[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Notices]
[Pages 21064-21066]
[FR Doc No: 2020-07911]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2020-0027-N-6]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Request (ICR) abstracted below. Before submitting this ICR
to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public comment on specific aspects of the activities
identified in the ICR.

DATES: Interested persons are invited to submit comments on or before
June 15, 2020.

ADDRESSES: Submit written comments on the ICR activities by mail to
either: Ms. Hodan Wells, Information Collection Clearance Officer,
Office of Railroad Safety, Regulatory Analysis Division, Federal
Railroad Administration, 1200 New Jersey Avenue SE, Washington, DC
20590; or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Information Technology, Federal Railroad Administration, 1200
New Jersey Avenue SE, Washington, DC 20590. Commenters requesting FRA
to acknowledge receipt of their respective comments must include a
self-addressed stamped postcard stating, ``Comments on OMB Control
Number 2130-0010,'' and should also include the title of the ICR.
Alternatively, comments may be faxed to<PHONE_NUMBER> or<PHONE_NUMBER>,
or emailed to Ms. Wells at<EMAIL_ADDRESS>or Ms. Toone at
<EMAIL_ADDRESS>Please refer to the assigned OMB control number in
any correspondence submitted. FRA will summarize comments received in
response to this notice in a subsequent notice and include them in its
information collection submission to OMB for approval.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICR
regarding: (1) Whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5
CFR 1320.8(d)(1).
    FRA believes that soliciting public comment may reduce the
administrative and paperwork burdens associated with the collection of
information that Federal regulations mandate. In summary, FRA reasons
that comments received will advance three objectives: (1) Reduce
reporting burdens; (2) organize information collection requirements in
a ``user-friendly'' format to improve the use of such information; and
(3) accurately assess the resources expended to retrieve and produce

information requested. See 44 U.S.C. 3501.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Track Safety Standards.
    OMB Control Number: 2130-0010.
    Abstract: The information collection associated with 49 CFR part
213 is used by FRA to ensure and enhance rail safety by monitoring
complete compliance with all regulatory requirements. Part 213
prescribes minimum safety requirements for railroad track that is part
of the general railroad system of transportation. While the
requirements prescribed in this part generally apply to specific track
conditions existing in isolation, a combination of track conditions,
none of which individually amounts to a deviation from the requirements
in this part, may require remedial action to provide safe operations
over that track. Qualified persons inspect track and take action to
allow safe passage of trains and ensure compliance with the prescribed
standards. In 2013, FRA amended the Track Safety Standards and
Passenger Equipment Safety Standards to promote the safe interaction of
rail vehicles with the track over which they operate under a variety of
conditions at speeds up to 220 m.p.h.
    Type of Request: Extension with change (revised estimates) of a
currently approved collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Respondent Universe: 746 railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                Respondent
         CFR section             universe     Total annual     Average time per    Total annual     Total cost
                               (railroads)      responses          responses       burden hours   equivalent \1\
----------------------------------------------------------------------------------------------------------------
213.4(f)--Excepted track--             746  15 notices......  10 minutes........             2.5            $190
 Notification to FRA about
 removal of excepted track.
213.5(c)--Responsibility for           746  15 notices......  1 hour............              15           1,140
 compliance--Notification of
 assignment to FRA.
213.7(a)-(b)--Designations:            746  2,500 documents.  10 minutes........           416.7          31,669
 Names on list with written
 authorizations.
213.17(a)--Waivers...........          746  10 petitions....  2 hours...........              20           1,520
213.57(e)--Curves, elevation           746  4 requests......  8 hours...........              32           2,432
 and speed limitations--
 Request to FRA for vehicle
 type approval.
213.57(f)--Written                     746  4 notifications.  2 hours...........               8             608
 Notification to FRA prior to
 implementation of higher
 curving speeds.
213.57(g)--Written consent of          746  4 written         45 minutes........               3             228
 track owners obtained by                    consents.
 railroad providing service
 over that track.
213.110(a)--Gage restraint             746  1 notification..  45 minutes........              .8              61
 measurement systems (GRMS)--
 Implementing GRMS--notices &
 reports.
213.110(g)--GRMS vehicle               746  1 report........  5 minutes.........              .1               8
 output reports.
213.110(h)--GRMS vehicle               746  1 report........  5 minutes.........              .1               8
 exception reports.
213.110(j)--GRMS/PTLF--                746  1 documented      1 hour............               1              76
 procedures for data                         procedure.
 integrity.
213.110(n)--GRMS inspection            746  2 records.......  30 minutes........               1              76
 records.
213.118(a)-(c)--Continuous             438  10 plans........  4 hours...........              40           3,040
 welded rail (CWR)--Revised
 plans w/procedures for CWR.
213.118(d)--Notification to            438  750               15 seconds........             3.1             236
 FRA and RR employees of CWR                 notifications
 plan effective date.                        to employees.
213.118(e)--Written                    438  5 written         2 hours...........              10             760
 submissions after plan                      submissions.
 disapproval.
213.118(e)--Final FRA                  438  5 amended plans.  1 hour............               5             380
 disapproval and plan
 amendment.
213.234(f)--Automated                   30  2,000 records...  30 minutes........           1,000          76,000
 inspection of track
 constructed with concrete
 crossties--Recordkeeping
 requirements.
213.237(b)(2)--Inspection of            65  4 requests......  15 minutes........               1              76
 Rail--Detailed request to
 FRA to change designation of
 a rail inspection segment or
 establish a new segment.
213.237(b)(3)--Notification             65  1 notice to FRA   15 minutes........               4             304
 to FRA and all affected                     + 15 bulletins.
 employees of designation's
 effective date after FRA's
 approval/conditional
 approval.
213.237(d)--Notice to FRA               65  4 notices.......  15 minutes........               1              76
 that service failure rate
 target in paragraph (a) of
 this section is not achieved.
213.237(d)--Explanation to              65  4 letters of      15 minutes........               1              76
 FRA as to why performance                   explanation/
 target was not achieved and                 plans.
 provision to FRA of remedial
 action plan.
213.241--Inspection                    746  1,375,000         10 minutes........       229,166.7      17,416,669
 records\2\.                                 records.
213.303(b)--Responsibility               2  5 notices.......  30 minutes........             2.5             190
 for compliance--Notification
 of assignment to FRA.
213.305(a)-(c)--Designation              2  20 written        30 minutes........              10             760
 of qualified individuals;                   documents.
 general qualifications--
 Written authorization for
 remedial actions.
213.305(e)--Designation of               2  200 records.....  10 minutes........            33.3           2,531
 qualified individuals;
 general qualifications;
 recordkeeping requirements
 for designations.

213.317(a)-(b)--Waivers......            2  2 petitions.....  8 hours...........              16           1,216
213.329(e)--Curves, elevation            2  2 cover letters   30 minutes + 16               33.5           2,546
 and speed limitations--FRA                  + 2 technical     hours + 15
 approval of qualified                       reports + 2       minutes.
 vehicle types based on                      diagrams.
 results of testing.
213.329(f)--Written                      2  2 notices.......  2 hours...........               4             304
 notification to FRA 30 days
 prior to implementation of
 higher curving speeds.
213.329(g)--Written consent              2  2 written         45 minutes........             1.5             114
 of other affected track                     consents.
 owners by railroad.
213.333(d)--Automated vehicle-           7  7 reports.......  1 hour............               7             532
 based inspection systems--
 Track Geometry Measurement
 System (TGMS) output/
 exception reports.
213.341(b)-(d)--Initial                  2  800 records.....  2 minutes.........            26.7           2,029
 inspection of new rail &
 welds--Inspection records.
213.343(a)-(e)--Continuous               2  2 plans.........  4 hours...........               8             608
 welded rail (CWR)--
 Procedures for installations
 and adjustments of CWR.
213.343(h)--Recordkeeping                2  8,000 records...  2 minutes.........           266.7          20,269
 requirements.
213.345(a)-(c)--Vehicle                  2  2 program plans.  120 hours.........             240          18,240
 qualification testing--
 Vehicle qualification
 program for all vehicle
 types operating at track
 Class 6 speeds or above.
213.345(d)--Previously                   2  2 program plans.  8 hours...........              16           1,216
 qualified vehicle types
 qualification programs.
213.345(h)--Written consent              4  4 written         30 minutes........               2             230
 of other affected track                     consents.
 owners by railroad.
213.369(d)--Inspection                   2  15,000 records..  10 minutes........           2,500         190,000
 Records--Record of
 inspection of track.
                              ----------------------------------------------------------------------------------
    Total....................          746  1,404,410         N/A...............         233,899     17,776,417
                                             responses.
----------------------------------------------------------------------------------------------------------------
\1\ The dollar equivalent cost is derived from the Surface Transportation Board's Full Year Wage A&B data series
  using the appropriate employee group hourly wage rate that includes a 75-percent overhead charge.
\2\ Note: Each record of an inspection under Sec.  Sec.   213.4, 213.119, 213.233, 213.235, and 213.237 is
  covered under Sec.   213.241.

    Total Estimated Annual Responses: 1,404,410.
    Total Estimated Annual Burden: 233,899 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$17,776,417.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Chief Counsel.
[FR Doc. 2020-07911 Filed 4-14-20; 8:45 am]
BILLING CODE 4910-06-P


                  BIOPESTICIDES REGISTRATION ACTION DOCUMENT

                           Ethyl-2E,4Z-decadienoate
                                  (Pear Ester)

                               PC Code: 	144022

	U.S. Environmental Protection Agency
	Office of Pesticide Programs
                Biopesticides and Pollution Prevention Division

                         (last updated August 7, 2013)

                               Table of Contents
I.	EXECUTIVE SUMMARY	5
II.	ACTIVE INGREDIENT OVERVIEW	6
III.	REGULATORY BACKGROUND	6
A.	Application for Pesticide Registration	6
B.	Food Clearances/Tolerances	6
IV.	RISK ASSESSMENT	7
A.	Product Analysis Assessment (40 CFR § 158.2030)	7
B.	Human Health Assessment	8
1.	Tier I Toxicology	8
2.	Tier II and Tier III Toxicity Studies	9
3.	Effects on the Endocrine System	9
4.	Dose Response Assessment	10
5.	Drinking Water Exposure and Risk Characterization	10

6.	Occupational, Residential, School and Day Care Exposure and Risk Characterization	10
a.	Occupational Exposure and Risk Characterization	10
b.	Residential, School and Day Care Exposure and Risk Characterization	10

7.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation	11
a.	Food Exposure	11
b.	Drinking Water Exposure	11
c.	Other Non-occupational Exposure	11

8.	Cumulative Effects from Substances with a Common Mechanism of Toxicity	11
9.	Determination of Safety for United States Population, Infants and Children	11
10.	Risk Characterization	12
C.	Environmental Assessment	12
1.	Ecological Hazards	12
2.	Environmental Fate and Ground Water Data	13
3.	Ecological Exposure and Risk Characterization	13
4.	Endangered Species Assessment	13
D.	Product Performance Data	14
V.	RISK MANAGEMENT DECISION	14
A.	Determination of Eligibility for Registration	14
B.	Regulatory Decision	14
C.	Environmental Justice	15
VI.	ACTIONS REQUIRED BY REGISTRANTS	15
A.	Reporting of Adverse Effects	15
B.	Reporting of Hypersensitivity Incidents	15
VII.	 Appendix A. Data Requirements (40 CFR Part 158-Subpart U)	16
VIII.  Appendix B. References	19
IX.	GLOSSARY OF ACRONYMS AND ABBREVIATIONS	21

BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief
Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms
Clara Fuentes, Ph.D., Entomologist

Regulatory Action Leader
Gina Burnett, M.S.

EXECUTIVE SUMMARY

Ethyl-2E,4Z-decadienoate (pear ester) is a naturally occurring, volatile substance emitted from mature, ripening fruit, that is particularly attractive to the codling moth (CM), Cydia pomonella. This species of moth is a major agricultural pest of pome fruit worldwide (Ref. 1). Both male and female moths have receptors for pear ester in their antenna, which attracts them to ripening fruit where they can mate and their eggs will be laid in the fruit. Synthetic pear ester is structurally and functionally identical to its natural counterpart, and its intended pesticidal use is to disrupt the CM mating behavior by confusing the moths and attracting them away from the fruit, and reducing their chances of finding mates and laying eggs in fruit orchards.

The manufacturing-use pesticide product, Pear Ester Technical Grade (EPA File Symbol No. 52991-ET), is proposed to be registered. This product contains pear ester at 93.4% and is intended for formulating end-use products that will be applied pre-harvest, as a foliar spray or contained within polymeric dispensers, to pome fruit orchards in agricultural settings where codling moths appear in order to disrupt their normal mating patterns.

Data derived from appropriate tests give no indication that pear ester is toxic or pathogenic to humans. No unreasonable adverse effects to humans are expected from its use as a codling moth mating disruptor. Furthermore, pesticide products containing pear ester are not likely to pose a risk to the environment, including nontarget organisms.

On October 1, 2009, the U.S. Environmental Protection Agency (EPA or the Agency) announced a policy to provide a more meaningful opportunity for the public to participate in major registration decisions before they occur. According to this policy, EPA provides a public comment period prior to making a registration decision for the following types of applications:  new active ingredients; first food uses; first outdoor uses; first residential uses; or any other registration actions for which EPA believes there may be significant public interest.

Consistent with the policy of making registration decisions more transparent, the public is provided 15 days in which to submit comments to the Agency regarding its pending decision to register pear ester as a new pesticide active ingredient, including its first food use and first outdoor use. The following documents are available for comment in the docket, identification number EPA-HQ-OPP-2011-1031: this draft Biopesticides Registration Action Document (BRAD) and the draft product label for Pear Ester Technical Grade (EPA File Symbol 52991-ET), accessed through either http://www.regulations.gov or http://www.epa.gov/pesticides/regulating/registration-status.html.

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.

ACTIVE INGREDIENT OVERVIEW

      Common Name: 		Pear Ester

      Chemical Names:		Ethyl-2E,4Z-decadienoate

      Trade & Other Names: 	Pear Ester Technical Grade

      CAS Registry Number: 	3025-30-7

      OPP Chemical Code: 	144022

      Type of Pesticide:            	Biochemical Pesticide  -  Mating Disruptor

Biochemical Classification

To be classified as a biochemical pesticide, an active ingredient must be naturally occurring and have a non-toxic mode of action on their targeted pests. As a structural and functional mimic of naturally occurring ethyl-2E,4Z-decadienoate, with a non-toxic mode of action (mating disruption by confusion) towards the target pest, pear ester meets the qualifications to be classified as a biochemical pesticide.

For more information regarding product chemistry data requirements, please refer to Tables 1 and 2 in Appendix A.

REGULATORY BACKGROUND

Application for Pesticide Registration

On July 12, 2011, Wagner Regulatory Associates, Inc., on behalf of Bedoukian Research, Inc. (hereafter referred to as "Bedoukian" or "applicant"), 21 Finance Drive, Danbury, CT, 06810, submitted applications to register a new biochemical pesticide product, Pear Ester Technical Grade (EPA File Symbol No. 52991-ET), containing ethyl-2E,4Z-decadienoate (pear ester) as the active ingredient. The product is intended to be used to manufacture end-use pesticide products that cause mating disruption in codling moths in pome fruit orchards. A notice of receipt (NOR) of the applications was published in the Federal Register on February 29, 2012, (77 FR 12295). No comments were received during the 30-day comment period following publication of the NOR.

Food Clearances/Tolerances

On July 12, 2011, Wagner Regulatory Associates, on behalf of Bedoukian, filed a petition (PP 1F9701) proposing to establish an exemption from the requirement of a tolerance for residues of Pear Ester in or on all food commodities. A notice of filing (NOF) was published in the Federal Register on March 14, 2012 (77 FR 15012). No comments were received regarding pear ester during the 30-day comment period following the publication of the NOF.

Pear ester is an approved additive listed by the U.S. Food and Drug Administration (FDA) on the Everything Added to Food in the United States (EAFUS) list (Ref. 2). It has an intensely fruity flavor and is used in candies and other processed foods. The average daily intake of pear ester reported by the Joint Food and Agriculture Organization of the United States/World Health Organization Expert Committee on Food Additives is 34ug in Europe and 3ug in the United States. JECFA has determined that current intake of pear ester poses no safety concerns (Ref. 1).

Foliar sprays of pear ester that reach the fruit are expected to degrade over the course of the season prior to harvest because this biochemical is a volatile kairomone (Henry's Law Constant estimated 7 x 10[-4] atm m[3]/mol) that dissipates rapidly in the environment and undergoes degradation in the presence of air and light (Ref. 1). However, assuming a foliar spray worst case scenario (no volatilization or degradation), the potential dietary exposure of pear ester has been calculated as 6.4ug in unwashed fruit. When the product is to be released over time (volatilization) from a polymeric dispenser attached to the tree branch, a worst case scenario indicates 0.16 ug pear ester in unwashed fruit (Ref. 3). Therefore, consumption of pear ester as a result of pesticidal exposure is not expected to exceed the current exposure to pear ester as a flavoring agent.

Based on information submitted in support of the tolerance petition, and the comprehensive risk assessment conducted by the Agency, EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to pear ester, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination for the following reasons: (1) available toxicology data and information indicate that the active ingredient is of low acute toxicity and is not a likely developmental toxicant, mutagen, or toxic via repeat oral exposure (2) available information from the scientific literature indicates that humans are already exposed to pear ester in their diet from foods that naturally contain the chemical and from foods to which the chemical has been added as higher levels.

 RISK ASSESSMENT

A. Product Analysis Assessment (40 CFR § 158.2030)

Biochemical pesticide product analysis data requirements include product chemistry and composition, analysis and certified limits, and physical and chemical characteristics. Product chemistry and composition data include information about the identity of the active ingredient, the manufacturing process, and discussion of the potential for formation of unintentional ingredients. Analysis and certified limits data include information on analysis of samples and certification of limits. Physical and chemical characteristics data describe basic characteristics of the registered pesticide products, including color, physical state, odor, stability, miscibility, pH, corrosion characteristics, viscosity and density.

EPA assigned a unique PC code (144022) to pear ester, and all product analysis data required for an unconditional registration have been fulfilled.
Refer to Table 1 in Appendix A for a summary of product chemistry and composition, analysis and certified limits data. Refer to Table 2 in Appendix A for a summary of physical and chemical characteristics data.

Human Health Assessment

Tier I Toxicology

Adequate mammalian toxicology data and information are available to support registration of pear ester as a biochemical pesticide. All toxicology data requirements for pear ester have been satisfied, and are summarized below (see also Table 3 in Appendix A of this document).

Acute Toxicity (OCSPP Guideline Nos. 870.1100, 870.1200, 870.1300, 870.2400, 870.2500, and 870.2600; Master Record Identification (MRID) Nos. 48538708, 48538906, 48975101):

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes, and 3) determine the potential for skin sensitization (allergic contact dermatitis).  Acute toxicity categories I, II, III, or IV are assigned to an active ingredient and end-use product(s) containing that active ingredient, and are based on the hazard(s) identified from studies and/or other information submitted to support the application to register an active ingredient and on file with the Agency. Toxicity Category I indicates the highest toxicity, and Toxicity Category IV indicates the lowest toxicity.

The applicant submitted data on two pear ester analogs, ethyl-2,4,7-decatrienoate and methyl-2-nonenoate, in order to fulfill the biochemical pesticide date requirements for Acute Toxicity. These two compounds are structural and functional analogs of pear ester, according to the Research Institute for Fragrance Materials (RIFM), and are expected to have biochemical pathways comparable to pear ester (Ref. 4). RIFM categorizes pear ester and the two analogs as "Ester/Simple C1-C4 Alcohol Straight Chain Ester/Unsatured/α, β-Unsaturated (Ref. 4)." Based upon data on ethyl-2, 4, 7-decatrienoate and methyl-2-nonenoate, pear ester is estimated to have an Acute Oral Toxicity (rat) of LD50 > 4,027 mg/kg (Ref. 4). Researchers have found a nearly 100% concordance between results of oral and dermal routes for over 1,600 substances where the oral LD50 > 2,000 mg/kg (Ref. 4). Therefore, the Agency predicts the Acute Dermal Toxicity (rat) of pear ester to be LD50 > 2,000 mg/kg.

The applicant provided scientific rationale to fulfill the data requirement of Acute Inhalation Toxicity: Pear ester has a low vapor pressure (0.173 mm Hg) and is 137 times less volatile than water at 25°C (Pear ester volatility = 23.8 mm Hg at 25oC. Maximum manufacturing operating temperatures are 110 °C and 50 °C, which is much lower than its boiling point (258.4 °C). This information suggests that airborne concentrations of Pear ester will be minimal and unlikely to pose potential risk from inhalation exposure in the work place. In addition, Bedoukian, Inc., has produced pear ester for more than 30 years for non-pesticide uses with no reported worker related adverse effects (Ref. 4).

Acute toxicity data on pear ester submitted by the applicant indicate Primary Eye Irritation (rabbit): moderately irritating; Primary Dermal Irritation (rabbit): non-irritant; and Dermal Sensitization (guinea pig): not a dermal sensitizer (Ref. 4).

Subchronic Toxicity, Developmental Toxicity, and Mutagenicity Testing (Tier I) (OCSPP Guideline Nos. 870.3100, 870.3250, 870.3465; 870.3700, 870.5100, 870.5300, 870.5375; MRID Nos. 48975101, 48975102):

The applicant submitted scientific rationale to fulfill Subchronic Toxicity, Developmental and Mutagenicity Tier I testing data requirements. The rationale states that 1) pear ester is ubiquitous in nature and the maximum amount of pear ester recommended for foliar application (1.2 grams pear ester per acre per month) is about three times less than the natural background levels reported for pear ester release in a typical orchard (3.712 grams of pear ester per acre per month) (Ref. 1, Ref. 3); 2) the maximum amount of pear ester recommended for a dispenser treatment program is about three times more than the amount that can be expected from natural background emissions (about 12g pear ester per acre per month) but results of a theoretical air concentration calculation show pear ester levels of only 0.0008 ppm within the orchard (Ref. 3); 3) pear ester dietary pesticidal exposure is not expected to exceed the current exposure to pear ester as a flavoring agent (Ref. 3, Ref 4.) ; 4) pear ester is a volatile kairomone (Henry's Law Constant estimated 7 x 10[-4] atm m[3]/mol) that dissipates rapidly in the environment and undergoes degradation in the presence of air and light (Ref. 1); 5) pear ester is structurally similar to straight chain lepidopteran pheromones (unbranched aliphatic chains between 9 and 18 carbons ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone), which have well documented low toxicity (Ref. 5); and 6) has a non-toxic mode of action (Ref. 1); and 7) data submitted to fulfill the requirements for Acute Toxicity data indicate that pear ester is of low toxicity (Unit B. 1. a., above).

Tier II and Tier III Toxicity Studies

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III were not required due to the low toxicity of the active ingredient and the low levels of exposure expected from its intended uses in EP products.

Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders and data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients.  This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios.  This list should not be construed as a list of known or likely endocrine disruptors.

Pear ester is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test orders and data call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:  http://www.epa.gov/endo/.

Dose Response Assessment

No toxicological endpoints were identified for this active ingredient; therefore, a dose-response assessment was not required.

Drinking Water Exposure and Risk Characterization

No significant exposure from drinking water is expected when pear ester is used according to the product label directions. The active ingredient is a naturally occurring component of the human diet and biodegrades rapidly in the environment. Its proposed use requires low application rates, and will not be directly applied to water, so residues of pear ester are unlikely to accumulate in drinking water. In the event that exposure to pear ester via drinking water occurs, human health risks are expected to be minimal due to its low toxicity.

Occupational, Residential, School and Day Care Exposure and Risk Characterization

         a. Occupational Exposure and Risk Characterization

Agricultural treatments of pome fruit orchards with pear ester are limited to pre-harvest applications, and appropriate PPE requirements on end-use product labels will mitigate any potential exposure to applicators and/or handlers. Additionally, no relevant toxicological endpoints have been identified. Based on the data and information available to the Agency, anticipated exposure is not likely to result in unreasonable risk to humans.

         b. Residential, School and Day Care Exposure and Risk Characterization

Exposure to pear ester from its pesticidal uses in residential, school, and day care areas will be minimal, as the active ingredient is intended only for use in agriculture.

Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty of no harm to U.S. populations, including infants and children, from aggregate exposures to residues of pear ester when used as proposed. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.  Moreover, potential non-occupational inhalation and dermal exposure is not likely to pose any adverse effects to exposed populations via aggregate and cumulative exposure.

         c. Food Exposure

Dietary exposure of pear ester is already occurring, given that this substance is used as a flavoring agent in many foods commonly consumed by humans (for its intensely fruity flavor) and is emitted naturally from mature, ripening fruit, including Bartlett pears and concord grapes (Ref. 1). In addition, the proposed rates of application for use of pear ester as a codling moth mating disruptor, under worst case scenarios, are not expected to produce dietary exposure to pear ester exceeding that of current exposure due to use of pear ester as a flavoring agent (Ref. 3, Ref. 4).

         d. Drinking Water Exposure

Polymer dispenser products containing pear ester would not result in water residues because the product would be volatizing from the dispenser, dissipating, and degrading rapidly. Foliar spray products containing pear ester are intended for use at rates of less than one gram of active ingredient per acre with no direct applications to bodies of water. Therefore, drinking water exposure from the proposed used pattern is not expected to pose incremental risk to adults, infants and children via drinking water consumption (Ref. 4).

         e. Other Non-occupational Exposure

Non-occupational dermal exposure to pear ester when used as a codling moth mating disrupter is considered negligible because agricultural treatments of pome orchards are limited by label directions to pre-harvest applications (Ref. 4). Non-occupational dermal exposure via treated food commodities is not greater than naturally occurring background levels of pear ester and not greater than exposure due to use of pear ester as a food additive (Ref. 4).

Cumulative Effects from Substances with a Common Mechanism of Toxicity

Pear ester has no demonstrated toxicity, and there are no other pear ester-based products registered as pesticides; thus, there is no reason to expect cumulative effects of exposure to Pear Ester and to other substances with common mechanism of toxicity.

Determination of Safety for United States Population, Infants and Children

Pear ester is a synthetic compound that is structurally identical to, and mimics the naturally occurring form which is ubiquitous in nature and is responsible the characteristic aroma of pears and other fruits. Synthesized pear ester is structurally identical to naturally occurring pear ester. Therefore, as with straight chain lepidopteran pheromones, the Agency does not distinguish between the synthesized kairomone and its naturally occurring form with regards to physical-chemical characteristics or toxicology. The available data and information on pear ester indicate that the chemical (1) is of low toxicity and not a likely developmental toxicant, (2) naturally occurs in the human diet, and (3) has been approved by FDA for use in foods as a food additive without limitation. When compared to the amount of pear ester that is likely already consumed in the human diet, dietary exposure from pesticidal use is not anticipated to significantly increase overall dietary exposure of infants and children.

Therefore, it is expected that no harm will result from aggregate exposure to the United States population, including infants and children, to the residues of pear ester on food commodities.  This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Thus, there are not threshold effects of concern and consequently, provisions requiring additional margin of safety do not apply. Furthermore, considerations of consumption patterns, special susceptibility, and cumulative effects do not apply to pesticides without a demonstrated significant adverse effect.

Risk Characterization

The Agency considered human exposure to pear ester in light of the relevant safety factors in FQPA and FIFRA. A determination has been made that no unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, will result from the use of pear ester when label instructions are followed.

Environmental Assessment

   1. Ecological Hazards

The non-target toxicology information submitted by the applicant satisfies the non-target toxicology data requirements for pear ester and supports its registration.

Avian Oral Acute Toxicity, Avian Dietary Toxicity, Fish Acute Toxicity, Freshwater and Marine, and Aquatic Invertebrate Acute Toxicity (OCSPP Guideline Nos. 850.2100, 850.2200,850.1075, and 850.1010)

The following biochemical ecological data requirements are not required if the pesticide is highly volatile (estimated volatility > 5 x 10[-5] atm-m[3]/mol) (40 CFR 158.2060): Avian Oral Acute Toxicity, Avian Dietary Toxicity, Fish Acute Toxicity, Freshwater and Marine, and Aquatic Invertebrate Acute Toxicity (OCSPP Guideline Nos. 850.2100, 850.2200, 850.1075, and 850.1010). The volatility of pear ester (7.54 x 10[-4] atm-m[3]/mol (Henry's Law Constant at 25°C)) is above that value. Due to its volatility it dissipates rapidly in the environment.

Seedling Emergence and Vegetative Vigor (OCSPP Guidelines Nos. 850.4100 and 850.4150)

Pear ester is intended for formulation into EPs in which the active ingredient is contained in a polymeric dispenser to passively dissipate, or as a folier spray with maximum application of 24 grams of pear ester/acre/application. Assuming an equal, steady release of pear ester active ingredient over a 120-day = 4 months growing season, the respective exposures would be 24 g pear ester/acre/application / 4 months growing season, and 15 g pear ester/acre/application / 4 months growing season = 6, which equates to 6 and 3.75 g a.i./Acre/month, respectively. Due to the volatility and ready photodegradability of pear ester, it is unlikely that the use of these EPs at the recommended rate would result in adverse effects of pear ester to non-target plants.

Non-target Insect Testing (OCSPP Guideline 880.4350)

Pear ester is a non-toxic kairomone very similar to straight chain lepidopteran pheromones.  It is specific to lepidopteran pests, especially the codling moth, Cydia pomonella (Ref. 6). Pear ester also exhibits a degree of species specificity similar to that of pheromone, by being non-attractive to other insect species, both beneficial and pests, including eight key lepidopteran pests of pome fruits and other horticultural fruit and nut crops (Ref. 7). Furthermore, once it volatilizes, it readily undergoes oxidative photodegradation (Ref. 8). As a result, it presents no or very low toxicity risk to non-target insect species such as the honeybee.

Environmental Fate and Ground Water Data

Environmental fate and groundwater data are not required at this time because the results of the nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II data requirements.

Ecological Exposure and Risk Characterization

As stated above, pear ester exhibits a degree of species specificity similar to that of a pheromone, by being non-attractive to other insect species, both beneficial and pests, including eight key lepidopteran pests of pome fruits and other horticultural fruit and nut crops (Ref. 7). In addition, it is highly volatile and dissipates rapidly in the environment. Little to no exposure is expected for non-target organisms; however, any incidental exposures are not anticipated to be of any concern due to the low toxicity of this active ingredient.

Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The ecological risk assessment planned during registration review will allow the Agency to determine whether the uses of pear ester have "no effect" or "may effect" federally listed threatened or endangered species (listed species) or their designated critical habitats. Pear ester is structurally identical to the naturally occurring compound produced in pome fruit. It is not known to be toxic to any insect species or other non-target organisms. In addition, pear ester exhibits a degree of species specificity similar to that of a pheromone, by not attracting other insect species, including beneficials and several key lepidopteran pests of pome and other fruit and nut crops, while being highly attractive to the codling moth, Cydia pomonella. Based on this information, it is unlikely that pear ester will affect listed species. Furthermore, the listed lepidopteran species do not share the same habitats as the targeted pest.  For example, the Karner blue butterfly (Lycaeldes melissa samuelis) is a listed lepidopteran species that feeds exclusively on wild lupine (Lupinus perennis) in oak savannas and sandy lands and thus is not likely to inhabit areas where the products containing pear ester as an active ingredient will be used. Should this species inhabit areas where pome fruits are grown, they would be exposed to naturally occurring pear ester; however, due to the use patterns and high volatility of pear ester, it would not be expected to affect this or any other listed species.

Should an assessment conclude that a pesticide's use "may affect" a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

Product Performance Data

Product performance (efficacy) data must be developed for all pesticides to ensure that the products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. The Agency reserves the right to require, on a case-by- case basis, the submission of efficacy data for any pesticide product registered or proposed for registration, but applications to register pesticide products intended to control a pest of significance public health importance, as defined in FIFRA section 28(d) and section 2(nn), must include such data. For further guidance on the product performance data requirement, refer to Pesticide Registration Notice (PR) Notices 96-7, 2002-1 and Explanation of Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides (http://www.epa.gov/PR _Notices/pr1996-7.pdf) (http://www.ea.gov/PR_Notices/pr2002-1.pdf) and (http://www.epa.gov/pesticides/health/risk-benefit.htm).

This pear ester is not intended to be formulated into products to control public health pests as defined in FIFRA section 28(d) and section 2(nn), and product performance (efficacy) was not evaluated by the Agency.

RISK MANAGEMENT DECISION

B. Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is determined that: (A) its composition warrants proposed claims; (B) its labeling and other materials comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment.

The four eligibility criteria have been satisfied for the proposed pesticide products containing the active ingredient, pear ester; therefore, pear ester is eligible to be registered for the intended uses.

Regulatory Decision

The data submitted fulfill the requirements for the unconditional registration of pear ester as a mating disrupter for the codling moth. For product-specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

Environmental Justice

EPA seeks to achieve environmental justice -- the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income -- with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. At this time, EPA does not believe that use of pear ester pesticide products will cause harm or a disproportionate impact on at-risk communities. For additional information regarding environmental justice issues, please visit EPA's website at http://www.epa.gov/compliance/environmentaljustice/index.html.

ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the new active ingredient, pear ester, and determined that these data are sufficient to satisfy current registration data requirements. At this time, no additional data must be submitted to EPA for these particular products. For new uses and/or changes to existing uses, EPA may require additional data.
Notwithstanding the information stated in the previous paragraph, it should be clearly understood that certain specific data are required to be reported to EPA as a requirement for maintaining the federal registration for a pesticide product. A brief summary of these types of data are listed below.

C. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment must be submitted to EPA.

REPORTING OF HYPERSENSITIVITY INCIDENTS

Under the provisions of 40 CFR Part 158.2050(d), all incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency.

Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

NOTE:  Master Record Identification (MRID) numbers listed in the following tables are representative of supporting data/information for the original registration of the product containing this active ingredient. Subsequent to this registration, there may be additional MRIDs that support registration of other products containing this active ingredient.

TABLE 1. Product Identify, Composition, Analysis and Certified Limits for  Bedoukian Pear Ester Technical (40 CFR § 158.2030) MRIDs 48538901 thru 48538903
                        OPPTS Guideline Reference No.
                                     Study
                                   Results
                                   830.1550
                                      to
                                   830.1670
                               Product identity;
                            Manufacturing process;
             Discussion of formation of unintentional ingredients
              Acceptable; Confidential Business Information (CBI)
                                   830.1700
                              Analysis of samples
                                Acceptable; CBI
                                   830.1750
                            Certification of limits
              Limits listed in the CSF are adequate / acceptable.
                                   830.1800
                               Analytical method
                                Acceptable; CBI

TABLE 2.  Physical and Chemical Properties for Bedoukian Pear Ester Technical (40 CFR § 158.2030)
                               MRIDs 48538904 and 48538905

                    OCSPP Guideline Reference No./Property

                             Description of Result

                                    Methods

830.6302	Color
                                   Colorless
                               Visual inspection

830.6303	Physical State
                          Liquid at room temperature
                               Visual inspection

830.6304	Odor
                     Characteristic odor of Bartlett pear
                             Olfactory inspection

830.6313	Stability
Deteriorates slightly after 14 days at 54°C. Stable in the presence of iron, iron acetate, aluminum, or aluminum acetate for 14 days at room temperature or 54°C.
                                OCSPP 860.6313

830.6314	Oxidation/Reduction:
        Chemical Incompatibility
      Not applicable, the product does not contain oxidizing ingredients.

830.6315	Flammability
                            Flash point >230°F
                           Pensky Martens Closed Cup

830.6316	Explodability
      Not applicable, the product does not contain explosive ingredients.

830.6317	Storage Stability[b]
                   Stable for 12 months when stored at 0°C.
                                OCSPP 860.6317

830.6319	Miscibility
Not applicable, the product is not an emulsifiable liquid to be diluted with petroleum solvents.
                                       -

830.6320	Corrosion Characteristics[b]
No changes in integrity or appearance of aluminum containers after 12 months storage at 0°C.
                                OCSPP 830.6320

830.6321	Dielectric Breakdown Voltage
    Not applicable, the product is not for use around electrical equipment.
                                       -

830.7000	pH
      Not applicable, the product is not soluble or dispersible in water.
                                       -

830.7100	Viscosity
                                   4.56 cSt
                                   ASTM D445

830.7200	Melting Range
                   Not applicable, the product is a liquid.
                                       -

830.7220	Boiling Range
                                   258.41°C
                                   EPISuite

830.7300	Density/Relative Density/Bulk Density
                       Specific gravity = 0.903 at 25°C
                           Anton Parr Density Meter

830.7370	Dissociation Constant in Water
      Not applicable, the product is not soluble or dispersible in water.
                                       -

830.7550	Partition Coefficient
                                     4.36
                       SRC Interactive PhysProp database

830.7840	Water Solubility
                              8.588 mg/L at 25°C
                                   EPISuite

830.7950	Vapor Pressure
                             0.0173 mm Hg at 25°C
                                   EPISuite

TABLE 3.  Acute Toxicity Data for Bedoukian Pear Ester Technical (40 CFR 158.2050)

                          Study Type/OPPTS Guideline

                               LD50/LC50/Results

                               Toxicity Category
                                     MRID

Acute Oral Toxicity/OPPTS 870.1100
                                4027 mg/kg [a]

                                      III
                                 Firmenic,1966
                                 Givaudan,1982

Acute Dermal Toxicity/OPPTS 870.1200

                                2,000 mg/kg [b]

                                      III
                              Seidle at al. 2011

Acute Inhalation Toxicity/OPPTS 870.1300

                           Registrant's rationale
                                      IV
                                   48975101

Acute Eye Irritation/OPPTS 870.2400

                              Moderate irritating
                                      III
                                Firmenich,1996

Acute Dermal Irritation/OPPTS 870.2500
                                 Non-irritant

                                      IV
                                   48538906
                                   48538708

Skin Sensitization/OPPTS 870.2600

                              Not skin sensitizer

                                      IV
                                Givaudan, 1981
a	Predicted value (estimated using the US EPA program "Toxicity estimation Software Tool" (T.E.S.T.) version 4.1, available at http://www.epa.gov/ordntrnt/ORD/NRMRL/std/qsar.html).
b	Predicted value

TABLE 4. Ecological Toxicity Data Requirements for Bedoukian Pear Ester Technical (40 CFR § 158.2060)
                                  Guideline #
                                     Test
                           Results/Toxicity Category
                                     MRID
                               Study Conclusion
Acute Avian Oral
OCSPP 850.2100
                                Waiver Request
                                   48538907
                                  Acceptable
Acute Avian Dietary
OCSPP 850.2200
                                Waiver Request
                                   48538907
                                  Acceptable
Fish Acute Toxicity
OCSPP 850.1075
                                Waiver Request
                                   48538907
                                  Acceptable
Acute Aquatic Invertebrate
OCSPP 850.1010
                                Waiver Request
                                   48538907
                                  Acceptable

Terrestrial Plant (Seedling Emergence)
OCSPP 850.4100
Due to the volatility and ready photodegradability of pear ester, it is unlikely that its use would result in adverse effects to non-target plants.
                                   48538907
                                  Acceptable
Terrestrial Plant (Vegetative Vigor)
OCSPP 850.4150

                                   48538907
                                  Acceptable

Nontarget Insect
OCSPP 880.4350
Pear ester exhibits a degree of species specificity similar to that of pheromone, by being non-attractive to other insect species.
                                   48538907
                                  Acceptable

Appendix B. References

1. U.S. EPA, 2012. Memorandum from Clara Fuentes, Ph.D., to Gina Burnett. Tolerance Exemption Petition Review in support of registration of the following products: a) Bedoukian Pear Ester Technical  -  a manufacturing use product, containing 93.4 % w/w of 2,4-Decadienoic acid, ethyl ester, (2E,4Z); b) end use microencapsulated formulation Cidetrak DA-MEC, containing 5.0% w/w of Pear Ester, for foliar application to control larvae and adult Codling moth, Cydia pomonella, in apple, pear and walnut trees, and c) Cidetrack CM-DA Combo MD polymeric dispensers: Cidetrak CM-DA 115/30, containing 115 mgs of Codling Moth Pheromone and 30 mgs of Pear Ester; Cidetrak CM-DA 185/60, containing 185 mgs of Codling Moth Pheromone and 60 mgs of Pear Ester, and Cidetrak CM-DA 90/60, containing 90 mgs of Codling Moth Pheromone and 60 mgs of Pear Ester to control Codling moth, Cydia pomonella, and hickory Shuckworm, Cydia caryana, in apple, pear, walnut, pecan, quince, and other pome fruit trees. U.S. Environmental Protection Agency, Office of Pesticide Programs. June 28, 2012.

2. U.S. FDA, 2013. Everything Added to Food in the United States (EAFUS) list. U.S. Food and Drug Administration (FDA), accessed on April 1, 2013. Available at: http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=eafusListing&id=1183

3. Trece, 2011. Petition proposing the exemption from the requirement of a tolerance under 40 CFR § 180 for the biochemical active ingredient Ethyl 2,4 Decadienoate (CAS 3025-30-7) for pre-harvest uses on all agricultural commodities. Trece, Inc. July 8, 2011.

4. U.S. EPA, 2013. Memorandum from Clara Fuentes, Ph.D., to Gina Burnett. Science review of registrant's response to deficiencies concerning Tolerance Exemption Petition in support of registration of Bedoukian Pear Ester Technical  -  a manufacturing use product, containing 93.4 % w/w of 2,4-Decadienoic acid, ethyl ester, (2E,4Z). U.S. Environmental Protection Agency, Office of Pesticide Programs. January 10, 2013.

5. U.S. EPA, 2008. Biopesticide Registration Action Document Straight Chain Lepidopteran Pheromones. U.S. Environmental Protection Agency, Office of Pesticide Programs. October 2, 2008. Available at: http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_G-109_02-Oct-08.pdf

6. Pasqualini, E., Villa, M., Civolani S., Espinha I., Ioriatti, C. Schmidt, S., Molinari, F., DeCristofaro A., Sauphanor B., and Ladurner, E., 2005. The Pear Ester Ethyl (E,Z)-2,4-decadienoate as a Potential Tool for the control of Cydia pomonella larvae: Preliminary Investigation.  Bull. of Insectology, Vol. 58. No. 1: 65-69.

7. Knight, A. L. and Light D. M. 2004. Use of (E,Z)-2,4-decadienoic Acid in Codling Moth management improved Monitoring in Bartlett Pear with high dose Lures. J. Entomol. Soc. Br. Columbia. 101:59 - 66.

8. Heinz, D. E. and Jennings, W.G., 1966. Volatile Components of Bartlett Pear. Journal of Food Science. Vol 31, Issue 1: 69-80.

GLOSSARY OF ACRONYMS AND ABBREVIATIONS

   a.i.	active ingredient
   BPPD	Biopesticides and Pollution Prevention Division
   BRAD	Biopesticide Registration Action Document
   bw	body weight
   CBI	Confidential Business Information
   CFR	Code of Federal Regulations

   cm[3] 	cubic centimeter
   CSF	Confidential Statement of Formula
   °C 	degrees Celsius
   EC50	median effective concentration. A statistically derived single concentration in environmental medium that can be expected to cause an effect in 50% of the test animals when administrated by the route indicated (inhalation). It is expressed as a concentration in air or water (e.g. mg/L).
   EDSP	Endocrine Disruptor Screening Program
   EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee
   EP	end-use product
   EPA	Environmental Protection Agency (the "Agency")
   FDA	Food and Drug Administration
   FFDCA	Federal Food, Drug, and Cosmetic Act
   FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act
   FQPA 	Food Quality Protection Act
   FR	Federal Register
   g 	gram
   ha	hectare
   kg	kilogram
   Kow	octanol-water partition coefficient
   L                   liter
   LC50	median lethal concentration. A statistically derived single concentration in air or water that can be expected to cause death in 50% of the test animals when administrated by the route indicated (inhalation and environment). It is expressed as a concentration in air or water (e.g. mg/L).
   LD50	median lethal dose. A statistically derived single dose that can be expected
   	to cause death in 50% of the test animals when administered by the route
   	indicated (oral and dermal). It is expressed as a weight of
   	substance per unit weight of animal (e.g., mg/kg).
   MRID No.	Master Record Identification Number
   mg	milligram
   mPa	millipascal
   mL	milliliter
   MP	manufacturing-use product
   N/A	not applicable
   NE	"No Effect"
   NIOSH 	National Institute for Occupational Safety and Health
   nm	nanometer
   NOEL	no-observed-effect-level
   NOF	notice of filing
   NOR	notice of receipt
   OPP	Office of Pesticide Programs
   OCSPP 	Office of Chemical Safety and Pollution Prevention
   pa	pascal
   PPE 	personal protective equipment
   PR Notice	Pesticide Registration Notice
       TGAI 	   technical grade of the active ingredient
       ug 		   microgram
       USDA 	   United States Department of Agriculture
       UV 	   ultra-violet


was only recently enacted, we do not have data on the number of
savings and loan holding companies seeking to deregister. However,
we do not expect the rate of deregistration for savings and loan
holding companies to be as high as for bank holding companies, as
many of the newly eligible savings and loan holding companies (20 of
26) would have to give up an exchange listing in order to terminate
registration and suspend reporting.
---------------------------------------------------------------------------

    As explained in the Proposing Release, because the rule amendments
are not expected to substantially impact the overall burden estimates
associated with our rules and forms and in light of the limitations on
available data, we have not submitted revised burden estimates for
these collections of information to OMB for review in accordance with
the PRA and its implementing regulations.\157\ However, as we
periodically update our PRA estimates in accordance with applicable
regulations, we will make any necessary adjustments to reflect the
actual number of filings received, including adjustments to reflect any
reduction in filings arising from today's amendments.
---------------------------------------------------------------------------

    \157\ 44 U.S.C. 3507(d); 5 CFR 1320.11.
---------------------------------------------------------------------------

VI. Final Regulatory Flexibility Act Analysis

    This Final Regulatory Flexibility Act Analysis has been prepared in
accordance with 5 U.S.C. 604. This analysis relates to the amendments
to Securities Act Rule 405 and Exchange Act Rules 3b-4, 12g-1, 12g-2,
12g-3, 12g-4, 12g5-1, and 12h-3.

A. Need for, and Objectives of, the Action

    The primary reason for, and objective of, the proposed amendments
is to implement Title V and Title VI of the JOBS Act and Title LXXXV of
the FAST Act. The JOBS Act directs the Commission to issue rules to
implement the statutory changes and specifically charges the Commission
with amending the definition of ``held of record'' and establishing a
safe harbor for the determination relating to ``employee compensation
plan'' securities. The amendments adopted today revise existing rules
to reflect the new, higher Exchange Act registration, termination of
registration and suspension of reporting thresholds for banks, savings
and loan holding companies and bank holding companies, apply the
definition of ``accredited investor'' in Securities Act Rule 501(a) in
making determinations under Exchange Act Section 12(g)(1), revise the
definition of ``held of record'' to exclude certain securities held by
persons who received them pursuant to employee compensation plans, and
establish a non-exclusive safe harbor for issuers to follow when
determining whether those securities are ``held of record.''
Additionally, revising the definition and providing a non-exclusive
safe harbor to issuers relating to the determination of securities
``held of record'' will assist issuers in determining which holders of
record they are required to count under the registration requirements
of Exchange Act Section 12(g).

B. Significant Issues Raised by Public Comment

    In the Proposing Release, we requested comment on all aspects of
the Initial Regulatory Flexibility Act (``IRFA''), including the number
of small entities that would be affected by the proposed amendments,
the nature of the impact, how to quantify the number of small entities
that would be affected and how to quantify the impact of the proposed
amendments. We did not receive comments specifically addressing the
IRFA. We did, however, receive comments from members of the public on
matters that could potentially impact small entities. Several
commenters recommended a safe harbor for the establishment of a
reasonable belief of accredited investor status.\158\ In contrast, one
commenter opposed such a safe harbor out of concern that it would
become a de facto minimum standard.\159\ Commenters also sought
additional guidance or revisions to the proposed amendment to Rule
12g5-1 and Securities Act Rule 701.\160\
---------------------------------------------------------------------------

    \158\ See letters from ADISA, CFM, Cleary, IPA. One commenter
recommended a safe harbor for the determination specifically for
private investment funds.
    \159\ See letter from ABA.
    \160\ See letters from ABA and ADISA.
---------------------------------------------------------------------------

C. Small Entities Subject to the Rule Amendments

    Exchange Act Rule 0-10(a) \161\ defines an entity, other than an
investment company, to be a ``small business'' or ``small
organization'' if it had total assets of $5 million or less on the last
day of its most recent fiscal year. For

purposes of the Regulatory Flexibility Act, an investment company is a
small entity if it, together with other investment companies in the
same group of related investment companies, has net assets of $50
million or less as of the end of its most recent fiscal year.\162\ We
estimate that there are approximately 841 issuers that file with the
Commission, other than investment companies, that may be considered
small entities.\163\
---------------------------------------------------------------------------

    \161\ 17 CFR 240.0-10(a).
    \162\ 17 CFR 270.0-10(a).
    \163\ The staff estimate is based on a review of Form 10-K, 20-
F, 40-F filings (from EDGAR XBRL) with fiscal periods ending between
January 31, 2015-January 31, 2016.
---------------------------------------------------------------------------

    The rule amendments establishing the use of the Securities Act Rule
501(a) definition of ``accredited investor'' under Exchange Act Section
12(g)(1) and revising the definition of ``held of record'' to exclude
certain securities and establish a non-exclusive safe harbor may affect
small issuers relying on the revised rules and safe harbor to determine
the number of holders of record. While an issuer is not required to
register a class of equity securities pursuant to Section 12(g) of the
Exchange Act until the issuer's total assets exceed $10 million, a
small business or small organization may rely on the rules when
determining to whom to issue securities and whether to compensate
employees with securities. By providing guidance on the meaning of the
term ``accredited investor'' in the Exchange Act context, the rule
amendments may facilitate private offerings and the ability of an
issuer to determine their registration and reporting obligations. By
excluding certain employee compensation securities from the definition
of ``held of record,'' the rule amendments may facilitate the use of
equity compensation by small issuers, thereby helping them to preserve
cash and giving them greater ability to determine when the Exchange Act
Section 12(g) registration obligation would be triggered.
    We cannot reliably estimate the number of small entities affected
by these rule amendments. By definition, such entities are not yet
subject to Section 12(g) registration and reporting requirements, which
are triggered by the issuer having total assets exceeding $10 million
as of the last day of its fiscal year. We do not otherwise have
information about the number of shareholders at small entities,
including those who have received securities as a result of employee
compensation plans.

D. Reporting, Recordkeeping and Other Compliance Requirements

    The amendments' use of the Securities Act Rule 501(a) definition of
``accredited investor'' and the definition of ``held of record'' will
assist an issuer in determining the number of holders of record. In
order for an issuer to rely on the safe harbor, the securities must be
issued in a transaction exempt from, or not subject to, the
registration requirements of Securities Act Section 5 and satisfy the
requirements of Securities Act Rule 701(c), which includes the
requirement that the securities be offered or sold under a written
compensatory benefit plan or written compensation contract. In
addition, issuers seeking to rely upon the safe harbor may need to
maintain records to help establish their compliance with the conditions
of the safe harbor.
    The rule amendments affecting banks, bank holding companies and
savings and loan holding companies do not create any new reporting,
recordkeeping or other compliance requirements for those entities. The
rule amendments raise the thresholds relating to registration for those
entities and therefore reduce their compliance burdens.

E. Agency Action To Minimize Effect on Small Entities

    The Regulatory Flexibility Act directs us to consider significant
alternatives that would accomplish the stated objective of our
proposals, while minimizing any significant adverse impact on small
entities. In connection with the rule amendments, we considered the
following alternatives: (1) The establishment of differing compliance
or reporting requirements or timetables that take into account the
resources available to small entities; (2) the clarification,
consolidation or simplification of compliance and reporting
requirements under the rule for small entities; (3) the use of
performance rather than design standards; and (4) an exemption from
coverage of the rules, or any part of the rules, for small entities.
    We are applying the current definition of ``accredited investor''
in Securities Act Rule 501(a) in making determinations under Exchange
Act Rule 12g-1(b)(1). Alternatively, we could have developed a new
definition of ``accredited investor'' for purposes of Section 12(g)(1);
however, given the prevalence of the use of Regulation D for exempt
offerings, many issuers are familiar with and rely upon the definition
in Rule 501(a). The increased registration threshold established by the
JOBS Act is intended to permit issuers, including small entities, to
defer Exchange Act registration until issuers have a larger shareholder
base. Because proposed Rule 12g-1(b)(1) is intended to facilitate an
issuer's ability to make the determination of when it is required to
register, we believe use of the familiar performance standard in Rule
501(a) definition of ``accredited investor'' will further this
regulatory objective for all issuers, including small entities.
    We determined not to propose or adopt a safe harbor for the
determination of accredited investor status. Requiring issuers to
consider their particular facts and circumstances to establish a
reasonable basis for their determination will provide issuers with
flexibility in making the determination and diminish concerns that the
information relied upon could be unreliable. Additionally, some
standards that might be included in a safe harbor could, as one
commenter noted, result in establishing a de facto minimum standard for
the determination.\164\ This could shift the standard from a
performance standard to a design standard which would provide issuers
with less flexibility when making the determination.
---------------------------------------------------------------------------

    \164\ See letter from ABA.
---------------------------------------------------------------------------

    The revised definition of ``held of record'' and related safe
harbor apply to all issuers, including small entities, that choose to
exclude securities held by persons who received them pursuant to
employee compensation plans in transactions exempt from, or not subject
to, the registration requirements of Securities Act Section 5. The
amendment and safe harbor help define the contours of an exemption from
registration for issuers that might otherwise cross the Section 12(g)
registration thresholds.
    The amendments are intended to permit issuers, including small
entities, to exclude certain securities from the ``held of record''
determination and to assist issuers in making that determination by
clarifying and simplifying requirements for all entities. Establishing
different compliance or reporting requirements relating to employee
compensation plan securities or accredited investor determinations for
small entities could complicate the rules and make them more difficult
to apply as those issuers grow, cease to be small entities, and are
required to determine whether they must register with the Commission.
With respect to the use of performance standards rather than design
standards, we note that the holder of record threshold is a

statutorily created design standard, requiring issuers to register if
their holders of record coupled with their total assets cross certain
thresholds. As we are modifying the definition of ``held of record''
and clarifying the determination of ``accredited investor'' under this
statutory design standard, we did not evaluate whether a performance
standard would be more useful.

VII. Statutory Authority and Text of Rule Amendments

    The amendments contained in this release are being adopted under
the authority set forth in Section 19 of the Securities Act, as
amended, Sections 3(b), 12(g), 12(h), 15(d) and 23(a) of the Exchange
Act, as amended, and Section 503 and Section 602 of the JOBS Act.

List of Subjects in 17 CFR Parts 230 and 240

    Reporting and recordkeeping requirements, Securities.

Text of the Amendments

    For the reasons set out above, the Commission amends Title 17,
chapter II of the Code of Federal Regulations as follows:

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
1. The authority citation for part 230 continues to read, in part, as
follows:

    Authority:  15 U.S.C. 77b, 77b note, 77c, 77d, 77d note, 77f,
77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n,
78o, 78o-7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28,
80a-29, 80a-30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec.
401, 126 Stat. 313 (2012), unless otherwise noted.
* * * * *

0
2. Amend Sec.  230.405 by adding a Note to paragraph (1) of the
definition of ``Foreign private issuer'' to read as follows:

Sec.  230.405  Definitions of terms.

* * * * *

Foreign private issuer. (1) * * *
    Note to paragraph (1) of the definition of Foreign private issuer:
To determine the percentage of outstanding voting securities held by
U.S. residents:
    A. Use the method of calculating record ownership in Sec.
240.12g3-2(a) of this chapter, except that:
    (1) The inquiry as to the amount of shares represented by accounts
of customers resident in the United States may be limited to brokers,
dealers, banks and other nominees located in:
    (i) The United States,
    (ii) The issuer's jurisdiction of incorporation, and
    (iii) The jurisdiction that is the primary trading market for the
issuer's voting securities, if different than the issuer's jurisdiction
of incorporation; and
    (2) Notwithstanding Sec.  240.12g5-1(a)(8) of this chapter, the
issuer shall not exclude securities held by persons who received the
securities pursuant to an employee compensation plan.
    B. If, after reasonable inquiry, the issuer is unable to obtain
information about the amount of shares represented by accounts of
customers resident in the United States, the issuer may assume, for
purposes of this definition, that the customers are residents of the
jurisdiction in which the nominee has its principal place of business.
    C. Count shares of voting securities beneficially owned by
residents of the United States as reported on reports of beneficial
ownership provided to the issuer or filed publicly and based on
information otherwise provided to the issuer.
* * * * *

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

0
3. The general authority citation for part 240 is revised to read as
follows:

    Authority:  15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f,
78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78o, 78o-4,
78o-10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78x, 78ll, 78mm, 80a-20,
80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, 7201 et seq., and
8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18 U.S.C. 1350;
Pub. L. 111-203, 939A, 124 Stat. 1376 (2010); and Pub. L. 112-106,
sec. 503 and 602, 126 Stat. 326 (2012), unless otherwise noted.

* * * * *

0
4. Amend Sec.  240.3b-4 by redesignating the Instruction to paragraph
(c)(1) as Note to paragraph (c)(1), and revising newly redesignated
Note to paragraph (c)(1) to read as follows:

Sec.  240.3b-4  Definition of ``foreign government,'' ``foreign
issuer'' and ``foreign private issuer''.

* * * * *
    (c) * * *
    Note to paragraph (c)(1): To determine the percentage of
outstanding voting securities held by U.S. residents:
    A. Use the method of calculating record ownership in Sec.
240.12g3-2(a), except that:
    (1) Your inquiry as to the amount of shares represented by accounts
of customers resident in the United States may be limited to brokers,
dealers, banks and other nominees located in:
    (i) The United States,
    (ii) Your jurisdiction of incorporation, and
    (iii) The jurisdiction that is the primary trading market for your
voting securities, if different than your jurisdiction of
incorporation; and
    (2) Notwithstanding Sec.  240.12g5-1(a)(8) of this chapter, you
shall not exclude securities held by persons who received the
securities pursuant to an employee compensation plan.
    B. If, after reasonable inquiry, you are unable to obtain
information about the amount of shares represented by accounts of
customers resident in the United States, you may assume, for purposes
of this definition, that the customers are residents of the
jurisdiction in which the nominee has its principal place of business.
    C. Count shares of voting securities beneficially owned by
residents of the United States as reported on reports of beneficial
ownership provided to you or filed publicly and based on information
otherwise provided to you.
* * * * *

0
5. Revise Sec.  240.12g-1 to read as follows:

Sec.  240.12g-1  Registration of securities; exemption from section
12(g).

    An issuer is not required to register a class of equity securities
pursuant to section 12(g)(1) of the Act (15 U.S.C. 78l(g)(1)) if on the
last day of its most recent fiscal year:
    (a) The issuer had total assets not exceeding $10 million; or
    (b) (1) The class of equity securities was held of record by fewer
than 2,000 persons or 500 persons who are not accredited investors (as
such term is defined in Sec.  230.501(a) of this chapter, determined as
of such day rather than at the time of the sale of the securities); or
    (2) The class of equity securities was held of record by fewer than
2,000 persons in the case of a bank; a savings and loan holding
company, as such term is defined in section 10 of the Home Owners' Loan
Act (12 U.S.C. 1461); or a bank holding company, as such term is
defined in section 2 of the Bank Holding Company Act of 1956 (12 U.S.C.
1841).

0
6. Revise Sec.  240.12g-2 to read as follows:

Sec.  240.12g-2  Securities deemed to be registered pursuant to section
12(g)(1) upon termination of exemption pursuant to section 12(g)(2)(A)
or (B).

    Any class of securities that would have been required to be
registered pursuant to section 12(g)(1) of the Act (15 U.S.C.
78l(g)(1)) except for the fact

that it was exempt from such registration by section 12(g)(2)(A) of the
Act (15 U.S.C. 78l(g)(2)(A)) because it was listed and registered on a
national securities exchange, or by section 12(g)(2)(B) of the Act (15
U.S.C. 78l(g)(2)(B)) because it was issued by an investment company
registered pursuant to section 8 of the Investment Company Act of 1940
(15 U.S.C. 80a-8), shall upon the termination of the listing and
registration of such class or the termination of the registration of
such company and without the filing of an additional registration
statement be deemed to be registered pursuant to section 12(g)(1) of
the Act if at the time of such termination:
    (a) The issuer of such class of securities has elected to be
regulated as a business development company pursuant to sections 55
through 65 of the Investment Company Act of 1940 (15 U.S.C. 80a-54
through 64) and such election has not been withdrawn; or
    (b) Securities of the class are not exempt from such registration
pursuant to section 12 of the Act (15 U.S.C. 78l) or rules thereunder
and all securities of such class are held of record by 300 or more
persons, or 1,200 or more persons in the case of a bank; a savings and
loan holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841).
0
7. Amend Sec.  240.12g-3 by revising paragraphs (a)(2), (b)(2), and
(c)(2) to read as follows:

Sec.  240.12g-3  Registration of securities of successor issuers under
section 12(b) or 12(g).

    (a) * * *
    (2) All securities of such class are held of record by fewer than
300 persons, or 1,200 persons in the case of a bank; a savings and loan
holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841).
* * * * *
    (b) * * *
    (2) All securities of such class are held of record by fewer than
300 persons, or 1,200 persons in the case of a bank; a savings and loan
holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841).
* * * * *
    (c) * * *
    (2) All securities of such class are held of record by fewer than
300 persons, or 1,200 persons in the case of a bank; a savings and loan
holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841).
* * * * *
0
8. Amend Sec.  240.12g-4 by revising paragraph (a) to read as follows:

Sec.  240.12g-4  Certifications of termination of registration under
section 12(g).

    (a) Termination of registration of a class of securities under
section 12(g) of the Act (15 U.S.C. 78l(g)) shall take effect 90 days,
or such shorter period as the Commission may determine, after the
issuer certifies to the Commission on Form 15 (Sec.  249.323 of this
chapter) that the class of securities is held of record by:
    (1) Fewer than 300 persons, or in the case of a bank; a savings and
loan holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841), 1,200 persons; or
    (2) Fewer than 500 persons, where the total assets of the issuer
have not exceeded $10 million on the last day of each of the issuer's
most recent three fiscal years.
* * * * *
0
9. Amend Sec.  240.12g5-1 by adding paragraph (a)(8) to read as
follows:

Sec.  240.12g5-1  Definition of securities ``held of record''.

    (a) * * *
    (8)(i) For purposes of determining whether an issuer is required to
register a class of equity securities with the Commission pursuant to
section 12(g)(1) of the Act (15 U.S.C. 78l(g)(1)), an issuer may
exclude securities:
    (A) Held by persons who received the securities pursuant to an
employee compensation plan in transactions exempt from, or not subject
to, the registration requirements of section 5 of the Securities Act of
1933 (15 U.S.C. 77e); and
    (B) Held by persons who received the securities in a transaction
exempt from, or not subject to, the registration requirements of
section 5 of the Securities Act (15 U.S.C. 77e) from the issuer, a
predecessor of the issuer or an acquired company in substitution or
exchange for excludable securities under paragraph (a)(8)(i)(A) of this
section, as long as the persons were eligible to receive securities
pursuant to Sec.  230.701(c) of this chapter at the time the excludable
securities were originally issued to them.
    (ii) As a non-exclusive safe harbor under this paragraph (a)(8):
    (A) An issuer may deem a person to have received the securities
pursuant to an employee compensation plan if such plan and the person
who received the securities pursuant to the plan met the plan and
participant conditions of Sec.  230.701(c) of this chapter; and
    (B) An issuer may, solely for the purposes of Section 12(g) of the
Act (15 U.S.C. 78l(g)(1)), deem the securities to have been issued in a
transaction exempt from, or not subject to, the registration
requirements of Section 5 of the Securities Act (15 U.S.C. 77e) if the
issuer had a reasonable belief at the time of the issuance that the
securities were issued in such a transaction.
* * * * *
0
10. Amend Sec.  240.12h-3 by revising paragraph (b)(1) to read as
follows:

Sec.  240.12h-3  Suspension of duty to file reports under section
15(d).

* * * * *
    (b) * * *
    (1) Any class of securities, other than any class of asset-backed
securities, held of record by:
    (i) Fewer than 300 persons, or in the case of a bank; a savings and
loan holding company, as such term is defined in section 10 of the Home
Owners' Loan Act (12 U.S.C. 1461); or a bank holding company, as such
term is defined in section 2 of the Bank Holding Company Act of 1956
(12 U.S.C. 1841), 1,200 persons; or
    (ii) Fewer than 500 persons, where the total assets of the issuer
have not exceeded $10 million on the last day of each of the issuer's
three most recent fiscal years; and
* * * * *

    By the Commission.

    May 3, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-10746 Filed 5-9-16; 8:45 am]
 BILLING CODE 8011-01-P