Propyzamide; Pesticide Tolerance for Emergency Exemptions, 60937-60943 [2019-24295]
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Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Rules and Regulations
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
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
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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: October 25, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
The additions read as follows:
§ 180.474 Tebuconazole; tolerances for
residues.
(a) * * *
(1) * * *
*
*
*
*
Brassica, leafy greens, subgroup 4–
16B, except watercress .....................
*
*
*
*
*
Cottonseed, subgroup 20C ...................
Fruit, pome, group 11–10 ......................
Fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F ................
*
*
*
*
*
Nut, tree, group 14–12 ..........................
*
*
*
*
*
Peach subgroup 12–12B .......................
*
*
*
*
*
Plum subgroup 12–12C ........................
*
*
*
*
*
Sunflower, subgroup 20B ......................
Tropical and subtropical, small fruit, inedible peel, subgroup 24A .................
*
*
*
*
*
Watercress ............................................
*
1. The authority citation for part 180
continues to read as follows:
2. In § 180.474, amend the table in
paragraph (a)(1) as follows:
■ a. Remove the entry for ‘‘Brassica,
leafy greens, subgroup 5B’’;
■ b. Add alphabetically the entry for
‘‘Brassica, leafy greens, subgroup 4–16B,
except watercress’’;
■ c. Remove the entry for ‘‘Cotton,
undelinted seed’’;
■ d. Add alphabetically the entry for
‘‘Cottonseed, subgroup 20C’’;
■ e. Remove the entry for ‘‘Fruit, pome,
group 11’’;
■ f. Add alphabetically the entries for
‘‘Fruit, pome, group 11–10’’ and ‘‘Fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F’’;
■ g. Remove the entries for ‘‘Fruit, stone,
group 12, except cherry’’; ‘‘Grape’’;
‘‘Lychee’’; and ‘‘Nut, tree, group 14’’;
■ h. Add alphabetically the entry for
‘‘Nut, tree, group 14–12’’;
■ i. Remove the entry for ‘‘Peach’’;
■ j. Add alphabetically the entry for
‘‘Peach subgroup 12–12B’’;
■ k. Remove the entries for ‘‘Pistachio’’
and ‘‘Plum, pre- and post-harvest’’;
■ l. Add alphabetically the entry for
‘‘Plum subgroup 12–12C’’;
■ m. Remove the entry for ‘‘Sunflower,
seed’’; and
■ n. Add alphabetically the entries for
‘‘Sunflower, subgroup 20B’’; ‘‘Tropical
and subtropical, small fruit, inedible
peel, subgroup 24A’’; and ‘‘Watercress’’.
■
PO 00000
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Parts per
million
Commodity
■
Authority: 21 U.S.C. 321(q), 346a and 371.
60937
*
*
*
*
*
*
*
*
2.5
2
1
6
0.05
2
1
0.1
1.6
9
*
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[FR Doc. 2019–24267 Filed 11–8–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0283; FRL–10000–50]
Propyzamide; Pesticide Tolerance for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
time-limited tolerance for residues of
propyzamide in or on cranberry. This
action is in response to EPA’s granting
of an emergency exemption under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on cranberry. This
regulation establishes a maximum
permissible level for residues of
propyzamide in or on this commodity.
The time-limited tolerance expires on
December 31, 2022.
DATES: This regulation is effective
November 12, 2019. Objections and
requests for hearings must be received
on or before January 13, 2020 and must
be filed in accordance with the
SUMMARY:
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Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Rules and Regulations
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0283, 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, Director, 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 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 section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
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21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0283 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
January 13, 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–
2019–0283, 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. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6) of, 21 U.S.C. 346a(e) and
346a(1)(6), is establishing a time-limited
tolerance for residues of the herbicide
propyzamide, including its metabolites
and degradates in or on cranberry.
Compliance with the tolerance level in
or on cranberry at 1 part per million
(ppm) is to be determined by measuring
only those propyzamide residues
convertible to methyl 3,5dichlorobenzoate, expressed as the
stoichiometric equivalent of
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Frm 00056
Fmt 4700
Sfmt 4700
propyzamide, 3,5-dichloro-N-(1,1dimethyl-2-propynyl)benzamide. This
time-limited tolerance expires on
December 31, 2022.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
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. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Propyzamide on Cranberry and FFDCA
Tolerances
The Massachusetts Department of
Food and Agriculture (MDAR) notified
EPA that an emergency condition exists
for cranberry growers due to the
presence of dodder in newly planted
and renovated cranberry fields in five
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Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Rules and Regulations
counties throughout the state.
According to MDAR, dodder is a serious
and devasting pest in commercial
cranberry production. The state reported
that an urgent and nonroutine situation
exists because cranberry fields are
heavily infested with dodder and that
the available registered alternatives do
not provide effective control. Significant
economic losses were expected due to
yield and quality decreases without a
suitable pesticide tool to control dodder.
After having reviewed the
submission, EPA determined that an
emergency condition exists for this
State, and that the criteria for approval
of an emergency exemption are met.
EPA has authorized a specific
exemption under FIFRA section 18 for
the use of propyzamide on cranberry for
control of dodder in Massachusetts.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of propyzamide in or on
cranberry. In doing so, EPA considered
the safety standard in FFDCA section
408(b)(2), and EPA decided that the
necessary tolerance under FFDCA
section 408(l)(6) would be consistent
with the safety standard and with
FIFRA section 18. Consistent with the
need to move quickly on the emergency
exemption to address an urgent nonroutine situation and to ensure that the
resulting food is safe and lawful, EPA is
issuing this tolerance without notice
and opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although this time-limited tolerance
expires on December 31, 2022, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerance remaining in
or on cranberry after that date will not
be unlawful, provided the pesticide was
applied in a manner that was lawful
under FIFRA, and the residues do not
exceed a level that was authorized by
this time-limited tolerance at the time of
that application. EPA will take action to
revoke this time-limited tolerance
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether propyzamide
meets FIFRA’s registration requirements
for use on cranberry or whether a
permanent tolerance for this use would
be appropriate. Under these
circumstances, EPA does not believe
that this time-limited tolerance decision
serves as a basis for registration of
propyzamide by a State for special local
needs under FIFRA section 24(c). Nor
does this tolerance by itself serve as the
authority for persons in any State other
than Massachusetts to use this pesticide
on the applicable crop under FIFRA
section 18 absent the issuance of an
emergency exemption applicable within
that State. For additional information
regarding the emergency exemption for
propyzamide, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
Consistent with 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 expected as a result
of this emergency exemption request
60939
and the time-limited tolerance for
propyzamide on cranberry at 1 ppm.
EPA’s assessment of exposures and risks
associated with establishing this timelimited tolerance follows.
A. 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 propyzamide
used for human risk assessment is
shown in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPYZAMIDE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of
departure and
uncertainty/safety
factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (Females 13 to
49 years of age).
An endpoint attributable to a single exposure was not available in the database including the developmental
toxicity studies in rats and rabbits.
Acute dietary (All Populations)
LOAEL = 40 mg/kg/
day.
UFA = 10x UFH =
10x FQPA SF
(UFL) = 10x
(LOAEL to NOAEL
extrapolation).
LOAEL= 40 mg/kg/
day.
Chronic dietary (All populations)
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Acute RfD = 0.04
mg/kg/day.
aPAD = 0.04 mg/kg/
day
Acute Neurotoxicity Rat Study.
Chronic RfD = 0.013
mg/kg/day.
The POD of 40 mg/kg/day based on a weight of evidence approach from the 4 rat studies listed below.
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NOAEL was not established; LOAEL = 40 mg/kg/day (the lowest dose tested) based on increased landing foot splay in females and decreased motor activity in both sexes on Day 1.
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Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Rules and Regulations
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPYZAMIDE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of
departure and
uncertainty/safety
factors
RfD, PAD, LOC for
risk assessment
UFA = 10x
cPAD = 0.013 mg/
kg/day
Study and toxicological effects
Subchronic neurotoxicity (SCN) (Fischer rat): NOAEL of 2.38
mg/kg/day based on the significant decreases in body
weight, body weight gain, and food consumption seen at
11.28 mg/kg/day (LOAEL) in males.
UFH = 10x
FQPA SF (UFL/
UFDB) = 30x (for
lack of CTA study
and LOAEL to
NOAEL extrapolation).
Incidental oral short-term (1 to
30 days).
Acute neurotoxicity (ACN) (Fischer rat): NOAEL was not established. The LOAEL is 40 mg/kg/day based on the increase in
landing foot splay in female rats and the decrease in motor
activity seen in both genders on Day 1. (A 10X LOAEL to
NOAEL uncertainty factor (UFL) yields a derived POD of 4
mg/kg/day (40÷10)).
Combined chronic toxicity/carcinogenicity (CD rats): NOAEL of
8.46/10.69 mg/kg/day based on increased relative liver
weight and histopathological lesions in the liver, thyroid, and
ovaries at 42.59/55.09 mg/kg/day (LOAEL).
Male pubertal study (CD rats): NOAEL of 2.5 mg/kg/day based
on decreased serum T4 at 10 mg/kg/day (LOAEL).
Same as Chronic RfD.
LOAEL= 40 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF
(UFL /UFDB) = 30x
(for lack of CTA
study and LOAEL
to NOAEL extrapolation).
NOAEL = 100 mg/
kg/day.
Residential LOC for
MOE = 3000.
Residential LOC for
MOE = 1000.
UFA = 10x
UFH = 10x
FQPA SF (UFDB)
=10x (for lack of
CTA study).
28-day dermal toxicity study in rat: LOAEL = 500 mg/kg/day
based on decreases in body weight and food consumption in
males.
Inhalation short-term (1 to 30
days) and Intermediate-term
(1 to 6 months).
LOAEL= 40 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF (UFL/
UFDB)
= 30x (for lack of
CTA study and
LOAEL to NOAEL
extrapolation).
Residential LOC for
MOE = 3,000.
Same as Chronic RfD.
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ at doses that do not result in induction of hepatic
cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes.
Dermal short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
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. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to propyzamide, EPA
considered exposure under the time-
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limited tolerance established by this
action as well as all existing
propyzamide tolerances in 40 CFR
180.317. EPA assessed dietary
exposures from propyzamide in food as
follows:
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i. Acute exposure. Such effects were
identified for propyzamide. In
estimating acute dietary exposure, EPA
used food consumption information
from the Dietary Exposure Evaluation
and Model-Food Commodity Intake
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Database (DEEM–FCID). As to residue
levels in food, EPA assumed that
propyzamide residues were present at
tolerance levels in all commodities for
which tolerances have been established
or proposed and that 100% of the crops
were treated with propyzamide.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the Dietary Exposure Evaluation
and Model-Food Commodity Intake
Database (DEEM–FCID). As to residue
levels in food, EPA assumed that
propyzamide residues were present at
tolerance levels in all commodities for
which tolerances have been established
or proposed and that 100% of the crops
were treated with propyzamide.
iii. Cancer. Based on the data
summarized in Unit IV.A., EPA has
concluded that propyzamide does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for propyzamide. Tolerance level
residues and 100% CT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used Tier II
screening level water exposure models
in the dietary exposure analysis and risk
assessment for propyzamide in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of propyzamide. Further
information regarding EPA drinking
water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Tier II Surface Water
Concentration Calculator (SWCC) and
Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated
drinking water concentrations (EDWCs)
of propyzamide for acute exposures are
estimated to be 102 parts per billion
(ppb) for surface water and 21 ppb for
ground water; for chronic exposures for
non-cancer assessments are estimated to
be 47 ppb for surface water and 18.6
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 102 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
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value of 47 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).
Propyzamide is currently registered for
use on golf courses that could result in
post-application residential exposures
to adults and children. EPA assessed
residential post-application dermal
exposures from golfing for adults,
children 6 to <11 and children 11 to
<16 and determined that there are no
post-application risk estimates of
concern since the dermal margin of
exposures (MOEs) are >1,000. For the
golf course post-application scenarios
for adults and children identified above,
MOEs ranged from 1,900 to 2,500.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at: https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/standard-operatingprocedures-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 propyzamide to
share a common mechanism of toxicity
with any other substances, and
propyzamide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that propyzamide 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.
C. 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
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Fmt 4700
Sfmt 4700
60941
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 SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of quantitative
or qualitative increased susceptibility in
developing fetuses or in offspring of rats
or rabbits following prenatal and/or
postnatal exposure to propyzamide.
However, a comparative thyroid assay
study is required to determine whether
pregnant women or developing young
are more or less susceptible, compared
to adults, to thyroid toxicity.
3. Conclusion. EPA has determined
that reliable data show that the safety of
infants and children would be
adequately protected if the FQPA SF
were increased to 10X for both
interspecies and intraspecies variation,
and 30X for the lack of a NOAEL and
lack of a comparative thyroid study.
That decision is based on the following
findings:
i. The toxicity database for
propyzamide is incomplete. The
required comparative thyroid assay and
subchronic inhalation studies have not
been received for propyzamide;
therefore, uncertainty factors identified
above have been applied to account for
these deficiencies. In addition, the acute
dietary endpoint for the general
population (including infants and
children) was chosen from an acute
neurotoxicity study with a lowest
observed adverse effect level of 40 mg/
kg/day based on the increase in landing
foot splay in female rats and the
decrease in motor activity observed on
Day 1. As such, the lack of an
established NOAEL as well as
uncertainties attributed to intraspecies
variability and interspecies
extrapolations contributed to an
incomplete toxicity database for
propyzamide.
ii. There is no indication that
propyzamide is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study;
however, there is need for additional
UFs to account for the lack of a
comparative thyroid study and the use
of a LOAEL to extrapolate a NOAEL.
iii. There is no evidence that
propyzamide 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.
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iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to propyzamide
in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by propyzamide.
D. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
propyzamide will occupy 46% of the
aPAD for all infants <1 year old, the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic dietary exposure to
propyzamide from food and water will
utilize 33% of the cPAD for children 1
to 2 years old, the population group
receiving the greatest exposure.
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). Propyzamide is
currently registered for a use that could
result in short-term residential
exposure. The Agency has identified
and assessed short-term residential
dermal post-application exposures for
the registered golf course use for
propyzamide. There are no postapplication risk estimates of concern
(i.e., dermal MOEs ≥1,000) for the golf
course use. The short-term residential
exposures from the golfing use pattern
were not aggregated with dietary
exposures since the risk assessment
endpoints for dermal and oral toxicity
were different. The acute and chronic
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aggregate risk estimates are equivalent
to the dietary risk estimates and are not
of concern.
4. Intermediate-term risk.
Intermediate-term residential exposures
are not anticipated from the registered
propyzamide uses, therefore, an
intermediate-term aggregate assessment
was not conducted.
5. Aggregate cancer risk for U.S.
population. In accordance with the
Agency’s 2005 Guidelines for
Carcinogenic Risk Assessment,
propyzamide is classified as ‘‘Not likely
to be Carcinogenic to Humans’’ at doses
that do not result in induction of
hepatic cell proliferation or metabolic
enzymes leading to disruption of
thyroid or gonadal endocrine axes.
Quantification of carcinogenic risk is
not required.
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 propyzamide
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
are available to enforce the tolerance
expression of residues in/or plant
commodities (PAM II Method I, using
gas-liquid chromatography with
electron-capture detection (GLC/ECD))
and livestock commodities (Method
GRM 02.21, using gas chromatography
with negative-ion chemical ionization
mass spectrometry detection (GC/MS)).
These methods 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
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Fmt 4700
Sfmt 4700
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 any MRLs for propyzamide.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of the herbicide
propyzamide, including its metabolites
and degradates. Compliance with the
tolerance level in or on cranberry at 1
ppm is to be determined by measuring
only those propyzamide residues
convertible to methyl 3,5dichlorobenzoate expressed as the
stoichiometric equivalent of
propyzamide, 3,5-dichloro-N-(1,1dimethyl-2propynyl)benzamide. This
tolerance expires on December 31, 2022.
VII. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). 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 in accordance with
FFDCA sections 408(e) and 408(l)(6),
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
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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).
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VIII. 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: October 16, 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 § 180.317, revise paragraph (b) to
read as follows:
■
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Sfmt 9990
60943
§ 180.317 Propyzamide; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
The time-limited tolerance specified in
the table in this paragraph (b) is
established for residues of the herbicide
propyzamide, including its metabolites
and degradates, in or on the specified
agricultural commodity in the table in
this paragraph (b), resulting from use of
the pesticide pursuant to FIFRA section
18 emergency exemptions. Compliance
with the tolerance level specified in the
table in this paragraph (b) is to be
determined by measuring only those
propyzamide residues convertible to
methyl 3,5-dichlorobenzoate, expressed
as the stoichiometric equivalent of
propyzamide, 3,5-dichloro-N-(1,1dimethyl-2-propynyl)benzamide in or
on the commodity. The time-limited
tolerance expires on the date specified
in the table in this paragraph (b).
Commodity
Parts per
million
Cranberry.
1
*
*
*
Expiration date
December 31, 2022.
*
*
[FR Doc. 2019–24295 Filed 11–8–19; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Rules and Regulations]
[Pages 60937-60943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24295]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0283; FRL-10000-50]
Propyzamide; Pesticide Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of propyzamide in or on cranberry. This action is in response
to EPA's granting of an emergency exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on cranberry. This regulation establishes a maximum
permissible level for residues of propyzamide in or on this commodity.
The time-limited tolerance expires on December 31, 2022.
DATES: This regulation is effective November 12, 2019. Objections and
requests for hearings must be received on or before January 13, 2020
and must be filed in accordance with the
[[Page 60938]]
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0283, 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, Director, 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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2019-0283 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 January 13, 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-2019-0283, 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. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing a time-limited tolerance for residues of the herbicide
propyzamide, including its metabolites and degradates in or on
cranberry. Compliance with the tolerance level in or on cranberry at 1
part per million (ppm) is to be determined by measuring only those
propyzamide residues convertible to methyl 3,5-dichlorobenzoate,
expressed as the stoichiometric equivalent of propyzamide, 3,5-
dichloro-N-(1,1-dimethyl-2-propynyl)benzamide. This time-limited
tolerance expires on December 31, 2022.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Propyzamide on Cranberry and FFDCA
Tolerances
The Massachusetts Department of Food and Agriculture (MDAR)
notified EPA that an emergency condition exists for cranberry growers
due to the presence of dodder in newly planted and renovated cranberry
fields in five
[[Page 60939]]
counties throughout the state. According to MDAR, dodder is a serious
and devasting pest in commercial cranberry production. The state
reported that an urgent and nonroutine situation exists because
cranberry fields are heavily infested with dodder and that the
available registered alternatives do not provide effective control.
Significant economic losses were expected due to yield and quality
decreases without a suitable pesticide tool to control dodder.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of propyzamide on
cranberry for control of dodder in Massachusetts.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of propyzamide
in or on cranberry. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in FFDCA section 408(l)(6). Although this time-
limited tolerance expires on December 31, 2022, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on cranberry after that date
will not be unlawful, provided the pesticide was applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this time-limited tolerance at the time of that
application. EPA will take action to revoke this time-limited tolerance
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
propyzamide meets FIFRA's registration requirements for use on
cranberry or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
propyzamide by a State for special local needs under FIFRA section
24(c). Nor does this tolerance by itself serve as the authority for
persons in any State other than Massachusetts to use this pesticide on
the applicable crop under FIFRA section 18 absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding the emergency exemption for propyzamide, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with 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 expected as a result of this emergency exemption request and
the time-limited tolerance for propyzamide on cranberry at 1 ppm. EPA's
assessment of exposures and risks associated with establishing this
time-limited tolerance follows.
A. 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 propyzamide used for human risk assessment is shown in
Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Propyzamide 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 (Females 13 to 49 An endpoint attributable to a single exposure was not available in the
years of age). database including the developmental toxicity studies in rats and rabbits.
------------------------------------------------------------------------------
Acute dietary (All Populations).. LOAEL = 40 mg/kg/day Acute RfD = 0.04 mg/ Acute Neurotoxicity Rat Study.
kg/day.
UFA = 10x UFH = 10x aPAD = 0.04 mg/kg/ NOAEL was not established; LOAEL =
FQPA SF (UFL) = 10x day 40 mg/kg/day (the lowest dose
(LOAEL to NOAEL tested) based on increased
extrapolation). landing foot splay in females and
decreased motor activity in both
sexes on Day 1.
Chronic dietary (All populations) LOAEL= 40 mg/kg/day. Chronic RfD = 0.013 The POD of 40 mg/kg/day based on a
mg/kg/day. weight of evidence approach from
the 4 rat studies listed below.
[[Page 60940]]
UFA = 10x cPAD = 0.013 mg/kg/ Subchronic neurotoxicity (SCN)
day (Fischer rat): NOAEL of 2.38 mg/
kg/day based on the significant
decreases in body weight, body
weight gain, and food consumption
seen at 11.28 mg/kg/day (LOAEL)
in males.
UFH = 10x
FQPA SF (UFL/UFDB) =
30x (for lack of
CTA study and LOAEL
to NOAEL
extrapolation).
Acute neurotoxicity (ACN) (Fischer
rat): NOAEL was not established.
The LOAEL is 40 mg/kg/day based
on the increase in landing foot
splay in female rats and the
decrease in motor activity seen
in both genders on Day 1. (A 10X
LOAEL to NOAEL uncertainty factor
(UFL) yields a derived POD of 4
mg/kg/day (40/10)).
Combined chronic toxicity/
carcinogenicity (CD rats): NOAEL
of 8.46/10.69 mg/kg/day based on
increased relative liver weight
and histopathological lesions in
the liver, thyroid, and ovaries
at 42.59/55.09 mg/kg/day (LOAEL).
Male pubertal study (CD rats):
NOAEL of 2.5 mg/kg/day based on
decreased serum T4 at 10 mg/kg/
day (LOAEL).
Incidental oral short-term (1 to LOAEL= 40 mg/kg/day. Residential LOC for Same as Chronic RfD.
30 days). MOE = 3000.
UFA = 10x
UFH = 10x...........
FQPA SF.............
(UFL /UFDB) = 30x
(for lack of CTA
study and LOAEL to
NOAEL
extrapolation).
Dermal short-term (1 to 30 days) NOAEL = 100 mg/kg/ Residential LOC for 28-day dermal toxicity study in
and intermediate-term (1 to 6 day. MOE = 1000. rat: LOAEL = 500 mg/kg/day based
months). UFA = 10x.......... on decreases in body weight and
UFH = 10x.......... food consumption in males.
FQPA SF (UFDB) =10x
(for lack of CTA
study).
------------------------------------------------------------------------------
Inhalation short-term (1 to 30 LOAEL= 40 mg/kg/day. Residential LOC for Same as Chronic RfD.
days) and Intermediate-term (1 UFA = 10x........... MOE = 3,000.
to 6 months). UFH = 10x...........
FQPA SF (UFL/UFDB)..
= 30x (for lack of
CTA study and LOAEL
to NOAEL
extrapolation).
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans'' at doses that do
not result in induction of hepatic cell proliferation or metabolic enzymes
leading to disruption of thyroid or gonadal endocrine axes.
----------------------------------------------------------------------------------------------------------------
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. UFA = extrapolation from
animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH =
potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL
to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propyzamide, EPA considered exposure under the time-limited
tolerance established by this action as well as all existing
propyzamide tolerances in 40 CFR 180.317. EPA assessed dietary
exposures from propyzamide in food as follows:
i. Acute exposure. Such effects were identified for propyzamide. In
estimating acute dietary exposure, EPA used food consumption
information from the Dietary Exposure Evaluation and Model-Food
Commodity Intake
[[Page 60941]]
Database (DEEM-FCID). As to residue levels in food, EPA assumed that
propyzamide residues were present at tolerance levels in all
commodities for which tolerances have been established or proposed and
that 100% of the crops were treated with propyzamide.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the Dietary Exposure
Evaluation and Model-Food Commodity Intake Database (DEEM-FCID). As to
residue levels in food, EPA assumed that propyzamide residues were
present at tolerance levels in all commodities for which tolerances
have been established or proposed and that 100% of the crops were
treated with propyzamide.
iii. Cancer. Based on the data summarized in Unit IV.A., EPA has
concluded that propyzamide does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for propyzamide. Tolerance level residues and 100%
CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used Tier II
screening level water exposure models in the dietary exposure analysis
and risk assessment for propyzamide in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of propyzamide. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier II Surface Water Concentration Calculator (SWCC)
and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of propyzamide for acute
exposures are estimated to be 102 parts per billion (ppb) for surface
water and 21 ppb for ground water; for chronic exposures for non-cancer
assessments are estimated to be 47 ppb for surface water and 18.6 ppb
for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 102 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value of 47 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). Propyzamide is
currently registered for use on golf courses that could result in post-
application residential exposures to adults and children. EPA assessed
residential post-application dermal exposures from golfing for adults,
children 6 to <11 and children 11 to <16 and determined that there are
no post-application risk estimates of concern since the dermal margin
of exposures (MOEs) are >1,000. For the golf course post-application
scenarios for adults and children identified above, MOEs ranged from
1,900 to 2,500.
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 propyzamide to share a common mechanism of
toxicity with any other substances, and propyzamide does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
propyzamide 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.
C. 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 SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
quantitative or qualitative increased susceptibility in developing
fetuses or in offspring of rats or rabbits following prenatal and/or
postnatal exposure to propyzamide. However, a comparative thyroid assay
study is required to determine whether pregnant women or developing
young are more or less susceptible, compared to adults, to thyroid
toxicity.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were increased to 10X for both interspecies and intraspecies
variation, and 30X for the lack of a NOAEL and lack of a comparative
thyroid study. That decision is based on the following findings:
i. The toxicity database for propyzamide is incomplete. The
required comparative thyroid assay and subchronic inhalation studies
have not been received for propyzamide; therefore, uncertainty factors
identified above have been applied to account for these deficiencies.
In addition, the acute dietary endpoint for the general population
(including infants and children) was chosen from an acute neurotoxicity
study with a lowest observed adverse effect level of 40 mg/kg/day based
on the increase in landing foot splay in female rats and the decrease
in motor activity observed on Day 1. As such, the lack of an
established NOAEL as well as uncertainties attributed to intraspecies
variability and interspecies extrapolations contributed to an
incomplete toxicity database for propyzamide.
ii. There is no indication that propyzamide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study;
however, there is need for additional UFs to account for the lack of a
comparative thyroid study and the use of a LOAEL to extrapolate a
NOAEL.
iii. There is no evidence that propyzamide 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.
[[Page 60942]]
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propyzamide 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
propyzamide.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propyzamide will occupy 46% of the aPAD for all infants <1 year old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic dietary
exposure to propyzamide from food and water will utilize 33% of the
cPAD for children 1 to 2 years old, the population group receiving the
greatest exposure.
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). Propyzamide
is currently registered for a use that could result in short-term
residential exposure. The Agency has identified and assessed short-term
residential dermal post-application exposures for the registered golf
course use for propyzamide. There are no post-application risk
estimates of concern (i.e., dermal MOEs >=1,000) for the golf course
use. The short-term residential exposures from the golfing use pattern
were not aggregated with dietary exposures since the risk assessment
endpoints for dermal and oral toxicity were different. The acute and
chronic aggregate risk estimates are equivalent to the dietary risk
estimates and are not of concern.
4. Intermediate-term risk. Intermediate-term residential exposures
are not anticipated from the registered propyzamide uses, therefore, an
intermediate-term aggregate assessment was not conducted.
5. Aggregate cancer risk for U.S. population. In accordance with
the Agency's 2005 Guidelines for Carcinogenic Risk Assessment,
propyzamide is classified as ``Not likely to be Carcinogenic to
Humans'' at doses that do not result in induction of hepatic cell
proliferation or metabolic enzymes leading to disruption of thyroid or
gonadal endocrine axes. Quantification of carcinogenic risk is not
required.
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 propyzamide residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available to enforce the
tolerance expression of residues in/or plant commodities (PAM II Method
I, using gas-liquid chromatography with electron-capture detection
(GLC/ECD)) and livestock commodities (Method GRM 02.21, using gas
chromatography with negative-ion chemical ionization mass spectrometry
detection (GC/MS)). These methods 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 any MRLs for propyzamide.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
the herbicide propyzamide, including its metabolites and degradates.
Compliance with the tolerance level in or on cranberry at 1 ppm is to
be determined by measuring only those propyzamide residues convertible
to methyl 3,5-dichlorobenzoate expressed as the stoichiometric
equivalent of propyzamide, 3,5-dichloro-N-(1,1-dimethyl-
2propynyl)benzamide. This tolerance expires on December 31, 2022.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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
[[Page 60943]]
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).
VIII. 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: October 16, 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. 180.317, revise paragraph (b) to read as follows:
Sec. 180.317 Propyzamide; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. The time-limited tolerance
specified in the table in this paragraph (b) is established for
residues of the herbicide propyzamide, including its metabolites and
degradates, in or on the specified agricultural commodity in the table
in this paragraph (b), resulting from use of the pesticide pursuant to
FIFRA section 18 emergency exemptions. Compliance with the tolerance
level specified in the table in this paragraph (b) is to be determined
by measuring only those propyzamide residues convertible to methyl 3,5-
dichlorobenzoate, expressed as the stoichiometric equivalent of
propyzamide, 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide in or on
the commodity. The time-limited tolerance expires on the date specified
in the table in this paragraph (b).
------------------------------------------------------------------------
Parts per
Commodity million Expiration date
------------------------------------------------------------------------
Cranberry..................... 1 December 31, 2022.
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-24295 Filed 11-8-19; 8:45 am]
BILLING CODE 6560-50-P
