Fluridone; Pesticide Tolerances, 29633-29637 [2020-08963]
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations
the tolerance exemption in this action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (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. As a
result, this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA 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, EPA 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 (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act (15
U.S.C. 272 note).
V. Congressional Review Act (CRA)
Under the CRA (5 U.S.C. 801 et seq.),
EPA will submit a rule report 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.
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Dated: April 2, 2020.
Richard Keigwin,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1375 to subpart D to read
as follows:
■
§ 180.1375 Methyl mercaptan; exemption
from the requirement of a tolerance.
Residues of methyl mercaptan are
exempt from the requirement of a
tolerance in or on all food commodities,
when methyl mercaptan is used as a
gopher repellent in irrigation lines in
accordance with label directions and
good agricultural practices.
[FR Doc. 2020–08964 Filed 5–15–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0074; FRL–10007–09]
Fluridone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluridone in or
on avocados, mandarins, pomegranates,
pistachios, and the stone fruit group
(crop group 12). SePRO Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
18, 2020. Objections and requests for
hearings must be received on or before
July 17, 2020, 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–2019–0074, is
available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
SUMMARY:
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29633
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
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 Publishing Office’s
e-CFR site at https://www.ecfr.gov/cgibin/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–2019–0074 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 July 17, 2020. 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
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notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0074, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of February
11, 2020 (85 FR 7708) (FRL–10005–02),
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 8F8710) by
SePRO Corporation, 11550 North
Meridian Street, Suite 600, Carmel, IN
46032. The petition requested that 40
CFR part 180 be amended by
establishing tolerances for residues of
the herbicide fluridone in or on
avocados, mandarins, pomegranates,
pistachios, and the stone fruit group
(crop group 12) at 0.1 parts per million
(ppm). That document referenced a
summary of the petition prepared by
SePRO Corporation, the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA is
establishing the requested tolerances
with slight variations to reflect the
correct commodity definitions.
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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
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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 fluridone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fluridone 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 liver and kidneys were identified
as the primary target organs based on a
multitude of organ specific effects noted
across the toxicity database. All model
species exhibited indications of liver
toxicity that were often accompanied by
body weight effects. No signs of
neurotoxicity were identified in the rest
of the toxicity database. Toxicity from
repeated dose dermal exposures was
limited to irritation effects on the skin
(erythema, desquamation, epidermal
fissures). No evidence of
immunotoxicity, mutagenicity, or
carcinogenicity were noted in the
toxicity database. Fluridone did not
demonstrate mutagenic behavior either
in vitro or in vivo nor did exposure
result in an increased incidence of
tumors. The EPA concluded that
fluridone should be classified as ‘‘not
likely’’ to be a human carcinogen.
Specific information on the studies
received and the nature of the adverse
effects caused by fluridone as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
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toxicity studies can be found at https://
www.regulations.gov in document
Fluridone. Human Health Risk
Assessment for the Section 3
Registration on: Avocado, Mandarin
(Tangerine), Pistachio, Pomegranate,
and Stone Fruit (Crop Group 12–12) in
docket ID number EPA–HQ–OPP–2019–
0074.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for fluridone used for human
risk assessment is discussed in Unit
III.B. of the final rule published in the
Federal Register of February 17, 2016
(81 FR 7982) (FRL–9941–69).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fluridone, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
fluridone tolerances in 40 CFR 180. EPA
assessed dietary exposures from
fluridone 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
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exposure. Such effects were identified
for fluridone. In estimating acute dietary
exposure, EPA used food consumption
information from the United States
Department of Agriculture (USDA)
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). This
dietary survey was conducted from 2003
to 2008. 100 percent crop treated (PCT),
tolerance-level residues, and default
processing factors were assumed for this
assessment.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA NHANES/WWEIA. This
dietary survey was conducted from 2003
to 2008. 100 PCT, tolerance-level
residues, and default processing factors
were assumed.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that fluridone does not pose
a cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for fluridone. Tolerance-level residues
and/or 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 fluridone in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of fluridone.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model v2.0,
the estimated drinking water
concentrations (EDWCs) of fluridone for
acute exposures are estimated to be 150
parts per billion (ppb) for surface water
and 45 ppb for ground water. For
chronic exposures for non-cancer
assessments are estimated to be 107 ppb
for surface water and 43 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 150 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 107 ppb was used to assess the
contribution to drinking water.
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3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Fluridone is currently registered for
the following uses that could result in
residential exposures: From use on
ponds (including a homeowner use),
lakes, reservoirs, and rivers. EPA
assessed residential exposure using the
following assumptions: Adult
applicators may be exposed (dermal and
inhalation) while applying the pesticide
to residential ponds. Residential
handler exposure is expected to be
short-term in duration only.
Intermediate-term and chronic
exposures are not likely because of the
intermittent nature of applications by
homeowners. There is also potential for
residential post-application exposure
(dermal, inhalation and incidental
ingestion) for adults and children (3 to
<6 years old) swimming in treated
water. Residential post-application
exposure is expected to be short-term in
duration only. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www.epa.gov/pesticides/trac/science/
trac6a05.pdf.
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 fluridone to share a common
mechanism of toxicity with any other
substances, and fluridone does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
fluridone 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 https://
www.epa.gov/pesticides/cumulative.
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
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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.
There was no evidence of qualitative
susceptibility in fetuses in the rat and
rabbit developmental study. Equivocal
susceptibility was observed in the
young from the F2 population in the
reproductive study during the lactation
phase (based decreased body weight);
however, body weight of the F2
offspring returned to control levels after
the lactation period and no evidence of
susceptibility was observed in the F3
offspring.
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. More information
on that decision can be found at https://
www.regulations.gov in document
Fluridone. Human Health Risk
Assessment for the Section 3
Registration on: Avocado, Mandarin
(Tangerine), Pistachio, Pomegranate,
and Stone Fruit (Crop Group 12–12) in
docket ID number EPA–HQ–OPP–2019–
0074.
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
fluridone will occupy 2.3% of the aPAD
for all infants (<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
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that chronic exposure to fluridone from
food and water will utilize 7% of the
cPAD for children aged 1 to 2 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 fluridone 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). Fluridone is currently
registered for uses that could result in
short-term 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
fluridone. 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 1,300 for
adults and 1,600 for children. Because
EPA’s level of concern for fluridone 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, fluridone is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm 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
fluridone.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
fluridone is not expected to pose a
cancer risk to humans.
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 fluridone
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography (HPLC) method
(originally submitted as method AM–
AA–CA–RO52–AA–755)) is available to
enforce the tolerance expression.
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 fluridone.
V. Conclusion
Therefore, tolerances are established
for residues of fluridone, in or on
avocado, tangerine, pomegranate,
pistachio, and the fruit, stone, group 12–
12 at 0.1 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) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
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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
E:\FR\FM\18MYR1.SGM
18MYR1
Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
This notification is to inform
the public that the Department of Health
and Human Services (HHS) is exercising
List of Subjects in 40 CFR Part 180
its discretion in how it applies the
Environmental protection,
Privacy, Security, and Breach
Administrative practice and procedure,
Notification Rules under the Health
Agricultural commodities, Pesticides
Insurance Portability and
and pests, Reporting and recordkeeping Accountability Act of 1996 (HIPAA). As
requirements.
a matter of enforcement discretion, the
HHS Office for Civil Rights (OCR) will
Dated: April 13, 2020.
not impose penalties for noncompliance
Michael Goodis,
with the regulatory requirements under
Director, Registration Division, Office of
the HIPAA Rules against covered health
Pesticide Programs.
care providers or their business
Therefore, 40 CFR chapter I is
associates in connection with the good
amended as follows:
faith participation in the operation of a
COVID–19 Community-Based Testing
PART 180—[AMENDED]
Site (CBTS) during the COVID–19
nationwide public health emergency.
■ 1. The authority citation for part 180
continues to read as follows:
DATES: The notification of enforcement
discretion was effective on April 9,
Authority: 21 U.S.C. 321(q), 346a and 371.
2020, and had a retroactive effect to
■ 2. Amend § 180.420 by:
March 13, 2020, and will remain in
■ a. Adding alphabetically entries for
‘‘Avocado’’; ‘‘Fruit, stone, group 12–12’’; effect until the Secretary of HHS
declares that the public health
‘‘Pistachio’’; ‘‘Pomegranate’’; and
emergency no longer exists, or upon the
‘‘Tangerine’’ in the table in paragraph
expiration date of the declared public
(a)(2); and
health emergency, including any
■ b. Removing the entries ‘‘Avocado’’;
and ‘‘Fruit, stone, group 12’’ in the table extensions, (as determined by 42 U.S.C.
247d),1 whichever occurs first.
in paragraph (d).
The additions read as follows:
FOR FURTHER INFORMATION CONTACT:
Rachel Seeger at (202) 619–0403 or (800)
§ 180.420 Fluridone; tolerances for
537–7697 (TDD).
residues.
SUPPLEMENTARY INFORMATION: HHS is
(a) * * *
informing the public that it is exercising
(2) * * *
its discretion in how it applies the
Privacy, Security, and Breach
Parts
per
Commodity
Notification Rules under the Health
million
Insurance Portability and
Avocado ................................
0.1 Accountability Act of 1996 (HIPAA) 2
during the nationwide public health
*
*
*
*
*
emergency declared by the Secretary of
Fruit, stone, group 12–12 .....
0.1
HHS.3
*
*
*
Pistachio ...............................
Pomegranate ........................
*
*
*
*
Tangerine ..............................
*
*
*
*
*
SUMMARY:
*
0.1
0.1
*
*
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with RULES
45 CFR Parts 160 and 164
Enforcement Discretion Regarding
COVID–19 Community-Based Testing
Sites (CBTS) During the COVID–19
Nationwide Public Health Emergency
Office of the Secretary, HHS.
Notification of enforcement
discretion.
AGENCY:
ACTION:
16:02 May 15, 2020
The Office for Civil Rights (OCR) at
the U.S. Department of Health and
Human Services (HHS) is responsible
0.1
[FR Doc. 2020–08963 Filed 5–15–20; 8:45 am]
VerDate Sep<11>2014
I. Background
Jkt 250001
1 Public Health Emergency Declaration issued by
HHS Secretary, pursuant to Section 319 of the
Public Health Service Act, on January 31, 2020,
with retroactive effective date of January 27, 2020.
For more information, see https://www.phe.gov/
emergency/news/healthactions/phe/Pages/2019nCoV.aspx.
2 Due to the public health emergency posed by
COVID–19, the HHS Office for Civil Rights (OCR)
is exercising its enforcement discretion under the
conditions outlined herein. We believe that this
guidance is a statement of agency policy not subject
to the notice and comment requirements of the
Administrative Procedure Act (APA). 5 U.S.C.
553(b)(3)(A). OCR additionally finds that, even if
this guidance were subject to the public
participation provisions of the APA, prior notice
and comment for this guidance is impracticable,
and there is good cause to issue this guidance
without prior public comment and without a
delayed effective date. 5 U.S.C. 553(b)(3)(B) & (d)(3).
3 https://www.phe.gov/emergency/news/
healthactions/phe/Pages/2019-nCoV.aspx.
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
29637
for enforcing certain regulations issued
under the Health Insurance Portability
and Accountability Act of 1996
(HIPAA), and the Health Information
Technology for Economic and Clinical
Health (HITECH) Act, to protect the
privacy and security of protected health
information (PHI), namely the HIPAA
Privacy, Security, and Breach
Notification Rules (HIPAA Rules).
During the COVID–19 national
emergency,4 which also constitutes a
nationwide public health emergency,5
certain covered health care providers,
including some large pharmacy chains,
and their business associates may
choose to participate in the operation of
COVID–19 specimen collection and
testing sites (Community-Based Testing
Sites, or CBTS). For purposes of this
notification, a CBTS includes mobile,
drive-through, or walk-up sites that only
provide COVID–19 specimen collection
or testing services to the public.
OCR will exercise its enforcement
discretion and will not impose penalties
for noncompliance with regulatory
requirements under the HIPAA Rules
against covered health care providers
and their business associates in
connection with the good faith
participation in the operation of a CBTS
during the COVID–19 nationwide public
health emergency as described below.
II. Who/what is covered by this
notification?
This notification applies to all HIPAA
covered health care providers and their
business associates when such entities
are, in good faith, participating in the
operation of a CBTS. The operation of
a CBTS includes all activities that
support the collection of specimens
from individuals for COVID–19 testing.
III. Covered Health Care Providers and
Their Business Associates Should
Implement Reasonable Safeguards
OCR encourages covered health care
providers participating in the good faith
operation of a CBTS to implement
reasonable safeguards to protect the
privacy and security of individuals’ PHI.
Reasonable safeguards include the
following:
• Using and disclosing only the
minimum PHI necessary except when
disclosing PHI for treatment.
4 Presidential Proclamation on Declaring a
National Emergency Concerning the Novel
Coronavirus Disease (COVID–19) Outbreak (Mar 13,
2020), available at https://www.whitehouse.gov/
presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/.
5 Secretary of HHS Alex M. Azar, Determination
that a Public Health Emergency Exists (Jan. 31,
2020), available at https://www.phe.gov/emergency/
news/healthactions/phe/Pages/2019-nCoV.aspx.
E:\FR\FM\18MYR1.SGM
18MYR1
]]>Agencies
[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29633-29637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08963]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0074; FRL-10007-09]
Fluridone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluridone in or on avocados, mandarins, pomegranates, pistachios, and
the stone fruit group (crop group 12). SePRO Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May 18, 2020. Objections and
requests for hearings must be received on or before July 17, 2020, 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-2019-0074, is available at https://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 https://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: (703) 305-7090; 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
Publishing Office's e-CFR site at https://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-2019-0074 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
July 17, 2020. 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
[[Page 29634]]
notice. Submit the non-CBI copy of your objection or hearing request,
identified by docket ID number EPA-HQ-OPP-2019-0074, by one of the
following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), 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
8F8710) by SePRO Corporation, 11550 North Meridian Street, Suite 600,
Carmel, IN 46032. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide
fluridone in or on avocados, mandarins, pomegranates, pistachios, and
the stone fruit group (crop group 12) at 0.1 parts per million (ppm).
That document referenced a summary of the petition prepared by SePRO
Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing the requested tolerances with slight variations to reflect
the correct commodity definitions.
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 fluridone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluridone 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 liver and kidneys were identified as the primary target organs
based on a multitude of organ specific effects noted across the
toxicity database. All model species exhibited indications of liver
toxicity that were often accompanied by body weight effects. No signs
of neurotoxicity were identified in the rest of the toxicity database.
Toxicity from repeated dose dermal exposures was limited to irritation
effects on the skin (erythema, desquamation, epidermal fissures). No
evidence of immunotoxicity, mutagenicity, or carcinogenicity were noted
in the toxicity database. Fluridone did not demonstrate mutagenic
behavior either in vitro or in vivo nor did exposure result in an
increased incidence of tumors. The EPA concluded that fluridone should
be classified as ``not likely'' to be a human carcinogen.
Specific information on the studies received and the nature of the
adverse effects caused by fluridone 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 https://www.regulations.gov in document Fluridone. Human Health Risk Assessment
for the Section 3 Registration on: Avocado, Mandarin (Tangerine),
Pistachio, Pomegranate, and Stone Fruit (Crop Group 12-12) in docket ID
number EPA-HQ-OPP-2019-0074.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluridone used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of February 17, 2016 (81 FR 7982)
(FRL-9941-69).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluridone, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluridone tolerances in 40 CFR 180.
EPA assessed dietary exposures from fluridone 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
[[Page 29635]]
exposure. Such effects were identified for fluridone. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
This dietary survey was conducted from 2003 to 2008. 100 percent crop
treated (PCT), tolerance-level residues, and default processing factors
were assumed for this assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. 100 PCT,
tolerance-level residues, and default processing factors were assumed.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluridone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fluridone. Tolerance-level residues and/or 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 fluridone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluridone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model v2.0, the estimated drinking water
concentrations (EDWCs) of fluridone for acute exposures are estimated
to be 150 parts per billion (ppb) for surface water and 45 ppb for
ground water. For chronic exposures for non-cancer assessments are
estimated to be 107 ppb for surface water and 43 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 150 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 107 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).
Fluridone is currently registered for the following uses that could
result in residential exposures: From use on ponds (including a
homeowner use), lakes, reservoirs, and rivers. EPA assessed residential
exposure using the following assumptions: Adult applicators may be
exposed (dermal and inhalation) while applying the pesticide to
residential ponds. Residential handler exposure is expected to be
short-term in duration only. Intermediate-term and chronic exposures
are not likely because of the intermittent nature of applications by
homeowners. There is also potential for residential post-application
exposure (dermal, inhalation and incidental ingestion) for adults and
children (3 to <6 years old) swimming in treated water. Residential
post-application exposure is expected to be short-term in duration
only. Further information regarding EPA standard assumptions and
generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 fluridone
to share a common mechanism of toxicity with any other substances, and
fluridone does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that fluridone 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
https://www.epa.gov/pesticides/cumulative.
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. There was no evidence of
qualitative susceptibility in fetuses in the rat and rabbit
developmental study. Equivocal susceptibility was observed in the young
from the F2 population in the reproductive study during the lactation
phase (based decreased body weight); however, body weight of the F2
offspring returned to control levels after the lactation period and no
evidence of susceptibility was observed in the F3 offspring.
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. More information on that decision can be
found at https://www.regulations.gov in document Fluridone. Human Health
Risk Assessment for the Section 3 Registration on: Avocado, Mandarin
(Tangerine), Pistachio, Pomegranate, and Stone Fruit (Crop Group 12-12)
in docket ID number EPA-HQ-OPP-2019-0074.
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 fluridone will occupy 2.3% of the aPAD for all infants (<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
[[Page 29636]]
that chronic exposure to fluridone from food and water will utilize 7%
of the cPAD for children aged 1 to 2 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
fluridone 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). Fluridone is
currently registered for uses that could result in short-term
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 fluridone. 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 1,300 for adults and 1,600 for
children. Because EPA's level of concern for fluridone 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,
fluridone 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
fluridone.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluridone is not expected to pose a cancer risk to humans.
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 fluridone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography (HPLC) method (originally submitted as method AM-AA-CA-
RO52-AA-755)) is available to enforce the tolerance expression.
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 fluridone.
V. Conclusion
Therefore, tolerances are established for residues of fluridone, in
or on avocado, tangerine, pomegranate, pistachio, and the fruit, stone,
group 12-12 at 0.1 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) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under 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
[[Page 29637]]
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 13, 2020.
Michael Goodis,
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. Amend Sec. 180.420 by:
0
a. Adding alphabetically entries for ``Avocado''; ``Fruit, stone, group
12-12''; ``Pistachio''; ``Pomegranate''; and ``Tangerine'' in the table
in paragraph (a)(2); and
0
b. Removing the entries ``Avocado''; and ``Fruit, stone, group 12'' in
the table in paragraph (d).
The additions read as follows:
Sec. 180.420 Fluridone; tolerances for residues.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Avocado................................................. 0.1
* * * * *
Fruit, stone, group 12-12............................... 0.1
* * * * *
Pistachio............................................... 0.1
Pomegranate............................................. 0.1
* * * * *
Tangerine............................................... 0.1
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-08963 Filed 5-15-20; 8:45 am]
BILLING CODE 6560-50-P
