[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Proposed Rules]
[Pages 50053-50055]
[FR Doc No: 2018-21440]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 10

[Docket No. OST-2016-0028]
RIN 2105-AE46

Maintenance of and Access to Records Pertaining to Individuals

AGENCY: Office of the Secretary (OST), U.S. Department of
Transportation (DOT).

ACTION: Noticed of proposed rulemaking.

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SUMMARY: This proposed rulemaking would amend the Department of
Transportation's Privacy Act regulations to exempt the Department of
Transportation's new insider threat program system of records from
certain requirements of the Privacy Act to protect properly classified
information from disclosure, preserve the integrity of insider threat
inquiries, and protect the identities of sources in such inquiries and
any related investigations.

DATES: Submit comments on or before December 3, 2018.

ADDRESSES: You may file comments identified by the docket number DOT-
OST-2016-0028 by any of the following methods:
     Federal Rulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Ave. SE, between 9:00 a.m. and 5:00 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: You must include the agency name and docket number
DOT-OST-2016-0028 or the Regulatory Identification Number (RIN) for the
rulemaking at the beginning of your comment. All comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received in any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.) You may review DOT's
system of records notice for dockets in the Federal Register notice
published on January 17, 2008 (73 FR 3316-3317).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to the street
address listed above. Follow the online instructions for accessing the
docket.

FOR FURTHER INFORMATION CONTACT: Claire Barrett, Departmental Chief
Privacy Officer, Office of the Chief Information Officer, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC
20590 or [email protected] or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Executive Order 13587, Structural Reforms to
Improve the Security of Classified Networks and the Responsible Sharing
and Safeguarding of Classified Information, directs Federal departments
and agencies to establish insider threat programs consistent with
guidance and standards developed by the National Insider Threat Task
Force, which was established under section 6 of Executive Order 13587.
The National Insider Threat Policy and Minimum Standards for Executive
Branch Insider Threat Programs were issued in November 2012. As
described in Executive Order 13587 and the National Insider Threat
Policy and Minimum Standards for Executive Branch Insider Threat
Programs, insider threat programs are intended to deter and detect
insider threats and mitigate the risks associated with an individual
using his or her authorized access to Government information and
facilities to do harm to the security of the United States. The
potential harms posed by an insider threat can include espionage,
terrorism, unauthorized disclosure of national security information, or
the loss or degradation of Government resources or capabilities.
    The DOT has established an Insider Threat Program within the Office
of the Secretary (OST) and the Federal Aviation Administration (FAA).
Together, these programs are referred to as the ``DOT Insider Threat
Program.'' The DOT Insider Threat Program will adhere to the
requirements of Executive Order 13587, and the National Insider Threat
Policy and Minimum Standards for Executive Branch Insider Threat
Programs, and include protocols for reporting and responding to
potential or suspected insider threat activity.
    The Privacy Act of 1974, 5 U.S.C. 552a, requires that agencies tell
the public when they maintain information about a person in a file
which is retrieved by reference to that person's name or some other
identifying particular. A group of these files is a ``system of
records,'' and the existence of each system must be published in a
``system of records notice'' (SORN). In accordance with the Privacy
Act, DOT proposes to create a new DOT system of records titled, ``DOT/
ALL 26 Insider Threat Program'' for insider threat program records.
This notice will be published in the Federal Register.
    The DOT Insider Threat Program will maintain information about DOT
employees about whom the DOT Insider Threat Program has received
reports of indicia of potential insider threats from other Federal
agencies, DOT employees, or any other source. As defined in Executive
Order 12968, a DOT employee, for purposes of the DOT Insider Threat
Program, means ``a person, other than the President and Vice President,
employed by, detailed or assigned to, an agency, including members of
the Armed Forces; an expert or consultant to an agency; an industrial
or commercial contractor, licensee, certificate holder; or any other
category of person who acts for or on behalf of an agency, as
determined by the'' Secretary of Transportation or, for the FAA, the
FAA Administrator. A licensee, certificate holder (such an airman), or
grantee, who is not also a DOT employee, is generally excluded from the
DOT Insider Threat Program; however, such individuals may be included
if a determination is made that the nature and extent of an
individual's access to DOT personnel, facilities, equipment, systems,
networks, operations, and information necessitates their inclusion.
    The DOT Insider Threat Program will review reports of indicia of
potential insider threats in accordance with established DOT and FAA
Insider Threat Program management policy and procedures, as applicable.
Based on this review, an appropriate authorized OST or FAA official
will determine whether to proceed with an insider threat inquiry, refer
the matter to appropriate law enforcement officials, close the matter,
or take other appropriate action. Insider threat inquiries will be
comprised primarily of existing DOT information assets, including, but
not limited to, records from information security, personnel security,
and human resources, and also may include information obtained from
other Federal agencies or from publicly available resources (such as
internet searches). The DOT Insider Threat Program records also will be
used to track reports of indicia of potential insider threats, whether
or not an inquiry was opened, the rationale for opening or not opening
an inquiry; the disposition of all inquiries, and referrals to law

enforcement (such as the DOT Office of the Inspector General or the
Federal Bureau of Investigation), and to report on DOT's Insider Threat
Program activities.
    An agency wishing to exempt portions of some systems of records
from certain provisions of the Privacy Act must notify the public of
that exemption in both the SORN and in an exemption rule. This proposed
rule would exempt certain records maintained by the DOT Insider Threat
Program from the access and notification provisions of the Privacy Act.
An exemption from these requirements would be necessary to: Protect
classified national security information; preclude the subject of an
inquiry from frustrating an inquiry or evading detection; avoid
disclosure of insider threat inquiry techniques; protect the identity
of confidential informants and third parties; and support DOT and FAA's
ability to obtain information relevant to resolving an insider threat
concern. The DOT or FAA may take administrative or other appropriate
action within scope of their respective legal authorities in response
to an insider threat inquiry or, if circumstances indicate a potential
violation of law or a national security concern, refer the matter to
the appropriate law enforcement or intelligence entity, such as the DOT
Office of Inspector General or the Federal Bureau of Investigation.
Thus, the system of records may include some classified national
security information and, thus, insofar as it does, the subsection
(k)(1) exemption (5 U.S.C. 552a(k)(1)) would be applicable. In
addition, an insider threat inquiry is comprised of records compiled
for law enforcement and the subsection (k)(2) exemption (5 U.S.C.
552a(k)(2) would be applicable to this system of records.
    In appropriate circumstances, where compliance with the request
would not appear to interfere with or adversely affect the conduct of
an insider threat inquiry or result in the unauthorized disclosure of
classified information, OST or FAA may opt to waive these exemptions.
In addition, some information may be available under the Freedom of
Information Act, 5 U.S.C. 552 (FOIA). Any request for information from
this system under the FOIA would be assessed on a case-by-case basis to
determine what, if any, information could be released consistent with
section (b)(2) of the Privacy Act, 5 U.S.C. 552a(b)(2).
    The DOT identifies a system of records that is exempt from one or
more provisions of the Privacy Act (pursuant to 5 U.S.C. 552a(j) or
(k)) both in the SORN published in the Federal Register for public
comment and in an Appendix to DOT's regulations implementing the
Privacy Act (49 CFR part 10, Appendix). This rule would exempt records
in the Insider Threat Program system of records from subsections (c)(3)
(Accounting of Certain Disclosures), (d) (Access to Records), (e)(1)
and (e)(4)(G) through (I) (Agency Requirements) and (f) (Agency Rules)
of the Privacy Act to the extent that records are properly classified,
in accordance with 5 U.S.C. 552a(k)(1), or consist of investigatory
material compiled for law enforcement purposes in accordance with 5
U.S.C. 552a(k)(2).

Regulatory Analysis and Notices

A. Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures

    The DOT has considered the impact of this proposed rulemaking
action under Executive Orders 12866 and 13563 (January 18, 2011,
``Improving Regulation and Regulatory Review''), and the DOT's
regulatory policies and procedures (44 FR 11034; February 26, 1979).
The DOT has determined that this action would not constitute a
significant regulatory action within the meaning of Executive Order
12866 and within the meaning of DOT regulatory policies and procedures.
This rulemaking has not been reviewed by the Office of Management and
Budget. This rulemaking is not anticipated to result in any costs.
Since these records would be exempt from certain provisions of the
Privacy Act, DOT would not have to expend any funds in order to
administer those aspects of the Act.

B. Regulatory Flexibility Act

    DOT has evaluated the effect these changes would have on small
entities and does not believe that this rulemaking would impose any
costs on small entities because the reporting requirements themselves
are not changed and because the rule applies only to information on
individuals that is maintained by the Federal Government or that is
already publically available. Therefore, I hereby certify that this
proposal would not have a significant economic impact on a substantial
number of small entities.

C. National Environmental Policy Act

    The Department has analyzed the environmental impacts of this
proposed action pursuant to the National Environmental Policy Act of
1969 (42 U.S.C. 4321 et seq.) and has determined that it is
categorically excluded pursuant to DOT Order 5610.1C, Procedures for
Considering Environmental Impacts (44 FR 56420, Oct. 1, 1979).
Categorical exclusions are actions identified in an agency's NEPA
implementing procedures that do not normally have a significant impact
on the environment and therefore do not require either an environmental
assessment (EA) or environmental impact statement (EIS). See 40 CFR
1508.4. In analyzing the applicability of a categorical exclusion, the
agency must also consider whether extraordinary circumstances are
present that would warrant the preparation of an EA or EIS. Id.
Paragraph 3.c.5 of DOT Order 5610.1C incorporates by reference the
categorical exclusions for all DOT Operating Administrations. This
action is covered by the categorical exclusion listed in the Federal
Highway Administration's implementing procedures, ``[p]romulgation of
rules, regulations, and directives.'' 23 CFR 771.117(c)(20). The
purpose of this rulemaking is to amend the Appendix to DOT's Privacy
Act regulations. The Department does not anticipate any environmental
impacts and there are no extraordinary circumstances present in
connection with this rulemaking.

D. Executive Order 12898 (Environmental Justice)

    The Department evaluated the environmental effects of this proposed
rule in accordance with Executive Order 12898, Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations, and DOT Order, 5010.2(a), 91 FR 27534 (May 10, 2012)
(available online at www.fhwa.dot.gov/enviornment/environmental_justice/ej_at_dot/order_56102a/index.cfm), which require
DOT to achieve environmental justice (EJ) as part of its mission by
identifying and addressing, as appropriate, disproportionately high and
adverse human health or environmental effects, including interrelated
social and economic effects, of its programs, policies, and activities
on minority and low income populations in the United States. The DOT
Order requires DOT to address compliance with the Executive Order and
the DOT Order in all rulemaking activities. The Department has
evaluated this proposed rule under the Executive Order and the DOT
Order, and has determined preliminarily that the rule would not cause
disproportionately high and adverse human health and environmental
effects on minority or low income populations.

E. Executive Order 13132 (Federalism)

    This proposed action has been analyzed in accordance with the
principles and criteria contained in Executive Order 13132, Federalism,
dated August 4, 1999, and it has been determined that it would not have
a substantial direct effect on, or sufficient Federalism implications
for, the States, nor would it limit the policymaking discretion of the
States. Therefore, the preparation of a Federalism Assessment is not
necessary.

F. Executive Order 13084 (Consultation and Coordination With Indian
Tribal Governments)

    This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 13084 (``Consultation and
Coordination with Indian Tribal Governments''). Because it would not
effect on Indian Tribal Governments, the funding and consultation
requirements of Executive Order 13084 do not apply.

G. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et
seq.), Federal agencies must obtain approval from the Office of
Management and Budget for each collection of information they conduct,
sponsor, or require through regulations. The DOT has determined that
this action would not contain a collection of information requirement
for the purposes of the PRA.

H. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub.
L. 104-4, 109 Stat. 48, March 22, 1995) requires Federal agencies to
assess the effects of certain regulatory actions on State, local, and
tribal governments; and the private sector. The UMRA requires a written
statement of economic and regulatory alternatives for proposed and
final rules that contain Federal mandates. A ``Federal mandate'' is a
new or additional enforceable duty, imposed on any State, local, or
tribal Government; or the private sector. If any Federal mandate causes
those entities to spend, in aggregate, $143.1 million or more in any
one year (adjusted for inflation), an UMRA analysis is required. This
proposed rule would not impose Federal mandates on any State, local, or
tribal governments; or the private sector.

List of Subjects in 49 CFR Part 10

    Penalties, Privacy.

    In consideration of the foregoing, DOT proposes to amend part 10 of
title 49, Code of Federal Regulations, as follows:

0
1. The authority citation for part 10 continues to read as follows:

    Authority: 5 U.S.C. 552a; 49 U.S.C. 322.

0
2. Amend the Appendix to Part 10 by:
0
a. In Part II, adding paragraphs A.10, B.4., F.5., and G.2.
    The revisions and additions read as follows:

APPENDIX TO PART 10--EXEMPTIONS

    Part II. Specific Exemptions
    A. * * *
    10. Insider Threat Program (DOT/ALL 26),
    B. * * *
    4. Insider Threat Program (DOT/ALL 26).
* * * * *
    F. * * *
    5. Insider Threat Program (DOT/ALL 26).
* * * * *
    G. * * *
    2. Insider Threat Program (DOT/ALL 26).

    Issued in Washington, DC, on August 17, 2018.
Elaine L. Chao,
Secretary.
[FR Doc. 2018-21440 Filed 10-3-18; 8:45 am]
 BILLING CODE 4910-9X-P


MEMORANDUM TO: Najm Shamim cc. 11.0248.5000.001.03 Wanda Jacob Cletis Mixon Pat Wood FROM: Jignasha Patel/ Traci Brody/ Ron Lee, Versar Inc.

DATE: January 23, 2006 SUBJECT: DDAC Dietary Risk Assessment Attached below is the dietary risk assessment for DDAC.

Please note the following:

  Product # 10324 117 may be used in potato storage areas where the potatoes are used as food/ feed. When treating potato storage areas, the label states that all potatoes should be removed from the premises before application, and returned following air drying of treatment solution. Since the product is not to be used directly on potatoes, it was assumed that exposures associated with this use are smaller than the exposures associated with food that comes into contact with treated utensils or countertops.   According to the Chlorine Dioxide, Sodium Chlorite Memorandum ( USEPA, 2005), a method for assessing treated mushroom facilities has already been designed by USEPA. Versar, Inc. did not have more information regarding this method; therefore the assessment of treated mushroom facilities has not been incorporated into our assessment. It was assumed that dietary exposures from general agricultural premise use, poultry hatcheries, mushroom houses and hydroponic uses are much lower than the dietary exposures resulting from surface disinfectant and sanitizing uses.

Please contact us if you have any questions. DIDECYL DIMETHYL AMMONIUM CHLORIDE DIETARY RISK ASSESSMENT ( OPPTS 248.5000)

Prepared for: Office of Pesticide Programs Antimicrobial Division U. S. Environmental Protection Agency 1921 Jefferson Davis Highway Arlington, VA 22202 Prepared by: Versar, Inc. 6850 Versar Center Springfield, VA 22151 EPA Contract Number: 68 W 01 036 Work Assignment No. 0248.5000.001.03 TAF: 1 3 13 Date: January 20, 2006 Executive Summary Didectyl dimethyl ammonium chloride ( DDAC) can be used as a disinfectant or sanitizer on counter tops, utensils, appliances, tables, refrigerators, on animal premises and/ or farms, and in mushroom premises. The use of antimicrobial on food or feed contact surfaces, agricultural commodities, in animal premises and poultry premises including hatcheries and application to food grade eggs may result in pesticide residues in human food. Residues from treated surfaces, such as utensils, countertops, equipment, and appliances can migrate to food coming into contact with the treated and rinsed surfaces and can be ingested by humans.

In the absence of data for residues of DDAC on treated food contact surfaces, the Agency estimated residue levels that may occur in food from the application rates on food contact surfaces. Dietary exposures from general agricultural premise use, poultry hatcheries, mushroom houses and hydroponic uses are expected to be much lower than the dietary exposures resulting from the surface disinfectant and sanitizing uses; therefore, these uses were not assessed.

To estimate the Estimated Daily Intake ( EDI) to treated food contact surfaces and food utensils, an FDA ( FDA, 2003) model was used in lieu of residue data. The maximum application rate for DDAC in food handling establishments from the various labeled ready to use products is 0.0043 pounds per gallon of treatment solution. The EDI calculations presented in this assessment assumes that food can contact 2,000 cm2 or 4,000 cm2 ( 50% and 100% of the FDA worst case scenario) of treated surfaces, and that 10% of the pesticide migrate to food, based on the Agency Residential SOPs. The use of the 10% transfer rate, instead of the use of a 100% transfer rate that is used in the FDA Sanitizer Solution Guidelines, requires the submission of confirmatory data to establish the reliability of the use of the10% transfer rate. These daily estimates were conservatively used to assess both acute and chronic dietary risks. None of the calculated % aPad or % cPad values exceeded 100%.

The maximum application rate for DDAC for bottling/ packing of food is 0.0020 lbs a. i per gallons of treatment solution. EDI values were calculated using an approach similar to that used for treated food contact surfaces and food utensils. Exposure was assumed to occur through the ingestion of three food products that might be packaged with treated material: milk, egg products, and beverages ( alcoholic and non alcoholic). None of the calculated % aPad or % cPad values exceeded 100%. 1. Dietary Toxicity The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is presented in Table 1. The aPAD and cPAD were both 0.1 mg/ kg/ day ( Versar, 2006).

Table 1: DDAC Dietary Toxicity Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE/ UF, Special FQPA SF for Risk Assessment Study and Toxicological Effects NOAEL ( developmental) = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x interspecies extrapolation, 10x intra species variation) Prenatal Developmental Toxicity  Rat MRID 41886701 LOAEL = 20 mg/ kg/ day based on increased incidence of skeletal variations. Acute Dietary ( Females 13 50)

aPAD = 0.1 mg/ kg/ day ( for Females age 13 50)

NOAEL = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x interspecies extrapolation, 10x intra species variation Chronic Toxicity Study  Dog MRID 41970401 LOAEL = 20 mg/ kg/ day based on decreased total cholesterol levels in females. Chronic Dietary ( general population)

cPAD = 0.1 mg/ kg/ day a. cPAD or aPAD= the RfD/ FQPA SF ( acute RFD and FQPA for aPAD and chronic RFD and FQPA SF for the cPAD)

2. Use Information Seven DDAC products were identified that have uses that could lead to incidental ingestion. These uses/ products are presented in Table 2. The labels with the maximum listed application rate for each use are presented in bold. Table 2: Use Site Categories and Application Rates Use Site Product Label ( Registration No.) Method of Application Range of Application Rates ( lb a. i./ gal) Egg handling equipment: Incubator and hatchers 10324 80 1839 173 10324 81 10324 108 10324 117 Fogger 0.0223 0.0563 Hatchery: hatchery, settlers, trays, racks, carts, sexing tables, delivery trucks, and other hard surfaces 10324 80 1839 173 10324 81 10324 108 10324 117 Mop, cloth, sponge, hand pump trigger sprayer, or low pressure coarse sprayer 0.0014 0.0043 Egg handling rooms: hatcheries 10324 80 1839 173 10324 81 10324 108 10324 117 10324 134 Fogger 0.0007 0.2193 Egg packing plants: food grade eggs 1839 173 10324 81 10324 117 Immersion, low pressure coarse sprayer, or swabs 0.0007 0.0020 Food handling establishments: utensils and equipment 1839 173 10324 81 10324 117 Immersion, low pressure coarse sprayer, or swabs 0.0020 Food handling establishments: countertops, appliances, and tables 10324 81 10324 108 10324 117 1839 173 10324 80 Mop, cloth, sponge, hand pump trigger sprayer, or low pressure coarse sprayer 0.0023 0.0043 Food processing plants: ( poultry, meat, fish, tobacco etc.): hard surfaces and equipment, including utensils, dishes, silverware, glasses, sink tops, countertops, refrigerated storage, display equipment, storage shelves, appliances, conveyers ( fruits/ vegetables or meat/ poultry) etc. 10324 81 10324 108 10324 117 10324 80 1839 173 10324 134 Mop, cloth, sponge, hand pump trigger sprayer, or low pressure coarse sprayer, feeding equipment 0.0020 0.0043 Use Site Product Label ( Registration No.) Method of Application Range of Application Rates ( lb a. i./ gal) Bottling/ packaging sanitizer: food contact surface sanitizer ( i. e. bottle sanitizing, beer storage tanks, and beverage dispensing unit) 1839 173 10324 81 10324 117 Towel, circulation, liquid pour  mechanical or automated systems 0.0020 Mushroom facilities 10324 80 10324 81 10324 108 10324 117 Mop, cloth, sponge, hand trigger sprayer, or coarse spray device 0.0023 0.0086 Farm ( poultry, swine, dairy) premises, feed storage areas, and cows ( uters, flanks, and teats) 1839 173 10324 81 10324 80 1839 173 10324 108 10324 117 Towel, mop, cloth, sponge, hand trigger sprayer, or coarse spray device 0.0007 0.0043 3. Quantitative Dietary assessment 3.1 Egg handling equipment, Agricultural Premise Use, and Poultry Hatcheries DDAC products may be used on egg shells in both poultry hatcheries and food gradeeggs Although it is possible that some of sanitizer/ disinfectant chemicals may penetrate the egg shells, at this time the Agency believes that the amount of the chemical transferred into food is likely to be minimal. Dietary exposures from general agricultural premise use, poultry hatcheries, mushroom houses and hydroponic uses are expected to be much lower than the dietary exposures resulting from the surface disinfectant and sanitizing uses; therefore, these uses were not assessed.

3.2 Food Handling Establishments and Food Processing Plants To calculate the EDI associated with use of a DDAC product as a food utensil sanitizer in food handling establishments, a number of assumptions have been made based on the FDA guidelines ( FDA, 2003).

1. When a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface ( Residual Solution). The FDA recommended worst case concentration for this quantity is 1 mg of solution per square centimeter of treated surface area. In the absence of any other data, this value has been used.

2. The FDA suggests that, as a worst case scenario, all food that an individual consumes will come into contact with 4,000 cm2 of sanitized non porous food contact surfaces. This contact area represents all the surface area from silverware, china, and glass used by a person who regularly eats three meals per day at an institutional or public facility.

3. It is assumed that 10% of the active material present on food contact surfaces will migrate.

4. The body weights used for this assessment are: adult man = 70 kg; adult woman = 60 kg, and 3 yr old toddler = 15 kg ( USEPA, 1997).

For use of a DDAC product as a counter top disinfectant in food handling establishments, the same assumptions as listed above were used, and one additional assumption was added:

1. The amount of counter top surface area that comes in contact with food should be much smaller than the amount of food utensil area that comes into contact with food. As a conservative estimate, it is assumed that 50% of the FDA value, or 2,000 cm2 of treated counter top surface area, comes into contact with an individual's food per day.

The above assumptions and the following equations were used to calculate EDI and Dietary Daily Dose ( DDD):

EDI ( mg/ p/ day) = AR x RS x SA x F x 10 6 ( 1) DDD ( mg/ kg/ day) = AR x RS x SA x F x 10 6/ BW ( 2)

Where: AR = Application rate ( ppm) RS = Residual solution ( mg/ cm2) SA = Surface area of the treated surface which comes into contact with food ( cm2) F = Fraction of the pesticide transferred or migrated to food ( unitless) BW = Body weight ( kg)

The input parameters listed in Table 4 and equations 1 and 2 were used to calculate the output parameters listed in Table 5.

Table 4: Input Parameters for Food Handling Establishments and Food Processing Plants Hard Surface Sanitizer Parameter Value Rationale Food Utensil Countertop Residual Solution on Surface 1 mg/ cm2 FDA worst case assumption Area of Treated Surface 4,000 cm2 2,000 cm2 100% and 50% of FDA worstcase assumption for food utensils DDAC concentration in diluted Solutiona 0.0020 lb a. i./ gal or 240 ppm 0.0043 lb a. i./ gal or 515 ppm Diluted Solution concentration, based on maximum concentration.

Fraction Transferred 10% EPA Assumption Body Weight ( kg) Adult man = Adult woman = Child = 70 60 15 EPA, 1997 a. Maximum application rates for food utensils were from product labels 1839 173, 10324 81, and 10324 117 for Utensils and product label 10324 80 for counter tops. Table 5: Calculated EDIs, aPAD, and cPAD for Utensils and Countertops Utensils Countertops Aggregate Exposure Group EDI ( mg/ p/ d) DDD ( mg/ kg/ d) % PADa EDI ( mg/ p/ d) DDD ( mg/ kg/ d) % PADa EDI ( mg/ p/ d) DDD ( mg/ kg/ d) % PADa ( mg/ kg/ d) Adult males 0.0959 0.00137 1.37 0.103 0.00147 1.47 0.199 0.00284 2.84 Adult females 0.0959 0.00160 1.60 0.103 0.00172 1.72 0.199 0.00332 3.32 Children 0.0959 0.00639 6.39 0.103 0.00687 6.87 0.199 0.0133 13.3 a. % PAD = exposure ( DDD) /( aPAD or cPAD) x 100. The acute and chronic population average dose is the same; therefore the % PADs are the same.

For DDAC treatments of food processing plants, the application rates are similar to food handling establishments presented above, and hence the exposure, EDIs, DDDs, and % aPAD and cPADs are also similar.

3.4. Food Bottling/ Packaging DDAC may also be used as a sanitizer or disinfectant in processing equipments, utensils in dairies, breweries, canning operations, meat and vegetable processing plants. In assessing this use, the following assumptions were made, based on USEPA ( 2005):

1. The DDAC concentration in the treatment solution is 0.0020 lb a. i./ gal, or 240 ppm ( 0.00024 wt/ wt)

2. When a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface ( Residual Solution). The FDA recommended worst case concentration for this quantity is 1 mg of solution per square centimeter of treated surface area. In the absence of any other data, this value has been used.

3. For the fraction of pesticide that migrates from the residue to the food ( F in equations 3 and 4), a transfer rate of 100% was used instead of 10% because the food is in contact with the treated surfaces for potentially very long periods of time.

4. For a given person, the grams of food per surface area of container were as follows ( g/ cm2): a. Milk ( dairy): 6.6 b. Egg/ mayonnaise: 64.0 c. Beer, beverages: 150 5. The daily intake rates for an adult ( g/ person/ day) were as follows:

a. Beverages, alcoholic/ beer: 182 b. Beverages, non alcoholic: 240 c. Egg products: 9.0 d. Milk: 124 6. A child will consume a smaller quantity of calories in a given day. To account for differences between intake values among children and adults a calorie intake modification factor of 0.64 was applied to the EDI for a child. Recommended energy allowances measured in kilocalories per body weight for different age groups and genders were taken from the National Research Counsil's Recommended Energy Allowances. The values are based on the resting energy expenditure and the energy required for light to moderate levels of activity, as determined by the World Health Organization ( USAID, 2005). The calculation of the factor is presented in Table 6 below.

The above assumptions and the following equations were used to calculate EDI and Dietary Daily Dose ( DDD):

EDI ( mg/ p/ day) = AR x RS x DIR x MSA 1 x F x 10 6 x CMF ( 3)

DDD ( mg/ kg/ day) = AR x RS x DIR x MSA 1 x F x 10 6 x CMF/ BW ( 4)

Where: AR = Application rate ( ppm) RS = Residual solution ( mg/ cm2) MSA = Mass surface area ratio ( the treated surface that comes into contact with food) ( g/ cm2) DIR = Daily intake rate of food in a given day ( g/ p/ day) F = Fraction of the pesticide transferred or migrated to food ( unitless) BW = Body weight ( kg) CMF = Calorie intake modification factor ( 100% adults; 64.4% Children)

Assumptions 1 4, inputs from Table 6 and 7, and equations 3 and 4 were used to calculate the dietary rates and doses presented in Table 8.

Table 6: Toddler ( 3 yr old) and Adult Calorie Intake Comparison Group ( Age) Body Weight ( kg) Kilocalories per kga Kilocaloriesb Child ( 1 3) 15.0 102 1,530 Female ( 25 50) 60.0 36.0 2,160 Male ( 25 50) 70.0 37.0 2,590 Output Child Modification Factor ( CMF) c 0.644 a. USAID, 2005 b. Kilocalories = Kcal/ Kg x BW c. CMF = Kcal child ÷ [( Kcal female + Kcal male)/ 2] Table 7: Input Parameters for Food Bottling/ Packaging Hard Surface Sanitizer Parameter Input Rational Milk 6.6 Egg/ Mayonnaise 64 Food mass/ surface ( g/ cm2) Beer, beverages 150 USEPA, 2005 Milk 124 Egg products 9 Beer, beverages 182 Intake rates ( g/ p/ d) Beverages/ nonalcoholic 240 USEPA, 2005 Fraction Transferred 100% FDA worst case assumption Residual Solution on Surface 1 mg/ cm2 FDA worst case Assumption Quantity DDAC 0.0020 lb ai or 240 ppm Diluted solution concentration, based on maximum concentration. Body Weight ( kg) Adult man = Adult woman = Child = 70 60 15 USEPA, 1997 a. Maximum application rates for food utensils were from product labels 1839 173, 10324 81, and 10324 117.

Table 8: Calculated EDIs, aPAD, and cPAD for Representative Dairy and Beverage Consumption Food Type Exposure Group EDI ( mg/ p/ d) DDD ( mg/ kg/ d) % PAD Adult Male 6.44x10 5 0.0644 Adult Female 0.00451 7.52x10 5 0.0752 Milk Childa 0.00290 1.94x10 4 0.194 Adult Male 1.16x10 10 1.16x10 7 Adult Female 8.10x10 9 1.35x10 10 1.35x10 7 Egg product Child a 5.22x10 9 3.48x10 10 3.48x10 7 Adult Male 3.29x10 4 0.329 Adult Female 0.0230 3.84x10 4 0.384 Beverages, non alcoholic Childa 0.0148 9.90x10 4 0.990 Adult Male 4.16x10 6 0.00416 Beverages, alcoholic, beer Adult Female 2.91x10 4 4.85x10 6 0.00485 a. Child EDI values are multiplied by a modification factor of 0.644 4.0 References FDA. 2003. " Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions." http:// www. cfsan. fda. gov/~ dms/ opa cg3a. html. Last accessed June 9, 2003.

USAID. 2005. " ANNEX III: Recommended Energy Allowance Tables." November 2005. http:// www. usaid. gov/ our_ work/ humanitarian_ assistance/ ffp/ crg/ annex 3. htm. Last viewed January 23, 2006.

USEPA. 1997. Exposure Factors Handbook. Volume I II. Office of Research and Development. Washington, D. C. EPA/ 600/ P 95/ 002Fa. August 1997.

USEPA. 2005. Dietary Assessment of Chlorine Dioxide, Sodium Chlorite From Their Use As Indirect Food Contact Sanitizers/ Disinfectants ( Hard Surface Sanitizers). Memorandum from Najm Shamim, USEPA to Melba Morrow and Jennifer Slotnick, USEPA. Dates August 15, 2005.

Versar. 2006. DDAC Occupational and Residential Exposure Assessment. Memorandum from Adria Diaz/ Karie Riley/ Kelly McAloon, Versar, Inc., to Laura Bailey, USEPA dated January 20, 2006.


[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Notices]
[Pages 53059-53060]
[FR Doc No: 2014-21168]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14087-001]

Black Canyon Hydro, LLC; Notice of Successive Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On July 1, 2014, Black Canyon Hydro, LLC filed an application for a
successive preliminary permit, pursuant to section 4(f) of the Federal
Power Act (FPA), proposing to study the feasibility of the Black Canyon
Pumped Storage Project (project) to be located at the U.S. Bureau of
Reclamation's Kortes and Seminoe Dams near Rawlins in Carbon County,
Wyoming. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owners' express
permission.
    The proposed project has five alternatives and would consist of the
following:

East Reservoir-Kortes Alternative

    (1) The existing Kortes Reservoir as the lower reservoir; (2) a
new, 45-foot-high, 8,724-foot-long earthen or rockfill East Reservoir
embankment; (3) a new artificial, lined East Reservoir with a storage
capacity of 9,700-acre-foot; (4) a 3,800-foot-long, 18.7-foot-diameter
concrete-lined pressure shaft; (5) a 200-foot-long, 22.4-foot-diameter
concrete-lined tailrace; (6) a 280-foot-long, 70-foot-wide, 120-foot-
high powerhouse; and (7) 0.75-mile-long, 230-kilovolt (kV) transmission
line to an interconnection point to the Western Area Power
Administration (WAPA) Miracle Mile-Cheyenne transmission line on the
Seminoe Reservoir side of the project.

East Reservoir-Seminoe Alternative

    (1) The existing Seminoe Reservoir as the lower reservoir; (2) a
new, 45-foot-high, 8,724-foot-long earthen or rockfill East Reservoir
embankment; (3) a new artificial, lined East Reservoir with a storage
capacity of 9,700-acre-foot; (4) a 800-foot-long, 20.4-foot-diameter
unlined or concrete-lined low-pressure tunnel; (5) a 5,800-foot-long,
20.4-foot-diameter concrete-lined pressure shaft; (6) a 200-foot-long,
24.5-foot-diameter concrete-lined tailrace; and (7) a 280-foot-long, 70
foot-wide, 120-foot-high powerhouse. The interconnection point to the
WAPA Miracle Mile-Cheyenne line is adjacent to the powerhouse and a
transmission line is not required.

North Reservoir-Kortes Alternative

    (1) The existing Kortes Reservoir as the lower reservoir; (2) a
new, 45-foot-high, 6,280-foot-long earthen or rockfill North Reservoir
embankment; (3) a new artificial, lined North Reservoir with a storage
capacity of 5,322-acre-foot; (4) a 1,400-foot-long, 18.7-foot-diameter
unlined or concrete-lined low-pressure tunnel; (5) a 1,960-foot-long,
18.7-foot-diameter concrete-lined pressure tunnel; (6) a 560-foot-long,
22.4-foot-diameter concrete-lined tailrace; (7) a 250-foot-high, 60-
foot-wide, 120-foot-high powerhouse; and (8) a 1-mile-long, 230-kV
transmission line to an interconnection point of the WAPA Miracle Mile-
Cheyenne transmission line on the Seminoe Reservoir side of the
project.

North Reservoir-Seminoe Alternative A

    (1) The existing Seminoe Reservoir as the lower reservoir; (2) a
new, 45-foot-high, 6,280-foot-long earthen or rockfill North Reservoir
embankment; (3) a new artificial, lined North Reservoir with a storage
capacity of 5,322-acre-foot; (4) a 1,400-foot-long, 20.4-foot-diameter
unlined or concrete-lined low-pressure tunnel; (5) a 3,780-foot-long,
20.4-foot-diameter concrete-lined pressure tunnel; (6) a 1,307-foot-
long, 24.5-foot-diameter concrete-lined tailrace; (7) an 250-foot-high,
60-foot-wide, 120-foot-high powerhouse; and (8) a 0.25-mile-long, 230-
kV transmission line interconnecting with the WAPA Miracle Mile-
Cheyenne line.

North Reservoir-Seminoe Alternative B

    (1) The existing Seminoe Reservoir as the lower reservoir; (2) the
new North Reservoir embankment and Reservoir also proposed in North
Reservoir-Kortes Alternative (items 2 and 3 above); (3) a 1,400-foot-
long, 20.4-foot-diameter unlined or concrete-lined low-pressure tunnel;
(4) a 3,780-foot-long, 20.4-foot-diameter concrete-lined pressure
tunnel; (5) a 1,307-foot-long, 24.5-foot-diameter concrete-lined
tailrace; (6) an 250-foot-high, 60-foot-wide, 120-foot-high semi-
surface powerhouse; and (7) a 0.35-mile-long, 230-kV transmission line
interconnecting with the WAPA Miracle Mile-Cheyenne line.
    The generating equipment for all of the alternatives will consist
of three 166-megawatt (MW) adjustable-speed reversible pump-turbines
with a total generating and pumping capacity of 500 MW. The estimated
annual generation of the project would be 2,628 gigawatt-hours.
    Applicant Contact: Mr. Matthew Shapiro, Black Canyon Hydro, LLC,
1210 W. Franklin Street, Suite 2, Boise, Idaho 83702; phone: (208) 246-
9925.
    FERC Contact: Kelly Wolcott; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at
http:[sol][sol]www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http:[sol][sol]www.ferc.gov/
docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426. The first page of any
filing should include docket number P-14087-001.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http:[sol][sol]www.ferc.gov/docs-filing/
elibrary.asp. Enter the docket number (P-14087) in the docket number
field to access the document. For assistance, contact FERC Online
Support.

    Dated: August 26, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-21168 Filed 9-4-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Notices]
[Pages 71543-71544]
[FR Doc No: 2021-27183]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Modifications to
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein. Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before January 3, 2022.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety, General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-13, 1200 New
Jersey Avenue Southeast, Washington, DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on December 7, 2021.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special
       Application No.               Applicant            Regulation(s) affected           permits thereof
----------------------------------------------------------------------------------------------------------------
8757-M......................  Milton Roy, LLC........  173.201(c), 173.202(c),       To modify the special
                                                        173.203(c), 173.302a(a)(1),   permit by updating the
                                                        173.304a(a)(1), 180.205.      drawing revision numbers.
                                                                                (modes 1, 2, 3, 4)
11180-M.....................  Affival Inc............  172.300, 172.400, 172.500,    To modify the special
                                                        173.1, 173.24(c).             permit to authorize welded
                                                                                metal tubing and
                                                                                additional hazardous
                                                                                materials. (modes 1, 2, 3)
16061-M.....................  Battery Solutions, LLC.  172.102(c), 172.102(c)(1),    To modify the special
                                                        172.200, 172.300, 172.400,    permit to authorize
                                                        172.500, 172.600,             additional packagings and
                                                        172.700(a), 173.159a(c)(2),   to clarify requirements of
                                                        173.185(c),                   the special permit. (modes
                                                        173.185(c)(1)(iii),           1, 3)
                                                        173.185(c)(1)(iv),
                                                        173.185(c)(1)(v),
                                                        173.185(c)(3).

20470-M.....................  Imperial Automotive      172.101(j)..................  To modify the special
                               Logistics GmbH.                                        permit to authorize
                                                                                additional authorized
                                                                                lithium ion batteries.
                                                                                (mode 4)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-27183 Filed 12-15-21; 8:45 am]
BILLING CODE 4909-60-P


[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Rules and Regulations]
[Pages 15971-15977]
[FR Doc No: 2018-07739]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0169; FRL-9975-76]

Fluensulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluensulfone in or on multiple commodities that are identified and
discussed later in this document. Makhteshim Agan of North America
(MANA) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2018. Objections and
requests for hearings must be received on or before June 12, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0169, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room

is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the OPP Docket is (703)
305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0169 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 12, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0169, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8538) by Makhteshim Agan of North America (MANA) (d/b/a ADAMA), 3120
Highlands Blvd., Suite 100, Raleigh, NC 27604. The petition requested
that 40 CFR part 180 be amended by establishing tolerances for residues
of the nematicide fluensulfone, in or on fruit, pome, crop group 11-10
at 0.3 parts per million (ppm); fruit, stone crop group 12-12 at 0.06
ppm; small fruit vine climbing subgroup 13-07D at 0.5 ppm; grape,
raisin at 0.8 ppm; nut, tree, crop group 14-12 at 0.02 ppm; almond,
hulls at 3.0 ppm; sugarcane at 0.03 ppm; sugarcane and molasses at 0.2
ppm, and for inadvertent residues of fluensulfone, in or on (10-month
plant-back interval): Grain, cereal, crop group 15 at 0.03 ppm; forage,
fodder and straw of cereal grains, crop group 16 at 2 ppm; (90-day
plant-back interval): Wheat, grain at 0.06 ppm; barley, grain at 0.06
ppm; buckwheat, grain at 0.06 ppm; oat, grain at 0.06 ppm; teosinte,
grain at 0.06 ppm; wheat, bran at 0.10 ppm; barley, bran at 0.10 ppm;
wheat, middlings at 0.07 ppm; wheat, shorts at 0.08 ppm; wheat, germ at
0.07 ppm; wheat, straw at 4 ppm; barley, straw at 4 ppm; oat, straw at
4 ppm; wheat, forage at 4 ppm; oat, forage at 4 ppm; wheat, hay at 8
ppm; barley hay at 8 ppm; and oat, hay at 8 ppm. That document
referenced a summary of the petition prepared by MANA, the registrant,
which is available in the docket, http://www.regulations.gov. A comment
was received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established in most
commodities. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fluensulfone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluensulfone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity,

completeness, and reliability as well as the relationship of the
results of the studies to human risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.
    The residue of concern for dietary assessment is the parent
compound, fluensulfone. Residues of the metabolites butene sulfonic
acid (BSA) and thiazole sulfonic acid (TSA) occur at levels
significantly greater than fluensulfone; however, these metabolites are
considered non-toxic at levels that may occur from the use of
fluensulfone. Based on the available data addressing toxicity of the
BSA and TSA metabolites, the Agency has determined that they are not of
toxicological concern.
    Exposure to fluensulfone results in effects on the hematopoietic
system (decreased platelets, increased white blood cells, hematocrit,
and reticulocytes), kidneys, and lungs. Body weight and clinical
chemistry changes were observed across multiple studies and species.
Evidence of qualitative increased susceptibility of infants and
children to the effects of fluensulfone was observed in the 2-
generation reproduction study in rats, wherein pup death was observed
at a dose that resulted in decreased body weight in the dams. There was
no evidence of either qualitative or quantitative susceptibility in
developmental toxicity studies in rats or rabbits. The most sensitive
endpoints for assessing safety of aggregate exposures to fluensulfone
under the FFDCA are the increased pup-loss effects for acute dietary
exposure; and body weight, hematological and clinical chemistry changes
for chronic dietary as well as short/intermediate term dermal
exposures. Decreased locomotor activity in females, and decreased
spontaneous activity, decreased rearing, and impaired righting response
in both sexes were observed in the acute neurotoxicity study at the
lowest dose tested. No other evidence for neurotoxicity was observed in
the other studies in the toxicity database, including a subchronic
neurotoxicity study. The doses and endpoints chosen for risk assessment
are all protective of the effects seen in the acute neurotoxicity
study. A developmental neurotoxicity study is not required.
    Although the mouse carcinogenicity study showed an association with
alveolar/bronchiolar adenomas and carcinomas in the female, EPA has
determined that quantification of risk using the chronic reference dose
(RfD) will account for all chronic toxicity, including carcinogenicity,
that could result from exposure to fluensulfone and its metabolites.
That conclusion is based on the following considerations: (1) The
tumors occurred in only one sex in one species. (2) no carcinogenic
response was seen in either sex in the rat. (3) the tumors in the mouse
study were observed at a dose that is almost 13 times higher than the
dose chosen for risk assessment. (4) fluensulfone and its metabolites
are not mutagenic.
    Specific information on the studies received and the nature of the
adverse effects caused by fluensulfone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Fluensulfone--Aggregate Human Health
Risk Assessment in Support of Section 3 Registration of New Uses
(Sugarcane, Small Vine Climbing Fruits, Pome Fruits, Stone Fruits, and
Tree Nuts), Rotational Crop Tolerances, and Label Amendments'' on pages
37-50 in docket ID number EPA-HQ-OPP-2017-0169.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for fluensulfone used for human risk assessment is discussed
in Unit III.B. of the final rule published in the Federal Register of
June 1, 2016 (81 FR 34898) (FRL-9946-07).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluensulfone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluensulfone tolerances in 40
CFR 180.680. EPA assessed dietary exposures from fluensulfone in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for fluensulfone. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, the acute dietary risk assumed tolerance-
equivalent residues and 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption information from the
USDA's NHANES/WWEIA. As to residue levels in food, the chronic dietary
risk assumed tolerance-equivalent residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to fluensulfone. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for fluensulfone. Tolerance-equivalent residue levels and
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluensulfone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluensulfone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-
exposuremodels-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW) models, the estimated drinking water concentrations (EDWCs) for
acute exposures are estimated to be 11.8 parts per billion (ppb) for
surface water and 77.6 ppb for ground water and for chronic exposures
are estimated to be 0.173 ppb for surface water and 52.5 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 77.6 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 52.5 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    No residential handler exposure for fluensulfone is expected
because the products are not intended for homeowner use. The product
label requires that handlers wear specific clothing (e.g., long sleeve
shirt/long pants) and/or personal protective equipment (PPE). The
Agency has made the assumption that the product is not for homeowner
use and is intended for use by professional applicators. As a result, a
residential handler assessment has not been conducted.
    For adult residential post-application exposure, the Agency
evaluated dermal post application exposure only to outdoor turf/lawn
applications (high contact activities). The Agency also evaluated
residential post-application exposure for children via dermal and hand-
to-mouth routes of exposure, resulting from treated outdoor turf/lawn
applications (high contact activities). Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/standard-operating-proceduresresidential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
fluensulfone to share a common mechanism of toxicity with any other
substances, and fluensulfone does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluensulfone does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased
quantitative or qualitative susceptibility was seen in developmental
toxicity studies in rats and rabbits. Fetal effects in those studies
occurred in the presence of maternal toxicity and were not considered
more severe than the maternal effects. However, there was evidence of
increased qualitative, but not quantitative, susceptibility of pups in
the 2-generation reproduction study in rats. Maternal effects observed
in that study were decreased body weight and body weight gain; at the
same dose, effects in offspring were decreased pup weights, decreased
spleen weight, and increased pup loss (post-natal day 1-4). Although
there is evidence of increased qualitative susceptibility in the 2-
generation reproduction study in rats, there are no residual
uncertainties with regard to pre- and post-natal toxicity following in
utero exposure to rats or rabbits and pre- and post-natal exposures to
rats. Considering the overall toxicity profile, the clear NOAEL for the
pup effects observed in the 2-generation reproduction study, and that
the doses selected for risk assessment are protective of all effects in
the toxicity database including the offspring effects, the degree of
concern for the susceptibility is low.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for fluensulfone is complete.
    ii. Evidence of potential neurotoxicity was only seen following
acute exposure to fluensulfone and the current PODs chosen for risk
assessment are protective of the effects observed. There is no need for
a developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    iii. There is no indication of quantitative susceptibility in the
developmental and reproductive toxicity studies, and there are no
residual uncertainties concerning pre- or post-natal toxicity. In
addition, the endpoints and doses chosen for risk assessment are
protective of the qualitative susceptibility observed in the 2-
generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance equivalent-level residues. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluensulfone in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by fluensulfone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary

exposure from food and water to fluensulfone will occupy 9.4% of the
aPAD for all infants less than 1 year old, the population group
receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluensulfone from food and water will utilize 4.1% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluensulfone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Fluensulfone is currently registered for uses that could result in
short-term post-application residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to fluensulfone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 5,600 adults and
2,800 for children. Because EPA's level of concern for fluensulfone is
a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
fluensulfone is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
fluensulfone.
    5. Aggregate cancer risk for U.S. population. EPA assessed cancer
risk using a non-linear approach (i.e., RfD) since it adequately
accounts for all chronic toxicity, including carcinogenicity, that
could result from exposure to fluensulfone. As the chronic dietary
endpoint and dose are protective of potential cancer effects,
fluensulfone is not expected to pose an aggregate cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluensulfone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (acetonitrile/water (1:1, v/v)
extraction and analysis by reverse-phase high performance liquid
chromatography mass spectrometry (HPLC-MS/MS)) is available to enforce
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email
address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for fluensulfone for commodities covered by this
document.

C. Response to Comments

    One comment was submitted in response to the September 15, 2017
Notice of Filing. The commenter opposed the petition generally,
alleging that there are too many toxic chemicals being used in America
without citing any specific human health concerns about fluensulfone
itself. The Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops; however, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Most of the petitioned-for tolerance levels differ from those being
established by the Agency. In its petition, the petitioner stated that
the proposed tolerances were derived using the Organization for
Economic Cooperation and Development (OECD) MRL calculation procedure;
however, the petitioner did not provide the OECD MRL calculator's input
or output tables for any of the requested tolerances. When EPA ran the
OECD MRL calculation procedure on the requested new use commodities
(primary crops) using residue values from the field trials, the results
obtained did not agree with any of the petitioned-for tolerances,
except in pome fruits group 11-10 and molasses. Therefore, EPA is
establishing tolerances that differ from those requested in stone
fruits group 12-12, small vine climbing fruits subgroup 13-07D,
raisins, tree nuts group 14-12, almond hulls, and sugarcane based on
available data and the OECD calculation procedure. In the case of tree
nuts group 14-12, EPA is establishing the tolerance in tree nuts at
0.01 ppm (the LOQ) because residues in all samples of almonds and
pecans were <0.01 ppm.
    With respect to tolerances for inadvertent residues, the Agency is
establishing a tolerance for residues in/on cereal grains (crop group
15) based on data from the representative commodities for that crop
group and reflecting the labeled rotational crop plant-back restriction
applicable to the crop group as a whole. Separate tolerances for
inadvertent residues are being established for barley, buckwheat, oat,
and wheat commodities due to a shorter plant-back restriction, specific
to those crops, which results in higher residue levels. A separate
tolerance was proposed for inadvertent residues in/on teosinte;
however, a separate tolerance listing is not necessary since it is a
member of crop group 15 and does not

have a separate, shorter, plant-back restriction. A tolerance in wheat
milled byproducts, the preferred term covering wheat shorts and
middlings, is being established at 0.08 ppm, rather than separate
tolerances in wheat shorts and wheat middlings.
    Furthermore, EPA's tolerance levels are expressed to provide
sufficient precision for enforcement purposes, and this may include the
addition of trailing zeros (such as 0.30 ppm rather than 0.3 ppm). This
is in order to avoid the situation where rounding of an observed
violative residue to the level of precision of the tolerance expression
would result in a residue considered non-violative (such as 0.34 ppm
being rounded to 0.3 ppm). This revision has been made for pome fruits
group 11-10; molasses; forage, fodder and straw of cereal grains group
16; and straw, forage, and hay of wheat, barley and oats.

V. Conclusion

    Therefore, tolerances are established for residues of fluensulfone,
in or on almond, hulls at 4.0 ppm; fruit, pome, group 11-10 at 0.30
ppm; fruit, small, vine climbing, subgroup 13-07D at 0.60 ppm; fruit,
stone group 12-12 at 0.07 ppm; grape, raisin at 0.90 ppm; nut, tree,
group 14-12 at 0.01 ppm; sugarcane, cane at 0.04 ppm; and sugarcane,
molasses at 0.20 ppm. In addition, tolerances for indirect or
inadvertent residues of fluensulfone are established in or on barley,
bran at 0.10 ppm; barley, grain at 0.06 ppm; barley hay at 8.0 ppm;
barley, straw at 4.0 ppm; buckwheat, grain at 0.06 ppm; grain, cereal,
forage, fodder and straw, group 16 at 2.0 ppm; grain, cereal, group 15
at 0.03 ppm; oat, forage at 4.0 ppm; oat, grain at 0.06 ppm; oat, hay
at 8.0 ppm; oat, straw at 4.0 ppm; wheat, bran at 0.10 ppm; wheat,
forage at 4.0 ppm; wheat, germ at 0.07 ppm; wheat, grain at 0.06 ppm;
wheat, hay at 8.0 ppm; wheat, milled byproducts at 0.08 ppm; and wheat,
straw at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 4, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.680:
0
a. In the table to paragraph (a), add alphabetically the entries
``Almond, hulls''; ``Fruit, pome, group 11-10''; ``Fruit, small, vine
climbing, subgroup 13-07D''; ``Fruit, stone, group 12-12''; ``Grape,
raisin''; ``Nut, tree, group 14-12''; ``Sugarcane, cane''; and
``Sugarcane, molasses''.
0
b. Revise paragraph (d).
    The additions and revisions read as follows:

Sec.  180.680   Fluensulfone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Almond, hulls..................................................      4.0

                                * * * * *
Fruit, pome, group 11-10.......................................     0.30
Fruit, small, vine climbing, subgroup 13-07D...................     0.60
Fruit, stone, group 12-12......................................     0.07
Grape, raisin..................................................     0.90
Nut, tree, group 14-12.........................................     0.01

                                * * * * *
Sugarcane, cane................................................     0.04
Sugarcane, molasses............................................     0.20

                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established
for residues of the nematicide fluensulfone, including its metabolites
and degradates, in or on the commodities in

the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only 3,4,4-trifluoro-but-3-ene-1-
sulfonic acid.

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Barley, bran...................................................     0.10
Barley, grain..................................................     0.06
Barley, hay....................................................      8.0
Barley, straw..................................................      4.0
Buckwheat, grain...............................................     0.06
Grain, cereal, forage, fodder and straw, group 16..............      2.0
Grain, cereal, group 15........................................     0.03
Oat, forage....................................................      4.0
Oat, grain.....................................................     0.06
Oat, hay.......................................................      8.0
Oat, straw.....................................................      4.0
Wheat, bran....................................................     0.10
Wheat, forage..................................................      4.0
Wheat, germ....................................................     0.07
Wheat, grain...................................................     0.06
Wheat, hay.....................................................      8.0
Wheat, milled byproducts.......................................     0.08
Wheat, straw...................................................      4.0
------------------------------------------------------------------------

[FR Doc. 2018-07739 Filed 4-12-18; 8:45 am]
 BILLING CODE 6560-50-P