```

[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Rules and Regulations]
[Pages 68257-68261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27891]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0695; FRL-9934-05]

Diethofencarb; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of 
diethofencarb in or on banana. Sumitomo Chemical Company requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 4, 2015. Objections and 
requests for hearings must be received on or before January 4, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0695 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0695 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 
January 4, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0695, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a

[[Page 68258]]

pesticide petition (PP 4E8232) by Sumitomo Chemical Company, LTD., 27-1 
Shinkawa 2 Chrome, Chuo-Ku, Tokyo 104-8260, Japan. The petition 
requested that 40 CFR part 180 be amended by establishing a tolerance 
without a U.S. registration for residues of the fungicide diethofencarb 
in or on banana at 0.09 parts per million (ppm). That document 
referenced a summary of the petition prepared by Sumitomo Chemical 
Company, LTD, the registrant, which is available in the docket, http://www.regulations.gov. There were no FFDCA-related comments received in 
response to the notice of filing.
    Based on available data, EPA is establishing a tolerance at a level 
that is slightly different from what was requested. The reason for this 
change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for diethofencarb including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with diethofencarb 
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. The toxicology database is complete for diethofencarb. In 
repeated dose animal studies, the liver was a target organ in the rat, 
mouse, and dog. Increased liver pigmentation observed histologically in 
the dog, and foci of necrosis and hepatocellular hyperplasia in the 
mouse, were considered adverse and evidence of toxicity. Other target 
organs identified were the kidney (proteinaceous cast and regenerative 
epithelium), urinary bladder (submucosal lymphoid hyperplasia) and 
thyroid (follicular cell adenomas and carcinomas) in the rat, and the 
nervous system (changes in functional observational battery parameters, 
decreased motor activity, and decreased pupillary reflex) in the rat. 
The neurotoxicity in the rat, however, occurred only at high dose 
levels, at or above the limit dose, and were minimal in severity and 
there was no other evidence of neurotoxicity in the data base; 
therefore, there is no concern for neurotoxicity. There was no evidence 
of immunotoxicity in the data base, including the immunotoxicity study. 
Decreased body weight and food consumption and increased salivation 
were observed in the dog. In the pre-natal developmental studies in 
rats and rabbits, increased abortions were observed in the rabbit only 
at dose levels near the limit dose; in the multi-generation 
reproduction study in rats, decreased body weight was seen in F2 pups 
during lactation in the absence of parental toxicity, raising a concern 
for increased susceptibility in offspring. However, appropriate 
endpoints and points of departure were used to address the 
susceptibility issue and there are no residual pre- and/or post-natal 
uncertainties for offspring. The Agency has classified diethofencarb as 
``suggestive evidence of carcinogenicity'' based on the presence of 
thyroid tumors in male and female rats. There was no evidence of 
carcinogenicity in male or female mice at dose levels that were 
considered adequate to assess carcinogenicity. Additionally, there is 
no concern for mutagenicity. Quantification of human cancer risk is not 
required. The chronic reference dose (RfD) will adequately account for 
all chronic toxicity, including carcinogenicity, which could result 
from exposure to diethofencarb.
    Specific information on the studies received and the nature of the 
adverse effects caused by diethofencarb 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, ``Human Health Risk Assessment for the 
Proposed Tolerance of Diethofencarb in/on Banana'' at pp. 15-18 in 
docket ID number EPA-HQ-OPP-2014-0695.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or 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 diethofencarb used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 68259]]

 Table 1--Summary of Toxicological Doses and Endpoints for Diethofencarb for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All Populations)..                     A toxicity endpoint was not identified.
                                      Toxicological effects attributable to a single exposure (dose) were not
                                                         observed in oral toxicity studies.
Chronic dietary (All populations)  NOAEL = 50 mg/kg/day  Chronic RfD = 0.50   Chronic Toxicity, Dog.
                                   UFA = 10X...........   mg/kg/day           LOAEL = 250 mg/kg/day based on
                                   UFH = 10X...........  cPAD = 0.50 mg/kg/    decreased body weights and
                                                          day.                 emesis.
                                   FQPA SF = 1X
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``suggestive evidence of carcinogenicity to humans'' based on
                                    the rat thyroid follicular cell tumors; quantification is not required.
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. RfD = Reference Dose. cPAD =
  chronic Population Adjusted Dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to diethofencarb, EPA assessed dietary exposures from 
diethofencarb 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.
    No such effects were identified in the toxicological studies for 
diethofencarb; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). The 
assessment assumes residues of diethofencarb are present at tolerance 
levels and that 100% of bananas are treated with diethofencarb.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that diethofencarb was assigned the classification 
``suggestive evidence of carcinogenicity to humans'' based on the rat 
thyroid tumors, but quantification is not required.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for diethofencarb. Tolerance-level residues and 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. An assessment of residues 
in drinking water is not required for this assessment because 
diethofencarb is not registered for use in the United States, and thus, 
there is no exposure to diethofencarb in drinking water in the United 
States.
    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).
    Diethofencarb 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 diethofencarb to share a common mechanism of 
toxicity with any other substances, and diethofencarb does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
diethofencarb does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. In the rat developmental 
study, there were no indications of toxicity in the dams or fetuses up 
to the limit dose. An acceptable (non-guideline) rabbit developmental 
toxicity study showed late-term abortions (considered evidence of both 
maternal and fetal toxicity) at dose levels near the limit dose (800 
milligram/kilogram/day (mg/kg/day) and above). In the rat reproduction 
study, offspring effects (decreased pup body weight in F2 
males and females) were noted below the parental NOAEL, indicating 
increased quantitative susceptibility in offspring. However, clear 
NOAELs and LOAELs are available for all parental and offspring effects 
and endpoints and PODs are based on the effects in the offspring.
    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 diethofencarb is complete.
    ii. There are no concerns for neurotoxicity and there is no need 
for a developmental neurotoxicity study or additional uncertainty 
factors (UFs) to account for neurotoxicity.

[[Page 68260]]

    iii. There is evidence that diethofencarb results in reproductive 
susceptibility as shown in the multi-generation reproduction study, but 
the effect is well characterized; therefore, there is no need to retain 
the 10X FQPA safety factor to account for effects on infants and 
children.
    iv. There are no residual uncertainties identified in the exposure 
databases. The Agency used tolerance-level residues and 100 PCT. No 
drinking water and residential exposures are expected as there are no 
U.S. registrations containing diethofencarb.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
diethofencarb is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
diethofencarb from food will utilize MS/
MS), PTRL West Method No. 2348W) 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: 
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 diethofencarb.

C. Revisions to Petitioned-For Tolerances

    The requested tolerance levels differ from those being established 
by EPA. The petitioner used the Organization for Economic Co-operation 
and Development Maximum Residue Limit (OECD MRL) methodologies and 
entered 12 trials. EPA determined that 2 sets of trials (out of 12 
total) were not independent. As a result, EPA entered 10 values only 
into the calculator, and is establishing a tolerance level slightly 
higher than what was proposed.

V. Conclusion

    Therefore, a tolerance is established for residues of 
diethofencarb, in or on banana at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian

[[Page 68261]]

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: October 21, 2015.
Jack E. Housenger,
Director, 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. Add Sec.  180.688 to subpart C to read as follows:

Sec.  180.688  Diethofencarb; tolerance for residue.

    (a) General. (1) Tolerances are established for residues of the 
fungicide diethofencarb, 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 
diethofencarb (1-methylethyl N-(3,4-diethoxyphenyl)carbamate).

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Banana *................................................            0.10
------------------------------------------------------------------------
* There is no U.S. registration for use on this commodity as of November
  4, 2015.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues [Reserved]

[FR Doc. 2015-27891 Filed 11-3-15; 8:45 am]
 BILLING CODE 6560-50-P
```