[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Rules and Regulations]
[Pages 1526-1531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00534]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0680; FRL-9940-90]


Propyzamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
propyzamide, also known as pronamide, in or on leaf lettuce. Dow 
AgroSciences, LLC requested this tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 13, 2016. Objections and 
requests for hearings must be received on or before March 14, 2016, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0680, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
the request by the docket ID number EPA-HQ-OPP-2014-0680 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 March 14, 2016. 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-2014-0680, 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

[[Page 1527]]

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. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, December 17, 2014 (79 FR 
75109) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 4F8301) by Dow AgroSciences, LLC, 9330 Zionsville Rd., 
Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.317 
be amended by establishing a tolerance for residues of the herbicide 
pronamide (propyzamide) and its metabolite containing the 3,5-
dichlorobenzoyl moiety calculated as 3,5-dichloro-N-(1,1-dimethyl-2-
propynyl)benzamide, in or on lettuce, leaf at 1.0 part per million 
(ppm). That document referenced a summary of the petition prepared by 
Dow AgroSciences, LLC, the registrant, which is available in the docket 
EPA-HQ-OPP-2014-0680 at http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe''. Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information''. This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for propyzamide including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with propyzamide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Propyzamide has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure, is non-irritating to the eyes or skin, 
and is not a dermal sensitizer.
    The primary target organ for propyzamide is the liver. There are 
other target organs as well, including the thyroid, testes, and 
pituitary, but effects on these organs are secondary to primary effects 
on the liver. Liver-related effects include increases in absolute and 
relative liver weights, hypertrophy, elevated levels of enzymes 
associated with liver damage, and histopathology of liver cells. 
Adverse liver effects were consistently observed in every animal 
species studied, with progression towards more severe effects over time 
ultimately leading to tumorigenesis in rats and mice. Based on the 
studies submitted, the rat is the most sensitive species. In most 
studies, there is no gender sensitivity in response to propyzamide.
    Propyzamide is a carcinogen in rats and mice, causing liver tumors 
in mice, thyroid tumors in male rats, and testicular tumors in rats. 
Based on MOA studies, tumorigenesis for all three tumor types has been 
shown to be mediated by liver enzymes induced in response to treatment 
with propyzamide. In mice, the MOA data clearly show rapid induction of 
Cyp2b10 associated with the constitutive androstane nuclear receptor 
(CAR), as well as induction of peroxisomes and peroxisomal enzymes such 
as Cyp4a10 associated with a second nuclear receptor, PPAR-[alpha]. 
Induction of the nuclear receptors leads to mitogenesis followed by 
hepatocellular proliferation and eventually, liver tumors.
    In rats, propyzamide induces Cyp2b1 200-fold over background 
levels, but has no effect on other CYPs commonly associated with 
carcinogenic modes of action. In the rat Cyp2b1 is a biological marker 
for the CAR receptor. The CAR pathway is associated with the activation 
of uridine diphosphate glucuronyl transferase (UGT) which catalyzes the 
condensation of glucuronic acid with thyroxine (T4), leading to 
enhanced biliary excretion of T4. Eventually the continued stimulus to 
produce more T4 leads to the formation of thyroid follicular tumors. In 
male rats, the tumorigenic dose of propyzamide for both thyroid tumors 
and Leydig cell tumors is 1,000 ppm in the diet (34-75 mg/kg/day based 
on age of the rats). Tumor precursor effects such as decreases in T4 
levels, increases in liver weight, liver hypertrophy, and elevated 
testosterone metabolism occur at doses below or equivalent to the 
tumorigenic dose.
    In nearly every oral repeated-dose study of propyzamide as well as 
in the 28-day dermal toxicity study in rats, there were dose-related 
decreases in body weight, body weight gain, and food consumption. 
Typically, these effects on body weight occurred at or above effects on 
the liver such as hypertrophy or increases in liver weight.
    There was evidence of neurotoxicity in rats based on an increase in 
landing foot splay in females and decreases in motor activity in both 
genders in the acute neurotoxicity study. In the subchronic 
neurotoxicity study however, there was no evidence of neurotoxicity 
following dietary administration, and only body-weight effects were 
observed. There was no evidence of neurotoxicity in the rest of the 
toxicology database across other species or other strains of rat. There 
was no evidence of immunotoxicity.
    There was no evidence of quantitative or qualitative increased 
susceptibility in the fetuses or the offspring of rats or rabbits 
following pre- and/or postnatal exposure to propyzamide. In the 
prenatal developmental toxicity study in rabbits and the multi-
generation reproduction study in rats, any observed toxicity to the 
fetuses or offspring occurred at equivalent or higher doses than 
effects to parental animals.
    Specific information on the studies received and the nature of the 
adverse effects caused by propyzamide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Pronamide Human Health Risk 
Assessment for Registration Review and to Support New Section 3 Use on 
Leaf Lettuce (Revised)'' on pages 14-22 in docket ID number EPA-HQ-OPP-
2014-0680.

[[Page 1528]]

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 (All populations)..  LOAEL = 40 mg/kg/day  Acute RfD = 0.04 mg/ Acute Neurotoxicity Rat Study
                                   UFA = 10x...........   kg/day.             No NOAEL established.
                                   UFH = 10x...........  aPAD = 0.04 mg/kg/   LOAEL = 40 mg/kg/day based on
                                   UFL = 10x...........   day.                 increased landing foot splay and
                                   FQPA SF = 1x........                        decreased motor activity.
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49          No endpoint attributable to a single exposure was identified, including
 years of age).                                  developmental toxicity studies in rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  LOAEL = 40 mg/kg/day  Chronic RfD = 0.04   POD = 4 mg/kg/day based on a
                                   UFA = 10x...........   mg/kg/day.           weight-of-evidence approach from
                                   UFH = 10x...........  cPAD = 0.04 mg/kg/    the following rat studies:
                                   UFL = 10x...........   day.                Acute Neurotoxicity Study.
                                   FQPA SF = 1x........                       No NOAEL established.
                                                                              LOAEL = 40 mg/kg/day based on
                                                                               increased landing foot splay and
                                                                               decreased motor activity
                                                                              POD = 4 mg/kg/day (LOAEL of 40 mg/
                                                                               kg/day /10x UFL)
                                                                              Subchronic Neurotoxicity Study
                                                                              NOAEL = 2.38 mg/kg/day LOAEL =
                                                                               11.28 mg/kg/day based on
                                                                               significant decreases in body
                                                                               weight, body weight gain, and
                                                                               food consumption in males
                                                                              Combined Chronic Toxicity/
                                                                               Carcinogenicity Study
                                                                              NOAEL = 8.46/10.69 mg/kg/day
                                                                              LOAEL = 42.59/55.09 mg/kg/day
                                                                               based on increased relative liver
                                                                               weight and histopathological
                                                                               lesions in the liver, thyroid,
                                                                               and ovaries
                                                                              Male Pubertal Study
                                                                              NOAEL = 2.5 mg/kg/day
                                                                              LOAEL = 10 mg/kg/day based on
                                                                               decreased serum T4
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   LOAEL = 40 mg/kg/day  LOC for MOE = 1,000  Same as Chronic dietary section
 30 days).                                                                     above
                                   UFA = 10x
                                   UFH = 10x...........
                                   UFL = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   NOAEL = 100 mg/kg/    LOC for MOE = 100..  Subchronic Dermal Toxicity Rat
 and intermediate-term (1 to 6      day (dermal                                Study
 months).                           absorption rate =                         LOAEL = 500 mg/kg/day based on
                                    24%).                                      decreases in body weight and food
                                                                               consumption
                                   UFA = 10x
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

[[Page 1529]]

 
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. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propyzamide, EPA considered exposure under the petitioned-
for tolerance 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. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for propyzamide. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). 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 USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). 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 III.A., EPA has 
concluded that propyzamide does not pose a cancer risk to humans at 
doses that do not result in induction of hepatic cell proliferation or 
metabolic enzymes leading to disruption of thyroid or gonadal 
endrocrine axes. The MOAs were adequately supported by studies that 
clearly identified the sequence of key events, dose-response 
concordance and temporal relationship to the particular tumor type. 
Quantification of carcinogenic risk is not required. The chronic RfD 
would be protective of both carcinogenic and non-carcinogenic effects 
observed in the mouse and rat carcinogenicity studies and MOA studies 
conducted at higher doses. 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 
PCT 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://www.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 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 the following uses that could result in 
residential exposures: Turf grass and golf courses. EPA assessed 
residential exposure using the following assumptions: Post-application 
dermal and incidental oral exposures for children 1 to < 2 years old 
(physical activities on turf and hand-to-mouth ingestion of treated 
soil); and post-application dermal exposure for children 6 to < 11 
years old (golfing), children 11 to < 16 years old (golfing and 
mowing), and adults (golfing, mowing, and physical activities on turf). 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.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

[[Page 1530]]

the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
quantitative or qualitative increased susceptibility in developing 
fetuses or in offspring of rats or rabbits following prenatal and/or 
postnatal exposure to propyzamide.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF was reduced to 1X. This decision is based on the following 
findings:
    i. The toxicity database for propyzamide is complete.
    ii. There is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity despite evidence of 
neurotoxicity in the acute study based on the increase in landing foot 
splay in female rats and the decrease in motor activity seen in both 
genders on day 1. This decision is based on no evidence of 
neurotoxicity in the subchronic study at dose levels tested via 
different routes of administration, and no evidence of neurotoxicity in 
the rest of the toxicology database across other species and other 
strains of rat.
    iii. There is no evidence that propyzamide results in increased 
susceptibility in in utero rabbits in the prenatal developmental 
toxicity study or in young rats in the two-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to 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.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to propyzamide will occupy 46% of the aPAD for all infants < 1 year 
old, the population subgroup 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 11% of the 
cPAD for children 1 to 2 years old, the population subgroup receiving 
the greatest exposure. Based on the explanation in Unit III.C.3. 
regarding residential use patterns, chronic residential exposure to 
residues of propyzamide is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be background exposure level). Propyzamide is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
water, and residential exposure results in an aggregate MOE of 1,700 
for children 1 to < 2 years old (chronic dietary exposure with post-
application incidental oral exposure from turf use). Because EPA's 
level of concern for propyzamide is a MOE of 1,000 or below, this MOE 
is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be background exposure 
level). Propyzamide is currently registered for uses that could result 
in intermediate-term residential exposure. However, since the maximum 
single and yearly application rates are the same, the short-term 
assessment is protective of intermediate-term incidental oral exposure.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.C.iii., 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. Therefore, quantification of 
aggregate cancer 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression of residues in/on 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,

[[Page 1531]]

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.

V. Conclusion

    Therefore, tolerances are established for residues of propyzamide 
(pronamide), 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, in or 
on lettuce, leaf at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 31, 2015.
Susan Lewis,
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, add alphabetically ``Lettuce, leaf'' to the table 
in paragraph (a) to read as follows:


Sec.  180.317  Propyzamide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Lettuce, leaf...........................................             1.0
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-00534 Filed 1-12-16; 8:45 am]
BILLING CODE 6560-50-P