Document ID: EPA-HQ-OPP-2008-0887-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Propamocarb
Posted Date: 2013-06-05T04:00Z

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33731-33736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13190]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0887; FRL-9388-1]

Propamocarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
propamocarb in or on succulent lima bean. Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 5, 2013. Objections and 
requests for hearings must be received on or before August 5, 2013, 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-2008-0887, 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), EPA West 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email address: nollen.laura@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).

[[Page 33732]]

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/ocspp and select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0887 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 
August 5, 2013. 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-2008-0887, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
6), 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 
8E7473) by IR-4, Rutgers University, 500 College Rd. East, Suite 201W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.499 be 
amended by establishing a tolerance for residues of the fungicide 
propamocarb hydrochloride (propamocarb HCl), propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride, in or on succulent 
lima bean at 2.0 parts per million (ppm). That document referenced a 
summary of the petition prepared on behalf of IR-4 by Bayer 
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance expression for all established commodities to be 
consistent with current Agency policy. The reason for this change is 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for propamocarb including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with propamocarb 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.
    In all species tested for toxicity to propamocarb, decreased body 
weights, body-weight gains, and food consumption were observed 
following subchronic and chronic durations of exposure. Effects 
indicative of toxicity were noted in the digestive and gastrointestinal 
(GI) tracts in dogs, including chronic erosive gastritis and 
vacuolization of the salivary glands, stomach, and duodenum. Ocular 
effects were noted in rats (opacity of the eye and yellow colored eyes 
in females) and in dogs (vacuolization of the lacrimal gland, retinal 
degeneration, and hyporeflectivity of the inner eye tissue below the 
lens). Respiratory tract effects were also noted in dogs, including 
vacuolization of the cells of the trachea and lung. In rats, there were 
signs of neurotoxicity including decreased motor activities in females 
following acute exposure and vacuolization of the ventricles of the 
brain that produce cerebral spinal fluid noted for subchronic and 
chronic durations. There were no signs of immunotoxicity in the 
guideline immunotoxicity study for propamocarb.
    Fetal effects due to propamocarb treatment were noted at doses 
which also caused maternal toxicity. Effects in the rat included 
increased fetal death and post-implantation loss, increases in minor 
skeletal anomalies, and increased incidences of small fetuses. There 
were also inter-atrial septal defects, and hemorrhage in the ears, 
upper GI tract, and nasopharynx/sinuses. Maternal effects consisted of 
decreased absolute body weights, body-weight gains and food 
consumption, and mortality. In rabbits, the only developmental effect 
was an increase in post-implantation loss. Maternal effects consisted 
of increased abortions, and body-weight decrements.
    Additionally, in the rat 2-generation reproduction studies, 
parental and offspring effects occurred at the same

[[Page 33733]]

dose. Parental effects were similar to the effects observed in the rat 
subchronic and chronic studies in addition to clinical signs including 
salivation, reddish material around the mouth, and urine staining. 
Offspring effects consisted of pup deaths, decreased viability and 
lactation indices and litter size, and decreased pup body weights and 
body weight gains. Reproductive effects consisted of increased 
vacuolization and decreased weight of the epididymides, decreased sperm 
counts and motility, and abnormal sperm morphology.
    Propamocarb has been classified as ``not likely to be carcinogenic 
to humans'' by all routes of exposure, based upon lack of evidence of 
carcinogenicity in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by propamocarb 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 the document entitled ``Propamocarb 
Hydrochloride (Propamocarb-HCl). Section 3 Request for use on Lima 
Beans (Succulent). Human-Health Risk Assessment'' at pp. 32-37 in 
docket ID number EPA-HQ-OPP-2008-0887.

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/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for propamocarb used for 
human-health risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Propamocarb for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 RfD, PAD, LOC for risk  Study and toxicological
          Exposure/scenario                POD and UFs/SFs             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 150 mg/kg/day.   Acute RfD = 1.5 mg/kg/   Developmental Toxicity
 age).                                 UFA = 10X..............   day..                    Study--Rabbit.
                                       UFH = 10X..............  aPAD = 1.5 mg/kg/day...  LOAEL = 300 mg/kg/day
                                       FQPA SF = 1X...........                            based on decreased
                                                                                          body weight gain and
                                                                                          decreased motor
                                                                                          activity.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      NOAEL = 200 mg/kg/day.   Acute RfD = 2 mg/kg/     Acute Neurotoxicity
 including infants and children).      UFA = 10X..............   day..                    Screening Battery--
                                       UFH = 10X..............  aPAD = 2 mg/kg/day.....   Rat.
                                       FQPA SF = 1X...........                           LOAEL = 2,000 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          decreased motor
                                                                                          activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 12 mg/kg/day.    Chronic RfD = 0.12 mg/   Carcinogenicity Study--
                                       UFA = 10X..............   kg/day..                 Mouse.
                                       UFH = 10X..............  cPAD = 0.12 mg/kg/day..  LOAEL = 95 mg/kg/day
                                       FQPA SF = 1X...........                            based on decreased
                                                                                          body weight and body
                                                                                          weight gain in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).....  Dermal (or oral) study   LOC for MOE = 100......  2-Generation
                                       NOAEL = 150 mg/kg/day..                            Reproduction Toxicity
                                       UFA = 10X..............                            Study--Rat.
                                       UFH = 10X..............                           LOAEL = 406.69 mg/kg/
                                       FQPA SF = 1X...........                            day for males and
                                                                                          467.13 mg/kg/day for
                                                                                          females based on
                                                                                          decreased body
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). POD = points of departure. RfD = reference
  dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propamocarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing propamocarb tolerances in 40 CFR 
180.499. EPA assessed dietary exposures from propamocarb 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 propamocarb. In estimating acute dietary exposure, EPA used Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) Version 3.16, which uses food consumption data 
from the U.S. Department of Agriculture's

[[Page 33734]]

National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels 
in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level 
residues for all commodities. In addition, DEEM version 7.81 default 
processing factors were used, when appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID Version 3.16. As to residue levels in 
food, EPA assumed 100 PCT and tolerance-level residues for all 
commodities. In addition, DEEM version 7.81 default processing factors 
were used, when appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that propamocarb 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 propamocarb. Tolerance level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for propamocarb in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of propamocarb. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
propamocarb for surface water are estimated to be 8,762 parts per 
billion (ppb) for acute exposures and 1,067 ppb for chronic exposures 
for non-cancer assessments. For ground water, the EDWC is estimated to 
be 15.6 ppb for acute and chronic exposures for non-cancer assessments.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 8,762 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 1,067 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). Propamocarb is 
currently registered for use on golf course turf, which may result in 
residential exposure. EPA assessed residential exposure using the 
following assumptions: Chemical-specific turf transferable residue 
(TTR) data for propamocarb were used to assess potential short-term 
dermal post-application exposures to adult and youth golfers. Post-
application oral and inhalation exposures, as well as residential 
handler exposures, are not expected based on the current use patterns 
for propamocarb. Intermediate-term residential exposures are not 
expected based on the current use patterns; however, the short-term 
aggregate assessment would be protective of any potential intermediate-
term exposures, as the short- and intermediate-term PODs are the same. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.'' Although a carbamate, 
propamocarb is not an N-methyl carbamate and does not cause 
cholinesterase inhibition. Therefore, it was not included in the N-
methyl carbamate cumulative risk assessment. EPA has not found 
propamocarb to share a common mechanism of toxicity with any other 
substances, and propamocarb does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that propamocarb 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 Web site at http://www.epa.gov/pesticides/cumulative.

 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 Food Quality 
Protection Act Safety Factor (FQPA 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 increased 
quantitative prenatal sensitivity due to propamocarb treatment. Effects 
in developing rats occurred at the same dose as maternal effects and 
included increased fetal death and post-implantation loss, increases in 
minor skeletal anomalies, and an increased incidence of small fetus. 
Effects in maternal rats at that dose consisted of decreased absolute 
body weights, body weight gains, food consumption, and mortality. In 
rabbits, the only developmental effect was an increase in post-
implantation loss in the presence of maternal effects (increased 
abortions, and body weight decrements). In the rat 2-generation 
reproduction studies, parental effects were similar to the effects 
observed in the rat subchronic and chronic studies, in addition to 
clinical signs including salivation, reddish material around the mouth, 
and urine staining. Offspring effects consisted of pup deaths, 
decreased viability and lactation indices and litter size, and 
decreased pup body weights and body weight gains. Reproductive effects 
at the same dose as parental effects consisted of increased 
vacuolization and decreased weight of the epididymides, decreased sperm 
counts and motility, and abnormal sperm morphology.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for propamocarb is complete.
    ii. There are two guideline acute neurotoxicity studies and two 
subchronic neurotoxicity studies for propamocarb HCl. The effects of 
these studies are well characterized, and

[[Page 33735]]

include decreased motor activities in females following acute exposure. 
However, the endpoints selected are protective of these effects, as the 
rat acute oral neurotoxicity study was used to select the endpoint for 
the aRfD of 2.0 mg/kg/day for the general U.S. population, including 
infants and children. The lack of quantitative increased fetal 
sensitivity should remove concern for a developmental neurotoxicity 
study (DNT).
    iii. There is no evidence that propamocarb results in increased 
quantitative susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. Although there are qualitative effects observed in both 
developmental studies, as well as in one of the 2-generation 
reproduction studies, EPA has determined that no additional UF is 
necessary to account for these effects because:
    a. The effects are well characterized.
    b. Clear NOAELs were established.
    c. The developmental rabbit and rat 2-generation reproduction 
studies are being used in endpoint selection.
    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 propamocarb in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of 
children. Incidental oral exposure is not expected for children. These 
assessments will not underestimate the exposure and risks posed by 
propamocarb.

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 exposures, the acute dietary exposure from food and 
water to propamocarb will occupy 34% of the aPAD selected for females 
13-49 years old; and 75% of the aPAD for infants less than 1 year old, 
the population group receiving the greatest exposure for the general 
U.S. population, including infants and children.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
propamocarb from food and water will utilize 50% of the cPAD for 
infants less than 1 year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
propamocarb is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Propamocarb 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to propamocarb.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 310 for adult 
male golfers, 280 for golfers aged 11 to less than 16 years old, and 
240 for golfers aged 6 to less than 11 years old. Because EPA's level 
of concern for propamocarb is a MOE of 100 or below, these MOEs are not 
of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
propamocarb is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
propamocarb.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, propamocarb is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to propamocarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography with nitrogen-phosphorus detection 
(GC/NPD) method (Analytical Method No. XAM-34) is available to enforce 
tolerance expression on plant commodities. The method may be found in 
the Pesticide Analytical Method (PAM) Vol. II.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for propamocarb.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the tolerance expression to clarify that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of propamocarb not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

 V. Conclusion

    Therefore, tolerances are established for residues of propamocarb 
(propyl N-[3-(dimethylamino)propyl]carbamate) in or on bean, lima, 
succulent at 2.0 ppm.

[[Page 33736]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 28, 2013.
Daniel J. Rosenblatt,
Acting 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.  180.499, revise the section heading, paragraph (a) 
introductory text, and paragraph (c) to read as follows:

Sec.  180.499  Propamocarb; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
propamocarb, including its metabolites and degradates, in or on the 
commodities specified in the following table resulting from the 
application of the hydrochloride salt of propamocarb. Compliance with 
the following tolerance levels is to be determined by measuring only 
propamocarb (propyl N-[3-(dimethylamino)propyl]carbamate):
* * * * *
    (c) Tolerance with regional registrations. Tolerances with regional 
registrations are established for the residues of propamocarb, 
including its metabolites and degradates, in or on the commodities 
specified in the following table resulting from the application of the 
hydrochloride salt of propamocarb. Compliance with the following 
tolerance levels is to be determined by measuring only propamocarb 
(propyl N-[3-(dimethylamino)propyl]carbamate):

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent..................................             2.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-13190 Filed 6-4-13; 8:45 am]
BILLING CODE 6560-50-P