7.1.4 Summary of Risk Concerns and Data Gaps for Handlers All residential handler exposure scenarios did not exceed HED's level of concern. [ Note: Although the risk for mixing/ loading/ applying propiconazole with a low pressure handwand is not a concern, ( MOE = 1100) it is important to note that most labels identify a hose end sprayer as the method of application. Additionally, all risk calculations were conducted using the maximum turf application rate ( 1.8 lb ai/ acre). However, a turf application rate of 0.51 lb ai/ acre was identified on a residential use product label ( 100 773). This lower application rate may better represent homeowner use.

Key data gaps have been identified and noted in the above table as N/ A. Neither ORETF nor PHED currently have data for hose end sprayer applications using wettable powder in water soluble packets ( see note in Section 1.5).

7.1.5 Recommendations for Refining Residential Handler Risk Assessment In order to refine this residential risk assessment, more data on actual use patterns including typical rates, timing, and areas treated would help better characterize propiconazole risks. Exposure studies for many equipment types that lack data or that are not well represented in PHED ( e. g., because of low replicate numbers or data quality) should also be considered based Page 52 of 60 on the data gaps identified above and based on a review of the quality of the data used in this assessment.

7.2 Residential Post application Exposures and Risks HED uses the term " post application" to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Propiconazole can be used in many areas that can be frequented by the general population including residential areas ( e. g., home lawns, golf courses). As a result, individuals can be exposed by entering these areas if they have been previously treated.

7.2.1 Residential Post application Exposure Scenarios A wide array of individuals of varying ages can potentially be exposed to propiconazole when they do activities in areas that have been previously treated. Post application exposure scenarios were developed for each residential setting where propiconazole can be used. Assessing post application exposures and risks resulting from residential uses is very similar to assessing occupational post application exposures and risks, except in residential assessments:

  Residential exposure assessments for propiconazole were classified as short term exposure scenarios ( 1 30 days).

  Exposures were calculated for children as well as adults.

  Non dietary ingestion exposures to toddlers were calculated ( i. e., soil ingestion, hand / object to mouth).

HED relies on a standardized approach for completing residential risk assessments that is based on current propiconazole labels and guidance contained in the following three documents.

  Series 875, Occupational and Residential Exposure Test Guidelines: Group B   Post application Exposure Monitoring Test Guidelines ( V 5.4, Feb. 1998) This document provides general risk assessment guidance and criteria for analysis of residue dissipation data.

  Standard Operating Procedures for Residential Exposure Assessment ( Dec. 1997). This document provides the overarching guidance for developing residential risk assessments including scenario development, algorithms, and values for inputs.

  Science Advisory Council For Exposure Policy 12 ( Feb. 2001): Recommended Revisions To The Standard Operating Procedures ( SOPs) For Residential Exposure Assessment This document provides additional, revised guidance for completing residential exposure assessments. Page 53 of 60 When the guidance in current labels and these documents is considered, it is clear that HED should consider children as well as adults in its assessments. It is also clear that different age groups should be considered in different situations. The populations that were considered in the assessment include:   Residential Adults: these individuals are members of the general population that are exposed to chemicals by engaging in activities at their residences ( e. g., in their lawns) and also in areas not limited to their residence ( e. g., golf courses or parks) previously treated with a pesticide. These kinds of exposures are attributable to a variety of activities and usually addressed by HED in risk assessments by considering a representative activity as the basis for the exposure calculation.

  Residential Children: children are members of the general population that can also be exposed in their residences ( e. g., on lawns) as well as other areas previously treated with a pesticide ( e. g., parks). These kinds of exposures are attributable to a playing outside. Toddlers have been selected as a sentinel ( or representative) population for turf. They are usually addressed by HED in risk assessments by considering representative activities in an exposure calculation.

The SOPs for Residential Exposure Assessment defines several scenarios that apply to uses specified in current labels. These scenarios served as the basis for the residential postapplication assessment along with the modifications to them and the additional data and approaches described above. HED used this guidance to define the exposure scenarios that essentially include dermal and non dietary ingestion exposure to toddlers and adults on treated lawns. The SOPs and the associated scenarios are presented below:

  Post Application Dermal Potential Dose from Pesticide Residues on Turf: Postapplication dermal dose calculations for toddlers and adults from playing on treated turf;

  Post Application Potential Dose among Toddlers from Incidental Non dietary Ingestion of Pesticide Residues on Residential Lawns from hand to mouth Transfer: Postapplication dose calculations for toddlers from incidental non dietary ingestion of pesticide residues on treated turf from hand to mouth transfer ( i. e., those residues that are swallowed when toddlers get pesticide residues on their hands from touching treated turf and then put their hands in their mouth);

  Post Application Potential Dose among Toddlers from Incidental Non dietary Ingestion of Pesticide Residues on Residential Lawns from object to mouth Transfer: Postapplication dose calculations for toddlers from incidental non dietary ingestion of pesticide residues on treated turf from object to mouth transfer ( i. e., those residues that are swallowed when toddlers put treated turf in their mouths);

  Post Application Potential Dose among Toddlers from Incidental Ingestion of Soil from Pesticide Treated Residential Areas: Post application dose calculations for toddlers from incidental non dietary ingestion of pesticide residues from ingesting soil in a Page 54 of 60 treated turf area ( i. e., those soil residues are swallowed when toddlers get pesticide residues on their hands from touching treated soil and then put their hands in their mouth);

The detailed residential post application calculations are presented in Appendix D of this document.

7.2.2 Data and Assumptions for Residential Post application Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing residential post application risk assessments. The assumptions and factors used in the risk calculations are consistent with current HED policy for completing residential exposure assessments ( i. e., SOPs For Residential Exposure Assessment). The assumptions and exposure factors used in this assessment include:

  Factors that are common to the occupational and residential Post application risk assessments, such as body weights for adults, analysis of residue dissipation data, and transfer coefficients are used in this assessment for the garden exposure scenarios. Please refer to the assumptions and factors in Section 5.1.1 for further information concerning these common values.

  HED combines risks resulting from exposures to individual chemicals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. Within a residential assessment, the approach is to add together risks for individual exposure scenarios from all likely sources of exposure such as after an application to turf or use on a pet. For propiconazole, HED has combined risks ( i. e., MOEs) for different kinds of exposures for the turf scenarios ( i. e., dermal, hand to mouth, object to mouth, and soil ingestion).

  Exposures to adults and children on treated turf have been addressed using the latest HED standard operating procedures for this scenario including: Page 55 of 60   Study specific data was used for Turf Transferable Residue ( TTR) values in each scenario ( see note about submitted TTR data in Section <IP_ADDRESS>);

  A percent of the application rate has been used to calculate the day zero residue levels used for assessing risks from hand to mouth behaviors;

  20 percent of the application rate has been used to calculate the day zero residue levels used for assessing risks from object to mouth behaviors ( a higher percent transfer has been used for object to mouth behaviors, because it involves a teething action believed to be more analogous to DFR/ leaf wash sample collection where 20 percent is also used);

  Year old toddlers are expected to weigh 15 kg ( average of 1 to 6 year olds);

  Hand to mouth exposures are based on a frequency of 20 events/ hour and a surface area per event of 20 cm2 representing the palmar surfaces of three fingers;

  Saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately ½ of the residues on the hand are removed;

  Object to mouth exposures are based on a 25 cm2 surface area;

  Exposure durations are assumed to be 2 hours based on information in HED's Exposure Factors Handbook except for golfing which is 4 hours per day;

  100 percent of the application rate has been used to calculate the day zero soil residue levels used for assessing risks from soil ingestion behavior; soil residues are contained in the top centimeter and soil density is 0.67 mL/ gram.

  Dermal, hand and object to mouth, and soil ingestion are combined to represent an overall risk from exposure to turf while granular ingestion is considered to be a much more episodic behavior and is considered separately by HED.

7.2.3 Residential Post application Exposure and Non cancer Risk Estimates Dermal exposures and risks from residential uses were calculated in the same manner as described above in Section 6.1.3. The algorithms used for each type of calculation which have not been previously addressed in Section 6.1.3 are presented below.

  Dermal Exposure from Treated Lawns ( adult and toddler)

The approach used to calculate the dermal exposures that are attributable to exposure from contacting treated lawns is: Page 56 of 60 ADD = ( TTR0 * ET * TC * DA * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

TTRt = turf transferable residue on day " 0" ( µ g/ cm2 );

ET = exposure time ( 2 hr/ day);

TC = transfer coefficient DA = dermal absorption factor ( 40%);

CF1 = weight unit conversion factor to convert µ g units to mg for the daily exposure ( 0.001 mg/ µ g);

BW = body weight ( 70 kg for general population and 15 kg for toddlers)

Non dietary Ingestion Exposure from Treated Turf: Non dietary ingestion exposure from treated turf was calculated using the following equations.

  Hand to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate the non dietary ingestion exposures that are attributable to handto mouth behavior on treated turf is:

ADD = ( TTR0 * SA * FQ * ET * SE * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

TTRt = turf transferable residue on day " 0" ( µ g/ cm2);

SA = surface area of the hands ( 20 cm2/ event);

FQ = frequency of hand to mouth activity ( 20 events/ hr);

ET = exposure time ( 2 hr/ day);

SE = extraction by saliva ( 50%); Page 57 of 60 CF1 = weight unit conversion factor to convert µ g units in the DFR value to mg for the daily exposure ( 0.001 mg/ µ g); and BW = body weight ( 15 kg).

  Object to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate exposures that are attributable to object to mouth behavior on treated turf that is represented by a child mouthing on a handful of turf is:

ADD = ( TTR0 * IgR* CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day); TTRt = turf transferable residue on day " 0" ( µ g/ cm2);

IgR = ingestion rate of grass ( 25 cm2/ day);

CF1 = weight unit conversion factor to convert the µ g of residues on the grass to mg to provide units of mg/ day ( 1E 3 mg/ µ g); and BW = body weight ( 15 kg).

  Incidental Ingestion of Soil from Pesticide Treated Residential Areas ( toddler).

The approach used to calculate exposures that are attributable to soil ingestion is:

ADD = ( SR0t * IgR * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

SR0t = soil residue on day " 0" ( 0.0022 µ g/ g);

IgR = ingestion rate of soil ( 100 mg/ day);

CF1 = weight unit conversion factor to convert the µ g of residues on the soil to grams to provide units of mg/ day ( 1E 6 g/ µ g); and BW = body weight ( 15 kg). Page 58 of 60 7.2.4 Residential Post application Non cancer Risk Summary Detailed risk calculations for the various residential propiconazole assessments are included in Appendices C and D. A summary of risk estimates for residential post application risks for adults and children is provided in the following tables. Additionally, HED combines risk values resulting from separate post application exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population ( see Table 16). [ Note: Propiconazole is classified as a non volatile chemical; therefore a residential ( inhalation) post application assessment is not needed].

Table 15: Adult Residential Risk Estimates for Post application Exposure to Propiconazole Exposure Scenario TC cm ² / hr Route of Exposure Application Rate MOE at Day 0 Outdoors Residential Turf ( Gen. High Contact Activities) 70000 Dermal 1.8 lb ai/ acre 350 Residential Turf ( Mowing) 500 Dermal 1.8 lb ai/ acre 50000 Note: Level of Concern: MOE = 100 Table 16: Toddler Residential Risk Estimates for Post application Exposure to Propiconazole Exposure Scenario TC cm ² / hr Route of Exposure Application Rate MOE at Day 0 1 Combined MOE Outdoors Hand to Mouth Activity on Turf N/ A Oral 1.8 lb ai/ acre 1100 Object to Mouth Activity on Turf N/ A Oral 1.8 lb ai/ acre 4500 Soil Ingestion N/ A Oral 1.8 lb ai/ acre 330000 Turf   General High Contact Activities 25000 Dermal 1.8 lb ai/ acre 210 170 Note: ¹ Combined MOE = NOAEL/( PDRhand to mouth + PDRobject to mouth + PDRincidental soil ingestion + ADDdermal) Level of Concern: MOE = 100 7.2.5 Summary of Residential Post application Risk Concerns and Data Gaps HED considered a number of exposure scenarios for products that can be used in the residential environment representing different segments of the population including toddlers and adults. In residential settings, HED does not use restricted entry intervals or other mitigation approaches to limit post application exposures because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern. Page 59 of 60   For all short term post application scenarios, risks did not exceed HED's level of concern ( MOEs > 100).

HED combines risks resulting from different routes of exposures to individuals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For propiconazole, HED has combined risk values ( i. e., MOEs) for children, the different routes of exposures associated with the turf ( dermal, hand to mouth, object to mouth, and soil ingestion). These are typically added together when pesticides are used on turf, because it is logical they can co occur. The combined risks did not exceed HED's level of concern ( i. e., the MOEs > 100).

Note; Residential Post application scenarios ( Toddler: Hand to Mouth/ Soil Ingestion), have been characterized as Short term risk scenarios for the following reasons.

  All post application exposure scenarios have been calculated using Propiconazole as the parent compound. For further explanation of parent compounds as they compare to metabolic breakdown products, see ( Memorandum dated July 8, 2002 titled: Review of " Profile of the Triazole derivative Fungicide Compounds and their Common Metabolites" ( MRID#: 45575501; DP Barcode: D284131).

  Compound specific TTR data indicates that at the Indiana, California, and Pennsylvania test sites, average total propiconazole residues declined below the minimum quantifiable limit ( MQL) by DAT = 14, DAT = 10, and DAT = 8 respectively. These dissipation rates, combined with label specific use rates and frequency of use specifications, reinforce the hand to mouth short term exposure scenario.

For short term exposure to Children 1 2 years old, the driving factors for this risk assessment are hand to mouth, object to mouth, and dermal exposure. Soil ingestion is insignificant ( MOE> 300,000) compared to these factors, indicating that the post application scenario should be short term only.

7.2.6 Recommendations for Refining Residential Post application Risk Assessment In order to refine this residential assessment, data on actual use patterns including rates, timing, and the kinds of tasks that are required to better characterize propiconazole risks. Page 60 of 60 Appendices ( A). Occupational ( B). Occupational Post Application ( C). Residential ( D). Residential Post Application


[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Page 46029]
[FR Doc No: 2019-18885]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4438-DR; Docket ID FEMA-2019-0001]

Oklahoma; Amendment No. 8 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4438-DR), dated June 1, 2019, and
related determinations.

DATES: This amendment was issued August 13, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of June 1, 2019.

    Tillman County for Public Assistance [Categories A-G], including
direct federal assistance, under the Public Assistance program.
    Okmulgee and Ottawa Counties for Public Assistance [Categories
A-G], including direct federal assistance, under the Public
Assistance program (already designated for Individual Assistance).
    Noble County for Public Assistance [Categories A-G] (already
designated for Individual Assistance and assistance for emergency
protective measures [Category B], limited to direct federal
assistance under the Public assistance program).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-18885 Filed 8-30-19; 8:45 am]
 BILLING CODE 9111-23-P