[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.

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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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under 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: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. 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 http://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
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                                    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 http://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: http://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 http://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