Reregistration Eligibility Decision

Inorganic Sulfites

Special Review and Reregistration Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1801 South Bell Street

Arlington, VA 22202

Introduction

The Environmental Protection Agency (EPA) has completed its
Reregistration Eligibility Decision (RED) for the inorganic sulfites
case, which includes the chemicals sulfur dioxide and sodium
metabisulfite.  This assessment provides information to support the
issuance of a Reregistration Eligibility Decision for inorganic
sulfites.  EPA’s pesticide reregistration process provides for the
review of older pesticides (those initially registered prior to November
1984) under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) to ensure that they meet current scientific and regulatory
standards.

In this document, EPA presents the results of its review of the
potential human health effects of dietary, drinking water and
occupational/bystander exposure to inorganic sulfites, as well as its
ecological risk findings.  Evaluations performed by the World Health
Organization (WHO), the International Agency for Research on Cancer
(IARC), and the Agency for Toxic Substances and Disease Registry (ATSDR)
were relied upon for this assessment, in addition to peer-reviewed
evaluations performed by the Cosmetic Ingredient Review (CIR), the
Organization for Economic Cooperation and Development-Screening
Information Data Set (OECD-SIDS) and from other open literature sources.
 Based on this assessment, the Agency has determined that products
containing sulfur dioxide or sodium metabisulfite are eligible for
reregistration provided the necessary label changes are made.  As a
result of this assessment, one tolerance has been reassessed.

I.  Use Information

The inorganic sulfites reregistration case includes the chemicals sulfur
dioxide (CAS No. 7446-09-5) and sodium metabisulfite (CAS No.
7681-57-4).  As active ingredients, these chemicals are fungicides
typically used to treat for Botrytis cinerea, the fungus which causes
bunch rot, or gray mold disease on grapes.  The sulfur dioxide products
are formulated as a compressed liquid that converts to a gas upon
release.  These products are used in cold-storage warehouses, trucks,
vans and train cars for post-harvest grape fumigation.  In addition to
the fungicidal use against Botrytis cinerea, sulfur dioxide is also used
in combination with carbon dioxide to treat for black widow spider on
grapes in warehouse settings.  The black widow spider treatment is not
included on any sulfur dioxide product labels, as this use is permitted
solely under a FIFRA 24(c) carbon dioxide registration (CA920007).  The
sodium metabisulfite products are composed of the anhydrous, solid
active ingredient contained in semi-sealed pads which are added to
containers holding grapes prior to shipping.  The pads absorb moisture
generated by grapes, and release low levels of sulfur dioxide in the
range of 1-5 ppm.

End-use inorganic sulfite products contain sulfur dioxide at 99.9 to
100%, and sodium metabisulfite at 37.5 to 98.5%.  The Agency currently
has six of the ten sodium metabisulfite products designated as
containing sodium bisulfite (078201) as the active ingredient.  As of
the publication of this RED, the Agency will transfer these
registrations to the sodium metabisulfite designation (111409).  The
tolerance being reassessed in this document, with the
respectivecitation in the Code of Federal Regulations (CFR), and the
use pattern as an active ingredient is listed in Table 1.

Table 1. Tolerance Being Reassessed for Inorganic Sulfites

Tolerance Expression

CAS No.

40 CFR

PC Code

Limit

Use Pattern

Active Ingredient

Sulfur dioxide (as sulfite residues)

7446-09-5

§180.444

77601

10 ppm

grape, postharvest/used as fungicide and preservative

Sodium metabisulfite (as sulfite residues)

7681-57-4

 §180.444

111409

10 ppm

grape, postharvest/used as fungicide and preservative

Both sulfur dioxide (21CFR §182.3862) and sodium metabisulfite (21CFR
§182.3766) are listed as GRAS (Generally Recognized as Safe) by the FDA
(Food and Drug Administration) as preservatives in certain foods.
Sodium metabisulfite is also used up to a concentration of 1% as an
antioxidant in hair care products and as a reducing agent in cosmetic
formulations (CIR 2003). Sources of sulfur dioxide include the
combustion of fossil fuels, smelting of sulfide ores, volcanic
emissions, and other natural sources.  Sulfur dioxide is also used to
manufacture hydro- sulfites, to bleach wood pulp and paper, to process,
disinfect, and bleach food, for waste and water treatment, in metal and
ore refining, and in oil refining (ATSDR-MMG 2004).

II.  Physical/Chemical Properties

The physical and chemical properties of the inorganic sulfites are
provided in Table 2.

Table 2.  Physical/Chemical Properties of Inorganic Sulfites

Sulfur Dioxide

References

Sodium Metabisulfite

References

Molecular weight

64.06

ATSDR, 1998a

(*NIOSH, 1994)

190.109

HSDB, 2005

Color/Form

colorless

white crystals or powder

Odor

strong odor; suffocating

slight odor of sulfur dioxide

Melting point

-72.7oC

150o C

Boiling point

-10o C

Decomposes

OECD, 2001

Density

2.927 g/L (gas)

1.434 g/L (liquid)

1.4

HSDB, 2005

Solubilities

22.8 g/100 mL (water at 0o C)

8.5 mL/100 mL (water at 25o C)*

11.3 g/100 mL (water at 20o C)

0.58 g/100 mL (water at 90o C)

54,000 mg/L water @ 20o C

81.7 g/100 mL water @ 100o C

Vapor Pressure

3000 mm Hg at 20o C

Not available

Relative vapor density

2.25 (air = 1)

NIOSH, 1994

Relative density

1.4 at -10o C (water = 1)

Specific gravity

2.26

MSDS, 1996

III.  Hazard Assessment

A. Acute Toxicity

Sufficient toxicity information is available for both sulfur dioxide and
sodium metabisulfite from publicly available sources.

Sodium Metabisulfite

Table 3.  Acute Toxicity Data for Sodium Metabisulfite

Study Type

Species

Lethal Dose (LD50) or Lethal Concentration (LC50)

Toxicity Category1

Reference

Acute Oral

rat

LD50 = 1540 mg/kg, death observed (1250 mg/kg

LD50 = 1131 mg/kg

III 	  TOXNET, 2005

OECD, 2001

Acute Dermal 	rat	LD50  >  2000 mg/kg	III	TOXNET, 2005

Acute Inhalation

Not Available

 Dermal Sensitization

guinea pig

Non-sensitizer

----

OECD, 2001

Skin and Eye Irritation

	rabbit

Not irritating to the skin; Irritating to the eyes

Not provided	OECD, 2001

1 The toxicity category ratings were not provided by OECD.

At high oral doses (> 1% or 10,000 ppm in the diet), effects seen in
rats were local irritation, including inflammatory changes and
hyperplasia in the stomach (WHO, 1999).  Although dermal toxicity
studies performed with sodium metabisulfite in laboratory animals have
not been submitted to the Agency, a report by the Cosmetic Ingredient
Review Committee (CIR, 2003) indicates that dermal penetration is
unlikely due to the highly charged nature of sulfites.  Cosmetic
products containing sodium metabisulfite range from shampoos and hair
coloring products, to eye and skin lotions, and makeup foundations.
Sodium metabisulfite was not sensitizing in the standard skin
sensitization test in the guinea pig.

Sulfur Dioxide:

Table 4.  Acute Toxicity Data for Sulfur Dioxide

Study Type

Species

 Lethal Dose (LD50) or Lethal Concentration (LC50) Results

Toxicity Category1

Reference

Acute Oral

Not Available

Acute Dermal

Not Available

Acute Inhalation

guinea pig

Lowest published LC: 1039 ppm/24 hr (2.7 mg/L/24 hr)

IV	NIOSH, 2004

	guinea pig

LC50 = 1000 ppm/20 hr; 130 ppm/154 hr

=2620 mg/m3/20hr or 2.6 mg/L

IV

HSDB, 2005

	mouse	LC50: 3000ppm/30 min (7.9 mg/L/30min)

IV

NIOSH, 2004

	mouse

LC50 = 150 ppm/847 hr;

1000 ppm/4 hr (2.6 mg/L)

IV

HSDB, 2005

rat

Lethal concentration (LC50): 2520 ppm/1 hr or 1.65 mg/L; 2168 mg/m3; 20
mg/m3/5 hr; 30 mg/m3	III

NIOSH, 2004

         Dermal                sensitization
                                Not Available

1 The toxicity category ratings were not provided by NIOSH.

B.  Reproduction/Developmental Toxicity/Endocrine Disruption:

No evidence of reproductive toxicity was observed in rats exposed orally
to 942 mg/kg bw/day of sodium metabisulfite (2% in the diet) in a diet
supplemented with thiamine (OECD 2001).  Developmental studies reported
by the CIR 2003 indicate sodium metabisulfite produced no adverse
findings, either maternal or fetal, in mice up to 160 mg/kg in a water
solution, in rats up to 110 mg/kg in the diet, in hamsters up to 120
mg/kg in the diet, or in rabbits up to 123 mg/kg in the diet.  These
results are supported by developmental information reported by WHO
(1999) in which no effects were observed on implantation, or on maternal
or fetal survival in sodium metabisulfite doses of up to 150, 110 and
120 mg/kg bw in mice, rats, and hamsters, respectively (WHO Series 18).
Reproductive effects were not observed in rats exposed to 5-30 ppm
sulfur dioxide for a period from 9 days prior to mating until 12-14 days
of pregnancy; or in mice exposed to 25 ppm sulfur dioxide 7 hours/day on
gestation days 6-15; or in rabbits exposed to 70 ppm sulfur dioxide 7
hours/day on gestation days 6-18 (ATSDR, 1998a).

C.  Carcinogenicity:

Sulfur dioxide and sodium metabisulfite are currently not classifiable
(Group 3) as to their carcinogenicity to humans (IARC 1992).  As for
laboratory animals, there was limited evidence for the carcinogenicity
to sulfur dioxide, based on inhalation studies reviewed by the IARC,
which indicated an increased incidence of lung tumors in female mice
after exposure to sulfur dioxide.  However, the concentrations of sulfur
dioxide evaluated in these inhalation studies were not reported.
Conclusions of the OECD SIDS report indicated 2% sodium metabisulfite
via feed (20,000 ppm or 1,000 mg/kg/day) for 104 weeks was not
carcinogenic in Wistar rats.

D.  Genotoxicity/Mutagenicity:

Sodium metabisulfite was negative in an Ames/microsome assay (SRI
International 1978b as cited by CIR 2003).  Negative results were also
reported for a host-mediated assay using mice to test mutagenicity
against bacteria and yeast, in a cytogenetic assay using rats (Litton
Bionetics 1972 as cited in CIR 2003), and a cytogenetic assay using
sulfite oxidase-deficient hamsters and mice (Renner and Wever 1983 as
cited in CIR 2003).  Sodium metabisulfite was negative in one dominant
lethal assay using rats while another study indicated further testing
was needed (CIR 2003).  However, genetic toxicity studies summarized by
the OECD 2001 indicate sodium metabisulfite is equivocal in in vitro
testing, but is not genotoxic in the in vivo testing.

E.  Special Considerations for Infants and Children

There is sufficient toxicological information for sulfur dioxide and
sodium metabisulfite to address FQPA considerations.  The available
information indicates that there is no evidence of increased
quantitative or qualitative susceptibility of the offspring after in
utero or post-natal exposure.  Based on this information, there is no
concern, at this time, for increased sensitivity to infants and children
to sulfur dioxide and sodium metabisulfite when used on postharvest
grapes.

	F.  Incident Data

In evaluating incidents to humans from sulfur dioxide and sodium
metabisulfite exposure, the Agency evaluated data from the National
Pesticide Information Center, the National Institute of Occupational
Safety and Health (NIOSH), National Poison Control Centers, the
California Department of Pesticide Regulation (CDPR), and the Agency’s
Incident Data System.  The CDPR sulfur dioxide search identified 87
incident reviews from 1982 through 2003, many of which resulted from
non-pesticidal uses.  The NIOSH system search indicated that 19
incidents were reported involving sulfur dioxide from 1998 through 2003.
 Most of these cases involved effects such as chest pains, dizziness,
numb hands, teary eyes, blurred vision, itching, and rashes. A 1991
report from the CDPR system also identified a case involving a delivery
worker developing an asthmatic response following exposure to sulfur
dioxide drift from a nearby fumigation facility.  No incidents were
reported for sodium metabisulfite; however, sodium bisulfite was
implicated in the deaths of three workers using sodium bisulfite with a
non-pesticidal use pattern.

IV. Occupational Risk Assessment

Regulatory exposure levels for inhalation exposure to sulfur dioxide
include the OSHA PEL, NIOSH IDLH, and AIHA ERPG-1.  The OSHA PEL
(permissible exposure limit) is set at 5 ppm and is based on a time
weighted average over an 8 hour workshift.  The NIOSH IDLH (immediately
dangerous to life or health) is 100 ppm and the AIHA ERPG-1 is 0.3 ppm.
The AIHA (American Industrial Hygiene Association) ERPG-1 is the maximum
airborne concentrations below which it is believed that nearly all
persons could be exposed for up to 1 hour without experiencing other
than mild transient adverse health effects or perceiving a clearly
defined, objectionable odor.

Sodium Metabisulfite

Products which contain sodium metabisulfite as the active ingredient
are comprised of the solid, anhydrous active ingredient contained in
semi-sealed pads, which are placed in containers holding grapes for
shipping and storage.  In each crate the sodium metabisulfite pads are
separated from the grapes by a layer of tissue paper and a layer of
kraft paper, and then the entire contents are wrapped in a porous
polyethylene liner bag before the crate is closed.  As the pads absorb
ambient moisture, they release sulfur dioxide to a level of 1-5 ppm
within the crate.  Since

the crates are partially open on the sides and top, the free exchange of
low levels of sulfur dioxide with the surrounding air occurs
continuously.  Grapes are usually kept in these containers for 4-6 weeks
before arrival at retail establishments.  Once the grapes arrive for
retail sale, the pads are removed from the crates and discarded.  The
low level of sulfur dioxide present in the crates or released to the
surrounding environment is not expected to result in an occupational
inhalation exposure of concern, as any exposure is expected to be of
short duration and at or below the 8 hour OSHA PEL.  Furthermore, since
the sodium metabisulfite is contained in sealed pads, the likelihood of
either oral or dermal exposure to the solid is considered minimal,
providing the pads stay intact.

Pad disposal directions vary among the product labels; therefore, the
Agency has determined that standardization of the labeling on the pad
itself, is necessary.  This labeling will include revised handling and
disposal statements, in addition to a statement for asthmatics and
sulfite sensitive individuals which identifies the presence of sulfites
in these products.  These label statements are detailed in Section XIII
of this document.  Based on the product use patterns, the low levels of
sulfur dioxide released and the additional label requirements included
in this document, the Agency expects occupational exposures to sodium
metabisulfite to be below levels of concern.

Sulfur Dioxide

Products which contain sulfur dioxide as the active ingredient are
formulated as a liquid under pressure which forms a gas upon release for
grape fumigation.  These products are stored in steel cylinders and
applied to the treatment area via a hose system with a detector tube at
a maximum rate of 1% concentration (based on measured volume of the
fumigation chamber) for the initial fumigation, and up to 0.5% gas
concentration for maintenance fumigations.  Grapes are fumigated on a
7-10 day interval, and may be treated up to 20 times.  Fumigation may
occur in various types of cold-storage warehouses, or in truck trailers,
vans and railcars.

Current sulfur dioxide end-use product labels require various levels of
personal protective equipment (PPE) during application and while
checking hose connections.  Workers must use sulfur dioxide detection
devices (Draeger handpumps, Sensidyne or Kitagawa syringe samplers) to
monitor the concentration in the fumigation area.  If concentrations
exceed 2.0 ppm in the fumigation area, the use of a NIOSH/MSHA approved
respirator is required for “short exposures of limited duration.”
Labels also require a self-contained breathing apparatus (SCBA) or
combination air-supplied respirator/SCBA for exposures to unknown
concentrations, re-entry into a treated area with concentrations in
excess of 2.0 ppm, and for emergencies.  Other PPE requirements on
current labels include protective clothing, gloves and boots impervious
to sulfur dioxide, in addition to eye protection.  These PPE
requirements, as well as the respirator requirements, however, are
inconsistent among product labels.  Respirator requirements are also not
clear regarding when a standard respirator (with an
organic-vapor-removing cartridge) is acceptable or when a SCBA
respirator is required.  In order to clarify when SCBA respiratory
protection is necessary and to address other PPE inconsistencies, the
Agency has developed standard personal protective equipment (PPE) label
requirements as stated in Section XIII of this document.

The Agency believes that the current PPE requirements with the
additional labeling language required in this reregistration decision
are adequate to ensure that workers are not exposed to sulfur dioxide
levels of concern.

V. Bystander Inhalation Risk Assessment

Several regulatory endpoints and standards for ambient air
concentrations of sulfur dioxide have been established at the state,
Federal and international levels (see Table 5).  The endpoint selected
by the Agency for the bystander inhalation risk assessment is 0.25 ppm
sulfur dioxide, with a 1-hour exposure duration.  The 0.25 ppm
concentration is based on an ambient air quality standard set by the
California Air Resources Board.  This endpoint is deemed most applicable
to this exposure scenario, as it is based on effects of concern for
bystanders (such as broncho-constriction, shortness of breath, wheezing,
and chest tightness during physical activity in persons with asthma),
and is recognized by the State in which nearly all grape treatments
occur.  Further, considering the 15-30 minute aeration period used with
the grape treatment, an endpoint based on an exposure duration of 1-hour
is considered appropriate.  The following table lists additional
regulatory and guideline concentrations for sulfur dioxide in ambient
air.

Table 5. Sulfur Dioxide Air Concentrations used for Regulatory/Guideline
Purposes

Exposure Limit	Agency/Group	Regulatory/Guideline Level (ppm)

1-hour	WHO	0.13

	California Air Resources Board	0.25

	AIHA (ERPG-1)	0.3

	State of Washington	0.25

	State of North Dakota	0.27

	State of Montana	0.5

3-hour	US EPA	0.5

	State of Florida	0.5

	State of Maine	0.4

	State of New Mexico	0.5

	State of New York	0.25

	State of Oregon	0.02

Based on the Probabilistic Exposure and Risk Model for Fumigants,
version 2.1.1 (PERFUM2) and available incident data, the Agency has
concerns for bystander exposure during grape fumigations which involve
the release of high levels of sulfur dioxide during aeration.  For
Botrytis cinerea treatments, a practice known as “total utilization”
is almost exclusively employed.  Total utilization involves circulating
the sulfur dioxide gas (typically 1000 to 2500 ppm) within the
fumigation chamber until it is almost completely absorbed into the
grapes, packaging material and any ambient moisture.  As a result, only
very low concentrations (i.e., less than 30 ppm) of sulfur dioxide are
typically released from the ventilation stack during the aeration phase.
 However, current product labels do not limit sulfur dioxide release
concentrations for this treatment; therefore if total utilization is not
employed and much higher levels of sulfur dioxide are vented to the
atmosphere, bystander exposure is a concern.  To address this concern,
the Agency is establishing a maximum release concentration for Botrytis
cinerea warehouse treatments of 30 ppm, and truck/trailer treatments of
2 ppm.  The disparity between these two release concentrations is based
on the fact that the release of treated air following warehouse
fumigation is performed at a flow rate of 2700 to 8100 ft3/min and at a
typical height of 15 feet above ground level, thereby further reducing
the potential for bystander exposure.  Based on the results of the
PERFUM2 model, this 30 ppm release concentration level is expected to
limit bystander exposure potential with this use to sulfur dioxide
concentrations at or below 0.25 ppm.  This bystander exposure scenario
is considered “worst-case,” in that it assumes the ventilation stack
is at the edge of the treatment warehouse, and the warehouse is in close
proximity to the fumigation facility property line.

Treatment for black widow spider, however, is performed at a much higher
concentration of sulfur dioxide (up to 10,000 ppm) than is used for
Botrytis cinerea treatments.  Further, due to the potential for damaging
the fruit, these high concentrations may not be held in contact with the
grapes for more than approximately 30 minutes; thus total utilization is
not feasible.  As a result, much higher sulfur dioxide concentrations
are released during aeration for treatment of black widow spider;
therefore, the Agency has bystander exposure concerns for this use.  To
address bystander concerns during black widow spider treatment, the
Agency is also placing a limit of 30 ppm on the sulfur dioxide release
concentration during the aeration phase of black widow spider treatment.
 As stated above, based on the results of the PERFUM2 model, this
release restriction is expected to limit bystander exposure potential
with this use to sulfur dioxide concentrations at or below 0.25 ppm.
The Agency has been working with the California Table Grape Commission
(CTGC) and the California Grape and Tree Fruit League (CGTFL) to
determine the feasibility of using air scrubbers during black widow
spider treatments to reduce the release concentrations.  However, the
use of scrubbers requires additional time, which results in the treated
grapes being exposed to high concentrations of sulfur dioxide for longer
than 30 minutes, risking damage to the fruit.  Hence, CTGL and CGTFL
have indicated a need to perform a comprehensive fumigation study in
order to determine the lowest sulfur dioxide release concentration which
can be achieved using scrubbers or other such equipment, without
damaging the fruit.  If such a fumigation study is performed, the Agency
may reconsider the 30 ppm release limit for black widow spider treatment
if the study findings indicate that 30 ppm cannot be achieved without
damaging the treated fruit.  However, any reconsideration of the release
limit would be in conjunction with the use of higher ventilation stacks,
a buffer zone to protect bystanders, or other measures to ensure that
bystanders are not exposed to sulfur dioxide levels above 0.25 ppm as a
result of this use.  As reference, the following table details the
correlation between buffer zone size and release concentration for the
sulfur dioxide grape fumigation scenario.

Table 6.  PERFUM2 Sulfur Dioxide Grape Fumigation Parameters

 for 0.25 ppm Endpoint

Buffer Size (meters)	Release concentration (ppm)

15	55

30	90

65	150

The details of the PERFUM2 assessments supporting the 30 ppm release
rate, as well as the findings in Table 6 are attached as Appendix III.
Required label language resulting from the release limits implemented in
this section are detailed in Section XIII of this document.

VI.  Dietary Exposure Assessment

Both sulfur dioxide (21CFR 182.3862) and sodium metabisulfite (21CFR
182.3766) are listed as GRAS by the FDA, with limitations, as food
preservatives.  Sulfites are found in many foods, primarily as a result
of the GRAS preservative use.  It is estimated that sulfite
concentrations of >100 ppm may be found in dried fruits (excluding dark
raisins and prunes), lemon and lime juices, wine, molasses, and
sauerkraut juice.  Dried potatoes, grape juice, wine vinegar, gravies,
fruit topping, and maraschino cherries may contain between 50 and 100
ppm sulfur dioxide.  Foods containing between 10 ppm and 50 ppm include
pectin, fresh shrimp, corn syrup, sauerkraut, pickled foods, corn
starch, hominy, frozen potatoes, maple syrup, imported jams and jellies,
and fresh mushrooms (Lester 1995 as cited in CIR 2003).

The World Health Organization has emphasized the use of appropriate
labeling for alerting individuals who cannot tolerate sulfites.  After
receiving and reviewing reports of adverse reactions in certain
individuals following ingestion of sulfiting agents used as
preservatives in food products, beverages, and fresh fruits and
vegetables, the FDA required ingredient labels to list sulfite
concentrations in excess of 10 ppm.

The uses of products containing inorganic sulfites are limited to use as
indoor fumigants and as fungicidal control agents on grapes.  A
tolerance limit of 10 ppm (expressed as sulfite) for sulfur dioxide is
established in 40 CFR 180.444, and sufficient data are available to
support the reassessment of this tolerance.  This 10 ppm tolerance is
relatively low compared to concentrations of sulfites in many common
foods and viewed as “GRAS” by FDA.  Further this level is below the
level for which FDA requires labeling to alert sulfite-sensitive
individuals.   Therefore, residues resulting from the postharvest use of
sulfur dioxide and sodium metabisulfite on grapes are not expected to be
at a level of concern for the general population or any population
subgroups.

VII. Drinking Water

Based on the use pattern and fate characteristics of these chemicals,
the Agency does not have any drinking water concerns for sulfur dioxide
and sodium metabisulfite.

VIII.  Aggregate Assessment

The aggregate risk assessment integrates the assessments conducted for
dietary, drinking water, and residential exposure if applicable.
Currently there are no residential uses for either sulfur dioxide or
sodium metabisulfite, as the use of inorganic sulfites is limited to
fumigation of postharvest grapes, and bystander inhalation exposure
concerns are being addressed in this decision document.  Further, no
common effects were seen in inhalation and oral toxicity studies. Based
on environmental fate information for both chemicals, concentrations of
concern are not expected in drinking water.  Therefore, based on the
uses of sulfur dioxide and sodium metabisulfite, no anticipated presence
in drinking water, expected low residues on grapes, and consideration of
the presence of sulfites in other common foods as a result of an FDA
GRAS determination, the Agency has determined that aggregate exposure to
sulfites does not pose a risk concern.

IX.  Cumulative Exposure

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  EPA does not have, at this time,
available data to determine whether inorganic sulfites have a common
mechanism of toxicity with other substances.  Unlike other pesticides
for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to inorganic sulfites and any other substances, and inorganic
sulfites do not appear to produce a toxic metabolite produced by other
substances.

For the purposes of this tolerance action, therefore, EPA has assumed
that inorganic sulfites do not have a common mechanism of toxicity with
other substances.  For information regarding the Agency’s efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA’s Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA’s website at
http://www.epa.gov/pesticides/cumulative/.

X.  Human Health Risk Characterization

Taking into consideration all available information on sulfur dioxide
and sodium metabisulfite, including the specific use pattern and limited
exposure potential, FDA’s classification of generally recognized as
safe (GRAS), as well the historical presence of sodium metabisulfite in
cosmetics and hair care products, the use of sulfur dioxide and sodium
metabisulfite on postharvest grapes is unlikely to pose a significant
risk to the general population or any population subgroup.  Potential
bystander exposure concerns have been addressed, and anticipated
occupational exposures are not expected to pose a risk of concern to
workers.

XI.  Ecological Risk Assessment

Sulfur dioxide (SO2) is a nonflammable, colorless gas.  It is very
soluble in water, with its solubility varying from 5.88 % at 104 °F to
22.9% at 32 °F.  In moist air or fogs, it combines with water to form
sulfurous acid (H2SO3), but it is only very slowly oxidized to sulfuric
acid.  Sulfur dioxide has a high vapor pressure (3,000 mm Hg at 20°C)
and, thus is typically present in a gaseous phase.  It can be absorbed
in soil, with uptake being dependent on the pH and moisture content of
the soil (ATSDR, 1998a).  The Environmental Fate and Effects Division
(EFED) has reported that the only environmental fate data potentially
needed for sulfur dioxide would be a hydrolysis study; however, the
Agency has determined that the chemistry of sulfur dioxide is so well
documented in the open literature that an additional study is not
necessary (EPA, 1993b).  Sodium metabisulfite dissolves in water and
forms sodium cations, disulfite anions and sulfur dioxide (OECD, 2001).

Concentration of sulfur dioxide as low as 1-2 ppm have been reported to
cause severe stress to green plants, and dissolved sulfur dioxide could
be toxic to aquatic life.  A few acute toxicity tests for sodium
metabisulfite have been reported.  The 96-hour LC50 was 100 mg/L for
fish and the 72-hr EC50 for algae was 48.1 mg/L.  An acute 48-hr EC50
for daphnids has been reported to be 88.76 mg/L and a chronic NOEC of
>10 mg/L was reported.  In addition, a memo from the Ecological Effects
Branch of EFED (EPA 1992), stated that all ecotoxicological studies for
the indoor food uses of sodium bisulfite were waived, as it was
determined that there would be little likelihood of a hazard to
non-target organisms.  Therefore, based on the high vapor pressure, the
current use pattern (indoor food-use) and limits established for sulfur
dioxide release in this decision document, the Agency has no ecological
risk concerns resulting from the pesticidal use of sulfur dioxide and
sodium metabisulfite.

XII. Tolerance Reassessment

The Agency is proposing no changes in the level or definition of the
existing tolerance.  Therefore, the current tolerance established at
40CFR 180.444 for sulfur dioxide residues (expressed as sulfite) in
grapes is now considered reassessed under section 408(q) of the FFDCA.

XIII. Labeling for End-Use Products

The following tables have been developed by the Agency, and indicate the
required label statements for sulfur dioxide and sodium metabisulfite
end-use products:

Table 7.  Label Revisions

Label Statements for Sulfur Dioxide End-Use Products

“When treating grapes for Botrytis cinerea (bunch rot/gray mold) or
black widow spider in a warehouse fumigation chamber, do not release
treated air into the atmosphere containing concentrations of sulfur
dioxide in excess of 30 ppm (as determined by a Sensidyne or Kitagawa
syringe sampler, or a Draeger handpump).”

“When treating grapes in a truck, trailer or other transport vehicle,
do not release treated air into the atmosphere containing concentrations
of sulfur dioxide in excess of 2 ppm (as determined by a Sensidyne or
Kitagawa syringe sampler, or a Draeger handpump).”

“Sulfur dioxide concentration in transport vehicles must be below 2
ppm before moving over public roads or highways.”

“Before moving or using this product, handlers must be trained how to
appropriately use respirators which conform to OSHA requirements
(described in 29 CFR Part 1910.124) and how to appropriately handle and
use sulfur dioxide.”

“When making gas applications or checking connections wear a
NIOSH/MSHA approved full face respirator with an organic-vapor removing
cartridge, in addition to sulfur dioxide- impervious gloves, boots and
coveralls over long-sleeved shirt and long pants.”

“If a sulfur dioxide concentration of 2 ppm is exceeded at any time,
all persons working in the fumigation area must wear a NIOSH/MSHA
approved full face respirator with an organic-vapor removing cartridge.
If sulfur dioxide concentrations of 10 ppm are exceeded, or when
concentrations are unknown, an approved self-contained breathing mask
(SCBA) or combination air supplied SCBA respirator must be used by all
persons working in the fumigation area.”

“Do not perform sulfur dioxide aerations concurrently from multiple
chambers.”

Table 8.  Label Revisions

Label Statements for Sodium Metabisulfite End-Use Products (pad
labeling)

“This pad contains sodium metabisulfite which may trigger an asthmatic
response in sulfite sensitive individuals.”

“This pad must be removed and disposed of prior to displaying grapes
for sale.  Do not allow consumers access to pads.”

“If pad is torn: Carefully dispose of pad, pad contents, and grapes
which have contacted pad contents.”

“For Disposal: Place pad in a plastic bag, seal bag and place in an
outdoor trash receptacle (dumpster).”

XIV.  References

Agency for Toxic Substances and Disease Registry.  1998a.  Toxicological
Profile for Sulfur Dioxide.
http://www.atsdr.cdc.gov/toxprofiles/tp116.html

Agency for Toxic Substances and Disease Registry.  2004.  Medical
Management Guidelines (MMGs) for Sulfur Dioxide (SO2).
http://www.atsdr.cdc.gov/MHMI/mmg116.html

Cosmetic Ingredient Review (CIR) 2003.  Final report on the safety
assessment of sodium sulfite, potassium sulfite, ammonium sulfite,
sodium bisulfite, ammonium bisulfite, sodium metabisulfite, and
potassium metabisulfite.  International Journal of Toxicology, 22 (Suppl
2): 63-88.

Hazardous Substances Data Bank (HSDB). 2005. Sulfur Dioxide.
http://toxnet.nlm.nih.gov.

Hazardous Substances Data Bank (HSDB). 2005. Sodium Metabisulfite.
http://toxnet.nlm.nih.gov.

International Agency for Research on Cancer (IARC). 1992, IARC
Monographs; Vol 54.

Material Safety Data Sheet for Sulfur Dioxide.  Printed 2005; Last
updated 1996. BOC Gases.

http://phyvirtual.nju.edu.cn/material/MSDS/G79.pdf

NIOSH (National Institute for Occupational Safety and Health.  2004.
The Registry of Toxic Effects of Chemical Substances: Sulfur Dioxide.
http://www.cdc.gov/niosh/rtecs/ws456d70.html

OECD (Organization for Economic Co-operation and Development) SIDS
(Screening Information Data Set).  2001.  Disodium disulphite (CAS No.
7681-57-4).  Http://www.inichem.org/documents/sids/sids/disodium.pdf

U.S. EPA. 1992.  Memo to Bruce Sidwell, PM 53; Accelerated
Reregistration Branch, Special Review and Reregistration Division from
Douglas Urban, Acting Branch Chief; Ecological Effects Branch,
Environmental Fate and Effects Division.  Re: Phase 4 Review of
Reregistration Case #4056 for Sodium Bisulfite (DP Barcode D182472)

U.S. EPA. 1993b.  Memo to Fred Betz, Acting Chief; Accelerated
Reregistration Branch, Special Review and Reregistration Division and
Bruce Sidwell, PM 53; Accelerated Reregistration Branch, Special Review
and Reregistration Division from Silvia Termes, Chemist; Environmental
Fate and Ground Water Branch, Environmental Fate and Effects Division.
Re: Sulfur Dioxide (“The Fruit Doctor”), Reregistration Case #4086.

World Health Organization (WHO) 1999. Safety Evaluation of Certain Food
Additives.  WHO Food Additives Series 42.  International Programme on
Chemical Safety.  Sulfur Dioxide and Sulfites (addendum).

World Health Organization (WHO). Sulfur Dioxide and Sulfite.  WHO Food
Additives Series 18.  International Programme on Chemical Safety.

Sodium metabisulfite and sulfur dioxide are GRAS when used in accordance
with good manufacturing practice, except that it is not used in meats;
in food recognized as a source of vitamin B1; on fruits or vegetables
intended to be served raw to consumers or sold raw to consumers; or to
be presented to consumers as fresh.

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1 Date: May 15, 2003 Subject: Telephone Conference Summary  EPA and representatives from the taconite industry From: Conrad Chin, EPA To: Docket OAR 2002 0039 I. Purpose The primary purpose of the meeting was to clarify comments from the taconite industry on the proposed rule. The discussion topics were the continuation of previous discussions from conference calls held on April 21, May 1, and May 9.

II. Date May 15, 2003 III. Attendees U. S. Environmental Protection Agency Steve Fruh, OAQPS/ ESD/ MG Conrad Chin, OAQPS/ ESD/ MG Taconite industry representatives Tishie Woodwell, U. S. Steel Leonard Parker, Tilden Mining John Meier, Cleveland Cliffs Gus Josephson, Ispat Inland Mining Dennis Wagner, Northshore Mining Brad Anderson, EVTAC Bill Kubiak, U. S. Steel LaTisha Gietzen, National Steel Raymond Potts, U. S. Steel Dave Skolasinski, Northshore Mining Don Ahola, Empire Mining Andrea Hayden, Hibbing Taconite Alpha Gamma Technologies Chuck Zukor Chris Sarsony OAR 2002 0039 IV E 6 2 IV. Discussion Parametric Monitoring A. Venturi Rod Deck Scrubbers ° Minntac informed the EPA that they cannot adjust their scrubber fans to maintain a certain pressure drop across the scrubber. The dampers to the fans are controlled to maintain the overall indurating process.

° The EPA inquired about the possibility of establishing a correlation between pressure drop and throughput rate. Minntac agreed to look into it.

° The EPA stated that it may be possible to consider using historical data from recent compliance tests in addition to the initial compliance test for establishing the operating limits for venturi rod deck scrubbers. Industry will investigate if this possibility will help them alleviate some of their concerns.

B. Wet ESP ° Northshore indicated that water flow would be a good parametric monitoring choice. Because of scaling problems, Northshore stated that secondary voltage fluctuates too much and would not be a good monitoring parameter. Northshore will investigate whether the fluctuation decreases after maintenance to determine if this concern is more of a maintenance problem.

° The EPA suggested another possible monitoring parameter: outlet gas temperature. This suggestion was provided by an in house expert and the suggestion was sent to Northshore and Tilden for reference. Both plants will follow up with this suggestion.

° Tilden concurred that water flow monitoring for its wet ESP is a good indicator of emission control performance. Tilden is currently not monitoring secondary voltage and current from its wet ESP, but will also study suggestions from EPA on these monitoring parameters.

C. Dry ESP ° Empire stated that their dry ESPs are computer controlled ( e. g., spark rate, amps, volts). If some of the set parameters fail, alarms will then be triggered. Empire suggested that if no alarms are triggered, then it should meet EPA's monitoring requirements. However, EPA was concerned that the current corrective action plan in place when alarms are triggered may be inadequate. Under their current title V permit operation of the ESP continues unless visible emissions are observed at the stacks. The EPA pointed out that this malfunction plan would not be acceptable because of the more stringent MACT emission limit. The plant would 3 not be able to observe a visible emission even if the MACT limit is not met. Furthermore, the plant has operated and tested in the past with some ESP modules off line. This practice would not be acceptable under the MACT rule. Empire will review current corrective action/ malfunction plan and provide EPA with a suggestion how to resolve these issues.

D. Dynamic Scrubbers ° Industry concurs with the EPA that fan amperage and water flow rate are appropriate performance parameters for dynamic wet scrubbers.

E. Water Pressure as a Surrogate for Water Flow ° Industry concurs with EPA's concern that water line pluggage can give an inaccurate water pressure reading.

° EVTAC indicated that the costs of installation of water flow meters are their real major concern. They estimated they would need to install three flow meters for their furnaces at a total cost of approximately $ 30K ( about $ 10K per flow meter). EVTAC will investigate how to resolve the water line pluggage issue. Without resolving this concern, it will be difficult for EPA to accept the use of water pressure as a surrogate for water flow.

° National Steel indicated that they have approximately 28 wet scrubbers that they are currently using water pressure as an indicator of performance. These are all on smaller emission units and the cost for installing flow meters on smaller units is approximately $ 100 per flow meter.

° Tilden also reported that they use some water pressure gauges and will review their situation for the next conference call.

F. Rolling 6 hour Average for Compliance Determination ° Industry is not sure how this concept will benefit the plants. Minntac indicated that a six hour averaging period would not resolve the venturi rod deck issues. The EPA will explore this possibility more for the next discussion.

Emissions Testing for Furnaces ° Industry informed EPA that half of the plants are already testing their furnaces at twice per permit term. Based on this information, it is difficult for EPA to justify any changes from the proposed test frequency.

° Industry suggested that EPA allow plants to reduce their testing frequency if they can demonstrate that they are able to meet the MACT limit by an ample margin for a few tests in a row. The EPA stated it would consider this suggestion.


The IQE procedure is designed to reflect expectations of interlaboratory performance, including routine variability. The procedure contains extensive instructions for dealing with unusual conditions, including sources of variability and outliers. Based on studies of the single laboratory variant of the procedure in which the model selection proved to be highly subjective, EPA is skeptical about the procedure being able to demonstrate realistic expectations of laboratory and method performance.

The IQE procedure suggests attempting to fit study results to a constant, linear, or hybrid model. If all of these fail, the procedure suggests trying a different model, such as the exponential model. ( The exponential model figures more prominently in the IDE procedure, where it is one of the three main models discussed, replacing the Rocke and Lorenzato model.) Although the exponential model may be appropriate for the IDE ( which is not tied to a fixed RSD), it yields unacceptable results when applied to the IQE procedure. Under the exponential model, relative variability ( standard deviation divided by the true concentration) is a parabolic function ( i. e., as concentration increases, relative variability decreases down to a specific percentage, and then begins to increase). This is not realistic of laboratory and method performance. In addition, the exponential model will often result in having two possible values each for IQE10% , IQE20% , and IQE30% .

Another concern with the IQE procedure is that use of the non mandatory appendices in ASTM D 6512 to determine the fit of a model may produce results that differ from those that would be obtained using the default procedures for testing model fit that are built into off the shelf statistical software.

Given the subjectivity and confusion involved in selecting the model, EPA tried using the same data set to calculate a single laboratory variant of the IQE with each of the available models and found that the calculated IQEs varied widely when different models were used.

Based on the problems described above, EPA believes the IQE fails this criterion.

<IP_ADDRESS>.3 Criterion 3: The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance.

The IQE procedure is neither practical nor affordable in a single laboratory context.. It is designed for use by an ASTM study supervisor or task manager and not as a procedure that a single February 2003 5 23 Assessment of Detection and Quantitation Approaches laboratory can use to evaluate method performance. EPA is aware that ASTM Committee D 19 is contemplating development of a within laboratory quantitation estimate ( WQE), but the WQE has not been approved through an ASTM ballot and therefore, it cannot be adequately evaluated at this time. The WQE may meet this criterion, but the IQE does not.

Regarding affordability, EPA estimates that the cost of implementing IQE procedure would be more than twice the cost of EPA's present implementation of the ML. The increased cost stems from the additional low level data required to assure that variability versus concentration is being characterized in the region of detection and quantitation, challenges involved in applying the statistical procedures in the IQE, and because of the anticipated reanalysis and rework required if either the procedure failed to produce an IQE or if the resulting IQE failed to meet the specifications in the IQE procedure.

<IP_ADDRESS>.4 Criterion 5: The quantitation limit approach should identify the concentration that gives a recognizable signal that is consistent with the capabilities of the method when a method is performed by experienced staff in well operated laboratories.

If the IQE were developed in an interlaboratory study that met the requirements of D 6512, the calculated IQE would likely be achievable by experienced staff in a well operated laboratory. Therefore, the IQE passes this criterion. However, EPA also notes that although it passes the criterion, based on this assessment, EPA believes that it is very likely that the IQE may not identify the lowest concentration at which the signal is recognizable when the method is performed by experienced staff in a well operated laboratory.

<IP_ADDRESS>.5 Criterion 6: Detection and quantitation approaches should be applicable to the variety of decisions made under the Clean Water Act, and should support state and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal government Although the IQE could be applied to some decisions to be made under CWA, it may not support decisions when pollutant levels need to be protective of human health and the environment because the IQE may be considerably higher than these levels. At best, the IQE only partially passes this criterion.

5.2.3 Assessment of the ACS Limit of Quantitation The Limit of Quantitation ( LOQ) was developed by the Committee on Environmental Improvement of the American Chemical Society ( ACS) and published in the same two papers as the LOD.

<IP_ADDRESS> Description of the ACS LOQ Approach and Procedure The 1983 " Principles" define the LOQ as:

"... the level above which quantitative results may be obtained with a specified degree of confidence."

The same relationship used to define the LOD is used for the LOQ:

but the recommended minimal value for Kd be set at 10. Thus, the LOQ is 10F above the gross blank signal, Sb . According to the 1983 publication, the LOQ corresponds to an uncertainty of ± 30% ( 10F ± 5 24 February 2003 Chapter 5 3F). This uncertainty statement is based on F equal to 10% of the LOQ. Other statements of uncertainty are, of course, possible using knowledge of F and/ or the RSD.

Neither the 1980 nor 1983 ACS publications provide a specific procedure for estimating the LOQ, nor do they provide a minimum number of observations needed to estimate the gross blank signal or the variability term Fb .

<IP_ADDRESS> Assessment of the ACS LOQ Against the Evaluation Criteria The following five subsections discuss the ACS LOQ approach and procedure in the context of the five evaluation criteria that concern detection limit approaches ( i. e., Criteria 1 3, and Criteria 5 and 6).

<IP_ADDRESS>.1 Criterion 1: The detection and quantitation limit approaches should be scientifically valid.

Condition 1: It can be ( and has been) tested. Testing of the LOQ is hampered by 1) the lack of a supporting procedure for establishing an LOQ, and 2) its conceptual dependence on the variability of blank measurements. If the blank measurements fail to produce a response, it is impossible to calculate an LOQ because the standard deviation of zero is zero. One solution for testing the approach is to assume that the LOQ is functionally equivalent to the ML as the blank signal approaches zero. EPA believes this is a reasonable assumption, and therefore, that the ML procedure is a viable means for testing the LOQ approach. Therefore, the LOQ meets this condition.

Condition 2: It has been subjected to peer review and publication. The ACS LOQ definition was published in the peer reviewed journal Analytical Chemistry in 1980 and 1983. Therefore, the ACS LOQ meets this condition.

Condition 3: The error rate associated with the procedure is either known or can be estimated. The definition of the LOQ specifically estimates the uncertainty associated with a concentration at the LOQ as ± 30% based on 10% RSD. Other valid statements in terms of % RSD may be made based on study requirements, policy judgments and/ or specific results. For example, the estimate of an uncertainty of ± 30% based on 10% RSD is inconsistent with EPA and ISO/ IUPAC estimations that place the uncertainty at ± 20% ( at ± 2F), and is inconsistent with the Episode 6000 data that place the median RSD at 7% and therefore, the ± 2F uncertainty at approximately ± 14%.

Condition 4: Standards exist and can be maintained to control its operation. The ACS LOQ lacks a clearly defined procedure for estimating the important terms required to derive it. Although it may be possible to derive ACS LOQ values from data used to derive EPA MDL values, there is no discussion of using replicate blanks, replicate spiked samples, or a minimum recommendation for the number of replicates. Therefore, the ACS LOQ fails this condition.

Condition 5: It has attracted widespread acceptance within a relevant scientific community. Because the ACS does not develop and publish reference analytical methods, it is difficult to determine the degree of acceptance of the LOQ. EPA has not investigated the numbers of papers published in ACS journals that include LOQ values, but EPA's literature search for detection and quantitation approaches did not uncover a large number of citations that promote the LOQ in particular.

February 2003 5 25 Assessment of Detection and Quantitation Approaches <IP_ADDRESS>.2 Criterion 2: The approach should address demonstrated expectations of laboratory and method performance, including routine variability The LOQ approach is designed to address demonstrated expectations of laboratory and method performance, including routine variability, and therefore, it appears to meet this criterion. Unfortunately, ACS has not published a procedure to implement the approach. In other words, the LOQ addresses demonstrated expectations of laboratory and method performance in theory, but in practice, provides no direct means for performing these demonstrations. Therefore, EPA believes the ACS LOQ only partially meets this criterion.

<IP_ADDRESS>.3 Criterion 3: The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance.

The ACS LOQ approach is not supported by a clearly defined procedure for establishing the LOQ. Therefore, it fails this criterion.

<IP_ADDRESS>.4 Criterion 5: The quantitation limit approach should identify the concentration that gives a recognizable signal that is consistent with the capabilities of the method when a method is performed by experienced staff in well operated laboratories.

Given the relationship of the ACS LOQ to the ML, EPA believes the LOQ meets this criterion for the reasons outlined in Section <IP_ADDRESS>.4, which discusses EPA s assessment of the ML against Criterion 4 for evaluating quantitation limit approaches.

<IP_ADDRESS>.5 Criterion 6: Detection and quantitation approaches should be applicable to the variety of decisions made under the Clean Water Act, and should support state and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal government.

In the absence of a procedure for determining LOQ values, the ACS LOQ fails to meet this criterion because it cannot be used in a regulatory context. The LOQ passes this criterion only if it is assumed to be functionally equivalent to the ML ( i. e., the ML procedure is used to establish an LOQ).

5.2.4 Assessment of the IUPAC/ ISO Limit of Quantitation A similar LOQ approach was developed by IUPAC/ ISO and published in the same papers as the CRV and MDV ( see Sections 5.1.4 and 5.1.5).

<IP_ADDRESS> Description of the ISO/ IUPAC LOQ Approach The 1995 " Recommendations" define the LOQ as:

"... the ability of a CMP [ chemical measurement process] to adequately   quantify  an analyte. The ability to quantify is generally expressed in terms of the signal or analyte ( true) value that will produce estimates having a specified relative standard deviation ( RSD), commonly 10 %.

The relationship used to define the LOQ is:

LQ = KQ × FQ 5 26 February 2003 Chapter 5 The recommended value for KQ is 10. Thus, the LOQ is 10F above the blank signal, FQ .

<IP_ADDRESS> Assessment of the IUPAC/ ISO LOQ Against the Evaluation Criteria The following five subsections discuss the IUPAC/ ISO LOQ approach and procedure in the context of the five evaluation criteria that concern detection limit approaches ( i. e., Criteria 1 3, and Criteria 5 and 6).

<IP_ADDRESS>.1 Criterion 1: The detection and quantitation limit approaches should be scientifically valid.

Condition 1: It can be ( and has been) tested. Testing of the IUPAC/ ISO LOQ is hampered by 1) the lack of a supporting procedure for establishing and LOQ, and 2) it s conceptual dependence on the variability of blank measurements. If the blank measurements fail to produce a response, it is impossible to calculate an LOQ because the standard deviation of zero is zero. One solution for testing the approach is to assume that the ISO/ IUPAC LOQ is functionally equivalent to the ML as the blank signal approaches zero. EPA believes this is a reasonable assumption, and that the ML procedure is a viable means for testing the LOQ approach. Therefore, the ISO/ IUPAC LOQ meets this condition.

Condition 2: It has been subjected to peer review and publication. The IUPAC/ ISO LOQ definition has been published by Currie in the peer reviewed journals Pure and Appl. Chem. in 1995; in Anal. Chim. Acta in 1999, in Chemometrics and Intelligent Lab Systems in 1997; and in J. Radioanal. and Nuclear Chem. in 2000. Therefore, the IUPAC/ ISO LOQ meets this condition.

Condition 3: The error rate associated with the procedure is either known or can be estimated. EPA used data generated in the Episode 6000 study to estimate the error rate associated with the LOQ. The Episode 6000 results show that the median error across all analytes and analytical techniques at 10F is approximately ± 14% with approximately 95% confidence.

Condition 4: Standards exist and can be maintained to control its operation. The IUPAC/ ISO LOQ lacks a clearly defined procedure for estimating the important terms required to derive it. Although it may be possible to derive IUPAC/ ISO LOQ values from data used to derive EPA MDL values, there is no discussion of using replicate blanks, replicate spiked samples, or a minimum recommendation for the number of replicates. Therefore, EPA believes that the IUPAC/ ISO LOQ fails this condition.

Condition 5: It has attracted widespread acceptance within a relevant scientific community. Acceptance by the scientific community is not known. Acceptance would be indicated by use of the LOD in ISO methods. EPA did not perform a search of ISO methods because of copyright restrictions. However, EPA's literature search for detection and quantitation approaches in the open technical literature did not uncover a large number of citations that reference the LOQ. Therefore, it is difficult to determine if the ISO/ IUPAC LOQ meets this condition.

<IP_ADDRESS>.2 Criterion 2: The approach should address demonstrated expectations of laboratory and method performance, including routine variability.

The most recent publication on the IUPAC/ ISO LOQ ( J. Radioanal. and Nuclear Chem., op. cit.) provides insight into this issue through measurements of 14 C by accelerator mass spectrometry. Therefore, EPA believes that the IUPAC/ ISO LOQ passes this criterion for at least some measurement techniques.

February 2003 5 27 Assessment of Detection and Quantitation Approaches <IP_ADDRESS>.3 Criterion 3: The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance.

The ISO/ IUPAC LOQ approach is not supported by a clearly defined procedure for establishing the LOQ. Therefore, it fails this criterion.

<IP_ADDRESS>.4 Criterion 5: The quantitation limit approach should identify the concentration that gives a recognizable signal that is consistent with the capabilities of the method when a method is performed by experienced staff in well operated laboratories.

Given the relationship of the IUPAC/ ISO LOQ to the ML, EPA believes that the LOQ satisfies this criterion for the reasons outlined in Section <IP_ADDRESS>.4, which discusses EPA s assessment of the ML against Criterion 4 for evaluating quantitation limit approaches.

<IP_ADDRESS>.5 Criterion 6: Detection and quantitation approaches should be applicable to the variety of decisions made under the Clean Water Act, and should support state and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal government In the absence of a procedure for determining LOQ values, the ISO/ IUPAC LOQ fails to meet this criterion because it cannot be used in a regulatory context. The ISO/ IUPAC LOQ passes only if the ML procedure is used to establish an LOQ.

5 28 February 2003 Table 5 1. Assessment of Detection Limit Approaches Against Evaluation Criteria Evaluation Criteria MDL IDE ACS LOD ISO/ IUPAC CRV ISO/ IUPAC MDV The detection limit approach should be scientifically valid:

  It can be ( and has been tested)

  Has undergone peer review and publication   Has an error rate that is known or can be estimated   Has standards that can be maintained to control its operation   Has achieved widespread acceptance in a relevant scientific community Meets all 5 conditions for scientific validity with slight modifications noted to clarify understanding of error rate. Meets 1, partially meets 1, and fails 3 of the 5 conditions for scientific validity.

  Can be, but has not been fully tested ( partial)

  Subjectivity makes calculation of error rate impossible ( fails)

  Has a standard but, due to the high degree of subjectivity, errors,

and conceptual inconsistency, it is unlikely to control its operation ( fails)

  Is familiar to and accepted by a very narrow segment of the scientific community ( fails) Meets 4 of the 5 conditions for scientific validity.

  No standards exist to control its operation Meets 3 of the 5 conditions for scientific validity.

  No standards exist to control its operation   Degree of acceptance is unclear Meets 3 of the 5 conditions for scientific validity.

  No standard exist to control its operation   Degree of acceptance is unclear The approach should address demonstrated expectations of laboratory and method performance, including routine variability. Can meet this criterion if properly applied. Conceptually passes this criterion,

but fails in practice due to problems with model selection Partially meets the criterion. Approach meets the criterion but no procedure for implementing the approach is given.

Passes the criterion only if equivalency to the MDL is assumed. Partially meets this criterion. Approach meets the criterion but no procedure for implementing the approach is given.

Passes the criterion only if equivalency to the MDL is assumed. Could be used in planning method development and evaluation studies as recommended but not in operational detection decision making.

The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance. Meets this criterion.

Procedure can be performed by a single laboratory during a single shift, or for method development by multiple labs in a single shift Fails this criterion. Requires interlaboratory study involving a reference lab or coordinating body, a minimum of 6 complete data sets,

and a skilled statistician. The cost of implementing this procedure would exceed most method development budgets. Fails this criterion.

No procedure provided. Fails this criterion.

No procedure provided. Fails this criterion.

No procedure provided. 5 29 5 30 Table 5 1. Assessment of Detection Limit Approaches Against Evaluation Criteria Evaluation Criteria MDL IDE ACS LOD ISO/ IUPAC CRV ISO/ IUPAC MDV The detection level approach should identify the signal or estimated concentration at which there is 99% confidence that the substance is actually present when the analytical method is performed by experienced staff in a well operated laboratory. Meets this criterion. When the allowance for false negatives and for prediction and tolerance are taken into account, the resulting detection limit ( IDE) is raised to the point at which detection probability is estimated to be greater than 99.999999%; this yields numerical values that have no practical meaning as a detection standard. Therefore, the IDE fails this criterion. Meets this criterion. Meets this criterion. The MDV is a true concentration value not used in the actual detection decision.

Does not meet the criterion.

Detection and quantitation approaches should be applicable to the variety of decisions made under the Clean Water Act, and should support state and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal government. Meets this criterion. At best, only partially passes this criterion. Not likely to meet this criterion in instances in which a compliance limit is close to a detection limit determined by a procedure such as the MDL. In the absence of a procedure for determining LOD values, fails to meet this criterion. In the absence of a procedure for determining CRV values, fails to meet this criterion. In the absence of a procedure for determining MDV values, fails to meet this criterion. 5 31 Table 5 2.

Evaluation Criteria ML IQE ACS LOQ ISO/ IUPAC LOQ The quantitation limit approach should be scientifically valid.

  It can be ( and has been tested)

  Has undergone peer review and publication   Has an error rate that is known or can be estimated   Has standards that can be maintained to control its operation   Has achieved widespread acceptance in a relevant scientific community Meets all 5 conditions for scientific validity,

though slight modification to the definition is suggested to improve operation when other than 7 replicates are used to estimate the ML. Meets 1 condition, partially meets 1 condition, and fails 3 conditions.

  Can be, but has not been fully tested ( partial)

  Error rate cannot be estimated due to problems with the procedure ( fail)

  Standards are not likely to control its operation ( fail)

  Has not achieved widespread acceptance ( fail) Meets 3 of the 5 conditions for scientific validity.

  Lacks a standard to control its operation   Difficult to determine the degree of acceptance Meets 4 of the 5 conditions for scientific validity.

  Lacks a standard to control its operation   Difficult to determine the degree of acceptance The approach should address demonstrated expectations of laboratory and method performance, including routine variability. Meets this criterion.

Procedure can be performed by a single laboratory during a single shift,

or for method development by multiple labs in a single shift. Fails this criterion due to subjectivity,

errors, and theoretical inconsistencies in the procedure. Partially meets this criterion.

The approach is designed to address these expectations but in practice, there is no procedure for performing such demonstrations. Meets this criterion.

The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance. Meets this criterion. Fails this criterion. Requires interlaboratory study involving a reference lab or coordinating body, 6 complete data sets, and a highly skilled statistician.

this procedure would exceed most method development budgets. Fails this criterion. Fails this criterion.

The quantitation limit approach should identify the concentration that gives a recognizable signal that is consistent with the capabilities of the method when a method is performed by experienced staff in well operated laboratories. Meets this criterion. Meets this criterion, but is not likely to estimate the lowest level at which reliable measurements can be made by an experienced analyst in a well operated lab Meets this criterion. Meets this criterion.

Assessment of Quantitation Limit Approaches Against Evaluation Criteria The cost of implementing 5 32 Table 5 2.

Evaluation Criteria ML IQE ACS LOQ ISO/ IUPAC LOQ Assessment of Quantitation Limit Approaches Against Evaluation Criteria Detection and quantitation approaches should be applicable to the variety of decisions made under the Clean Water Act, and should support state and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal government. Meets this criterion. At best, only partially passes this criterion. Fails for those instances in which the IQE limit is greater than an effluent limit or water quality based limit. Fails this criterion.

absence of a procedure for determining ACS LOQ values, the ACS LOQ cannot be used in a regulatory context. Fails this criterion.

absence of a procedure for determining LOQ values, the ISO/ IUPAC used in a regulatory context.

In the In the LOQ cannot be Chapter 6 Conclusions This chapter summarizes the results of EPA s assessment of detection and quantitation limit approaches. This assessment, which is detailed in the previous five chapters, was based on:

  Identification of relevant approaches to include in the assessment ( Chapter 2),   Identification of issues that may be relevant to the assessment from an analytical chemistry, statistical, or regulatory perspective ( Chapter 3),   Development of criteria that reflect EPA s views concerning these issues ( Chapter 4) and form the primary basis for evaluating the ability of each approach to meet EPA needs under the Clean Water Act,   Assessment of how well each approach met the evaluation criteria ( Chapter 5), and,   Use of real world data to evaluate both the theoretical and practical limitations of each approach ( Appendices B and C).

EPA evaluated four sets of detection and quantitation limit approaches advanced by EPA, ASTM International, ACS, and both ISO and IUPAC. Each approach was assessed against the suite of criteria described in Chapter 4. The EPA approaches ( i. e., the MDL and ML) and the ASTM International approaches ( i. e., the IDE and IQE) were supported by clearly defined procedures for implementing the approach. Neither the ACS nor the ISO/ IUPAC approaches are supported by detailed procedures for implementation; this lack of supporting procedures was reflected in the outcome of EPA s overall assessment.

After evaluating each approach against each of the evaluation criteria, EPA found that 1) no single pair of detection and quantitation limit approaches perfectly meets EPA s criteria, 2) the MDL and ML are closest to meeting EPA s criteria, and 3) minor revisions and clarifications to the MDL and ML would allow both approaches to fully meet the Agency s needs under the CWA.

EPA also found that, although the IDE and IQE procedures may be acceptable for planning and implementing interlaboratory studies to develop and validate analytical methods, there are a number of difficulties with these procedures that make them unsuitable as the primary means of establishing sensitivity under the Clean Water Act. In particular, the IDE is analogous by definition and formulaic construction to the   Detection Limit  defined by Currie ( 1968, 1995), while it is Currie s   Critical Value  approach that is most relevant to Agency needs under the CWA. Currie ( 1995) states that the decision   detected  or   not detected  is made by comparison of the estimated quantity or measured value with the critical value. Currie describes his   Detection Limit  as a true concentration that has a high probability of generating measured values that exceed the critical value, and states that the single most important application of the detection limit is for planning and evaluation of measurement procedures and that the detection limit:

 ... allows one to judge whether the CMP ( Chemical Measurement Process) under consideration is adequate for detection requirements. This is in sharp contrast to application of the critical value for decision making, given the result of a measurement.

It is important to note that the formulation of the MDL is analogous to the Currie critical value, and as such, is intended to be used to make detection decisions in the manner described by Currie ( i. e., the MDL is designed and used to make the decision of   detected  or   not detected ). EPA believes that form of detection decision best supports the use of   detection limits  under CWA programs.

February 2003 6 1 Assessment of Detection and Quantitation Approaches In contrast, although the IDE is intended to be used in a manner analogous to Currie s critical value ( i. e., to make the decision of   detected  or   not detected ), it is, by definition and design, functionally analogous to Currie s detection limit ( i. e., it identifies a concentration that will have a high probability of generating measured values that exceed the critical value). ( See Chapter 2, Section 2.1 for a discussion of Currie s critical value and detection limit).

Other drawbacks with the ASTM International approach include the complexities of the IDE and IQE procedures, along with their inability to address individual laboratory performance. Despite these limitations, however, EPA believes the IDE and IQE can be used to establish sensitivity for certain applications. For example, consider the theoretical situation of an ASTM method for the determination of an analyte regulated under the NPDES program that uses the IDE or IQE to describe method sensitivity and for which the value of the IDE or IQE was below the relevant criterion or regulatory limit. EPA would evaluate the overall performance of such a method for approval at 40 CFR part 136, despite the fact that the method did not contain an MDL determined using the procedure described in 40 CFR part 136, Appendix B. ( See Chapter 3, Section 3.2.8 for a more in depth discussion of using alternative procedures to establish sensitivity.)

EPA s assessment of the theoretical and practical applications of each detection and quantitation approach ( see Appendices B and C) is summarized in Exhibit 6 1. This exhibit suggests that no approach produces the   right  answer, and that different approaches produce different detection and quantitation limits. Observed differences are largely due to different sources of variability accounted for among the approaches.

As part of this assessment, EPA identified the need for approaches that can support CWA programs, including:

 method performance verification at a laboratory,  method development and promulgation,  National Pollutant Discharge Elimination System ( NPDES) applications,  non regulatory studies and monitoring,  descriptive versus prescriptive uses of lower limits to measurement, and  use of a pair of related detection and quantitation procedures in all OW applications EPA has concluded that the MDL and ML can meet all of these applications and that the addition of a scope and application section to the procedure would help clarify use of the MDL for these applications. However, as noted in Chapter 3, outside organizations use different detection and quantitation approaches that meet their own needs. Given EPA s diverse needs and desire to encourage the development of improved measurement techniques, EPA does not believe it is necessary or appropriate to require the exclusive use of the MDL and ML approaches in CWA programs. As indicated above, EPA would allow use of alternative detection and quantitation procedures to establish detection and quantitation limits in an analytical method, provided that the resulting detection and quantitation limits meet the sensitivity needs for the specific application.

6 2 February 2003 Chapter 6 Exhibit 6 1: Theoretical and Practical Application of Each Approach Finding 1: Each approach yields different values. Detection Limit Approaches   The EPA MDL and ACS LOD approaches, which are functionally analogous, produced detection limits that are a median of 1.25 times higher than the limits produced by the CRV advanced by ISO and IUPAC ( Appendix C of this document).   The Minimum Detectable Value ( MDV) advanced by ISO and IUPAC produced detection limits that are a median of 1.2 times higher than the limits produced by the MDL and LOD approaches ( Appendix C of this document).   A single laboratory variant of the IDE ( the IDE has been advanced by ASTM International) produced detection limits that are a median of 2.9 times higher than the median limits produced by the MDL and LOD approaches ( Appendix C of this document). This result is not surprising given that the IDE is functionally analogous to Currie's detection level, while the MDL and LOD are analogous to Currie's critical value. Quantitation Limit Approaches   The EPA ML and the functionally equivalent ACS LOQ produced quantitation limits that are a median of 1.1 times higher than the limits produced by the LOQ approach advanced by ISO and IUPAC ( Appendix C of this document).   A single laboratory variant of the IQE ( the IQE has been advanced by ASTM International) produced median quantitation limits that are equivalent to the median limits produced by the EPA ML and ACS LOQ approaches ( Appendix C of this document).

Finding 2: More than the 5 levels specified by ASTM are required to produce a reliable IDE and IQE   EPA found that the IDEs produced with a subset of data generated from the minimum of 5 concentrations recommended in the IDE procedure differed widely from the IDEs produced with a larger set of data involving 16 concentrations ( which included the subset of 5 concentrations) ( Appendix C of this document).   Findings suggest that more than 5 concentrations are needed to produce a reliable IDE, due to the limited power of the statistical tests for significant model parameters and the difficulty of drawing conclusions based on residual plots with only 5 points ( Appendix C of this document).   Parallel reasoning can be applied to the IQE based on its similarity to the IDE.

Finding 3: The ML procedure yields quantitation limits that are generally in the range of the 10% RSD intended in the ML ( and the functionally analogous ACS LOQ) approach.   EPA calculated the uncertainty associated with replicate measurements made at the ML for a large number of analytes and techniques ( Appendix C of this document).   EPA found that on average, across all techniques tested, the RSD of replicate measurements at the ML was approximately 7%. Median RSDs calculated for each multi analyte method ranged from 6  14%, and RSD values calculated for each single analyte method ranged from 4  16% ( Appendix C of this document).

Finding 4: No single model adequately predicts the behavior of all analytes and all methods across the measurement range.   EPA produced graphs representing hundreds of analyte/ method combinations. Selection of an appropriate model based on these graphs is highly subjective, at best, due to the lack of clear patterns and the residuals observed with each model applied ( Chapter 3, Section 3.3, and Appendix B of this document).   The IDE and IQE are the only approaches other than the MDL and ML that are supported by a procedure for their implementation. The IDE and IQE procedures rely heavily on model selection, and the degree of subjectivity involved in selecting these models makes implementation of the IDE and IQE difficult ( Chapter 5, Sections, 5.1.2 and 5.2.2, and the third conclusion in Appendix C).

Finding 5: Use of a recovery correction when establishing detection and quantitation limits may not be appropriate.   EPA found that using a regression to estimate a recovery correction at zero concentration causes great swings in the resulting detection and quantitation limits ( Appendix C of this document).   Use of a recovery correction procedure also can result in   double correcting  for recovery because 1) nearly all methods already contain specifications for acceptable recovery performance, and 2) some methods include recovery correction in the computation of sample results ( Chapter 3, Section 3.1.4).

February 2003 6 3 Assessment of Detection and Quantitation Approaches Exhibit 6 2: Summary of Recommended Modifications to the MDL and ML procedures EPA believes that the following revisions and clarifications to the MDL and ML would allow these procedures to fully meet the Agency's needs under the CWA.

  Refine the definition of the MDL to make it more consistent with the MDL procedure and note the functional analogy of the MDL with the " critical value" described by Currie ( 1968 and 1995) and with the " limit of detection" ( LOD) described by the American Chemical Society in 1980 and 1983 ( Chapter 5, Section <IP_ADDRESS>.1).   Expand the Scope and Application discussion to acknowledge that there are a variety of purposes and analytical methods for which the MDL procedure may be employed and to provide examples of common uses of the MDL procedure ( i. e., demonstrating laboratory capability with a particular method; monitoring trends in laboratory performance; characterizing method sensitivity in a particular matrix; and establishing an MDL for a new or revised method for nationwide use).   Clarify the considerations for estimating the detection limit in Step 1 of the current MDL procedure, and suggest that the method specified MDL can be used as the initial estimate when performing an MDL study to verify laboratory performance or to demonstrate that the MDL can be achieved in a specific matrix ( Chapter 5, Section <IP_ADDRESS>.1).   Revise the specifications for establishing the test concentration range ( i. e., determining the spike levels) in Section 3.1 according to the intended application of the MDL as follows: 1) if verifying a published MDL, the test concentration should be no more than five times the published MDL; 2) if verifying an MDL to support a regulatory objective or the objective of a study or program, the test concentration should be no more than one third the compliance or target limit; 3) if determining an MDL for a new or revised method, the test concentration should be no more than five times the estimated detection limit; and 4) if performing an iteration, the test concentration should be no more than five times the MDL determined in the most recent iteration.   Delete the calculation of a 95% confidence interval estimate for the MDL from Step 6. EPA has determined that these calculations are neither routinely performed by laboratories, nor are the results employed by regulatory agencies, including EPA.   Revise Step 7 to 1) require that the iterative procedure be used to verify the reasonableness of the MDL when developing an MDL for a new or revised method or when developing a matrix specific MDL, but that it remain optional when verifying a method, matrix, program, or study specific MDL, and 2) provide specific instructions on how to assess the reasonableness of an MDL used to verify laboratory performance ( Chapter 5, Section <IP_ADDRESS>.1).   Add a new Step 8 to the MDL procedure to address the treatment of suspected outliers ( Chapter 5, Section <IP_ADDRESS>.1).   Delete the discussion of analysis and use of blanks included in Section 4( a) of the current MDL procedure. The current discussion applies to methods in which a blank measurement is required to calculate the measured level of an analyte; it requires separate measurements of blank samples for each MDL sample aliquot analyzed and subtraction of the average result of the blank samples from each respective MDL sample measurement. Deletion of this discussion recognizes that subtraction of a single ( or average) blank sample result from the result for each MDL sample would not change the standard deviation and thus, would have no effect on the resulting MDL. Although EPA believes laboratories would be prudent to analyze method blanks for assessing potential contamination, EPA also believes that requiring analysis of method blanks or subtraction of method blank results during MDL determinations is unnecessarily burdensome.   Revise the optional pre test described in Section 4( b) of the current MDL procedure to provide criteria that allow the analyst to determine if the test samples are the desirable range.   Improve overall readability and understanding of the MDL procedure through editorial changes to the specific numbering scheme, the addition of clearer titles to some of the steps, and minor clarifications.   Clarify the ML to emphasize its relationship to Currie s Quantitation Limit and ACS  Limit of Quantitation ( LOQ)   Clarify the ML procedure to address the use of other than seven replicates for determination of the MDL and ML.

6 4 February 2003


[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18045-18046]
[FR Doc No: 2014-07087]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2014-0091]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of an
extension to the following collection of information: 1625-0058,
Application for Permit to Transport Municipal and Commercial Waste. Our
ICR describes the information we seek to collect from the public.
Before submitting this ICR to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before May 30, 2014.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2014-0091] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at Room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICR(s) are available through the docket on the
Internet at http://www.regulations.gov. Additionally, copies are
available from: COMMANDANT (CG-612), ATTN PAPERWORK REDUCTION ACT
MANAGER, US COAST GUARD, 2703 MARTIN LUTHER KING JR AVE SE., STOP 7710,
WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Cheryl Collins, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) the practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of

information technology. In response to your comments, we may revise
these ICRs or decide not to seek approval of revisions of the
Collections. We will consider all comments and material received during
the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2014-0091], and
must be received by May 30, 2014. We will post all comments received,
without change, to http://www.regulations.gov. They will include any
personal information you provide. We have an agreement with DOT to use
their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2014-0091], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2014-0091'' in the
``Search'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Search'' box
insert ``USCG-2014-0091'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    1. Title: Application for Permit to Transport Municipal and
Commercial Waste.
    OMB Control Number: 1625-0058.
    Summary: This information collection provides the basis for issuing
or denying a permit, required under 33 U.S.C. 2601 and 33 CFR 151.1009,
for the transportation of municipal or commercial waste in the coastal
waters of the United States.
    Need: In accordance with 33 U.S.C. 2601, the U.S. Coast Guard
issued regulations requiring an owner or operator of a vessel to apply
for a permit to transport municipal or commercial waste in the United
States and to display an identification number or other marking on
their vessel.
    Forms: N/A.
    Respondents: Owners and operators of vessels.
    Frequency: Every 18 months.
    Burden Estimate: The estimated burden remains unchanged at 13 hours
a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: March 24, 2014.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2014-07087 Filed 3-28-14; 8:45 am]
BILLING CODE 9110-04-P