[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Rules and Regulations]
[Pages 66801-66805]
[FR Doc No: 2015-27790]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0035; FRL-9912-31]

Rimsulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
rimsulfuron in or on sorghum, grain, forage; sorghum, grain, grain; and
sorghum, grain, stover. E.I. du Pont de Nemours and Company requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective October 30, 2015. Objections and
requests for hearings must be received on or before December 29, 2015,
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-2013-0035, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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 Office
of Chemical Safety and Pollution Prevention (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-2013-0035 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
December 29, 2015. 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-2013-0035, 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 July 19, 2013 (78 FR 43115) (FRL-9392-
9), 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
2F8131) by E.I. du Pont de Nemours and Company, 1007 Market Street,
Wilmington, DE 19898. The petition requested that 40 CFR 180.478 be
amended by establishing tolerances for residues of the herbicide
rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide, in or on sorghum, forage;
sorghum, grain; and sorghum, stover at 0.01 parts per million (ppm).
That document referenced a summary of the petition prepared by E.I. du
Pont de Nemours and Company, 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 proposed commodity definitions. EPA has also revised the
chemical name nomenclature for rimsulfuron in the tolerance expression.
The reasons for these changes are 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 rimsulfuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with rimsulfuron 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.
    Rimsulfuron has low acute toxicity by oral, dermal, and inhalation
routes of exposure. It is moderately irritating to the eye, non-
irritating to the skin, and is not a skin sensitizer. In subchronic and
chronic toxicity studies in rats, toxic effects included decreased body
weight, decreased body weight gain, increased relative liver and
absolute kidney weights, and diuresis. In the subchronic study in mice,
increased red blood cell and hemoglobin, and decreased body weight gain
and food efficiency were observed. In the chronic study in mice,
decreased body weight, increased incidences of dilation and cysts in
the glandular stomach, and degeneration of the testicular artery and
tunica albuginea were observed. In the subchronic study in dogs,
diuresis was indicated by urinary volume, platelet concentration, and
kidney weights accompanied by decreased urinary osmolality. In the
chronic study in dogs, increased absolute liver and kidney weights,
increased seminiferous tubule degeneration, and increased number of
spermatid giant cells present in epididymides in males were observed.
In both sexes, decreases in mean body weights and body weight gain, and
increases in serum cholesterol levels, alkaline phosphatase activity,
absolute liver weight, relative liver, and relative kidney weights were
observed.
    In the developmental toxicity study in rats, no toxicity was seen
at the highest dose tested. In the developmental toxicity study in
rabbits (in which both maternal and fetal death were observed), and in
the 2-generation reproduction toxicity study in rats (in which
decreases in body weight gain were observed in both parents and
offspring), developmental and offspring effects were seen in the
presence of maternal/systemic toxicity at the same dose levels.
    In the acute and subchronic neurotoxicity studies, no evidence of
neurotoxicity was observed. In the immunotoxicity study, no evidence of
immunosuppression was observed. In the mutagenicity studies, no
evidence of clastogenicity or mutagenicity was observed. Rimsulfuron is
classified as ``Not Likely to be Carcinogenic to Humans'' based on lack
of evidence of carcinogenicity in rats and mice studies.
    Specific information on the studies received and the nature of the
adverse effects caused by rimsulfuron 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 ``Rimsulfuron. Human Health Risk
Assessment for Proposed Section 3 Use on Acetolactase Synthase (ALS)
Tolerant Grain Sorghum'' at pp. 27-32 in docket ID number EPA-HQ-OPP-
2013-0035.

B. Toxicological Points of Departure/Levels of Concern

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

  Table 1--Summary of Toxicological Doses and Endpoints for Rimsulfuron for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations)..              No endpoint attributable to a single dose identified.
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Chronic dietary (All populations)  NOAEL = 11.8 mg/kg/   Chronic RfD = 0.118  Combined Chronic/Carcinogenicity--
                                    day                   mg/kg/day.           Rat.
                                   UFA = 10x...........  cPAD = 0.118 mg/kg/  LOAEL = 121 mg/kg/day in males;
                                   UFH = 10x...........   day.                 568 mg/kg/day in females .
                                   FQPA SF = 1x........                       (NOAEL = 163 mg/kg/day in
                                                                               females), based on decreased body
                                                                               weight gains and liver effects.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. 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 rimsulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing rimsulfuron tolerances in 40 CFR
180.478. EPA assessed dietary exposures from rimsulfuron 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 rimsulfuron; 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 USDA's 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA assumed that
rimsulfuron residues were present at tolerance levels in all
commodities for which tolerances have been established or proposed, and
that 100% of those crops were treated with rimsulfuron.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that rimsulfuron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for rimsulfuron. Tolerance level residues and/or 100
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for rimsulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of rimsulfuron. 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 rimsulfuron
for chronic exposures for non-cancer assessments are estimated to be
0.38 parts per billion (ppb) for surface water and 19.7 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 19.7 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). Rimsulfuron 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
rimsulfuron to share a common mechanism of toxicity with any other
substances, and rimsulfuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that rimsulfuron 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 Federal
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 developmental
toxicity study in rats, no developmental toxicity was seen at the
highest dose tested. In the developmental toxicity study in rabbits and
in the 2-generation reproductive study in rats, developmental and
offspring toxicity were seen only in the presence of maternal/systemic
toxicity. Consequently, there is no evidence of quantitative or
qualitative increased susceptibility following pre- and/or postnatal
exposures.
    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 rimsulfuron is complete.
    ii. There is no indication that rimsulfuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional Uncertainty Factor (UF) to account for neurotoxicity.
    iii. There is no evidence that rimsulfuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to rimsulfuron in drinking water. These assessments
will not underestimate the exposure and risks posed by rimsulfuron.

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, rimsulfuron 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
rimsulfuron from food and water will utilize 1.4% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure. There are no residential uses for rimsulfuron.
    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).
    Because there are no residential uses, no short- or intermediate-
term aggregate risk assessments were conducted.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, rimsulfuron is not expected to pose a cancer risk to humans.
    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 rimsulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method DuPont-32277, a high
performance liquid chromatography with tandem mass spectroscopy (HPLC/
MS/MS)) 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 MRLs for rimsulfuron.

C. Revisions to Petitioned-For Tolerances

    The Agency is revising the proposed commodity definitions of
``sorghum, forage'' to ``sorghum, grain, forage''; ``sorghum, grain''
to ``sorghum, grain, grain''; and ``sorghum, stover'' to ``sorghum,
grain, stover''. The tolerance expression is revised to reflect the
preferred chemical name for rimsulfuron using CAS nomenclature.

V. Conclusion

    Therefore, tolerances are established for residues of rimsulfuron,
N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide, in or on sorghum, grain, forage; sorghum, grain,
grain; and sorghum, grain, stover at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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).

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.
G. Jeffrey Herndon,
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.  180.478, revise paragraph (a) and add alphabetically the
following commodities to the table in paragraph (a) to read as follows:

Sec.  180.478  Rimsulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide rimsulfuron, including its metabolites and degradates, in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only rimsulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Sorghum, grain, forage......................................        0.01
Sorghum, grain, grain.......................................        0.01
Sorghum, grain, stover......................................        0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-27790 Filed 10-29-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Notices]
[Page 73463-73464]
[DOCID:fr12de05-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EC06-31-000]

Cross-Sound Cable Company, LLC et al.; Notice of Filing

December 6, 2005.
    Take notice that on November 23, 2005, Cross-Sound Cable Company,
LLC et al., (Applicants) pursuant to section 203 of the Federal Power
Act submitted an application for transfer of certain assets.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.

    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on December 19, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7231 Filed 12-9-05; 8:45 am]

BILLING CODE 6717-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:		15-MAY-2013

SUBJECT:	Propamocarb Hydrochloride (Propamocarb-HCl) Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Lima Beans (Succulent).

PC Code:  119302 (propamocarb-HCl)
         119301 (propamocarb)
DP Barcode:  D367969
Decision No.:  402658
Registration No.:  264-678
Petition No.:  8E7473
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary
Case No.:  3124
TXR No.:  None
CAS No.:  25606-41-1 (propamocarb-HCl)
         24579-73-5 (propamocarb)
MRID No.:  None
40 CFR:  §180.499

FROM:	Jennifer R. Tyler, Chemist
	Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	David E. Hrdy, Senior Biologist
	Ideliz Negrón-Encarnación, Ph.D., Chemist
	Dietary Exposure Science Advisory Council (DESAC)

	George F. Kramer, Ph.D., Branch Senior Scientist
	RAB1/HED (7509P)

TO:		Tamue Gibson/Barbara Madden, RM Team 05
      Registration Division (RD; 7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the 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).  This assessment used dietary survey data conducted from 2003 to 2008.  The analyses were conducted in support of a human-health risk assessment for the proposed Section 3 use of propamocarb-HCl on lima beans.  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Dietary Exposure Assessment:  Unrefined acute dietary (food and drinking water) exposure assessments [using tolerance-level residues and assuming 100% crop treated (CT) for all registered and proposed commodities] were conducted for females 13-49 years old, and the general U.S. population and various population subgroups.  Exposure to drinking water was incorporated directly in the dietary assessment using the acute (peak) concentration for surface water generated by the PRZM-EXAMS.  This assessment indicates that the acute dietary exposure estimates are below HED's level of concern, <100% acute population-adjusted dose (aPAD), at the 95[th] exposure percentile for the general U.S. population and all other population subgroups.  The acute dietary exposure is estimated at 34% of the aPAD for females 13-49 years old, and 25% of the aPAD for the U.S. population.  The most highly exposed population subgroup is all infants (<1 year old) at 75% of the aPAD.

Chronic Dietary Exposure Assessment:  An unrefined chronic dietary (food and drinking water) exposure assessment (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities) was conducted for the general U.S. population and various population subgroups.  Exposure to drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the PRZM-EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are below HED's level of concern, <100% chronic population-adjusted dose (cPAD), for the general U.S. population and all population subgroups.  The chronic dietary exposure is estimated for the U.S. population at 31% of the cPAD, and the most highly exposed population subgroup, all infants (<1 years old), at 50% of the cPAD.

Propamocarb is classified as "not likely to be carcinogenic to humans"; therefore, a cancer assessment is not germane to this petition.

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the PAD.  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 21-JUN-2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).  The most recent dietary risk assessment for propamocarb-HCl was conducted by J. Tyler (Memo, 20-FEB-2004; D297250).

II.  Residue Information

Residues of Concern:  The nature of propamocarb-HCl residues in potatoes, cucumbers, and spinach is adequately understood based on acceptable metabolism studies.  The residue of concern in these crops for tolerance and risk assessment purposes is the parent propamocarb only (Memo, J. Rowell, 03-MAY-2000; D264293).  The nature of the residue in ruminants is adequately understood based on acceptable metabolism and feeding studies on dairy cattle, which were submitted as propamocarb-HCl is currently registered for use on ruminant feed items.  The residues of concern in livestock for tolerance and risk assessment purposes are the parent propamocarb and the 2-hydroxy propamocarb and propamocarb glucuronide metabolites (Memos, J. Rowell, 03-MAY-2000, D264293; and J. Tyler, 10-MAR-2005; D304509).  No poultry metabolism study has been submitted.  Propamocarb-HCl is currently not registered for use on any poultry feed items.

Established Tolerances:  Tolerances are established for the residues of propamocarb-HCl under 40 CFR §180.499(a) in/on lettuce, leaf (90 ppm); lettuce, head (50 ppm); potato (0.06 ppm); tomato, paste (5.0 ppm); vegetable, cucurbit, group 9 (1.5 ppm); and vegetable, fruiting, group 8 (2.0 ppm).  An adequate ruminant feeding study has been submitted (Memo, J. Tyler, 10-MAR-2005; D304509).  The feeding study data with the estimated maximum dietary burdens indicate that tolerances for the combined residues of propamocarb-HCl and its metabolites 2-hydroxy propamocarb and propamocarb glucuronide should be established for milk at 0.03 ppm, and liver of cattle, horse, goat, hog, and sheep at 0.15 ppm.  These tolerances are currently not in 40 CFR §180.499, but were included in the acute and dietary exposure assessment.

Recommended Tolerances:  The available residue chemistry database supports the establishment of the permanent tolerance with a geographical restriction for residues in/on bean, lima, succulent at 2.0 ppm.

Processing Factors:  The results of previously submitted potato and tomato processing studies indicate that propamocarb-HCl does not concentrate in processed samples of potato chips, flakes, wet peel, or dry peel (Memo, J. Stokes 10/17/96; Barcode D228264), but does concentrate in tomato puree (1.3x) and tomato paste (3.1x).  As the established tolerance of 2.0 ppm for fruiting vegetables will adequately cover residues in tomato puree, a tolerance was not required for this processed commodity; however, a tolerance of 5.0 ppm for residues in tomato, paste was established.  As a result of the potato and tomato processing studies, DEEM-FCID default processing factors were set to 1 for white potatoes-dry; tomato, paste; and tomato, puree.  DEEM-FCID default processing factors were used for all other registered and proposed commodities.

III.  Percent Crop Treated Information

The acute and chronic dietary exposure assessments assumed 100% CT for all registered and proposed uses.

IV.  Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the acute and chronic dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the memorandum dated 11-DEC-2012 (Memo, M. Ruhman; D368070).  Water residues were incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."  The surface water values (using PRZM/EXAMS) for the acute (peak) and chronic (annual average) EDWCs, based on the container-grown ornamental use pattern, are 8,762 ppb and 1,067 ppb, respectively.

V.  DEEM-FCID Program and Consumption Information

Propamocarb-HCl acute and chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's NHANES/WWEIA.  This dietary survey was conducted from 2003 to 2008.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  However, for acute exposure assessment, consumption data are retained as individual consumption events.  Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For an acute exposure assessment, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for analyses performed at all levels of refinement.  However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI.  Toxicological Information

A summary of the toxicological doses and endpoints selected for dietary exposure assessment is provided in Table 1.

Table 1.  Endpoint Selection Table for Propamocarb-HCl.[1]
                                   Exposure/
                                   Scenario
                              Point of Departure
                             Uncertainty/FQPA SFs
                                 RfD, PAD, LOC
                        Study and Toxicological Effects
Acute Dietary (Females 13-50 years of age)
NOAEL = 150 mg /kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
aRfD = aPAD = 1.5 mg/kg/day
Developmental Toxicity Study - Rabbit
Developmental LOAEL = 300 mg/kg/day based on increased post-implantation loss.
Acute Dietary (General Population, including Infants and Children)
NOAEL = 200 mg/kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
aRfD = aPAD = 2.0 mg/kg/day
Acute Neurotoxicity Screening Battery - Rat
LOAEL = 2000 mg/kg/day, based on decreased body-weight gain and decreased motor activity.
Chronic Dietary (All Populations)
NOAEL = 12 mg/kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
cRfD = cPAD = 0.12 mg/kg/day
Carcinogenicity Study - Mouse
LOAEL = 95 mg/kg/day, based on decreased body weight and body-weight gain in females.
Cancer (oral, dermal, inhalation)
Classification:  "Not likely to be Carcinogenic to Humans."
[1]  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, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose (a = acute, c = chronic).

VII.  Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 2 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50-99 years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis:  Separate unrefined (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities), acute dietary exposure assessments were conducted for females 13-49 years old, and the general U.S. population and various population subgroups.  Drinking water was incorporated directly in the dietary assessments using the acute (peak) concentration for surface water generated by the PRZM/EXAMS model.  This assessment concludes that the acute dietary exposure estimates are below HED's level of concern (<100% aPAD) at the 95[th] exposure percentile for females 13-49 years old (34% of the aPAD), the general U.S. population (25% of the aPAD), and all other population subgroups.  The most highly exposed population subgroup is all infants (<1 year old), at 75% of the aPAD.

 Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis:  An unrefined (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities), chronic dietary exposure assessment was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the PRZM/EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are below HED's level of concern (<100% cPAD) for the general U.S. population (31% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is all infants (<1 year old), at 50% of the aPAD.

 Table 2.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Propamocarb HCl.
                              Population Subgroup
                                 Acute Dietary
                              (95[th] Percentile)
                                Chronic Dietary

                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                            General U.S. Population
                                    0.507723
                                       25
                                    0.037228
                                       31
                          All Infants (<1 year old)
                                    1.496493
                                      75*
                                    0.060367
                                      50*
                             Children 1-2 years old
                                    0.762741
                                       38
                                    0.045611
                                       38
                             Children 3-5 years old
                                    0.633181
                                       32
                                    0.044067
                                       37
                            Children 6-12 years old
                                    0.473593
                                       24
                                    0.032129
                                       27
                             Youth 13-19 years old
                                    0.416725
                                       21
                                    0.028399
                                       24
                             Adults 20-49 years old
                                    0.501031
                                       25
                                    0.038290
                                       32
                              Adults 50+ years old
                                    0.449098
                                       22
                                    0.037513
                                       31
                            Females 13-49 years old
                                    0.510324
                                       34
                                    0.039067
                                       33
*The subpopulation(s) with the highest risk estimates.

 VIII.  Characterization of Inputs/Outputs

The acute and chronic dietary assessments were highly conservative, using tolerance-level residues, and 100% CT information for all registered and proposed uses.  DEEM(TM) default processing factors were set to one for white potatoes-dry, tomato, puree, and tomato, paste; default DEEM-FCID(TM) processing factors were used for all other registered and proposed processed commodities.  Various refinements could be made to the assessments.  However, as there are no risk estimates of concern, no refinements were incorporated.

 IX.  Conclusions

 Unrefined, acute dietary exposure assessment indicates that the acute dietary exposure estimates are below HED's level of concern, <100% aPAD, at the 95[th] exposure percentile for the general U.S. population and all other population subgroups.  The most highly exposed population subgroup was all infants (<1 year old) at 74% of the aPAD.  An unrefined chronic dietary exposure assessment indicates that the chronic dietary exposure estimates are below HED's level of concern (<100% cPAD) for the general U.S. population and all population subgroups.  The most highly exposed population subgroup was all infants (<1 year old) at 50% of the cPAD.  The acute and chronic assessments were highly conservative, using several upper-end assumptions.  Additional refinements, such as inclusion of ARs and %CT data could be made in order to refine the future assessments.  HED is confident that the assessments do not underestimate risk to the general U.S. population or any population subgroup.

 X.  List of Attachments

 Attachment 1:  Acute Food plus Water Residue Input File.
 Attachment 2:  Acute Results File.
 Attachment 3:  Chronic Food plus Water Residue Input File.
 Attachment 4:  Chronic Results File.

cc: J. Tyler
RDI:  D. Hrdy (1/4/13); I. Encarnacion (1/4/13); G. Kramer (5/15/13)
J. Tyler: S-10943: Potomac Yard 1 (PY1):<PHONE_NUMBER>: 7509P: RAB1

            Attachment 1:  Acute Food plus Water Residue Input File.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302acute.r08
Chemical: Propamocarb HCl
RfD(Chronic): .12 mg/kg bw/day  NOEL(Chronic): 12 mg/kg bw/day
RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day
Date created/last modified: 01-02-2013/14:21:05       Program ver. 3.16, 03-08-d
Comment: New use on lima beans
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
0103296000 1C   Potato, chips                      0.060000   1.000  1.000
0103297000 1C   Potato, dry (granules/ flakes)     0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0103297001 1C   Potato, dry (granules/ flakes)-b   0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0103298000 1C   Potato, flour                      0.060000   1.000  1.000
0103298001 1C   Potato, flour-babyfood             0.060000   1.000  1.000
0103300000 1C   Potato, tuber, w/o peel            0.060000   1.000  1.000
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.060000   1.000  1.000
0103299000 1C   Potato, tuber, w/peel              0.060000   1.000  1.000
0103299001 1C   Potato, tuber, w/peel-babyfood     0.060000   1.000  1.000
0401204000 4A   Lettuce, head                     50.000000   1.000  1.000
0401205000 4A   Lettuce, leaf                     90.000000   1.000  1.000
0602037000 6B   Bean, lima, succulent              2.000000   1.000  1.000  Propos
            Full comment: Proposed
0802148000 8BC  Eggplant                           2.000000   1.000  1.000
0802234000 8BC  Okra                               2.000000   1.000  1.000
0802270000 8B   Pepper, bell                       2.000000   1.000  1.000
0802271000 8B   Pepper, bell, dried                2.000000   1.000  1.000
0802271001 8B   Pepper, bell, dried-babyfood       2.000000   1.000  1.000
0802270001 8B   Pepper, bell-babyfood              2.000000   1.000  1.000
0802272000 8BC  Pepper, nonbell                    2.000000   1.000  1.000
0802273000 8BC  Pepper, nonbell, dried             2.000000   1.000  1.000
0802272001 8BC  Pepper, nonbell-babyfood           2.000000   1.000  1.000
0801374000 8A   Tomatillo                          2.000000   1.000  1.000
0801375000 8A   Tomato                             2.000000   1.000  1.000
0801380000 8A   Tomato, Tree                       2.000000   1.000  1.000
0801378000 8A   Tomato, dried                      2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801378001 8A   Tomato, dried-babyfood             2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801379000 8A   Tomato, juice                      2.000000   1.500  1.000  defaul
            Full comment: default processing factor
0801376000 8A   Tomato, paste                      5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801376001 8A   Tomato, paste-babyfood             5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801377000 8A   Tomato, puree                      2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801377001 8A   Tomato, puree-babyfood             2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801375001 8A   Tomato-babyfood                    2.000000   1.000  1.000
0902021000 9B   Balsam pear                        1.500000   1.000  1.000
0901075000 9A   Cantaloupe                         1.500000   1.000  1.000
0902088000 9B   Chayote, fruit                     1.500000   1.000  1.000
0902102000 9B   Chinese waxgourd                   1.500000   1.000  1.000
0902135000 9B   Cucumber                           1.500000   1.000  1.000
0901187000 9A   Honeydew melon                     1.500000   1.000  1.000
0902308000 9B   Pumpkin                            1.500000   1.000  1.000
0902309000 9B   Pumpkin, seed                      1.500000   1.000  1.000
0902356000 9B   Squash, summer                     1.500000   1.000  1.000
0902356001 9B   Squash, summer-babyfood            1.500000   1.000  1.000
0902357000 9B   Squash, winter                     1.500000   1.000  1.000
0902357001 9B   Squash, winter-babyfood            1.500000   1.000  1.000
0901399000 9A   Watermelon                         1.500000   1.000  1.000
0901400000 9A   Watermelon, juice                  1.500000   1.000  1.000
3100049000 31   Beef, liver                        0.150000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.150000   1.000  1.000
3200173000 32   Goat, liver                        0.150000   1.000  1.000
3400295000 34   Pork, liver                        0.150000   1.000  1.000
3500343000 35   Sheep, liver                       0.150000   1.000  1.000
3600222000 36   Milk, fat                          0.030000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.030000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.030000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000
3600224000 36   Milk, water                        0.030000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.030000   1.000  1.000
8601000000 86A  Water, direct, all sources         8.762000   1.000  1.000  acute
            Full comment: acute surface water = 8762 ppb
8602000000 86B  Water, indirect, all sources       8.762000   1.000  1.000  acute
            Full comment: acute surface water = 8762 ppb

                       Attachment 2:  Acute Results File.

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-Day
Residue file: 119302acute.r08                     Adjustment factor #2 NOT used.
Analysis Date: 01-02-2013/14:30:21    Residue file dated: 01-02-2013/14:21:05
NOEL (Acute) = 150.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
Run Comment: "New use on lima beans"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Female 13-49:
  0.510324   34.02     293    0.743490   49.57     201    1.011665   67.44     148

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-Day
Residue file: 119302acute.r08                     Adjustment factor #2 NOT used.
Analysis Date: 01-02-2013/14:29:47    Residue file dated: 01-02-2013/14:21:05
NOEL (Acute) = 200.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
Run Comment: "New use on lima beans"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Total US Population:
  0.507723   25.39     393    0.814838   40.74     245    1.497184   74.86     133
All Infants:
  1.496493   74.82     133    2.032841  101.64      98    2.979369  148.97      67
Children 1-2:
  0.762741   38.14     262    1.124264   56.21     177    2.725537  136.28      73
Children 3-5:
  0.633181   31.66     315    0.969279   48.46     206    1.512119   75.61     132
Children 6-12:
  0.473593   23.68     422    0.768693   38.43     260    1.153887   57.69     173
Youth 13-19:
  0.416725   20.84     479    0.679147   33.96     294    1.043993   52.20     191
Adults 20-49:
  0.501031   25.05     399    0.730983   36.55     273    1.025770   51.29     194
Adults 50-99:
  0.449098   22.45     445    0.663922   33.20     301    1.001162   50.06     199

           Attachment 3:  Chronic Food plus Water Residue Input File.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302chronic.r08
Chemical: Propamocarb HCl
RfD(Chronic): .12 mg/kg bw/day  NOEL(Chronic): 12 mg/kg bw/day
RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day
Date created/last modified: 01-02-2013/14:25:13       Program ver. 3.16, 03-08-d
Comment: New use on lima beans
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
0103296000 1C   Potato, chips                      0.060000   1.000  1.000
0103297000 1C   Potato, dry (granules/ flakes)     0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0103297001 1C   Potato, dry (granules/ flakes)-b   0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0103298000 1C   Potato, flour                      0.060000   1.000  1.000
0103298001 1C   Potato, flour-babyfood             0.060000   1.000  1.000
0103300000 1C   Potato, tuber, w/o peel            0.060000   1.000  1.000
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.060000   1.000  1.000
0103299000 1C   Potato, tuber, w/peel              0.060000   1.000  1.000
0103299001 1C   Potato, tuber, w/peel-babyfood     0.060000   1.000  1.000
0401204000 4A   Lettuce, head                     50.000000   1.000  1.000
0401205000 4A   Lettuce, leaf                     90.000000   1.000  1.000
0602037000 6B   Bean, lima, succulent              2.000000   1.000  1.000  Propos
            Full comment: Proposed
0802148000 8BC  Eggplant                           2.000000   1.000  1.000
0802234000 8BC  Okra                               2.000000   1.000  1.000
0802270000 8B   Pepper, bell                       2.000000   1.000  1.000
0802271000 8B   Pepper, bell, dried                2.000000   1.000  1.000
0802271001 8B   Pepper, bell, dried-babyfood       2.000000   1.000  1.000
0802270001 8B   Pepper, bell-babyfood              2.000000   1.000  1.000
0802272000 8BC  Pepper, nonbell                    2.000000   1.000  1.000
0802273000 8BC  Pepper, nonbell, dried             2.000000   1.000  1.000
0802272001 8BC  Pepper, nonbell-babyfood           2.000000   1.000  1.000
0801374000 8A   Tomatillo                          2.000000   1.000  1.000
0801375000 8A   Tomato                             2.000000   1.000  1.000
0801380000 8A   Tomato, Tree                       2.000000   1.000  1.000
0801378000 8A   Tomato, dried                      2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801378001 8A   Tomato, dried-babyfood             2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801379000 8A   Tomato, juice                      2.000000   1.500  1.000  defaul
            Full comment: default processing factor
0801376000 8A   Tomato, paste                      5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801376001 8A   Tomato, paste-babyfood             5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801377000 8A   Tomato, puree                      2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801377001 8A   Tomato, puree-babyfood             2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801375001 8A   Tomato-babyfood                    2.000000   1.000  1.000
0902021000 9B   Balsam pear                        1.500000   1.000  1.000
0901075000 9A   Cantaloupe                         1.500000   1.000  1.000
0902088000 9B   Chayote, fruit                     1.500000   1.000  1.000
0902102000 9B   Chinese waxgourd                   1.500000   1.000  1.000
0902135000 9B   Cucumber                           1.500000   1.000  1.000
0901187000 9A   Honeydew melon                     1.500000   1.000  1.000
0902308000 9B   Pumpkin                            1.500000   1.000  1.000
0902309000 9B   Pumpkin, seed                      1.500000   1.000  1.000
0902356000 9B   Squash, summer                     1.500000   1.000  1.000
0902356001 9B   Squash, summer-babyfood            1.500000   1.000  1.000
0902357000 9B   Squash, winter                     1.500000   1.000  1.000
0902357001 9B   Squash, winter-babyfood            1.500000   1.000  1.000
0901399000 9A   Watermelon                         1.500000   1.000  1.000
0901400000 9A   Watermelon, juice                  1.500000   1.000  1.000
3100049000 31   Beef, liver                        0.150000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.150000   1.000  1.000
3200173000 32   Goat, liver                        0.150000   1.000  1.000
3400295000 34   Pork, liver                        0.150000   1.000  1.000
3500343000 35   Sheep, liver                       0.150000   1.000  1.000
3600222000 36   Milk, fat                          0.030000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.030000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.030000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000
3600224000 36   Milk, water                        0.030000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.030000   1.000  1.000
8601000000 86A  Water, direct, all sources         1.067000   1.000  1.000  chroni
            Full comment: chronic surface water = 1067ppb
8602000000 86B  Water, indirect, all sources       1.067000   1.000  1.000  chroni
            Full comment: chronic surface water = 1067ppb

                      Attachment 4:  Chronic Results File.

EPA                                                             Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302chronic.r08
                                                 Adjustment factor #2 NOT used.
Analysis Date 01-02-2013/14:27:09     Residue file dated: 01-02-2013/14:25:13
Reference dose (RfD, Chronic) = .12 mg/kg bw/day
COMMENT 1: New use on lima beans
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.037228                31.0%
Hispanic                                    0.034975                29.1%
Non-Hisp-White                              0.039137                32.6%
Non-Hisp-Black                              0.028491                23.7%
Non-Hisp-Other                              0.038325                31.9%
Nursing Infants                             0.022271                18.6%
Non-Nursing Infants                         0.077381                64.5%
Female 13+ PREG                             0.036526                30.4%
Children 1-6                                0.044067                36.7%
Children 7-12                               0.030645                25.5%
Male 13-19                                  0.026481                22.1%
Female 13-19/NP                             0.030271                25.2%
Male 20+                                    0.034790                29.0%
Female 20+/NP                               0.040903                34.1%
Seniors 55+                                 0.036752                30.6%
All Infants                                 0.060367                50.3%
Female 13-50                                0.039077                32.6%
Children 1-2                                0.045611                38.0%
Children 3-5                                0.044067                36.7%
Children 6-12                               0.032129                26.8%
Youth 13-19                                 0.028399                23.7%
Adults 20-49                                0.038290                31.9%
Adults 50-99                                0.037513                31.3%
Female 13-49                                0.039067                32.6%

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


[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27367-27368]
[FR Doc No: 2014-10982]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0444]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption, request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 13 individuals
for an exemption from the prohibition against persons with a clinical
diagnosis of epilepsy or any other condition which is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV) from operating CMVs in interstate commerce. The
regulation and the associated advisory criteria published in the Code
of Federal Regulations as the ``Instructions for Performing and
Recording Physical Examinations'' have resulted in numerous drivers
being prohibited from operating CMVs in interstate commerce based on
the fact that they have had one or more seizures and are taking anti-
seizure medication, rather than an individual analysis of their
circumstances by a qualified medical examiner. If granted, the
exemptions would enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs for 2
years in interstate commerce.

DATES: Comments must be received on or before June 12, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2013-0444 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for
this Notice. Note that DOT posts all comments received without change
to http://www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on January 17, 2008 (73 FR 3316; January 17, 2008).
This information is also available at http://Docketinfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Elaine Papp, Chief, Medical Programs
Division,<PHONE_NUMBER>, or via email at<EMAIL_ADDRESS>or by
letter FMCSA, Room W64-113, Department of Transportation, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. Office hours are from
8:30 a.m. to 5 p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statutes also allow the
Agency to renew exemptions at the end of the 2-year period. The 13
individuals listed in this notice have recently requested an exemption
from the epilepsy prohibition in 49 CFR 391.41(b)(8), which applies to
drivers who operate CMVs as defined in 49 CFR 390.5, in interstate
commerce. Section 391.41(b)(8) states that a person is physically
qualified to drive a commercial motor vehicle if that person has no
established medical history or clinical diagnosis of epilepsy or any
other condition which is likely to cause the loss of consciousness or
any loss of ability to control a CMV.
    FMCSA provides medical advisory criteria for use by medical
examiners in determining whether drivers with certain medical
conditions should be certified to operate CMVs in intrastate commerce.
The advisory criteria indicate that if an individual has had a sudden
episode of a non-epileptic seizure or loss of consciousness of unknown
cause which did not require anti-seizure medication, the decision
whether that person's condition is likely to cause the loss of
consciousness or loss of ability to control a CMV should be made on an
individual basis by the medical examiner in consultation with the
treating physician. Before certification is considered, it is suggested
that a 6-month waiting period elapse from the time of the episode.
Following the waiting period, it is suggested that the individual have
a complete neurological examination. If the results of the examination
are negative and anti-seizure medication is not required, then the
driver may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has fully recovered from that
condition, has no existing residual complications, and is not taking
anti-seizure medication. Drivers who have a history of epilepsy/
seizures, off anti-seizure medication and seizure-free for 10 years,
may be qualified to operate a CMV in interstate commerce. Interstate
drivers with a history of a single unprovoked seizure may be qualified
to drive a CMV in interstate commerce if seizure-free and off anti-
seizure medication for a 5-year period or more.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission. To
submit your comment online, go to http://www.regulations.gov and in the
search box insert the docket number ``FMCSA-2013-0444'' and click the
search button. When the new screen appears, click on the blue ``Comment
Now!'' button on the right hand side of

the page. On the new page, enter information required including the
specific section of this document to which each comment applies, and
provide a reason for each suggestion or recommendation. If you submit
your comments by mail or hand delivery, submit them in an unbound
format, no larger than 8\1/2\ by 11 inches, suitable for copying and
electronic filing. If you submit comments by mail and would like to
know that they reached the facility, please enclose a stamped, self-
addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change this
proposed rule based on your comments. FMCSA may issue a final rule at
any time after the close of the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble. To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
``FMCSA-2013-0444'' and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

Summary of Applications

Travis Arend

    Mr. Arend is a 41 year-old driver in Virginia. He has a history of
seizure and has remained seizure free for 8 years. He does not take
anti-seizure medication. If granted the exemption, he would like to
drive a CMV. His physician states that he is supportive of Mr. Arend
receiving an exemption.

Heath Crowe

    Mr. Crowe is a 36 year-old driver in Louisiana. He has a history of
epilepsy and has remained seizure free since 1998. He takes anti-
seizure medication with the dosage and frequency remaining the same
since that time. If granted the exemption, he would like to drive a
CMV. His physician states that he is supportive of Mr. Crowe receiving
an exemption.

Richard Degnan

    Mr. Degnan is a 46 year-old driver in Arizona. He has a history of
seizure disorder and has remained seizure free since 2004. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 2 years. If granted the exemption, he would like to drive
a CMV. His physician states that he is supportive of Mr. Degnan
receiving an exemption.

Peter Della Rocco

    Mr. Della Rocco is a 47 year-old class B CDL holder in
Pennsylvania. He has a history of seizure and has remained seizure free
since 1992. He takes anti-seizure medication with the dosage and
frequency remaining the same for over 3 years. If granted the
exemption, he would like to drive a CMV. His physician states that he
is supportive of Mr. Della Rocco receiving an exemption.

Mark Dodson

    Mr. Dodson is a 44 year-old class A CDL holder in North Carolina.
He has a history of seizures and has remained seizure free since 2011.
He takes anti-seizure medication with the dosage and frequency
remaining the same for over 2 years. If granted the exemption, he would
like to drive a CMV. His physician states that he is supportive of Mr.
Dodson receiving an exemption.

Edward Jacobs

    Mr. Jacobs is a 45 year-old driver in Virginia. He has a history of
seizure disorder and has remained seizure free since 2002. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 2 years. If granted the exemption, he would like to drive
a CMV. His physician states that he is supportive of Mr. Jacobs
receiving an exemption.

Domenick Panfile

    Mr. Panfile is a 55 year-old class B CDL holder in New Jersey. He
has a history of seizures and has remained seizure free since 1982. He
takes anti-seizure medication with the dosage and frequency remaining
the same for over 20 years. If granted the exemption, he would like to
drive a CMV. His physician states that he is supportive of Mr. Panfile
receiving an exemption.

Scott Reaves

    Mr. Reaves is a 50 year-old driver in Texas. He has a history of
seizure disorder and has remained seizure free since 2002. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 10 years. If granted the exemption, he would like to
drive a CMV. His physician states that he is supportive of Mr. Reaves
receiving an exemption.

Paul Seekins

    Mr. Seekins is a 70 year-old class A CDL holder in New York. He has
a history of seizure disorder and has remained seizure free since 2013.
He takes anti-seizure medication with the dosage and frequency
remaining the same since that time. If granted the exemption, he would
like to drive a CMV. His physician states that his is supportive of Mr.
Seekins receiving an exemption.

Milton Tatham

    Mr. Tatham is a 55 year-old class A CDL holder in Nevada. He has a
history of seizure disorder and has remained seizure free since 1994.
He takes anti-seizure medication with the dosage and frequency
remaining the same for over 2 years. If granted the exemption, he would
like to drive a CMV. His physician states that he is supportive of Mr.
Tatham receiving an exemption.

Thomas Tincher

    Mr. Tincher is a 48 year-old driver in North Carolina. He has a
history of seizure and has remained seizure free for over 4 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for over 3 years. If granted the exemption, he would like to
drive a CMV. His physician states that he is supportive of Mr. Tincher
receiving an exemption.

Duane Troff

    Mr. Troff is a 52 year-old class A CDL holder in Minnesota. He has
a history of seizure and has remained seizure free for 7 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same since that time. If granted the exemption, he would like to
drive a CMV. His physician states that he is supportive of Mr. Troff
receiving an exemption.

Earnest Williams

    Mr. Williams is a 25 year-old driver in California. He has a
history of seizure disorder and has remained seizure free for 13 years.
He does not take anti-seizure medication since 2010. If granted the
exemption, he would like to drive a CMV. His physician states he is
supportive of Mr. Williams receiving an exemption.

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests
public comment from all interested persons on the exemption
applications described in this notice. We will consider all comments
received before the close of business on the closing date indicated
earlier in the notice.

    Issued on: April 28, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-10982 Filed 5-12-14; 8:45 am]
BILLING CODE 4910-EX-P