[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Rules and Regulations]
[Page 4284-4288]
[DOCID:fr27ja10-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0276; FRL-8808-6]

Triticonazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
triticonazole in or on grain, cereal, group 15, except rice, and grain,
cereal, forage, fodder and straw, group 16, except rice. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 27, 2010. Objections and
requests for hearings must be received on or before March 29, 2010, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0276. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tawanda Maignan, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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 cite at http://www.gpoaccess.gov/ecfr. To
access the OPPTS harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/oppts and select ``Test
Methods & Guidelines'' on the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0276 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before March 29, 2010.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0276, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of August 19, 2009, (74 FR 41900) (FRL-
8426-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7420) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709-3528. The petition requested that 40 CFR 180.583 be amended by
establishing tolerances for residues of the fungicide triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal, group 15,
except rice, and grain, cereal, forage, fodder and straw, group 16,
except rice, at 0.05 and 0.10 parts per million (ppm), respectively.
That notice referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available to the public 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 modified both the crop group
terminology, and tolerance levels for

grain, cereal, group 15, except rice, at 0.01 ppm, and the crop group
terminology (only) for grain, cereal, forage, fodder and straw, group
16, except rice, at 0.10 ppm. These tolerances replace previously
established individual tolerances for barley, grain; barley, hay;
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat,
straw at 0.05 ppm. The reason for these changes 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for residues of triticonazole, (1RS)-(E)-5-[(4-
chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol on grain, cereal, group 15, except rice, at 0.01
ppm, and grain, cereal, forage, fodder and straw, group 16, except
rice, at 0.10 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances 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.
    Triticonazole has low acute toxicity, is not a skin, eye, or
respiratory irritant, or a dermal sensitizer. Non-acute toxicity
studies show that the liver (rat, mouse, dog) and adrenals (rat, dog,
rabbit) are target organs across species. Adverse body weight changes
(rat, dog, rabbit, mouse) and clinical signs (rat, dog, mouse) also
were observed in multiple species. In the developmental and
reproductive toxicity studies, adverse effects were seen at the same
dose level in the offspring and parental animals, and the offspring
were not qualitatively more susceptible compared with adults. In the
rat subchronic study, decreased thymus weights were reported at a dose
level (~2,300 milligrams/kilogram/day (mg/kg/day)) two times higher
than the limit dose (1,000 mg/kg/day). Triticonazole was negative for
mutagenicity, and the cancer classification is ``Not Likely to Be
Carcinogenic to Humans'' based on a lack of evidence of carcinogenicity
in the two guideline studies conducted on rats and mice.
    Specific information on the studies received and the nature of the
adverse effects caused by triticonazole 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 the document ``Triticonazole. Human Health Risk
Assessment for Proposed Seed Treatment Use on Cereal Grains (Crop Group
15) Including Barley, Field Corn, Oats, Popcorn, Rye, Sorghum Grain,
Sweet Corn, Triticale, and Wheat (Excluding Rice); and Forage, Fodder,
and Straw of Cereal Grains (Crop Group 16), Excluding Rice,'' at pages
34 to 36 in docket ID number EPA-HQ-OPP-2009-0276.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    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
greater than that 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 triticonazole used for
human risk assessment can be found at http://www.regulations.gov in the
document ``Triticonazole. Human Health Risk Assessment for Proposed
Seed Treatment Use on Cereal Grains (Crop Group 15) Including Barley,
Field Corn, Oats, Popcorn, Rye, Sorghum Grain, Sweet Corn, Triticale,
and Wheat (Excluding Rice); and Forage, Fodder, and Straw of Cereal
Grains (Crop Group 16), Excluding Rice,'' at pages 15 to 16 in docket
ID number EPA-HQ-OPP-2009-0276.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triticonazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing triticonazole
tolerances in 40 CFR 180.583. EPA assessed dietary exposures from
triticonazole 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.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of

Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed tolerance level residues of triticonazole were found in all
commodities and that all commodities consumed were 100% crop treated.
Anticipated residues and/or percent crop treated (PCT) information were
not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues in all commodities, and 100% crop treated for all
treated commodities. Anticipated residues and/or PCT information were
not used.
    iii. Cancer. Triticonazole is classified as ``not likely to be
carcinogenic to humans'' based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies. There is no
evidence that triticonazole is carcinogenic to humans, therefore an
exposure assessment to evaluate cancer risk is not needed.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for triticonazole. Tolerance level residues and/or
100% crop treated 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 triticonazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of triticonazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The estimated drinking water concentrations (EDWCs) used in the
dietary risk assessment were provided by OPP's Environmental Fate and
Effects Division and incorporated directly into the dietary assessment.
The EDWCs used in the dietary assessment were modeled using the surface
water model, Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS). For the acute point estimate, the PRZM-EXAMS 1-in-
10 year annual maximum EDWC was used. For the chronic point estimate,
the PRZM-EXAMS 1-in-10 year annual mean EDWC was used. PRZM-EXAMS EDWCs
were used because they were higher (and therefore more protective) than
the groundwater model's, (Screening Concentration in Groudwater model
(SCI-GROW's)) EDWC. Based on the PRZM/EXAMS, the EDWCs of triticonazole
for acute exposures are 75.5 parts per billion (ppb) for surface water
and 5.7 ppb for ground water, and chronic exposures for non-cancer
assessments are estimated to be 32.8 ppb for surface water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 75.5 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 32.8 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Triticonazole is
currently registered for the following uses that could result in
residential exposures: Residential and commercial turfgrass, golf
courses, and sod farms. EPA quantitatively assessed the risk from
residential exposure to children from children's incidental oral post-
application scenarios (hand to mouth, mouthing grass, and soil
ingestion). Children and adults may also have post-application dermal
exposure but dermal toxicity studies with triticonazole did not
identify any adverse effects from such 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 triticonazole to share a common mechanism of
toxicity with any other substances, and triticonazole does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
triticonazole 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 website at http://
www.epa.gov/pesticides/cumulative.
    Triticonazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice; some induce thyroid tumors in rats; and
some induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/
cumulative.
    Triticonazole and other triazole-containing pesticides can form the
common metabolite 1,2,4-triazole and two triazole conjugates
(triazolylalanine and triazolylacetic acid). To support existing
tolerances and to establish new tolerances for triazole-derivative
pesticides, including triticonazole, EPA conducted a human health risk
assessment for exposure to 1,2,4-triazole, triazolylalanine, and
triazolylacetic acid resulting from the use of all current and pending
uses of any triazole-derived fungicide. The risk assessment is a highly
conservative, screening-level evaluation in terms of hazards associated
with common metabolites (e.g., use of a maximum combination of
uncertainty factors) and potential dietary and non-dietary exposures
(i.e., high end estimates of both dietary and non-dietary exposures).
In addition, the Agency retained the additional 10X FQPA safety factor
for the protection of infants and children. The assessment includes
evaluations of risks for various subgroups, including those comprised
of infants and children. The Agency's complete risk assessment is found
in the propiconazole reregistration docket at http://
www.regulations.gov, Docket

Identification (ID) Number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for triticonazole includes rat and rabbit
developmental toxicity studies and a two generation reproduction study
in rats. There is no evidence of increased susceptibility following in
utero and/or postnatal exposure in the developmental toxicity studies
in rats or rabbits, and in the 2-generation rat reproduction study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for triticonazole is complete with the
exception of a newly required immunotoxicity study. In accordance with
40 CFR Part 158 toxicity data requirements, an immunotoxicity study
(Harmonized guideline 870.7800) is required for triticonazole. In the
absence of specific immunotoxicity studies, EPA has evaluated the
available triticonazole toxicity data to determine whether an
additional uncertainty factor is needed to account for potential
immunotoxicity. The toxicological database for triticonazole does not
indicate that the immune system is the primary target organ. Decreased
thymus weight was observed in only one species (rat) at the highest
dose tested (~2x the limit dose of 1,000 mg/kg/day); these findings may
be due to secondary effects of overt systemic toxicity. Based on this
evidence, EPA does not believe that conducting immunotoxicity testing
will result in a point of departure lower than those already selected
for triticonazole risk assessment, and an additional uncertainty factor
is not needed to account for potential immunotoxicity.
    ii. There are no indications that triticonazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that triticonazole 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
database. The dietary food exposure assessments were performed based on
100% crop treated and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to triticonazole in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the
POD by all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases 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 POD to ensure that the MOE called for by the product of
all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the combined acute dietary exposure from food
and water to triticonazole will occupy < 1% of the aPAD for (females 13
to 49 years old), the population subgroups receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
triticonazole from food and water will utilize 1.4% of the cPAD for all
infants (< 1 year old), the subgroup receiving the greatest exposure.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of triticonazole is
not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Triticonazole
is currently registered for use(s) that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to triticonazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food,
water, and residential exposures aggregated result in aggregate MOEs
of: 1,100 for children 1 to 2 years old, and 1,100 for all infants < 1
year old. Because the level of concern is for MOEs below 100, these
MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Triticonazole is currently registered for use(s) that could
result in intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure to
triticonazole through food and water with intermediate-term exposures
for triticonazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of: 780 for children 1 to 2 years old, and 740
for all infants < 1 year old. Because the level of concern is for MOEs
below 100, these MOEs are not of concern.
     5. Aggregate cancer risk for U.S. population. Triticonazole is
classified as ``not likely to be carcinogenic to humans'' based on the
absence of significant tumor increases in two adequate rodent
carcinogenicity studies. Thus, triticonazole is not expected to pose a
cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to triticonazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry (LC/MS), and liquid chromatography/mass spectrometry/mass
spectrometry (LC/MS/MS) methods (Method 148.02) is available to

enforce the tolerance expression. These methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established Codex or Mexican maximum residue levels
(MRLs)/tolerances for triticonazole on wheat or barley. Triticonazole
is registered as a seed treatment in Canada for oats, barley, and
wheat, and has established MRL levels at 0.01 ppm on barley, oats, and
wheat and for livestock commodities at 0.05 ppm. The Canadian MRLs on
barley, oats, and wheat are in harmony with the United States' 0.01 ppm
tolerance level for grain, cereal, group 15, except rice. Additionally,
no U.S. tolerances have been established on livestock commodities. No
harmonization issues exist in connection with the proposed use on turf.

C. Revisions to Petitioned-for Tolerances

    EPA determined the tolerances for grain, cereal, group 15, except
rice, should be established at 0.01 ppm, based on a harmonization
concern with Canada, and residue data which supported this tolerance
level. Thus the proposed tolerance level of 0.05 ppm was deemed
excessive. Upon establishing the grain, cereal, group 15, except rice,
tolerance at 0.01 ppm, the individual tolerances established for
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat,
straw at 0.05 ppm are being removed from 40 CFR 180.583(a).

V. Conclusion

    Therefore, tolerances are established for residues of
triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-
(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal,
group 15, except rice, at 0.01 ppm, and grain, cereal, forage, fodder
and straw, group 16, except rice, at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 19, 2010.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.583 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  180.583  Triticonazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, group 16, except           0.10
 rice......................................................
Grain, cereal, group 15, except rice.......................         0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-1614 Filed 1-26-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Proposed Rules]
[Pages 19509-19511]
[FR Doc No: 2016-07575]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5040; Directorate Identifier 2013-NM-192-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A300 series airplanes; and Model A300 B4-600, B4-
600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F
airplanes (collectively called Model A300-600 series airplanes). This
proposed AD was prompted by the determination that certain existing
inspection thresholds and intervals must be reduced. This proposed AD
would require repetitive detailed inspections for corrosion, and
related investigative and corrective actions if necessary. We are
proposing this AD to detect and correct corrosion and cracking on the
lower wing root joint, which could reduce the structural integrity of
the airframe.

DATES: We must receive comments on this proposed AD by May 20, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
SAS, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5040; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-5040;
Directorate Identifier 2013-NM-192-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0230, dated September 24, 2013 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A300 and A300-600 series airplanes. The MCAI states:

    Several cases of corrosion on the lower wing root joint, located
in the wing bottom skin inboard and outboard of the external lower
surface splice, have been reported by operators.
    This condition, if not detected and corrected, could affect the
structural integrity of the airframe.
    Prompted by these findings, [Directorate General for Civil
Aviation] (DGAC) France issued AD 1997-006-210 [which corresponds to
FAA AD 98-21-34, Amendment 39-10842 (63 FR 55524, October 16, 1998)]
to require repetitive inspections to detect the presence of
corrosion and prevent crack propagation at the wing bottom skin,
inboard and outboard of the Rib 1 external lower surface splice,
between Frame (FR) 40 and FR47.
    DGAC France * * * issued [an AD] to expand the choice of
applicable Service Bulletins (SB). [The] DGAC France AD * * * was
issued to allow A300-600 operators to use Revision 04 of Airbus SB
A300-57-6047, converting flight cycles/``Fatigue rating'' into
flight cycles (FC)/flight hours (FH).
    Subsequently, Airbus modification 10599 was developed to improve
the corrosion behaviour of the area. This improvement allowed
refining the inspection programme of the A300-600 aeroplane. For
post-modification 10599 A300-600 aeroplanes, the application of the
Maintenance Review Board Report (MRBR) inspection tasks was deemed
sufficient for maintaining an adequate level of safety on these
aeroplanes.
    Consequently, EASA issued AD 2008-0208 [http://ad.easa.europa.eu/blob/easa_ad_2008_0208_R2.pdf/AD_2008-0208R2_1]
(later revised), retaining the requirements of [a] DGAC France AD *
* *, which was superseded, to require the use of Airbus SB A300-57-
6047 Revision 05 for the inspections and to exclude post-
modification

10599 A300-600 aeroplanes from the Applicability.
    Since EASA AD 2008-0208R1 was issued, a fleet survey and updated
Fatigue and Damage Tolerance analyses have been performed in order
to substantiate the second A300-600 Extended Service Goal (ESG2)
exercise. The results of these analyses determined that the
threshold and interval must be reduced to allow timely detection of
these cracks and the accomplishment of an applicable corrective
action.
    For the reasons described above, this [EASA] AD takes over and
retains the requirements for A300 and A300-600 aeroplanes from EASA
AD 2008-0208R1 (which has been revised, remaining applicable only to
A310 aeroplanes) and requires accomplishment of the inspections
within the new thresholds and intervals.

    Required actions include repetitive detailed inspections for
corrosion of the rib 1 external lower surface splice between FR40 and
FR47, and repetitive fatigue inspections for cracking of the fasteners
and on the surface of the forward and aft lower surface panels if
necessary, and corrective actions (including application of new
protective coating, removal of corrosion, and measurement of the
reworked depth) if necessary. You may examine the MCAI in the AD docket
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-5040.

Related Rulemaking

    AD 98-21-34, Amendment 39-10842 (63 FR 55524, October 16, 1998)
(``AD 98-21-34''), applies to all Model A300, A300-600, and A310 series
airplanes. This NPRM proposes to apply to only certain Model A300 and
A300-600 series airplanes. The actions in this proposed AD are the same
as those required by AD 98-21-34, but with certain revised compliance
times. Accomplishment of the initial inspection specified in this
proposed AD would terminate the repetitive inspection requirements of
AD 98-21-34 for the affected airplanes. Certain modified Model A300-600
series airplanes would not be subject to the inspection requirements of
this AD, and would no longer be subject to the repetitive inspection
requirements of AD 98-21-34.

Related Service Information Under 1 CFR Part 51

    We reviewed Service Bulletin A300-57-0204, Revision 01, dated April
2, 1999; and Airbus Service Bulletin A300-57-6047, Revision 06, dated
October 17, 2011. This service information describes procedures for
repetitive detailed inspections for corrosion of the rib 1 external
lower surface splice between FR40 and FR47, repetitive fatigue
inspections for cracking of the fasteners and on the surface of the
forward and aft lower surface panels if necessary, and corrective
actions (including application of new protective coating, removal of
corrosion, and measurement of the reworked depth) if necessary. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 29 airplanes of U.S.
registry. We also estimate that it would take about 8 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Based on these figures, we
estimate the cost of this proposed AD on U.S. operators to be $19,270,
or $680 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 8 work-hours, for a cost of $680 per product. We have no way
of determining the number of aircraft that might need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2016-5040; Directorate Identifier 2013-NM-
192-AD.

(a) Comments Due Date

    We must receive comments by May 20, 2016.

(b) Affected ADs

    This AD affects AD 98-21-34, Amendment 39-10842 (63 FR 55524,
October 16, 1998) (``AD 98-21-34'').

(c) Applicability

    This AD applies to all Airbus airplanes, certificated in any
category, identified in paragraphs (c)(1) and (c)(2) of this AD.

    (1) Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and
B4-203 airplanes.
    (2) Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R,
F4-605R, F4-622R, and C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by the determination that certain existing
inspection thresholds and intervals must be reduced. We are issuing
this AD to detect and correct corrosion and cracking on the lower
wing root joint, which could reduce the structural integrity of the
airframe.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Airplanes Excluded From Requirements of This AD and AD 98-21-34

    For airplanes identified in paragraph (c)(2) of this AD on which
Airbus modification 10599 has been incorporated:
    (1) No action is required by this AD; and
    (2) As of the effective date of this AD, the actions specified
in AD 98-21-34 are no longer required.

(h) Inspection and Corrective Actions

    Within 60 months since the airplane's first flight, or within 60
months since accomplishment of the last inspection specified in
Airbus Service Bulletin A300-57-0204 or A300-57-6047, whichever
occurs later: Do a detailed inspection for corrosion of the rib 1
external lower surface splice between frame (FR)40 and FR47, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A300-57-0204, Revision 01, dated April 2, 1999; or Airbus
Service Bulletin A300-57-6047, Revision 06, dated October 17, 2011;
as applicable. Repeat the inspection thereafter at intervals not to
exceed 60 months. Accomplishment of the initial inspection required
by this paragraph terminates the requirements of AD 98-21-34 for
Model A300 and A300-600 series airplanes.

(i) Corrective Actions for Corrosion

    If any corrosion is found during any inspection required by
paragraph (h) of this AD, do the actions specified in paragraph
(i)(1) and (i)(2) of this AD.
    (1) Before further flight, do all applicable corrective actions
in accordance with the Accomplishment Instructions of Airbus Service
Bulletin A300-57-0204, Revision 01, dated April 2, 1999; or Airbus
Service Bulletin A300-57-6047, Revision 06, dated October 17, 2011;
as applicable; except as required by paragraph (j)(1) of this AD.
    (2) At the applicable time specified in paragraph (i)(2)(i) or
(i)(2)(ii) of this AD, except as required by paragraph (j)(2) of
this AD: Do fatigue inspections to detect cracks of the fasteners
and on the surface of the forward and aft lower surface panels, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A300-57-0204, Revision 01, dated April 2, 1999; or Airbus
Service Bulletin A300-57-6047, Revision 06, dated October 17, 2011;
as applicable. Repeat the fatigue inspections thereafter at the
applicable interval specified in paragraph B.(5) of Airbus Service
Bulletin A300-57-0204, Revision 01, dated April 2, 1999; or Figure
A-FBGAA, Sheet 01, of Airbus Service Bulletin A300-57-6047, Revision
06, dated October 17, 2011; as applicable; except as required by
paragraph (j)(2) of this AD. If any cracking is found during any
fatigue inspection required by this paragraph: Before further
flight, repair using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA).
    (i) For Model A300 series airplanes: Do the initial inspection
at the applicable time specified in paragraph B.(5) of Airbus
Service Bulletin A300-57-0204, Revision 01, dated April 2, 1999.
    (ii) For Model A300-600 series airplanes: Do the initial
inspection at the later of the times specified in paragraphs
(i)(2)(ii)(A) and (i)(2)(ii)(B) of this AD.
    (A) At the applicable time specified in Figure A-FBGAA, Sheet
01, of Airbus Service Bulletin A300-57-6047, Revision 06, dated
October 17, 2011.
    (B) Within 500 flight cycles or 1,050 flight hours after the
effective date of this AD, whichever occurs first, without exceeding
the time specified in paragraph (i)(2)(ii)(A) of this AD.

(j) Exceptions to Service Bulletin Specifications

    (1) Where Airbus Service Bulletin A300-57-0204, Revision 01,
dated April 2, 1999; or Airbus Service Bulletin A300-57-6047,
Revision 06, dated October 17, 2011; specifies to contact Airbus for
appropriate corrective action, this AD requires repair before
further flight using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus's EASA DOA.
    (2) Where Airbus Service Bulletin A300-57-6047, Revision 06,
dated October 17, 2011, specifies to contact Airbus for the
appropriate threshold or repetitive interval, this AD requires that
the compliance time be determined using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or EASA; or Airbus's EASA DOA.

(k) Calculating Average Flight Time (AFT)

    The accumulated flight hours (counted from the takeoff up to the
landing) divided by the number of accumulated flight cycles is the
AFT per flight cycle.

(l) Credit for Previous Actions

    This paragraph provides credit for the inspections and
corrective actions required by paragraphs (h) and (i) of this AD, if
those actions were performed before the effective date of this AD
using the applicable service information specified in paragraphs
(l)(1) through (l)(3) of this AD.
    (1) Airbus Service Bulletin A300-57-6047, Revision 02, dated
April 2, 1999, which is not incorporated by reference in this AD.
    (2) Airbus Service Bulletin A300-57-6047, Revision 03, dated
September 28, 1999, which is not incorporated by reference in this
AD.
    (3) Airbus Service Bulletin A300-57-6047, Revision 05, dated May
27, 2008, which is not incorporated by reference in this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Airbus's EASA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0230, dated September 24,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-5040.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 24, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-07575 Filed 4-4-16; 8:45 am]
BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget. Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request Environmental Protection Agency/ Office of Air Quality Planning and Standards 2. OMB control number b. G None a. 2060 0421 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number For b f, note item A2 of Supporting Statement instructions 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: ______/______/______ c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No 6. Requested expiration date a. X Three years from approval date b. G Other Specify: ______/______

7. Title Information Collection Request for Proposed Regional Haze Regulations ( Renewal)

8. Agency form number( s) ( if applicable) ICR 1813.04 9. Keywords Regional Haze, Visibility, Smog, Best Available Retrofit Technology, Clean Air Act, Air Pollution Control, Environmental Protection 10. Abstract Section 169A of the Clean Air Act sets forth a national goal for visibility which is the " prevention of any future, and the remedying of any existing, impairment of visibility in Class I areas which impairment results from manmande air pollution." There are 156 Class I areas across the country, including many well known national parks and wilderness areas, such as the Grand Canyon, Great Smokies, Yellowstone, Yosemite, and the Everglades. Regional haze is visibility impairment caused by the cumulative air pollutant emissions from numerous sources over a wide geographic area. The Regional Haze Regulations address regional haze visibility impairment and calls for States and tribes ( that choose to do so) to establish goals and emission reduction strategies for improving visibility in all 156 mandatory Class I areas. EPA is also encouraging States to work together in regional partnerships to develop and implement multistate strategies to reduce emissions of visibility impairing fine particle pollution.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. ___ Individuals or households d.___ Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local, or Tribal Governments 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. X Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 205 b. Total annual responses 205 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 44,917 d. Current OMB inventory 11,500 e. Difference 33,417 f. Explanation of difference 1. Program change ____ 0______________________ 2. Adjustment ___ 33,417__________________ 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) ____ 0__________________________ c. Total annualized cost requested $ 0 d. Current OMB inventory $ 0 e. Difference $ 0 f. Explanation of difference 1. Program change _____ 0_____________ 2. Adjustment ____$ 0 _______

15. Purpose of information collection ( Mark primary with " P" and all others that apply with " X") a. ____ Application for benefits e. ____ Program planning or management b. X Program evaluation f. ____ Research c. ____ General purpose statistics g. P Regulatory or compliance d. ____ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. G Third party disclosure c. X Reporting 1. G On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi annually 6. X Annually 7. G Biennially 8. G Other ( describe) _________________

17. Statistical methods Does this information collection employ statistical methods?

G Yes X No 18. Agency contact ( person who can best answer question regarding the content of this submission)

Name: Tim Smith Phone: ( 919) 541 4718 OMB 83 I 10/ 95 19. Certification for paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and related provisions of 5 CFR 1320.8 ( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8 ( b)( 3):

( I) Why the information is being collected;

( ii) Use of information;

( iii) Burden estimate;

( iv) Nature of response ( voluntary, required for a benefit, or mandatory);

( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective manage ment and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95


[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2242-2243]
[FR Doc No: 2018-00493]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-236, OMB Control No. 3235-0222]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 17f-1

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget for extension and approval.
    Rule 17f-1 (17 CFR 270.17f-1) under the Investment Company Act of
1940 (the ``Act'') (15 U.S.C. 80a) is entitled: ``Custody of Securities
with Members of National Securities Exchanges.'' Rule 17f-1 provides
that any registered management investment company (``fund'') that
wishes to place its assets in the custody of a national securities
exchange member may do so only under a written contract that must be
ratified initially and approved annually by a majority of the fund's
board of directors. The written contract also must contain certain
specified provisions. In addition, the rule requires an independent
public accountant to examine the fund's assets in the custody of the
exchange member at least three times during the fund's fiscal year. The
rule requires the written contract and the certificate of each
examination to be transmitted to the Commission. The purpose of the
rule is to ensure the safekeeping of fund assets.
    Commission staff estimates that each fund makes 1 response and
spends an average of 3.5 hours annually in complying with the rule's
requirements. Commission staff estimates that on an annual basis it
takes: (i) 0.5 hours for the board of directors \1\ to review and
ratify the custodial contracts; and (ii) 3 hours for the fund's
controller to assist the fund's independent public auditors in
verifying the fund's assets.

Approximately 6 funds rely on the rule annually, with a total of 6
responses.\2\ Thus, the total annual hour burden for rule 17f-1 is
approximately 21 hours.\3\
---------------------------------------------------------------------------

    \1\ Estimates of the number of hours are based on conversations
with representatives of mutual funds that comply with the rule. The
actual number of hours may vary significantly depending on
individual fund assets. The hour burden for rule 17f-1 does not
include preparing the custody contract because that would be part of
customary and usual business practice.
    \2\ Based on a review of Form N-17f-1 filings over the last
three years the Commission staff estimates that an average of 4
funds rely on rule 17f-1 each year.
    \3\ This estimate is based on the following calculation: (6
respondents x 3.5 hours = 21 hours). The annual burden for rule 17f-
1 does not include time spent preparing Form N-17f-1. The burden for
Form N-17f-1 is included in a separate collection of information.
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    Funds that rely on rule 17f-1 generally use outside counsel to
prepare the custodial contract for the board's review and to transmit
the contract to the Commission. Commission staff estimates the cost of
outside counsel to perform these tasks for a fund each year is $800.\4\
Funds also must have an independent public accountant verify the fund's
assets three times each year and prepare the certificate of
examination. Commission staff estimates the annual cost for an
independent public accountant to perform this service is $8,500.\5\
Therefore, the total annual cost burden for a fund that relies on rule
17f-1 would be approximately $9,300.\6\ As noted above, the staff
estimates that 4 funds rely on rule 17f-1 each year, for an estimated
total annualized cost burden of $55,800.\7\
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    \4\ This estimate is based on the following calculation: (2
hours of outside counsel time x $400 = $800). The staff has
estimated the average cost of outside counsel at $400 per hour,
based on information received from funds, fund intermediaries, and
their counsel.
    \5\ This estimate is based on information received from fund
representatives estimating the aggregate annual cost of an
independent public accountant's periodic verification of assets and
preparation of the certificate of examination.
    \6\ This estimate is based on the following calculation: ($800 +
$8,500 = $9,300).
    \7\ This estimate is based on the following calculation: (6
funds x $9,300 = $55,800).
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    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules. Compliance with the collections of information
required by rule 17f-1 is mandatory for funds that place their assets
in the custody of a national securities exchange member. Responses will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid control number.
    The Commission requests written comments on: (a) Whether the
collections of information are necessary for the proper performance of
the functions of the Commission, including whether the information has
practical utility; (b) the accuracy of the Commission's estimate of the
burdens of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 20549; or send an email
to: [email protected].

    Dated: January 9, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00493 Filed 1-12-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 19, 2006 (Volume 71, Number 243)]
[Notices]
[Page 76007-76008]
[DOCID:fr19de06-98]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission Office of Filings and Information Services, Washington, DC
20549.

Extension: Rules 8b-1 to 8b-33; SEC File No. 270-135; OMB Control
No. 3235-0176

    .Notice is hereby given that pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information discussed below.
    Rules 8b-1 to 8b-33 (17 CFR 270.8b-1 to 8b-33) under the Investment
Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (the ``Act'') are the
procedural rules an investment company must follow when preparing and
filing a registration statement. These rules were adopted to
standardize the mechanics of registration under the Act and to provide
more specific guidance for persons registering under the Act than the
information contained in the statute. For the most part, these
procedural rules do not require the disclosure of information. Two of
the rules, however, require limited disclosure of information.\1\ The
information required by the rules is necessary to ensure that investors
have clear and complete information upon which to base an investment
decision. The Commission uses the information that investment companies
provide on registration statements in its regulatory, disclosure
review, inspection and policy-making roles. The respondents to the
collection of information are investment companies filing registration
statements under the Act.
---------------------------------------------------------------------------

    \1\ Rule 8b-3 (17 CFR 270.8b-3) provides that whenever a
registration form requires the title of securities to be stated, the
registrant must indicate the type and general character of the
securities to be issued. Rule 8b-22 (17 CFR 270.8b-22) provides that
if the existence of control is open to reasonable doubt, the
registrant may disclaim the existence of control, but it must state
the material facts pertinent to the possible existence of control.
---------------------------------------------------------------------------

    The Commission does not estimate separately the total annual
reporting and recordkeeping burden associated with rules 8b-1 to 8b-33
because the burden associated with these rules are included in the
burden estimates the Commission submits for the investment company
registration statement forms (e.g., Form N-1A, Form N-2, Form N-3, and
Form N-4). For example, a mutual fund that prepares a registration
statement on Form N-1A must comply with the rules under section 8(b),
including rules on riders, amendments, the form of the registration
statement, and the number of copies to be submitted. Because the fund
only incurs a burden from the section 8(b) rules when preparing a
registration statement, it would be impractical to measure the
compliance burden of these rules separately. The Commission believes
that including the burden of the section 8(b) rules with the burden
estimates for the investment company registration statement forms
provides a more accurate and complete estimate of the total burdens
associated with the registration process.

    Investment companies seeking to register under the Act are required
to provide the information specified in rules 8b-1 to 8b-33 if
applicable. Responses will not be kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: December 11, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-21643 Filed 12-18-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Notices]
[Page 68272]
[DOCID:fr23de09-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 23, 2010, from
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On February 23, 2010, the committee will discuss the
efficacy and safety of new drug application (NDA) 22-554, for XIFAXAN
(rifaximin) Tablets, 550 milligrams, by Salix Pharmaceuticals, for the
indication (use) of maintenance of remission of hepatic encephalopathy,
a condition in which severe liver disease contributes to an
accumulation of toxic substances that impair brain function. This
indication is for patients 18 years of age and older.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 8, 2010. Oral presentations from the public will be scheduled
between 1 p.m. to 2 p.m. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before January 29, 2010. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by February
1, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristine T. Khuc at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 17, 2009.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning, and Budget.
[FR Doc. E9-30442 Filed 12-22-09; 8:45 am]

BILLING CODE 4160-01-S


1 of 10 MEMORANDUM Date: 3/ 23/ 2006 SUBJECT: Dietary Risk Assessment for Alkylbenzene Sulfonates REVIEWER: Robert Quick, Chemist Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

THROUGH: Norm Cook, Chief Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

TO: Heather Garvie, Chemical Review Manager Regulatory Management Branch Antimicrobials Division ( 7510C)

PC CODES: 079010 Sodium dodecylbenzene sulfonic acid 098002 Dodecylbenzene sulfonic acid 190116 C10 16 Alkylbenzene sulfonic acid DP BARCODES: D327731 DECISION #: 362580 2 of 10 Alkylbenzene Sulfonate Dietary Exposure The Registration Elgibility Document ( RED) covers the potential dietary exposure to the active ingredient( s) sodium dodecylbenzene sulfonate, dodecylbenzene sulfonate and benzene sulfonic acid. This RED does not address the dietary exposure that will result from the use of products containing these chemicals as inert ingredients. Chemicals classed as any of these chemicals are being considered together because chemicals named dodecylbenzene sulfonate actually contain alkylbenzene sulfonates in addition to dodecylbenzene sulfonate. Labeling modifications will be made to these chemicals as a result of the reregistration process.

The uses for these chemicals include: ( 1), food handling/ storage establishments, premises and equipment; ( 2) agricultural premises and equipment; and ( 3) fruit and vegetable rinses.

The 21 CFR 178.1010 Regulation for sanitizing solutions read:

Dodecylbenzene sulfonate: 178.1010( b)( 7) and 178.1010( c)( 5). The site reads: " In addition to use on food processing equipment and utensils, this solution may be used on glass bottles and other glass containers intended for holding milk". The use limitation for the chemical is 400 ppm.

Dodecylbenzene sulfonic acid: 178.1010 ( b)( 10) and 178.1010 ( c)( 7). The site reads: " In addition to use on food processing equipment and utensils, this solution may be used on beverage containers except milk containers or equipment". The use limitation is 400 ppm.

Sodium dodecylbenzenesulfonate: 178.1010( b)( 21) and 178.1010( c)( 16). The site reads, " In addition to use on food processing equipment and utensils this solution can be used on glass bottles and other glass containers intended for holding milk". The use limitation is 430 ppm equivalent to ~ 400ppm of the free acid.

Dodecylbenzene sulfonic acid; 178.1010( b)( 40) and 178.1010( c)( 35). The site reads: " In addition to use on food processing equipment and utensils, this solution may be used on dairy processing equipment". The use limitation is 5.5 ppm.

It appears that dodecylbenzenesulfonic acid solutions containing up to 400 ppm can be used on glass bottles and containers containing milk but cannot be used on dairy processing equipment at this level. The registrant and user may have difficulty in distinguishing between glass lined equipment and glass containers. 3 of 10 These 21 CFR citations do not specifically state that the solutions may be used on food contact articles including dishes, pots and pans, glasses etc. However, there are many labels registered for use on these sites.

The 40 CFR 180 Regulation reads:

Tolerance Exemption Expression/ Chemical Name CAS No. PC Code 40 CFR 180. Use Pattern ( Pesticidal) Active Products 940 ( b) food contact sanitizing solutions for dairy processing equipment, and food processing equipment and utensils; end use concentration not to exceed 5.5 ppm Benzenesulfon ic acid, dodecyl 27176 87 0 098002 940 ( c) food contact sanitizing solutions for food processing equipment and utensils; end use concentration not to exceed 400 ppm 18 Benzenesulfon ic acid dodecyl, sodium salt 25155 30 0 079010 940 ( c) food contact sanitizing solutions for food processing equipment and utensils; end use concentration not to exceed 430 ppm 3 The RMB II Chemical Review Manager should ascertain the correct use sites and limitations for these chemicals.

Many of the labels include uses for the sanitization of food serving equipment, glasses, dishes, utensils and pots and pans. These surfaces that have been treated with the dodecylbenzene sulfonate products may bear small residues of the dodecylbenzene sulfonate Residues from treated surfaces can migrate to food coming into contact with the treated surfaces and can be ingested by humans.

The maximum label rates for the dodecylbenzene sulfonates are 400 ppm for use in antimicrobial formulations ( Food contact surface sanitizing solutions).

The maximum rate for dodecylbenzene sulfonates in sanitizer end use solutions is 400 ppm except for dairy processing equipment. Uses on food processing equipment are discussed below under " Food Processing Industry". 4 of 10 FOOD CONTACT SURFACES IN THE FOOD SERVICE INDUSTRY AD will use the 400 ppm level permitted in an end use solution in our calculations.

In the absence of residue data for residues of dodecylbenzene sulfonate on treated food contact surfaces reflecting the registered use patterns, the Agency can calculate residue levels that may occur in food from the application rates on food contact surfaces.

To estimate the Estimated Daily Intake ( EDI), the Agency has used the following model calculation. This model is taken from FDA Guidelines.

The maximum ingredient percentage for dodecylbenzene sulfonates registered for use in food handling establishments in kitchens, cafeterias, supermarkets and meat and poultry plants is 400 ppm).

EDI = ( 1 mg/ cm2) x wt. fraction of wash solution ( AR) x SA x FMF/ BW Where: AR = Application rate SA = surface to which food is exposed, assume 4000 cm2 FMF = Fraction of pesticide migrating to food, assume 100%* BW = 70 for male adults, 60 kg for female adults and 15 kg for children EDI from the FDA model = 400 µ g/ 1000 mg ( ppm) x 1.0 mg/ cm2 x 4000 cm2 / person/ day = 1600 µ g dodecylbenzene sulfonate/ person/ day Assuming that an average adult consumes 3000 gm of food per day,

Then 1600 µ g a. i./ 3000 gm food = 0. 53 µ g a. i./ gm ( ppm) of food This calculation reduces the dietary consumption to µ g of a. i. per gm of food.

Assume that an adult consumes 3000 gm of food / day 1600 µ g a. i./ 70 kg BW = 22.9 µ g dodecylbenzene sulfonate/ kg/ day for a male adult 1600 µ g a. i./ 60 kg BW = 26.7 µ g dodecylbenzene sulfonate/ kg/ day for a female adult Assuming that a child consumes 1500 gm of food per day, Then: 0. 53 µ g a. i./ gm ( ppm) of food x 1500 = 795 µ g a. i./ day 800 µ g a. i./ 15 kg BW = 53 µ g dodecylbenzene sulfonate/ kg/ day for child 5 of 10 FOOD CONTACT SURFACES IN THE FOOD PROCESSING INDUSTRY The 21 CFR 178.1010 Regulations and the 40 CFR 940 Regulations do not specifically permit the use on milk processing equipment at a level of 400 ppm.

However, the labels include uses for the sanitization of food processing equipment such as tanks, pipelines, evaporators, filters, pasteurizers, aseptic equipment including dairies, wineries, breweries and beverage plants, meat and poultry processing/ packing plants, milk and dairy products / packing plants, seafood and vegetable processing/ packing plants, food processing/ packing plants and egg processing/ packing equipment surfaces. These uses would permit the sanitization of the interior of food processing and storage equipment.

This use could be additive to the treatment of food contact surfaces such as glasses, dishes, utensils and pots and pans.

AD will use an FDA model to estimate residues that could transfer from treated surfaces to food from this type of use.

According to the FDA, the exposure estimates for this type of use can be calculated using the milk truck model that is described in the FDA document, " Sanitizing Solutions: Chemistry Guidelines For Food Additive Petitions", pages 9 10.

This guidance states on page 9, " For applications limited to use of the food sanitizer on food processing equipment and utensils, the Agency has determined that estimates of sanitary exposure from use in dairy processing plants significantly exceed estimates based on other uses with food processing equipment and utensils. Depending on the available safety data, the petitioner may either submit a petition for the broader use of its sanitizer on " food processing equipment and utensils including dairy processing plants" or for the more limited use on " food processing equipment and utensils excepting use in dairy processing plants."

The next paragraph of the document states, " The following simplified example will illustrate the calculation of the EDI of residual sanitizer solution in milk from sanitizer use in a dairy processing plant. Although in practice consideration of all of the components of a milk handling system must be included as sources of sanitizer residue in milk, for this example the only source is assumed to be a sanitized tank truck to transport the milk. It is further assumed that the milk undergoes no additional dilution prior to reaching the consumer. Assuming a cylindrical model for the tank truck ( 4000 gallon capacity) with a length of 19.9 feet and cross sectional diameter of 6 feet, and an internal surface area of 413 sq ft is calculated for the tank. Assuming that the sanitizer treatment leaves a residue of 1 mg/ sq cm and the ` at use' concentration of component X is 200 ppm, the concentration of X in the milk residing in the tank would equal: 6 of 10 413 sq ft/ 1 truck x 1truck/ 4000gal x 1 mg/ sq cm x 200 µ g/ 1000 mg x 929 sq cm/ 1 sq ft x 0.264 gal/ 1L = 5.1 µ g x/ L milk ~ 5.1 ppb".

The maximum application rate for the dodecylbenzene sulfonate chemicals in food processing equipment is 400 ppm.

Then using the FDA model, residues resulting in milk from the use would be calculated as:

413 sq ft/ 1 truck x 1truck/ 4000gal x 1 mg/ sq cm x 400 µ g/ 1000 mg x 929 sq cm/ 1 sq ft x 0.264 gal/ 1L = 5.1 µ g x/ L milk ~ 10.1 ppb.

If an adult were to consume 3000 gm of food per day containing 10.1 µ g/ L or 10.1 µ g/ kg ( 1000 gm), then the person would ingest 30.4 µ g of dodecylbenzene sulfonate per day.

A child consuming 1500 gm of food per day would consume would ingest 15.2 µ g of dodecylbenzene sulfonate per day.

DIETARY EXPOSURE ASSESSMENT FOR THE FOOD SERVICE AND FOOD PROCESSING INDUSTRIES TABLE 1 Cumulative Estimated Dietary Intake of LAS Use Dietary Conc. ( ppb) Estimated Daily Intake ( µ g/ person/ day) Daily Dietary Dose ( mg/ kg bw/ day) Food Service Industry 0.53 ppb 1600 ( adult M) 1600 ( adult F) 800 ( child) 0.023 ( adult M) 0.027 ( adult F) 0.053 ( child) Food Processing Industry 10.1 ppb 30.3 ( adult M) 30.3 ( adult F) 15.1 ( child) 0.00043 ( adult M) 0.00050 ( adult F) 0.001 ( child) Cumulative 12.6 ppb 1630.3 ( adult M) 1630.3 ( adult F) 815.1 ( child) 0.023 ( adult M) 0.027 ( adult F) 0.054( child)

There were no effects attributable to a single dose for the acute dietary risk ( Deborah Smegal memo.

Utilizing the chronic RfD or cPAD of 0.5 mg/ kg/ day taken from the Deborah Smegal memo, the dietary risks were estimated in Table 2 below.

% PAD = exposure/ PAD x 100 7 of 10 TABLE 2 Dietary Risks of LAS USE DAILY DIETARY DOSE ( mg/ kg bw/ day) % aPAD % cPAD Food Service Industry 0.023 ( adult M) 0.027 ( adult F) 0.053 ( child) No effects No effects No effects 4.6% 5.4% 10.6% Food Processing Industry 0.00043( adult M) 0.00050 ( adult F) 0.001 ( child) No effects No effects No effects 0.086% 0.1% 0.2% Cumulative 0.0234( adult M) 0.0275( adult F) 0.054( child) No effects No effects No effects 4.69% 5.5% 10.8%

The food service and food processing industry uses do not result in dietary risks of concern.

FRUIT AND VEGETABLE WASH The label, CS 100 Acid Anionic Sanitizer, EPA Reg. # 71695 1, bears a use for washing fruits and vegetables.

The FDA Regulation, 21 CFR 173.315, permits this use provided that the wash solution does not contain dodecylbenzene sulfonic acid at a level greater than 0.2%. No potable water rinse is required by the Regulation. We presume that the use limitation is for the parent chemical because the Regulation makes no mention of formulations. The use limitation states, " Not to exceed 0.2% in wash water. May be used in washing or to assist in the lye peeling of fruits and vegetables". Note: If the use limitation were intended to apply to a formulation, there would be a broad range of application rates depending on the concentration of the chemical in the formulation.

The label bears a use that provides for a fruit and vegetable wash with a solution containing 0.16 % dodecylbenzene sulfonic acid, without a potable water rinse.

The label also bears a use a use that provides for a fruit and vegetable wash with a solution containing 0.31% dodecylbenzene sulfonic acid, with a potable water rinse.

There are no data to show that the level of residues on fruits and vegetables would be reduced to the level that would have occurred from a 0.2% wash. However, AD concludes that dodecylbenzene sulfonic acid residues would be significantly reduced by the potable water rinse and would be less than residues resulting from the 0.2% wash.

There are no residue data to show the level of dodecylbenzene sulfonic acid that will result on fruits and vegetables from the 0.2% wash solution with a potable water rinse. 8 of 10 Lacking residue data to show the level of residues expected on fruits and vegetables, we have calculated the level of residues on fruits and vegetables using the following model.

Dodecylbenzene sulfonate Fruit and Vegetable Wash Dietary Residue Calculations:

Calculation for percent dodecylbenzene sulfonate in the wash water:

The maximum use rate is 2000 ppm of dodecylbenzene sulfonate ( 0.2% x 10,000) for fruit and vegetables.

We will use the surface area and weight of Thompson Seedless grapes to calculate residues in fruits and vegetables. This is a small grape which accounts for half of the table grapes grown in California and is used to make over 90% of the grapes grown in the United States.

Grapes specifications: Diameter of one grape = 16 mm ( Source: University of California Cooperative Extension, Tulare County http:// cetulare. ucdavis. edu/ pubgrape/ tb195. htm Mass of one grape = 4.0 gm or 0.0040 kg ( Source: University of California Cooperative Extension, Tulare County http:// cetulare. ucdavis. edu/ pubgrape/ tb195. htm )

Surface area of one grape = 15.88 cm2 Based on surface area of a sphere where A = 4 r2 ( where r = 8 mm) A = 4 x 3.14 x ( 8 mm) 2 A = 803.8 mm2 A = 8.04 cm2 Amount of Residue on Grapes: Assume the film thickness of the solution on the surface of the grape is 0.0023 g/ cm2 ( Source: Proctor and Gamble exposure assessment for ingestion of dishwashing product residues  based on the amt of rinse water in contact with dishware surfaces http:// www. scienceinthebox. com/ en_ UK/ safety/ ingestionfromsurface_ en. html)

0.0023 g/ cm2 x 8.04 cm2 x 0.002 ( 0.2%) dodecylbenzene sulfonate = 0.0000369 gm or 0.037 mg dodecylbenzenesulfonate 0.037 mg dodecylbenzene sulfonate/ 0.004 kg grape = 9.25 mg/ kg or ppm DIETARY EXPOSURE ASSESSMENT FOR THE FRUIT AND VEGETABLE WASH 9 of 10 This part of the non cancer dietary risk assessment was carried out by Cassi Walls ( RASSB/ AD). It was conducted using the Dietary Exposure Evaluation Model ( DEEMFDIC   ) , Version 2.03 which uses food consumption data from the USDA's Continuing Surveys of Food Intake by Individuals ( CSFII) from 1994 1996 and 1998. This assessment is Tier 1, conservative ( assumes 100% crop treatment) and uses the deterministic approach. As input parameters for modeling analyses, the level of 9.25 ppm was used based on the modeling discussed above.

TABLE 3 Dietary Risk for Fruit and Vegetable Wash USE DAILY DIETARY DOSE ( mg/ kg bw/ day) % aPAD % cPAD Fruit and Vegetable Wash 0.0979 ( U. S. Pop.) 0.2793 ( child 1 6) 0.3558 ( child 1 2) 0.2573 ( child 3 5) No Effects No Effects No Effects No Effects 19.6% 55.9% 71.2% 51.5%

Dietary risks were calculated in the above table for the U. S. general population and for those groups exposed to the highest risk. The chronic analyses were below the Agency's level of concern for all of the Population Subgroups using the Agency DEEM. The most highly exposed group was children 1 2 years old with 71.2% of the cPAD).

These residue calculations provide an acceptable dietary risk of concern for population subgroups for this chemical.

Issues That Must Be Resolved I. For the 40 CFR 180.940 Regulations for sanitizing solutions:

Many of the labels include uses for the sanitization of food serving equipment, glasses, dishes, utensils and pots and pans. These surfaces that have been treated with the dodecylbenzene sulfonate products may bear small residues of the dodecylbenzene sulfonate Residues from treated surfaces can migrate to food coming into contact with the treated surfaces and can be ingested by humans.

Benzenesulfonic acid, dodecyl: 40 CFR 180.940( c) The site reads: " Food processing equipment and utensils". The use limitation is 400 ppm.

Benzenesulfonic acid dodecyl, sodium salt: 40 CFR 180.940( c) The site reads, " Food processing equipment and utensils". The use limitation is 430 ppm equivalent to ~ 400ppm of the free acid. 10 of 10 Benzenesulfonic acid, dodecyl : 40 CFR 180.940( b) The site reads: " Dairy processing equipment, and food processing equipment and utensils". The use limitation is 5.5 ppm.

It appears that dodecylbenzenesulfonic acid solutions containing up to 400 ppm can be used on dairy processing equipment and food processing equipment. The registrant and user may have difficulty in distinguishing between food processing equipment and dairy processing equipment. Many labels bear use directions with a treatment rate of greater than 5.5 ppm for dairy processing equipment.

Also, these 40 CFR citations also do not specifically state that the solutions may be used on food contact articles including dishes, pots and pans, glasses etc. However, there are many labels registered for use on these sites.

The Chemical Review Manager should ascertain the correct use sites and limitations for these chemicals.