82_FR_9543 82 FR 9519 - Propamocarb; Pesticide Tolerance

82 FR 9519 - Propamocarb; Pesticide Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 24 (February 7, 2017)

Page Range9519-9523
FR Document2017-02479

This regulation establishes a tolerance for residues of propamocarb in or on potato. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 24 (Tuesday, February 7, 2017)
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9519-9523]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-02479]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0083; FRL-9957-68]


Propamocarb; Pesticide Tolerance

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 potato. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 7, 2017. Objections and 
requests for hearings must be received on or before April 10, 2017, 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-2016-0083, 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: 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.

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-2016-0083 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 10, 2017. 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-2016-0083, 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 October 27, 2016 (81 FR 74753) (FRL-
9954-27), 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 
5F8430) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.499 be amended by increasing the tolerance for residues of the 
fungicide propamocarb hydrochloride, in or on potato from 0.06 to 0.30 
parts per million (ppm). That document referenced a summary of the 
petition prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received concerning this action for propamocarb 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

[[Page 9520]]

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-HCl including exposure resulting from the tolerances 
established by this action. EPA's assessment of exposures and risks 
associated with propamocarb-HCl 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.
    Propamocarb-HCl is a List C carbamate fungicide with specific 
activity against numerous Oomycete species, which cause foliar diseases 
and seedling, seed, root, foot, and stem rot in various edible and 
ornamental crops.
    Consistent with other carbamates, propamocarb-HCl's database showed 
evidence of neurotoxicity in rats, though it does not inhibit 
cholinesterase. Neurotoxic effects include decreased motor activity 
following acute exposure and vacuolization of the choroid plexus 
(ventricles of the brain which produce cerebral spinal fluid) following 
subchronic and chronic durations. Other effects observed are indicative 
of toxicity to the digestive and GI tracts in dogs (chronic erosive 
gastritis, vacuolization of the salivary gland and stomach), and the 
eye in dogs and rats (hyporeflectability of the fundus, retinal 
degeneration, and vacuolization of the retinal gland). In all species, 
decreases in body weights, body-weight gains, and food consumption were 
observed following subchronic and chronic exposure. Available 
immunotoxicity data does not indicate an immunotoxic effect from 
exposure to propamocarb.
    Effects in the route-specific dermal and inhalation studies were 
primarily portal-of-entry effects. Dermal exposure caused dermal 
irritation in rats and rabbits at relatively high doses (>500 
milligram/kilogram/day (mg/kg/day)). Inhalation exposure caused labored 
breathing and the appearance of red material around the nose. Systemic 
effects were observed following inhalation exposure at similar doses 
that caused portal-of-entry effects and included kidney cysts and 
changes in hematological parameters.
    Effects were observed in fetuses and offspring in the database at 
the same doses that elicited less severe effects in parental animals. 
In the developmental rat study, fetal effects included increased death, 
increased incidences of minor skeletal anomalies, increased incidences 
of small fetus, inter-atrial septal defects, and hemorrhage in the 
ears, upper GI tract, and nasopharynx/sinuses. Maternal effects 
consisted of decreased absolute body-weights, decreased food 
consumption, post-implantation loss, and mortality. In the rat two-
generation reproduction study, offspring effects consisted of deaths, 
decreased weights, and decreased viability and lactation indices and 
litter size. Parental effects were consistent with those previously 
described for adults in the hazard database. Reproductive effects 
consisted of increased vacuolization and decreased weight of the 
epididymides, decreased sperm counts and motility, and abnormal sperm 
morphology.
    Propamocarb-HCl was categorized as having low acute toxicity via 
the oral, dermal, and inhalation routes (Toxicity Categories III-IV). 
It is not a dermal irritant or a dermal sensitizer. It is considered a 
slight eye irritant.
    EPA classified propamocarb-HCl 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-HCl 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, ``Propamocarb Hydrochloride 
(propamocarb-HCl): Human Health Assessment for Registration Review and 
a Petition for Increasing the Permanent Tolerance for Residues in/on 
Potato'' at pp. 16-18 in docket ID number EPA-HQ-OPP-2016-0083.

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 the NOAEL and the LOAEL are identified. 
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 toxicological endpoints for propamocarb-HCl 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
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-50       NOAEL = 150 mg/kg/    Acute RfD = 1.5 mg/  Developmental Toxicity Study-
 years of age).                     day.                  kg/day.              Rabbit LOAEL = 300 mg/kg/day
                                   UFA = 10x...........  aPAD = 1.5 mg/kg/     based on post-implantation loss.
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........

[[Page 9521]]

 
Acute dietary (General population  NOAEL = 200 mg/kg/    Acute RfD = 2 mg/kg/ Acute Neurotoxicity Screening
 including infants and children).   day.                  day.                 Battery--Rat LOAEL = 2,000 mg/kg/
                                   UFA = 10x...........  aPAD = 2 mg/kg/day.   day based on decreased motor
                                   UFH = 10x...........                        activity.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 12 mg/kg/day  Chronic RfD = 0.12   Carcinogenicity Study--Mouse LOAEL
                                   UFA = 10x...........   mg/kg/day.           = 95 mg/kg/day based on decreased
                                   UFH = 10x...........  cPAD = 0.12 mg/kg/    absolute body-weights in females.
                                   FQPA SF = 1x........   day.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``not likely to be carcinogenic to humans'' based on the
                                    absence of treatment-related tumors in two adequate rodent carcinogenicity
                                    studies.
----------------------------------------------------------------------------------------------------------------
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).

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 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 used tolerance-level residues and assumed 100% crop treated 
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level 
residues and assumed 100 PCT for all commodities.
    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.
    The revised estimated drinking water concentrations (EDWCs) are 
those modeled for surface waters based on current labels and newly 
submitted fate and transport data for the registration review of 
propamocarb-HCl. All currently labeled uses were assessed including the 
potato tolerance increase described in this action.
    Surface water values were obtained from FLnurserySTD_V2 model for 
the acute value, and NJnurserySTD_V2 model for the chronic values 
representing foliar application to ornamentals in nurseries. Ground 
Water acute and chronic values were obtained from FLCITRUS_STD.SCN GW 
scenario.
    The EDWCs of propamocarb for acute exposures are 4,860 parts per 
billion (ppb) for surface water, and 73 ppb for ground water. The EDWCs 
of propamocarb for chronic exposure for non-cancer assessments are 385 
ppb for surface water, and 70 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 4,860 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 385 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 
registered for use on golf course turf, which may result in dermal 
post-application exposures. Although potential dermal post-application 
exposures were previously assessed (K. Lowe, 05/15/2013, D377624), EPA 
no longer considers the effects found in the dermal study to be adverse 
and therefore, no longer identifies a dermal hazard. As a result, there 
is no need to conduct a quantitative residential exposure assessment.
    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 
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. Although a carbamate, 
propamocarb-HCl is not an

[[Page 9522]]

N-methyl carbamate and does not cause cholinesterase inhibition. Thus, 
it was not included in the N-methyl carbamate cumulative risk 
assessment. 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 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative pre- or post-natal susceptibility following 
exposure to propamocarb-HCl. There is evidence of increased qualitative 
susceptibility in the database; however, concern for these effects is 
low because: (1) The effects are well characterized, (2) clear NOAELs 
were established, (3) the endpoints selected are protective of these 
effects, and (4) the effects were seen in the presence of maternal/
parental toxicity.
    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. Although there was evidence of neurotoxicity (decreased motor 
activity and vacuolization of the choroid plexus) in several studies 
following propamocarb-HCl exposure, including the ACN and SCN studies; 
there is no need for a developmental neurotoxicity study or additional 
uncertainty factors (UFs) to account for neurotoxicity because the 
neurotoxicity effects are well-characterized with clear NOAEL/LOAEL 
values and the selected endpoints are protective of the observed 
effects.
    iii. Although there is evidence of increased qualitative 
susceptibility from exposure to propamocarb, there is no need to retain 
the 10X FQPA SF because: (1) The effects are well characterized; (2) 
clear NOAELs were established; (3) the endpoints selected are 
protective of these effects; and (4) the effects were seen in the 
presence of maternal/parental toxicity.
    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. 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 exposure, the acute dietary exposure from food and water 
to propamocarb will occupy 21% of the aPAD for females (13-49 years 
old) and 42% of the aPAD for 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 exposure to 
propamocarb from food and water will utilize 26% of the cPAD for 
children (3-5 years old) the population group receiving the greatest 
exposure. There are no chronic or long-term residential exposures from 
uses of propamocarb.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term or intermediate-term adverse effect was identified, 
propamocarb is not expected to pose a short-term or intermediate-term 
risk.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A gas chromatography/nitrogen-phosphorus detection (GC/NPD) method 
is available for the enforcement of residues of propamocarb in plant 
commodities. This method has undergone a successful independent 
laboratory validation (ILV) and petition method validation (PMV), and 
is currently listed in the Pesticide Analytical Manual (PAM) Vol. II. 
An adequate liquid chromatography with tandem mass spectrometry (LC/MS/
MS) for the enforcement of residues of propamocarb and its metabolites 
in livestock commodities has been submitted to the Agency. This method 
has undergone successful ILVs and a PMV. The results of a Food and Drug 
Administration (FDA) multiresidue testing study indicate that 
propamocarb and its metabolites are not recovered by any of the 
protocols. The recoveries of propamocarb with the QuEChERS multiresidue 
method are marginally adequate (68-69%; http://www.crl-pesticides.eu/library/docs/fv/CRLFV_Multiresidue_methods.pdf).

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 established a MRL for propamocarb in or on potato at 
0.30 ppm. This MRL is the same as the tolerance established for 
propamocarb in the United States.

V. Conclusion

    Therefore, a tolerance is established for residues of propamocarb 
in or on potato at 0.30 ppm.

[[Page 9523]]

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: January 6, 2017.
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 entry for ``Potato'' in the table in 
paragraph (a) to read as follows:


Sec.  180.499  Propamocarb; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato..................................................            0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-02479 Filed 2-6-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                          9519

                                                stationary source monitoring and                        producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                                reporting requirements of section                       pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                110(a)(2)(F). We will address these                     list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                                requirements in a separate action.                      Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                                [FR Doc. 2017–02530 Filed 2–6–17; 8:45 am]              not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                BILLING CODE 6560–50–P                                  provides a guide to help readers                      arrangements for hand delivery or
                                                                                                        determine whether this document                       delivery of boxed information, please
                                                                                                        applies to them. Potentially affected                 follow the instructions at http://
                                                ENVIRONMENTAL PROTECTION                                entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                AGENCY                                                     • Crop production (NAICS code 111).                  Additional instructions on
                                                                                                           • Animal production (NAICS code                    commenting or visiting the docket,
                                                40 CFR Part 180                                         112).                                                 along with more information about
                                                                                                           • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                                [EPA–HQ–OPP–2016–0083; FRL–9957–68]
                                                                                                        311).                                                 www.epa.gov/dockets.
                                                Propamocarb; Pesticide Tolerance                           • Pesticide manufacturing (NAICS
                                                                                                                                                              II. Summary of Petitioned-For
                                                                                                        code 32532).
                                                AGENCY:  Environmental Protection                                                                             Tolerance
                                                Agency (EPA).                                           B. How can I get electronic access to                    In the Federal Register of October 27,
                                                                                                        other related information?                            2016 (81 FR 74753) (FRL–9954–27),
                                                ACTION: Final rule.
                                                                                                           You may access a frequently updated                EPA issued a document pursuant to
                                                SUMMARY:   This regulation establishes a                electronic version of EPA’s tolerance                 FFDCA section 408(d)(3), 21 U.S.C.
                                                tolerance for residues of propamocarb in                regulations at 40 CFR part 180 through                346a(d)(3), announcing the filing of a
                                                or on potato. Bayer CropScience                         the Government Printing Office’s e-CFR                pesticide petition (PP 5F8430) by Bayer
                                                requested these tolerances under the                    site at http://www.ecfr.gov/cgi-bin/text-             CropScience, 2 T.W. Alexander Drive,
                                                Federal Food, Drug, and Cosmetic Act                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  P.O. Box 12014, Research Triangle Park,
                                                (FFDCA).                                                40tab_02.tpl.                                         NC 27709. The petition requested that
                                                DATES: This regulation is effective                                                                           40 CFR 180.499 be amended by
                                                                                                        C. How can I file an objection or hearing
                                                February 7, 2017. Objections and                                                                              increasing the tolerance for residues of
                                                                                                        request?
                                                requests for hearings must be received                                                                        the fungicide propamocarb
                                                on or before April 10, 2017, and must                     Under FFDCA section 408(g), 21                      hydrochloride, in or on potato from 0.06
                                                be filed in accordance with the                         U.S.C. 346a, any person may file an                   to 0.30 parts per million (ppm). That
                                                instructions provided in 40 CFR part                    objection to any aspect of this regulation            document referenced a summary of the
                                                178 (see also Unit I.C. of the                          and may also request a hearing on those               petition prepared by Bayer CropScience,
                                                SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              the registrant, which is available in the
                                                ADDRESSES: The docket for this action,                  or request a hearing on this regulation               docket, http://www.regulations.gov.
                                                identified by docket identification (ID)                in accordance with the instructions                   There were no comments received
                                                number EPA–HQ–OPP–2016–0083, is                         provided in 40 CFR part 178. To ensure                concerning this action for propamocarb
                                                available at http://www.regulations.gov                 proper receipt by EPA, you must                       in response to the notice of filing.
                                                or at the Office of Pesticide Programs                  identify docket ID number EPA–HQ–
                                                                                                        OPP–2016–0083 in the subject line on                  III. Aggregate Risk Assessment and
                                                Regulatory Public Docket (OPP Docket)                                                                         Determination of Safety
                                                in the Environmental Protection Agency                  the first page of your submission. All
                                                Docket Center (EPA/DC), West William                    objections and requests for a hearing                    Section 408(b)(2)(A)(i) of FFDCA
                                                Jefferson Clinton Bldg., Rm. 3334, 1301                 must be in writing, and must be                       allows EPA to establish a tolerance (the
                                                Constitution Ave. NW., Washington, DC                   received by the Hearing Clerk on or                   legal limit for a pesticide chemical
                                                20460–0001. The Public Reading Room                     before April 10, 2017. Addresses for                  residue in or on a food) only if EPA
                                                is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                  determines that the tolerance is ‘‘safe.’’
                                                Monday through Friday, excluding legal                  and hearing requests are provided in 40               Section 408(b)(2)(A)(ii) of FFDCA
                                                holidays. The telephone number for the                  CFR 178.25(b).                                        defines ‘‘safe’’ to mean that ‘‘there is a
                                                Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               reasonable certainty that no harm will
                                                and the telephone number for the OPP                    hearing request with the Hearing Clerk                result from aggregate exposure to the
                                                Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               pesticide chemical residue, including
                                                the visitor instructions and additional                 submit a copy of the filing (excluding                all anticipated dietary exposures and all
                                                information about the docket available                  any Confidential Business Information                 other exposures for which there is
                                                at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            reliable information.’’ This includes
                                                FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   exposure through drinking water and in
                                                Registration Division (7505P), Office of                pursuant to 40 CFR part 2 may be                      residential settings, but does not include
                                                Pesticide Programs, Environmental                       disclosed publicly by EPA without prior               occupational exposure. Section
                                                Protection Agency, 1200 Pennsylvania                    notice. Submit the non-CBI copy of your               408(b)(2)(C) of FFDCA requires EPA to
                                                Ave. NW., Washington, DC 20460–0001;                    objection or hearing request, identified              give special consideration to exposure
                                                main telephone number: (703) 305–                       by docket ID number EPA–HQ–OPP–                       of infants and children to the pesticide
                                                7090; email address: RDFRNotices@                       2016–0083, by one of the following                    chemical residue in establishing a
                                                epa.gov.                                                methods:                                              tolerance and to ‘‘ensure that there is a
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                                                                                                          • Federal eRulemaking Portal: http://               reasonable certainty that no harm will
                                                SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                result to infants and children from
                                                I. General Information                                  instructions for submitting comments.                 aggregate exposure to the pesticide
                                                                                                        Do not submit electronically any                      chemical residue. . . .’’
                                                A. Does this action apply to me?                        information you consider to be CBI or                    Consistent with FFDCA section
                                                  You may be potentially affected by                    other information whose disclosure is                 408(b)(2)(D), and the factors specified in
                                                this action if you are an agricultural                  restricted by statute.                                FFDCA section 408(b)(2)(D), EPA has


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                                                9520              Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations

                                                reviewed the available scientific data                     Effects in the route-specific dermal               effects caused by propamocarb-HCl as
                                                and other relevant information in                       and inhalation studies were primarily                 well as the no-observed-adverse-effect-
                                                support of this action. EPA has                         portal-of-entry effects. Dermal exposure              level (NOAEL) and the lowest-observed-
                                                sufficient data to assess the hazards of                caused dermal irritation in rats and                  adverse-effect-level (LOAEL) from the
                                                and to make a determination on                          rabbits at relatively high doses (>500                toxicity studies can be found at http://
                                                aggregate exposure for propamocarb-HCl                  milligram/kilogram/day (mg/kg/day)).                  www.regulations.gov in document,
                                                including exposure resulting from the                   Inhalation exposure caused labored                    ‘‘Propamocarb Hydrochloride
                                                tolerances established by this action.                  breathing and the appearance of red                   (propamocarb-HCl): Human Health
                                                EPA’s assessment of exposures and risks                 material around the nose. Systemic                    Assessment for Registration Review and
                                                associated with propamocarb-HCl                         effects were observed following                       a Petition for Increasing the Permanent
                                                follows.                                                inhalation exposure at similar doses that             Tolerance for Residues in/on Potato’’ at
                                                                                                        caused portal-of-entry effects and                    pp. 16–18 in docket ID number EPA–
                                                A. Toxicological Profile
                                                                                                        included kidney cysts and changes in                  HQ–OPP–2016–0083.
                                                   EPA has evaluated the available                      hematological parameters.
                                                toxicity data and considered its validity,                                                                    B. Toxicological Points of Departure/
                                                                                                           Effects were observed in fetuses and
                                                completeness, and reliability as well as                                                                      Levels of Concern
                                                                                                        offspring in the database at the same
                                                the relationship of the results of the                  doses that elicited less severe effects in               Once a pesticide’s toxicological
                                                studies to human risk. EPA has also                     parental animals. In the developmental                profile is determined, EPA identifies
                                                considered available information                        rat study, fetal effects included                     toxicological points of departure (POD)
                                                concerning the variability of the                       increased death, increased incidences of              and levels of concern to use in
                                                sensitivities of major identifiable                     minor skeletal anomalies, increased                   evaluating the risk posed by human
                                                subgroups of consumers, including                       incidences of small fetus, inter-atrial               exposure to the pesticide. For hazards
                                                infants and children.                                   septal defects, and hemorrhage in the                 that have a threshold below which there
                                                   Propamocarb-HCl is a List C                          ears, upper GI tract, and nasopharynx/                is no appreciable risk, the toxicological
                                                carbamate fungicide with specific                       sinuses. Maternal effects consisted of                POD is used as the basis for derivation
                                                activity against numerous Oomycete                      decreased absolute body-weights,                      of reference values for risk assessment.
                                                species, which cause foliar diseases and                decreased food consumption, post-                     PODs are developed based on a careful
                                                seedling, seed, root, foot, and stem rot                implantation loss, and mortality. In the              analysis of the doses in each
                                                in various edible and ornamental crops.                 rat two-generation reproduction study,                toxicological study to determine the
                                                   Consistent with other carbamates,                    offspring effects consisted of deaths,                dose at which the NOAEL and the
                                                propamocarb-HCl’s database showed                       decreased weights, and decreased                      LOAEL are identified. Uncertainty/
                                                evidence of neurotoxicity in rats, though               viability and lactation indices and litter            safety factors are used in conjunction
                                                it does not inhibit cholinesterase.                     size. Parental effects were consistent                with the POD to calculate a safe
                                                Neurotoxic effects include decreased                    with those previously described for                   exposure level—generally referred to as
                                                motor activity following acute exposure                 adults in the hazard database.                        a population-adjusted dose (PAD) or a
                                                and vacuolization of the choroid plexus                 Reproductive effects consisted of                     reference dose (RfD)—and a safe margin
                                                (ventricles of the brain which produce                  increased vacuolization and decreased                 of exposure (MOE). For non-threshold
                                                cerebral spinal fluid) following                        weight of the epididymides, decreased                 risks, the Agency assumes that any
                                                subchronic and chronic durations.                       sperm counts and motility, and                        amount of exposure will lead to some
                                                Other effects observed are indicative of                abnormal sperm morphology.                            degree of risk. Thus, the Agency
                                                toxicity to the digestive and GI tracts in                 Propamocarb-HCl was categorized as                 estimates risk in terms of the probability
                                                dogs (chronic erosive gastritis,                        having low acute toxicity via the oral,               of an occurrence of the adverse effect
                                                vacuolization of the salivary gland and                 dermal, and inhalation routes (Toxicity               expected in a lifetime. For more
                                                stomach), and the eye in dogs and rats                  Categories III–IV). It is not a dermal                information on the general principles
                                                (hyporeflectability of the fundus, retinal              irritant or a dermal sensitizer. It is                EPA uses in risk characterization and a
                                                degeneration, and vacuolization of the                  considered a slight eye irritant.                     complete description of the risk
                                                retinal gland). In all species, decreases                  EPA classified propamocarb-HCl as                  assessment process, see http://
                                                in body weights, body-weight gains, and                 ‘‘not likely to be carcinogenic to                    www.epa.gov/pesticides/factsheets/
                                                food consumption were observed                          humans’’ by all routes of exposure based              riskassess.htm.
                                                following subchronic and chronic                        upon lack of evidence of carcinogenicity                 A summary of toxicological endpoints
                                                exposure. Available immunotoxicity                      in rats and mice.                                     for propamocarb-HCl used for human-
                                                data does not indicate an immunotoxic                      Specific information on the studies                health risk assessment is shown in
                                                effect from exposure to propamocarb.                    received and the nature of the adverse                Table 1 of this unit.

                                                  TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPAMOCARB FOR USE IN HUMAN HEALTH RISK
                                                                                             ASSESSMENT
                                                                                         Point of departure        RfD, PAD, LOC for
                                                       Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                                    risk assessment
                                                                                           safety factors

                                                Acute dietary (Females 13–50           NOAEL = 150 mg/            Acute RfD = 1.5 mg/        Developmental Toxicity Study-Rabbit LOAEL = 300 mg/kg/day
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                                                  years of age).                        kg/day.                     kg/day.                    based on post-implantation loss.
                                                                                       UFA = 10x                  aPAD = 1.5 mg/kg/
                                                                                       UFH = 10x                    day.
                                                                                       FQPA SF = 1x




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                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                         9521

                                                  TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPAMOCARB FOR USE IN HUMAN HEALTH RISK
                                                                                       ASSESSMENT—Continued
                                                                                         Point of departure        RfD, PAD, LOC for
                                                       Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                                    risk assessment
                                                                                           safety factors

                                                Acute dietary (General popu-           NOAEL = 200 mg/            Acute RfD = 2 mg/          Acute Neurotoxicity Screening Battery—Rat LOAEL = 2,000
                                                  lation including infants and          kg/day.                     kg/day.                    mg/kg/day based on decreased motor activity.
                                                  children).                           UFA = 10x                  aPAD = 2 mg/kg/day
                                                                                       UFH = 10x
                                                                                       FQPA SF = 1x
                                                Chronic dietary (All populations)      NOAEL = 12 mg/kg/          Chronic RfD = 0.12         Carcinogenicity Study—Mouse LOAEL = 95 mg/kg/day based
                                                                                        day.                        mg/kg/day.                 on decreased absolute body-weights in females.
                                                                                       UFA = 10x                  cPAD = 0.12 mg/kg/
                                                                                       UFH = 10x                    day.
                                                                                       FQPA SF = 1x

                                                Cancer (Oral, dermal, inhala-          Classification: ‘‘not likely to be carcinogenic to humans’’ based on the absence of treatment-related tumors in
                                                  tion).                               two adequate rodent carcinogenicity studies.
                                                  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).


                                                C. Exposure Assessment                                  not use anticipated residue and/or PCT                into the dietary exposure model. For
                                                   1. Dietary exposure from food and                    information in the dietary assessment                 acute dietary risk assessment, the water
                                                feed uses. In evaluating dietary                        for propamocarb. Tolerance level                      concentration value of 4,860 ppb was
                                                exposure to propamocarb, EPA                            residues and/or 100 PCT were assumed                  used to assess the contribution to
                                                                                                        for all food commodities.                             drinking water. For chronic dietary risk
                                                considered exposure under the
                                                                                                          2. Dietary exposure from drinking                   assessment, the water concentration of
                                                petitioned-for tolerances as well as all
                                                                                                        water. The Agency used screening level                value 385 ppb was used to assess the
                                                existing propamocarb tolerances in 40                   water exposure models in the dietary                  contribution to drinking water.
                                                CFR 180.499. EPA assessed dietary                       exposure analysis and risk assessment                    3. From non-dietary exposure. The
                                                exposures from propamocarb in food as                   for propamocarb in drinking water.                    term ‘‘residential exposure’’ is used in
                                                follows:                                                These simulation models take into                     this document to refer to non-
                                                   i. Acute exposure. Quantitative acute                account data on the physical, chemical,               occupational, non-dietary exposure
                                                dietary exposure and risk assessments                   and fate/transport characteristics of                 (e.g., for lawn and garden pest control,
                                                are performed for a food-use pesticide,                 propamocarb. Further information                      indoor pest control, termiticides, and
                                                if a toxicological study has indicated the              regarding EPA drinking water models                   flea and tick control on pets).
                                                possibility of an effect of concern                     used in pesticide exposure assessment                 Propamocarb is registered for use on
                                                occurring as a result of a 1-day or single              can be found at http://www.epa.gov/                   golf course turf, which may result in
                                                exposure. Such effects were identified                  oppefed1/models/water/index.htm.                      dermal post-application exposures.
                                                for propamocarb. In estimating acute                      The revised estimated drinking water                Although potential dermal post-
                                                dietary exposure, EPA used food                         concentrations (EDWCs) are those                      application exposures were previously
                                                consumption information from the                        modeled for surface waters based on                   assessed (K. Lowe, 05/15/2013,
                                                United States Department of Agriculture                 current labels and newly submitted fate               D377624), EPA no longer considers the
                                                (USDA) 2003–2008 National Health and                    and transport data for the registration               effects found in the dermal study to be
                                                Nutrition Examination Survey, What We                   review of propamocarb-HCl. All                        adverse and therefore, no longer
                                                Eat in America, (NHANES/WWEIA). As                      currently labeled uses were assessed                  identifies a dermal hazard. As a result,
                                                to residue levels in food, EPA used                     including the potato tolerance increase               there is no need to conduct a
                                                tolerance-level residues and assumed                    described in this action.                             quantitative residential exposure
                                                100% crop treated (PCT) for all                           Surface water values were obtained                  assessment.
                                                commodities.                                            from FLnurserySTD_V2 model for the                       4. Cumulative effects from substances
                                                   ii. Chronic exposure. In conducting                  acute value, and NJnurserySTD_V2                      with a common mechanism of toxicity.
                                                the chronic dietary exposure assessment                 model for the chronic values                          Section 408(b)(2)(D)(v) of FFDCA
                                                EPA used the food consumption data                      representing foliar application to                    requires that, when considering whether
                                                from the USDA 2003–2008 NHANES/                         ornamentals in nurseries. Ground Water                to establish, modify, or revoke a
                                                WWEIA. As to residue levels in food,                    acute and chronic values were obtained                tolerance, the Agency consider
                                                EPA used tolerance-level residues and                   from FLCITRUS_STD.SCN GW scenario.                    ‘‘available information’’ concerning the
                                                assumed 100 PCT for all commodities.                       The EDWCs of propamocarb for acute                 cumulative effects of a particular
                                                   iii. Cancer. Based on the data                       exposures are 4,860 parts per billion                 pesticide’s residues and ‘‘other
                                                summarized in Unit III.A., EPA has                      (ppb) for surface water, and 73 ppb for               substances that have a common
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                                                concluded that propamocarb does not                     ground water. The EDWCs of                            mechanism of toxicity.’’ EPA has not
                                                pose a cancer risk to humans. Therefore,                propamocarb for chronic exposure for                  found propamocarb to share a common
                                                a dietary exposure assessment for the                   non-cancer assessments are 385 ppb for                mechanism of toxicity with any other
                                                purpose of assessing cancer risk is                     surface water, and 70 ppb for ground                  substances, and propamocarb does not
                                                unnecessary.                                            water.                                                appear to produce a toxic metabolite
                                                   iv. Anticipated residue and percent                     Modeled estimates of drinking water                produced by other substances. Although
                                                crop treated (PCT) information. EPA did                 concentrations were directly entered                  a carbamate, propamocarb-HCl is not an


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                                                9522              Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations

                                                N-methyl carbamate and does not cause                   LOAEL values and the selected                         propamocarb is not expected to pose a
                                                cholinesterase inhibition. Thus, it was                 endpoints are protective of the observed              short-term or intermediate-term risk.
                                                not included in the N-methyl carbamate                  effects.
                                                                                                           iii. Although there is evidence of                 IV. Other Considerations
                                                cumulative risk assessment. For the
                                                purposes of this tolerance action,                      increased qualitative susceptibility from             A. Analytical Enforcement Methodology
                                                therefore, EPA has assumed that                         exposure to propamocarb, there is no
                                                propamocarb does not have a common                      need to retain the 10X FQPA SF                           A gas chromatography/nitrogen-
                                                mechanism of toxicity with other                        because: (1) The effects are well                     phosphorus detection (GC/NPD) method
                                                substances. For information regarding                   characterized; (2) clear NOAELs were                  is available for the enforcement of
                                                EPA’s efforts to determine which                        established; (3) the endpoints selected               residues of propamocarb in plant
                                                chemicals have a common mechanism                       are protective of these effects; and (4)              commodities. This method has
                                                of toxicity and to evaluate the                         the effects were seen in the presence of              undergone a successful independent
                                                cumulative effects of such chemicals,                   maternal/parental toxicity.                           laboratory validation (ILV) and petition
                                                see EPA’s Web site at http://                              iv. There are no residual uncertainties            method validation (PMV), and is
                                                www.epa.gov/pesticides/cumulative.                      identified in the exposure databases.                 currently listed in the Pesticide
                                                                                                        The dietary food exposure assessments                 Analytical Manual (PAM) Vol. II. An
                                                D. Safety Factor for Infants and                        were performed based on 100 PCT and                   adequate liquid chromatography with
                                                Children                                                tolerance-level residues. EPA made                    tandem mass spectrometry (LC/MS/MS)
                                                   1. In general. Section 408(b)(2)(C) of               conservative (protective) assumptions in              for the enforcement of residues of
                                                FFDCA provides that EPA shall apply                     the ground and surface water modeling                 propamocarb and its metabolites in
                                                an additional tenfold (10X) margin of                   used to assess exposure to propamocarb                livestock commodities has been
                                                safety for infants and children in the                  in drinking water. These assessments                  submitted to the Agency. This method
                                                case of threshold effects to account for                will not underestimate the exposure and               has undergone successful ILVs and a
                                                prenatal and postnatal toxicity and the                 risks posed by propamocarb.                           PMV. The results of a Food and Drug
                                                completeness of the database on toxicity                                                                      Administration (FDA) multiresidue
                                                                                                        E. Aggregate Risks and Determination of
                                                and exposure unless EPA determines                                                                            testing study indicate that propamocarb
                                                                                                        Safety
                                                based on reliable data that a different                                                                       and its metabolites are not recovered by
                                                margin of safety will be safe for infants                  EPA determines whether acute and                   any of the protocols. The recoveries of
                                                and children. This additional margin of                 chronic dietary pesticide exposures are               propamocarb with the QuEChERS
                                                safety is commonly referred to as the                   safe by comparing aggregate exposure                  multiresidue method are marginally
                                                Food Quality Protection Act Safety                      estimates to the acute PAD (aPAD) and                 adequate (68–69%; http://www.crl-
                                                Factor (FQPA SF). In applying this                      chronic PAD (cPAD). For linear cancer                 pesticides.eu/library/docs/fv/CRLFV_
                                                provision, EPA either retains the default               risks, EPA calculates the lifetime                    Multiresidue_methods.pdf).
                                                value of 10X, or uses a different                       probability of acquiring cancer given the
                                                additional safety factor when reliable                  estimated aggregate exposure. Short-,                 B. International Residue Limits
                                                data available to EPA support the choice                intermediate-, and chronic-term risks                    In making its tolerance decisions, EPA
                                                of a different factor.                                  are evaluated by comparing the                        seeks to harmonize U.S. tolerances with
                                                   2. Prenatal and postnatal sensitivity.               estimated aggregate food, water, and                  international standards whenever
                                                There is no evidence of increased                       residential exposure to the appropriate               possible, consistent with U.S. food
                                                quantitative pre- or post-natal                         PODs to ensure that an adequate MOE                   safety standards and agricultural
                                                susceptibility following exposure to                    exists.                                               practices. EPA considers the
                                                propamocarb-HCl. There is evidence of                      1. Acute risk. Using the exposure                  international maximum residue limits
                                                increased qualitative susceptibility in                 assumptions discussed in this unit for                (MRLs) established by the Codex
                                                the database; however, concern for these                acute exposure, the acute dietary                     Alimentarius Commission (Codex), as
                                                effects is low because: (1) The effects are             exposure from food and water to                       required by FFDCA section 408(b)(4).
                                                well characterized, (2) clear NOAELs                    propamocarb will occupy 21% of the                    The Codex Alimentarius is a joint
                                                were established, (3) the endpoints                     aPAD for females (13–49 years old) and                United Nations Food and Agriculture
                                                selected are protective of these effects,               42% of the aPAD for infants (<1 year                  Organization/World Health
                                                and (4) the effects were seen in the                    old), the population group receiving the              Organization food standards program,
                                                presence of maternal/parental toxicity.                 greatest exposure.                                    and it is recognized as an international
                                                   3. Conclusion. EPA has determined                       2. Chronic risk. Using the exposure
                                                                                                                                                              food safety standards-setting
                                                that reliable data show the safety of                   assumptions described in this unit for
                                                                                                                                                              organization in trade agreements to
                                                infants and children would be                           chronic exposure, EPA has concluded
                                                                                                                                                              which the United States is a party. EPA
                                                adequately protected if the FQPA SF                     that chronic exposure to propamocarb
                                                                                                                                                              may establish a tolerance that is
                                                were reduced to 1X. That decision is                    from food and water will utilize 26% of
                                                                                                                                                              different from a Codex MRL; however,
                                                based on the following findings:                        the cPAD for children (3–5 years old)
                                                                                                                                                              FFDCA section 408(b)(4) requires that
                                                   i. The toxicity database for                         the population group receiving the
                                                                                                                                                              EPA explain the reasons for departing
                                                propamocarb is complete.                                greatest exposure. There are no chronic
                                                   ii. Although there was evidence of                                                                         from the Codex level.
                                                                                                        or long-term residential exposures from
                                                neurotoxicity (decreased motor activity                 uses of propamocarb.                                     The Codex has established a MRL for
                                                and vacuolization of the choroid plexus)                   3. Short-term and intermediate-term                propamocarb in or on potato at 0.30
                                                in several studies following                            risk. Short-term and intermediate-term                ppm. This MRL is the same as the
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                                                propamocarb-HCl exposure, including                     aggregate exposure takes into account                 tolerance established for propamocarb
                                                the ACN and SCN studies; there is no                    short-term and intermediate-term                      in the United States.
                                                need for a developmental neurotoxicity                  residential exposure plus chronic                     V. Conclusion
                                                study or additional uncertainty factors                 exposure to food and water (considered
                                                (UFs) to account for neurotoxicity                      to be a background exposure level).                     Therefore, a tolerance is established
                                                because the neurotoxicity effects are                   Because no short-term or intermediate-                for residues of propamocarb in or on
                                                well-characterized with clear NOAEL/                    term adverse effect was identified,                   potato at 0.30 ppm.


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                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                                  9523

                                                VI. Statutory and Executive Order                       described under Title II of the Unfunded                      ENVIRONMENTAL PROTECTION
                                                Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                          AGENCY
                                                   This action establishes a tolerance                  1501 et seq.).
                                                under FFDCA section 408(d) in                                                                                         40 CFR Part 180
                                                                                                          This action does not involve any
                                                response to a petition submitted to the                 technical standards that would require                        [EPA–HQ–OPP–2016–0594; FRL–9958–07]
                                                Agency. The Office of Management and                    Agency consideration of voluntary
                                                Budget (OMB) has exempted these types                   consensus standards pursuant to section                       2,4–D; Pesticide Tolerances
                                                of actions from review under Executive                  12(d) of the National Technology                              AGENCY:  Environmental Protection
                                                Order 12866, entitled ‘‘Regulatory                      Transfer and Advancement Act                                  Agency (EPA).
                                                Planning and Review’’ (58 FR 51735,                     (NTTAA) (15 U.S.C. 272 note).                                 ACTION: Final rule.
                                                October 4, 1993). Because this action
                                                has been exempted from review under                     VII. Congressional Review Act                                 SUMMARY:   This regulation establishes a
                                                Executive Order 12866, this action is                                                                                 tolerance for residues of 2,4–D in or on
                                                not subject to Executive Order 13211,                     Pursuant to the Congressional Review
                                                                                                                                                                      cotton, gin byproducts and amends the
                                                entitled ‘‘Actions Concerning                           Act (5 U.S.C. 801 et seq.), EPA will                          existing tolerance on cotton, undelinted
                                                Regulations That Significantly Affect                   submit a report containing this rule and                      seed. Dow AgroSciences requested these
                                                Energy Supply, Distribution, or Use’’ (66               other required information to the U.S.                        tolerances under the Federal Food,
                                                FR 28355, May 22, 2001) or Executive                    Senate, the U.S. House of                                     Drug, and Cosmetic Act (FFDCA).
                                                Order 13045, entitled ‘‘Protection of                   Representatives, and the Comptroller                          DATES: This regulation is effective
                                                Children from Environmental Health                      General of the United States prior to                         February 7, 2017. Objections and
                                                Risks and Safety Risks’’ (62 FR 19885,                  publication of the rule in the Federal                        requests for hearings must be received
                                                April 23, 1997). This action does not                   Register. This action is not a ‘‘major                        on or before April 10, 2017, and must
                                                contain any information collections                     rule’’ as defined by 5 U.S.C. 804(2).                         be filed in accordance with the
                                                subject to OMB approval under the                                                                                     instructions provided in 40 CFR part
                                                                                                        List of Subjects in 40 CFR Part 180
                                                Paperwork Reduction Act (PRA) (44                                                                                     178 (see also Unit I.C. of the
                                                U.S.C. 3501 et seq.), nor does it require                 Environmental protection,                                   SUPPLEMENTARY INFORMATION).
                                                any special considerations under                        Administrative practice and procedure,                        ADDRESSES: The docket for this action,
                                                Executive Order 12898, entitled                         Agricultural commodities, Pesticides                          identified by docket identification (ID)
                                                ‘‘Federal Actions to Address                            and pests, Reporting and recordkeeping                        number EPA–HQ–OPP–2016–0594, is
                                                Environmental Justice in Minority                       requirements.                                                 available at http://www.regulations.gov
                                                Populations and Low-Income                                                                                            or at the Office of Pesticide Programs
                                                Populations’’ (59 FR 7629, February 16,                    Dated: January 6, 2017.
                                                                                                                                                                      Regulatory Public Docket (OPP Docket)
                                                1994).                                                  Daniel J. Rosenblatt,                                         in the Environmental Protection Agency
                                                   Since tolerances and exemptions that                 Acting Director, Registration Division, Office                Docket Center (EPA/DC), West William
                                                are established on the basis of a petition              of Pesticide Programs.                                        Jefferson Clinton Bldg., Rm. 3334, 1301
                                                under FFDCA section 408(d), such as                                                                                   Constitution Ave. NW., Washington, DC
                                                the tolerance in this final rule, do not                  Therefore, 40 CFR chapter I is
                                                                                                                                                                      20460–0001. The Public Reading Room
                                                require the issuance of a proposed rule,                amended as follows:
                                                                                                                                                                      is open from 8:30 a.m. to 4:30 p.m.,
                                                the requirements of the Regulatory                                                                                    Monday through Friday, excluding legal
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                  PART 180—[AMENDED]
                                                                                                                                                                      holidays. The telephone number for the
                                                seq.), do not apply.                                                                                                  Public Reading Room is (202) 566–1744,
                                                   This action directly regulates growers,              ■ 1. The authority citation for part 180
                                                                                                                                                                      and the telephone number for the OPP
                                                food processors, food handlers, and food                continues to read as follows:
                                                                                                                                                                      Docket is (703) 305–5805. Please review
                                                retailers, not States or tribes, nor does                   Authority: 21 U.S.C. 321(q), 346a and 371.                the visitor instructions and additional
                                                this action alter the relationships or                                                                                information about the docket available
                                                distribution of power and                               ■  2. In § 180.499, revise the entry for                      at http://www.epa.gov/dockets.
                                                responsibilities established by Congress                ‘‘Potato’’ in the table in paragraph (a) to
                                                                                                                                                                      FOR FURTHER INFORMATION CONTACT:
                                                in the preemption provisions of FFDCA                   read as follows:
                                                section 408(n)(4). As such, the Agency                                                                                Michael Goodis, Registration Division
                                                has determined that this action will not                § 180.499 Propamocarb; tolerances for                         (7505P), Office of Pesticide Programs,
                                                have a substantial direct effect on States              residues.                                                     Environmental Protection Agency, 1200
                                                or tribal governments, on the                                                                                         Pennsylvania Ave. NW., Washington,
                                                                                                            (a) * * *                                                 DC 20460–0001; main telephone
                                                relationship between the national
                                                government and the States or tribal                                                                                   number: (703) 305–7090; email address:
                                                                                                                                                       Parts per      RDFRNotices@epa.gov.
                                                governments, or on the distribution of                              Commodity                           million
                                                power and responsibilities among the                                                                                  SUPPLEMENTARY INFORMATION:
                                                various levels of government or between                                                                               I. General Information
                                                the Federal Government and Indian                       *            *             *             *         *
                                                tribes. Thus, the Agency has determined                                                                               A. Does this action apply to me?
                                                that Executive Order 13132, entitled                    Potato ...................................             0.30      You may be potentially affected by
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                               this action if you are an agricultural
mstockstill on DSK3G9T082PROD with RULES




                                                1999) and Executive Order 13175,                        *            *             *             *         *          producer, food manufacturer, or
                                                entitled ‘‘Consultation and Coordination                                                                              pesticide manufacturer. The following
                                                with Indian Tribal Governments’’ (65 FR                                                                               list of North American Industrial
                                                67249, November 9, 2000) do not apply                   *       *        *         *        *                         Classification System (NAICS) codes is
                                                                                                        [FR Doc. 2017–02479 Filed 2–6–17; 8:45 am]
                                                to this action. In addition, this action                                                                              not intended to be exhaustive, but rather
                                                                                                        BILLING CODE 6560–50–P
                                                does not impose any enforceable duty or                                                                               provides a guide to help readers
                                                contain any unfunded mandate as                                                                                       determine whether this document


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Document Created: 2017-02-07 00:27:50
Document Modified: 2017-02-07 00:27:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective February 7, 2017. Objections and requests for hearings must be received on or before April 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactRegistration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 9519 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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