Prohexadione Calcium; Pesticide Tolerances, 8457-8461 [2020-02036]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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: January 24, 2020.
Michael Goodis,
Director, Registration Division, 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:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.672, revise the entry for
‘‘Strawberry’’ in the table in paragraph
(a) to read as follows:
■
§ 180.672 Cyantraniliprole; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Strawberry ..................................
*
1.5
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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).
This regulation establishes
tolerances with a regional registration
for residues of prohexadione calcium in
or on alfalfa forage, alfalfa hay, and field
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2020–02238 Filed 2–13–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0785; FRL–10003–04]
Prohexadione Calcium; Pesticide
Tolerances
khammond on DSKJM1Z7X2PROD with RULES
corn forage, grain, and stover.
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
February 14, 2020. Objections and
requests for hearings must be received
on or before April 14, 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–2018–0785, 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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
AGENCY:
SUMMARY:
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
PO 00000
Frm 00085
Fmt 4700
Sfmt 4700
8457
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.
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–2018–0785 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 April 14, 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
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2018–0785, 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 April 19,
2019 (84 FR 16430) (FRL–9991–14),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
E:\FR\FM\14FER1.SGM
14FER1
8458
Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES
346a(d)(3), announcing the filing of a
pesticide petition (PP 8E8716) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.547 be
amended by establishing tolerances
with regional registrations in Wisconsin
and Pennsylvania for residues of
prohexadione calcium (calcium 3-oxido5-oxo-4-propionylcyclohex-3enecarboxylate) in or on the raw
agricultural commodities corn, field,
forage at 0.10 parts per million (ppm);
corn, field, grain at 0.10 ppm; corn,
field, stover at 0.10 ppm; alfalfa, forage
at 0.10 ppm; and alfalfa, hay at 0.10
ppm. That document referenced a
summary of the petition prepared by
Fine Agrochemicals, Ltd., the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
EPA is establishing the requested
tolerances, although the tolerance
values have been adjusted to be
consistent with Organization for
Economic Cooperation and
Development (OECD) Rounding Class
Practice.
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 prohexadione
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
calcium including exposure resulting
from the tolerances established by this
action. EPA’s assessment of exposures
and risks associated with prohexadione
calcium 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.
By the oral route, the most sensitive
effect in the prohexadione calcium
hazard database is kidney toxicity in
dogs for both the subchronic and
chronic durations. Minor hematological
changes (decreased white blood cell
counts in males), and fore-stomach
hyperplasia were seen only at very high
doses in rodents. No dermal toxicity
was observed up to the limit dose of
1000 mg/kg/day.
In rats and rabbits, no increased
quantitative or qualitative pre- or
postnatal susceptibility was observed. In
rats, no maternal or developmental
toxicity was observed up to the limit
dose (1000 mg/kg/day). Three
developmental studies in rabbits are
available in the toxicological database
for prohexadione calcium. In one study,
late abortions occurred during
gestational days (GD) 24–29 at 200 mg/
kg/day, with increased mortality in
maternal animals (GD 15–24) also noted
at this dose. In another rabbit
developmental study, two premature
deliveries (on GD 24 and 26) were noted
at the highest-dose tested (350 mg/kg/
day) with no developmental effects
observed. No maternal or developmental
effects were seen in a third rabbit
developmental study up to 150 mg/kg/
day. In the 2-generation reproductive
toxicity study with rats, parental
toxicity (minimal mortality) occurred at
a dose well below the dose that caused
decreases in offspring body weight.
There is no evidence of neurotoxicity
in the toxicological database for
prohexadione calcium, which includes
acute and subchronic neurotoxicity
studies.
Prohexadione calcium is classified as
not likely to be carcinogenic to humans
based on lack of evidence of
carcinogenicity in rats and mice.
Specific information on the studies
received and the nature of the adverse
effects caused by prohexadione calcium
as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
PO 00000
Frm 00086
Fmt 4700
Sfmt 4700
from the toxicity studies can be found
at https://www.regulations.gov in the
document titled ‘‘Prohexadione
Calcium. Section 3 Registration for Use
on Strawberry and Watercress. Human
Health Risk Assessment’’ on pages 26–
28 in docket ID number EPA–HQ–OPP–
2018–0785.
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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide.
A summary of the toxicological
endpoints for prohexadione calcium
used for human risk assessment is
discussed in Unit III.B. of the final rule
published in the Federal Register of
July 8, 2015 (80 FR 38976) (FRL–9927–
25).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to prohexadione calcium, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing prohexadione calcium
tolerances in 40 CFR 180.547. EPA
assessed dietary exposures from
prohexadione calcium in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
E:\FR\FM\14FER1.SGM
14FER1
khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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 prohexadione
calcium; therefore, a quantitative acute
dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In estimating
chronic dietary exposure, EPA used
2003–2008 food consumption
information from the U.S. Department of
Agriculture’s (USDA’s) National Health
and Nutrition Examination Survey,
What We Eat in America, (NHANES/
WWEIA). As to residue levels in food,
the chronic assessment was based on
tolerance-level residues and 100 percent
crop treated (PCT).
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that prohexadione calcium
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 PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for
prohexadione calcium. 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 prohexadione calcium in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of prohexadione calcium.
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 Pesticide in Water
Calculator (PWC), the estimated
drinking water concentrations (EDWCs)
of prohexadione calcium for chronic
exposures are estimated to be 29 ppb for
surface water and 5.1 × 10¥7 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For the
chronic dietary risk assessment, the
water concentration of value 29 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,
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
indoor pest control, termiticides, and
flea and tick control on pets).
Prohexadione calcium is currently
registered for the following uses that
could result in residential exposures:
Residential lawns, ornamentals, athletic
fields, parks, and golf courses. EPA
assessed residential exposure using the
following assumptions: Residential
handler exposure is not expected
because all registered labels require the
use of personal protective equipment
(PPE) and are not intended for
application by homeowners. Short-term
exposure was assessed for postapplication incidental oral exposures of
children 1 to less than 2 years old. The
Agency assessed hand-to-mouth
exposures and incidental soil ingestion
from applications to turf for children.
Intermediate- and long-term exposures
are not expected since there are no
registered or proposed uses of
prohexadione calcium that result in
intermediate- or long-term residential
exposures.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found prohexadione
calcium to share a common mechanism
of toxicity with any other substances,
and prohexadione calcium does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
prohexadione calcium 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
PO 00000
Frm 00087
Fmt 4700
Sfmt 4700
8459
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.
In rats and rabbits, no increased
quantitative or qualitative pre- or
postnatal susceptibility was observed. In
the 2-generation reproductive toxicity
study with rats, parental toxicity
(minimal mortality) occurred at a dose
well below the dose that caused
decreases in offspring body weight.
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
prohexadione calcium is complete.
ii. There is no indication that
prohexadione calcium is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
prohexadione calcium results in
increased susceptibility in in utero rats
or rabbits in the prenatal developmental
studies or in young rats in the 2generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The 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 prohexadione
calcium in drinking water. EPA used
similarly conservative assumptions to
assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by prohexadione calcium.
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
E:\FR\FM\14FER1.SGM
14FER1
khammond on DSKJM1Z7X2PROD with RULES
8460
Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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, prohexadione
calcium 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 prohexadione
calcium from food and water will utilize
17% of the cPAD for children 1 to 2
years old, the population group
receiving the greatest exposure. Based
on the explanation in Unit III.C.3.,
regarding residential use patterns,
chronic residential exposure to residues
of prohexadione calcium 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).
Prohexadione calcium 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
prohexadione calcium.
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 an
aggregate MOE of 2,300 for children 1 to
less than 2 years old. Because EPA’s
level of concern for prohexadione
calcium is an MOE below 100, this MOE
is 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, prohexadione
calcium 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
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
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 intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for prohexadione calcium.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
prohexadione calcium 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
prohexadione calcium residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/mass-selective
detector (GC/MSD) and liquid
chromatography with tandem mass
spectroscopy (LC–MS/MS)) is available
to enforce the tolerance expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
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 MRLs
on alfalfa or corn for prohexadione
calcium.
PO 00000
Frm 00088
Fmt 4700
Sfmt 4700
V. Conclusion
Therefore, tolerances with regional
registration are established for residues
of prohexadione calcium in or on
alfalfa, forage at 0.1 ppm; alfalfa, hay at
0.1 ppm; corn, field, forage at 0.1 ppm;
corn, field, grain at 0.1 ppm; and corn,
field, stover at 0.1 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes and modifies
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 tolerances 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
E:\FR\FM\14FER1.SGM
14FER1
Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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: December 30, 2019.
Michael Goodis,
Director, Registration Division, 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:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.547, revise paragraph (c) to
read as follows:
■
§ 180.547 Prohexadione calcium;
tolerances for residues.
khammond on DSKJM1Z7X2PROD with RULES
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration are established for residues
of the plant growth regulator,
prohexadione calcium, including its
metabolites and degradates, in or on the
commodities in table 2 in this paragraph
(c). Compliance with the tolerance
VerDate Sep<11>2014
17:46 Feb 13, 2020
Jkt 250001
levels specified in table 2 in this
paragraph (c) is to be determined by
measuring only prohexadione calcium
(calcium 3-oxido-5-oxo-4propionylcyclohex-3-enecarboxylate) in
or on the following commodities.
TABLE 2 TO PARAGRAPH (c)
Parts per
million
Commodity
Alfalfa, forage .............................
Alfalfa, hay ..................................
Corn, field, forage .......................
Corn, field, grain .........................
Corn, field, stover .......................
*
*
*
*
0.1
0.1
0.1
0.1
0.1
*
[FR Doc. 2020–02036 Filed 2–13–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0297; FRL–10004–03]
Flutriafol; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flutriafol in or
on multiple commodities which are
identified and discussed later in this
document. Cheminova A/S on behalf of
FMC Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 14, 2020. Objections and
requests for hearings must be received
on or before April 14, 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–2018–0297, 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
SUMMARY:
PO 00000
Frm 00089
Fmt 4700
Sfmt 4700
8461
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:
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 eCFR 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–2018–0297 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 April 14, 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
E:\FR\FM\14FER1.SGM
14FER1
]]>Agencies
[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8457-8461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02036]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0785; FRL-10003-04]
Prohexadione Calcium; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances with a regional
registration for residues of prohexadione calcium in or on alfalfa
forage, alfalfa hay, and field corn forage, grain, and stover.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 14, 2020. Objections and
requests for hearings must be received on or before April 14, 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-2018-0785, 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-2018-0785 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
April 14, 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 notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0785, 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 April 19, 2019 (84 FR 16430) (FRL-9991-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C.
[[Page 8458]]
346a(d)(3), announcing the filing of a pesticide petition (PP 8E8716)
by IR-4, IR-4 Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.547 be amended by establishing
tolerances with regional registrations in Wisconsin and Pennsylvania
for residues of prohexadione calcium (calcium 3-oxido-5-oxo-4-
propionylcyclohex-3-enecarboxylate) in or on the raw agricultural
commodities corn, field, forage at 0.10 parts per million (ppm); corn,
field, grain at 0.10 ppm; corn, field, stover at 0.10 ppm; alfalfa,
forage at 0.10 ppm; and alfalfa, hay at 0.10 ppm. That document
referenced a summary of the petition prepared by Fine Agrochemicals,
Ltd., the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
EPA is establishing the requested tolerances, although the
tolerance values have been adjusted to be consistent with Organization
for Economic Cooperation and Development (OECD) Rounding Class
Practice.
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 prohexadione calcium including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with prohexadione
calcium 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.
By the oral route, the most sensitive effect in the prohexadione
calcium hazard database is kidney toxicity in dogs for both the
subchronic and chronic durations. Minor hematological changes
(decreased white blood cell counts in males), and fore-stomach
hyperplasia were seen only at very high doses in rodents. No dermal
toxicity was observed up to the limit dose of 1000 mg/kg/day.
In rats and rabbits, no increased quantitative or qualitative pre-
or postnatal susceptibility was observed. In rats, no maternal or
developmental toxicity was observed up to the limit dose (1000 mg/kg/
day). Three developmental studies in rabbits are available in the
toxicological database for prohexadione calcium. In one study, late
abortions occurred during gestational days (GD) 24-29 at 200 mg/kg/day,
with increased mortality in maternal animals (GD 15-24) also noted at
this dose. In another rabbit developmental study, two premature
deliveries (on GD 24 and 26) were noted at the highest-dose tested (350
mg/kg/day) with no developmental effects observed. No maternal or
developmental effects were seen in a third rabbit developmental study
up to 150 mg/kg/day. In the 2-generation reproductive toxicity study
with rats, parental toxicity (minimal mortality) occurred at a dose
well below the dose that caused decreases in offspring body weight.
There is no evidence of neurotoxicity in the toxicological database
for prohexadione calcium, which includes acute and subchronic
neurotoxicity studies.
Prohexadione calcium is classified as not likely to be carcinogenic
to humans based on lack of evidence of carcinogenicity in rats and
mice.
Specific information on the studies received and the nature of the
adverse effects caused by prohexadione calcium 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 the document titled ``Prohexadione Calcium.
Section 3 Registration for Use on Strawberry and Watercress. Human
Health Risk Assessment'' on pages 26-28 in docket ID number EPA-HQ-OPP-
2018-0785.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
A summary of the toxicological endpoints for prohexadione calcium
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of July 8, 2015 (80 FR 38976)
(FRL-9927-25).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prohexadione calcium, EPA considered exposure under the
petitioned-for tolerances as well as all existing prohexadione calcium
tolerances in 40 CFR 180.547. EPA assessed dietary exposures from
prohexadione calcium in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide,
[[Page 8459]]
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
prohexadione calcium; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In estimating chronic dietary exposure, EPA
used 2003-2008 food consumption information from the U.S. Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, the chronic assessment was based on tolerance-level residues and
100 percent crop treated (PCT).
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that prohexadione calcium 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 PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
prohexadione calcium. 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 prohexadione calcium in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of prohexadione calcium. 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 Pesticide in Water Calculator (PWC), the estimated
drinking water concentrations (EDWCs) of prohexadione calcium for
chronic exposures are estimated to be 29 ppb for surface water and 5.1
x 10-\7\ ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration of value 29 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).
Prohexadione calcium is currently registered for the following uses
that could result in residential exposures: Residential lawns,
ornamentals, athletic fields, parks, and golf courses. EPA assessed
residential exposure using the following assumptions: Residential
handler exposure is not expected because all registered labels require
the use of personal protective equipment (PPE) and are not intended for
application by homeowners. Short-term exposure was assessed for post-
application incidental oral exposures of children 1 to less than 2
years old. The Agency assessed hand-to-mouth exposures and incidental
soil ingestion from applications to turf for children. Intermediate-
and long-term exposures are not expected since there are no registered
or proposed uses of prohexadione calcium that result in intermediate-
or long-term residential exposures.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found prohexadione calcium to share a common mechanism
of toxicity with any other substances, and prohexadione calcium does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that prohexadione calcium 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://www2.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 additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. In rats and rabbits, no
increased quantitative or qualitative pre- or postnatal susceptibility
was observed. In the 2-generation reproductive toxicity study with
rats, parental toxicity (minimal mortality) occurred at a dose well
below the dose that caused decreases in offspring body weight.
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 prohexadione calcium is complete.
ii. There is no indication that prohexadione calcium is a
neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that prohexadione calcium 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 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 prohexadione calcium in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
prohexadione calcium.
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
[[Page 8460]]
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,
prohexadione calcium 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
prohexadione calcium from food and water will utilize 17% of the cPAD
for children 1 to 2 years old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
prohexadione calcium 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).
Prohexadione calcium 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 prohexadione
calcium.
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 an aggregate MOE of 2,300 for
children 1 to less than 2 years old. Because EPA's level of concern for
prohexadione calcium is an MOE below 100, this MOE is 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,
prohexadione calcium 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 prohexadione calcium.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, prohexadione calcium 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 prohexadione calcium residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass-selective
detector (GC/MSD) and liquid chromatography with tandem mass
spectroscopy (LC-MS/MS)) is available to enforce the tolerance
expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs on alfalfa or corn for
prohexadione calcium.
V. Conclusion
Therefore, tolerances with regional registration are established
for residues of prohexadione calcium in or on alfalfa, forage at 0.1
ppm; alfalfa, hay at 0.1 ppm; corn, field, forage at 0.1 ppm; corn,
field, grain at 0.1 ppm; and corn, field, stover at 0.1 ppm.
VI. Statutory and Executive Order Reviews
This action establishes and modifies 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 tolerances 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
[[Page 8461]]
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: December 30, 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. 180.547, revise paragraph (c) to read as follows:
Sec. 180.547 Prohexadione calcium; tolerances for residues.
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registration are established for residues of the plant growth
regulator, prohexadione calcium, including its metabolites and
degradates, in or on the commodities in table 2 in this paragraph (c).
Compliance with the tolerance levels specified in table 2 in this
paragraph (c) is to be determined by measuring only prohexadione
calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in
or on the following commodities.
Table 2 to Paragraph (c)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................. 0.1
Alfalfa, hay................................................ 0.1
Corn, field, forage......................................... 0.1
Corn, field, grain.......................................... 0.1
Corn, field, stover......................................... 0.1
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-02036 Filed 2-13-20; 8:45 am]
BILLING CODE 6560-50-P
