Pyriofenone; Pesticide Tolerances, 24983-24987 [2019-11261]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Rules and Regulations
24983
EPA-APPROVED NEW JERSEY SOURCE-SPECIFIC PROVISIONS—Continued
Identifier No.
CMC Steel New Jersey ..........
Program Interest 18052; Activity Number BOP 180001;
Emission Unit U2; Operating Scenario OS301; Ref
#2.
December 5,
2018.
EPA approval date
May 30, 2019, [Insert FR citation].
BILLING CODE 6560–50–P
C. How can I file an objection or hearing
request?
II. Summary of Petitioned-For
Tolerance
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–2018–0677 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 29, 2019. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In the Federal Register of December
21, 2018 (83 FR 65660) (FRL–9985–67),
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 7F8647) by ISK
Biosciences Corporation, 7470 Auburn
Road, Suite A, Concord, Ohio 44077.
The petition requested that 40 CFR
180.660 be amended by establishing
tolerances for residues of the fungicide
pyriofenone, in or on fruiting vegetable,
crop group 8–10 at 0.30 parts per
million (ppm). That document
referenced a summary of the petition
prepared by ISK Biosciences
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
I. General Information
40 CFR Part 180
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).
A. Does this action apply to me?
Pyriofenone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of pyriofenone in
or on fruiting vegetable, crop group 8–
10. ISK Biosciences Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
30, 2019. Objections and requests for
hearings must be received on or before
July 29, 2019 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–2018–0677, 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:
SUMMARY:
VerDate Sep<11>2014
16:48 May 29, 2019
Jkt 247001
New ownership from Gerdau
Ameristeel Sayreville to
Commercial Metal Company (CMC).
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2018–0677; FRL–9993–11]
Comments
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–
2018–0677, 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.
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–11181 Filed 5–29–19; 8:45 am]
jbell on DSK3GLQ082PROD with RULES
State effective
date
Name of source
B. How can I get electronic access to
other related information?
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
E:\FR\FM\30MYR1.SGM
30MYR1
24984
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Rules and Regulations
comments received in response to the
notice of filing. Based upon review of
the data supporting the petition and
under its authority in FFDCA section
408(d)(4)(A)(i), EPA is establishing a
tolerance that varies slightly from what
the petitioner sought. The reason for
this change is explained in Unit IV.C.
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 pyriofenone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with pyriofenone follows.
A. Toxicological Profile
jbell on DSK3GLQ082PROD with RULES
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
VerDate Sep<11>2014
16:48 May 29, 2019
Jkt 247001
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The liver (dog, rat, and mouse),
kidney (rat and mouse), and cecum (rat)
were the primary organs affected in
toxicity studies associated with the
species identified above. Indications of
liver toxicity included increased weight,
dark color, histological abnormalities,
and serum hepatic enzyme changes.
Indications of kidney toxicity included
increased weight, coarse surface,
histological abnormalities, increased
urinary ketones, and perigenital
staining. Cecum effects included
increased weight; and enlarged,
distended, and inflamed conditions.
There are no inhalation risks of concern,
due to high margins of exposure via the
inhalation route as well as very low
toxicity observed in the acute inhalation
toxicity study (Toxicity Category IV).
Based on a weight of evidence
approach, it was determined that a
subchronic inhalation study was not
required. No dermal toxicity was noted
at the limit dose. No developmental
toxicity was noted at the limit dose in
rats; abortions were noted in rabbits at
300 mg/kg/day. The rabbit abortions
were associated with decreased
maternal body weight gain and food
consumption. There was no
reproductive toxicity observed at the
highest dose tested in rats (334 mg/kg/
day), no neurotoxicity observed in the
database, and no quantitative or
qualitative sensitivity was noted in
offspring. Based on a battery of
mutagenicity studies, there was no
evidence of genotoxicity nor an
increased incidence of tumors. There
was no evidence that pyriofenone
directly targets the immune system
based on the results of the
immunotoxicity study and the other
studies in the toxicity database. Based
on a lack of evidence of carcinogenicity
in available studies conducted with
mice and rats, pyriofenone is classified
as ‘‘Not Likely to Be Carcinogenic to
Humans.’’
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Specific information on the studies
received and the nature of the adverse
effects caused by pyriofenone as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
Pyriofenone. Human Health Risk
Assessment for the Section 3
Registration on Fruiting Vegetables
(Crop Group 8–10) on pages 29–37 in
docket ID number EPA–HQ–OPP–2018–
0677.
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 pyriofenone used for
human risk assessment is shown in
Table 1 of this unit.
E:\FR\FM\30MYR1.SGM
30MYR1
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Rules and Regulations
24985
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRIOFENONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
Acute dietary (All populations) ..
Chronic dietary (All populations)
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
A dose and endpoint of concern attributable to a single dose was not observed.
NOAEL= 9.1 mg/kg/
day.
UFA = 10x.
UFH = 10x.
FQPA SF = 1x.
Cancer (Oral, dermal, inhalation).
Chronic RfD = cPAD Carcinogenicity in rat.
= 0.091 mg/kg/day. LOAEL = 46.5 mg/kg/day based on chronic nephropathy in females.
Classification: ‘‘Not likely to be Carcinogenic to Humans’’.
jbell on DSK3GLQ082PROD with RULES
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyriofenone, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing pyriofenone tolerances in 40
CFR 180.660. EPA assessed dietary
exposures from pyriofenone 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. No such effects were
identified in the toxicological studies
for pyriofenone; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In estimating
chronic dietary exposure, EPA used
food consumption information from the
United States Department of
Agriculture’s National Health and
Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA) as
incorporated in the Dietary Exposure
and Evaluation Model with Food
Commodity Intake Database (DEEM–
FCID) Version 3.16. As to residue levels
in food, EPA assumed 100 percent crop
treated (PCT) and tolerance-level
residues. Potential residues in drinking
water were included in the DEEM–FCID
categories ‘‘water, all sources’’ and
‘‘water, indirect all sources’’. All
populations were evaluated for chronic
dietary exposure and risk from food and
drinking water.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that pyriofenone is not likely
to be carcinogenic; therefore, a dietary
exposure assessment for the purpose of
assessing cancer risk is unnecessary.
VerDate Sep<11>2014
16:48 May 29, 2019
Jkt 247001
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for pyriofenone. Tolerance level
residues and 100 PCT 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 pyriofenone in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of pyriofenone.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Tier I Cranberry Model
and Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated
drinking water concentrations (EDWCs)
of pyriofenone for chronic exposures for
non-cancer assessments are estimated to
be 2.7 ppb for surface water and 3.9 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration value of 3.9 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Pyriofenone is not registered for any
specific use patterns that would result
in residential exposure. Therefore, a
residential exposure assessment is not
required.
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
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 pyriofenone to share a common
mechanism of toxicity with any other
substances, and pyriofenone does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
pyriofenone 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/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
E:\FR\FM\30MYR1.SGM
30MYR1
24986
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
Exposure to pyriofenone did not result
in any developmental effects at the limit
dose in rats, but abortions were noted in
rabbits at 300 mg/kg/day. EPA is
regulating pyriofenone at doses that are
protective of this effect. The abortions
were associated with decreased
maternal body weight gain and food
consumption. There were no
reproductive effects observed in rats at
the highest tested dose (334 mg/kg/day),
nor was any quantitative or qualitative
sensitivity noted in 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. That decision is
based on the following findings:
i. The toxicity database for
pyriofenone is complete.
ii. There is no indication that
pyriofenone is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors (UFs) to
account for neurotoxicity.
iii. There is no evidence that
pyriofenone results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessment was performed based on 100
PCT and tolerance-level residues. EPA
made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to pyriofenone in drinking water. These
assessments will not underestimate the
exposure and risks posed by
pyriofenone.
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. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
VerDate Sep<11>2014
16:48 May 29, 2019
Jkt 247001
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, pyriofenone is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to pyriofenone
from food and water will utilize 6.9% of
the cPAD for children 1–2 years old the
population group receiving the greatest
exposure. There are no residential uses
for pyriofenone, therefore, the chronic
aggregate risk is limited to the chronic
dietary risk and is not of concern.
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). There are no residential
uses for pyriofenone; therefore, shortterm aggregate risks are addressed by
the chronic aggregate risk estimates and
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).
There are no residential uses for
pyriofenone; therefore, intermediateterm aggregate risks are addressed by
the chronic aggregate risk estimates and
are not of concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
pyriofenone 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 pyriofenone
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography method with
tandem mass spectrometric detection
[LC–MS/MS]) is available to enforce the
tolerance expression. The method was
independently validated to a limit of
quantitation (LOQ) of 0.01 ppm in
grapes, wheat grain, and wheat straw.
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
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
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 pyriofenone.
C. Revisions to Petitioned-For
Tolerances
Under FFDCA section 408(d)(4)(A)(i),
EPA may establish tolerances that vary
from those sought by the petition. EPA
has modified the commodity definition
to be consistent with Agency
nomenclature. Additionally, the
tolerance level has been modified to be
consistent with the Agency’s rounding
class practice.
V. Conclusion
Therefore, tolerances are established
for residues of pyriofenone, including
its metabolites and degradates in or on
fruiting vegetable, crop group 8–10 at
0.3 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 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
E:\FR\FM\30MYR1.SGM
30MYR1
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES
(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,
VerDate Sep<11>2014
16:48 May 29, 2019
Jkt 247001
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
24987
This final rule is available
on the internet at https://
www.regulations.gov and https://
www.fws.gov/daphne. Comments and
Dated: May 22, 2019.
materials we received, as well as some
Michael Goodis,
supporting documentation we used in
Director, Registration Division, Office of
preparing this rule, are available for
Pesticide Programs.
public inspection at https://
Therefore, 40 CFR chapter I is
www.regulations.gov. All of the
amended as follows:
comments, materials, and
documentation that we considered in
PART 180—[AMENDED]
this rulemaking are available by
appointment, during normal business
■ 1. The authority citation for part 180
hours at: U.S. Fish and Wildlife Service,
continues to read as follows:
Alabama Ecological Services Field
Authority: 21 U.S.C. 321(q), 346a and 371.
Office, 1208 Main Street, Daphne, AL
36526; telephone 251–441–5184.
■ 2. In § 180.660, add alphabetically
The coordinates or plot points or both
‘‘Vegetable, fruiting, group 8–10’’ to the
table in paragraph (a) to read as follows: from which the maps are generated are
included in the administrative record
for this critical habitat designation and
§ 180.660 Pyriofenone; tolerances for
residues.
are available at https://
www.regulations.gov at Docket No.
(a) * * *
FWS–R4–ES–2013–0010, and at the
Alabama Ecological Services Field
Parts per
Commodity
million
Office (https://www.fws.gov/daphne)
(see FOR FURTHER INFORMATION CONTACT).
Any
additional tools or supporting
*
*
*
*
*
Vegetable, fruiting, group 8–10 ..
0.3 information that we developed for this
critical habitat designation will also be
available at the Fish and Wildlife
*
*
*
*
*
Service website and Field Office
identified above, and may also be
*
*
*
*
*
included in the preamble and at https://
[FR Doc. 2019–11261 Filed 5–29–19; 8:45 am]
www.regulations.gov.
BILLING CODE 6560–50–P
FOR FURTHER INFORMATION CONTACT:
William Pearson, Field Supervisor, U.S.
Fish and Wildlife Service, telephone
DEPARTMENT OF THE INTERIOR
251–441–5184. If you use a
telecommunications device for the deaf
Fish and Wildlife Service
(TDD), call the Federal Relay Service at
800–877–8339.
50 CFR Part 17
SUPPLEMENTARY INFORMATION:
[Docket No. FWS–R4–ES–2013–0010;
4500090023]
RIN 1018–BD54
Endangered and Threatened Wildlife
and Plants; Designation of Critical
Habitat for Spring Pygmy Sunfish
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), designate
critical habitat for the spring pygmy
sunfish (Elassoma alabamae) under the
Endangered Species Act of 1973 (Act),
as amended. In total, approximately
10.9 kilometers (6.7 miles) of streams
and 1,330 acres (538 hectares) in
Limestone and Madison Counties,
Alabama, fall within the boundaries of
the critical habitat designation.
DATES: This rule is effective July 1,
2019.
SUMMARY:
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
ADDRESSES:
Executive Summary
Why we need to publish a rule. Under
the Endangered Species Act of 1973
(Act), as amended, if we determine that
a species is an endangered or threatened
species, we must designate critical
habitat to the maximum extent prudent
and determinable. We listed the spring
pygmy sunfish as a threatened species
on October 2, 2013 (78 FR 60766).
Designations of critical habitat can only
be completed by issuing a rule.
Basis for this rule. Section 4(b)(2) of
the Act states that the Secretary shall
designate critical habitat on the basis of
the best available scientific data after
taking into consideration the economic
impact, national security impact, and
any other relevant impact of specifying
any particular area as critical habitat.
This rule designates critical habitat
for the spring pygmy sunfish. The
critical habitat areas we are designating
in this rule constitute our current best
E:\FR\FM\30MYR1.SGM
30MYR1
]]>Agencies
[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Rules and Regulations]
[Pages 24983-24987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11261]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0677; FRL-9993-11]
Pyriofenone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
pyriofenone in or on fruiting vegetable, crop group 8-10. ISK
Biosciences Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 30, 2019. Objections and
requests for hearings must be received on or before July 29, 2019 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-2018-0677, 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-2018-0677 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 29, 2019. 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-2018-0677, 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 December 21, 2018 (83 FR 65660) (FRL-
9985-67), 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
7F8647) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR 180.660 be
amended by establishing tolerances for residues of the fungicide
pyriofenone, in or on fruiting vegetable, crop group 8-10 at 0.30 parts
per million (ppm). That document referenced a summary of the petition
prepared by ISK Biosciences Corporation, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
[[Page 24984]]
comments received in response to the notice of filing. Based upon
review of the data supporting the petition and under its authority in
FFDCA section 408(d)(4)(A)(i), EPA is establishing a tolerance that
varies slightly from what the petitioner sought. The reason for this
change is explained in Unit IV.C.
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 pyriofenone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with pyriofenone 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 (dog, rat, and mouse), kidney (rat and mouse), and cecum
(rat) were the primary organs affected in toxicity studies associated
with the species identified above. Indications of liver toxicity
included increased weight, dark color, histological abnormalities, and
serum hepatic enzyme changes. Indications of kidney toxicity included
increased weight, coarse surface, histological abnormalities, increased
urinary ketones, and perigenital staining. Cecum effects included
increased weight; and enlarged, distended, and inflamed conditions.
There are no inhalation risks of concern, due to high margins of
exposure via the inhalation route as well as very low toxicity observed
in the acute inhalation toxicity study (Toxicity Category IV). Based on
a weight of evidence approach, it was determined that a subchronic
inhalation study was not required. No dermal toxicity was noted at the
limit dose. No developmental toxicity was noted at the limit dose in
rats; abortions were noted in rabbits at 300 mg/kg/day. The rabbit
abortions were associated with decreased maternal body weight gain and
food consumption. There was no reproductive toxicity observed at the
highest dose tested in rats (334 mg/kg/day), no neurotoxicity observed
in the database, and no quantitative or qualitative sensitivity was
noted in offspring. Based on a battery of mutagenicity studies, there
was no evidence of genotoxicity nor an increased incidence of tumors.
There was no evidence that pyriofenone directly targets the immune
system based on the results of the immunotoxicity study and the other
studies in the toxicity database. Based on a lack of evidence of
carcinogenicity in available studies conducted with mice and rats,
pyriofenone is classified as ``Not Likely to Be Carcinogenic to
Humans.''
Specific information on the studies received and the nature of the
adverse effects caused by pyriofenone 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 Pyriofenone. Human Health Risk
Assessment for the Section 3 Registration on Fruiting Vegetables (Crop
Group 8-10) on pages 29-37 in docket ID number EPA-HQ-OPP-2018-0677.
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 pyriofenone used for
human risk assessment is shown in Table 1 of this unit.
[[Page 24985]]
Table--Summary of Toxicological Doses and Endpoints for Pyriofenone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations).. A dose and endpoint of concern attributable to a single dose was not
observed.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 9.1 mg/kg/day Chronic RfD = cPAD Carcinogenicity in rat.
UFA = 10x........... = 0.091 mg/kg/day. LOAEL = 46.5 mg/kg/day based on
UFH = 10x........... chronic nephropathy in females.
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans''.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyriofenone, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyriofenone tolerances in 40 CFR
180.660. EPA assessed dietary exposures from pyriofenone 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. No such effects were
identified in the toxicological studies for pyriofenone; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In estimating chronic dietary exposure, EPA
used food consumption information from the United States Department of
Agriculture's National Health and Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA) as incorporated in the Dietary Exposure
and Evaluation Model with Food Commodity Intake Database (DEEM-FCID)
Version 3.16. As to residue levels in food, EPA assumed 100 percent
crop treated (PCT) and tolerance-level residues. Potential residues in
drinking water were included in the DEEM-FCID categories ``water, all
sources'' and ``water, indirect all sources''. All populations were
evaluated for chronic dietary exposure and risk from food and drinking
water.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyriofenone is not likely to be carcinogenic; 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 pyriofenone. Tolerance level residues and 100
PCT 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 pyriofenone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyriofenone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier I Cranberry Model and Pesticide Root Zone Model
Ground Water (PRZM GW), the estimated drinking water concentrations
(EDWCs) of pyriofenone for chronic exposures for non-cancer assessments
are estimated to be 2.7 ppb for surface water and 3.9 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 3.9 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). Pyriofenone is not
registered for any specific use patterns that would result in
residential exposure. Therefore, a residential exposure assessment is
not required.
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
pyriofenone to share a common mechanism of toxicity with any other
substances, and pyriofenone does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that pyriofenone 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-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
[[Page 24986]]
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. Exposure to pyriofenone did
not result in any developmental effects at the limit dose in rats, but
abortions were noted in rabbits at 300 mg/kg/day. EPA is regulating
pyriofenone at doses that are protective of this effect. The abortions
were associated with decreased maternal body weight gain and food
consumption. There were no reproductive effects observed in rats at the
highest tested dose (334 mg/kg/day), nor was any quantitative or
qualitative sensitivity noted in 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. That decision is based on the following
findings:
i. The toxicity database for pyriofenone is complete.
ii. There is no indication that pyriofenone is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that pyriofenone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyriofenone in drinking water. These assessments
will not underestimate the exposure and risks posed by pyriofenone.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
pyriofenone is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyriofenone from food and water will utilize 6.9% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. There are no residential uses for pyriofenone, therefore, the
chronic aggregate risk is limited to the chronic dietary risk and is
not of concern.
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). There are no
residential uses for pyriofenone; therefore, short-term aggregate risks
are addressed by the chronic aggregate risk estimates and 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). There are no residential uses for pyriofenone; therefore,
intermediate-term aggregate risks are addressed by the chronic
aggregate risk estimates and are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyriofenone 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 pyriofenone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography method with
tandem mass spectrometric detection [LC-MS/MS]) is available to enforce
the tolerance expression. The method was independently validated to a
limit of quantitation (LOQ) of 0.01 ppm in grapes, wheat grain, and
wheat straw.
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 pyriofenone.
C. Revisions to Petitioned-For Tolerances
Under FFDCA section 408(d)(4)(A)(i), EPA may establish tolerances
that vary from those sought by the petition. EPA has modified the
commodity definition to be consistent with Agency nomenclature.
Additionally, the tolerance level has been modified to be consistent
with the Agency's rounding class practice.
V. Conclusion
Therefore, tolerances are established for residues of pyriofenone,
including its metabolites and degradates in or on fruiting vegetable,
crop group 8-10 at 0.3 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 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
[[Page 24987]]
(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: May 22, 2019.
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. In Sec. 180.660, add alphabetically ``Vegetable, fruiting, group 8-
10'' to the table in paragraph (a) to read as follows:
Sec. 180.660 Pyriofenone; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Vegetable, fruiting, group 8-10............................. 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-11261 Filed 5-29-19; 8:45 am]
BILLING CODE 6560-50-P
