[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Rules and Regulations]
[Pages 88627-88634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29245]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0496, EPA-HQ-OPP-2012-0841; FRL-9954-37]


Dicamba; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of dicamba 
in or on cotton, gin byproducts; cotton, undelinted seed; soybean, 
forage; and soybean, hay. Monsanto Company requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 8, 2016. Objections and 
requests for hearings must be received on or before February 6, 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).

[[Page 88628]]


ADDRESSES: The dockets for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0496 for soybeans and EPA-
HQ-OPP-2012-0841 for cotton respectively are available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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-2010-0496 and EPA-HQ-OPP-2012-0841 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 February 6, 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-2010-0496 and EPA-
HQ-OPP-2012-0841, by one of the following methods:
     Federal e-Rulemaking 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 August 4, 2010 (75 FR 46924) (FRL-8834-
9) and December 19, 2012 (77 FR 75082) (FRL-9372-6), EPA issued a 
document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 0F7725 and 2F8067, 
respectively) by Monsanto Company, 1300 I St. NW., Suite 450 East, 
Washington, DC 20052. The petitions requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide 
dicamba, 3,6-dichloro-o-anisic acid and its metabolites 3,6-dichloro-5-
hydroxy-o-anisic acid (5-OH dicamba) and 3,6-dichloro-2-hydroxybenzoic 
acid (DCSA), as follows: PP 0F7725 requested tolerances for residues in 
or on soybean, forage at 45 parts per million (ppm) and soybean, hay at 
70 ppm and PP 2F8067 requested tolerances for residues in or on cotton, 
undelinted seed at 3 ppm and cotton, gin byproducts at 70 ppm. Those 
documents referenced summaries of the petitions prepared by Monsanto 
Company, the registrant, which are available in the dockets, http://www.regulations.gov. Comments were received, and EPA's responses to 
these comments are discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances for soybean, forage and soybean, hay that are 
higher than requested. The reason for these changes are explained in 
Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity,

[[Page 88629]]

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 sub-groups of consumers, including infants and children.
    For dicamba, toxicology studies for dicamba acid; its salts 
(isopropylamine (IPA), diglycolamine (DGA), and N, N-Bis-(3-
aminopropyl) methylamine (BAPMA)); and its plant metabolites (DCSA (3, 
6-dichlorosalicylic acid) and DCGA (3, 6-dichlorogentisic acid)) were 
all considered for risk assessment. The dicamba BAPMA salt is the BAPMA 
base added to the dicamba acid form. The DCSA exposure is primarily 
from dietary exposures (food + water) from uses on transgenic crops, 
and the dicamba acid exposure is relevant for the incidental oral 
exposure. In scenarios where co-exposure to the various forms could 
occur, the most protective point of departure (POD) was utilized for 
regulation.
    Neurotoxic signs (e.g., ataxia, decreased motor activity, impaired 
righting reflex and gait) were observed in dicamba acid studies in rats 
and rabbits at doses over 150 mg/kg/day. The DCSA metabolite is less 
neurotoxic than dicamba acid, although a rat developmental study 
involving the BAPMA salt indicated neurotoxic effects (e.g., unsteady 
gait, ataxia, and convulsions) at lower doses (86 mg/kg/day).
    The rat reproduction study and the developmental studies in rats 
and rabbits showed no evidence (qualitative or quantitative) for 
increased susceptibility following in utero or postnatal exposure of 
dicamba acid or its salts. In the rabbit developmental toxicity study, 
a single incidence of abortion (1/20 does) was seen at doses that also 
caused maternal toxicity, as evidenced by clinical signs of 
neurotoxicity. In a 2-generation reproductive toxicity study involving 
dicamba acid, offspring toxicity was manifested as decreases in pup 
weight at a dose where parental toxicity was also observed. There was 
however, an indication of potential increased quantitative 
susceptibility from exposure to the metabolite DCSA (decreased pup body 
weight was observed at 37 mg/kg/day, where no parental toxic effects 
were noted).
    Dicamba is classified as ``not likely to be carcinogenic to 
humans''. Mutagenicity studies did not demonstrate mutagenic concern 
for dicamba. There was no evidence of dermal or systemic toxicity 
following repeated dermal application of dicamba acid or the salts at 
the limit dose (1,000 mg/kg/day). There is no concern for 
immunotoxicity following exposure to dicamba. Following oral 
administration, dicamba is rapidly absorbed and rapidly excreted in 
urine and feces without significant metabolism. Dicamba has a low acute 
toxicity via the oral, dermal or inhalation route (Acute Toxicity 
Categories III or IV). It is an eye and dermal irritant but it is not a 
skin sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by dicamba 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 Dicamba and Dicamba BAPMA salt: Human-
Health risk Assessment for Proposed Section 3 New Uses on dicamba-
tolerant Cotton and Soybean in docket ID number EPA-HQ-OPP-2016-0187.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for dicamba used for human 
risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Dicamba Acid and Dicamba BAPMA Salt for Use in Human
                                             Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13 to 50    Not Applicable (NA).  NA.................  No developmental toxicity
 years of age).                                                                attributed to acute exposure in
                                                                               the toxicity database.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 29 mg/kg/day  Acute RfD = 0.29 mg/ Developmental Rat Study Dicamba
 including infants and children).  UFA = 10x...........   kg/day.              BAPMA.
                                   UFH = 10x...........  aPAD = 0.29 mg/kg/   LOAEL = 86 mg/kg/day in dams based
                                   FQPA SF = 1x........   day.                 on ataxia, unsteady gait and
                                                                               convulsions observed shortly
                                                                               after dosing.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  Offspring NOAEL= 4    Chronic RfD = 0.04   Reproductive Rat Study with
                                    mg/kg/day.            mg/kg/day.           Metabolite DCSA.
                                   UFA = 10x...........  cPAD = 0.04 mg/kg/   Offspring LOAEL = 37 mg/kg/day
                                   UFH = 10x...........   day.                 based on decreased pup weights in
                                   FQPA SF = 1x........                        F1 generation PND 14 and 21 (both
                                                                               sexes) and week 18 (females).
----------------------------------------------------------------------------------------------------------------

[[Page 88630]]

 
Incidental oral short- (1 to 30    Offspring NOAEL= 136  Residential LOC for  Reproductive Study in Rats with
 days) and intermediate- (1 to 6    mg/kg/day.            MOE = 100.           Dicamba Acid Offspring.
 months) term.                     UFA = 10x...........                       LOAEL = 450 mg/kg/day based on
                                   UFH = 10x...........                        decreased pup weights.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
No endpoints for assessing dermal risk were identified since the dermal toxicology studies for dicamba acid, IPA
 and DGA salts all had NOAELs of 1,000 mg/kg/day..
----------------------------------------------------------------------------------------------------------------
Inhalation short-, intermediate-,  Inhalation study      Residential LOC for  Aerosol Inhalation Rat Study with
 and long-term.                     NOAEL = 0.005 mg/L.   MOE = 30.            Dicamba Acid.
                                   UFA = 3x............                       LOAEL = 0.050 mg/L based on
                                   UFH = 10x...........                        minimal multifocal bronchiole-
                                   FQPA SF = 1x........                        alveolar hyperplasia in males,
                                                                               multiple microscopic findings in
                                                                               the lung and associated lymph
                                                                               nodes in females.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)       Dicamba is classified as ``not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. PND = postnatal
  day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dicamba, EPA considered exposure under the petitioned-for 
tolerances as well as all existing dicamba tolerances in 40 CFR 
180.227. EPA assessed dietary exposures from dicamba 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 dicamba. 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 levels and 100 percent 
crop treated (PCT) for the acute dietary exposure assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA used average 
residues based on field trial studies for crops, tolerance levels for 
livestock commodities and relevant PCT data for several existing uses 
to assess chronic dietary exposure.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that dicamba 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. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows: 
Asparagus: 5%; barley: 5%; corn: 10%; oats: 2.5%; sorghum: 15%; 
sugarcane: 20%; sweet corn: 1%; and wheat: 10%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 to 7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The

[[Page 88631]]

maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant sub-populations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which dicamba may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for dicamba in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of dicamba. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of dicamba for 
acute exposures are calculated to be 53.37 parts per billion (ppb) for 
surface water and 329 ppb parent plus 0.041 ppb DCSA for ground water. 
For chronic exposures for non-cancer assessments are estimated to be 
44.5 ppb for surface water and 187 ppb parent plus 0.041 ppb DCSA for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The combined estimated 
drinking water residues (parent + DCSA) for peak concentration used in 
the acute assessment and chronic were 329 and 187 ug/L (ppb), 
respectively.
    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).
    There are no residential uses being proposed in connection with 
this action for either dicamba or the dicamba BAPMA salt; however, 
there are existing residential turf uses of dicamba that have been 
reassessed to reflect updates to the Agency's 2012 Residential Standard 
Operating Procedures (SOPs).
    There is no potential hazard via the dermal route for dicamba; 
therefore, the handler assessment includes only the inhalation route of 
exposure, and the post-application assessment includes only the 
incidental oral routes of exposure.
    The quantitative exposure/risk assessment developed for residential 
handlers to adults is based on the following lawn/turf application 
scenarios:

 Mix/Load/Apply Liquid with Hand-held Equipment
 Apply Ready-To-Use with Hand-held Equipment
 Load/Apply Granule with Hand-held Equipment

    The quantitative exposure/risk assessment for residential post-
application exposures to children is based on the following scenarios:
     Children (1 to <2 years old) incidental oral exposure to 
treated turf.
     Children (1 to <2 years old) episodic granular ingestion 
exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found dicamba to share a common mechanism of toxicity 
with any other substances, and dicamba does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that dicamba 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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
susceptibility to the young following in utero exposure to dicamba acid 
or its salts. Although quantitative offspring susceptibility was 
observed in the 2-generation reproduction study for the DCSA metabolite 
based on decreased pup weights, the degree of concern for the 
susceptibility is low because there is a well-established NOAEL for 
offspring toxicity in that study and DCSA has rapid clearance. 
Additionally, the current points of departure are health protective and 
therefore address the concern for offspring toxicity observed in this 
reproduction study.
    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 dicamba is complete for purposes of 
assessing the safety of existing and petitioned-for tolerances under 
the FFDCA.
    ii. Although consistent neurotoxic signs (e.g., ataxia, decreased 
motor activity, impaired righting reflex and gait) were observed in 
multiple studies in rats and rabbits, there is no need for a 
developmental neurotoxicity study to account for neurotoxicity for the 
following reasons: (1) Although clinical signs of neurotoxicity were 
seen in pregnant animals, no evidence of developmental anomalies of the 
fetal nervous system were observed in the

[[Page 88632]]

prenatal developmental toxicity studies, in either rats or rabbits, at 
maternally toxic doses up to 300 or 400 mg/kg/day, respectively; (2) 
there was no evidence of behavioral or neurological effects on the 
offspring in the two-generation reproduction study in rats; and (3) the 
ventricular dilation of the brain in the combined chronic toxicity and 
carcinogenicity study in rats was only observed in females at the high 
dose after two years of exposure at doses of 127 mg/kg/day. The 
significance of this dilation observation is questionable, since no 
similar histopathological finding was seen in two sub-chronic 
neurotoxicity studies at the limit dose or other chronic studies. 
Endpoints and points of departure chosen to quantify chronic risks are 
well below the dose level at which these effects were observed, and are 
therefore protective.
    iii. As indicated in Unit III.D.2., the degree of concern for 
potential susceptibility is low; therefore, there is no need to retain 
the 10X FQPA safety factor to address any concern for prenatal or 
postnatal exposure.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on tolerance-level residues for the acute dietary, and average field 
trial data and percent crop treated information for the chronic 
dietary. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to dicamba in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by dicamba.

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 dicamba will occupy 31% of the aPAD for all infants (<1 year old), 
the population sub-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 
dicamba from food and water will utilize 42% of the cPAD for children 1 
to 2 years old the population sub-group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
dicamba is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential post-application exposures to children (1 to 2 years 
old) on turf result in an aggregate MOE of 3,600. Because EPA's level 
of concern for dicamba is a MOE of 100 or below, this MOE is not of 
concern.
    EPA has determined that it is not appropriate to aggregate short-
term exposures for adults, since there was no dermal hazard identified 
in the route-specific dermal studies and the inhalation effects were 
not systemic.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
dicamba is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
dicamba.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies on dicamba acid and one on DCSA, dicamba is not expected to 
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to dicamba residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass 
spectrometer/mass spectrometer (LC/MS/MS) method, BASF Method D0902 is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for dicamba in or on soybean, 
forage; soybean, hay; and cotton, gin byproducts.
    The Codex has established a MRL for dicamba in or on cotton seed at 
0.04 ppm. This MRL is different than the tolerance being established 
for dicamba in or on cotton, undelinted seed at 3.0 ppm in the United 
States. Since the use pattern of dicamba on dicamba-tolerant cotton has 
been changed to late season, the currently established international 
tolerances are not adequate to cover residues likely from the new use 
in the United States. In addition, the dicamba residues of concern for 
dicamba-tolerant cotton also include the DCSA metabolite, which is not 
found nor regulated in the other common varieties of cotton. Therefore, 
harmonization with respect to the tolerance expression

[[Page 88633]]

is not possible at this time for cotton seed.

C. Response to Comments

    Several comments were received in both dockets EPA-HQ-OPP-2010-0496 
and EPA-HQ-OPP-2012-0841, objecting to any approval of new dicamba uses 
on cotton and soybeans under the Federal Insecticide, Fungicide, and 
Rodenticide Act. Several comments raised concerns about a sharp 
increase of dicamba use due to a longer application season, the 
possible spread of weed resistance, off-site drift to non-targets, 
volatility, negative environmental effects, possible threat to 
endangered species, and the negative impact the new uses may have on 
the U.S. agricultural business as a whole. These comments do not appear 
to be concerned with the issuance of the tolerances under the FFDCA, 
but rather the approval of the uses under FIFRA. In any event, the 
existing legal framework provided by section 408 of the FFDCA states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by the statute, taking into consideration human health 
impacts from aggregate exposure (including dietary and other non-
occupational exposure) from the pesticide and other related chemicals. 
The scope of review under the FFDCA does not extend to other 
environmental considerations. Therefore, the Agency is not addressing 
these comments here. Where appropriate, the Agency may address them in 
connection with the associated pending pesticide registration action.
    Comments were submitted in both docket EPA-HQ-OPP-2010-0496 and 
EPA-HQ-OPP-2012-0841 raising issues about the establishment of 
tolerances for dicamba on cotton and soybeans. Commenters raised 
concerns about the potential toxicity of dicamba, questioned the 
Agency's endpoint selection, and alleged that increased use of the 
pesticide would increase exposure to farmers and workers and dietary 
exposure. The Agency considered all the available toxicity and exposure 
data for dicamba and its sales and metabolites and determined that 
these tolerances are safe for the reasons spelled out in detail within 
the risk assessment Dicamba and Dicamba Salt: Human-Health Risk 
Assessment for Proposed Section 3 New Uses on Dicamba-tolerant Cotton 
and Soybean located in Docket ID number EPA-HQ-OPP-2016-0187 on  
Although many of the commenters' concerns are about toxicity that may 
occur or be associated with occupational exposure to dicamba and even 
though occupational exposure is outside the scope of the Agency's FFDCA 
safety analysis, the Agency did consider the available toxicity 
information and has concluded that dicamba does not pose risks of 
carcinogenicity or developmental toxicity. In addition, to take into 
account new toxicology received since the last risk assessment, the 
Agency has updated the chronic endpoint and is no longer relying on the 
endpoint about which the commenters expressed concern in their 
comments. The updated chronic reference dose takes into account all the 
available information, which has been updated since the 1987 Health 
Advisory that the commenters mention. The Agency also reviewed comments 
and requests for evaluating residue tolerances for dicamba tolerant 
crops and the tolerances proposed by a SOCC petition concurrently due 
to the potential dangers of dicamba drift and volatilization. After 
completing our final assessments of the new dicamba uses (which can be 
found in Docket ID # EPA-HQ-OPP-2016-0187) it has been determined that 
through proper label mitigations and restrictions, the Agency does not 
expect use of dicamba on cotton or soybeans to result in any 
inadvertent residues on neighboring crops. As a result, the Agency 
believes there is no need to establish tolerances for inadvertent 
residues on food crops as a result of the new uses for dicamba on 
cotton and soybean.
    Finally, the commenters expressed concern that approval of new uses 
would increase exposure to workers and urged the Agency to take into 
account the likely increased dietary exposure, including any residues 
of dicamba that are in cattle diets and livestock commodities from 
treated cotton plants, from increased use of dicamba from approval of 
these tolerances. Because the FFDCA directs EPA to aggregate non-
occupational exposure with dietary exposure, the Agency's assessment 
under the FFDCA does not assess the levels of occupational exposure to 
farmers and other workers. As to the dietary exposure, as noted in Unit 
III.C.1., the Agency considers exposure under the petitioned-for 
tolerances (including residues ingested by livestock diets that may 
result in residues livestock commodities) as well as all existing 
dicamba tolerances. Upon assessing those levels of exposure, the Agency 
has determined that these tolerances will be safe.

D. Revisions to Petitioned-For Tolerances

    Tolerances for soybean forage and hay requested by the petitioner 
were estimated using the North American Free Trade Agreement (NAFTA) 
MRL calculator. EPA is establishing tolerances, which differ from the 
proposed tolerances, based on the Organization for Economic Co-
operation Development (OECD) MRL calculation procedures, which is the 
Agency's current standard for determination of tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of dicamba, 3,6-
dichloro-2-methoxybenzoic acid, in or on cotton, gin byproducts at 70 
ppm; cotton, undelinted seed at 3.0 ppm; soybean, forage at 60 ppm; and 
soybean, hay at 100 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does

[[Page 88634]]

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: November 9, 2016.
Michael Goodis,
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.  180.227:
0
a. Remove from the table in paragraph (a)(1), the entry ``Cotton, 
undelinted seed''.
0
b. Add alphabetically the following entries to the table in paragraph 
(a)(3) ``Cotton, gin byproducts''; ``Cotton, undelinted seed''; 
``Soybean, forage''; and ``Soybean, hay''.
    The additions read as follows:


Sec.  180.227   Dicamba; tolerances for residues.

    (a) * * *
    (3) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................          70
Cotton, undelinted seed.....................................         3.0
 
                                * * * * *
Soybean, forage.............................................          60
Soybean, hay................................................         100
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-29245 Filed 12-7-16; 8:45 am]
 BILLING CODE 6560-50-P