specific use prescribed on the label and the activity of concern,
including formulation type, application methods and rates, type of
activity, and other pertinent information.
    (2) Occupational uses include not only handlers, mixers, loaders,
and applicators, but also commercial applications to residential sites.
Residential uses are limited to non-occupational, i.e., non-
professional, antimicrobial applications. Both occupational and
residential applicator data may be required for the same product.
    (b) Criteria for testing. Applicator exposure data described in the
table to paragraph (d) of this section are required based on toxicity
and exposure criteria. Data are required if at least one of the
toxicity criteria in paragraph (b)(1) of this section, and at least one
of the exposure criteria in paragraph (b)(2) of this section are met.
    (1) Toxicity criteria. (i) Evidence of potentially significant
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident
data with a clear cause-effect relationship indicating that adverse
health effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria. (i) Dermal exposure may occur during product
use.
    (ii) Respiratory exposure may occur during product use.
    (c) Key. R = Required; CR = Conditionally required; TEP = Typical
end-use product.
    (d) Antimicrobial applicator exposure data requirements table. The
following table shows the data requirements for applicator exposure.
The test notes appear in paragraph (e) of this section.

                                               Table--Antimicrobial Applicator Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use sites
           Guideline No.                  Data requirements      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100...........................  Dermal exposure............  R......................  R......................  TEP....................   1, 2, 3, 4
875.1200
875.1300...........................  Inhalation exposure........  R......................  R......................  TEP....................   1, 2, 3, 4
875.1400
875.1500...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................      1, 2, 3
875.1600...........................  Data reporting and           R......................  R......................  TEP....................            5
                                      calculations.
875.1700...........................  Product use information....  R......................  R......................  TEP....................  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
    1. Prior to initiation of the study, protocols involving
intentional exposure of human subjects must be submitted for review by
EPA and then the Human Studies Review Board (HSRB) according to 40 CFR
26.1125. Examples of proposed human study research can be found in
various reviews provided by the Human Studies Review Board (http://www.epa.gov/osa/hsrb/index.htm).
    2. Biological monitoring data may be submitted in addition to, or
in lieu of, dermal and inhalation passive dosimetry exposure data,
provided the human pharmacokinetics of the pesticide or metabolite/
analog compounds (i.e., whichever method is

selected as an indicator of body burden or internal dose) allow for the
back calculation to the total internal dose.
    3. For products with both indoor and outdoor uses, and similar
conditions of use, data are generally required for the indoor
applications only. However, data for outdoor uses are required if the
Agency expects outdoor uses to result in greater exposure than indoor
uses (e.g., higher use rates and application frequency, or longer
exposure duration, or application methods/equipment create potential
for increased dermal or inhalation exposure in outdoor versus indoor
use sites). In certain cases, when a pesticide may be used both indoors
and outdoors under dissimilar conditions of use, the Agency may require
submission of applicator exposure data for both use patterns.
    4. EPA will consider waiving this data requirement for
antimicrobials applied via closed loading systems if the antimicrobial
has a low vapor pressure.
    5. Data reporting and calculations are required only if handler
exposure data are required.

Sec.  158.2270  Post-application exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (d) of this section to determine the
post-application exposure data requirements for antimicrobial pesticide
products. The data generated during these studies are used to determine
the quantity of pesticide to which people may be exposed after
application. Notes that apply to an individual test, including specific
conditions, qualifications, or exceptions to the designated test, are
listed in paragraph (e) of this section.
    (1) Post-application exposure data are required when certain
toxicity criteria are met and the human activities associated with the
pesticide's use pattern can lead to potential adverse exposures.
    (2) The Agency may accept surrogate exposure data estimations and/
or modeling estimations from other sources to satisfy exposure data
requirements. The surrogate data must meet the basic quality assurance,
quality control, good laboratory practice, and other scientific
requirements set by EPA. To be acceptable, the Agency must find that
the surrogate exposure data estimations have adequate information to
address the applicable exposure data requirements and contain adequate
monitoring events of acceptable quality. The data must reflect the
specific use prescribed on the label and the activity of concern,
including formulation type, application methods and rates, type of
activity, and other pertinent information.
    (b) Criteria for testing. Post-application exposure data described
in the table to paragraph (d) of this section are required based on
toxicity and exposure criteria. Data are required if at least one of
the toxicity criteria in paragraph (b)(1) of this section, and at least
one of the exposure criteria in paragraph (b)(2) of this section are
met.
    (1) Toxicity criteria. (i) Evidence of potentially significant
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident
data with a clear cause-effect relationship indicating that adverse
health effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria--(i) Outdoor uses. (A) Occupational human
post-application or bystander exposure to residues of antimicrobial
pesticides could occur as the result of, but is not limited to, worker
reentry into treatment sites, clean-up and equipment maintenance tasks,
handling wood preservative-treated wood, or other work-related
activity.
    (B) Residential human post-application or bystander exposure to
residues of antimicrobial pesticides could occur following the
application of antimicrobial pesticides to outdoor areas and spaces at
residential sites, such as, but not limited to homes, daycare centers,
and other public buildings.
    (ii) Indoor uses. (A) Occupational human post-application or
bystander exposure to pesticide residues could occur following the
application of the antimicrobial pesticide to indoor spaces or
surfaces.
    (B) Residential human post-application or bystander exposure to
pesticide residues could occur following the application of the
antimicrobial pesticide to indoor spaces or surfaces at residential
sites, such as, but not limited to homes, daycare centers, hospitals,
schools, and other public buildings.
    (c) Key. R = Required; CR = Conditionally required; NR = Not
required; TEP = Typical end-use product.
    (d) Antimicrobial post-application exposure data requirements
table. The following table shows the data requirements for post-
application exposure. The test notes appear in paragraph (e) of this
section.

                                            Table--Antimicrobial Post-Application Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use sites
           Guideline No.                   Data requirement      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2200...........................  Soil residue dissipation...  CR.....................  CR.....................  TEP....................         2, 3
875.2300...........................  Indoor surface residue       CR.....................  R......................  TEP....................   3, 4, 5, 6
                                      dissipation.
875.2400...........................  Dermal exposure............  CR.....................  CR.....................  TEP....................      1, 7, 8
875.2500...........................  Inhalation exposure........  CR.....................  CR.....................  TEP....................    1,7, 8, 9
875.2600...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................         1, 8
875.2700...........................  Product use information....  R......................  R......................  TEP....................  ...........
875.2800...........................  Description of human         R......................  R......................  TEP....................  ...........
                                      activity.
875.2900...........................  Data reporting and           R......................  R......................  TEP....................           10
                                      calculations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
    1. Prior to initiation of the study, protocols involving
intentional exposure of human subjects must be submitted for review by
EPA and then the Human Studies Review Board (HSRB) according to 40 CFR
26.1125. Examples of proposed human study research can be found in
various reviews provided by the Human Studies Review Board (HSRB)
(http://www.epa.gov/osa/hsrb/index.htm).
    2. For residential wood preservative uses, data may be required if
soil has the potential to be an important exposure pathway, and soil is
in contact with or adjacent to treated wood, including but not limited
to decks, play sets, and gazebos,
    3. Protocols must be approved by the Agency prior to the initiation
of the study.

    4. For wood preservatives, data are required for treated wood
surfaces where post-application contact with treated wood is
anticipated.
    5. For occupational uses, data are required if the pesticide may be
applied to or around surfaces, and if the human activity data indicate
that workers are likely to have post-application dermal contact with
treated surfaces while participating in typical activities.
    6. Data are required for residential use sites, schools, and
daycare institutions. This includes but is not limited to the
following: Residential and public access premises; material
preservatives (including those used in residential products, including
but not limited to clothing and plastic toys) and wood preservatives
(when contact with treated wood is likely to occur).
    7. Data are required for occupational and residential uses if the
human activity data indicate the potential for post-application dermal
and/or inhalation exposures while participating in typical activities
and no acceptable modeling options are available.
    8. Biological monitoring data may be submitted in addition to, or
in lieu of, dermal and inhalation passive dosimetry exposure data
provided the human pharmacokinetics of the pesticide or metabolite/
analog compounds (i.e., whichever method is selected as an indicator of
body burden or internal dose) allow for a back-calculation to the total
internal dose.
    9. Data are required for occupational and residential uses if there
is the potential for bystander exposure and the pesticide use could
result in respirable and/or inhalable material (e.g., gas, vapor,
aerosol, or particulates).
    10. Data reporting and calculations are required only if post-
application exposure data are required.

Sec.  158.2280  Environmental fate.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (c) of this section to determine the
environmental fate data requirements for antimicrobial pesticide
products. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (d)
of this section.
    (1) Environmental fate data are required to support the
registrations of all end-use and manufacturing-use antimicrobial
products.
    (2) Data on transformation/degradation products or leachate
residues of the parent compound are also required to support
registration, if the transformation/degradation products or leachate
residues meet one of the following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or
aquatic reproductive studies; or
    (iii) The moiety of concern (i.e., functional group in the parent
chemical molecule that imparts adverse effects) remains intact.
    (3) For the purpose of determining data requirements, the all other
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product; PAIRA = Pure active ingredient radiolabeled; ROC = residue of
concern.
    (c) Antimicrobial environmental fate data requirements table. The
following table shows the data requirements for environmental fate. The
test notes appear in paragraph (d) of this section.

                                                                    Table--Antimicrobial Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use pattern                                                        Test substance
                                       ------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement        Industrial                                                                                Test note No.
                                        processes and  water  Antifoulant coatings         Wood            Aquatic areas       All other use           MP               EP
                                               systems             and paints          preservatives                        patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Degradation Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.2120.........  Hydrolysis.........  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               1
835.2240.........  Photodegradation in  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               2
                    water.
835.2410.........  Photodegradation in  NR..................  NR..................  R.................  NR................  NR................  TGAI or PAIRA..  TGAI or PAIRA..              10
                    soil.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Toxicity and Fate in Wastewater Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.6800.........  Activated Sludge,    R...................  R...................  R.................  NR................  R.................  TGAI...........  TGAI...........              21
                    Respiration
                    Inhibition Test.
                   OECD 209...........
835.1110.........  Activated Sludge     CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........          19, 20
                    Sorption Isotherm.
835.3110.........  Ready                CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........        3, 4, 18
                    Biodegradability.
835.3220.........  Porous Pot Study...  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
835.3280.........  Simulation Tests to  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Assess the
                    Biodegradability
                    of Chemicals
                    Discharged in
                    Wastewater.

835.3240.........  Simulation Test--    CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Aerobic Sewage
                    Treatment: A.
                    Activated Sludge
                    Units.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1230.........  Leaching and         R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 6
                    adsorption/de-
                    sorption.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1240
                                                                                Metabolism Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4100.........  Aerobic soil         CR..................  NR..................  R.................  CR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..         7, 8, 9
                    metabolism.
835.4200.........  Anaerobic soil       NR..................  NR..................  R.................  NR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
835.4300.........  Aerobic aquatic      R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
835.4400.........  Anaerobic aquatic    R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Dissipation Studies--Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6200.........  Aquatic (sediment).  CR..................  R...................  CR................  R.................  CR................  TEP............  TEP............      11, 12, 13
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Ground and Surface Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Monitoring of        CR..................  CR..................  CR................  CR................  CR................  ROC............  ROC............      11, 14, 17
                    representative
                    U.S. waters.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Special Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Special leaching...  NR..................  R...................  R.................  NR................  NR................  TGAI...........  TEP............          15, 16
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data
requirements in the table in paragraph (c) of this section:
    1. For testing antifoulant paints and coatings, testing is to be
performed separately with both sterile buffered distilled water and
sterile synthetic seawater at pHs 5, 7, and 9.
    2. Not required if:
    i. The electronic absorption spectra, measured at pHs 5, 7 and 9,
of the chemical and its hydrolytic products, if any, show no absorption
or tailing between 290 and 800 nm, inclusive; or
    ii. The results of the hydrolysis study at all three pHs (5, 7, and
9) demonstrates a half-life of less than 30 days.
    3. The results of the activated sludge, respiration inhibition
(ASRI) test determine which of the following tests are required: Ready
biodegradability, porous pot, the biodegradation in activated sludge
study as described in the ``Simulation Tests to Assess the
Biodegradability of Chemicals Discharged in Wastewater,'' or simulation
test--aerobic sewage treatment: A. activated sludge units.
    i. If the ASRI test EC50 is equal to or less than 20 mg/
L, then the applicant must choose either to:
    A. Conduct the biodegradation in activated sludge study as
described in the ``Simulation Tests to Assess the Biodegradability of
Chemicals Discharged in Wastewater'';
    B. Conduct the porous pot test; or
    C. Conduct the simulation test--aerobic sewage treatment: A.
activated sludge units.
    ii. If the ASRI test EC50 is greater than 20 mg/L, then
the applicant must choose either to:
    A. Conduct a ready biodegradability study; or
    B. Conduct one of the following studies: The biodegradation in
activated sludge study as described in the ``Simulation Tests to Assess
the Biodegradability of Chemicals Discharged in Wastewater,'' the
porous pot test, or the simulation test--aerobic sewage treatment: A.
activated sludge units.
    4. Pass criteria for the ready biodegradability study are: 70
percent removal of dissolved organic carbon (DOC) and 60 percent
removal of theoretical oxygen demand (ThOD) or theoretical carbon
dioxide (ThCO2) production for respirometric methods. These
pass levels must be reached in a 10-day window within the 28-day period
of the test. If the antimicrobial passes the ready biodegradability
study, then no further testing is required. If the antimicrobial fails
the ready biodegradability study, then the applicant must conduct one
of the following studies: The biodegradation in activated sludge study
as described in the ``Simulation Tests to Assess the Biodegradability
of Chemicals Discharged in Wastewater,'' the porous pot test, or the
simulation test--aerobic sewage treatment: A. activated sludge units.
    5. For the all other use patterns category (as specified in Sec.
158.2280(a)(3)), data are required based on a weight-of-evidence
evaluation of the results of the hydrolysis, photodegradation in water,
activated sludge sorption isotherm, biodegradability, and activated
sludge, respiration inhibition tests.
    6. Adsorption and desorption using a batch equilibrium method is
preferred.

In some cases, as when the antimicrobial pesticide degrades rapidly,
soil column leaching with unaged or aged columns may be more
appropriate to fully characterize the potential mobility of the parent
compound and major transformation products.
    7. For industrial processes and water systems, aquatic areas, and
the all other use patterns category (as specified in Sec.
158.2280(a)(3)), data are required based on a weight-of-evidence
evaluation of the results of the hydrolysis, photodegradation in water,
activated sludge sorption isotherm, biodegradability, and activated
sludge, respiration inhibition tests.
    8. The environmental media (soil, water, hydrosoil, and biota) to
be utilized in these studies must be collected from areas
representative of potential use sites.
    9. For industrial processes and water systems, and aquatic areas,
data are required for use sites that are intermittently dry.
    10. Data are not required if the antimicrobial is an inorganic
substance or a metal salt; or if the standardized soil profiles
demonstrate that the antimicrobial is likely to readily degrade either
microbially or via redox reactions (chemically) and no transformation/
degradate/leachate products of concern (as described under Sec.
158.2280(a)(2)) are produced.
    11. Analytical methods used to generate data associated with this
study must include results of a successful confirmatory method trial by
an independent laboratory.
    12. Protocols must be approved by the Agency prior to the
initiation of the study.
    13. For industrial processes and water systems, wood preservatives,
and the all other use patterns category (as specified in Sec.
158.2280(a)(3)), data are required based on the potential for aquatic
exposure and if the weight-of-evidence indicates that the active
ingredient or principal transformation products are likely to have the
potential for persistence, mobility, nontarget aquatic toxicity, or
bioaccumulation.
    14. Data are required if the weight-of-evidence indicates that the
active ingredient or principal transformation products are likely to
occur in nontarget freshwater, estuarine, or marine waters such that
human or environmental exposures are likely to occur. In making that
determination, the Agency takes into account other factors such as the
toxicity of the chemical(s), available monitoring data and the
vulnerability of the freshwater, estuarine, or marine water resources
in the antimicrobial use area.
    15. For wood preservatives, an aquatic leaching study is required.
A soil leaching study is required if human or environmental exposures
are likely to occur from leachates that contain the active ingredient
or principal transformation products from wood treated with a
preservative product. Protocols must be approved by the Agency prior to
the initiation of the study.
    16. For antifoulant paints and coatings, a leaching study is
required. Protocols must be approved by the Agency prior to the
initiation of the study.
    17. Protocols, which include the residues of concern (such as
parent, degradate/transformation product, and/or leachate residues)
that would be monitored, must be approved by the Agency prior to the
initiation of the study.
    18. A biodegradation study is not required if the antimicrobial
meets one or more of the following criteria:
    i. Classified as a metal,
    ii. Relatively volatile, but not hydrophobic,
    iii. Highly reactive,
    iv. Both the parent and all transformation/degradate products (as
described under Sec.  158.2280(a)(2)) have half-lives of less than 3
hours,
    v. None of the registered or proposed product uses would result in
transport of the parent and its transformation/degradate products (as
described under Sec.  158.2280(a)(2)) to a wastewater treatment plant.
    19. The activated sludge sorption isotherm test is not required if
the antimicrobial is:
    i. Relatively volatile, but not hydrophobic;
    ii. Highly reactive; or
    iii. The log Kow is less than 3.0.
    20. If the criteria of test note 19 of this paragraph are not met,
then the activated sludge sorption isotherm test is required if one or
more of the following criteria are also met:
    i. The antimicrobial is a metal,
    ii. The log Kow is greater than or equal to 3.0,
    iii. The antimicrobial is positively charged or polycationic,
    iv. The EC50 in the activated sludge, respiration
inhibition test is less than or equal to 20 mg/L,
    v. The EC50 in the activated sludge, respiration
inhibition test is greater than 20 mg/L, and the antimicrobial fails
the ready biodegradability study.
    21. The activated sludge respiration inhibition study is not
required if none of the registered or proposed product uses would
result in transport of the parent and its transformation/degradate
products (as described under Sec.  158.2280(a)(2)) to a wastewater
treatment plant.

Sec.  158.2290  Residue chemistry.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (h) of this section to determine the
residue chemistry data requirements for antimicrobial pesticide
products. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (i)
of this section.
    (b) Residue chemistry data are required for:
    (1) Antimicrobial end-use products with uses that may result in
residues in or on food, including but not limited to:
    (i) Products that require a tolerance, tolerance exemption, or food
additive regulation or clearance.
    (ii) Products that may be used to treat livestock or poultry
drinking water, for food egg washing, or for fruit and vegetable
rinses.
    (iii) Products that may be applied to a surface or incorporated
into a material that may contact food or feed. Data are required
regardless of whether the antimicrobial is applied or impregnated for
the purpose of imparting antimicrobial protection to external surfaces
of the substance or article, or for the purpose of protecting the
substance or article itself.
    (iv) Products that may be applied to water that have the potential
to result in residues in potable water, or in water used for livestock
and poultry drinking water, irrigation of crops, or water containing
fish that may be used for human food.
    (v) Wood preservative or antifoulant products intended for treating
submerged materials that may result in food contact (e.g., lobster
pots, fish cages on fish farms).
    (2) Each manufacturing-use product bearing directions for
formulation into an end-use product bearing uses described in paragraph
(b)(1) of this section.
    (c) Residue chemistry data are not required under paragraph (b) of
this section if no adverse effects (no toxicity endpoints) are
associated with dietary exposure to the active ingredient or if
theoretical (high-end) dietary exposure estimates combined with the
applicable toxicity endpoint result in acute and chronic dietary risks
that are below the Agency levels of concern.
    (d) For purposes of this section, Magnitude of the Residue Studies
include the following: Food-handling, migration studies, potable water,
fish,

irrigated crops, meat/milk/poultry/eggs, crop field trails, processed
food or feed, and anticipated residues.
    (e) If the antimicrobial chemical may be applied to a field crop,
then the residue chemistry data requirements of Sec.  158.1410 apply.
    (f) The following term is defined for the purposes of this section:
Residue of concern means the parent pesticidal compound and its
metabolites, degradates, and impurities of toxicological concern.
    (g) Key. R = Required; CR = Conditionally required; NR = Not
required; TGAI = Technical grade of the active ingredient; TEP =
Typical end-use product; PAI = Pure active ingredient; PAIRA = Pure
active ingredient radiolabeled; ROC = Residue of concern.
    (h) Antimicrobial residue chemistry data requirements table. The
following table shows the data requirements for residue chemistry. The
test notes appear in paragraph (i) of this section.

                                                Table--Antimicrobial Residue Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Uses
                                     ------------------------------------------------------------------------------------                     Test note
  Guideline No.    Data requirement       Agricultural                                                                     Test  substance       No.
                                            premise           Indirect food         Direct food            Aquatic
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1100........  Chemical identity.  R..................  R..................  R..................  R..................  TGAI.............  ...........
860.1200........  Directions for use  R..................  R..................  R..................  R..................  .................  ...........
860.1550........  Proposed tolerance/ R..................  R..................  R..................  R..................  .................            1
                   tolerance
                   exemption.
860.1560........  Reasonable grounds  R..................  R..................  R..................  R..................  .................            1
                   in support of
                   petition.
860.1650........  Submittal of        R..................  R..................  R..................  R..................  PAI/ROC..........            2
                   analytical
                   reference
                   standards.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Food-Contact Surfaces or Impregnated Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1460........  Food-handling.....  CR.................  CR.................  CR.................  CR.................  TEP..............            3
None............  Nature of residue   CR.................  CR.................  CR.................  CR.................  PAIRA or TGAI....            4
                   on surfaces.
None............  Migration studies.  CR.................  CR.................  CR.................  CR.................  TEP..............            5
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............            6
                   method for data
                   collection.
860.1380........  Storage stability.  R..................  R..................  R..................  R..................  TEP or ROC.......            7
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Higher tiered
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            8
                   residue in plants.
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            9
                   residue in
                   livestock.
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............           10
                   methods for
                   tolerance/
                   tolerance
                   exemption
                   enforcement.
860.1360........  Multiresidue        CR.................  CR.................  CR.................  CR.................  ROC..............           11
                   method testing.
860.1400........  Potable water.....  CR.................  CR.................  CR.................  CR.................  TEP..............           12
860.1400........  Fish..............  CR.................  CR.................  CR.................  CR.................  TEP..............           13
860.1400........  Irrigated crops...  CR.................  CR.................  CR.................  CR.................  TEP..............           14
860.1480........  Meat/milk/poultry/  CR.................  CR.................  CR.................  CR.................  TGAI or ROC......           15
                   eggs.
860.1500........  Crop field trials.  CR.................  CR.................  CR.................  CR.................  TEP..............           16
860.1520........  Processed food or   CR.................  CR.................  CR.................  CR.................  TEP..............           17
                   feed.
None............  Anticipated         CR.................  CR.................  CR.................  CR.................  ROC..............           18
                   residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (i) Test notes. The following test notes apply to the data
requirements in the table to paragraph (h) of this section:
    1. A petition proposing a numerical tolerance or a tolerance
exemption is required for any food or feed use subject to section 408
of FFDCA if the use is not covered by an existing tolerance or
tolerance exemption. If the use is subject to FFDCA section 409, the
applicant must identify to EPA an applicable section 409 food additive
regulation or clearance, or submit a copy of a petition to FDA
requesting a section 409 food additive regulation or clearance for the
food or feed use.
    2. An analytical reference standard is required for any food or
feed use requiring a numeric tolerance or exemption. Material safety
data sheets as specified by the Occupational Safety and Health
Administration in 29 CFR 1910.1200 must accompany analytical standards.
    3. Data are required if a pesticide may be used in a food-handling
establishment unless data including, but not limited to, theoretical
(high-end) estimates, radiolabeled laboratory data, or the nature of
the residue on surfaces study show that residues will not occur in food
or feed.
    4. If an antimicrobial pesticide may be applied to a food-contact
surface or impregnated into a food-contact material and if theoretical
(high-end) estimates of exposure exceed EPA's risk level of concern,
then the nature of the residue on surfaces study is required. Protocols
must be approved by the Agency prior to the initiation of the study.
    5. Based on the results of the nature of the residue on surfaces
study, if residues of concern are identified, then the migration study
will be required. Protocols must be approved by the Agency prior to the
initiation of the study.

    6. If a magnitude of the residue study, as specified in Sec.
158.2290(d), is required, then a residue analytical method suitable for
collecting data is also required. The method must be capable of
determining all residues of concern, to permit calculation of dietary
risk or to establish a tolerance or tolerance exemption.
    7. If a magnitude of the residue study, as specified in Sec.
158.2290(d), is required, then storage stability data are also
required, unless analytical samples are stored for 30 days or less. If,
during hazard characterization, a residue has been identified as ``of
concern'' and is known to be volatile or labile, then storage stability
data are required regardless of sample storage time.
    8. If crop plants or metabolically active raw agricultural
commodities of food crops may be directly or indirectly exposed to an
antimicrobial, plant metabolism studies are required to determine the
transformation products that may enter the human diet. Such exposure
could include, but is not limited to:
    i. Treatment of storage or shipping containers,
    ii. Postharvest fruit and vegetable treatment prior to shipping or
storage,
    iii. Use of antimicrobial-treated water for irrigation, and
    iv. Any direct food contact use.
    9. If livestock may be exposed to an antimicrobial, then hen and
ruminant metabolism studies are required to determine the identities of
residues of concern that may enter the human diet from consumption of
livestock commodities. Livestock may be exposed via the oral, dermal,
or inhalation route following treatment or contamination of sites
including, but not limited to, livestock premises, feed, and drinking
water. Shell eggs and other metabolically active livestock products may
also be treated. If livestock may be exposed to one or more residues of
concern differing from those found in animals, then one or more
additional livestock metabolism studies involving dosing with these
residues may be required.
    10. If there is a numerical tolerance or tolerance exemption level
to enforce, then a residue analytical method suitable for enforcement
purposes is required. The method must be supported by an independent
laboratory validation.
    11. If there is a numerical tolerance or tolerance exemption level
to enforce, then testing is required to determine whether the Food and
Drug Administration/United States Department of Agriculture
multiresidue methodology would detect and identify the antimicrobial
and its residues of concern, as part of programs to monitor pesticides
in the U.S. food supply.
    12. Data are required if an antimicrobial may be applied directly
to water or if there is the potential that the antimicrobial-treated
water could be used directly for drinking water purposes by humans or
animals or that contaminated water could run-off, leach, or be
discharged from treated sites or materials and make its way into
potable water.
    13. Data are required if an antimicrobial may be applied directly
to water inhabited by fish or that will be inhabited by fish or if
contaminated water could run-off, leach, or be discharged from treated
sites or materials and make its way into bodies of water containing
fish that may be used for human consumption.
    14. Data are required if an antimicrobial may be applied directly
to water used for irrigation of food crops or such that contaminated
water could run-off, leach, or be discharged from treated sites or
materials to make its way into water used for irrigation of food crops.
    15. If the antimicrobial may be applied directly to livestock,
metabolically-active livestock commodities (e.g., eggs), livestock feed
or drinking water, or livestock premises, or a livestock metabolism
study indicates that residues of the antimicrobial may result in
livestock commodities, studies are required to determine the magnitude
of the residues of concern in fat, meat, meat by-products, milk,
poultry, and eggs that may be consumed by humans. These studies,
however, may not be required in cases where the livestock metabolism
studies indicate that transfer of pesticide residues of concern to
tissues, milk, and eggs is not expected to occur at the maximum
expected exposure level for the animals.
    16. If food crops or raw agricultural commodities of food crops may
be exposed to an antimicrobial, then residue studies are required to
determine the magnitude of the residues of concern that may enter the
human diet. Such exposures include, but are not limited to, postharvest
fruit and vegetable treatments and application of antimicrobial
chemicals to field crops, mushroom houses, empty or occupied beehives,
or wood used to construct beehives.
    17. Data on the nature and magnitude of residues in processed food
or feed are required if antimicrobial residues could potentially
concentrate on processing. If so, the establishment of a separate
tolerance higher than that in the raw agricultural commodity may be
required.
    18. Data are required when dietary exposure values at the tolerance
level or screening-level (high-end) result in estimates of dietary or
aggregate risk that meet or exceed the Agency's level of concern. These
data may include, but are not limited to, washing, cooking, processing,
or degradation studies as well as market basket surveys for a more
realistic residue determination. Protocols must be approved by the
Agency prior to the initiation of the study.

PART 161--[REMOVED]

0
6. Remove part 161.

[FR Doc. 2013-10162 Filed 5-7-13; 8:45 am]
BILLING CODE P


[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Rules and Regulations]
[Page 45555-45560]
[DOCID:fr03se09-7]

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DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

15 CFR Part 909

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 151

[USCG-2007-0164]
RIN 0648-AV68; 1625-AB24

Definition of Marine Debris for Purposes of the Marine Debris
Research, Prevention, and Reduction Act

AGENCY: National Ocean Service (NOS), National Oceanic and Atmospheric
Administration (NOAA), Department of Commerce; Coast Guard, Department
of Homeland Security (DHS).

ACTION: Final rule.

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

SUMMARY: NOAA and the Coast Guard are defining ``marine debris'' for
purposes of the Marine Debris Research, Prevention, and Reduction Act
(the Act). The Act requires NOAA and the Coast Guard to jointly develop
a definition and promulgate it through regulations; this rule
represents the agencies' compliance with the Act. For the purposes of
the Marine Debris Research, Prevention, and Reduction Act only, marine
debris is defined as any persistent solid material that is

manufactured or processed and directly or indirectly, intentionally or
unintentionally, disposed of or abandoned into the marine environment
or the Great Lakes.

DATES: This final rule is effective October 5, 2009.

ADDRESSES: Comments and related material received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2007-0164 and are available for
inspection and copying at the 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, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. You also may find
this docket on the Internet by going to http://www.regulations.gov,
selecting the Advanced Docket Search option on the right side of the
screen, typing USCG-2007-0164 into the Docket ID box, pressing Enter,
and then clicking on the item in the Docket ID column.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call Dr. Holly A. Bamford, NOAA Marine Debris Program, telephone 301-
713-2989, or David Major, Environmental Standards Division, U.S. Coast
Guard Headquarters, telephone<PHONE_NUMBER>. If you have questions about
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Regulatory History
III. Background and Purpose
IV. Discussion of Comments and Changes
    A. Comments on the Purpose of the Definition
    B. Comments on ``Marine Environment''
    C. Comments on ``Solid''
    D. Comments on ``Persistent''
    E. Comments on ``Manufactured or Processed''
    F. Comments on ``Disposed of or Abandoned Into''
    G. Comments on Discharges in Compliance With Law
    H. Comments on Items Placed in the Marine Environment by Permit
    I. Comments on Medical Waste and Hazardous Materials
    J. Comments on Consultation With the Interagency Marine Debris
Coordinating Committee
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Department of Commerce Docket Number
    N. Environment

I. Abbreviations

IMDCC Interagency Marine Debris Coordinating Committee
CFR Code of Federal Regulations
FR Federal Register
MARPOL 73/78 International Convention for the Prevention of
Pollution from Ships, 1973, as modified by the protocol of 1978
NEPA National Environmental Policy Act
NOAA National Oceanic and Atmospheric Administration
NOAA Program NOAA's Marine Debris Prevention and Removal Program
NOS National Ocean Service
NPRM Notice of proposed rulemaking
NRC National Research Council
OMB Office of Management and Budget
U.S.C. United States Code

II. Regulatory History

    On May 27, 2008, NOAA and the Coast Guard published a notice of
proposed rulemaking entitled ``Definition of Marine Debris for Purposes
of the Marine Debris Research, Prevention, and Pollution Act'' in the
Federal Register (73 FR 30322). The title of the rulemaking has been
corrected by replacing the word ``pollution'' with ``reduction,'' to
reflect the correct name of the Act. NOAA and the Coast Guard received
six letters, containing a total of 24 comments, from the public, and
four letters, containing 17 comments, from Federal agencies commenting
on the proposed rule. All comments are discussed below. No public
meeting was requested and none was held.

III. Background and Purpose

    As society has developed new uses for materials, particularly
plastics, the variety and quantity of items found in the marine
environment has increased dramatically. These products range from
common domestic material (e.g., bags, cups, bottles, balloons) to
industrial products (e.g., strapping bands, plastic sheeting, hard
hats, resin pellets) to lost or discarded fishing gear (e.g., nets,
buoys, traps, lines, light sticks).
    In 2006, Congress passed the Marine Debris Research, Prevention,
and Reduction Act (the Act) (33 U.S.C. 1951-1958 (2006)), with the
purpose of identifying, determining the sources of, assessing,
reducing, and preventing marine debris and its adverse impacts on the
marine environment and navigation safety.
    The Act makes permanent a Marine Debris Prevention and Removal
Program within NOAA (NOAA Program) that intends to reduce and prevent
the occurrence and adverse impacts of marine debris on the marine
environment and navigation safety. The NOAA Program includes mapping,
identification, impact assessment, removal, and prevention of marine
debris, with a focus on threats to living marine resources, including
commercial fisheries and species protected under the Endangered Species
Act and Marine Mammal Protection Act, and the habitat upon which they
depend. The NOAA Program uses non-regulatory measures to reduce and
prevent marine debris and the loss of fishing gear, including the
development of local or regional protocols for lost gear reduction and
prevention. Examples of such measures include new fishing gear
technology, implementation of incentives to reduce lost gear, outreach
and education to commercial users and the general public, and other
non-regulatory measures to minimize the volume of marine debris and
lost and discarded fishing gear, and to aid in its recovery. The Act
authorizes NOAA to provide grants to entities for the research,
prevention, and reduction of marine debris.
    The Act requires the Coast Guard to enforce the International
Convention for the Prevention of Pollution from Ships, 1973, as
modified by the 1978 Protocol (MARPOL 73/78), Annex V, and the Act to
Prevent Pollution from Ships, 33 USC 1901-1915 (1996). The Coast Guard
will continue to monitor and enforce the requirements of these acts
among the appropriate regulated industries and communities. The Coast
Guard intends to increase international cooperation to reduce marine
debris, and to maintain its voluntary reporting program in order to
ensure the reporting of damage to vessels and disruption to navigation
caused by marine debris. The Act also required the Coast Guard to
submit to Congress a report evaluating the Coast Guard's progress on
these initiatives; the report required under 33 U.S.C. 1953(b) was
completed in 2007. In addition, the Act required the Coast Guard to
obtain a report from the National Research Council (NRC) on the
effectiveness of international and domestic measures to prevent and
reduce marine debris and its impacts; this report was completed and
presented to Congress by NRC in September, 2008.
    The Act also reactivated the Interagency Marine Debris Coordinating
Committee (IMDCC), an interagency Federal body responsible for
developing and recommending comprehensive and

multi-disciplinary approaches to reduce the sources and impacts of
marine debris to the nation's marine environment, natural resources,
public safety, and economy. The IMDCC meets quarterly to ensure
coordination of research, monitoring, education, and regulatory actions
addressing the persistent marine debris problem.
    As codified in Title 33 of the United States Code, the Act requires
NOAA and the Coast Guard, in consultation with the IMDCC, to ``jointly
develop and promulgate through regulations a definition of the term
`marine debris' for the purposes of this Act.'' 33 U.S.C.
1954(b)(2006). The Act expressly limits the application of the
definition of marine debris to the implementation and requirements of
the Act. The Act does not authorize NOAA or the Coast Guard to
undertake regulatory actions other than the promulgation of this
definition, and the definition of marine debris does not affect the
regulatory or management activities of other Federal agencies.
    NOAA and the Coast Guard worked together to develop and propose a
definition, taking into account both agencies' responsibilities under
the Act. The term ``marine debris'' has a variety of meanings to the
many entities working in and affecting the marine environment. The
definition promulgated by this rule, however, focuses on solid debris
from land-based and ocean-based sources. While NOAA and the Coast Guard
considered alternative definitions, this definition will allow NOAA to
consider the broadest possible range of marine debris activities for
grant and research support as provided in the Act. The definition will
also provide the Coast Guard sufficient parameters to conduct useful
and focused studies and reports required by the Act.
    As required by the Act, the two agencies consulted with the IMDCC
during the development of this definition. Some IMDCC members suggested
that the definition include the term ``unauthorized'' in order to
exclude materials explicitly permitted to be discharged into the marine
environment. NOAA and the Coast Guard did not include the term
``unauthorized'' in the definition. As discussed in more detail below,
such a limited definition would be inconsistent with the objectives of
the Act, which are to identify, determine the sources of, assess,
reduce, and prevent the full range of marine debris and its adverse
effects on the marine environment and navigation safety. Authority to
dispose of or abandon material that may be considered marine debris as
defined in this regulation is not affected by the promulgation of this
definition or the implementation of the programs established pursuant
to the Act. Some IMDCC members also suggested that the definition of
marine debris be limited to debris with adverse effects on the marine
environment. NOAA and the Coast Guard did not include this limitation
because it would prevent the NOAA program from supporting or conducting
research where impacts of debris on marine resources are unknown or
uncertain. Limiting the range of research opportunities in this way
would diminish the ability of NOAA and the Coast Guard to fulfill the
objectives of the Act.
    On May 27, 2008, the two agencies published a notice of proposed
rulemaking (NPRM) proposing a definition of marine debris for purposes
of the Act. The proposed definition read as follows: ``For the purposes
of the Marine Debris Research, Prevention, and Reduction Act (33 U.S.C.
1951-1958 (2006)) only, marine debris is defined as any persistent
solid material that is manufactured or processed and directly or
indirectly, intentionally or unintentionally, disposed of or abandoned
into the marine environment or the Great Lakes.''

IV. Discussion of Comments and Changes

    The Coast Guard and NOAA received 10 letters containing a total of
41 comments on the proposed definition. After consideration of all the
comments, and for the reasons set out below, the Coast Guard and NOAA
adopt the proposed definition without changes.

A. Comments on the Purpose of the Definition

    Several commenters approached the definition of marine debris from
an enforcement perspective, assuming that items within the definition
of marine debris would necessarily be subject to anti-pollution
mandates. An item that satisfies the definition of marine debris may,
in some cases, be addressed by anti-pollution laws that prohibit the
disposal or abandonment of the material. However, the fact that a
material satisfies the definition of marine debris does not mean its
disposal or abandonment is prohibited.
    The Act does not prohibit the disposal or abandonment of marine
debris, nor does it provide regulatory authority to do so. Instead, the
Act is intended to help identify, assess, reduce, and prevent marine
debris. See Section III of this preamble for details on agency
involvement in addressing these areas. The definition of marine debris
will be used only for the implementation of the Act.

B. Comments on ``Marine Environment''

    Two commenters asked what areas are included in the term ``marine
environment.'' NOAA and the Coast Guard use the term ``marine
environment'' consistently with its use in other sections of the United
States Code. The term ``marine environment'' is defined in various
parts of the United States Code to include the high seas, exclusive
economic zone, territorial sea, coastal waters, Great Lakes, navigable
waters of the United States, and the lands therein and thereunder, and
adjacent shorelines and shorelands. NOAA and the Coast Guard
specifically included the Great Lakes in the definition of marine
debris to avoid confusion. The marine environment does not include
airspace above bodies of water.
    One commenter requested that the term ``marine environment'' be
replaced with the term ``aquatic environment'' in order to cover debris
originating from land-based sources via creeks and tributaries. As
explained in part F below, such debris is already addressed by the
definition.

C. Comments on ``Solid''

    Three commenters asked whether specific materials they consider to
be ``semi-solid'' would be included within the definition of marine
debris, or encouraged that such materials be included. Marine debris,
pursuant to the Act, is defined as any persistent solid material and
therefore does not include semi-solids, such as tar balls and sewer
cakes. NOAA and the Coast Guard concluded that the Act was not intended
to cover materials other than solid materials. Internationally and
domestically, the generally accepted usage of ``marine debris,''
including in research, refers to solid items. For example, all of the
marine debris items catalogued in the 1988 Report of the Interagency
Task Force on Persistent Debris are solids.

D. Comments on ``Persistent''

    Three commenters asked for clarification of the word ``persistent''
as used in the definition. The term ``persistent'' is intended to
capture items that degrade slowly, as noted in the CEQ Ocean Blueprint
for the 21st Century and the House Report on the Act (H.R. Rep. No.
109-332, pt. 2, at 1759 (2006)). This also is consistent with the 1988
Report of the Interagency Task Force on Persistent Debris, in which
small pieces of plastic and plastic particles are recognized as marine

debris. Persistency is affected by material composition, movement
within the water column, and exposure to sunlight, among other things.
The ability of marine debris to travel long distances away from the
point of origin is taken into account in considering persistency.

E. Comments on ``Manufactured or Processed''

    Five commenters requested the definition be modified to include
``naturally occurring'' debris such as downed trees, or expressed
interest in the treatment of lost agricultural cargo. The Coast Guard
and NOAA concluded that organic matter that is not processed or
manufactured, that enters the marine environment, would not meet the
definition of marine debris within the context of the Act, which
focuses on manufactured and processed items. To the extent that organic
matter has been subject to manufacturing or processing, those items may
be considered marine debris if they satisfy the remainder of the
definition.
    One commenter requested the definition be modified to include
materials ``intended to be processed.'' The commenter provided the
specific example of raw materials used for plastic production, namely
pre-production plastic pellets. All plastic items have been created
through a manufacturing process, as they do not exist naturally in the
environment. Therefore, plastic in any form and of any size already is
included in the definition of marine debris. Similar manufactured
persistent solids mentioned by commenters, such as golf balls, also are
considered marine debris.

F. Comments on ``Disposed of or Abandoned Into''

    Commenters described a variety of means by which material can be
disposed of or abandoned into the marine environment, such as transport
by wind or storm drains, and inquired how or whether the manner of
transport affects whether or not the material is within this definition
of marine debris. The means by which material enters into marine
environment does not affect whether that material is considered marine
debris. As noted in the preamble above, a variety of both sea and
landside events and activities, such as storm water runoff, wind, or
natural disasters, may ultimately result in materials being abandoned
or disposed of in the marine environment. For that reason, the
definition of marine debris includes materials disposed of or abandoned
``directly or indirectly, intentionally or unintentionally'' into the
marine environment.

G. Comments on Discharges in Compliance With Law

    Three commenters commented on whether the definition of marine
debris should include materials discharged in compliance with relevant
enforcement regimes. A persistent solid material that is manufactured
or processed, and disposed of or abandoned into the marine environment,
is considered marine debris even when the disposal or abandonment is
legally permissible. As noted above, NOAA and the Coast Guard define
marine debris exclusively for the purposes of the Act, and the Act does
not create an enforcement regime. Existing enforcement regimes
referenced in the Act, such as the Act to Prevent Pollution from Ships
and MARPOL Annex V, allow the legal discharge of items into the sea.
Congress did not state in the Act or legislative history that a
definition exclude those items. Moreover, it would be impractical to
classify items based on source rather than location. For example, a tin
can located in the sea may have been discharged in accordance with
MARPOL or may have blown into the ocean from a pier. In both
circumstances, considering the tin can to be marine debris fulfills the
intent of the Act.
    The Act is non-regulatory and overlaps with current enforcement
regimes established by other laws. The fact that an item is legally
disposed of or abandoned does not prevent it being studied or tracked.
Environmental goals can be achieved through non-regulatory means,
including study and the promotion of new methods to prevent, reduce,
and mitigate the effects of debris. Thus, marine debris of any type is
open for research or other activities as specified in the Act.

H. Comments on Items Placed in the Marine Environment by Permit

    Four commenters raised concerns that materials placed in the marine
environment by public agencies or under permit by public agencies--such
as artificial reefs, marine structures, vessels, rigs, pipelines, and
navigational and weather buoys--may be deemed marine debris. The Coast
Guard and NOAA do not consider such items disposed of or abandoned,
because the items are intact, on station, and monitored. However, an
item or piece of an item originally placed or permitted in the marine
environment, but that subsequently breaks apart, becomes lost, or is no
longer actively monitored, could be considered disposed of or abandoned
and would meet the definition of marine debris. The Coast Guard and
NOAA emphasize that a government approval or permission for disposal or
abandonment of material into the marine environment does not exclude
that material from research, removal, or outreach activities
contemplated by the Act. For example, a tire reef off the coast of
Florida, legally placed there in 1972, has fragmented and allowed tires
to drift across the seafloor; those tires are considered marine debris
for purposes of the Act.

I. Comments on Medical Waste and Hazardous Materials

    Three commenters expressed concern about medical waste, such as
syringes, located in the marine environment, and about floating
containers containing hazardous, or unknown but potentially hazardous,
substances. Solid medical waste material such as syringes and floating
or submerged containers are marine debris under the definition.
Hazardous material response is not within the scope of the Act;
however, the remediation of many types of marine debris, including
hazardous materials covered by the Comprehensive Environmental Response
and Liability Act (42 U.S.C. 9601 et seq.), is provided for by a
variety of statutes.

J. Comments on Consultation With the Interagency Marine Debris
Coordinating Committee

    Two commenters questioned the lack of consensus with some members
of the IMDCC regarding the definition of marine debris. The Act directs
NOAA and the Coast Guard to consult with the IMDCC in developing the
definition of marine debris, and this consultation took place at a
number of quarterly IMDCC meetings through August, 2007. NOAA and the
Coast Guard have addressed the comments made by IMDCC members in this
preamble and will continue to work with the IMDCC in implementing the
Act.

V. Regulatory Analyses

    The Coast Guard and NOAA developed this rule after considering
numerous statutes and executive orders related to rulemaking. Below is
a summary of our analyses based on 13 of these statutes or executive
orders.

A. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and

Budget has not reviewed it under that Order.
    Public comments on the NPRM are summarized in Section IV of this
preamble, ``Discussion of Comments and Changes.'' NOAA and the Coast
Guard received no public comments and made no changes that would alter
the assessment of impacts in the NPRM. A summary of the assessment
follows.
    The Act requires the Coast Guard and NOAA to jointly develop and
promulgate a definition of marine debris for the purposes of the Act.
Accordingly, this rulemaking creates a joint Coast Guard and NOAA
definition of the term ``marine debris'' for the purposes of the Act.
The Act does not authorize NOAA or the Coast Guard to undertake
regulatory or management activities of other Federal agencies. Instead,
the drafting agencies expect to use the definition of marine debris for
the administration of research and educational grants. Such grants may
map, identify, or assess the impacts of marine debris.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the
drafting agencies considered whether this rule would have a significant
economic impact on a substantial number of small entities. 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.
    In the NPRM, NOAA and the Coast Guard certified under 5 U.S.C.
605(b) that the proposed rule would not have a significant economic
impact on a substantial number of small entities. See the ``Regulatory
Flexibility Act'' section of the NPRM for the complete threshold
analysis. NOAA and the Coast Guard found no additional data or
information that would change the certification in the NPRM.
    Therefore, the Coast Guard and NOAA certify under 5 U.S.C. 605(b)
that this rule will not have a significant economic impact on a
substantial number of small entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), NOAA and the Coast Guard will
assist all entities, including small entities, in understanding this
rule. NOAA and the Coast Guard do not retaliate against any entity,
including small entities, that may question or complain about this rule
or any policy or action of the NOAA or the Coast Guard.

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. NOAA and the Coast Guard have
analyzed this rule under that Order and have determined that it does
not have implications for federalism.

F. 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 or more in any
one year. Though this rule will not result in such an expenditure, NOAA
and the Coast Guard do discuss the effects of this rule elsewhere in
this preamble.

G. Taking of Private Property

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

H. 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.

I. Protection of Children

    NOAA and the Coast Guard 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
might disproportionately affect children.

J. 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.

K. Energy Effects

    NOAA and the Coast Guard have analyzed this rule under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use. NOAA and the Coast Guard have
determined that it is not a ``significant energy action'' under that
order because it is not a ``significant regulatory action'' under
Executive Order 12866 and is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. The Administrator
of the Office of Information and Regulatory Affairs has not designated
it as a significant energy action. Therefore, it does not require a
Statement of Energy Effects under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, NOAA and the
Coast Guard did not consider the use of voluntary consensus standards.

M. Department of Commerce Docket Number

    The clearance docket number for the Department of Commerce is:
070615197-91195-02.

N. Environment

    The Coast Guard has analyzed this rule under Department of Homeland
Security 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 NOAA has analyzed
the proposed rule under NOAA Administrative Order 216-6, which sets
forth NOAA's

environmental review procedures for implementing NEPA. The agencies
have concluded 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 is categorically excluded under section 6(b) of
the ``Appendix to National Environmental Policy Act: Coast Guard
Procedures for Categorical Exclusions, Notice of Final Agency Policy''
(67 FR 48244, July 23, 2002) and NOAA NAO 216-6 sections 5.05 and
6.03(c)(3)(i). This rule involves congressionally mandated regulations
designed to improve or protect the environment. An environmental
analysis checklist and the relevant categorical exclusion
determinations are available in the docket where indicated under
ADDRESSES.

List of Subjects

15 CFR Part 909

    Marine resources, Marine debris, Marine pollution, and Ocean
dumping.

33 CFR Part 151

    Administrative practice and procedure, Oil pollution, Penalties,
Reporting and recordkeeping requirements, and Water pollution control.

    NOAA signature.

    Dated: August 19, 2009.
John H. Dunnigan,
Assistant Administrator for Ocean Services and Coastal Zone Management.
    Coast Guard signature.

    Dated: August 20, 2009.
B.M. Salerno,
RADM, Coast Guard, Assistant Commandant for Marine Safety, Security and
Stewardship.

0
For the reasons discussed in the preamble, NOAA adds 15 CFR part 909
and the Coast Guard amends 33 CFR part 151 as follows:
0
1. 15 CFR Part 909 is added to read as follows:

PART 909--MARINE DEBRIS

Sec.  909.1  Definition of marine debris for the purposes of the Marine
Debris Research, Prevention, and Reduction Act.

    Authority:  33 U.S.C. 1951-1958 (2006).

Sec.  909.1  Definition of marine debris for the purposes of the Marine
Debris Research, Prevention, and Reduction Act.

    (a) Marine debris. For the purposes of the Marine Debris Research,
Prevention, and Reduction Act (33 U.S.C. 1951-1958 (2006)) only, marine
debris is defined as any persistent solid material that is manufactured
or processed and directly or indirectly, intentionally or
unintentionally, disposed of or abandoned into the marine environment
or the Great Lakes.
    (b) NOAA and the Coast Guard have jointly promulgated the
definition of marine debris in this part. Coast Guard's regulation may
be found in 33 CFR 151.3000.

PART 151--VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE,
MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER

0
2. Add Subpart E to Part 151, to read as follows:

Subpart E--Definition of Marine Debris for the purposes of the
Marine Debris Research, Prevention, and Reduction Act

    Authority:  33 U.S.C. 1951-1958 (2006); 33 CFR 1.05-1;
Department of Homeland Security Delegation No. 0170.1.

Sec.  151.3000  Definition of Marine Debris for the purposes of the
Marine Debris Research, Prevention, and Reduction Act.

    (a) Marine debris. For the purposes of the Marine Debris Research,
Prevention, and Reduction Act (33 U.S.C. 1951-1958 (2006)) only, marine
debris is defined as any persistent solid material that is manufactured
or processed and directly or indirectly, intentionally or
unintentionally, disposed of or abandoned into the marine environment
or the Great Lakes.
    (b) NOAA and the Coast Guard have jointly promulgated the
definition of marine debris in this part. NOAA's regulation may be
found in 15 CFR part 909.

[FR Doc. E9-21261 Filed 9-2-09; 8:45 am]

BILLING CODE 3510-JE-P


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60891-60892]
[FR Doc No: 2015-25633]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD15-34-000]

City of Manitou Springs, Colorado;

Notice of Preliminary Determination of a Qualifying Conduit Hydropower
Facility and Soliciting Comments and Motions To Intervene

    On September 24, 2015, the City of Manitou Springs, Colorado, filed
a notice of intent to construct a qualifying conduit hydropower
facility, pursuant to section 30 of the Federal Power Act (FPA), as
amended by section 4 of the Hydropower Regulatory Efficiency Act of
2013 (HREA). The proposed Manitou Springs WTP Hydro Project would have
an installed capacity of 40 kilowatts (kW), and would be located along
an existing 16-inch-diameter raw water pipeline supplying water to the
city's water treatment plant. The project would be located in the City
of Manitou Springs in El Paso County, Colorado.
    Applicant Contact: Jason Wells, City Administrator, 606 Manitou
Ave., Manitou Springs, CO 80829, Phone No.<PHONE_NUMBER>.
    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A proposed powerhouse, approximately 12.5
feet by 23 feet, adjacent to the existing water treatment plant
building; (2) a short, 6-inch-diameter penstock teeing off the existing
16-inch-diameter raw water supply pipeline; (3) one vertical in-line
Francis turbine/generator unit with an installed capacity of 40
kilowatts (kW); (4) a short, 6-inch-diameter discharge returning water
to the existing 16-inch-diameter raw water pipeline; and (5)
appurtenant facilities.
    The proposed project would have a total installed capacity of 40
kW.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

      Table 1--Criteria for Qualifying Conduit Hydropower Facility
------------------------------------------------------------------------
                                                               Satisfies
        Statutory provision                Description           (Y/N)
------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by      The conduit the facility          Y
 HREA.                               uses is a tunnel,
                                     canal, pipeline,
                                     aqueduct, flume, ditch,
                                     or similar manmade
                                     water conveyance that
                                     is operated for the
                                     distribution of water
                                     for agricultural,
                                     municipal, or
                                     industrial consumption
                                     and not primarily for
                                     the generation of
                                     electricity.
FPA 30(a)(3)(C)(i), as amended by   The facility is                   Y
 HREA.                               constructed, operated,
                                     or maintained for the
                                     generation of electric
                                     power and uses for such
                                     generation only the
                                     hydroelectric potential
                                     of a non-federally
                                     owned conduit.
FPA 30(a)(3)(C)(ii), as amended by  The facility has an               Y
 HREA.                               installed capacity that
                                     does not exceed 5
                                     megawatts.
FPA 30(a)(3)(C)(iii), as amended    On or before August 9,            Y
 by HREA.                            2013, the facility is
                                     not licensed, or
                                     exempted from the
                                     licensing requirements
                                     of Part I of the FPA.
------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff preliminarily determines that the proposal satisfies
the requirements for a qualifying conduit hydropower facility, which is
not required to be licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2015).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (i.e., CD15-34) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY, call
(202) 502-8659.

    Dated: October 1, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-25633 Filed 10-7-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66000-66001]
[FR Doc No: 2015-27470]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0435; FRL-9935-79]

Agency Information Collection Activities; Proposed Renewal of the
Collection under OMB Control No. 2070-0030, EPA ICR No. 0795.15;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Notification of Chemical Exports--TSCA Section
12(b)'' and identified by EPA ICR No. 0795.15 and OMB Control No. 2070-
0030, represents the renewal of an existing ICR that is scheduled to
expire on August 31, 2016. Before submitting the ICR to OMB for review
and approval, EPA is soliciting comments on specific aspects of the
proposed information collection that is summarized in this document.
The ICR and accompanying material are available in the docket for
public review and comment.

DATES: Comments must be received on or before December 28, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2015-0435, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Mike Mattheisen, Chemical Control Division (7405-M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3077; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to Paperwork Reduction Act (PRA) section 3506(c)(2)(A) (44
U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and
information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.

    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Notification of Chemical Exports--TSCA Section 12(b).
    ICR number: EPA ICR No. 0795.15.
    OMB control number: OMB Control No. 2070-0030.
    ICR status: This ICR is currently scheduled to expire on August 31,
2016. The Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Section 12(b) of the Toxic Substances Control Act (TSCA)
requires any person who exports or intends to export a chemical
substance or mixture that is regulated under TSCA sections 4, 5, 6 and/
or 7 to notify EPA of such export or intent to export. This requirement
is described in more detail at 40 CFR part 707, subpart D. Upon receipt
of notification, EPA advises the government of the importing country of
the U.S. regulatory action that required the notification with respect
to that substance. EPA uses the information obtained from the submitter
via this collection to advise the government of the importing country.
This information collection addresses the burden associated with
industry reporting of export notifications.
    Responses to the collection of information are mandatory (see 40
CFR part 707, subpart D). Respondents may claim all or part of a notice
confidential. EPA will disclose information that is covered by a claim
of confidentiality only to the extent permitted by, and in accordance
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.3
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR are companies that export chemical substances or mixtures from
the United States to foreign countries.
    Estimated total number of potential respondents: 240.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
12.9.
    Estimated total annual burden hours: 4,032 hours.
    Estimated total annual costs: $278,118. This includes an estimated
burden cost of $278,118 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is an increase of 7 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects EPA's correction of errors in the previous
submission. This change is an adjustment.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: October 19, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-27470 Filed 10-27-15; 8:45 am]
 BILLING CODE 6560-50-P