of 2.96 ppb.  Output
from FIRST resulted in a Tier I chronic value of 7.84 ppb.  Therefore
the FIRST value of 0.00784 ppm was employed as the conservative drinking
water residue from both direct and indirect sources within the DEEM
calculator for dietary risk.]>

<	2. Non-dietary exposure. [Commercial and homeowner uses of isoxaben
products in residential settings can lead to non-dietary exposures.  To
determine the maximum exposure scenarios by product type, the isoxaben
labels were reviewed and two key application scenarios which represent
the range of potential exposures assessed for residential turf and
ornamentals: 1) homeowner application of granular fertilizers to lawns
and ornamentals and 2) commercial applications via broadcast of the dry
flowable formulation.  Tier I residential assessments based on the
EPA’s SOPs were conducted for chronic exposure scenarios which
included multiple routes of post-application exposure for children.  To
aggregate the final exposures for the general population and children,
the appropriate chronic yearly averages from the dietary and residential
assessments are summed.  For both children and adults, use of the dry
flowable product resulted in slightly higher exposure, thus estimated
exposures from the dry flowable are used from the residential
assessment.  The most sensitive subpopulation from the dietary
assessment (non-nursing infants) is used to represent children, and for
adults the dietary exposure for the general population is used.]>

<D. Cumulative Effects>

<	[Isoxaben is uniquely classed as a “benzamide”; no cumulative
assessment is deemed necessary.]>

<E. Safety Determination>

<	1. U.S. population. [For adults, the Tier I chronic dietary exposure
component was determined to be 1.7x10-4 mg/kg bw/day and the largest
contribution to the dietary exposure came from the Tier I estimate for
drinking water.  The predicted residential exposure was 4.2x10-5 mg/kg
bw/day, resulting in an aggregate total exposure of 2.1x10-4 mg/kg
bw/day.  This potential exposure represents 0.42 % of the cRfD and when
multiplied by the Q* value results in a potential cancer risk value of
4x10-7.  These estimated exposures and lifetime risks are understood to
be below the Agency’s concern, with lifetime risks on the order of
10-6 and exposures at less then one percent of the established chronic
reference dose.]>

<	2. Infants and children. [For children, the chronic dietary exposure
component was determined to be 6.8x10-4 mg/kg bw/day (non-nursing
infant), the most exposed population subgroup, and the largest
contribution to the dietary exposure came from the Tier I estimate for
drinking water.  The predicted residential exposure was 1.8x10-5 mg/kg
bw/day, resulting in an aggregate total exposure of 7.0x10-4 mg/kg
bw/day.  This potential exposure represents 1.4 % of the cRfD and when
multiplied by the Q* value results in a potential cancer risk value of
1.6x10-6.  These estimated exposures and lifetime risks are understood
to be below the Agency’s concern, with lifetime risks on the order of
10-6 and exposures at less then two percent of the established chronic
reference dose.]>

<F. International Tolerances>

<	[To the best of our knowledge, no corresponding MRLs have been
established for grapes or tree nuts by CODEX, Canada, or Japan.  No
harmonized EU MRL exists for grapes or nuts.  Several EU member states
have historic national MRLs for both grapes and nuts ranging from 0.01
to 0.02 ppm.  The US proposed food tolerances are covered under the
current Canadian default of 0.1 ppm; grapes are covered under the
Japanese default of 0.01 ppm.]>

* Trademark of Dow AgroSciences

 PAGE

 PAGE   5

well i can't pick one cause we are doing both

Could make another heading here for "Oncology" or just leave under
chronic I suppose.


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Notices]
[Pages 35540-35543]
[FR Doc No: 2014-14591]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9912-59-Region-5: EPA-R05-OPPT-2014-0360]

TSCA Sections 402(a), 402(c), and 406(b) Program Authorization
Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comments and opportunity for public
hearing.

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

SUMMARY: On May 19, 2014, the Environmental Protection Agency (EPA)
determined that the Bois Forte Band of Chippewa (Bois Forte) had
submitted a complete application under section 404 of the Toxic
Substances Control Act (TSCA) requesting authorization to administer
and enforce the requirements for TSCA sections 402(a), 402(c), and
406(b) in accordance with the provisions of TSCA for trust lands
located within the exterior boundaries of the reservation. These
programs ensure that: Individuals engaged in certain work that may
disturb lead-based paint, including but not limited to abatement and
renovation, are properly trained; that training programs are
accredited; that contractors engaged in such activities are certified;
that owners and occupants of target housing and/or child-occupied
facilities are provided information concerning potential hazards of
lead-based paint exposure before certain renovations are begun; and
that the required work is performed in accordance with work practice
standards. This notice announces receipt of the Bois Forte Band of
Chippewa's application and request for authorization to administer the
program in lieu of the federal program. EPA has determined that the
Bois Forte application is complete, and is now

providing a 45-day public comment period and opportunity to request a
public hearing.

DATES: Comments, identified by docket identification (ID) number EPA-
R05-OPPT-2014-0360, must be received on or before August 7, 2014. In
addition, a public hearing request must be submitted on or before July
8, 2014.

ADDRESSES: Comments and requests for a public hearing may be submitted
by mail, electronically, or in person. Please follow the detailed
instructions for each method as provided in Unit I. of the
SUPPLEMENTARY INFORMATION section in this notice. To ensure proper
receipt by EPA, it is imperative that you identify docket ID number
EPA-R05-OPPT-2014-0360 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: Emma Avant, Land and Chemicals
Division (LCD), Toxics Section, U.S. Environmental Protection Agency,
77 W. Jackson Boulevard, Chicago, IL 60604; telephone number: (312)
886-7899; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be specifically of interest to firms and individuals engaged
in lead-based paint activities and/or renovation and remodeling
activities involving pre-1978 housing on the Bois Forte Reservation.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How can I get additional information, including copies of this
document or other related documents?

    1. Electronically. EPA has established an official record for this
action under docket ID number EPA-R05-OPPT-2014-0360. The official
record consists of the documents specifically referenced in this
action, this notice, the Bois Forte TSCA program authorization
application, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as Confidential Business information (CBI).
    All documents in the official record are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the address listed below.
    2. In person: You may view this document and related documents by
visiting the Bois Forte Tribal Government Environmental Services
Office, 5344 Lakeshore Drive, P.O. Box 16, Nett Lake, Minnesota 55772,
contact telephone number<PHONE_NUMBER>, or EPA Region 5, 77 W. Jackson
Boulevard, Chicago, Illinois 60604, contact telephone number (312) 886-
7899.

C. How and to whom do I submit comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-R05-OPPT-2014-0360 in the subject
line on the first page of your response.
    1. By mail: Submit your comments and hearing requests to: Emma
Avant, LCD, Toxics Section, U.S. Environmental Protection Agency, 77 W.
Jackson Boulevard, Chicago, IL 60604.
    2. By person or courier: Deliver your comments and hearing requests
to: EPA Region 5, LCD, Toxics Section, 77 W. Jackson Blvd., Chicago, IL
60604. The Regional office is open from 8 a.m. to 5 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
regional office is<PHONE_NUMBER>.
    3. Electronically: You may submit your comments and hearing
requests electronically by email to<EMAIL_ADDRESS>or through
http://www.regulations.gov, or mail your computer disk to the address
identified above. Do not submit any information electronically that you
consider to be CBI. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard disks in Microsoft
Word or ASCII file format.

D. How should I handle CBI information that I want to submit to the
agency?

    You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.

E. What should I consider as I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments.
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection
activity.
    7. Make sure to submit your comments by the deadline in this
notice.
    8. To ensure proper receipt by EPA, identify the docket ID number
assigned to this action in the subject line on the first page of your
response. You may also provide the name, date, and Federal Register
citation.

II. Background

A. What action is the agency taking?

    On July 14, 2010, the Bois Forte Band of Chippewa (Bois Forte or
the Tribe), located in St. Louis and Koochiching Counties in Northern
Minnesota, submitted an application under section 404 of TSCA
requesting authorization to administer and enforce requirements for:
Lead-based paint activities (such as abatement) in accordance with
section 402(a) of TSCA; renovation, repair and painting (referred to as
``RRP''), in accordance with section 402(c) of TSCA; and pre-renovation
education in accordance with section 406(b) of TSCA. These programs
contain procedures and requirements for the accreditation of lead-based
paint activities and RRP training programs, procedures and requirements
for the certification of individuals and firms

engaged in lead-based paint activities or RRP activities, and work
practice standards for performing such activities, and ensure that
owners and occupants of target housing are provided information
concerning potential hazards of lead-based paint exposure before
certain lead-based paint activities or RRP activities are begun.
Subsequently, Bois Forte supplemented the application on August 30,
2010, September 23, 2011, January 31, 2012, February 23, 2012, and July
13, 2013. After reviewing all the application materials, EPA now
considers the Tribe's application to be complete.
    The Tribe's application requests authorization to administer and
enforce these requirements on lands held in trust for the Tribe within
the reservation boundaries. The Tribe has not, at this time, requested
authorization to administer and enforce these programs on non-member
owned fee lands within the reservation boundaries. If EPA authorizes
the Tribal program, EPA will continue to administer and enforce the
requirements on non-member owned fee lands within the reservation
boundaries. The Tribe may, however, apply to administer and enforce
these requirements for all lands located within the exterior boundaries
of the reservation at some future time, but must meet all statutory and
regulatory requirements under section 404(b) of TSCA, 15 U.S.C. 2684(b)
and 40 CFR part 745 subpart Q.
    The Bois Forte Reservation includes five land areas, four of which
currently include lands held in trust for the Tribe. The Lake
Vermillion land area, approximately 2803 acres located near the town of
Tower, Minnesota, and the Sugar Bush and Indian Point land areas,
approximately 83 acres and 60 acres, respectively, both located near
the town of Orr, Minnesota, consist entirely of trust land for which
the Tribe will administer and enforce the program. The Nett Lake land
area, comprising of 103,000 acres surrounding Nett Lake, and the vast
majority of the Bois Forte Reservation land and members, includes both
trust land, where the Tribe will administer and enforce the program,
and non-member owned fee land, where the Tribe will not. The Deer Creek
land area, approximately 23,000 acres currently includes no trust
lands; at this time the Tribe will not administer the program on the
Deer Creek land area. There are a total of approximately 100 pre-1978
housing properties on trust lands where the Tribe will administer and
enforce the program. Because the program addresses lead-based paint
found in housing constructed prior to 1978, the only scenarios under
which additional housing will come into the universe of regulated
properties are: (1) Pre-1978 housing is moved onto trust land, and (2)
new lands are placed into trust upon which pre-1978 housing exists.
    The Tribe's proposed program includes one provision for which the
Tribal program is more stringent than the federal program. The Tribe's
definition of ``target housing'' includes all buildings on Tribal trust
lands. The federal program only applies to ``target housing,'' as
defined by section 401(17) of TSCA, 15 U.S.C. 2681, which includes
housing constructed prior to 1978, except housing for the elderly or
persons with disabilities (unless any child who is less than 6 years of
age resides or is expected to reside in such housing for the elderly or
persons with disabilities) or any zero-bedroom dwelling. As noted below
in Section IV of this notice, if approved, EPA may exercise its
enforcement authority under TSCA against a violation of, or a failure
or refusal to comply with, any requirement of the Bois Forte Lead
Program that is consistent with federal program requirements.
Therefore, if approved, EPA will not enforce the Bois Forte Lead
Program for violations arising at buildings not included in the federal
definition of ``target housing.''
    In order for EPA to authorize the Bois Forte program, it must
determine that the application includes information sufficient for EPA
to find Bois Forte eligible for treatment in the same manner as a state
(TAS). For the TSCA lead program, TAS requirements are found in 40 CFR
745.324(b)(4), and include, among other things, that the tribe is
recognized by the Secretary of the Interior; has an existing government
exercising substantial governmental duties and powers; has adequate
civil regulatory jurisdiction over the subject matter and entities
regulated; and is reasonably expected to be capable of administering
the federal program for which it is seeking authorization. In
determining that the Tribe's application is complete, EPA believes that
the Tribe has demonstrated that it can meet each of these requirements
for TAS under this program.
    Pursuant to section 404(b) of TSCA, 15 U.S.C. 2684(b) and 40 CFR
part 745, subpart Q, EPA provides notice and an opportunity for a
public hearing on a state or tribal program application before
approving the program. Therefore, by this notice EPA is soliciting
public comment on whether the Bois Forte application meets the
requirements for EPA approval. This notice also provides an opportunity
to request a public hearing on the application. If a hearing is
requested, EPA will issue a Federal Register notice announcing the
date, time and place of the hearing and EPA's final decision on the
application will also then be published in the Federal Register.

B. What is the agency's authority for taking this action?

    On October 28, 1992, the Housing and Community Development Act of
1992, Public Law 102-550, became law. Title X of that statute was the
Residential Lead-Based Paint Hazard Reduction Act of 1992. That Act
amended TSCA (15 U.S.C. 2601 et seq.) by adding Title IV (15 U.S.C.
2681-2692), entitled Lead Exposure Reduction. In the Federal Register
of August 29, 1996 (61 FR 45813) (FRL-5389-9), April 22, 2008 (73 FR
21758) (FRL-8355-7), and June 1, 1998 (63 FR 29908) (FR-5751-7),
respectively, EPA promulgated final TSCA section 402(a), 402(c), and
406(b) regulations governing lead-based paint activities (abatement)
training, certification and work practice standards; renovation, repair
and painting (RRP) training, certification and work practice standards;
and pre-renovation education (PRE) requirements in target housing and/
or child-occupied facilities. These programs establish requirements for
training individuals conducting lead-based paint activities and RRP
activities; accrediting lead-based paint activities and RRP activities
training providers; and for lead-based paint activities and RRP work
practices. The program also ensures that owners and occupants of target
housing and child-occupied facilities are provided information
concerning potential hazards of lead-based paint exposure before
certain renovations are conducted. In addition to providing general
information on the health hazards associated with exposure to lead, the
lead hazard information pamphlet advises owners and occupants to take
appropriate precautions to avoid exposure to lead-contaminated dust and
debris that are sometimes generated during renovations. EPA believes
that distribution of the pamphlet will help to reduce the exposures
that cause serious lead poisonings, especially in children under age 6,
who are particularly susceptible to the hazards of lead. Under section
404 of TSCA, 15 U.S.C. 2684, a state or tribe may seek authorization
from EPA to administer and enforce its own lead-based paint activities,
RRP and/or pre-renovation education program in lieu of the federal
program. The regulations governing the authorization of a state or
tribal program under both sections 402 and 406 of TSCA are codified at
40 CFR part 745,

subpart Q. A state or tribe that chooses to apply for program
authorization must submit a complete application to the appropriate
regional EPA office for review. Those applications will be reviewed by
EPA within 180 days of receipt of the complete application. To receive
EPA approval, a state or tribe must demonstrate that its program is at
least as protective of human health and the environment as the federal
program, and provides for adequate enforcement under section 404(b) of
TSCA, 15 U.S.C. 2684(b). EPA's regulations at 40 CFR part 745, subpart
Q provide the detailed requirements a state or tribal program must meet
in order to obtain EPA approval.

III. Tribal Program Description Summary

    The following is the Tribe's proposed TSCA Lead-Based Paint program
summary, which the Bois Forte Tribe prepared as a required part of its
application:

    The Bois Forte has adopted by Resolution  6-2011, the
ordinance entitled Bois Forte Lead Program in order to provide clear
and specific authority and guidance for regulating renovation
requirements, and pre-renovation notification requirements and lead-
based paint activities, including assessment, inspection, and
abatement of lead-based paint on the Bois Forte Reservation.
Penalties for non-compliance are established. The ordinance targets
all buildings located on the Bois Forte Reservation.
    The ordinance is designed to be at least as protective as the
federal law and provide for adequate enforcement of all provisions
through a schedule of flexible remedies. This is accomplished
through a combination of Tribe-specific requirements (training
accreditation) that are identical to the federal regulations and
through incorporation by reference of other required federal
elements (certification of individuals, pre-renovation notification
activities, renovation, and definitions of lead-based paint
hazards). Also incorporated by reference are the federal definitions
with the notable expansion of the definition of target housing to
include all reservation buildings.
    The ordinance contains enforcement and compliance requirements
consisting of a schedule of flexible remedies and an appeals
process.
    The Bois Forte Reservation Lead Program request for federal
delegation of authority is a natural application of tribal sovereign
power over environmental regulatory activities on the Tribe's lands
for the health, welfare, and safety of community members.

EPA believes that the Tribe's program description, above, together
with the rest of the application, demonstrates adequate civil
regulatory jurisdiction over the matter and entities regulated.

IV. Federal Overfilling

    Section 404(b) of TSCA makes it unlawful for any person to violate,
or fail or refuse to comply with, any requirement of an approved state
or tribal program. Therefore, if EPA approves the Bois Forte Lead
Program application, EPA reserves the right to exercise its enforcement
authority under TSCA against a violation of, or a failure or refusal to
comply with, any requirement of the Bois Forte Lead Program to the
extent that such requirement is consistent with federal law.

List of Subjects

    Environmental Protection, Hazardous Substances, Lead, Renovation
Notification, Reporting and Recordkeeping requirements.

    Dated: June 10, 2014.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2014-14591 Filed 6-20-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65854-65856]
[FR Doc No: 2019-25840]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87602; File No. SR-CboeBYX-2019-022]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Paragraph (a) of Rule 11.1 To Allow the Exchange To Accept Stop Orders
Entered Between 6:00 and 7:00 a.m. Eastern Time

November 22, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 19, 2019, Cboe BYX Exchange, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BYX Exchange, Inc. (``BYX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend paragraph (a) of Rule 11.1 to allow the
Exchange to accept Stop Orders entered between 6:00 and 7:00 a.m.
Eastern Time. The text of the proposed rule change is provided in
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/byx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend paragraph (a) of Rule 11.1 to allow
the Exchange to accept Stop Orders \3\ entered between 6:00 and 7:00
a.m. Eastern Time.
---------------------------------------------------------------------------

    \3\ A Stop Order is an order that becomes a BYX market order
when the stop price is elected. A Stop Order to buy is elected when
the consolidated last sale in the security occurs at, or above, the
specified stop price. A Stop Order to sell is elected when the
consolidated last sale in the security occurs at, or below, the
specified stop price. See Exchange Rule 11.9(c)(16).
---------------------------------------------------------------------------

    Paragraph (a) of Rule 11.1 provides that orders entered between
6:00 a.m. and 7:00 a.m. Eastern Time are not eligible for execution
until the start of the Early Trading Session,\4\ Pre-Opening Session
\5\ or Regular Trading Hours,\6\ depending on the Time in Force
selected by the User.\7\ Paragraph (a) also provides that the Exchange
will not accept certain orders \8\ entered prior to 7:00 a.m. Eastern
Time including BYX Market Orders \9\ with a Time in Force other than
Regular Hours Only (``RHO'').\10\ BYX Market Orders with a Time in
Force other than RHO are rejected by the Exchange prior to 7:00 a.m.
Eastern Time because BYX Market Orders are not eligible to trade prior
to the start of Regular Trading Hours and such orders are generally not
designated to queue for later entry onto the Exchange's order book.
Rather, BYX Market Orders with a Time in Force other than RHO are
designed to immediately execute at the NBBO when

the order reaches the Exchange, and thus are generally intended for
entry during a trading session where continuous trading is occurring.
Alternatively, other order types and modifiers, such as BYX Market
Orders with a Time in Force of RHO and Limit Orders,\11\ including Stop
Limit Orders,\12\ are allowed for entry on the Exchange between 6:00
and 7:00 a.m. Eastern Time as those order types and modifiers are
consistent with an order designated to queue for later entry on to the
Exchange's order book. Specifically, BYX Market Orders with a Time in
Force of RHO are effectively for use in the Opening Auction and are
cancelled if not executed in the Opening Auction.\13\ Therefore, BYX
Market Orders with a Time in Force of RHO would be queued until the
start of the regular trading session for participation in the Opening
Auction. Similarly, the stop price of a Stop Limit Order can only be
triggered by a consolidated last sale eligible trade.\14\ Therefore, a
Stop Limit Order would be queued until the time the stop price of the
order is triggered by a consolidated last sale eligible trade occurring
Regular Trading Hours.
---------------------------------------------------------------------------

    \4\ See Exchange Rule 1.5(ee).
    \5\ See Exchange Rule 1.5(r).
    \6\ See Exchange Rule 1.5(w).
    \7\ See Exchange Rule 1.5(cc).
    \8\ Specifically, Exchange Rule 11.1(a) provides that BYX Post
Only Orders, Partial Post Only at Limit Orders, Intermarket Sweep
Orders (``ISOs''), BYX Market Orders with a Time in Force other than
Regular Hours Only, Minimum Quantity Orders that also include a Time
in Force of Regular Hours Only, RPI Orders and all orders with a
Time in Force of Immediate-or-Cancel (``IOC'') or Fill-or-Kill
(``FOK'') are not accepted if entered prior to 7:00 a.m. Eastern
Time.
    \9\ A BYX Market Order is an ``order to buy or sell a stated
amount of a security that is to be executed at the NBBO when the
order reaches the Exchange. BYX market orders shall not trade
through Protected Quotations . . . BYX Market Orders are not
eligible for execution during the Early Trading Session, Pre-Opening
Session or the After Hours Trading Session.'' See Exchange Rule
11.9(a)(2).
    \10\ RHO refers to a ``limit or market order that is designated
for execution only during Regular Trading Hours, which includes the
Opening Process, as defined in Rule 11.23.'' See Exchange Rule
11.9(b)(7).
    \11\ A Limit Order is an ``order to buy or sell a stated amount
of a security at a specified price or better.'' See Exchange Rule
11.9(a)(1).
    \12\ A Stop Limit Order is ``an order that becomes a limit order
when the stop price is elected. A Stop Limit Order to buy is elected
when the consolidated last sale in the security occurs at, or above,
the specified stop price. A Stop Limit Order to sell becomes a sell
limit order when the consolidated last sale in the security occurs
at, or below, the specified stop price.'' See Exchange Rule
11.9(c)(17).
    \13\ An order with a Time in Force of RHO is a limit or market
order that is designated for execution only during Regular Trading
Hours, which includes the Opening Auction and Closing Auction. See
Exchange Rule 11.9(b)(7).
    \14\ See supra note 12.
---------------------------------------------------------------------------

    As proposed, the amendment would allow the Exchange to accept Stop
Orders entered between 6:00 and 7:00 a.m. Eastern Time, which is
consistent with an order designated to queue for later entry on to the
Exchange's order book. Similar to a Stop Limit Order, the stop price of
a Stop Order can only be triggered by a consolidated last sale eligible
trade.\15\ Therefore, a Stop Order can only become a BYX Market Order
after at least the start of Regular Trading Hours. Further, Stop Orders
entered on the Exchange between 6:00 and 7:00 a.m. Eastern Time would
behave similar to Stop Limit Orders between the time of entry up to at
least the start of Regular Trading Hours.
---------------------------------------------------------------------------

    \15\ See supra note 3.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\16\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \17\ requirements that the rules of an exchange be
designed to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As discussed above, all Stop Orders are designed to queue until at
least the start of Regular Trading Hours as such orders are only
eligible to be elected based on the consolidated last sale set during
Regular Trading Hours. Therefore, the proposed amendment to allow the
entry of Stop Orders between 6:00 and 7:00 a.m. Eastern Time would not
allow such Stop Orders to be elected and execute prior to the start of
Regular Trading Hours. Prior to the start of Regular Trading Hours,
Stop Orders entered between 6:00 and 7:00 a.m. Eastern Time would
behave similar to Stop Limit Orders entered during that time.
Therefore, the Exchange believes the proposed amendment would
consistently allow order types and modifiers that are consistent with
orders designated to queue to be entered on the Exchange between 6:00
and 7:00 a.m. Eastern Time.
    Additionally, the Exchange believes the proposed amendment would
allow Members the convenience to enter all Stop Orders and Stop Limit
Orders between 6:00 and 7:00 a.m. Eastern Time without those orders
being eligible for election, and consequently execution, until at least
the start of the Regular Trading Hours. Thus, the proposed amendment
would provide Members with both greater convenience and flexibility in
managing their Stop Orders and Stop Limit Orders without impacting how
those orders trade.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Rather, the proposed rule
change would consistently allow for the entry of order types and
modifiers that are designated to queue between 6:00 and 7:00 a.m.
Eastern Time. Stop Limit Orders are currently allowed for entry on the
Exchange between 6:00 and 7:00 a.m. Eastern Time and behave similar to
the manner in which a Stop Order would behave prior to the start of
Regular Trading Hours if allowed entry during that time. The Exchange
therefore believes that the proposed rule change would increase
consistency around the operation of the Exchange to the benefit of
Members and investors as well as provide greater flexibility to Members
in managing their Stop Orders, without imposing any significant burden
on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not:
    (i) significantly affect the protection of investors or the public
interest;
    (ii) impose any significant burden on competition; and
    (iii) become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \18\ and
Rule 19b-4(f)(6) \19\ thereunder.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBYX-2019-022 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeBYX-2019-022. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBYX-2019-022, and should be
submitted on or before December 20, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-25840 Filed 11-27-19; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL December 8, 2004 Allen R. Blem, Ph. D Crompton Corporation 74 Amity Road Bethany, CT 06524 Re: Preliminary Risk Assessments for the Reregistration Eligibility Decision for Dimethipin Dear Dr. Blem:

Enclosed is a copy of the preliminary human health and the environmental risk assessment for the reregistration of Dimethipin including its uses on all crops. This advance opportunity to review EPA's pesticide risk assessments for errors and for confidential business information is an integral part of a wider effort to involve the public in implementation of the Food Quality Protection Act of 1996. Accordingly, the EPA is following the public participation process for the reregistration of Dimethipin, as described in the Federal Register Notice published on March 14, 2004 ( 69 FR 26819).

Within the next 30 days, please identify and comment on any errors in the human health and the environmental risk assessment documents. During this phase of the reregistration process, you should address errors such as mathematical, computational, or typographic. The Agency will not respond to errors that pertain to matters of policy, interpretation, or applicability of data. Upon receipt of your " error correction" submission, the Agency will evaluate and respond to your comments, and will revise the risk assessments as necessary.

Also, in order to assist us in ensuring that your confidential business information ( CBI) is not inadvertently released to the public, we request that you review the risk assessments and supporting documents for CBI. Please inform the Agency in writing of any claims of CBI contained in this document. If we do not receive notification in writing of any such claims, within 30 days from the receipt of this letter, we may assume that the document is free of CBI. 2 Thirdly, please inform EPA of any pertinent completed, pending, or planned studies, and any other sources of information you intend to submit on Dimethipin. Providing EPA with a timetable for completing and submitting such information will enable us to better plan for refining the risk assessments and completing the reregistration and tolerance reassessments.

In March, 2005, EPA expects to release to the public your comments to both preliminary risk assessments, the Agency's review and discussion of your comments, and the revised human health and environmental risk assessments. These documents will be placed in EPA's electronic docket which is also accessible from the EPA's website ( www. epa. gov/ pesticides/ reregistration/ status. htm). The EPA will announce the availability of these documents via a Notice of Availability in the Federal Register and through an electronic listserver message.

Please send your response in both printed and electronic form, within 30 days of receipt of this letter, including claims of CBI, and other information to me at the address listed below:

Amaris Johnson, Chemical Review Manager US EPA ( 7508C) 1200 Pennsylvania Avenue, NW Washington, D. C. 20460 If you have any questions, please feel free to contact me at ( 703) 305 9542 or via email at johnson. amaris@ epa. gov. Thank you.

Sincerely,

Amaris K. Johnson Enclosures: Dimethipin: HED Chapter of the Reregistration Eligibility Decision Document ( RED). Reregistration Environmental Risk Assessment for Dimethipin. Tier I Estimated Environmental Concentrations of Dimethipin, for use in Human Health Risk Assessment. Dimethipin Chronic Dietary Exposure Assessment for the Reregistration Eligibility Decision Dimethipin. Residue Chemistry Considerations for Reregistration Eligibility Decision. Dimethipin. HED Product Chemistry Chapter for Reregistration Eligibility Decision. Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Dimethipin.


[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Rules and Regulations]
[Page 17910-17914]
[DOCID:fr02ap08-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0479; FRL-8347-9]

Ferric Citrate; Inert Ingredient; 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 under 40 CFR 180.910 for residues of ferric citrate (CAS
Reg. No. 2338-05-8) in or on raw agricultural commodities when applied/
used as inert ingredients in pesticide formulations. The Shepherd
Chemical Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996, requesting an exemption from the requirement of
a tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of ferric citrate.

DATES: This regulation is effective April 2, 2008. Objections and
requests for

hearings must be received on or before June 2, 2008, and must be filed
in accordance with the instructions provided in 40 CFR part 178 (see
also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0479. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR part 152. If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0479 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 June 2, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0479, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of June 7, 2006 (71 FR 32955) (FRL-8071-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
6E7062) by The Shepherd Chemical Company, 4900 Beech Street; Norwood,
OH 45212-2398. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of ferric citrate. No comments were received in response to
the notice of filing.
    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) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which 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.''
    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. Provided below in
Unit III is a brief summary and conclusions for the Agency's review of
ferric citrate. The full Inert Ingredient Decision Document for this
action is available on EPA's Electronic Docket at http://
www.regulations.gov/ under docket number EPA-HQ-OPP-2006-0479.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by ferric
citrate is discussed in this unit.
    The Agency reviewed the available information on ferric citrate and
determined that the toxicity database is sufficient. The toxicity
studies summarized below are from the published literature; their full
references are provided in the Decision Document. In summary, from what
is known about the sulfates of iron (as opposed to the citrate), it
appears that ferric citrate is not acutely toxic via the oral route. In
subchronic toxicity using mice, no effects were noted at the maximum
tolerated dose. In chronic toxicity testing, no effects were seen at
1,200 parts per million (ppm). Ferric citrate has not been shown to be
mutagenic or carcinogenic. Finally, no developmental and reproductive
effects have been shown.
    Acute toxicity. No acute toxicity studies per se were identified
for ferric citrate. In 2002 the Agency reassessed the tolerance
exemptions for the mineral acids and their salts. Among the chemicals
assessed were the iron sulfates. Acute toxicity values included: oral
LD50 rat--1,487 to 2,102 milligrams/kilograms (mg/kg); oral
LD50 mice--1,520 mg/kg; and dermal LD50 rabbit--
2,000 mg/kg. The National Academy of Sciences Institute of Medicine
(IOM) discusses reports of acute toxicity resulting from overdoses of
medicinal iron, especially in young children. Accidental iron overdose
is the most common cause of poisoning deaths in children under six
years of age in the U.S. The severity of iron toxicity is related to
the amount of elemental iron absorbed. Gastrointestinal (GI)
manifestations occur following the ingestion of 20 milligrams/kilograms
body weight (mg/kg bw) and systemic toxicity may occur following the
ingestion of 60 mg/kg bw. Vomiting and diarrhea characterize the
initial stages of iron intoxication while later systemic effects can
include those involving the heart, central nervous system, kidney,
liver, and blood. IOM reports that in studies with adults, GI effects
were seen at 50 milligrams/day (mg/day) of elemental iron; this finding
is supported by other studies showing similar effects.
    Subchronic toxicity. The open literature reports a study where
ferric citrate was administered to mice in drinking water at doses of
0; 0.06; 0.12; 0.25; 0.5; or 1% (which is equivalent to 0; 600; 1,200;
2,500; 5,000; or 10,000 ppm) for 13 weeks. The investigators determined
that the maximum tolerated dose is 1,200 ppm.
    Mutagenicity. The open literature provides results of Ames testing
(with S. typhimurium strains TA92, TA 1535, TA100, TA1537, TA94, and
TA98) and chromosomal aberration testing (with Chinese hamster
fibroblasts). In the Ames test using 25 milligrams/plate (mg/plate) of
ferric citrate (the maximum dose), no significant increases in the
number of revertant colonies were detected in any S. typhimurium
strains. In the chromosomal aberration testing using 0.5 milligrams/
milliLiters (mg/mL) (the maximum dose), polyploidy was observed in 3%
of the cells after 48 hours and structural aberration was observed in
1% of the cells after 48 hours; the investigators concluded that these
results were negative for chromosomal aberration.
    Chronic toxicity. In a study reported in the open literature,
ferric citrate was administered to mice in drinking water at doses of
0; 0.06; or 0.12% (which is equivalent to 0; 600 or 1,200 ppm) for 96
weeks. No evidence of chronic toxicity or carcinogenicity was
demonstrated in the study.
    Developmental and reproductive toxicity. To determine if toxic
fetal serum iron levels are reached when maternal serum iron
concentrations rise above what the body can homeostatically maintain,
investigators dosed pregnant sheep with toxic doses of iron.
Specifically, four gravid ewes were dosed with ferric chloride at 2 mg/
kg/bw via intravenous administration over 60 minutes; this route was
chosen over the oral route because only a small amount of iron is
absorbed from the gastrointestinal tract after overdose. A significant
rise was observed in the maternal serum iron concentration but not in
that of the fetuses. The investigators concluded that the fetus is
protected from elevated maternal serum iron concentrations during the
third trimester of pregnancy, a period when the fetus acquires most of
the iron that it needs during the gestational period.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
    EPA does not have information available to assess the potential for
exposure to ferric citrate in consumer products. Nevertheless, given:
The natural and ubiquitous occurrence of iron-containing compounds in
the environment; iron's known role in human physiology; and its
presence in various foods such as beef, soybeans, lentils, and spinach,
it is unlikely that residential exposures of concern would result from
the use of ferric citrate in nonpesticide products and as an ingredient
in pesticide. Therefore, no further aggregate assessment is necessary.
    Dietary Exposure Food. EPA estimated dietary exposures for use of
ferric citrate as an inert ingredient using DEEM\(tm)\, or Dietary
Exposure Evaluation Model, a generic screening model that assumes that
the inert ingredient is used on all commodities and that 100 percent of
crops are treated with the inert ingredient. Generic chronic exposure
for the overall U.S. population was estimated at 0.12 mg/kg/day.
    2. Drinking water exposure. Iron concentrations in groundwater have
been reported to range <0.5 to 100 mg/L; higher values have been found
in the absence of oxygen and in the presences of organic matter. In
surface waters, iron concentrations can vary widely, ranging from 61 to
2,680 milligrams/Liters (mg/L).

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to ferric citrate and any
other substances and, this material does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that ferric citrate
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative/.

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

    Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues. Accordingly, EPA finds that exempting from the requirement of
a tolerance will be safe.

VII. Other Considerations

A. Analytical Method

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Tolerances

    The Agency is not aware of any country requiring a tolerance for
ferric citrate (CAS Reg. No. 2338-05-8), nor have any CODEX Maximum
Residue Levels (MRLs) been established for any food crops at this time.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 21, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec. 180.910 the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ferric Citrate (CAS Reg. No.      ..................  Stabilizer
 2338-05-8)
                              * * * * * * *
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[FR Doc. E8-6818 Filed 4-1-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11345]
[DOCID:fr13mr07-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-160-003]

El Paso Natural Gas Company; Notice of Compliance Filing

March 7, 2007.
    Take notice that, on March 1, 2007, El Paso Natural Gas Company
(EPNG) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, the following tariff sheets, with an effective
date of April 1, 2007:

First Revised Sheet No. 290B.01
First Revised Sheet No. 290C
Original Sheet No. 290D
Fifth Revised Sheet No. 419

    EPNG states that the filing is being made in compliance with the
Commission's order issued February 15, 2007 in the above referenced
proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4482 Filed 3-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Page 29211]
[FR Doc No: 2022-10165]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No.: FAA-2021-1058; Summary Notice No.--2022-24]

Petition for Exemption; Summary of Petition Received;
International Aviation Services, LLC

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before June 1, 2022.

ADDRESSES: Send comments identified by docket number FAA-2021-1058
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Alphonso Pendergrass,<PHONE_NUMBER>,
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Timothy R. Adams,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2021-1058.
    Petitioner: International Aviation Services, LLC.
    Section(s) of 14 CFR Affected: Sec.  60.17(c)(i).
    Description of Relief Sought: The Petitioner is seeking an
exemption from the two (2) year time limit stated in 14 CFR part
60.17(c)(i) to allow the NASA Ames B747-400 FSTD, FAA ID #431 to have
its qualification restored using the original qualification basis in
accordance with Advisory Circular (AC) 120-40B.

[FR Doc. 2022-10165 Filed 5-11-22; 8:45 am]
BILLING CODE 4910-13-P