[Federal Register: September 6, 2007 (Volume 72, Number 172)]
[Rules and Regulations]
[Page 51180-51187]
[DOCID:fr06se07-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0572; FRL-8146-7]

Residues of Quaternary Ammonium Compounds di-n-Alkyl
(C8-10) dimethyl Ammonium chloride, Exemption
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends 40 CFR 180.940(a), the exemption from
the requirement of a tolerance for residues of Quaternary Ammonium
Compounds, di-n-Alkyl (C8-10) dimethyl ammonium
chloride, average molecular weight (in amu) 332 to 361 on food contact
surfaces when applied/used in public eating places, dairy processing
equipment, and food-processing equipment and utensils by increasing the
allowable use solution concentrations of quaternary compounds. Lonza
Inc. submitted a petition to EPA under the Federal Food,

Drug, and Cosmetic Act requesting an increase in the concentrations of
quaternary compounds in end-use products eligible for the exemption. As
amended, the regulation will exempt solutions from the requirement of a
tolerance residues resulting from contact with surfaces treated with
solutions where the end use concentration of the specific quaternary
compounds does not exceed 240 parts per million (ppm) of active
quaternary ammonium compounds, and the end-use concentration of all
quaternary chemicals in the solution does not exceed 400 ppm of active
quaternary compound.

DATES: This regulation is effective September 6, 2007. Objections and
requests for hearings must be received on or before November 5, 2007,
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-2006-0572. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), 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:
     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 provides
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 180.940
Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing solutions),
paragraph (a). 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you my access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the Food Quality
Protection Act (FQPA), any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
The EPA procedural regulations which govern the submission of
objections and requests for hearings appear in 40 CFR part 178. 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-
2006-0572 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 on or before November 5, 2007.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0572, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of October 25, 2006 (71 FR 62458) (FRL-
8099-6), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 6F7045) by Lonza, Inc, 90 Boroline Rd,
Allendale, NJ 07401. The petition requested that 40 CFR 180.940(a) be
amended by increasing concentration limits for aliphatic alkyl
quaternary compounds in end-use solutions eligible for the tolerance
exemption for Quaternary Ammonium compounds: Di-n-Alkyl (C8-
10) dimethyl ammonium chloride, average molecular weight (in
amu) 332 to 361) on food contact surfaces in public eating places,
dairy processing equipment, and food

processing equipment and utensils from 150 ppm to 240 ppm and the total
end use concentration of all quaternary chemicals in solution from 200
ppm to 400 ppm. The notice referenced a summary of the petition
prepared by Lonza Inc., 90 Boroline Rd Allendale, NJ 07401, the
registrant, which is available to the public in the docket at
http://www.regulations.gov, Docket ID Number EPA-HQ-OPP -2006-0572. There were

no comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for 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(c)(2)(A)(ii) 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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which 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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

A. Toxic Effects

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by the
Aliphatic Alkyl Quaternaries are discussed in this unit.
    The Aliphatic Alkyl Quaternaries are corrosive, highly irritating
to the eye and skin, with moderate acute toxicity by oral, dermal, and
inhalation routes of exposure. These chemicals are classified as ``not
likely'' to be a human carcinogen based on a negative carcinogenicity
study in rats and mice feeding studies using doses above the limit.
There is no evidence of these chemicals being associated with increased
susceptibility to developmental toxicity or reproductive toxicity based
on two developmental toxicity studies and a two-generation reproductive
study. Lastly, they are negative for mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects caused by Di-n-Alkyl (C8-10)
dimethyl ammonium chloride, average molecular weight (in amu) 332 to
361) (DDAC) 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; Docket ID Number

EPA-HQ-OPP-2005-0338; Toxicology Disciplinary Chapter for the
Reregistration Eligibility Decision (RED) for Didecyl Dimethyl Ammonium
Chloride (DDAC).

B. Toxic Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(NOAEL) from the toxicology study identified as appropriate for the
risk assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in variations
in sensitivity among members of the human population as well as other
unknowns.
    The Agency's level of concern (LOC) for residential Aliphatic Alkyl
Quaternaries' inhalation and oral exposures is 100 (i.e., a margin of
exposure (MOE) less than 100 exceeds the Agency's level of concern).
The level of concern is based on 10x for interspecies extrapolation and
10x for intraspecies extrapolation. However, the uncertainty factor or
``target'' MOE for Aliphatic Alkyl Quaternaries' dermal exposures is 10
for residential scenarios. The target MOE was chosen because the
established endpoint is for dermal irritation, not a systemic toxic
effect. In addition, dermal irritation is considered a reversible and
short-term effect, thus supporting a 10x uncertainty factor (half a log
(10.5) or approximately 3x for interspecies extrapolation and half log
(10.5) or approximately 3x for intraspecies variation). It should be
noted that the determination to reduce the 100x UF to 10X UF for
irritation endpoints is made on a case-by-case basis.
    Aliphatic Alkyl Quaternaries toxicological endpoint summary is
listed in the following table.

                              Table 1.--Summary of Toxicological Endpoints for DDAC
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                                                             Target MOE/UF, Special
         Exposure Scenario              Dose Used in Risk       FQPA SF for Risk       Study and Toxicological
                                     Assessment (mg/kg/day)        Assessment                  Effects
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Acute Dietary (Females 13-50)        FQPA SF = 1             Parenatal
NOAEL (developmental) = 10 mg/kg/    UF = 100 (10x inter-     Developmental
 day.                                 species                 Toxicity - Rat MRID
                                      extrapolation, 10x      41886701
                                      intra-species          LOAEL = 20 mg/kg/day
                                      variation).             based on increased
                                                              incidence of skeletal
                                                              variations..
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                                                  Acute RfD = 0.1 mg/kg/day (for Females age 13-50)
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Acute Dietary(general population)      An acute dietary endpoint was not identified in the data base. This risk
                                                              assessment is not required
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (general             NOAEL = 10 mg/kg/day    FQPA SF = 1             Chronic Toxicity Study -
 population)                                                 UF = 100 (10x inter-     Dog MRID 41970401
                                                              species                LOAEL = 20 mg/kg/day based
                                                              extrapolation, 10x      on increased incidence of
                                                              intra-species           clinical signs in males
                                                              variation.              and females and decreased
                                                                                total cholesterol levels
                                                                                in females
----------------------------------------------------------------------------------------------------------------
                                                             Chronic RfD = 0.1 mg/kg/day
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Incidental Oral (Short-Term)         NOAEL (developmental)   Target MOE = 100 (10x   Prenatal Developmental
                                      = 10 mg/kg/day          inter-species           Toxicity - Rat MRID
                                                              extrapolation, 10x      41886701
                                                              intra-species          LOAEL = 20 mg/kg/day based
                                                              variation)              on increased incidence of
                                                             FQPA SF = 1...........   skeletal variations.
----------------------------------------------------------------------------------------------------------------
Incidental Oral (Intermediate-Term)  NOAEL = 10 mg/kg/day    Target MOE = 100 (10x   Chronic Toxicity Study -
                                                              inter-species           Dog MRID 41970401
                                                              extrapolation, 10x     LOAEL = 20 mg/kg/day based
                                                              intra-species           on increased incidence of
                                                              variation)              clinical signs in males
                                                             FQPA SF = 1...........   and females and decreased
                                                                                total cholesterol levels
                                                                                in females.
----------------------------------------------------------------------------------------------------------------
Dermal, Short-term (formulated       No endpoint identified. No dermal or systemic effects identified in the 21-
 product 0.13% a.i.)                    day dermal toxicity study (MRID 45656601) up to and including the limit
                                                                dose of 1,000 mg/kg/day
----------------------------------------------------------------------------------------------------------------
Dermal, Short-term\a\                NOAEL (dermal) = 2 mg/  Target MOE = 10 (3x     90-day Dermal Toxicity -
                                      kg/day(8 [mu]g/cm2)     inter-species           Rat MRID 41305901
                                                              extrapolation, 3x      LOAEL = 6 mg/kg/day based
                                                              intra-species           on increased clinical and
                                                              variation)              gross findings (erythema,
                                                                                edema, exfoliation,
                                                                                excoriation, and
                                                                                ulceration)
----------------------------------------------------------------------------------------------------------------
Dermal, Intermediate- and Long-term                       No appropriate endpoint identified
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term               NOAEL\b\ = 10 mg/kg/    Target MOE = 100 (10x   Prenatal Developmental
                                      day                     inter-species           Toxicity - Rat MRID
                                                              extrapolation, 10x      41886701
                                                              intra-species          LOAEL = 20 mg/kg/day based
                                                              variation)              on increased incidence of
                                                             FQPA SF = 1...........   skeletal variations.
----------------------------------------------------------------------------------------------------------------
Inhalation, Intermediate- and Long-  NOAEL\b\ = 10 mg/kg/    Target MOE = 100 (10x   Chronic Toxicity Study -
 Term                                 day                     inter-species           Dog MRID 41970401
                                                              extrapolation, 10x     LOAEL = 20 mg/kg/day based
                                                              intra-species           on increased incidence of
                                                              variation)              clinical signs males and
                                                             FQPA SF = 1...........   females and decreased
                                                                                total cholesterol levels
                                                                                in females.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference
  dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable.
\a\ Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1,000 [mu]g/mg) / 50 cm2 area of rat dosed = 8
  [mu]g/cm2.
\b\An additional UF of 10x is used for route extrapolation from an oral endpoint to determine if a confirmatory
  study is warranted.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    Aliphatic Alkyl Quaternaries are used as a sanitizer on counter
tops, utensils, appliances, tables, refrigerators, food packaging, and
beverage bottling. The use of Aliphatic Alkyl Quaternaries as an
antimicrobial product on food or feed contact surfaces, agricultural
commodities, and application to food-grade eggs may result in pesticide
residues in human food. Residues from treated surfaces, such as
utensils, countertops, equipment, and appliances can migrate to food
coming into contact with the treated and rinsed surfaces and can be
ingested by humans.
    1. Food. The Agency assessed acute and chronic dietary exposure
from the use of Aliphatic Alkyl Quaternaries as a disinfectant and food
contact sanitizer on direct and indirect food-contact surfaces. This
assessment calculated the Daily Dietary Dose (DDD) and the Estimated
Daily Intake (EDI) using an FDA model (2003). The FDA model takes into
account application rates, residual solution, area of the treated
surface which comes into contact with food, pesticide migration
fraction, and body weight.
    The EDI calculations presented in this assessment are based on the
assumption that food can contact 2,000 cm2 of treated
surface per day (which represents contact with a treated countertop
surface area), 4,000 cm2 of treated surface per day (which
represents contact with treated silverware, china, and glass used by an
individual who regularly eats three meals per day at an institutional
or public facility ), or 6,000 cm2 of treated surface per
day (which represents treated countertops, silverware, china,

and glass by an individual who regularly eats three meals per day at an
institutional or public facility). It also assumes that 10% of the
pesticide would migrate to food.
    When assessing the food bottling/packaging use, EPA assumed a 100%
transfer rate because the food is potentially in contact with the
treated surfaces for very long periods of time. The maximum application
rate for Aliphatic Alkyl Quaternaries for bottling/packaging of food is
0.0020 lbs active ingredient (a.i) per gallon of treatment solution.
EDI values were calculated using an approach similar to that used for
treated food-contact surfaces and food utensils. Exposure was assumed
to occur through the ingestion of three food products that might be
packaged with treated material: milk, egg products, and beverages
(alcoholic and non-alcoholic). A calorie intake modification factor of
0.64 was applied to the EDI for a child to account for the differences
between intake values among children and adults.
    2. Drinking water exposure. The only Aliphatic Alkyl Quaternaries
outdoor uses are an algaecide in decorative/swimming pools,
antisapstain wood preservative treatment, once-through cooling tower
treatment, and oil field uses. The pond and oil field uses are
considered to be contained. The other uses are not expected to
significantly contaminate drinking water sources. Therefore, the
Aliphatic Alkyl Quaternaries contributions for drinking water exposure
are considered to be negligible and are not quantified.
    It should be noted that the Agency estimated concentrations for
exposure to aquatic animals resulting from the antisapstain and cooling
tower uses. These levels were not considered appropriate for use in the
drinking water assessment due to the very conservative nature of the
models used, that the model estimates runoff/point source
concentrations and not water body concentrations, and the fact that the
models does not account for dilution.
    Specific information on the dietary and drinking water exposure
assessments for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary

Risk Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC); Didecyl Dimethyl Ammonium
Chloride (DDAC).

B. Other Non-Occupational Exposure

    The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in
food or in drinking water. Exposures may occur during and after
application as a hard surfaces disinfectant (e.g., walls, floors,
tables, fixtures), to textiles (e.g., clothing, diapers) to swimming
pools and to carpets. Each route of exposure (oral, dermal, inhalation)
is assessed, where appropriate, and risk is expressed as a MOE, which
is the ratio of estimated exposure to an appropriate NOAEL
    Residential exposure may occur during the application of Aliphatic
Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping,
trigger pump sprays), carpets, swimming pools, wood as a preservative,
textiles (e.g., diapers treated during washing and clothes treated with
fabric spray), and humidifiers. The residential handler scenarios were
assessed to determine dermal and inhalation exposures. Surrogate dermal
and inhalation unit exposure values were estimated using data from the
Pesticide Handler Exposure Database (PHED) and the Chemical
Manufactures Association Antimicrobial Exposure Assessment Study
(USEPA, 1999), and the SWIMODEL 3.0 was utilized to conduct exposure
assessments of pesticides found in swimming pools and spas (Versar,
2003). Note that for this assessment, EPA assumed that residential
users complete all elements of an application (mix/load/apply) without
the use of personal protective equipment.
    The duration for most residential exposures is believed to be best
represented by the short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and post-application scenarios are assumed to be performed on an
episodic, not daily basis.
    Based on toxicological criteria and the potential for exposure, the
Agency has conducted dermal and inhalation exposure assessments for
Aliphatic Alkyl Quaternaries residential use. As noted previously, MOEs
greater than or equal to 100 for the inhalation route of exposure and
10 for dermal exposure are considered adequately protective for the
residential exposure assessment.
    Specific information on the residential exposure assessment for
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Didecyl

Dimethyl Ammonium Chloride (DDAC) Occupational and Residential Exposure
Assessment.

V. Cumulative Effects

    Another factor EPA must consider in making a section 408 reasonable
certainty of no harm determination is any ``available information''
concerning the cumulative effects of a particular pesticide's residues
and ``other substances that have a common mechanism of toxicity.''
    The Aliphatic Alkyl Quaternaries are a group of structurally
similar quaternary ammonium compounds that are characterized by having
a positively charged nitrogen covalently bonded to two alkyl group
substituents (at least one C8 or longer) and two methyl
substituents. In finished form, these quats are salts with the
positively charged nitrogen (cation) balanced by a negatively charged
molecule (anion). The anion for the quats in this cluster is chloride
or bromide. Didecyl dimethyl ammonium chloride, or DDAC, was chosen as
the representative chemical for this class in PR notice 88-2. On that
basis, the toxicology database for DDAC is accepted as representative
of the hazard for this class of quaternary ammonium compounds. However,
the toxicologic responses observed from animal toxicity studies with
DDAC are generalized responses to treatment and are difficult to
attribute to any one mechanism.
    EPA's risk assessment for the Group I Cluster is based on an
assessment of the cumulative exposure to all aliphatic alkyl quaternary
compounds. The individual exposure scenarios in the DDAC assessments
(as well as the aggregate assessment in the RED) were developed by
assuming that a DDAC compound was used on 100 percent of the surfaces
authorized on the label that could result in human exposure and summing
the percent active ingredients on the labels for all of the aliphatic
alkyl quaternary compounds when used in combination. Thus, because the
risk assessment for DDAC accounts for exposures to all of the aliphatic
alkyl quaternary compounds, there is no need for a separate cumulative
risk assessment for those compounds. The Agency has not identified any
other substances as sharing a common mode of toxicity with DDAC.

VI. Safety Factor for Infants and Children

    1. In general. Section 408 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 data base on toxicity and exposure unless EPA
determines based on reliable data that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the FQPA safety factor. In applying this
provision, EPA either retains the default value of 10X when reliable
data do not support the choice of a different factor, or, if reliable
data are available, EPA uses a different additional FQPA safety factor
value based on the use of traditional uncertainty/safety factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence that
Aliphatic Alkyl Quaternaries result in increased susceptibility in in
utero rats or rabbits in the prenatal developmental studies or in young
rats in the two-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete for assessing risk to infants and children under the FFDCA.
    ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
    iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. Although EPA may, in the future, refine exposure estimates
for Aliphatic Alkyl Quaternaries based on more sophisticated modeling
techniques, the current exposure assessment is based on a combination
of conservative assumptions that is likely to overstate exposure from
food to Aliphatic Alkyl Quaternaries.

VII. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate 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 LOC by all applicable
uncertainty/safety factors. For linear cancer risks, EPA calculates the
probability of additional cancer cases given aggregate exposure. Short-
, intermediate, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the MOE called for by the
product of all applicable uncertainty/safety factors is not exceeded.
    1. Acute and chronic risk. EPA compares the estimated dietary
exposures to an aPAD and a cPAD, 0.1 mg/kg/day, which are the same
value for the aliphatic alkyl quaternaries. Generally, a dietary
exposure estimate that is less than 100% of the aPAD or cPAD does not
exceed the Agency's levels of concern.
    The antimicrobial indirect food use acute/chronic risk estimates
from exposure to treated utensils and countertops are below the
Agency's level of concern. For adults, the acute and chronic dietary
exposure risk estimates are 3.32% of the aPAD and cPAD for adult
females of child bearing age (13 to 50), the highly exposed adult
group. For children ages 3 to 5, the most highly exposed population
subgroup, the acute and chronic dietary risk estimates are 13.3% of the
aPAD and cPAD. Therefore, dietary exposure estimates are below the
Agency's level of concern for all population subgroups. The
antimicrobial indirect food use acute/chronic risk estimates from
exposure to treated food packaging and beverage bottles are below the
the Agency's level of concern. Neither the percent aPAD or percent cPAD
values exceeded 100% and are not of concern.
    Specific information on the dietary exposure assessment for
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary

Risk Assessment on DDAC.
    2. Non-occupational risk. Aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Using the exposure assumptions described in this unit for other
non-occupational exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs greater than
or equal to 100 for the inhalation route of exposure and 10 for dermal
exposure; therefore, are not of concern.
    3. Aggregate cancer risk for U.S. population. Based on the
carcinogenic data, the EPA concludes that there is reasonable certainty
that Aliphatic Alkyl Quaternaries doe not pose an aggregate cancer risk
to the U. S. population.
    4. 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 Aliphatic Alkyl Quaternaries residues.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following recommendations of its Endocrine Disruptor and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program
include evaluations of potential effects in wildlife. For pesticide
chemicals, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). When appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disruption Screening Program
(EDSP) have been developed, the Aliphatic Alkyl Quaternaries (DDAC) may
be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.

B. Analytical Method(s)

    An analytical method for food is not needed. Food contact
sanitizers are typically regulated by state health departments to
ensure that the food industry is using these products in compliance
with the regulations in 40 CFR 180.940. The end use solution that is
applied to the food contact surface is analyzed not food items that may
come into contact with the treated surface. An analytical method is
available to analyze the use dilution that is applied to food contact
surfaces. A titration method is used to determine the total amount of
quaternary compound. If the use solution is a mixture of DDAC and alkyl
dimethyl benzyl ammonium chloride (ADBAC), then High Performance Liquid
Chromatography using Ultra

Violet Detection (HPLC-UV) is used to determine the amount of ADBAC.
The amount of DDAC is determined by calculating the difference between
the total amount of quaternary compounds and ADBAC.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption 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 rule
has been exempted from review under Executive Order 12866, this rule is
not subject to Executive Order 13211, 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 6,
2000) do not apply to this rule. In addition, This 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).

X. 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,
Food contact sanitizers, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.

    Dated: August 29, 2007.
Frank Sanders,
Director, Antimicrobials 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 180.940 is amended by revising the following entry to the
table in paragraph (a):

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
      Pesticide Chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
                              * * * * * * *
Quaternary Ammonium            None             When ready for use, the
 Compounds, Di-n-Alkyl (C8-                      end-use concentration
 10) dimethyl ammonium                           of these specific in
 chloride, average molecular                     quaternary ammonium
 weight (in amu) 332 to 361                      compounds is not to
                                                 exceed 240 ppm of
                                                 active quaternary
                                                 ammonium compound; the
                                                 end-use concentration
                                                 of all quaternary
                                                 chemicals in the
                                                 solution is not to
                                                 exceed 400 ppm of
                                                 active quaternary
                                                 compound.
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-17634 Filed 9-5-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Rules and Regulations]
[Pages 67065-67068]
[FR Doc No: 2014-26753]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0784]
RIN 1625-AA00

Safety Zone; Natchez Specialties New Year's Eve Firework Display,
Lower Mississippi River, Mile Marker, (MM) 363.5 to 364.5

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY:  The Coast Guard is establishing a temporary Safety Zone for
all waters of the Lower Mississippi River, from MM 363.5 to MM 364.5.
This safety zone is needed to protect persons and vessels from the
potential safety hazards associated with a fireworks display. Entry
into this zone is prohibited to all vessels, mariners, and persons
unless specifically

authorized by the Captain of the Port (COTP), Lower Mississippi River
or a designated representative.

DATES: This rule is effective from 7:30 p.m. to 8:00 p.m. on December
31, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-0784]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Tyrone Conner, Sector Lower Mississippi River
Waterways Management Division, U.S. Coast Guard; telephone (901) 521-
4725, email<EMAIL_ADDRESS>If you have questions on viewing
or submitting material to the docket, call Cheryl F. Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' While a full 30 days notice is provided, under 5 U.S.C.
553(b)(B), the Coast Guard finds that good cause exists for not
completing the full notice of proposed rulemaking (NPRM) process with
respect to this rule. After reviewing the details of the application
and the fireworks display, the Coast Guard determined that a fireworks
display taking place over a confined waterway presents certain safety
hazards requiring additional safety measures. This safety zone is
needed to protect fireworks display spectators, and other mariners from
those safety hazards. Delaying or foregoing this safety measure would
be contrary to the public interest.
    Additionally, this display has been advertised to the local
community and while the application for this event was not timely
submitted, we understand that the local community has undertaken
considerable planning for this event. It would thus be impracticable
and unnecessary to reschedule or delay the planned event in order to
complete the full NPRM process. Rescheduling or delaying the event
would interfere with commercial and contractual obligations.

B. Basis and Purpose

    The legal basis and authority for this rule are found in 33 U.S.C.
1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR
1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; and
Department of Homeland Security Delegation No. 0170.1, which authorizes
the Coast Guard to establish and define regulatory safety zones. The
Natchez Specialties New Year's Eve Firework Display is scheduled to
take place on December 31, 2014 on the Lower Mississippi River MM
364.0. The introduction of fireworks display into a commercially
transited waterway poses significant safety hazards to both the
operators and the commercial vessels.
    The COTP Lower Mississippi River is establishing a temporary safety
zone for a portion of the Lower Mississippi River from MM 363.5 to MM
364.5 to safeguard persons and vessels, during the fireworks display.
The COTP anticipates minimal impact on vessel traffic due to this
regulation. However, the temporary safety zone is deemed necessary for
the safeguard of life and property within the COTP Lower Mississippi
zone.

C. Discussion of the Final Rule

    The Natchez Specialties New Year's Eve Firework Display is
scheduled to take place on December 31, 2014 on the Lower Mississippi
River at MM 364.0. The Coast Guard is establishing a temporary safety
zone to protect life and property from the hazards associated with a
fireworks display on a commercially transited waterway. This temporary
safety zone encompasses all waters of the Lower Mississippi River from
MM 363.5 to MM 364.5. This temporary safety zone is effective from:
7:30 p.m. to 8:00 p.m. on December 31, 2014. Entry into, transiting or
anchoring in the safety zone is prohibited unless specifically
authorized by the COTP Lower Mississippi River or a designated
representative. Requests for deviation from this restriction should be
directed to the COTP Lower Mississippi River or designated
representative. Deviation requests will be considered on a case-by-case
basis.
    The COTP Lower Mississippi River may be contacted by telephone at
866-777-2784. The COTP Lower Mississippi River or a designated
representative will inform the public through broadcast notice to
mariners of changes in the effective period or planned schedule for
these restrictions.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The temporary safety zone listed in this rule will only restrict
vessel traffic from entering, transiting, or anchoring within a small
portion of the Lower Mississippi River. The effect of this regulation
will not be significant for several reasons: (1) This rule will only
affect vessel traffic for a short duration; (2) vessels may request
permission from the COTP to deviate from the restriction and transit
through the safety zone; and (3) the impacts on routine navigation are
expected to be minimal because notifications to the marine community
will be made through local notice to mariners (LNM) and broadcast
notice to mariners (BNM). Therefore, these notifications will allow the
public to plan operations around the safety zone and its enforcement
times.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.

    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit the Lower Mississippi River from MM 363.5 to MM 364.5 effective
from 7:30 p.m. to 8:00 p.m. on December 31, 2014. This safety zone will
not have a significant economic impact on a substantial number of small
entities because this rule will only be in effect during scheduled
firework display times for approximately thirty minutes on the day the
event is occurring. Traffic in this area is limited to almost entirely
recreational vessels and commercial towing vessels. Notifications to
the marine community will be made through BNMs and electronic mail.
Notices of changes to the safety zone and scheduled effective times and
enforcement periods will also be made. Deviation from the restrictions
may be requested from the COTP or designated representative and will be
considered on a case-by-case basis.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone that is not expected to
have any environmental impact as described in NEPA. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction.
    An environmental analysis checklist supporting this determination
and a Categorical Exclusion Determination are available in the docket
where indicated under ADDRESSES. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this rule.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1

0
2. A new temporary Sec.  165.T08-0784 is added to read as follows:

Sec.  165.T08-0784  Safety Zone; Natchez Specialties New Year's Eve
Firework Display, Lower Mississippi River Mile Marker, (MM) 363.5 to
(MM) 364.5, Natchez, MS.

    (a) Location. The following area is under a temporary safety zone:
waters of the Lower Mississippi River, from MM 363.5 to MM 364.5.
    (b) Effective date and times. This rule will be effective from 7:30
p.m. to 8:00 p.m. on December 31, 2014.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this area is prohibited unless
authorized by the Captain of the Port (COTP) Lower Mississippi River or
a designated representative.
    (2) Spectator vessels may safely transit outside the safety zone at
a minimum safe speed, but may not anchor, block, loiter, or impede
participants or official patrol vessels.
    (3) Vessels requiring entry into or passage through the safety zone
must request permission from the COTP Lower Mississippi River or a
designated representative. They may be contacted on VHF-FM channels 16
or by telephone at<PHONE_NUMBER>.
    (4) All vessels shall comply with the instructions of the COTP
Lower Mississippi River and designated personnel. Designated personnel
include commissioned, warrant, and petty officers of the U.S. Coast
Guard.
    (d) Informational Broadcasts. The Captain of the Port, Lower
Mississippi River or a designated representative will inform the public
through broadcast notices to mariners (BNM) of the effective period for
the safety zone and of any changes in the effective period, enforcement
times, or size of the safety zone.

    Dated: October 31, 2014.
J.D. Burns,
Acting, Commander, U.S. Coast Guard, Acting Captain of the Port, Lower
Mississippi River.
[FR Doc. 2014-26753 Filed 11-10-14; 8:45 am]
BILLING CODE 9110-04-P


  SEQ CHAPTER \h \r 1 Company Notice of Filings for DIBASIC ESTERS

 (Dated: 8/1/98)

EPA Registration Division contact: [Amelia M. Acierto,<PHONE_NUMBER>]

[INSTRUCTIONS: Please utilize this outline in preparing tolerance
petition submissions.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the FEDERAL REGISTER document.
Please do not remove or alter these codes or change the margins in your
submission. Simply type the information requested starting after the
heading.

1. [Whitmire Micro-Gen Research Laboratories, Inc.]

PP [#5E4442]

	EPA has received a pesticide petition (PP [#5E4442])from [Whitmire
Micro-Gen Research Laboratories, Inc.], [3568 Tree Court Industrial
Bvd., St. Louis MO 63122-6682].   proposing pursuant to section 408(d)
of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend
40 CFR Part 180 to establish an exemption from the requirement of a
tolerance for [Dibasic esters (DBE)].  EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition.  Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

DBE is a colorless liquid that consists of a mixture of dimethyl
glutarate (55-75%), dimethyl adipate (10-25%), and dimethyl succinate
(19-26%).  The identity and properties of each component of DBE is
summarized in the table below.

DBE Component	CAS #	Formula	MW	Density

Dimethyl succinate	106-65-0	CH3OOC(CH2)2COOCH3	146.14	1.12

Dimethyl glutarate	1119-40-0	CH3OOC(CH2)3COOCH3	160.17	1.09

Dimethyl adipate	627-93-0	CH3OOC(CH2)4COOCH3	174.20	1.06

1. Plant metabolism. [NA-REMOVE].

2. Analytical method. [DBE vapors may be detected by gas chromatography
using a flame ionization detector, for which a detection limit of 0.7
ug/L has been reported (Morris et al. 1991).  In aqueous media, DBE may
be detected by high pressure liquid chromatography using a diode ray
detector, for which no detection limit was reported (Bogdanffy et al.
1991)].

3. Magnitude of residues. [NA-REMOVE].

B. Toxicological Profile

1. Acute toxicity. [Acute (24 hours) dermal contact with DBE produced
mild to severe erythema and mild edema in rabbits exposed to undiluted
DBE (Sarver, 1989).  Fourteen-day dietary exposure to large
concentrations of DBE in feed (10,000, 20,000, or 50,000 ppm) did not
produce any gross or microscopic pathological changes in rats (Henry,
1981).  Body weight gain was slightly reduced in a dose-dependent manner
at the end of the exposure period.  This study identified a NOEL of
10,000 ppm (842 mg/kg-day).  Similarly, body weight gains were
significantly reduced in rats exposed via inhalation to concentrations
of 0.4 and 1.0 mg/L DBE for 6 hours/day, 5 days/week for 2 weeks
(Alvarez, 1988).  In both studies, however, decreases in body weight
gain appear to be attributable to a dose-dependent decreases in feed
consumption, rather than a pathological change caused by treatment].

2. Genotoxicity. [DBE was not mutagenic in a Salmonella typhimurium
assay in the presence or absence of a rat liver activation system
(Koops, 1977; Arce, 1988).  A significant increase in chromosomal
aberrations was observed in vitro in human lymphocytes when
metabolically activated  (using a rat liver S-9 fraction), but not in
the absence of metabolic activation (Vlachos, 1987).  However, in an in
vivo mouse bone marrow micronucleus assay, no significant increase in
micronucleated cells were observed (Rickard, 1987)].

3. Reproductive and developmental toxicity. [No effects on fetal
survival, fetal weight, litter size,  implantation, or the incidence of
terata were observed in rats exposed via inhalation to concentrations
0.16, 0.4, or 1.0 mg/L DBE on days 7 through 16 of gestation (Alvarez,
1988).  In addition, no treatment-related effects were observed for
various reproduction indices (male fertility, female fertility, born
alive, viability, gestation, and lactation) in rats exposed via
inhalation to 0.16, 0.4, or 1.0 mg/l DBE for 14-weeks prior to mating,
and continuing through breeding (15 days), gestation (21 days), and
lactation (21 days).   Pup weights were significantly reduced at
concentrations of 1.0 mg/L DBE, however,  this appears to be
attributable to decreased food intake and body weight gain in maternal
animals, which were significantly depressed at concentrations of 0.4
mg/L and higher (Kelly, 1988)].

4. Subchronic toxicity. [In rats exposed via inhalation to 0.02, 0.08,
or 0.40 mg/L DBE for 6 hours/day, 5 days/week, for 14 weeks, the only
histopathological change of significance included mild squamous
metaplasia in the olfactory epithelium (Kelly, 1987).  Slight changes in
liver weight, body weight, and blood calcium and sodium levels were also
reported, however, these were considered to be of minimal biologic
significance.  A no effect concentration was not identified for nasal
effects.  However, for systemic effects, the highest concentration
tested (0.4 mg/L) was considered to be a NOEL].

5. Chronic toxicity. [In rats exposed via inhalation to 0.16, 0.4, or
1.0 mg/L DBE for 22 weeks, the only histopathological change of
significance included squamous metaplasia in the olfactory epithelium
(Kelly, 1988).  The incidence and severity of the nasal lesions was
greater in this study in comparison to the 14-week study discussed
above.  A no effect concentration was not identified for nasal effects].

6. Animal metabolism. [The compounds that comprise DBE are derivatives
of three naturally occurring dicarboxylic acids (adipic, glutaric and
succinic acids).  Specifically, DBE consists of dimethyl esters of these
three acids.  Due to the presence of carboxylesterases and other
diesterases in mammalian tissues, these dimethyl esters are rapidly
cleaved in the body to form their corresponding dicarboxylic acids:
adipic, glutaric and succinic acids].

7. Metabolite toxicology. [By the oral route, the toxicity of DBE
metabolites is low.  The principle metabolites of DBE are naturally
occurring dicarboxylic acids: succinic, glutaric, and adipic acids.
Adipic and succinic acids are classified as Generally Recognized As Safe
(GRAS) by the U.S. Food and Drug Administration for substances directly
added to human food (CFR 184.1).  Although glutaric acid is not
classified as GRAS, its relative safety can be inferred since its carbon
chain length (5) is intermediate of adipic (6) and succinic (4) acids.
The dicarboxylic acids are substrates for glycolytic and gluconeogenic
reactions in the cell, and as such, the components of DBE possess
nutritional value (Ladriere et al. 1996).

By the inhalation route, the metabolites of DBE are irritants to the
nasal mucosa, and are likely responsible for the metaplasia of the
olfactory epithelia observed in exposed rats.  In vitro studies indicate
that inhibition of nasal carboxylase activity reduces the toxicity in
rat nasal explants (Trela and Bogdanffy, 1991).  In the rat,
carboxylesterases appear to be preferentially localized in cells of the
Bowman’s gland and  sustentacular epithelial cells which are
immediately adjacent to olfactory nerve cells (Olson et al. 1993)].

8. Endocrine disruption. [Mono- and dimethyl esters of succinic acid are
capable of stimulating insulin release in rats (Vicent et al. 1994;
Ladriere et al. 1996).  However, rather than evidence of endocrine
disruption, this observation is likely attributable to the nutritional
value of DBE].

C. Aggregate Exposure

1. Dietary exposure. [Dietary exposure due to use of DBE as an
antifreeze agent is believed to be minimal, as is discussed for food and
drinking water below].

2. Food. [DBE  is not intended to be directly applied to foods.  Rather,
the use of DBE in pesticide formulations for food handling areas will be
limited to sprays and aerosols for crack/crevice applications.  Any
incidental dietary exposure to DBE from such uses will be minimal in
comparison to the currently permitted use of DBE component, dimethyl
succinate, as a food additive in beverages, ice cream, candy, and baked
goods (CFR 21.3.170-199).  Furthermore, the levels of dimethyl esters
present in food as a result of DBE application in food areas are likely
to be far less, on a molar equivalent basis, than the levels of
naturally occurring dicarboxylic acids present in foods].

3. Drinking water. [Because DBE-containing pesticide formulations are
not applied to agricultural crops, its migration to groundwater aquifers
or to surface water bodies that may serve as suitable sources of
drinking water is not anticipated.].

4. Non-dietary exposure. [The greatest potential for exposure to DBE is
to pesticide applicators, who may be exposed via inhalation or dermal
routes.  USEPA’s Pilot Interdisciplinary Risk Assessment Team (PIRAT,
1997) evaluated potential exposures to workers using a handwand
applicator or a backpack applicator.

For the handwand applicator scenario, assuming a unit exposure of 29.178
mg/lb handled for the dermal pathway and a unit exposure of 1.063 mg/lb
handled for the inhalation pathway, average daily doses of 0.03 and
0.001 mg/kg-day were calculated for dermal and inhalation exposures,
respectively.  In their calculations, USEPA conservatively assumed 100%
absorption via both routes, a 70 kg body weight, an application rate of
0.08 lbs DBE/day for product containing 4.2% (w/w) DBE yielding a finish
spray containing 0.065% DBE.

For the backpack applicator scenario, assuming a unit exposure of
482.581 mg/lb handled for the dermal pathway and a unit exposure of
0.329 mg/lb handled for the inhalation pathway, average daily doses of
1.0 and 0.007 mg/kg-day were calculated for dermal and inhalation
exposures, respectively.  In their calculations, USEPA conservatively
assumed 100% absorption via both routes, a 70 kg body weight, an
application rate of 0.14 lbs DBE/day for product containing 4.2% (w/w)
DBE yielding a finish spray containing no more than 1% DBE].

D. Cumulative Effects

[Since exposures to DBE from food and drinking water are believed to be
minimal, the potential for cumulative exposures (i.e., summed across
multiple routes of exposure) exceeding those estimated for pesticide
applicators is very small.  Furthermore, because the components of DBE
are readily metabolized to polar, water-soluble metabolite, DBE is not
expected to be persistent in biological tissues.  Because DBE is
irritating to the skin and nasal passages, any exposures are expected to
be self-limiting.  For these reasons, the potential for cumulative
effects from exposure to DBE is low].

E. Safety Determination

1. U.S. population.[Potential dietary exposures to DBE are not likely to
pose a significant risk to the general U.S. population. The components
of DBE are dimethyl esters of three naturally occurring dicarboxylic
acids (adipate, succinate, and glutarate), two of which are currently
classified as GRAS by the U.S. Food and Drug Administration for direct
addition to human foods.  It should be noted that the presence of methyl
groups does not increase the toxicity of DBE.  To the contrary,
methylation is one of the metabolic pathways by which the body attempts
to detoxify xenobiotics (Hodgson and Levi, 1987).  As such, dimethyl
succinate, dimethyl glutarate, and dimethyl adipate are likely to be
less toxic than succinate, glutarate, and adipate, respectively.  In
support of this statement, Trela and Bogdanffy (1991) reported that
succinate, glutarate, and adipate produced concentration-dependent
increases in cytotoxicity in a rat nasal explant system.  The
cytotoxicity of DBE in the same system, however, was greatly diminished
by a carboxylesterase inhibitor which effectively blocks the conversion
of DBE to the dicarboxylic acids.

The potential hazards posed by DBE  to pesticide applicators exposed via
 inhalation and dermal routes are low.  For the handwand applicator, the
average daily dermal and inhalation doses of 0.03 mg/kg-day and 0.001
mg/kg-day, respectively, are well below exposures which are believed to
be without risk of deleterious effects (8.42 mg/kg-day for dermal
exposures, and 0.38 mg/kg-day for inhalation exposures).  Specifically,
USEPA conservative assumptions for a worker applying a DBE-containing
(4.2% w/w) product with a handwand maintain margin-of-exposures of 280
and 380 for dermal and inhalation exposures, respectively.  Based on
these margin-of-exposures, workers applying a hypothetical formulation
containing 100% DBE would still be adequately protected.  For the
backpack applicator, the average dermal and inhalation doses of 1 and
0.007 mg/kg-day, are also below exposures which are believed to be
without risk of deleterious effects.  USEPA’s conservative assumptions
for a backpack applicator maintain a margin-of-exposure of 8 and 54 for
dermal and inhalation exposures, respectively.  Based on these
margin-of-exposures, workers applying a hypothetical formulation
containing 33% DBE would still be adequately protected.  As this
percentage far exceeds the levels anticipated for DBE-containing
products, no concentration limit need  be specified for DBE.].

2. Infants and children. [There is no information available which
suggests that infants and children are more highly exposed or are more
susceptible to the effects of DBE.  The lack of any significant toxicity
in reproductive/developmental studies on DBE suggests the that growing
organisms are not at increased risk.  Since potential dietary exposures
to infants and children are minimal based on anticipated use patterns,
and since the toxicity of DBE by the oral route is very low, it is
unlikely that these types exposures will result in any deleterious
effects.  Direct exposures to infants and children via the inhalation
and dermal routes are not anticipated for the intended use of DBE].

F. International Tolerances

[Whitmire is not aware of any tolerances for DBE outside of the United
States].


[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65770-65771]
[FR Doc No: 2023-20730]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Modification to
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before October 10, 2023.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.
    Copies of the applications are available for inspection in the
Records Center, East Building, PHH-13, 1200 New Jersey Avenue
Southeast,

Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on September 11, 2023.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

------------------------------------------------------------------------
                                                        Nature of the
 Application No.     Applicant      Regulation(s)      special permits
                                       affected            thereof
------------------------------------------------------------------------
                          Special Permits Data
------------------------------------------------------------------------
12116-M.........  Proserv UK Ltd.  173.201,         To modify the
                                    173.301(f),      special permit to
                                    173.302a,        authorize an
                                    173.304a.        additional
                                                     cylinder. (modes 1,
                                                     2, 3, 4).
20351-M.........  Roeder Cartage   180.407(c),      To modify the
                   Company,         180.407(e),      special permit to
                   Incorporated.    180.407(f).      remove certain
                                                     cargo tank serial
                                                     numbers. (mode 1).
20567-M.........  Omni Tanker      107.503(b),      To modify the
                   Pty. Ltd.        107.503(c),      special permit to
                                    172.102(c)(3),   authorize
                                    173.241,         additional drawings
                                    173.242,         and packaging
                                    173.243,         specifications.
                                    178.345-1,       (mode 1).
                                    178.347-1,
                                    178.348-1.
20907-M.........  Versum           171.23(a)(1),    To modify the
                   Materials US,    171.23(a)(3).    special permit to
                   LLC.                              authorize a
                                                     cylinder in
                                                     transportation or a
                                                     cylinder filled
                                                     prior to the
                                                     expiration of the
                                                     authorized service
                                                     life to be
                                                     transported to be
                                                     emptied. (modes 1,
                                                     3).
21195-M.........  Panasonic        173.185(c).....  To modify the
                   Energy                            special permit to
                   Corporation of                    authorize an
                   America.                          additional lithium
                                                     metal cell, to
                                                     update the cell
                                                     testing
                                                     requirements, and
                                                     to authorize an
                                                     additional
                                                     location. (mode 1).
21222-M.........  Bren-Tronics,    172.101(j),      To modify the
                   Inc.             173.185(b)(1).   special permit to
                                                     reflect changes to
                                                     cell and battery
                                                     designs. (mode 4).
21300-M.........  Distributor      172.200,         To modify the
                   Operations,      172.300,         special permit to
                   Inc..            172.400,         remove the
                                    173.159(e).      requirement to
                                                     label compartments
                                                     containing lithium
                                                     batteries. (mode
                                                     1).
21139-M.........  KULR Technology  172.600,         To modify the
                   Corporation.     172.200,         special permit to
                                    172.300,         authorize an
                                    172.700(a),      alternative
                                    172.400,         shipping document,
                                    172.500,         to remove the
                                    173.185(b).      reference to ferry
                                                     vessel operations,
                                                     and to clarify the
                                                     requirement in
                                                     paragraph 7.b.(2).
                                                     (modes 1, 2).
------------------------------------------------------------------------

[FR Doc. 2023-20730 Filed 9-22-23; 8:45 am]
BILLING CODE P


[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Rules and Regulations]
[Page 15630]
[FR Doc No: 2017-06266]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0251

Drawbridge Operation Regulation; Barnegat Bay, Seaside Heights,
NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the S37 Bridge across the Barnegat Bay,
mile 14.1, New Jersey Intracoastal Waterway, at Seaside Heights, NJ.
This deviation is necessary to perform bridge maintenance and repairs.
This deviation allows the bridge to remain in the closed-to-navigation
position.

DATES: This deviation is effective from 8 p.m. on March 31, 2017, to 8
p.m. on April 21, 2017.

ADDRESSES: The docket for this deviation, [USCG-2017-0251] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6222, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The New Jersey Department of Transportation,
that owns and operates the S37 Bridge, has requested a temporary
deviation from the current operating regulations to continue performing
a maintenance and repair project on the bridge that commenced at 8 a.m.
on December 1, 2016, and was scheduled to cease at 8 p.m. on March 31,
2017. The bridge is a bascule draw bridge and has a vertical clearance
in the closed position of 30 feet above mean high water.
    The current operating schedule as set out in 33 CFR 117.733(c)
allows the bridge to remain in the closed-to- navigation position from
8 a.m. on December 1, 2016, until 8 p.m. on March 31, 2017. Under this
temporary deviation, the bridge will continue to remain in the closed-
to-navigation position from 8 p.m. on March 31, 2017, to 8 p.m. on
April 21, 2017.
    The Barnegat Bay on the New Jersey Intracoastal Waterway is used by
a variety of vessels including small government and public vessels,
small commercial vessels, and recreational vessels. The Coast Guard has
carefully considered the nature and volume of vessel traffic on the
waterway in publishing this temporary deviation.
    Vessels able to safely pass through the bridge in the closed
position may do so at any time. The bridge will not be able to open for
emergencies and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridge so that vessel operators can arrange
their transit to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 24, 2017.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2017-06266 Filed 3-29-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Proposed Rules]
[Pages 11361-11362]
[FR Doc No: 2015-03651]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 67

[Docket No. USCG-2010-0990]
RIN 1625-AB56

Vessel Documentation Renewal Fees

AGENCY: Coast Guard, DHS.

ACTION: Request for comments.

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

SUMMARY: The Coast Guard seeks public comment on whether to increase
the period of validity for renewing endorsements on Certificates of
Documentation. A separate fee of $26 for annual renewals of
endorsements upon the Certificate of Documentation was established in a
recent rulemaking. The Coast Guard is considering options for
implementing multiyear renewals and updating the fee for services, and
seeks information on factors to consider when implementing these
changes.

DATES: Comments and related material must either be submitted to the
online docket via http://www.regulations.gov on or before June 1, 2015
or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-0990 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
document, call or email Ms. Mary Jager, CG-DCO-832, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Ms.
Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION:

Public Participation and Comments

    We encourage you to submit comments (or related material) on the
possibility of extending the period of validity and modifying the fee
for renewal on endorsements on the Certificate of Documentation (COD).
We will consider all submissions and may adjust our final action based
on your comments. Comments should be marked with docket number USCG-
2010-0990 and should provide a reason for each suggestion or
recommendation. You may provide personal contact information so that we
can contact you if we have questions regarding your comments; but
please note that all comments will be posted to the online docket
without change and that any personal information you include can be
searchable online (see the Federal Register Privacy Act notice
regarding our public dockets, 73 FR 3316, Jan. 17, 2008).
    Mailed or hand-delivered comments should be in an unbound 8\1/2\ x
11 inch format suitable for reproduction. The Docket Management
Facility will acknowledge receipt of mailed comments if you enclose a
stamped, self-addressed postcard or envelope with your submission.
    Documents mentioned in this request for comments, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following the Web site's instructions. You can also
view the docket online at the Docket Management Facility (see the
mailing address under ADDRESSES) between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    We are not planning to hold a public meeting but will consider
doing so if public comments indicate a meeting would be helpful. We
would issue a separate Federal Register notice to announce the date,
time, and location of such a meeting.

Background

    On August 12, 2014, the Coast Guard published a final rule entitled
``Vessel Documentation Renewal Fees'' in the Federal Register (79 FR
47015). The final rule contained the Coast Guard's revision of 46 CFR
part 67, setting out fees for services provided.
    The Coast Guard received 2,720 comment submissions on the proposed
fees published on March 4, 2013 (78 FR 14053). Comments were received
from individuals, law firms, commercial vessel documentation services,
industry groups, and maritime corporations. We considered all comments
in promulgating the final rule. The Coast Guard received 1,316 comments
regarding the implementation of the new fee. The majority of these
comments (757 comments) suggested the Coast Guard institute a multiyear
renewal option program. We made no changes to the final rule. However,
we are now seeking public comments in considering options that could be
proposed in a future rulemaking. This document provides the public with
an opportunity to continue this discussion.

Discussion

    The legal basis for charging fees for this service is found in
section 10401 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L.
101-508, Nov. 5, 1990, 104 Stat. 1388), codified at 46 U.S.C. 2110,
which requires that the Coast Guard establish user fees for Coast Guard
vessel documentation services. That section provides that the Secretary
of the Department in which the Coast Guard is operating (Secretary)
shall establish a fee or charge for a service or thing of value that is
provided to the recipient or user of that service. The Secretary is
empowered in 46 U.S.C. 2104 to delegate the authorities in 46 U.S.C.
Subtitle II to the Coast Guard. The Secretary exercised that
delegation's authority for fees in Department of Homeland Security
Delegation No. 0170.1(92)(a).
    In establishing these fees, we are required to use the criteria
found in 31 U.S.C. 9701. Under this provision the fees must be fair,
and must be based on the costs to the government, the value of the
service or thing to the recipient, and the public policy or interest
served (see 31 U.S.C. 9701(b)). One of the vessel documentation
services the Coast Guard provides, and for which user fees are required
under 46 U.S.C. 2110, is renewal of endorsements upon a COD. A COD is
(1) required for the operation of a vessel in certain trades, (2)
serves as evidence of vessel nationality, and (3) permits owners of
vessels to benefit from preferred mortgages (46 CFR 67.1). An
endorsement means an entry that may be made on a COD, and, except for a
recreational endorsement, is conclusive evidence that a vessel is
entitled to engage in a specified trade (46 CFR 67.3).
    The Coast Guard sets fees at an amount calculated to achieve
recovery of the costs of providing the service, in a manner consistent
with the general user charges principles set out in the Office of
Management and Budget (OMB) Circular A-25. Under that OMB Circular,
each recipient should pay a reasonable user charge for Federal
Government services, resources, or goods from which he or she derives a
special benefit. The user fee should be at an amount sufficient for the
Federal Government to recover the full costs of providing the service,
resource, or good (see OMB Circular A-25, sec. 6(a)(2)(a)).
    After reviewing the comments to the proposed rule, the Coast Guard
is seeking comment on whether it should consider extending the period
of validity and modifying the fee for renewal on endorsements on the
COD.

Request for Information

    Through this document, the Coast Guard asks for comments and
information to consider in updating renewal of endorsements on COD
processes and fees. Please consider the following questions when
preparing comments:
    1. Would you prefer a multiyear renewal program with fees charged
at the time of renewal, or would you prefer to continue annual renewals
including an annual fee for service? Please explain why you prefer the
renewal period and its fee payment schedule.
    2. Would you prefer having the option of choosing a multiyear or
annual renewal each time you renew? Please explain why you prefer the
option that you chose.
    If the only option for renewal is multiyear, how would you suggest
the annual renewal is phased over to a multiyear renewal?
    3. Would you prefer a multiyear renewal program that requires
payment every other year, or one that requires payment every 3 years?
Please explain why you chose this option.
    4. What are the benefits of a multiyear renewal?
    5. Are there any negative impacts of a multiyear renewal?
    6. What, if any, concerns would you need to have addressed prior to
selecting the multiyear renewal option?
    7. What are the impacts to mortgages from multiyear information
verification and COD renewal? Will lenders require additional
information from the National Vessel Documentation Center (NVDC) to
manage loans?
    8. What period of renewal is best for mortgage lenders?
    9. What other suggestions do you have for reducing the burden of
obtaining a COD?
    This document is issued under authority of 5 U.S.C. 552(a).

    Dated: February 18, 2015.
J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2015-03651 Filed 3-2-15; 8:45 am]
BILLING CODE 9110-04-P