6. Non Detects Several recommendations were made regarding interpreting non detections in monitoring data sets [ 3, 6, 7]. One commentor [ 6] notes that non detects in monitoring data can be misleading and should be considered only in light of the concerns listed in the science policy document. Another commentor [ 7] recommends that the Agency confirm and " validate" nondetects in the same manner as detects. If non detects are from areas where the product is not used, the commentor recommends reporting the value as 0; if the non detects are in areas of use, report the value as as one half of the limit of detection ( LOD) or quantification ( LOQ). This commentor encouraged the development of statistical " imputation methods" to define the shape of data distributions below LOD/ LOQ.

Agency Response: Non detects can indicate that the pesticide of concern is not reaching the drinking water source. However, non detects can also result when the pesticide is analyzed in areas where or times when the pesticide is not being used. Limitations with analytical methods may also result in non detects. All of these factors will influence how the Agency interprets nondetects in monitoring data sets. This information, particularly on pesticide usage in relation to the monitoring sites, is not always available for the pesticide monitoring data provided to the Agency, thus making it difficult to interpret the meaning of some reported non detects. The Agency does not believe that it is appropriate at this time, given the current state of monitoring data and ancillary information, to establish a policy such as that which has been applied to non detects on food ( i. e., to assume that a pesticide is present at ½ the LOD whenever a non detect is reported).

K. Considering Water Treatment Effects in Drinking Water Assessments Two commentors [ 3, 7] stated that the Agency should always consider treated, or 41 " finished," water in its drinking water assessments, if such data are available, since this represents the actual exposure to the population. Both encouraged EPA to develop default pesticide reduction factors by evaluating effects of drinking water treatment on pesticide concentrations and effectiveness variability among plants. Another commentor [ 6] cited statistics showing that a " large number" of people consume drinking water that is not treated ( 17% of the nation uses private drinking water sources which are not usually treated; roughly half of drinking water comes from ground water, which is generally not treated with technology that is likely to reduce pesticide concentrations; " large numbers" of drinking water facilities do not use modern technology which would " substantially" reduce pesticide concentrations) to support the position that EPA should not focus on the effectiveness of drinking water treatment in pesticide exposure assessments.

A commentor representing a number of community water system operators [ 1] recommended that an appropriate default treatment should be " the minimum treatment allowed by federal regulations governing public water supplies and private wells." For ground water supplies, this would be equivalent to no treatment; for community surface water systems, this would be disinfection only ( e. g., chlorine) for some systems, or conventional treatment ( rapid mix coagulation flocculation sedimentation filtration disinfection) which covers the majority of surface water systems in the U. S. [ 1] However, this commentor urged the Agency to focus its decision making criteria on drinking water at the intake ( source water) and consider the impact of pesticides on water entering drinking water supplies and private wells.

Agency Response: The Agency is in the process of gathering information on the extent of drinking water treatments in use and the effectiveness of these treatments on reducing the level of pesticides in water. Consideration of water treatment effects on pesticides in water must take into account not only effectiveness in pesticide removal, but also the secondary formation of any transformation products of toxicological concern as a result of the treatment process. The area and population served by the particular treatments, as well as temporal variations in drinking water treatment effectiveness, must also be considered. The Agency plans to issue a paper addressing drinking water treatment effects in its drinking water exposure assessment in early 2000.

L. Use of the Drinking Water Level of Comparison ( DWLOC) in Aggregate Exposure Assessments 1. Consistency in DWLOC and MCL Approaches Two commentors [ 1, 6] felt that OPP's DWLOC was not consistent with the Office of Water's Maximum Contaminant Level ( MCL) and the Safe Drinking Water Act ( SDWA) standard setting process. They urged OPP to establish enforceable standards that support source water protection and drinking water program compliance with pesticide standards. One commentor [ 8], noting that the DWLOC procedure uses the Reference dose ( RfD) as the maximum daily intake, requested that the document clarify that this is a conservative approach since the true safe level is some value above the RfD. 42 Agency Response: The MCL established by the Office of Water is a regulatory standard based on the RfD that also takes into consideration such factors as what is technologically achievable in terms of contaminant removal and the costs associated with such removal. The DWLOC does not factor in such economic/ technology based considerations. Moreover, in practice the DWLOC is a " tool" that OPP uses in its human health aggregate risk assessment process to identify pesticides which require further evaluation and more sophisticated assessments. The DWLOC is an expression of the allowable level of a pesticide in drinking water which when combined with food exposures will not result in exposure above an acceptable level of risk. OPP strongly supports the need to prevent drinking water contamination and has available to it federal authority to control pesticide use and application methods to mitigate contamination of water.

2. Current Approach For Determining the DWLOC In the draft document, the Agency asked for comment on its current approach of calculating DWLOCs for drinking water exposure after contributions from food and residential sources have been considered. Responses to this question were divided. Two commentors [ 6, 7] called the approach reasonable, although one [ 7] said the process is only as valid as the dietary and nondietary assessments. If the assessments " grossly overestimate risk," then the DWLOC is not really a level of concern. One commentor [ 1] saw " no clear logic to making calculation of exposure through drinking water contingent on the contributions from food and residential exposure" and recommended that all routes of exposure should be considered equally. Another commentor [ 3] stated that total aggregate exposure should not depend on the order in which the potential routes of exposure are considered. This commentor expressed concern that current risk evaluation procedures for the three routes of exposure are " at vastly different levels of development" and encouraged the Agency to develop more sophisticated risk refinement methods for all important routes of exposure.

Agency Response: The DWLOC was originally designed as a tool to be used along with screening level estimates of pesticide concentrations in drinking water to determine the need for more sophisticated analyses of aggregate exposure. In many cases the comparison of the DWLOC to the screening level drinking water estimate has allowed EPA to cost effectively clear the pesticide from the perspective of total aggregate risk. Commentors raise a very legitimate issue, however, with regard to the approach that the Agency takes to mitigation or additional monitoring requirements in those cases where the DWLOC is met or exceeded and further refinements in the drinking water estimate of exposure still do not allow the pesticide to be cleared from an aggregate risk perspective. It would seem that a regulatory approach which would have as its objective the identification of the most cost effective method for reducing aggregate risk ( taking into consideration all pertinent regulatory authorities   SDWA as well as FIFRA and FFDCA and perhaps even relevant State and local regulatory authorities) would be the preferable approach. 43 List of Public Commentors and Affiliations I. D. # Name and Organization 1. John H. Sullivan, Deputy Executive Director, American Water Works Association. Denver, Colorado.

2. Arthur L. Craigmill, Extension Toxicity Specialist, Extension Toxicity Network ( EXTOXNET), University of California. Davis, California.

3. FQPA Implementation Working Group ( IWG). IWG is a non governmental coalition of farm, food, pest management, and manufacturing organizations.

4. Sam Moore, President, Kentucky Farm Bureau Federation. Louisville, Kentucky.

5. Jack Laurie, President, Michigan Farm Bureau. Lansing, Michigan.

6. Erik D. Olson, Senior Attorney, Natural Resources Defense Council ( NRDC). Washington, D. C.

7. Dave Whitacre, Vice President, Development, Novartis Crop Protection, Inc. Greensboro, North Carolina.

8. Elaine Francis, Director, Pesticides, Toxics and Multimedia Staff, Office of Science Policy, Office of Research and Development, U. S. Environmental Protection Agency. Washington, D. C. 44 Sources Cited in the Agency Responses Habicht, F. H. 1992. Guidance on Risk Characterization for Risk Managers and Risk Assessors. Memo from F. Henry Habicht II, Deputy Administrator, U. S. EPA, to Assistant and Regional Administrators, U. S. EPA, Feb. 26, 1992.

Hackett, A. G. 1996, 1997, 1998. Surface Drinking Water Monitoring Program for Acetochlor and Other Corn Herbicides. Acetochlor Registration Partnership. St. Louis, MO. See the EPA OPP home page at http:// www. epa. gov/ oppefed1/ aceto/ index. htm for more information.

National Research Council. 1993. Ground Water Vulnerability Assessment : Predicting Relative Contamination Potential under Uncertainty / Committee on Techniques for Assessing Ground Water Vulnerability, Water Science and Technology Board, Commission on Geosciences, Environment, and Resources, National Research Council, 1993.

Parker, R., J. Hetrick, et al. 1999. Review Comments on " A Simple Regression Model for Predicting Surface Water Concentrations Resulting from Agricultural Field Runoff and Erosion". A May 7, 1999, memo from Parker, Hetrick, and the Water Quality Tech Team, through Joe Merenda, EFED Director, to Keefer, Gilding, and the ACPA Drinking Water Exposure Workgroup.

Scribner, E. A., D. A. Goolsby, E. M. Thurman, M. T. Meyer, and W. A. Battaglin. 1996. Concentrations of Selected Herbicides, Herbicide Metabolites, and Nutrients in Outflow from Selected Midwestern Reservoirs, April 1992 Through September 1993. U. S. Geol. Surv. Open File Report 96 393. Prepared as part of the Toxic Substances Hydrology Program. Laurence, KS.

U. S. EPA. 1992. Guidelines for Exposure Assessment. FR Vol. 57, No. 104, Fri, May 29, 1992.

US. EPA FIFRA Scientific Advisory Panel. 1997. FIFRA SAP Report on A Set of Scientific Issues Being Considered by the Agency in Connection with Estimating Drinking Water Exposure as a Component of the Dietary Risk Assessment. Electronic copy available from the EPA OPP home page at http:// www. epa. gov/ pesticides/ SAP/ 1997/ december/ finaldec. pdf .

U. S. EPA Office of Pesticide Programs. 1998. Proposed Methods for Basin Scale Estimation of Pesticide Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment. Electronic copy available from the EPA OPP home page at http:// www. epa. gov/ pesticides/ SAP/ 1998/ index. htm# october .

U. S. EPA Office of Pesticide Programs. 1999. Proposed Methods for Determining Watershedderived Percent Crop Areas and Considerations for Applying Crop Area Adjustments to Surface Water Screening Models. Electronic copy available from the EPA home page under the Office of Pesticide Programs ( OPP) at http:// www. epa. gov/ pesticides/ SAP/ 1999/ may/ pca_ sap. pdf .


[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Rules and Regulations]
[Pages 50914-50916]
[FR Doc No: 2012-20345]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2011-0348]
RIN 1625-AA01

Anchorage; Change to Cottonwood Island Anchorage, Columbia River,
Oregon and Washington

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is revising the existing Cottonwood Island
anchorage and establishing a new designated anchorage. The change is
necessary to ensure that there are sufficient anchorage grounds on the
Columbia River.

DATES: This rule is effective September 24, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0348 and are available online
by going to http://www.regulations.gov, type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder
associated with this rulemaking. You may also visit the Docket
Management Facility in room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email ENS Ian McPhillips, Waterways Management Division, Coast
Guard MSU Portland; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    On June 13, 2011, the Coast Guard published an NPRM proposing to
increase the size of the Cottonwood Island Anchorage on the Columbia
River (76 FR 34197). On May 23, 2012, the Coast Guard published a
Supplemental NPRM revising that proposal in response to public comments
(77 FR 30440). During the 30-day comment period on the Supplemental
NPRM, the Coast Guard received eight comments on the proposed action.
Seven of the comments were from various maritime stakeholders in the
Lower Columbia River Basin and one of the comments was from the Mayor
of the City of Prescott.

B. Basis and Purpose

    The Secretary of Homeland Security has delegated to the Coast Guard
the authority to establish and regulate anchorage grounds in accordance
with 33 U.S.C. 471, 1221 through 1236, 2030, 2035, 2071; 33 CFR 1.05-1;
and Department of Homeland Security Delegation No. 0170.1. As currently
established, the Coast Guard Captain of the Port Columbia River
believes the size of the Cottonwood Island Anchorage is insufficient
based on both the current demand for anchorage grounds and the
forecasted growth of vessel traffic on the Columbia River. Sufficient
anchorage area, both in number and size, is especially important in
this area because of the unpredictable hazardous conditions of the
Columbia River Bar, which at times prevents vessels from safely
navigating downriver. This rule increases the size of the current
Cottonwood Island Anchorage and creates a new anchorage on the Columbia
River.

C. Discussion of Comments, Changes, and the Final Rule

    The Coast Guard received eight comments during the 30-day comment
period on the Supplemental NPRM.

Seven of the comments received were from maritime industry stakeholders
in support of the action. The eighth comment, submitted on behalf of
the City of Prescott, stated that the city was satisfied with the
regulatory action. That comment also referenced emergency anchoring
situations in areas outside the anchorages established by this rule.
This rule does not affect waters not designated as anchorages and,
consequently, the ability of vessels to anchor in these areas outside
the channel remains as it was before this rulemaking. Likewise, the
Captain of the Port continues to possess the same authority to direct
vessels to anchor under 33 CFR 160.111(c). However, the Coast Guard
believes that the City's concerns over noise, vessel exhaust, and
visual impact in emergency anchoring situations will be addressed by
anchoring standards of care being developed in the Lower Columbia River
Region Harbor Safety Plan and applied by the Columbia River Pilots
under 33 CFR 110.228(b)(3).
    After considering all comments submitted, the Coast Guard made no
changes to the rule proposed in the Supplemental NPRM.

D. Regulatory Analyses

    The Coast Guard developed this rule after considering numerous
statutes and executive orders related to rulemaking. Below, we
summarize our analyses based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under that Order. Modifying the existing
anchorage and establishing a new anchorage area will not have any
significant costs or impacts on maritime activities.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612, as
amended) requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities. This rule may affect the
following entities, some of which might be small entities: The owners
or operators of vessels operating in and around the anchorage areas
established by this rule and the City of Prescott. This rule will not
have a significant economic impact on vessel owners and operators
because the anchorage area is outside the channel and will not,
therefore, affect vessel traffic patterns. This rule will not have a
significant economic impact on the City of Prescott because the
anchorages established by the rule are upriver and downriver of the
city limits and because vessels anchoring at the anchorage will have
little or no economic activity with the City of Prescott or its
residents.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference With Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children From Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination With Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions

Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

13. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(f), of the Instruction. This rule involves the extension of one
anchorage and the establishment of another. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

0
1. The authority citation for part 110 continues to read as follows:

    Authority:  33 U.S.C. 471, 1221 through 1236, 2030, 2035, 2071;
33 CFR 1.05-1; Department of Homeland Security Delegation No.
0170.1.

0
2. Amend Sec.  110.228 by revising paragraph (a)(10) and adding
paragraph (a)(11) to read as follows:

Sec.  110.228  Columbia River, Oregon and Washington.

    (a) * * *
    (10) Cottonwood Island Anchorage. The waters of the Columbia River
bounded by a line connecting the following points:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
46[deg]05'56.88'' N                  122[deg]56'53.19'' W
46[deg]05'14.06'' N                  122[deg]54'45.71'' W
46[deg]04'57.12'' N                  122[deg]54'12.41'' W
46[deg]04'37.55'' N                  122[deg]53'45.80'' W
46[deg]04'13.72'' N                  122[deg]53'23.66'' W
46[deg]03'54.94'' N                  122[deg]53'11.81'' W
46[deg]03'34.96'' N                  122[deg]53'03.17'' W
46[deg]03'11.61'' N                  122[deg]52'56.29'' W
46[deg]03'10.94'' N                  122[deg]53'10.55'' W
46[deg]03'32.06'' N                  122[deg]53'19.69'' W
46[deg]03'50.84'' N                  122[deg]53'27.81'' W
46[deg]04'08.10'' N                  122[deg]53'38.70'' W
46[deg]04'29.41'' N                  122[deg]53'58.17'' W
46[deg]04'49.89'' N                  122[deg]54'21.57'' W
46[deg]05'06.95'' N                  122[deg]54'50.65'' W
46[deg]05'49.77'' N                  122[deg]56'58.12'' W
------------------------------------------------------------------------

    (11) Prescott Anchorage. The waters of the Columbia River bounded
by a line connecting the following points:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
46[deg]02'47.01'' N                  122[deg]52'53.90'' W
46[deg]02'26.32'' N                  122[deg]52'51.89'' W
46[deg]02'25.92'' N                  122[deg]53'00.38'' W
46[deg]02'46.54'' N                  122[deg]53'03.87'' W
------------------------------------------------------------------------

* * * * *

    Dated: August 1, 2012.
K.A. Taylor,
Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard District.
[FR Doc. 2012-20345 Filed 8-22-12; 8:45 am]
BILLING CODE 9110-04-P


Grape; 47372524-47372525; three applications at total rate of 0.446 lb ai/A (500 g ai/ha); 1x label rate; postemergence (BBCH 17-19, 71, and 81); 18-day PHI (fruit) and 19-day PHI (leaves).
Potato; 47372528-47372529; three applications at total rate of 0.446 lb ai/A (500 g ai/ha); postemergence (BBCH 16, 55, and 71); 51-day PHI.
Bean; 47372526-47372527; two applications at total rate of 0.446 lb ai/A (500 g ai/ha); postemergence (BBCH 51 and 75); 4-day PHI for green bean and foliage (BBCH 75), and 29-day PHI for mature succulent bean, dried bean, and straw.
Pepper, bell; 47372530-47372531; 5 mg ai/plant and 20 mg ai/plant, drip irrigation to plants grown on stone wool; x rate compared to label rate for tomato could not be determined; postemergence BBCH 15-17; fruit harvested at 55 to 96 days posttreatment and combined for analysis; 97-day PHI for remaining plant material; results for fruit treated at exaggerated rate reported only for PY-label.
Rotational Crops (turnip, Swiss chard & wheat); 47372631-32; 0.46-0.48 lb ai/A (514-534 g ai/ha); ~1x label rate; applied to bare soil; 30-, 139- and 280-day PBIs; metabolite levels across all PBIs are reported unless otherwise noted.
Hen; 47372532-33; 25.96-26.42 ppm; 14 days dosing; 24-hour PSI.
Goat; 47372534-35; 44.62-46.26 ppm; 5 days dosing; 24-hour PSI.  For milk, results represent morning and evening samples for PH study, and evening samples only for PY study.

Appendix C.  Physical/Chemical Properties

Table C1.	Physicochemical Properties of Fluopyram.
Parameter
Value
Reference
Melting point
118 ºC
MRID 47372240
pH
6.6 (1% aqueous solution; pure substance)
MRID 47372236
Density
1.53
MRID 47372242
Water solubility (20 °C)
Distilled water (pH 6.7) = 16 mg/L
pH 4 = 15 mg/L
pH 7 = 16 mg/L
pH 9 = 15 mg/L
MRID 47372247
Solvent solubility (g/L at 20 °C)
heptane	0.66
toluene	62.2
dichloromethane	>250
methanol	>250
acetone	>250
ethyl acetate	>250
dimethyl sulfoxide	>250
MRID 47372248
Vapor pressure
1.2 x 10-6 Pa at 20 ºC
3.1 x 10-6 Pa at 25 ºC
2.9 x 10-4 Pa at 50 ºC
MRID 47372249
Dissociation constant (pKa)
0.5 (23 ºC)
MRID 47372243
Octanol/water partition coefficient Log(KOW)
3.3
MRID 47372245
UV/visible absorption spectrum
Peak max at 270 nm
MRID 47372237

Appendix D.  Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure.  Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as PHED, ARTF, ORETF and AHETF.  EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted.  All applicable requirements of EPA's Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

Appendix E.  Occupational Exposure/Risk Summary Tables

Table E1. Non-Cancer Occupational Short- and Intermediate-Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram
                               Exposure Scenario
                                Crop or Target
                              ApplicationRate[a]
                                   (lb ai/A)
                        Area Treated Daily[b] (A/day)
                               Unit Exposure[d]
                         Daily Exposure[e] (mg/kg/day)
                                    MOE[f]

Baseline Dermal[c] (mg/lb ai)
PPE-G Dermal[c] (mg/lb ai)
Baseline Inhalation[c] (ug/lb ai)
Baseline Dermal
 PPE-G Dermal
Baseline Inhalation
Baseline Dermal
 PPE-G Dermal
Baseline Inhalation
                                 Mixer/Loader
          Mixing/Loading Liquid Concentrates for Aerial Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                     0.242
                                    0.0414
                                   0.000241
                                     1,200
                                     7,300
                                    60,000

                                  Dried Beans
                                     0.13

                                     0.143
                                    0.0244
                                   0.000142
                                     2,100
                                    12,000
                                    100,000

                                Cherry, Potato
                                     0.092

                                     0.101
                                    0.0173
                                   0.000101
                                     3,000
                                    17,000
                                    140,000
        Mixing/Loading Liquid Concentrates for Chemigation Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                     0.242
                                    0.0414
                                   0.000241
                                     1,200
                                     7,300
                                    60,000

                                    Potato
                                     0.18

                                     0.198
                                     0.338
                                   0.000197
                                     1,500
                                     8,900
                                    74,000

                                  Dried Beans
                                     0.13

                                     0.143
                                    0.0244
                                   0.000142
                                     2,100
                                    12,000
                                    100,000

                                  Sugar Beet
                                     0.11

                                     0.121
                                    0.0207
                                   0.000120
                                     2,500
                                    15,000
                                    120,000

                                    Cherry
                                     0.092

                                     0.101
                                    0.0173
                                   0.000101
                                     3,000
                                    17,000
                                    140,000
        Mixing/Loading Liquids Concentrates for Groundboom Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      80
                                     0.22
                                    0.0376
                                     0.219
                                    0.0553
                                    0.00945
                                   0.0000551
                                     5,400
                                    32,000
                                    260,000

                                    Potato
                                     0.18

                                    0.0452
                                    0.00773
                                   0.0000451
                                     6,600
                                    39,000
                                    320,000

                                  Dried Beans
                                     0.13

                                    0.0327
                                    0.00559
                                   0.0000325
                                     9,200
                                    54,000
                                    450,000

                                  Sugar Beet
                                     0.11

                                    0.0277
                                    0.00473
                                   0.0000275
                                    11,000
                                    63,000
                                    530,000

                                    Cherry
                                     0.092

                                    0.0231
                                    0.00395
                                   0.0000230
                                    13,000
                                    76,000
                                    630,000
         Mixing/Loading Liquids Concentrates for Airblast Applications
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.22
                                    0.0376
                                     0.219
                                    0.0277
                                    0.00473
                                   0.0000275
                                    11,000
                                    63,000
                                    530,000

                                    Cherry
                                     0.092

                                    0.0116
                                    0.00198
                                   0.0000115
                                    26,000
                                    150,000
                                   1,300,000
                                  Applicator
                     Applying Sprays via Aerial Equipment
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.005
                                    No Data
                                     0.068
                                    0.00550
                                    No Data
                                   0.0000748
                                    55,000
                                    No Data
                                    190,000

                                  Dried Beans
                                     0.13

                                    0.00325
                                    No Data
                                   0.0000442
                                    92,000
                                    No Data
                                    190,000

                                Cherry, Potato
                                     0.092

                                    0.00230
                                    No Data
                                   0.0000313
                                    130,000
                                    No Data
                                    190,000
                   Applying Sprays via Groundboom Equipment
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      80
                                    0.0786
                                    0.0161
                                     0.34
                                    0.0198
                                    0.00405
                                   0.0000855
                                    15,000
                                    74,000
                                    170,000

                                    Potato
                                     0.18

                                    0.0162
                                    0.00331
                                   0.0000699
                                    19,000
                                    91,000
                                    210,000

                                  Dried Beans
                                     0.13

                                    0.0117
                                    0.00239
                                   0.0000505
                                    26,000
                                    130,000
                                    290,000

                                  Sugar Beet
                                     0.11

                                    0.00988
                                    0.00202
                                   0.0000427
                                    30,000
                                    150,000
                                    340,000

                                    Cherry
                                     0.092

                                    0.00826
                                    0.00169
                                   0.0000357
                                    36,000
                                    180,000
                                    410,000
                    Applying Sprays via Airblast Equipment
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.36
                                     0.24
                                      4.5
                                    0.0453
                                    0.0302
                                   0.000566
                                     6,600
                                     9,900
                                    26,000

                                    Cherry
                                     0.092

                                    0.0189
                                    0.0126
                                   0.000237
                                     16,00
                                    24,000
                                    61,000
                                    Flagger
                    Flagging for Aerial Sprays Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.011
                                      NA
                                     0.35
                                    0.0121
                                      NA
                                   0.000385
                                    25,000
                                      NA
                                    38,000

                                  Dried Beans
                                     0.13

                                    0.00715
                                      NA
                                   0.000228
                                    42,000
                                      NA
                                    64,000

                                Cherry, Potato
                                     0.092

                                    0.00506
                                      NA
                                   0.000161
                                    59,000
                                      NA
                                    90,000
                            Mixer/Loader/Applicator
    Mixing/Loading/Applying Liquid Concentrates with Low Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      100
                                     0.43
                                      30
                                     1.57
                                    0.00676
                                   0.000471
                                      190
                                    44,000
                                    31,000
Mixing/Loading/Applying Liquid Concentrates with High Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      3.5
                                      2.5
                                     0.12
                                    0.0550
                                    0.0393
                                    0.00189
                                     5,500
                                     7,600
                                     7,700
          Mixing/Loading/Applying Liquid Concentrates with a Backpack
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                     2.51
                                      2.5
                                      30
                                    0.0394
                                    0.0393
                                   0.000471
                                     7,600
                                     7,600
                                    31,000
a. Application Rates are based on proposed uses from the fluopyram labels (Fluopyram 500 SC).
b. Science Advisory Council Policy No. 9.1.
c. 	Baseline Dermal:  Long-sleeve shirt, long pants, and no gloves.
  PPE-G Dermal: Baseline plus chemical-resistant gloves.
  Baseline Inhalation: no respirator.
  Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit.
d. Unit Exposures are based on PHED Version 1.1.
e. Daily Exposure (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) / 70 kg.
f. MOE = NOAEL (mg/kg/day) / Daily Exposure (mg/kg/day); where dermal NOAEL = 300 mg/kg/day and inhalation NOAEL = 14.5 mg/kg/day.

Table E2. Occupational Handler Estimated Cancer Risks for Private Growers.
                               Exposure Scenario
                                Crop or Target
                                  Application
                                   Rate[a]
                                   (lb ai/A)
                      Area Treated Daily[b] (acres/day)
                               Unit Exposure[d]
                       Average Daily Dose[e] (mg/kg/day)
                              LADD f (mg/kg/day)
                                Cancer Risk[g]

Baseline Dermal[c] (mg/lb ai)
PPE-G Dermal[c] (mg/lb ai)
Baseline Inhalation[c] (ug/lb ai)
Baseline Dermal
PPE-G Dermal
Baseline Inhalation
Baseline Dermal
PPE-G Dermal
Baseline Inhalation
Baseline Dermal + Inhalation
PPE-G Dermal + Inhalation
                                 Mixer/Loader
          Mixing/Loading Liquid Concentrates for Aerial Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                    4.60E-3
                                    7.87E-4
                                    2.41E-4
                                    6.30E-5
                                    1.08E-5
                                    3.30E-6
                                    1.1E-6
                                    2.2E-7

                                  Dried Beans
                                     0.13

                                    2.72E-3
                                    4.64E-4
                                    1.42E-4
                                    3.72E-5
                                    6.35E-6
                                    1.95E-6
                                    6.1E-7
                                    1.3E-7

                                Cherry, Potato
                                     0.092

                                    1.92E-3
                                    3.29E-4
                                    1.01E-4
                                    2.63E-5
                                    4.50E-6
                                    1.38E-6
                                    4.3E-7
                                    9.1E-8
        Mixing/Loading Liquid Concentrates for Chemigation Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                    4.60E-3
                                    7.87E-4
                                    2.41E-4
                                    6.30E-5
                                    1.08E-5
                                    3.30E-6
                                    1.1E-6
                                    2.2E-7

                                    Potato
                                     0.18

                                    3.76E-3
                                    6.42E-4
                                    1.97E-4
                                    5.15E-5
                                    8.80E-6
                                    2.70E-6
                                    8.4E-7
                                    1.8E-7

                                  Dried Beans
                                     0.13

                                    2.72E-3
                                    4.64E-4
                                    1.42E-4
                                    3.72E-5
                                    6.35E-6
                                    1.95E-6
                                    6.1E-7
                                    1.3E-7

                                  Sugar Beet
                                     0.11

                                    2.30E-3
                                    3.93E-4
                                    1.20E-4
                                    3.15E-5
                                    5.39E-6
                                    1.64E-6
                                    5.1E-7
                                    1.1E-7

                                    Cherry
                                     0.092

                                    1.92E-3
                                    3.29E-4
                                    1.01E-4
                                    2.63E-5
                                    4.50E-6
                                    1.38E-6
                                    4.3E-7
                                    9.1E-8
        Mixing/Loading Liquids Concentrates for Groundboom Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      80
                                     0.22
                                    0.0376
                                     0.219
                                    1.05E-3
                                    1.80E-4
                                    5.51E-5
                                    1.44E-5
                                    2.46E-6
                                    7.55E-7
                                    2.3E-7
                                    5.0E-8

                                    Potato
                                     0.18

                                    8.59E-4
                                    1.47E-4
                                    4.51E-5
                                    1.18E-5
                                    2.01E-6
                                    6.18E-7
                                    1.9E-7
                                    4.1E-8

                                  Dried Beans
                                     0.13

                                    6.21E-4
                                    1.06E-4
                                    3.25E-5
                                    8.51E-6
                                    1.45E-6
                                    4.45E-7
                                    1.4E-7
                                    2.9E-8

                                  Sugar Beet
                                     0.11

                                    5.26E-4
                                    8.99E-5
                                    2.75E-5
                                    7.21E-6
                                    1.23E-6
                                    3.77E-7
                                    1.2E-7
                                    2.5E-8

                                    Cherry
                                     0.092

                                    4.39E-4
                                    7.51E-5
                                    2.30E-5
                                    6.01E-6
                                    1.03E-6
                                    3.15E-7
                                    9.8E-8
                                    2.1E-8
         Mixing/Loading Liquids Concentrates for Airblast Applications
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.22
                                    0.0376
                                     0.219
                                    5.26E-4
                                    8.99E-5
                                    2.75E-5
                                    7.21E-6
                                    1.23E-6
                                    3.77E-7
                                    1.2E-7
                                    2.5E-8

                                    Cherry
                                     0.092

                                    2.20E-4
                                    3.76E-5
                                    1.15E-5
                                    3.02E-6
                                    5.15E-7
                                    1.58E-7
                                    4.9E-8
                                    1.0E-8
                                  Applicator
                     Applying Sprays via Aerial Equipment
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                             0.005 (Eng. Control)
                                    No Data
                             0.068 (Eng. Control)
                            1.04E-4 (Eng. Control)
                                    No Data
                           0.0000748 (Eng. Control)
                                    1.43E-6
                                    No Data
                                    1.02E-6
                                    3.8E-8
                                    No Data

                                  Dried Beans
                                     0.13

                                    6.18E-5
                                    No Data
                                   0.0000442
                                    8.46E-7
                                    No Data
                                    5.75E-7
                                    2.2E-8
                                    No Data

                                Cherry, Potato
                                     0.092

                                    4.37E-5
                                    No Data
                                   0.0000313
                                    5.99E-7
                                    No Data
                                    4.29E-7
                                    1.6E-8
                                    No Data
                   Applying Sprays via Groundboom Equipment
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes
                                     0.22
                                      80
                                    0.0786
                                    0.0161
                                     0.34
                                    3.76E-4
                                    7.70E-5
                                   0.0000855
                                    5.15E-6
                                    1.05E-6
                                    1.17E-6
                                    9.8E-8
                                    3.4E-8

                                    Potato
                                     0.18

                                    3.08E-4
                                    6.29E-5
                                    6.99E-5
                                    4.22E-6
                                    8.62E-7
                                    9.58E-7
                                    8.0E-8
                                    2.8E-8

                                  Dried Beans
                                     0.13

                                    2.22E-4
                                    4.54E-5
                                    5.05E-5
                                    3.04E-6
                                    6.22E-7
                                    6.92E-7
                                    5.8E-8
                                    2.0E-8

                                  Sugar Beet
                                     0.11

                                    1.88E-4
                                    3.84E-5
                                    4.27E-5
                                    2.57E-6
                                    5.26E-7
                                    5.85E-7
                                    4.9E-8
                                    1.7E-8

                                    Cherry
                                     0.092

                                    1.57E-4
                                    3.21E-5
                                    3.57E-5
                                    2.15E-6
                                    4.40E-7
                                    4.89E-7
                                    4.1E-8
                                    1.4E-8
                    Applying Sprays via Airblast Equipment
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.36
                                     0.24
                                      4.5
                                    8.61E-4
                                    5.74E-4
                                    5.66E-4
                                    1.18E-5
                                    7.86E-6
                                    7.75E-6
                                    3.0E-7
                                    2.4E-7

                                    Cherry
                                     0.092

                                    3.59E-4
                                    2.39E-4
                                    2.37E-4
                                    4.92E-6
                                    3.28E-6
                                    3.25E-6
                                    1.3E-7
                                    1.0E-7
                                    Flagger
                    Flagging for Aerial Sprays Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.011
                                      NA
                                     0.35
                                    2.30E-4
                                      NA
                                    3.85E-4
                                    3.15E-6
                                      NA
                                    5.27E-6
                                    1.3E-7
                                      NA

                                  Dried Beans
                                     0.13

                                    1.36E-4
                                      NA
                                    2.28E-4
                                    1.86E-6
                                      NA
                                    3.12E-6
                                    7.7E-8
                                      NA

                                Cherry, Potato
                                     0.092

                                    9.61E-5
                                      NA
                                    1.61E-4
                                    1.32E-6
                                      NA
                                    2.21E-6
                                    5.5E-8
                                      NA
                            Mixer/Loader/Applicator
   Mixing/Loading/ Applying Liquid Concentrates with Low Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      100
                                     0.43
                                      30
                                    2.98E-2
                                    1.28E-4
                                    4.71E-4
                                    4.09E-4
                                    1.76E-6
                                    6.45E-6
                                    6.4E-6
                                    1.3E-7
Mixing/Loading/ Applying Liquid Concentrates with High Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      3.5
                                      2.5
                                      120
                                    1.05E-3
                                    7.47E-4
                                    1.89E-3
                                    1.43E-5
                                    1.02E-5
                                    2.59E-5
                                    6.2E-7
                                    5.6E-7
         Mixing/Loading/ Applying Liquid Concentrates with a Backpack
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                     2.51
                                      2.5
                                      30
                                    7.49E-4
                                    7.47E-4
                                    4.71E-4
                                    1.03E-5
                                    1.02E-5
                                    6.45E-6
                                    2.6E-7
                                    2.6E-7
a. Application Rates are based on proposed uses from the fluopyram labels (Fluopyram 500 SC).
b. Science Advisory Council Policy No. 9.1.
c. 	Baseline Dermal:  Long-sleeve shirt, long pants, and no gloves.  PPE-G Dermal: Baseline plus chemical-resistant gloves.  Baseline Inhalation: no respirator.  Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit.
d. Unit Exposures are based on PHED Version 1.1, or AHETF data.
e. Average Daily Dose (ADD) (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) * Absorption Factor (1.9% dermal, 100% inhalation)/ 70 kg.
f. Lifetime Average Daily Dose (LADD) = ADD (mg/kg/day) x (10 days per year treated by Private Growers / 365 days per year) x (35 years working duration / 70 years per lifetime).
g. Cancer Risk = Q1* (1.55E-2 (mg/kg/day)[-1]) x LADD mg/kg/day).
Table E3. Occupational Handler Estimated Cancer Risks for Commercial Applicators.
                               Exposure Scenario
                                Crop or Target
                             Application Rate[a]
                                   (lb ai/A)
                      Area Treated Daily[b] (acres/day)
                               Unit Exposure[d]
                       Average Daily Dose[e] (mg/kg/day)
                              LADD f (mg/kg/day)
                                Cancer Risk[g]

Baseline Dermal[c] (mg/lb ai)
PPE-G Dermal[c] (mg/lb ai)
Baseline Inhalation[c] (ug/lb ai)
Baseline Dermal
PPE-G Dermal
Baseline Inhalation
Baseline Dermal
PPE-G Dermal
Baseline Inhalation
Baseline Dermal + Inhalation
PPE-G Dermal + Inhalation
                                 Mixer/Loader
          Mixing/Loading Liquid Concentrates for Aerial Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                    4.60E-3
                                    7.87E-4
                                    2.41E-4
                                    1.89E-4
                                    3.23E-5
                                    9.90E-6
                                    3.1E-6
                                    6.5E-7

                                  Dried Beans
                                     0.13

                                    2.72E-3
                                    4.64E-4
                                    1.42E-4
                                    1.12E-4
                                    1.91E-5
                                    5.84E-6
                                    1.8E-6
                                    3.9E-7

                                Cherry, Potato
                                     0.092

                                    1.92E-3
                                    3.29E-4
                                    1.01E-4
                                    7.89E-5
                                    1.35E-5
                                    4.15E-6
                                    1.3E-6
                                    2.7E-7
        Mixing/Loading Liquid Concentrates for Chemigation Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes,
                                     0.22
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                    4.60E-3
                                    7.87E-4
                                    2.41E-4
                                    1.89E-4
                                    3.23E-5
                                    9.90E-6
                                    3.1E-6
                                    6.5E-7

                                    Potato
                                     0.18

                                    3.76E-3
                                    6.42E-4
                                    1.97E-4
                                    1.55E-4
                                    2.64E-5
                                    8.10E-6
                                    2.5E-6
                                    5.3E-7

                                  Dried Beans
                                     0.13

                                    2.72E-3
                                    4.64E-4
                                    1.42E-4
                                    1.12E-4
                                    1.91E-5
                                    5.84E-6
                                    1.8E-6
                                    3.9E-7

                                  Sugar Beet
                                     0.11

                                    2.30E-3
                                    3.93E-4
                                    1.20E-4
                                    9.45E-5
                                    1.62E-5
                                    4.93E-6
                                    1.5E-6
                                    3.3E-7

                                    Cherry
                                     0.092

                                    1.92E-3
                                    3.29E-4
                                    1.01E-4
                                    7.89E-5
                                    1.35E-5
                                    4.15E-6
                                    1.3E-6
                                    2.7E-7
        Mixing/Loading Liquids Concentrates for Groundboom Applications
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes,
                                     0.22
                                      80
                                     0.22
                                    0.0376
                                     0.219
                                    1.05E-3
                                    1.8E-4
                                    5.51E-5
                                    4.32E-5
                                    7.38E-6
                                    2.26E-6
                                    7.1E-7
                                    1.5E-7

                                    Potato
                                     0.18

                                    8.59E-4
                                    1.47E-4
                                    4.51E-5
                                    3.53E-5
                                    6.04E-6
                                    1.85E-6
                                    5.8E-7
                                    1.2E-7

                                  Dried Beans
                                     0.13

                                    6.21E-4
                                    1.06E-4
                                    3.25E-5
                                    2.55E-5
                                    4.36E-6
                                    1.34E-6
                                    4.2E-7
                                    8.8E-8

                                  Sugar Beet
                                     0.11

                                    5.26E-4
                                    8.99E-5
                                    2.75E-5
                                    2.16E-5
                                    3.69E-6
                                    1.13E-6
                                    3.5E-7
                                    7.5E-8

                              Cherry, Stone Fruit
                                     0.092

                                    4.39E-4
                                    7.51E-5
                                    2.30E-5
                                    1.80E-5
                                    3.08E-6
                                    9.45E-7
                                    2.9E-7
                                    6.2E-8
         Mixing/Loading Liquids Concentrates for Airblast Applications
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.22
                                    0.0376
                                     0.219
                                    5.26E-4
                                    8.99E-5
                                    2.75E-5
                                    2.16E-5
                                    3.69E-6
                                    1.13E-6
                                    3.5E-7
                                    7.5E-8

                                    Cherry
                                     0.092

                                    2.20E-4
                                    3.76E-5
                                    1.15E-5
                                    9.06E-6
                                    1.55E-6
                                    4.73E-7
                                    1.5E-7
                                    3.1E-8
                                  Applicator
                     Applying Sprays via Aerial Equipment
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                             0.005 (Eng. Control)
                                    No Data
                             0.068 (Eng. Control)
                            1.05E-4 (Eng. Control)
                                    No Data
                            7.48E-5 (Eng. Control)
                                    4.29E-6
                                    No Data
                                    3.07E-6
                                    1.1E-7
                                    No Data

                                  Dried Beans
                                     0.13

                                    6.18E-5
                                    No Data
                                    4.42E-5
                                    2.54E-6
                                    No Data
                                    1.82E-6
                                    6.8E-8
                                    No Data

                                Cherry, Potato
                                     0.092

                                    4.37E-5
                                    No Data
                                    3.13E-5
                                    1.80E-6
                                    No Data
                                    1.29E-6
                                    4.8E-8
                                    No Data
                   Applying Sprays via Groundboom Equipment
Apples, Peanut, Strawberry, Tree Nuts, Watermelon (field and greenhouse), Viniferous variety Grapes,
                                     0.22
                                      80
                                    0.0786
                                    0.0161
                                     0.34
                                    3.76E-4
                                    7.70E-5
                                    8.55E-5
                                    1.55E-5
                                    3.16E-6
                                    3.51E-6
                                    2.9E-7
                                    1.0E-7

                                    Potato
                                     0.18

                                    3.08E-4
                                    6.29E-5
                                    6.99E-5
                                    1.26E-5
                                    2.58E-6
                                    2.87E-6
                                    2.4E-7
                                    8.5E-8

                                  Dried Beans
                                     0.13

                                    2.22E-4
                                    4.54E-5
                                    5.05E-5
                                    9.14E-6
                                    1.87E-6
                                    2.08E-6
                                    1.7E-7
                                    6.1E-8

                                  Sugar Beet
                                     0.11

                                    1.88E-4
                                    3.84E-5
                                    4.27E-5
                                    7.71E-6
                                    1.58E-6
                                    1.75E-6
                                    1.5E-7
                                    5.2E-8

                                    Cherry
                                     0.092

                                    1.57E-4
                                    3.21E-5
                                    3.57E-5
                                    6.45E-6
                                    1.32E-6
                                    1.47E-6
                                    1.2E-7
                                    4.3E-8
                    Applying Sprays via Airblast Equipment
                 Apples, Tree Nuts, Viniferous variety Grapes
                                     0.22
                                      40
                                     0.36
                                     0.24
                                      4.5
                                    8.61E-4
                                    5.74E-4
                                    5.66E-4
                                    3.54E-5
                                    2.36E-5
                                    2.33E-5
                                    9.1E-7
                                    7.3E-7

                                    Cherry
                                     0.092
                                      40
                                     0.36
                                     0.24
                                      4.5
                                    3.59E-4
                                    2.39E-4
                                    2.37E-4
                                    1.48E-5
                                    9.84E-6
                                    9.74E-6
                                    3.8E-7
                                    3.0E-7
                                    Flagger
                    Flagging for Aerial Sprays Applications
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                                     0.011
                                      NA
                                     0.35
                                    2.30E-4
                                      NA
                                    3.85E-4
                                    9.45E-6
                                      NA
                                    1.58E-5
                                    3.9E-7
                                      NA

                                  Dried Beans
                                     0.13

                                    1.36E-4
                                      NA
                                    2.28E-4
                                    5.58E-6
                                      NA
                                    9.34E-6
                                    2.3E-7
                                      NA

                                Cherry, Potato
                                     0.092

                                    9.61E-5
                                      NA
                                    1.61E-4
                                    3.95E-6
                                      NA
                                    6.62E-6
                                    1.6E-7
                                      NA
                            Mixer/Loader/Applicator
   Mixing/Loading/ Applying Liquid Concentrates with Low Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      100
                                     0.43
                                      30
                                    2.98E-2
                                    1.28E-4
                                    4.71E-4
                                    1.23E-3
                                    5.28E-6
                                    1.94E-5
                                    1.9E-5
                                    3.8E-7
Mixing/Loading/ Applying Liquid Concentrates with High Pressure Hand wand
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                      3.5
                                      2.5
                                      120
                                    1.05E-3
                                    7.47E-4
                                    1.89E-3
                                    4.29E-5
                                     3.07
                                    2.59E-5
                                    1.1E-6
                                    8.8E-7
         Mixing/Loading/ Applying Liquid Concentrates with a Backpack
                Greenhouse Only: Strawberries & Watermelon
                                     0.22
                                       5
                                     2.51
                                      2.5
                                      30
                                    7.49E-4
                                    7.47E-4
                                    4.71E-4
                                    3.08E-5
                                    3.07E-5
                                    1.94E-5
                                    7.8E-7
                                    7.8E-7
a. Application Rates are based on proposed uses from the fluopyram labels (Fluopyram 500 SC).
b. Science Advisory Council Policy No. 9.1.
c. 	Baseline Dermal: Long-sleeve shirt, long pants, and no gloves.  PPE-G Dermal: Baseline plus chemical-resistant gloves.  Baseline Inhalation: no respirator.  Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit.
d. Unit Exposures are based on PHED Version 1.1, or AHETF data.
e. Average Daily Dose (ADD) (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) * Absorption Factor (1.9% dermal, 100% inhalation)/ 70 kg.
f. Lifetime Average Daily Dose (LADD) = ADD (mg/kg/day) x (30 days per year treated by Commercial Growers / 365 days per year) x (35 years working duration / 70 years per lifetime).
g. Cancer Risk = Q1* (1.55E-2 (mg/kg/day)[-1]) x Dermal LADD mg/kg/day).

Table E.4.  Summary of Occupational Non-Cancer Postapplication Risks (Short- and Intermediate-Term) with HED Default Assumptions.
                                 Crop Grouping
                               Application rate
                                 (lb ai/acre)
              Default DFR on 0 days (12 hrs) after application[a]
                                   (μg/cm2)
                             Work Activity &
                  Maximum Transfer Coefficient[b] (cm[2]/hr)
                                 Daily Dose[c]
                                  (mg/kg/day)
                                    MOE[d]
                                  (LOC = 100)
                                    Apples
                                     0.22
                                     0.493
                               3,600 - Thinning
                                     0.203
                                     1,500
                                    Cherry
                                     0.092
                                     0.206
                               3,600 - Thinning
                                    0.0848
                                     3,500
                                  Dried Beans
                                     0.13
                                     0.292
                              1,900 - Irrigation
                                    0.0634
                                     4,700
                                    Peanuts
                                     0.22
                                     0.493
                              1,900 - Irrigation
                                     0.107
                                     2,800
                                   Potatoes
                                     0.18
                                     0.404
                              1,900 - Irrigation
                                    0.0877
                                     3,400
                                 Strawberries
                                     0.22
                                     0.493
                            1,100  -  Hand Harvest
                                    0.0620
                                     4,800
                                  Sugar Beets
                                     0.11
                                     0.247
                              1,900 - Irrigation
                                    0.0536
                                     5,600
                                   Tree Nuts
                                     0.22
                                     0.493
                               3,600 - Thinning
                                     0.203
                                     1,500
                                  Watermelon
                                     0.22
                                     0.493
                              1,900 - Irrigation
                                     0.107
                                     2,800
                          Viniferous variety Grapes
                                     0.22
                                     0.493
            10,100 - Harvest (hand), Training, Tying, Leaf Pulling
                                     0.569
                                      530
   a. Default DFR (ug/cm[2]) = application rate (lb ai/A) x (1- daily dissipation rate) [t] x 4.54E+8 ug/lb x 24.7E-9 A/cm[2] x 20% DFR after initial treatment.
   b. Crops were assessed using the highest transfer coefficient (TC) available.
   c. Daily Dose = DFR x TC x (1 mg/1000 ug) x ET (8 hr/day) / body weight (70 kg)
   d. MOE = NOAEL (300 mg/kg/day) / Daily Dose (mg/kg/day)

Table E5.  Summary of Occupational Postapplication Cancer Risks with HED Default Assumptions.
                                 Crop Grouping
                       Average DFR after application[a]
                                  (μg/cm2)
                             Work Activity &
                  Maximum Transfer Coefficient[b] (cm[2]/hr)
                   Dermal Average Daily Dose[c] (mg/kg/day)
                          Dermal LADD[d] (mg/kg/day)
                                Cancer Risk[e]
                                    Apples
                                     0.351
                               3,600 - Thinning
                                    2.74E-3
                                    1.13E-4
                                    1.7E-6
                                    Cherry
                                     0.161
                               3,600 - Thinning
                                    1.26E-3
                                    5.18E-5
                                    8.0E-7
                                  Dried Beans
                                     0.208
                              1,900 - Irrigation
                                    8.59E-4
                                    3.53E-5
                                    5.5E-7
                                    Peanuts
                                     0.261
                              1,900 - Irrigation
                                    1.08E-3
                                    4.44E-5
                                    6.9E-7
                                   Potatoes
                                     0.315
                              1,900 - Irrigation
                                    1.30E-3
                                    5.34E-5
                                    8.3E-7
                                 Strawberries
                                     0.385
                             1,100 - Hand Harvest
                                    9.20E-4
                                    3.78E-5
                                    5.9E-7
                                  Sugar Beets
                                     0.193
                              1,900 - Irrigation
                                    7.96E-4
                                    3.27E-5
                                    5.1E-7
                                   Tree Nuts
                                     0.351
                               3,600 - Thinning
                                    2.74E-3
                                    1.13E-4
                                    1.7E-6
                                  Watermelon
                                     0.385
                              1,900 - Irrigation
                                    1.59E-3
                                    6.53E-5
                                    1.0E-6
                           Viniferous variety Grapes
                                     0.283
            10,100 - Harvest (hand), Training, Tying, Leaf Pulling
                                    6.21E-3
                                    2.55E-4
                                    4.0E-6

   a.	Average DFR residue averaged over the shortest number of re-treatment days for each crop or crop group (ug/cm[2]).
   b.	Crops were assessed using the highest transfer coefficient (TC) available.
   c.	Dermal Average Daily Dose (ADD) = Average DFR x TC x (1 mg/1000 ug) x ET (8 hr/day) x Dermal Absorption Factor (1.9%)/ body weight (70 kg).
   d.	Dermal Lifetime Average Daily Dose (LADD) = Dermal ADD (mg/kg/day) x (30 days per year treated / 365 days per year) x (35 years working duration / 70 years per lifetime).
   e.	Cancer Risk = Q1* (1.55E-2 (mg/kg/day)[-1]) x Dermal LADD mg/kg/day).

Appendix F.  International Residue Limit Status Sheet

Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.XXX:
Plants: fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide).

Livestock: sum of fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide) and its benzamide metabolite [2-(trifluoromethyl)-benzamide], calculated as the stoichiometric equivalent of fluopyram

Identical to US

Plants:  fluopyram.
Animal commodities: Sum of fluopyram and 2-(trifluoromethyl)benzamide, expressed as fluopyram.

Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico[2]
Codex[3]
Almond hull
8.0

Apple
0.30

Apple wet pomace
0.60

Banana (import)
1.0

Bean, dry
0.09

Cherry
0.60

Nut, tree, group 14
0.05

Peanut
0.02

Pistachio
0.05

Potato
0.02

Potato processed waste
0.08

Strawberry
1.5

Sugar beet
0.04

Watermelon
1.0

Wine Grapes
2.0

 5 Dried grapes (=currants, raisins and sultanas) ; 2 Grapes  (proposed)

Alfalfa forage
0.45

Alfalfa hay
1.1

Canola
1.8

Cotton gin byproducts
0.05

Cotton undelinted seed
0.01

Grain, cereal, group 15, except rice
1.5

Grain, cereal, forage, fodder and straw, group 15, except rice; forage
4.0

Grain, cereal, forage, fodder and straw, group 15, except rice; hay, straw and stover
7.0

Soybean forage
4.0

Soybean hay
15

Soybean seed
0.10

Cattle, fat
0.11

Cattle, meat
0.15

0.1 Meat (from mammals other than marine mammals)
Cattle, meat byproducts
1.1

0.7 Edible offal (mammalian)
Cattle, liver

Eggs
0.25

Goat, fat
0.11

Goat, meat
0.15

Goat, meat byproducts
1.1

Hog, fat
0.05

Hog, meat
0.05

Hog, meat byproducts
0.70

Horse, fat
0.11

Horse, meat
0.15

Horse, meat byproducts
1.1

Milk
0.07

Milks 0.07
Poultry, fat
0.20

Poultry, meat
0.15

Poultry, meat byproducts
0.60

Sheep, fat
0.11

Sheep, meat
0.15

Sheep, meat byproducts
1.1

[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.