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[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8301-8308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03077]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0791; FRL-9905-22]

Linuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of linuron 
in or on multiple commodities which are identified and discussed later 
in this document. This regulation additionally removes a tolerance with 
regional registrations in or on parsley leaves, as it will be 
superseded by a tolerance without regional registrations. IR-4 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 12, 2014. Objections and 
requests for hearings must be received on or before April 14, 2014, and 
must be filed in accordance with 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-2012-0791, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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-2012-0791 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 14, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).

[[Page 8302]]

    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-2012-0791, 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.htm.

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 November 7, 2012 (77 FR 66781) (FRL-
9367-5), 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 
2E8083) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.184 be amended by 
establishing tolerances for residues of the herbicide linuron, 3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea), and its metabolites, in or on 
cilantro, dried leaves at 27 parts per million (ppm); cilantro, fresh 
leaves at 3 ppm; dillweed, dried leaves at 7.1 ppm; dillweed, fresh 
leaves at 1.5 ppm; dill oil at 4.8 ppm; dill seed at 0.3 ppm; 
horseradish at 0.050 ppm; parsley, dried leaves at 8.3 ppm; parsley 
leaves at 3 ppm; and pea, dry, seed at 0.08 ppm. The petition 
additionally requested to delete the regional tolerance in 40 CFR 
180.184(c) for residues of linuron in or on parsley, leaves at 0.25 ppm 
upon approval of the requested tolerances for parsley leaves. That 
document referenced a summary of the petition prepared on behalf of IR-
4 by Syngenta Crop Protection, LLC, the registrant, which is available 
in the docket, http://www.regulations.gov. Comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Subsequent to the publication of the November 7, 2012 Federal 
Register notice, the petitioner submitted a second petition, in which 
it requested again the same tolerances noticed in the November 7, 2012 
Federal Register document and added a new request for a tolerance for 
residues of linuron and its metabolites in or on coriander seed at 0.01 
ppm. So, in the Federal Register of July 19, 2013 (78 FR 43115) (FRL-
9392-9), EPA issued another document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 2E8083) by IR-4, seeking tolerances for commodities as 
noted in the November 7, 2012 document as well as a tolerance for 
coriander seed at 0.01 ppm. That document referenced a summary of the 
petition prepared on behalf of IR-4 by Syngenta Crop Protection, LLC, 
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerances for several proposed commodities. The Agency has 
also determined that the tolerance expression should be revised for all 
commodities. The reasons 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 linuron including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with linuron 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.
    With repeated dosing in test animals, linuron produces two primary 
effects: (1) Changes in the hematopoetic system in rats, mice, and dogs 
and; (2) changes in the male reproductive system in developing rats. 
Lowest observed adverse effect levels (LOAELs) for hematological 
effects produced by linuron were substantially lower than LOAELs for 
reproductive effects. Dogs were shown to be most sensitive to the 
hematological effects, including hemolytic anemia characterized by 
slightly reduced hemoglobin, hematocrit, and erythrocyte counts 
accompanied by hemosiderin deposition in liver Kupffer cells. Secondary 
erythropogenic activity (erythroid hyperplasia of bone marrow) was also 
found. Systemic toxicity observed in mice included increased 
methemoglobin formation, vacuolation and hemosiderosis of the spleen, 
and decreased erythrocyte counts. In the chronic rat study, microscopic 
observations consistent with hemolysis (hemosiderin in Kupffer cells 
and increased hemosiderosis in bone marrow, spleen, and/or mesenteric 
lymph nodes) were found.
    The rat developmental study showed increased post-implantation 
loss, fetal resorptions, decreased litter size, and decreased fetal 
body weight. In the rabbit developmental toxicity study, an increased 
incidence of fetuses with skeletal skull variations was found. In the 
2-generation reproductive toxicity study, rats exposed to linuron 
during both development and adulthood had gross lesions of the testes 
(including reduction in size); abnormally soft and small epididymides, 
deformities of the epididymides, decreased pup survival, decreased 
weanling body weights, decreased liver and kidney weights; and 
increased incidence of offspring liver atrophy.

[[Page 8303]]

    The developmental effects on the reproductive system seen in the 
guideline studies are consistent with those reported in the published 
literature, though it should be noted that most of the literature 
studies employed dose levels of 100 milligrams/kilogram (mg/kg) or 
greater. The available data indicate that linuron inhibits 
transcriptional activity of dihydrotestosterone (DHT), human androgen 
receptor (hAR) in vitro, and steroidogenic enzymes. Additional findings 
indicate that linuron exposure decreases anogenital distance; may 
increase retention of areole/nipples in male rat offspring following in 
utero exposure; increases luteinizing hormone (LH) levels in F0 and F1 
male rats; reduces the size of androgen dependent tissues such as 
seminal vesicles, epididymis, and ventral prostate; and demonstrates a 
weak affinity for androgen receptors, which may decrease fetal 
testosterone synthesis (Refs 1, 2, 3, and 4). At this time, linuron has 
not been demonstrated to be an estrogen receptor antagonist (Ref 5). It 
should be emphasized that the toxicity endpoints based on the 
hematological effects for chronic exposures were derived from the 
chronic oral toxicity study in dogs. The point of departure (POD) for 
hematological effects was approximately 40X lower than the LOAEL that 
caused the testicular effects seen in the rat reproduction toxicity 
study.
    In rat and mouse carcinogenicity studies, linuron induced 
interstitial cell adenomas in the testes of rats and hepatocellular 
adenomas in mice. In a special study with aged rats, linuron induced 
hyperplasia and adenomas of the testes within 6 to 12 months. However, 
EPA has concluded that quantification of cancer risk is not necessary 
because both interstitial cell adenomas and hepatocellular adenomas 
were benign and show no progression towards malignancy. In addition, 
linuron was not mutagenic in bacteria or in cultured mammalian cells. 
There was also no indication of a clastogenic effect up to toxic doses 
in vivo. Finally, the cRFD is a NOAEL of 0.77 mg/kg/day, which would be 
protective of any tumors caused by linuron in the rat and mouse 
carcinogenicity study at higher doses.
    At the highest dose tested, the acute neurotoxicity study 
demonstrated that linuron produced changes in the parameters of the 
field observation battery (FOB). These changes included rats holding 
their heads low, crusty deposits on the nose, impaired mobility, 
ataxia, low arousal, decreased rearing, no reaction to tail pinch or 
startle, decreased righting reflex, reduced or no hindlimb extensor 
strength, decreased grip strength in both hindlimbs and forelimbs, 
reduced rotarod performance, decreased hindlimb footsplay, and 
increased catalepsy. At the lowest-observed-adverse-effect-level 
(LOAEL), linuron produced decreases in motor activity and rearing. No 
compound-related changes in neurohistopathology were observed at any of 
the tested dose levels. In addition, linuron did not show any signs of 
immunotoxicity in the submitted immunotoxicity study up to the highest 
dose tested.
    Specific information on the studies received and the nature of the 
adverse effects caused by linuron as well as the no-observed-adverse-
effect-level (NOAEL) and the LOAEL from the toxicity studies can be 
found at http://www.regulations.gov in document: ``Linuron: Section 3 
Human Health Risk Assessment for Proposed Use on Coriander, Dill, 
Horseradish, Parsley, Celeriac, Rhubarb, and Pea (Dry).'' at pages 33-
38 in docket ID number EPA-HQ-OPP-2012-0791. References for the 
published toxicity studies cited in this section may be found Unit VI.

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 linuron used for human risk assessment is shown in Table 
1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Linuron 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 13-49       NOAEL = 12 mg/kg/day  Acute RfD = 0.12 mg/ Rat Developmental Toxicity.
 years of age).                    UFA = 10X...........   kg/day              LOAEL = 50 mg/kg/day based on
                                   UFH = 10X...........  aPAD = 0.12 mg/kg/    increased post-implantation loss
                                   FQPA SF = 1X........   day.                 and fetal/litter resorptions.
Acute dietary (General population  NOAEL = 20 mg/kg/day  Acute RfD = 0.2 mg/  Acute Neurotoxicity Study (Rat).
 including infants and children).  UFA = 10X...........   kg/day.             LOAEL = 100 mg/kg based on
                                   UFH = 10X...........  aPAD = 0.2 mg/kg/     decreases in rearing and in motor
                                   FQPA SF = 1X........   day.                 activity.
Chronic dietary (All populations)  NOAEL= 0.77 mg/kg/    Chronic RfD =        Chronic Oral Dog Study.
                                    day.                  0.0077 mg/kg/day.   LOAEL = 3.5 mg/kg/day based on
                                   UFA = 10X...........  cPAD = 0.0077 mg/kg/  hematological effects (increased
                                   UFH = 10X...........   day.                 met- and sulf-hemoglobin levels).
                                   FQPA SF = 1X........

[[Page 8304]]

 
Cancer (Oral, dermal, inhalation)    Quantification of human cancer risk is not necessary for reasons stated in
                                                                     Unit III.A.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligrams/kilogram/day. 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 linuron, EPA considered exposure under the petitioned-for 
tolerances as well as all existing linuron tolerances in 40 CFR 
180.184. EPA assessed dietary exposures from linuron 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 linuron. In estimating acute dietary exposure, EPA used Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) Version 3.16, which uses food consumption data 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) 
from 2003 through 2008. As to residue levels in food, EPA utilized 
tolerance-level residues, DEEM (Ver. 7.81) default processing factors 
as necessary, and 100 percent 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's 2003-
2008 NHANES/WWEIA. As to residue levels in food, EPA used tolerance-
level residues for all commodities, and DEEM default processing 
factors. The Agency utilized average PCT estimates, when available, and 
100 PCT for all other commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a cancer exposure assessment is not necessary.
    iv. Anticipated residue and PCT information. 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 for use in 
the chronic dietary assessment as follows:
    Asparagus, 25%; carrots, 85%; celery, 25%; corn, 1.0%; cotton, 
1.0%; potatoes, 5.0%; sorghum, 1.0%; soybeans, 1.0%; sweet corn, 1.0%; 
and wheat, 1.0%.
    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 6-7 
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 
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 subpopulations 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 linuron 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 linuron in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of linuron. 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 linuron for 
surface water are estimated to be 89.05 parts per billion (ppb) for 
acute exposures and 48.69 ppb for chronic exposures for non-cancer 
assessments. The EDWCs of linuron for groundwater are estimated to be 
48.8 ppb for acute

[[Page 8305]]

and chronic exposures for non-cancer assessments.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 89.05 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 48.8 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). Linuron is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 linuron 
to share a common mechanism of toxicity with any other substances, and 
linuron does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that linuron 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. The following acceptable 
studies are available to assess the prenatal and postnatal sensitivity 
to linuron: rat and rabbit developmental toxicity studies, a 2-
generation rat reproductive toxicity study, and a 3-generation rat 
reproductive toxicity study. There is no qualitative or quantitative 
evidence of increased susceptibility of rabbits in the developmental 
study; developmental effects were seen at a dose higher than those 
causing maternal toxicity. In the rat developmental study, increases in 
post-implantation losses and increases in fetal resorptions/litter were 
seen at a dose that caused decreases in maternal body weight and food 
consumption. Since increases in resorptions were marginal and there was 
no change in the number of live fetuses to corroborate the increases in 
post-implantation losses, these effects were not indicative of 
qualitative evidence of susceptibility.
    There was no quantitative evidence of susceptibility in either the 
2-generation or the 3-generation reproduction studies. In the 2-
generation study, reduced body weight gains of pups were seen at the 
same dose that caused decreases in parental body weights. In the 3-
generation study, offspring effects including deceased pup survival and 
pup body weight were seen a dose (44 mg/kg/day) higher than the dose 
that caused decreases in body weight gain in the parental animals (9 
mg/kg/day). However, when reproductive effects were examined, 
testicular atrophy was seen at the same dose (45 mg/kg/day) in both 
studies. In both studies, while the F0 males were not affected, 
testicular lesions and reduced fertility were seen in the F1 males. 
This effect in the F1 males is an indication of qualitative evidence of 
susceptibility.
    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 linuron is complete.
    ii. In an acute neurotoxicity study, FOB findings of impaired 
mobility, alterations in gait, lack of coordination, lowered body 
temperature, no reaction to stimuli, low arousal, and decreases in 
motor activity were seen at the time of peak effect (7 hours post 
dosing) on study day 0. These observations were mostly seen in the 500 
mg/kg group and no pathological changes were found in nervous system 
tissues. A clear NOAEL (20 mg/kg/day) was established, and this NOAEL 
was approximately 2-26X greater than most PODs selected for risk 
assessment. The nervous system was not a target organ for linuron. The 
requirement of a subchronic neurotoxicity study was waived by the 
Agency because the target systems for linuron toxicity are the 
hematopoietic and endocrine systems and not the nervous system as shown 
by all available/required toxicity studies. There is no need for a 
developmental neurotoxicity study because linuron affects testes and 
hematological parameters but did not produce an increased 
susceptibility in young rats. Therefore, the concern for neurotoxicity 
is low, and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that linuron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies. While increased qualitative susceptibility was 
identified from the reproductive findings in the 2-generation and 3-
generation rat toxicity studies, clear NOAELs were established for the 
effects on the reproductive system. Furthermore, the point of departure 
(POD) selected for assessment of chronic effects, is approximately 40X 
lower than the LOAEL that caused the testicular effects seen in the rat 
reproduction toxicity study; therefore, EPA considers the PODs for risk 
assessment to be protective of the effects seen on the male 
reproductive system and an additional safety factor to account for this 
qualitative susceptibility is not necessary.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on tolerance-level residues, 100 PCT for the acute assessment and 
average PCT for available commodities in the chronic dietary 
assessment. EPA made conservative (protective) assumptions in the 
ground-water and surface water modeling used to assess exposure to 
linuron in drinking water. These assessments will not underestimate the 
exposure and risks posed by linuron.

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

[[Page 8306]]

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 linuron will occupy 10% of the aPAD for all infants less than 1 year 
old, the most highly exposed U.S. population subgroup; and 5.7% of the 
aPAD for females 13-49 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
linuron from food and water will utilize 60% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for linuron.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, linuron is 
not registered for any use patterns that would result in short- or 
intermediate-term residential exposure. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures 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 short- or 
intermediate-term risks), no further assessments of short- or 
intermediate-term risk are necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating the short- and intermediate-term 
risks for linuron.
    4. Aggregate cancer risk for U.S. population. Based on the 
discussion of carcinogenicity for linuron in Unit III.A., EPA has 
concluded that the cPAD is protective of possible cancer effects. Given 
the results of the chronic risk assessment, EPA has concluded that 
linuron does not pose a cancer risk.
    5. 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 linuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, Method ABC-68406-M, is available 
to enforce the tolerance expression. This method involves reflux of 
crop samples in strong base to hydrolyze residues of linuron and its 
metabolites to 3,4-DCA, which is analyzed using gas chromatography/mass 
spectrometry (GC/MS).
    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: 
residuemethods@epa.gov.

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 linuron.

C. Response to Comments

    EPA received one comment to the notice of filing from November 7, 
2012 which opposed the use of linuron on any food. The commenter 
expressed a general opposition to the use of ``toxic chemicals'' on 
food and further noted that ``red blood cells are harmed in animals 
from this toxic chemical.'' The Agency understands the commenter's 
concerns and recognizes that some individuals believe that certain 
pesticide chemicals should not be permitted in our food. However, the 
existing legal framework provided by section 408 of the FFDCA states 
that tolerances may be set when the pesticide meets the safety standard 
imposed by that statute. The Agency is required by Section 408 of the 
FFDCA to estimate the risk of the potential exposure to these residues. 
EPA has concluded, based on data submitted in support of the petition 
and other reliable data, that there is a reasonable certainty that no 
harm will result from aggregate human exposure to linuron residues from 
these uses. The points of departure selected for risk assessment are 
protective of any effects on the hematopoietic system, including red 
blood cells. Additionally, testing requirements for pesticide 
tolerances have been specified by rulemaking after allowing for notice 
and comment by the public and peer review by appropriate scientific 
bodies. See 40 CFR part 158 for further information.

D. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA has revised the 
proposed tolerances for several commodities, as follows: Cilantro, 
dried leaves from 27 ppm to 10 ppm; dillweed, dried leaves from 7.1 ppm 
to 5.0 ppm; dill, seed from 0.3 ppm to 0.5 ppm; dill, oil from 4.8 ppm 
to 2.0 ppm; parsley, leaves from 3.0 ppm to 4.0 ppm; parsley, dried 
leaves from 8.3 ppm to 9.0 ppm; and pea, dry, seed from 0.08 ppm to 
0.09 ppm. The Agency revised the cilantro, fresh leaves; dillweed, 
fresh leaves, and pea, dry seed tolerance levels based on analysis of 
the residue field trial data using the Organization for Economic 
Cooperation and Development (OECD) tolerance calculation procedures. 
Due to a limited number of field trials, EPA used the formula of 5X the 
mean in order to establish tolerance levels for coriander, seed; dill, 
seed; and parsley, leaves. Finally, for the dried herbs (cilantro, 
dillweed, and parsley) and dill oil, the formula of the highest average 
field trial (HAFT), multiplied by the concentration factor was used to 
calculate the recommended tolerance levels for these commodities. These 
concentration factors were derived from dividing the average dried or 
oil commodity residue by the average fresh commodity residue. Based on 
this calculation method, all four tolerance levels were decreased.
    Finally, the Agency has revised the tolerance expression to clarify 
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of linuron not specifically mentioned; and 
(2) that compliance with the specified tolerance levels is to be 
determined by measuring only residues of linuron convertible to 3,4-
dichloroaniline.

 V. Conclusion

    Therefore, tolerances are established for residues of linuron, 3-
(3,4-dichlorophenyl)-1-methoxy-1-methylurea), and its metabolites, in 
or on cilantro, fresh leaves at 3.0 ppm; cilantro, dried leaves at 10 
ppm; coriander, seed at 0.01 ppm; dillweed, fresh leaves at 1.5 ppm; 
dillweed, dried

[[Page 8307]]

leaves at 5.0 ppm; dill, seed at 0.5 ppm; dill, oil at 2.0 ppm; 
horseradish at 0.05 ppm; parsley, leaves at 4.0 ppm; parsley, dried 
leaves at 9.0 ppm; and pea, dry, seed at 0.09 ppm. The regulation 
additionally removes the tolerance in or on parsley, leaves at 0.25 ppm 
from 40 CFR 180.184(c).

VI. References

    The following literature was referenced in the preamble of this 
document.

1. Gray, L; Wolf, C; Lambright, C; Mann, P; Price, M; Cooper, R; 
Ostby, J. 1999. Administration of potentially antiandrogenic 
pesticides (procymidone, linuron, iprodione, chlozolinate, p,p'-DDE, 
and ketoconazole) and toxic substances (dibutyl- and diethylhexyl 
phthalate, PCB 169, and ethane dimethane sulphonate) during sexual 
differentiation produces diverse profiles of reproductive 
malformations in the male rat. Toxicol Ind Health, 15 (1-2):94-118.
2. Hotchkiss, A; Parks-Saldutti, L; Ostby, J; Lambright, C; Furr, J; 
Vandenbergh, J; & Gray, L. 2004. A mixture of the ``antiandrogens'' 
linuron and butyl benzyl phthalate alters sexual differentiation of 
the male rats in a cumulative fashion. Biol.of Reprod 71:1852-1861.
3. Lambright, C; Ostby, J; Bobseine, K; Wilson, V; Hotchkiss, A; 
Mann, PC; Gray, L. 2000. Cellular and molecular mechanisms of action 
of linuron: an antiandrogenic herbicide that produces reproductive 
malformations in male rats. Toxicol Sci. 56(2):389-99.
4. McIntyre, B; Barlow, N; Wallace, D; Maness, S; Gaido, K; Foster, 
P. 2000. Effects of in utero exposure to linuron on androgen-
dependent reproductive development in the male Crl:CD(SD)BR rat. 
Toxicol Appl Pharmacol. 167(2):87-9.
5. Vinggaard, A., Breinholt, V., and Larsen, J. 1999. Screening of 
selected pesticides for oestrogen receptor activation in vitro. Food 
Addit Contam. 16(12):533-542.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 24, 2014.
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.  180.184:
0
a. Revise the introductory text in paragraph (a).
0
b. Add ``Cilantro, dried leaves'', Cilantro, fresh leaves'', 
``Coriander, seed'', ``Dill, oil'', ``Dill, seed'', ``Dillweed, dried 
leaves'', Dillweed, fresh leaves'', Horseradish'', ``Parsley, dried 
leaves'', ``Parsley, leaves'', and ``Pea, dry, seed'' to the table in 
paragraph (a).
0
c. Revise the introductory text in paragraph (b).
0
d. Revise the introductory text in paragraph (c).
0
e. Remove ``Parsley, leaves'' from the table in paragraph (c).
    The amendments read as follows:

Sec.  180.184  Linuron; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea), 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only those linuron residues 
convertible to 3,4-dichloroaniline, calculated as the stoichiometric 
equivalent of linuron, in or on the commodity:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cilantro, dried leaves..................................           10
Cilantro, fresh leaves..................................            3.0
Coriander, seed.........................................            0.01
 
                                * * * * *
Dill, oil...............................................            2.0
Dill, seed..............................................            0.5
Dillweed, dried leaves..................................            5.0
Dillweed, fresh leaves..................................            1.5

[[Page 8308]]

 
 
                                * * * * *
Horseradish.............................................            0.05
 
                                * * * * *
Parsley, dried leaves...................................            9.0
Parsley, leaves.........................................            4.0
 
                                * * * * *
Pea, dry, seed..........................................            0.09
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide linuron [3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea], including its metabolites and 
degradates, in or on the commodities in the table below, resulting from 
use of the pesticide pursuant to FIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels specified below is to be 
determined by measuring only those linuron residues convertible to 3.4-
dichloroaniline, calculated as the stoichiometric equivalent of 
linuron, in or on the commodity. The tolerance expires and is revoked 
on the date specified in the table.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations, as defined in Sec.  180.1(l), are established 
for residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-
methoxy-1-methylurea), including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only those 
linuron residues convertible to 3,4-dichloroaniline, calculated as the 
stoichiometric equivalent of linuron, in or on the commodity.
* * * * *
[FR Doc. 2014-03077 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P
```