[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7204-7205]
[FR Doc No: 2014-02554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0092]

Study Data Technical Conformance Guide and Data Standards
Catalog; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a Study Data Technical Conformance Guide and an update
to the Data Standards Catalog (formerly the Study Data Standards
Catalog). The Study Data Technical Conformance Guide supplements the
revised draft guidance for industry ``Providing Regulatory Submissions
in Electronic Format--Standardized Study Data'' and provides
specifications, recommendations, and general considerations on
submitting standardized study data using FDA supported data standards
specified in the Data Standards Catalog.

DATES: Although you can comment on these documents at any time, to
ensure that the Agency considers your comments, please submit either
electronic or written comments by May 7, 2014.

ADDRESSES: Submit written requests for a copy of the Study Data
Technical Conformance Guide and the Data Standards Catalog to the
Division of Drug Information, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist that office in processing your requests.
    Submit electronic comments on the Study Data Technical Conformance
Guide and the Data Standards Catalog to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1160, Silver Spring, MD 20993-0002,
CDERDataStandards@

fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a Study Data Technical
Conformance Guide (the Guide) and an update to the Study Data Standards
Catalog, which will be revised and renamed the Data Standards Catalog
(the Catalog). The Guide supplements the guidance for industry,
``Providing Regulatory Submissions in Electronic Format--Standardized
Study Data,'' (eStudy Data guidance) (available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm),
and provides technical recommendations to sponsors for the electronic
submission of standardized animal and human study data and related
information contained in certain submissions to new drug applications
(NDAs), abbreviated new drug applications (ANDAs), biologic license
applications (BLAs), and investigational new drug applications (INDs).
The eStudy Data guidance, when finalized, will implement the electronic
submission requirements of section 745A(a) of the Federal Food, Drug,
and Cosmetic Act with respect to standardized study data contained in
NDA, ANDA, BLA, and IND submissions.
    The Guide integrates and updates the Study Data Specifications and
the CDER Common Data Standards Issues document and is available on
FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The Guide is
intended to complement and promote interactions between sponsors and
FDA review divisions. It is not intended to replace the need for
sponsors to communicate directly with review divisions regarding data
standards implementation approaches or issues. The Guide, when
finalized, will supersede the Study Data Specifications (Versions 1.0-
2.0) and the CDER Study Data Common Issues Document (Versions 1.0-1.1).
The Guide is organized as follows:
    Section 1: Introduction--provides information on regulatory policy
and guidance background, purpose, and document control.
    Section 2: Planning and Providing Standardized Study Data--
recommends and provides details on preparing an overall study data
standardization plan and a study data reviewer's guide.
    Section 3: Exchange Format--Electronic Submissions--presents the
specifications, considerations, and recommendations for the file
formats currently supported by FDA.
    Section 4: Study Data Submission Format: Clinical and Non-
Clinical--presents general considerations and specifications for
sponsors using, for example, the following standards for the submission
of study data: Clinical Data Interchange Standards Consortium, Study
Data Tabulation Model, Analysis Data Model, and Standard for Exchange
of Nonclinical Data.
    Section 5: Therapeutic Area Standards--presents supplemental
considerations and specific recommendations when sponsors submit study
data using FDA supported TA standards.
    Section 6: Terminology--presents general considerations and
specific recommendations when using controlled terminologies/
vocabularies for clinical trial data.
    Section 7: General Electronic Submission Format--provides
specifications and recommendations on submitting study data using the
electronic Common Technical Document format.
    Section 8: Data Fitness--provides general recommendations on
standards compliance, data traceability expectations, legacy data
conversion, versioning, and data validation rules.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the Guide and the
Catalog at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02554 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Rules and Regulations]
[Pages 13254-13256]
[FR Doc No: 2014-04948]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2012-0661; A-1-FRL-9906-76-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
New Hampshire; Manchester and Nashua Carbon Monoxide Limited
Maintenance Plans

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of New
Hampshire. This SIP revision establishes carbon monoxide (CO) limited
maintenance plans for the City of Manchester, New Hampshire and the
City of Nashua, New Hampshire. As part of its limited maintenance plan,
New Hampshire will continue year-round CO monitoring at the Londonderry
Moose Hill station in Londonderry, New Hampshire with triggers to
reestablish CO monitoring sites in Manchester and Nashua if elevated CO
levels are recorded in Londonderry. Future carbon monoxide
transportation conformity evaluations for Manchester and Nashua will,
for the length of their limited maintenance plans, be considered to
satisfy the regional emissions analysis and ``budget test''
requirements. This action is being taken under the Clean Air Act.

DATES: This rule is effective on April 9, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2012-0661. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., 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 electronically through
www.regulations.gov or in hard copy at the Office of Ecosystem
Protection, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Quality Planning
Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA requests that if
at all possible, you contact the contact listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30
a.m. to 4:30 p.m., excluding legal holidays.
    Copies of the documents relevant to this action are also available
for public inspection during normal business hours, by appointment at
the State Air Agency; Air Resources Division, Department of
Environmental Services, 6 Hazen Drive, P.O. Box 95, Concord, NH 03302-
0095.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5
Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109--
3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background and Purpose
II. State Commitments
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On December 24, 2013 (78 FR 77632), EPA published a Notice of
Proposed Rulemaking (NPR) for the State of New Hampshire, proposing
approval of a SIP revision submitted on August 1, 2012. Specifically,
EPA proposed to approve conversion of the Manchester and Nashua current
carbon monoxide maintenance plans to a limited maintenance plan for the
remainder of the City of Manchester, and the City of Nashua, New
Hampshire CO maintenance plans which terminate on January 29, 2021.
    EPA also proposed to approve replacement of the CO air quality
monitoring in Manchester with carbon monoxide monitoring at the
Londonderry Moose Hill station in Londonderry, New Hampshire with
triggers to reestablish CO monitoring sites in Manchester and Nashua if
elevated CO levels are recorded in Londonderry.
    Other specific requirements of the limited maintenance plans for
the City of Manchester, New Hampshire and the City of Nashua, New
Hampshire, year-

round CO monitoring at the Londonderry Moose Hill station in
Londonderry, New Hampshire, and the rationale for EPA's approval action
are explained in the NPR and will not be restated here. No public
comments were received on the NPR.

II. State Commitments

    New Hampshire will monitor CO levels using the Londonderry Moose
Hill station and emissions inventories. Because New Hampshire is
discontinuing monitoring CO in Manchester, it has adopted a more
stringent contingency threshold or ``trigger'' than indicated in the
previously submitted and EPA-approved May 30, 2007 maintenance plan SIP
revision. See September 10, 2007; 72 FR 51564. In the event the second
highest CO concentration in any calendar year monitored in Londonderry
reaches 50 percent of the Federal 1-hour or 8-hour NAAQS for CO, New
Hampshire will, as committed to in the August 1, 2012 SIP revision,
within six months of recording such concentrations, reestablish the CO
monitoring site in Manchester consistent with EPA siting criteria, and
resume analyzing and reporting those data. If the reestablished
Manchester CO monitor measures a violation of the either the Federal 1-
hour or 8-hour NAAQS for CO, contingency measures will be implemented
in Manchester and Nashua. Contingency measures in Nashua would cease
once a reestablished CO monitor in Nashua shows that the area is in
attainment of the CO standard.
    If the Manchester or Nashua CO attainment areas monitor CO
concentrations at or above the limited maintenance eligibility criteria
or 7.65 parts per million, then that maintenance area would no longer
qualify for a limited maintenance plan and would revert to a full
maintenance plan. In this event, the limited maintenance plan would
remain applicable for conformity purposes only until the full
maintenance plan is submitted and EPA has found its motor vehicle
emissions budgets adequate for conformity purposes or EPA approves the
full maintenance plan SIP revision. Any required new conformity
determinations could not be made until there is an adequate budget or
approved full maintenance plan. At that time, regional emissions
analyses would resume as a transportation conformity criteria.

III. Final Action

    EPA is approving conversion of the Manchester and Nashua current
carbon monoxide maintenance plans to a limited maintenance plan for the
remainder of the City of Manchester, and the City of Nashua, New
Hampshire CO maintenance plans which terminate on January 29, 2021.
    EPA is also approving replacement of the CO air quality monitoring
in Manchester with carbon monoxide monitoring at the Londonderry Moose
Hill station in Londonderry, New Hampshire with triggers to reestablish
CO monitoring sites in Manchester and Nashua if elevated CO levels are
recorded in Londonderry.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 9, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

H. Curtis Spalding
Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart EE--New Hampshire

0
2. Section 52.1528 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1528  Control strategy: Carbon monoxide.

* * * * *
    (e) Approval--On August 1, 2012, the New Hampshire Department of
Environmental Services submitted modifications to the Manchester and
Nashua maintenance plans approved in paragraph (b) and (c) respectively
of this section. The Manchester and Nashua current carbon monoxide
maintenance plans are both converted to limited maintenance plans for
the remainder of their second-ten year maintenance periods which
terminate on January 29, 2021. Future carbon monoxide transportation
conformity evaluations for Manchester and Nashua will for the length of
their limited maintenance plans be considered to satisfy the regional
emissions analysis and ``budget test'' requirements. In addition, New
Hampshire will no longer conduct CO monitoring in Manchester, New
Hampshire as addressed in paragraph (d) of this section. The Manchester
monitoring site is replaced with the Londonderry Moose Hill station in
Londonderry, New Hampshire with triggers to reestablish CO monitoring
sites in Manchester and Nashua if elevated CO levels are recorded in
Londonderry.

[FR Doc. 2014-04948 Filed 3-7-14; 8:45 am]
BILLING CODE 6560-50-P


Supplementary Material

Investigation of Waste Incineration of Fluorotelomer-Based Polymers as a Potential Source of PFOA in the Environment

P. H. Taylora,*, T. Yamadaa, R. C. Striebicha, J. L. Grahama, and R. J. Giraudb

a 	University of Dayton Research Institute, Environmental Engineering Group, 300 College Park, Dayton, OH   45469

b 	E. I. du Pont de Nemours and Company, Inc., 1007 Market Street, Wilmington, DE   19898

*	Corresponding author.  Tel.: +1<PHONE_NUMBER>; fax: +1<PHONE_NUMBER>

E-mail address<EMAIL_ADDRESS> Table of Contents

  TOC \o "1-3" \h \z \u   HYPERLINK \l "_Toc273556574" 1.0  Stoichiometric Calculations	  PAGEREF _Toc273556574 \h  3

 HYPERLINK \l "_Toc273556575" 1.1	Establishing Experimental Conditions	  PAGEREF _Toc273556575 \h  3

 HYPERLINK \l "_Toc273556576" 1.1.1	Constraints	  PAGEREF _Toc273556576 \h  3

 HYPERLINK \l "_Toc273556577" 1.1.2	Calculating Experimental Run Duration	  PAGEREF _Toc273556577 \h  3

 HYPERLINK \l "_Toc273556578" 1.1.3	Summary	  PAGEREF _Toc273556578 \h  4

 HYPERLINK \l "_Toc273556579" 1.2	Setting Combustion Test Air and Methanol Feed Rates	  PAGEREF _Toc273556579 \h  4

 HYPERLINK \l "_Toc273556580" 1.3	References	  PAGEREF _Toc273556580 \h  6

Tables

 Table A-1.	Uncontrolled HF Emissions from Mass Burn MWCs

Table A-2.	Stoichiometric Calculation of Complete Oxidation of PTFE in the Presence of Excess Methanol

Table A-3.  Oxidation of Methanol: Stoichiometric Calculations with Refined Inputs

Table A-4.  Combustion Stoichiometry Calculations for Combustion of FTBP Composite 1

Table A-5.  Combustion Stoichiometry Calculations for Combustion of FTBP Composite 2

Table S-1.  Summary of FTBP Composites Elemental Analysis

Table S-2.  PFOA Analysis Method Description

Table S-3.  FTBP Combustion Test Analytical Results for Impinger Samples

Table S-4.  Fluoride Ion Recovery & Exhaust Gas Hydrogen Fluoride (HF) Concentration

Table S-5.  PFOA Exhaust Gas Concentration Calculations

Table S-6.  13C-PFOA Surrogate Spike Recovery for Combustion Test Aqueous Samples

Table S-7.  Typical Waste Incineration Exhaust Gas Oxygen Levels

Figure S-1.  Typical Structure of a Fluorotelomer-Based Polymer in this Study

Figure S-2.  Thermogravimetric Analysis of FTBP Composites at 25oC/min

Figure S-3.  Reactor Temperature Profile for FTBP Combustion Testing

1.0 Stoichiometric Calculations

1.1	Establishing Experimental Conditions

Prior to conducting Phase I transport testing, planned Phase II combustion testing experimental conditions for certain operating parameters (i.e., duration of experimental run, target exhaust gas oxygen concentration, and target exhaust gas water concentration) were established to assure consistent operating conditions during both phases of the experimental program.

1.1.1	Constraints

The Phase II Quality Assurance Project Plan (submitted to EPA prior to conduct of the Phase I transport test) clearly set the following constraints:

High temperature reactor operation at a temperature of 1000oC (±10oC) for a gas residence time of 2 seconds (± 0.2 sec),

Exhaust gas oxygen concentration “greater than 10% throughout the combustion test run following introduction of the methanol fuel”,

g, and

Combustion test run duration between 15 and 75 minutes after pyroprobe insertion.

Furthermore, an ABB EL 3020 continuous gas analyzer (CGA) was in place prior to the Phase I transport test and planned for use to provide continuous monitoring of oxygen, carbon dioxide, and carbon monoxide during Phase II combustion testing.  The CGA’s oxygen analyzer has a design flow rate of 30 to 60 liters per hour (ABB, 2005).  Thereby, an additional constraint was to maintain a vapor flow rate greater than 30 liters per hour (i.e., greater than 500 sccm).

1.1.2	Calculating Experimental Run Duration

The elemental composition for the expected Phase II test substances were not known because such analyses (required for Phase II) had not been conducted prior to the Phase I transport test.  Therefore, polytetrafluoroethylene (PTFE) was used as a model compound in combustion calculations because it is a fluorinated polymer of known molecular composition (76% F, 24% C).

Within the constraints above and for PTFE, it was possible to compute a target experimental run duration using a target exhaust gas hydrogen fluoride (HF) concentration and assuming complete oxidation of the PTFE and the methanol fuel.  A target HF concentration of 10 mg HF per dry standard cubic meter (dscm) was used to correspond to the high end of typical uncontrolled (i.e., combustion section exit) HF emission levels from municipal waste combustors (MWCs), considering the range of 2.3 to 7.9 mg/dscm based on available information summarized in Table A-1.  (Oxidation of a highly fluorinated polymer (i.e., PTFE) would be expected to yield a high end HF emission level.)  Information from mass burn MWCs was used because these units represent over 76% of MWC waste capacity in the U.S. (IWSA, 2002).

Based on the design of the 3-zone furnace in the thermal reactor system, an effective isothermal reactor length of 20 inches (50.8 cm) was originally expected.  (Subsequent temperature profile measurements for Phase I provided an effective reactor length of 23 inches (58.4 cm) at 250oC for Phase I and of 26 inches (66 cm) at 1000oC for Fluorotelomers Phase II.)  An effective reactor length of 50.8 cm was used with the reactor tube’s inside diameter (14 mm) to compute the reactor volume corresponding to a gas residence time of 2 seconds at 1000oC in the stoichiometric calculations shown in Table A-2.  The calculated values in Table A-2 show run duration as well as corresponding exhaust oxygen concentration (dry basis) and exhaust gas water concentration at different excess air levels for a fixed methanol to PTFE ratio.  This ratio was adjusted through iterative calculations until a run duration for complete oxidation of PTFE in the presence of excess methanol clearly greater than 15 minutes was obtained with an exhaust HF concentration close to the target value of 10 mg/dscm (i.e., 1.22 x 10-3 %) while assuring the other constraints noted above had been met.  Therefore, a run duration of 15.97 minutes (rounded to 16 minutes) was computed and the corresponding values for exhaust gas oxygen concentration (dry basis) and exhaust gas water concentration were 13.0% and 10.3%, respectively.

Selecting a target exhaust gas oxygen concentration of 13% dry basis (equivalent to 11.6% wet basis) seemed appropriate to assure oxygen concentration in exhaust gas greater than 10% throughout the combustion test run following introduction of the methanol fuel as this level appeared high enough to compensate for a potential drop in thermal reactor system exhaust oxygen concentration when the polymer would be introduced to the reactor system via pyroprobe gasification.

1.1.3	Summary

The following target values for Phase II combustion testing were calculated prior to Phase I transport testing:

Experimental run duration of 16 minutes,

Exhaust gas oxygen concentration (dry basis) of 13%, and

Exhaust gas water concentration of 10.3%.

These values were established as targets in Phase I testing to assure consistent operating conditions during both phases of the experimental program.

1.2	Setting Combustion Test Air and Methanol Feed Rates

Once the effective reactor length was experimentally determined prior to Phase II combustion testing, the effective high temperature reactor volume and total exhaust gas flow corresponding to 2 seconds gas residence time were set for the 14 mm inside diameter reactor tube.  Combustion stoichiometry calculations prior to Phase II testing were used to iteratively evaluate combinations of synthetic air and methanol feed rates yielding this target total exhaust gas flow rate versus the target values for exhaust gas oxygen (O2) and water (H2O) concentrations established prior to Phase I (see section 1.1.3 above), including consideration of the following factors to fine tune the combustion stoichiometry calculations:

methanol liquid density (as function of liquid temperature and pressure),

more refined values of Universal gas constant and methanol molecular weight,

same standard temperature used during calibration of the air mass flow controller,

oxygen level in the synthetic air on hand as noted on its certificate of analysis

reactor pressure as sum of monitored values for room pressure + back pressure, and

input setting/display resolution (number of available digits) for both the air mass flow controller and the methanol feed pump.

These calculations are based on complete oxidation of CH3OH according to the following reaction:

CH3OH + 1.5 O2 ( CO2 + 2 H2O

Therefore, for each mole of CH3OH combusted, 1.5 moles of O2 are consumed, 1 mole of CO2 is produced, and 2 moles of H2O are produced.  As the O2 is supplied in synthetic air made up of nominally 21% O2 and 79% nitrogen (N2), each mole of CH3OH combusted is also accompanied by 79/21 moles of N2 as both an inert reactant and a product.  The results of the refined methanol oxidation stoichiometry calculations shown in Table A-3 indicate the predicted concentrations for exhaust gas O2, CO2, and H2O.

Further calculations including the contribution of each test substance composite are described in Tables A-4 and A-5, which make use of the dry basis elemental analysis results provided by the analytical laboratories after normalizing to 100% to account for differences across the analytical techniques used.  The “monitor” entries in the first column in Tables A-3, A-4, and A-5 point out the parameters that are monitored in the thermal reactor system; the “analyzed” entries in the first column of Tables A-4 and A-5 point out the parameters were values from elemental analysis are used.  Comparison of the reaction products in Tables A-4 and A-5 to the reaction products in Table A-3 indicates that the oxidation of methanol is controlling.

Based on these calculations (i.e., described in Tables A-3,A- 4, and A-5), the estimated amount of oxygen needed for Phase II combustion testing to provide exhaust O2 and H2O concentrations comparable to those used in Phase I testing is 662 sccm synthetic air when 61.71 µL/min of methanol is fed.  The resulting predicted exhaust H2O concentration of 10.2% for the Phase II combustion test (Tables A-3, A-4, A-5) is very consistent with the 10.3% calculated value used during the Phase I transport test.  The resulting predicted exhaust O2 concentration of 13.1% (dry basis) is very consistent with the 13.0% O2 concentration for the Phase I transport test.

1.3	References

ABB, 2005.  EasyLine Continuous Gas Analyzers Model EL3020, Data Sheet 10/24_4.10 EN.

Environmental Standards, Inc., December 27, 2005, revised June 23, 2006.  Quality Assurance Plan for the ECA Incineration Testing Program—Phase II Fluorotelomer Incineration Testing.

IWSA (Integrated Waste Services Association), 2002.  The 2002 IWSA Directory of Waste-to-Energy Plants.

Table A-1.  Uncontrolled HF Emissions from Mass Burn MWCs

	Item	Value	Units	Reference and/or Comment

Low end	reference mass burn MWC uncontrolled HF emission 	0.009	kg HF/metric ton MSW	EPA, Locating and Estimating Air Toxics Emissions from Municipal Waste Combustors, PB89-1952226, April 1989.  [Table 4-3 for older mass burn MWCs]

	MWC exhaust gas volume (typical)	5000	Nm3/metric ton MSW	Environment Agency of Japan in “Meeting on Measures to Control Dioxin Emission, the second report, 25 June 1999” as reported by Ogura et al, Chemosphere 2001, 44, 1473-1487.

	mass burn MWC uncontrolled HF emission	1.8	mg HF/ Nm3	calculated (=0.009/5000*1E06mg/kg)

	mass burn MWC

uncontrolled HF emission	1.9	Mg HF/

scm	calculated (=1.8*293/273)

EPA, Municipal Waste Combustion: Background Information Document for Promulgated Standards and Guidelines, EPA-453/R-95-0136, October 1995.  [scm at 20 oC and Nm3 at 0 oC]

	MWC exhaust gas moisture

Environmental Standards, Inc.  Quality Assurance Project Plan for the ECA Incineration Testing Program—Phase II Fluorotelomer Incineration Testing, December 27, 2005, revised June 23, 2006.

	mass burn MWC uncontrolled HF emission	2.3	mg HF/ dscm

High end	typical mass burn MWC uncontrolled (spray dryer inlet) HF emission, corrected to 7% O2 (test average) 	7.9	mg HF/ dscm	Clean Air Engineering, Report on Compliance Testing Performed for Covanta of Fairfax, Inc Units 1, 2, 3, and 4 SDA Inlets and FF Outlets (Stacks) I-95 Energy/Resource Recovery Facility, Volume I of III, August 7, 2001.  [highest across 3 units tested]

Table A-2.  Stoichiometric Calculation of Complete Oxidation of PTFE in Presence of Excess Methanol

Sample: PTFE [C2F4]	Mass (µg)	100	mol wt (g/mol)	100

Constants

MeOH : Sample Ratio (Variable)	19,000

R	0.0821 L-atm/(mol-K)

	standard T	25oC

	Reactor Inside Diameter	Reactor Length

T (C)	RT (sec)	pressure	1 atm

	(mm)	14

(in)	20

1000	2

	(cm)	50.8

	x (xs Air)	Effluent O2 (%)	Effluent H2O (%)	Effluent CO2 (%)	Effluent HF (%)	Air Vol (L)	MeOH Vol (L)	Run duration (min)	MeOH Injection Rate Air Flow Rate	MeOH Vapor Flow Rate 	Input Vapor  Flow Rate

Variable	Target: >10	Target: 15 (8-20)	Target: 1.22E-3

(µL/min)	scc/min	scc/min	wet scc/min

	Dry Basis

Dry Basis	Dry Basis

	0%	0.0	23.1	15.1	3.17E-03	3.32	0.46	6.90	111.5	481.50	67.41	548.91

10%	2.0	21.4	13.6	2.86E-03	3.65	0.46	7.50	102.5	486.94	61.97	548.91

20%	3.7	19.9	12.4	2.61E-03	3.98	0.46	8.11	94.8	491.56	57.35	548.91

30%	5.1	18.5	11.4	2.40E-03	4.32	0.46	8.71	88.2	495.54	53.36	548.91

40%	6.3	17.4	10.5	2.22E-03	4.65	0.46	9.32	82.5	499.01	49.90	548.91

50%	7.3	16.4	9.8	2.06E-03	4.98	0.46	9.92	77.5	502.05	46.86	548.91

60%	8.2	15.5	9.2	1.93E-03	5.31	0.46	10.53	73.0	504.74	44.16	548.91

70%	9.0	14.7	8.6	1.81E-03	5.64	0.46	11.13	69.1	507.14	41.76	548.91

80%	9.7	13.9	8.1	1.70E-03	5.98	0.46	11.74	65.5	509.30	39.61	548.91

90%	10.3	13.3	7.7	1.61E-03	6.31	0.46	12.34	62.3	511.24	37.67	548.91

100%	10.9	12.7	7.3	1.53E-03	6.64	0.46	12.95	59.4	513.00	35.91	548.91

110%	11.4	12.1	6.9	1.45E-03	6.97	0.46	13.55	56.7	514.60	34.31	548.91

120%	11.8	11.6	6.6	1.38E-03	7.31	0.46	14.16	54.3	516.07	32.84	548.91

130%	12.2	11.2	6.3	1.32E-03	7.64	0.46	14.76	52.1	517.41	31.49	548.91

140%	12.6	10.7	6.0	1.27E-03	7.97	0.46	15.37	50.0	518.65	30.25	548.91

150%	13.0	10.3	5.8	1.21E-03	8.30	0.46	15.97	48.1	519.80	29.11	548.91

160%	13.3	10.0	5.5	1.17E-03	8.63	0.46	16.57	46.4	520.86	28.05	548.91

170%	13.6	9.6	5.3	1.12E-03	8.97	0.46	17.18	44.7	521.85	27.06	548.91

180%	13.9	9.3	5.1	1.08E-03	9.30	0.46	17.78	43.2	522.77	26.14	548.91

190%	14.1	9.0	4.9	1.04E-03	9.63	0.46	18.39	41.8	523.63	25.28	548.91

200%	14.3	8.7	4.8	1.01E-03	9.96	0.46	18.99	40.5	524.43	24.47	548.91

210%	14.6	8.5	4.6	9.73E-04	10.29	0.46	19.60	39.2	525.19	23.72	548.91

220%	14.8	8.2	4.5	9.42E-04	10.63	0.46	20.20	38.0	525.90	23.01	548.91

Table A-3. Oxidation of Methanol: Stoichiometric Calculations with Refined Inputs

Reactant: Methanol 	Units	Value	Reference/Comment

monitor	liquid temperature	oC	23.8	Feed pump isothermal T: measured with 1/16" calibrated thermocouple with chiller controlling to 24.0 C

monitor	liquid pressure	psig	2500	Feed pump controller readout: pump discharge pressure (typical value)

	liquid pressure	psia	2514.7

liquid density	g/mL	0.80296	NIST "Isothermal Properties for Methanol", http://webbook.nist.gov/chemistry/fluid/ a

monitor	injection rate	µL/min	61.71	Feed pump controller readout

	injection rate	mL/min	0.06171

mass feed rate	g/min	0.0496	= density (g/mL) * injection rate (mL/min)

	molecular weight	g/mole	32.0419	NIST "Methyl Alcohol", http://webbook.nist.gov/cgi/cbook.cgi?Name=methanol&Units=SI

	molar feed rate	mol/min	0.0015	= mass feed rate / molecular weight

Reactant: Synthetic air

std temperature	oC	21.1	Brooks gas mass flow controller calibration sheet

monitor	room pressure	torr	740	MKS pressure transducer readout (typical)

monitor	back pressure	in. W.C.	20	Magnehelic reading:back pressure on reactor = impinger liquid level + CGA back pressure

	pressure	Atm	1.0228	reactor pressure = room pressure + back pressure

	% oxygen (O2)	%	21.06	Airgas Certificate of Analysis, Reference Number 32-112669912-1

	% nitrogen (N2)	%	78.94	= 100 - % oxygen [COA says N2 = balance]

monitor	flow rate	scc/min	662	Brooks mass flow controller readout for Synthetic Air

	flow rate	std L/min	0.662

moles O2	mol/min	0.0059	Calculated using Ideal Gas Law [n = PV/RT] with Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	moles N2	mol/min	0.0221	Calculated using Ideal Gas Law [n = PV/RT] with Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

Product moles

moles CH3OH	mol/min	0.0000	Assuming complete oxidation: all CH3OH converts to CO2 and H20

	mole CO2	mol/min	0.0015	Assuming complete oxidation: moles CO2 out = moles CH3OH in

	moles H2O	mol/min	0.0031	Assuming complete oxidation: moles H2O out = 2 * moles CH3OH in

	moles O2	mol/min	0.0036	Assuming complete oxidation: moles O2 out = moles O2 in - moles O2 consumed

	moles N2	mol/min	0.0221	Assuming N2 is unreacted: Moles N2 in = Moles N2 out

	total	mol/min	0.0304

	Product volumes

CO2	std L/min	0.0365	Calculated using Ideal Gas Law [V = nRT/P] & Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	H2O	std L/min	0.0730	Calculated using Ideal Gas Law [V = nRT/P] & Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	O2	std L/min	0.0847	Calculated using Ideal Gas Law [V = nRT/P] & Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	N2	std L/min	0.5226	Calculated using Ideal Gas Law [V = nRT/P] & Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	total	std L/min	0.7168	Calculated using Ideal Gas Law [V = nRT/P] & Universal Gas Constant (R) of 0.08206 L-atm/(mol-K)

	total	scc/min	716.7602

	Table A-3.  Oxidation of Methanol: Stoichiometric Calculations with Refined Inputs (continued)

Product composition

wet basis	dry basis	(Note: Volume % = Mole %)

	CO2	vol %	5.09%	5.67%

H2O	vol %	10.19%

	O2	vol %	11.81%	13.15%

N2	vol %	72.91%	81.18%

total	vol %	100.00%	100.00%

	Excess Air

Entering moles O2	mol/min	0.0059	Portion of monitored synthetic air flow input that is oxygen, on a molar basis

	Required moles O2	mol/min	0.0023	Moles of O2 required for complete oxidation: 1.5 * moles CH3OH in

	Excess air	%	154.6%

	a	E.W. Lemmon, M.O. McLinden and D.G. Friend, "Thermophysical Properties of Fluid Systems" in NIST Chemistry WebBook, NIST

	Standard Reference Database Number 69, Eds. P.J. Linstrom and W.G. Mallard, June 2005, National Institute of Standards and Technology,

	Gaithersburg, MD   20899 (http://webbook.nist.gov).

 Table S-1.  Summary of FTBP Composites Elemental Analysis

	Sample	% Solids 	% Water	Carbon    (As Is)	Hydrogen (As Is) a	Carbon        (Dry Basis)	Hydrogen   (Dry Basis)b	Fluorine      (Dry Basis)

Reported Result	Calculated	Reported Result	Reported Result	Normalized Value	Normalized Value	Normalized Value

%	%	%	%	%

	FTBP Composite 1	72.02	27.98	45.80	6.092	57.7	3.7	38.6

	FTBP Composite 2	75.70	24.30	47.54	6.575	62.8	5.1	32.1

a	Reported value for Hydrogen (H) includes H present due to H2O in sample.

b	Corrected to exclude H in H2O in sample.

Table S-2.  PFOA Analysis Method Description

Sample Matrix	Impinger water (HPLC water with absorbed reactor exhaust gas)

Method Summary	40 mL of aqueous sample (spiked with surrogate) concentrated via C18 SPE cartridge eluted with 5 mL of methanol then determined via electrospray liquid chromatography/tandem mass spectrometry (LC/MS/MS) using selected reaction monitoring (SRM)

Sensitivity	Limit of Quantitation: 25 ng/L

rrelation coefficient (R) ≥ 0.992 (R2 ≥ 0.985) for initial calibration.

QC Criteria	Laboratory Control Standard (LCS) recovery: 70 – 130%

Extracted check standard recovery: 85 – 115%

Surrogate spike recovery: 70 – 130%

Surrogate	Phase I transport test: 13C-PFOA: mass-labeled perfluoro-n-octanoic acid (m+2) provided by DuPont (custom synthesized by PerkinElmer), i.e., perfluoro-n-[1,2-13C2]-octanoic acid or 1,2-13C2-PFOA

Phase II combustion test: 13C-PFOA: mass-labeled perfluoro-n-octanoic acid (m+4) purchased from Wellington Laboratories, i.e., perfluoro-n-[1,2,3,4-13C4]-octanoic acid or 1,2,3,4-13C4-PFOA

Chromatography

Instrument

Micromass Quattro Ultima

	HPLC Column	Genesis C-8, 5 cm x 2.1 mm i.d. x 4 µm

	Mobile Phase A	2 mM ammonium acetate in water

	Mobile Phase B	methanol

	Ions Monitored:	Analyte	Transition	Retention Time

PFOA	413 ( 369	~5 min

1,2-13C2-PFOA	415 ( 370	~5 min

1,2,3,4-13C4-PFOA	417 ( 372	~5 min

	Linear PFOA and branched PFOA are not chromatographically resolved by this method and thereby cannot be distinguished.

Laboratory	MPI Research Inc., State College, PA

Table S-3.  FTBP Combustion Test Results for Impinger Samples

Test Substance	Sample Identification	Fluoride

(mg/L)	PFOA (ng/L)

	None	Pre-Test Thermal Blank	<0.05	Not analyzed

	Pre-Test Steam Clean	0.82	Not analyzed

	Composite 1	Pre-Run Thermal Blank #1	0.20	ND

	Experimental Run #1	0.58	ND

	Steam Clean #1	0.59	ND

	Post-Run Thermal Blank #1	0.19	ND

	Pre-Run Thermal Blank #2	<0.05	ND

	Experimental Run #	0.48	ND

	Steam Clean #2	0.72	ND

	Post-Run Thermal Blank #2	<0.05	ND

	Pre-Run Thermal Blank #3	<0.05	ND

	Experimental Run #3	0.28	ND

	Steam Clean #3	0.78	ND

	Post-Run Thermal Blank #3	<0.05	ND

	HPLC Water Blank	<0.05	ND

	Composite 2	Pre-Run Thermal Blank #4	0.16	ND

	Experimental Run #4	0.45	ND

	Steam Clean #4	1.56	ND

	Post-Run Thermal Blank #4	0.11	ND

	Pre-Run Thermal Blank #5	0.10	ND

	Experimental Run #5	0.47	ND

	Steam Clean #5	1.30	ND

	Post-Run Thermal Blank #5	0.12	ND

	Pre-Run Thermal Blank #6	0.12	ND

	Experimental Run #6	0.29	ND

	Steam Clean #6	0.98	ND

	Post-Run Thermal Blank #6	0.11	ND

	HPLC Water Blank	0.05	ND

	ND – Compound not detected.  Limit of Detection (LOD) for this matrix is 5 ng/L.

As the pre-test thermal blank and pre-test steam cleaning show, the source of fluoride for the post-run steam cleaning runs was determined to be thermal degradation of the perfluoroelastomer O-ring on the exit end of the reactor.

Table S-5. PFOA Exhaust Gas Concentration Calculations

	Experimental Run	Measured PFOA concentration 	Equivalent PFOA concentration, assuming     ND = LOD	Water volume	Equivalent PFOA      exhaust gas concentration	Run Avg O2 conc	Equivalent PFOA     exhaust gas concentration at 7% O2

(ng/L)	(ng/L)	(mL)	(ng/dscm)	(%)	(ng/dscm)

	1	ND	5	60.28	30	13.32	54

	2	ND	5	60.51	30	13.29	54

	3	ND	5	60.43	30	13.25	54

	4	ND	5	60.81	30	13.20	54

	5	ND	5	60.69	30	13.22	54

	6	ND	5	60.20	30	13.23	53

	Notes:

	Water volume is total water volume in impingers for run, assuming water density = 1 g/mL.

	Dry gas volume is volumetric flow rate on dry basis * duration of pyroprobe heating (16 min)

	Volumetric flow rate (dry) = 	6.3184E-04	dscm/min (from stoichiometric calculations)

	Run Avg O2 conc is run average oxygen concentration from CGA for run.

Exhaust gas concentration at 7% O2 = (exhaust gas concentration) * (21.1% - 7%) / (21.1% - [(Run Avg O2 conc) %])

Table S-6.  13C-PFOA Surrogate Spike Recovery for Combustion Test Impinger Samples

Sample Identification	13C-PFOA Found (ng/L)	Amount 13C-PFOA Added (ng/L) 13C-PFOA Recovery (%)

	Pre-Run Thermal Blank #1	525	500	105

Experimental Run #1	529	500	106

Steam Clean #1	536	500	107

Post-Run Thermal Blank #1	531	500	106

Pre-Run Thermal Blank #2	537	500	107

Experimental Run #	527	500	105

Steam Clean #2	468	500	94

Post-Run Thermal Blank #2	546	500	109

Pre-Run Thermal Blank #3	536	500	107

Experimental Run #3	527	500	105

Steam Clean #3	524	500	105

Post-Run Thermal Blank #3	556	500	111

HPLC Water Blank	510	500	102

	Pre-Run Thermal Blank #4	495	500	99

Experimental Run #4	519	500	104

Steam Clean #4	492	500	98

Post-Run Thermal Blank #4	549	500	110

Pre-Run Thermal Blank #5	587	500	117

Experimental Run #5	531	500	106

Steam Clean #5	536	500	107

Post-Run Thermal Blank #5	596	500	119

Pre-Run Thermal Blank #6	526	500	105

Experimental Run #6	544	500	109

Steam Clean #6	474	500	95

Post-Run Thermal Blank #6	507	500	101

HPLC Water Blank	515	500	103

Table S-7.  Typical Waste Incineration Exhaust Gas Oxygen Levels

Exhaust O2 Level (dry basis)	Type of Incinerator	Reference

10% (nominal)	Mass burn MWCa	Blount Energy Resource Corp.  Correlation Procedure for Continuously Monitoring Furnace Temperatures (Warren County Resource Recovery Facility), March 22, 1989.

10.8% (average)	Mass burn MWC	Clean Air Engineering. Test Report for Covanta of Fairfax, Inc. I-95 Energy/Resource Recovery Facility, 1997.

8.4%b (average)	Refuse Derived Fuel (RDF) MWC	Finklestein, A. and R. D. Klicius.  National Incinerator Testing and Evaluation Program: The Environmental Characterization of Refuse-derived Fuel (RDF) Combustion Technology, Mid-Connecticut Facility, Hartford, Connecticut, EPA-600/R-94-140 (NTIS PB96-153432), December 1994.

10 – 13% 	Modular MWC	Pace Analytical.  Comprehensive Emissions Test Report: MSW Incinerator Unit No. 1 ESP Outlet & MSW Incinerator Unit No. 2 ESP Outlet (Polk County Solid Waste Plant), March 11-14, 2003.

13.5%	Medical waste incinerator	EPA.  Medical Waste Incineration Emission Test Report: Weeks Memorial Hospital, Lancaster, New Hampshire, EMC Report 96-MWI-11, March 1996.

a	MWC = municipal waste combustor

b	Calculated from spray dryer inlet O2 concentrations (basis not specified) across 8 runs over range of steam loads during performance test runs indicative of “good combustor operation”.

Figure S-1.  Typical Structure of a Fluorotelomer-Based Polymer in this Study

Figure S-2.  Thermogravimetric Analysis of FTBP Composites at 25oC/min

(Target Temperature = 1000°C)

With 600 standard cc/min of synthetic air (21.1% oxygen, balance nitrogen; Airgas) flowing through the reactor, the reactor temperature profile was performed by sequentially measuring the reactor internal gas temperature every 2.54 cm along the length of the quartz tube.  This profiling was conducted in air (without methanol fuel present) prior to combustion testing due to safety reasons.  The effective reactor length (indicative of gas residence time) at 1000oC was 66 cm of the 76 cm long section of the quartz tube radiantly heated by the split tube furnace.  Supplemental calculations after the completion of the testing program indicate that oxidation of the methanol fuel feed to the reactor could have resulted in temperature overshoot as high as 1283oC (adiabatic reaction temperature) at the inlet end of the reactor followed by approximately 0.15 second cool down.  Such overshoot would result in the mean gas temperature of the reactor increasing from 1000oC to 1003oC during combustion testing.

 PAGE

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Backbone


[Federal Register: November 2, 2010 (Volume 75, Number 211)]
[Notices]
[Page 67358]
[DOCID:fr02no10-49]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

October 25, 2010.
    Take notice that the Commission has received the following Natural
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    Accession Number: 20101022-5099.
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    Accession Number: 20101022-5035.
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per 154.203: RP10-772 Compliance to be effective 5/27/2010.
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[FR Doc. 2010-27652 Filed 11-1-10; 8:45 am]
BILLING CODE 6717-01-P


31 May 2001 MEMORANDUM SUBJECT: REVISED RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT FOR DISULFOTON FROM: Shanna Recore, Industrial Hygienist Christina Jarvis, Environmental Protection Specialist Reregistration Branch 2 Health Effects Division ( 7509C)

TO: Christina Scheltema Reregistration Branch 3 Special Review and Reregistration Division ( 7508W)

THRU: Al Nielsen, Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C)

Please find attached the residential review of disulfoton.

DP Barcode: D275170 Pesticide Chemical Codes: 032501 EPA Reg Nos. : 4 153, 4 253, 4 420, 16 171, 192 74, 192 119, 192 126, 192 164, 239 2134, 769 908, 802 426, 869 76, 869 223, 904 138, 3125 83, 3125 116, 3125 152, 3125 517, 5887 67, 5887 171, 7401 4, 4701 26, 7401 235, 7401 323, 9404 3, 8660 125, 8660 191, 11474 17, 32802 32, 42057 51, 46260 2, 46260 12, 46260 35, 59144 23 EPA MRID No. : 453334 01 PHED: Yes, Version 1.1 EXPOSURE AND RISK ASSESSMENT/ CHARACTERIZATION Purpose In this document, which is for use in EPA' s development of the disulfoton Reregistration Eligibility Decision document ( RED) , EPA presents the results of its review of the potential human health effects of residential exposure to disulfoton. This memorandum revises the residential exposure section of the February 7, 2000 memorandum titled   Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton.   2 The residential exposure and risk numbers presented in this document have been revised based on a new short term dermal endpoint, new exposure assumptions in the Residential Standard Operating Procedures ( SOPs) , and a new disulfoton residential handler study submitted by Bayer Corporation.

Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc. ) during use or to persons entering treated sites after application is complete. For disulfoton, both criteria are met.

Summary of Toxicity Concerns Relating to Residential Exposure Acute Toxicology Categories Table 1 presents the acute toxicity categories based on the active ingredient as outlined in the Hazard Identification document. 12 1 Table 1: Acute Toxicity Categories for Disulfoton Guideline No. Study Type MRID # ( S) . Results Toxicity Category 81 1 Acute Oral Acc# 072293 LD50 = M: 6. 2 mg/ kg; F: 1. 9 mg/ kg I 81 2 Acute Dermal Acc# 07793 LD50 = M: 15. 9 mg/ kg; F: 3. 6 mg/ kg I 81 3 Acute Inhalation Acc# 258569 LC50 = M: 0. 06 mg/ L; F: 0. 89 mg/ L I 81 4 Primary Eye Irritation None Data requirement waived. N/ A 81 5 Primary Skin Irritation None Data requirement waived. N/ A 81 6 Dermal Sensitization None Data requirement waived. N/ A 81 7 Acute Delayed Neurotoxicity 00129384 Equivocal.

81 8 Acute Neurotoxicity 42755801 Reversible neurotoxic signs consistent with the cholinesterase inhibition 1. 5 mg/ kg in female rats and 5. 0 mg/ kg in male rats. N/ A N/ A = Not Applicable Residential Endpoints of Concern The revised Hazard Identification document for disulfoton indicates that there are toxicological endpoints of concern for residential exposure. The endpoints used in assessing the residential risks for disulfoton are presented in the following Table 2. 12 2 Table 2: Endpoints for Assessing Residential Risks for Disulfoton Test Results Short term Dermal Exposure ( 1 to 7 days) 0. 5 mg/ kg/ day based on plasma and brain cholinesterase inhibition in a 3 day dermal study in rats ( Uncertainty Factor = 100)

Intermediate term Dermal Exposure ( 1 week to several months) 0.03 mg/ kg/ day based on plasma, red blood cell, and brain cholinesterase inhibition in a special 6 month cholinesterase inhibition feeding study in rats ( Uncertainty Factor = 100) * * this study also used for the incidental soil ingestion scenario* *

Inhalation Exposure ( All time periods) 0. 00016 mg/ L or 0.045 mg/ kg/ day based on plasma, red blood cell, and brain cholinesterase inhibition in a 90 day inhalation study in rats ( Uncertainty Factor = 100)

Dermal Absorption ( applied to intermediate term dermal endpoint only) 36%

Inhalation Absorption 100%

FQPA Safety Factor The FQPA Safety Factor Committee met on January 24, 2000 to re evaluate the hazard and exposure data for disulfoton, and recommended that the FQPA safety factor be removed ( 1X) for disulfoton. 10 The toxicity data base is complete, including neurotoxicity studies in rats and there is no evidence of either neurotoxicity or increased susceptibility of fetuses or offspring in prenatal and postnatal studies in rabbits or rats. The 1X FQPA factor is applicable for all populations.

Cancer Classification The HED RfD/ Peer Review classified disulfoton as a Group E chemical, meaning that it is not classifiable for carcinogenicity based on a lack of evidence in a carcinogenicity study in mice and rats at dose levels adequate to test for carcinogenicity. 12 SUMMARY OF USE PATTERN AND FORMULATIONS Homeowner Use Products The Agency acknowledges that this assessment includes some non occupational uses that are no longer supported by Bayer, but may be available on the market due to production by other 3 registrants or   existing stock   provisions. . The only non occupational uses supported by Bayer, at the time of this assessment, are those stated on the Bayer ready to use one percent granular label ( roses, ornamental flowers, and shrubs) .

Type of pesticide/ target pests Disulfoton, ( O, O Diethyl S [ 2 ( ethylthio) ethyl ] phosphorodithioate) ) is a selective systemic organophosphate insecticide used to control a variety of sucking insects. Insects that disulfoton controls include, but are not limited to, the following: 4 C Aphids, Birch leaf miner, Elm leaf beetle, European elm scale, Lace bug, Leafhoppers, Mites, Thrips, Whiteflies, Birch leafminers, Camellia scale, Holly leafminer, Leafhoppers, Mimosa webworm, Pine tip moth, Soft scale, Spider mites, Tea scale, Thrips and Whiteflies.

Formulation types and percent active ingredient for residential products Disulfoton is formulated as a technical product ( 98.5 percent active ingredient) and as a residential use granular product ( two, one, and 0.37 percent active ingredient) . Bayer is currently only supporting the one percent granular product. Disulfoton is often formulated in combination with fertilizers. 4 Registered use sites 4,7 Non occupational use sites The Agency acknowledges that some non occupational use sites listed below are not supported by Bayer; however, these sites have been included for informational purposes because they may be supported by other registrants. Potential residential and non occupational use sites may include indoor or outdoor residential sites ( e. g. , exposure to insecticide use on ornamentals) . The non occupational use sites in this RED have been grouped as follows:

C Residential Ornamental Flowers C C Residential Ornamental Shrubs and Trees C Residential Rose Bushes C Residential Vegetable Gardens C Residential Potted Plants Residential Application Rates 4,7 4 C Residential Ornamental Flowers : The maximum label application rate of the granular product not supported by Bayer is 0.3 lb ai/ 1,000 ft 2 . The maximum application rate for the Bayer one percent granular product is 0.21 lb ai/ 1000 ft 2 . The original assessment assumed a range of rates from 0.005 lb ai/ 1000 ft 2 to 0.3 lb ai/ 1000 ft 2 .

C Residential Ornamental Shrubs and Small Trees: The maximum label application rate for the products not supported by Bayer is 0.016 lb ai/ 5 inch diameter tree for the insecticidal spikes. The maximum application rate for the Bayer one percent granular product is 0.010 lb ai/ four foot shrub. The original assessment assumed a range of rates from 0.000321 lb ai/ four foot shrub to 1.32 lb ai/ four foot shrub.

C Residential Rose Bushes: The maximum label application rate to rose bushes using the insecticidal spikes, which are not supported by Bayer, is 0.048 lb ai/ bush. The maximum application rate for both the Bayer one percent granular and the non Bayer supported granular product is 0.00125 lb ai/ bush. The original assessment assumed a rate of 0.00188 lb ai/ bush.

C Residential Vegetable Gardens: The maximum label application rate is 0.069 lb ai/ 1000 ft 2 . Bayer does not support this use. The original assessment assumed a range of rates from 0.0313 lb ai/ 1000 ft 2 to 0.1125 lb ai/ 1000 ft 2 .

C Residential Potted Plants: The maximum label application rate for hand application of granulars to pots is 0.00034 lb ai/ six inch pot. The maximum application using insecticidal spikes is 0.000063 lb ai/ six inch pot. Bayer does not support this use. The original assessment assumed a rate of 0.00011 lb ai/ six inch pot.

Methods and Types of Equipment Used for Loading and Applying Residential Formulations: 4,7 The Agency acknowledges that some methods of application listed below are not supported by Bayer; however, these application methods and equipment have been included for informational purposes.

C Residential Ornamental Flowers: Belly grinder and push type spreader applications can be used for preplanting treatment, or treatments can be applied using a spoon, measuring scoop, shaker can or by hand, and then soil incorporated. Regardless of application method, the revised assessment assumes that 1000 ft 2 are treated per day. The original assessment assumed 10,000 ft 2 were treated per day using belly grinder equipment and 1000 ft 2 per day using all other equipment.

5 C Residential Ornamental Shrubs : Applications are made by distributing granules uniformly under the shrub canopy using a push type spreader, spoon, measuring scoop, shaker can or by hand and soil incorporated and then watered in. Both the revised and original assessments assumed that 25 shrubs are treated per day.

C Residential Rose Bushes: Belly grinder applications can be made for preplanting treatment. At planting, or to established bushes, application of granulars is made using a push type spreader, spoon, measuring scoop, shaker can or by hand. Both the revised and original assessments assumed that 50 rose bushes are treated per day.

C Residential Vegetable Gardens: Belly grinder or push type spreader applications can be made for preplanting treatment. At planting application of granulars is made using a spoon, measuring scoop, shaker can or by hand. The revised assessment assumes that 1000 ft 2 are treated per day. The original assessment assumed that 10,000 ft 2 were treated per day.

C Residential Potted Plants: Applications are made by hand by punching a hole into soil and pouring granules into the holes or sprinkling granules on the soil and soil incorporating. Both the revised and original assessments assumed that 20 six inch pots are treated per day.

RESIDENTIAL RISK ASSESSMENT AND CHARACTERIZATION Non Occupational Exposure Scenarios HED has determined that residential and other non occupational handlers are likely to be exposed during disulfoton use. The anticipated use patterns and current labeling indicate several exposure scenarios based on the types of equipment that potentially can be used to make disulfoton applications. The Agency acknowledges that some exposure scenarios listed below are not supported by Bayer; however, these exposure scenarios have been included for informational purposes. These scenarios include: ( 1) loading/ applying granulars with a belly grinder; ( 2) loading/ applying granulars with a push type spreader; ( 3) loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand; ( 4) loading/ applying Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars by hand using a measuring cup/ lid; or ( 5) application of insecticidal spikes. Registrants indicate that only dry formulations ( i. e. , only granulars or pellets/ tablets/ spikes) are permitted to be used around residences.

Handler Exposure Data  Surrogate PHED 6 Chemical specific data for assessing human exposures during pesticide handling activities were not submitted to the Agency in support of the reregistration of disulfoton, with the exception of a homeowner garden study ( MRID 453334 01) . It is the policy of HED to use data from the Pesticide Handlers Exposure Database ( PHED) Version 1.1 to assess handler exposures 8 for regulatory actions when chemical specific monitoring data are not available.

The PHED Task Force is comprised of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts: a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e. , replicates) . 8 Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g. , mixing/ loading, applying) , formulation type ( e. g. , wettable powders, granulars) , application method ( e. g. , aerial, groundboom) , and clothing scenarios ( e. g. , gloves, double layer clothing) . 8 Once the data for a given exposure scenario have been selected, the data are normalized ( i. e. , divided by) by the amount of pesticide handled resulting in standard unit exposures ( milligrams of exposure per pound of active ingredient handled) . Following normalization, the data are statistically summarized. The distribution of exposure values for each body part ( e. g. , chest upper arm) is categorized as normal, lognormal, or   other   ( ( i. e. , neither normal nor lognormal) . A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all   other   distributions. . Once selected, the central tendency values for each body part are composited into a   best fit   exposure value representing the entire body. 8 The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g. , duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. 8 In the revised assessment, PHED data are used to assess exposure from loading/ applying granulars with a belly grinder. In the original assessment, PHED data were used to assess exposure from loading/ applying granulars with belly grinder and push type spreader equipment, and from loading/ applying granulars by hand using a spoon, shaker can, or measuring scoop.

7 ORETF Some of the handler exposure data used in this assessment are from the Outdoor Residential Exposure Task Force ( ORETF) . The task force recently submitted proprietary data to the Agency on hose end sprayers, push type granular spreaders, and handgun sprayers ( MRID # 44972201) . The ORETF data were used in this assessment in place of PHED data for the   loading/ applying granulars using a push type spreader   scenario. . The ORETF data were designed to replace the present PHED data with higher confidence, higher quality data that 1 contains more replicates than the PHED data for those scenarios.

Other Handler exposure data from a proprietary granular mixer/ loader/ applicator study ( MRID 452507 02) in bananas using fipronil ( Regent 20GR) were used in place of PHED data for the   loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand   scenario. . This fipronil study is considered to be an appropriate source of surrogate handler exposure data for disulfoton because formulation types are similar ( granular) and application methods are similar ( applying granulars with a spoon) . The study is considered to be of sufficient quality for use in risk assessment. 3 Several factors should be considered when using fipronil data in the disulfoton exposure assessment. Protection factors used to calculate disulfoton dermal unit exposure values, based on the fipronil unit exposure values, include a standard 50% protection factor for the torso, a 10% protection factor for legs, based on shorts, and a 10% protection factor for arms, based on a short sleeved shirt. These protection factors represent the typical attire assumed to be worn by a homeowner during pesticide application ( shorts and short sleeved shirt) . The 10% protection factor for shorts and the 10% protection factor for a short sleeved shirt are not standard protection factors used by the Agency; rather, these values are based on the best professional judgement of Agency scientists and are appropriate for calculating range finding estimates only.

Some other issues and limitations to be considered when using the fipronil study include the following:

  Agency guidelines require that 15 replicates be completed in exposure studies in three different locations. In the fipronil study, only ten replicates were completed using spoons, and at only one location. However, the events that were monitored seemed to be reasonable representations of actual agricultural practices, so it is unlikely that additional replicates would significantly alter the final unit exposure results. Additionally, it is unlikely that cultural practices would significantly vary if the study was completed at different locations.

  The individual amounts of chemical applied were not recorded in this study. Instead, the investigators determined how much product was applied by the application teams used. Using this information, the investigators calculated the amount used for each individual 8 by assuming that each was equally productive ( i. e. , dividing the total amount used per team by the number of team members) .

  One applicator using the spoons had a spoon with no handle. The results for this individual were included with the other spoon applicators as it is a plausible variation of that application method.

The Agency notes that the geometric mean unit exposure value for spoon applications of fipronil was used for disulfoton risk assessment purposes.

Handler Exposure Data  Chemical Specific Data Review of MRID # 453334 01: Disulfoton 1% Granular Residential Applicator Exposure and Risk Estimates 5 In support of the reregistration of disulfoton Bayer Corporation submitted a study estimating handler exposures. The purpose of this study was to quantify potential dermal ( forearm and hand) and inhalation exposure for residential applicators of Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care ® , a granular formulation, which contains 1.04 percent disulfoton as the active ingredient. The maximum application rate for flower beds ( 4 ounces formulated product per 12 square feet) and for shrubs ( 4 ounces formulated product per 1 foot shrub height) was used in this study.

A total of 15 volunteers were monitored using passive dosimetry ( hand/ forearm wash solutions and personal air monitors) . Application of the product was made by pouring the granules into the measuring cup/ lid attached to the product package, and then distributing the granules onto the soil around the base of a shrub or onto a flower bed. The granules were then soil incorporated with a garden rake. A total of 30 replicates were reported. The test site was a fallow test field, approximately 1 acre in size. Two sets of sub plots were established: ( 1) shrub test plots, each containing 10 oleander shrubs ( approximately 48 inches high) ; and ( 2) flower bed sub plots, each containing simulated plants, ( e. g. , 12 to 14 inch high stakes placed on approximately 24 inch centers) .

All of the inhalation exposure data were either non detect or less than the limit of quantitation ( LOQ = 0.3 F g) . Most of the hand/ forearm dermal washing samples returned results greater than the LOQ.

The study was conducted in compliance with the major technical aspects of OPPTS Group A: 875.1300, Inhalation Exposure   Outdoor and 875.1100, Dermal Exposure   Outdoor, and Series 875 Group B, Part C, as they relate to this study. Reviewers noted the following deficiency:

C EPA provided the registrant with comments on study outlines submitted to the Agency. The following comment was not fully addressed in the conduct of the 9 study, as both real plants and simulated plants were used:

: The Agency prefers that the study use real plants Use of Simulated Plants because it is difficult, if not impossible, to tell how closely the   simulated   plant environment reflects what is actually encountered by a homeowner. If the registrant could not find a study site with enough roses or shrubs to treat, the Agency recommended that the study at least include a subset of real plants in established beds to compare the   real   and the   simulated   plants. .

Data from this study were used in place of PHED data for estimating residential handler exposure and risk from applying Bayer Advanced 2 in 1 Systemic Rose and Flower Care ® to roses, flowerbeds, and shrubs by hand. The geometric mean unit exposure value was used for risk assessment purposes.

Non Occupational Handler Exposure Scenario Data and Assumptions Residential handler exposure assessments were completed by HED using a baseline exposure scenario. PHED values used to estimate daily unit exposure values were taken from the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments and the   Recommended Revisions to the Standard Operating Procedures for Residential Exposure Assessments   Science Advisory Council for Exposure Policy # # 12. 6,11 Table 3 summarizes the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. The following assumptions and factors were used in order to complete this exposure assessment:

  Calculations are completed at the maximum application rates recommended by the available disulfoton labels to indicate worst case risk levels associated with the various use patterns. Application rates and exposure values were calculated separately for Bayer 1% granular product labels.

  Generally, the use of PPE and engineering controls are not considered acceptable options for products sold for use by homeowners because they are not available, and/ or inappropriate for the exposure scenario.

  PHED values represent a handler wearing typical residential clothing attire of short sleeve shirt, short pants, socks, shoes, and no gloves.

  The number of rose bushes assumed for treatment per day by a homeowner is 50 rose bushes.

  The number of pots assumed for treatment per day by a homeowner is 20 six inch pots.

  The number of ornamental shrubs or trees assumed for treatment per day by a 10 homeowner is 25 shrubs.

  The area treated with granulars for flower or vegetable gardens by a homeowner is assumed to be 1,000 ft 2 . For pre planting treatment of flower and vegetable gardens with a belly grinder or push type spreader, the treatment area is assumed to be 1,000 ft 2 .

  A respiratory rate of 16.7 L/ min was assumed, based on the draft NAFTA recommended inhalation rates.

Non occupational Handler Exposure and Risk Estimates The calculations of daily dermal and inhalation exposure, short term doses, and total short term MOEs were made using the following formulae. 8 Potential daily dermal exposure is calculated using the following formula:

Daily Dermal Exposure mg ai   Unit Exposure mg ai xUse Rate lb ai x Daily Acres Treated A day lb ai A day The potential short term dermal doses were calculated using the following formulae:

Short   term Daily Dermal Dose mg ai   Short   term Daily Dermal Exposure mg ai x 1 kg / day day Body Weight ( kg )

The short term MOEs were calculated using a NOAEL of 0.5 mg/ kg/ day. The previous assessment used a short term dermal NOAEL of 0.4 mg/ kg/ day from a dermal rabbit study. The intermediate term MOEs were calculated using a NOAEL of 0.03 mg/ kg/ day assuming 36 percent dermal absorption and 70 kg body weight.

Potential daily inhalation exposure was calculated using the following formula:

Daily Inhalation Exposure mg ai   day 1 mg A Unit Exposure F gai x Conversion Factor 1, 000 F g xUse Rate lb A ai x Daily Acres Treated day lb ai The potential short term inhalation doses were calculated using the following formulae:

Short   term Daily Inhalation Dose mg ai   Short   term Daily Inhalation Exposure mg ai x 1 kg / day day Body Weight ( kg )

11 For disulfoton, the inhalation doses were calculated using a 70 kg body weight and an inhalation absorption rate of 100 percent.

Table 4 presents residential dermal and inhalation exposures associated with the handling of disulfoton. Table 5 presents the short term dermal and inhalation risks as well as total MOEs resulting from those exposures. The Agency only assessed for short term non occupational ( residential) risks and not intermediate term non occupational ( residential) risks since it is assumed that handlers will be exposed less than seven days at a time. The Agency acknowledges that some exposure scenarios presented in the following tables may not be supported by Bayer; however, they may be supported by other registrants.

Summary of Concerns for Non occupational Handlers, Data Gaps, and Confidence in Exposure and Risk Estimates Short term dermal and inhalation risks for homeowner handlers were assessed as well as the total risks associated with the handling of disulfoton.

Handler Scenarios with Risk Concerns The calculations of short term dermal and inhalation risks indicate that the following total short term MOEs are greater than 100 at baseline:

( 2) loading/ applying granulars using a push type spreader ( 3) loading/ applying granulars using a spoon, measuring scoop, shaker can, or by hand for application to vegetable gardens, potted plants, and roses.

The calculations of short term dermal and inhalation risks indicate that the following total short term MOEs are less than 100 at baseline:

( 1) loading/ applying granulars with a belly grinder for flower and vegetable gardens ( pre planting) using an application rate of 0.3 lb ai/ 1000 ft 2 ( flower gardens, MOE = 1.1) and 0.069 lb ai/ 1000 ft 2 ( vegetable gardens, MOE = 4.6) .

( 3) loading/ applying granulars, using a spoon, measuring scoop, shaker can or by hand, to flower gardens and ornamental shrubs/ small trees using an application rate of 0.3 lb ai/ 1000 ft 2 ( flower gardens, MOE = 34) and 0.01 lb ai/ four foot shrub ( shrubs/ small trees, MOE = 41) .

The calculations of short term dermal and inhalation risks indicate that all total short term MOEs are greater than 100 at baseline for Bayer   s Advanced Garden 2 in 1 Systemic Rose and Flower Care ® :

( 4) loading/ applying granulars using a measuring cup/ lid at an application rate of 0.21 lb ai/ 1000 ft 2 ( flowerbeds, MOE = 5500) , 0.01 lb ai/ four foot shrub ( shrubs, MOE = 1500) , and 12 0.0013 lb ai/ bush ( rosebushes, MOE = 5800) .

The Agency notes that the Advanced Garden 2 in 1 product is the only homeowner product that Bayer intends to support. Residential risks from the use of this product are not of concern.

Data Gaps Data gaps exist for the following scenario:

( 5) applying insecticidal spikes to rose bushes, or ornamental shrubs and trees.

Data Quality and Confidence in Assessment Several issues must be considered when interpreting the non occupational exposure risks   Factors used to calculate daily exposures to handlers ( e. g. square footage treated per day, number of pots treated and number of shrubs or trees treated in a day) are based on the best professional judgement due to a lack of pertinent data.

Non occupational Postapplication Scenarios HED has determined that there are potential postapplication exposures to residents based on the following scenarios:

  transplanting, hoeing, and weeding treated ornamental shrubs and trees ( including rose bushes) ;

  transplanting, hoeing, and weeding treated ornamental flowers;

  non harvest activities such as weeding and hoeing of home vegetable crops;

  incidental granular ingestion; and   incidental soil ingestion.

Data Source Descriptions for Scenarios Considered A surrogate postapplication exposure assessment was conducted to determine potential risks for incidental soil ingestion. Other postapplication scenarios were not assessed because disulfoton granulars and insecticidal spikes are applied directly to the soil and EPA has no data 13 upon which to base postapplication contact with treated soil through activities such as weeding, hoeing, and transplanting home ornamentals and vegetable crops or houseplants. Furthermore, it is HED   s policy to routinely conduct screening level assessments ( based on standard values in the Residential SOPs) for children   s incidental ingestion of granules when a granular pesticide may be applied in residential settings; however, the Agency has no data upon which to base this postapplication scenario. The Agency requests information on particle density ( number of particles per pound or gram) , carrier type, granular color, and average granular size in order to conduct an exposure assessment for this scenario.

Assumptions Used in Postapplication Exposure Calculations The assumptions used in the calculations for residential postapplication risks include the following items:

  The oral NOAEL of 0.03 mg/ kg/ day from the six month feeding study in rats was used in the assessment.

C On the day of application, it was assumed that 20 percent of the application rate is located with the soil   s uppermost 1 cm. The Residential SOP   s specify a 100 percent assumption; however after disulfoton treatment followed by soil incorporation, the insecticide should be uniformly dispersed into the top 2 inches of soil. 6 C The soil ingestion rate for children ( ages 1 6 years) was assumed to be 100 mg/ day.

C Application rates used in the residential assessment are described in a previous section.

C Toddlers ( 3 years old) used to represent the 1 to 6 year old age group, were assumed to weigh 15 kg.

C Postapplication was assessed on the same day the pesticide is applied because it was assumed that the toddler could be exposed to soil immediately after application. Therefore, postapplication exposures were based on day 0.

Postapplication Exposure and Risk Estimates Table 6 presents the postapplication risks from the incidental soil ingestion by toddlers of soil treated with disulfoton. The following equations were used:

Incidental Soil Ingestion:

ADD = ( SRt * IgR * CF1) / BW 14 where: ADD = average daily dose ( mg/ kg/ day) SRt = soil residue on day " t" ( F g/ g) , assuming average day of reentry   t   is day 0 IgR = ingestion rate of soil ( mg/ day) , assumed to be 100 mg/ day CF1 = weight unit conversion factor to convert the F g of residues on the soil to grams to provide units of mg/ day ( 1E 6 g/ F g) BW = body weight ( kg) , assumed 15 kg for toddlers and SRt = AR * F * ( 1 D) t * CF2 * CF3 * CF4 where:

AR = application rate ( lb ai/ acre) F = fraction of ai available in uppermost cm of soil ( fraction/ cm) , assumed to be 20 percent based on soil incorporation into top 2 inches of soil after application D = fraction of residue that dissipates daily ( unitless) t = postapplication day on which exposure is being assessed CF2 = weight unit conversion factor to convert the lbs ai in the application rate to F g for the soil residue value ( 4.54E8 F g/ lb) CF3 = area unit conversion factor to convert the surface area units ( ft 2 ) in the application rate to cm 2 for the SR value ( 2.47E 8 acre/ cm 2 if the application rate is per acre) CF4 = volume to weight unit conversion factor to convert the volume units ( cm 3 ) to weight units for the SR value ( 0.67 cm 3 / g soil) 7 t = postapplication day on which exposure is being assessed, assumed to be day 0 Summary of Residential Postapplication Risks The target residential MOE is 100 for disulfoton. The resulting surrogate residential postapplication assessment for toddlers indicates that the disulfoton MOEs for incidental soil ingestion are greater than 100 for flower garden soil and vegetable garden soil ( application rates 13 lbs ai/ A and 3 lbs ai/ A, respectively) .

Data Gaps Data gaps exist for the following scenarios:

  transplanting, hoeing, and weeding treated ornamental shrubs and trees ( including rose bushes) ;

  transplanting, hoeing, and weeding treated ornamental flowers;

15   non harvest activities such as weeding and hoeing of home vegetable crops;

  incidental granular ingestion ( information on particle density, carrier type, granular color, and average granular size)

16 Table 3. Residential Exposure Scenario Descriptions for the Use of Disulfoton Exposure Scenario ( Scenario # ) Data Source Comments a Standard Assumptions 6,11 Loading/ applying granulars using a belly grinder ( 1) PHED V1. 1 Baseline: Dermal and hands data = ABC grades, inhalation = AB grade. Dermal 20 45 replicates; hands = 23 replicates; and inhalation = 40 replicates. Medium confidence for hands and dermal, and high confidence for inhalation.

PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre planting of flower/ vegetable gardens per day Loading/ applying granulars using a push type spreader ( 2) Summary of HED   s Reviews of Outdoor Residential Exposure Task Force ( ORETF) Chemical Handler Exposure Studies;

MRID 449722 01. April 30,

2001. Baseline: Dermal, hands, and inhalation data = A/ B grade. Dermal, hands, and inhalation data = 30 replicates. High confidence in all data.

PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre planting of flower/ vegetable gardens and 25 shrubs per day Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) Review of fipronil granular mixer/ loader/ applicator study as a source of surrogate data,

MRID 452507 01. J. Dawson memo, D270065, 1/ 5/ 01. Baseline: A 90% protection factor was applied to gloved hands data to backcalculate   no glove   hand exposure. . A standard 50% protection factor was used for the torso. A 10% protection factor was used to represent the protection afforded by shorts and a short sleeved shirt.

PPE and Engineering Controls : Not required for assessment. 1, 000 ft 2 for pre planting of flower/ vegetable gardens, 25 shrubs, and 50 rose bushes per day Loading/ applying Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care ®

Disulfoton 1% granulars using a measuring cup/ lid ( 4) Disulfoton 1% Granular Residential Applicator Exposure and Risk Estimates:

Report Number: 110137 5 25 shrubs and 50 rose bushes per day Application of insecticidal spikes ( 5) NA NA NA a " Best Available" grades are defined by HED SOP for meeting Subdivision U Guidelines. Best available grades are assigned as follows: matrices with grades A and B data and a minimum of 15 replicates; if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality and number of replicates. Data confidence are assigned as follows:

High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = grades A, B, C, D and E or any combination of grades with less than 15 replicates NA = Not Applicable 17 Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline Exposure Scenario ( Scenario # ) ( mg/ lb ai) a Baseline Dermal Unit Exposure ( g/ lb ai) b Baseline Inhalation Unit Exposure Maximum Application Rate c Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Mixer/ Loader/ Applicator Exposure Loading/ applying granulars using a belly grinder ( 1) 110 62 0.3 lb ai/ 1000 ft 2 Flower Gardens ( pre

planting) 1,000 ft 2 33 0.019 0.069 lb ai/ 1000 ft 2 Vegetable Gardens ( pre planting) 1,000 ft 2 7.8 0. 0043 Loading/ applying granulars using a push type spreader ( 2) 0.68 0.91 0.069 lb ai/ 1000 ft 2 Vegetable Gardens 1, 000 ft 2 0.047 6.3E 5 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 0.20 2.7E 4 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.17 2.3E 4 0.0013 lb ai/ bush Roses 50 bushes 0.043 5.7E 4 18 Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued)

Exposure Scenario ( Scenario # ) Baseline Dermal Unit Exposure ( mg/ lb ai) a Baseline Inhalation Unit Exposure ( g/ lb ai) b Maximum Application Rate Crop Type or Target d Amount Handled Per Day e Daily Dermal Exposure ( mg/ day) f Daily Inhalation Exposure ( mg/ day) g Loading/ applying granulars using a spoon, measuring scoop,

shaker can or by hand ( 3) 3.5 0. 045 0.069 lb ai/ 1,000 ft 2 Vegetable Gardens 1, 000 ft 2 0.24 3.1E 6 0.3 lb ai/ 1000 ft 2 Flower Gardens 1, 000 ft 2 1.04 1.4E 5 0.01 lb ai/ 4 ft shrub Ornamental Shrubs 25 shrubs 0.86 1.1E 5 0.00034 lb ai/ 6" pot Potted Plant 20 pots 0. 023 3.0E 7 0.0013 lb ai/ bush Roses 50 bushes 0.22 2.8E 6 Loading/ applying Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care ® Disulfoton 1% % granulars using a measuring cup/ lid ( 4) 0.03 0.013 0.21 lb ai/ 1000 ft 2 Flowerbeds 1,000 ft 2 0.0063 2.7E 6 0.092 0.013 0.01 lb ai/ 4 ft. bush Shrubs 25 0.023 3.3E 6 0.092 0.013 0.0013 lb ai/ bush Roses 50 bushes 0. 0060 8.5E 7 Application of insecticidal spikes ( 5) No Data No Data No Data No Data No Data No Data No Data Table 4: Residential Handler Dermal and Inhalation Exposures to Disulfoton at Baseline ( continued)

19 Footnotes: a Baseline Dermal Unit Exposure represents short pants, short sleeved shirt, no gloves, and open mixing/ loading.

b Baseline Inhalation Exposure represents no respirator.

c Application Rates are maximum rate values found on disulfoton labels ( EPA Reg. No. 4 153, 3125 517, 7401 323, 8660 191, 9404 3, 46260 2, 46260 12, 46260 35) .

d Crop Type or Target provides a general description of the intended uses of disulfoton. Separate categories are presented because of the distinct differences in application rates and amount handled.

e Daily Amount Handled values are default estimates from Exposure SAC Policy 12, or the best professional judgement of square footage, or number of bushes, shrubs, or pots that could be treated in a single day for each exposure scenario. 12 f Daily Dermal Exposure ( mg/ day) = Unit Exposure ( mg/ lb ai) * Appl. rate * Amount Handled per day.

g Daily Inhalation Exposure ( mg/ day) = Unit Exposure ( µ g/ lb ai) * ( 1mg/ 1000 µ g) Conversion * Application Rate ( lb ai/ A) * Acres treated ( acres/ day) .

h Residential application of disulfoton using a belly grinder are applicable for pre plant treatment applications only.

I Unit exposure data for application of granules by hand were used as surrogate values for these scenarios.

j Application rates for small vegetable gardens are based on 38 inch row spacing ( EPA Reg. No. 7401 323) .

20 Table 5: Residential Handler Short term Risks from Disulfoton at Baseline Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a belly grinder ( 1) Flower Gardens ( pre

planting) 1,000 ft 2 0.3 lb ai/ 1000 ft 2 0.47 1.1 2. 7E 4 170 1.1 Vegetable Gardens ( pre planting) 1,000 ft 2 0.069 lb ai/ 1000 ft 2 0.11 4.6 6. 1E 5 740 4.6 Loading/ applying granulars using a push

type spreader ( 2) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 6.7E 4 750 1.0E 6 5.0E4 740 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.0029 172 4.0E 6 1.2E4 170 Ornamental Shrubs/

Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 0024 210 3.0E 6 1.4E4 200 Roses 50 bushes 0. 00126 lb ai/ bush 6. 1E 4 820 1.0E 6 5.5E4 810 21 Table 5: Residential Handler Short term Risks from Disulfoton at Baseline ( continued)

Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying granulars using a spoon, measuring scoop, shaker can or by hand ( 3) Vegetable Gardens 1, 000 ft 2 0.069 lb ai/ 1,000 ft 2 h 0.0034 150 4.4E 8 1.0E6 150 Flower Gardens 1, 000 ft 2 0.3 lb ai/ 1,000 ft 2 0.015 34 1.9E 7 2.3E5 34 Ornamental Shrubs/

Small Trees 25 shrubs 0.01 lb ai/ 4 ft. shrub 0. 012 41 1.6E 7 2.8E5 41 Potted Plants 20 pots 0. 00034 lb ai/ 6" pot 3.3E 4 1500 4E 9 1.0E7 1500 Roses 50 bushes 0. 00126 lb ai/ bush 0. 0031 160 4.1E 8 1.1E6 160 22 Table 5: Residential Handler Short term Risks from Disulfoton at Baseline ( continued)

Exposure Scenario ( Scenario # ) Crop Type or Target a Amount Handled Per Day b Maximum Application Rate Baseline Dermal Baseline Inhalation Baseline Total Daily Dose ( mg/ kg/ day) c Short term MOE d Daily Dose ( mg/ kg/ day) e Short term MOE f Short term MOE g Mixer/ Loader/ Applicator Risks Loading/ applying Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care ® Disulfoton 1% %

granulars using a measuring cup/ lid ( 4) Flowerbeds 1000 ft 2 0.21 lb ai/ 1000 ft 2 9.0E 5 5600 3.9E 8 1.2E6 5500 Shrubs 25 shrubs 0.01 lb ai/ 4 ft shrub 3. 3E 4 1500 4.6E 8 9.7E5 1500 Roses 50 bushes 0. 0013 lb ai/ bush 9. 0E 5 5900 1.2E 8 3.7E6 5800 Application of insecticidal spikes ( 5) Roses/ Trees No Data No Data No Data No Data No Data No Data No Data Footnotes: a Crop Type or Target provides a general description of the intended use of various products containing disulfoton. Separate categories are presented because of the distinct differences in application rates and acres treated.

b Amount Handled Per Day values are from default estimates of square footage or number of bushes, shrubs, or pots treated a single day for each exposure scenario of concern.

Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day) / Body weight ( 70 kg) .

d Short term Dermal MOE = NOAEL ( 0.5 mg/ kg/ day) / Daily Dermal Dose ( mg/ kg/ day) .

e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day) / Body weight ( 70 kg) .

f Short term Inhalation MOE = NOAEL ( 0.045 mg/ kg/ day) / Daily Inhalation Dose ( mg/ kg/ day) .

g Total Short term MOE = 1/ [ ( 1/ Short term Dermal MOE) + ( 1/ Short term Inhalation MOE) ] .

h Application rates for small vegetable gardens are based on 38 inch row spacing ( EPA Reg No. 7401 323) .

23 c Table 6. Residential Post application Risks from Incidental Soil Ingestion of Disulfoton Scenario Receptor Application Rate Per Treatment ( AR) ( lbs ai/ A) a Srt ( g/ g) b IgR ( mg/ day) BW ( kg) ADD ( mg/ kg/ day) MOE d Incidental soil ingestion ( flowerbeds) Toddler 13 20 100 15 0.00013 230 Incidental soil ingestion ( vegetable garden beds) Toddler 3 4. 5 100 15 0.00003 1000 Footnotes: a Application rate for flower and vegetable gardens b Soil residue ( ug/ g) = [ AR ( lbs ai/ A) * 4.54E+ 8 ug/ lb * 2.47E 8 A/ cm 2 * 0.67 cm 3 / g soil * 0.2/ cm ] .

Average daily dose ( ADD) ( mg/ kg/ day) = [ SRt ( ug/ g) * IgR ( mg/ day) * g/ 1,000,000 ug ] / / [ BW ( kg) ] .

d MOE = NOAEL ( 0.03 mg/ kg/ day) / ADD. 24 c References 1) Bangs, G. ( 2001) Summary of HED   s Reviews of Outdoor Residential Exposure Task Force ( ORETF) Chemical Handler Exposure Studies; MRID 449722 01. Memorandum from Gary Bangs ( HED) to Demson Fuller ( Special Review and Reregistration Division) , April 30, 2001.

2) Becker, J. ( 2000) Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Disulfoton. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 7, 2000.

3) Dawson, J. ( 2001) Ethoprop. Review of fipronil granular mixer/ loader/ applicator study ( MRID 452507 01) in bananas as a source of surrogate data and accompanying ethoprop risk assessment Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. January 5, 2001.

4) Disulfoton Labels ( 4 153, 4 420, 16 171, 192 74, 192 119, 192 126, 192 164, 239 2134, 769 908, 802 426, 869 76, 869 223, 904 138, 3125 83, 3125 116, 3125 152, 3125 152, 3125 517, 5887 67, 5887 171, 7401 4, 4701 26, 7401 235, 7401 323, 9404 3, 8660 125, 8660 191, 11474 17, 32802 32, 42057 51, 46260 2, 46260 35, 59144 23) .

5) Merricks, D. Larry. ( 2001) Determination of Dermal ( Hand and Forearm) and Inhalation Exposure to Disulfoton Resulting from Residential Application of Bayer Advanced Garden 2 in 1Systemic Rose and Flower Care to Shrubs and Flower Beds. MRID # 45333401. February 8, 2001.

6) U. S. EPA ( 1997) Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, draft report. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. December 18, 1997.

7) U. S. EPA ( 1998) Disulfoton LUIS Table for Exposure Assessors ( PRD report dated 11/ 06/ 96 and report run date 02/ 04/ 98) .

8) U. S. EPA ( 1998) PHED Surrogate Exposure Guide, Version 1.1. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. August 1991.

9) U. S. EPA ( 1999) Use of Values from the PHED Surrogate Table and Chemical Specific Data, Science Advisory Council for Exposure Policy No. 7. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. January 28, 1999.

10) U. S. EPA ( 2000) Disulfoton. Report of the FQPA Committee. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 10, 2000 25 11) U. S. EPA ( 2001) Recommended Revisions to the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, Science Advisory Council for Exposure Policy No. 12. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. February 22, 2001.

12) U. S. EPA ( 2001) Disulfoton: Revised ( 3 rd ) Report of Hazard Identification Assessment Review Committee. Washington, D. C. : U. S. Environmental Protection Agency, Office of Pesticide Programs. April 10, 2001.

cc: David Anderson, OPP/ HED/ RRB2 OREB Files 26