[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45564-45565]
[FR Doc No: 2011-19287]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9446-2]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Consent Decree; Request for Public Comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed consent decree to resolve a lawsuit filed by the Sierra Club
(``Plaintiff'') in the United States District Court for the Western
District of Wisconsin: Sierra Club v. Jackson, No. 11-cv-36-SLC (W.D.
Wisc.). Plaintiffs filed a deadline suit to compel the Administrator to
respond to an administrative petition seeking EPA's objection to a CAA
Title V operating permit issued by the Wisconsin Department of Natural
Resources to Carmeuse Lime & Stone, a lime kiln facility in Manitowoc,
Wisconsin. Under the proposed consent decree, EPA would agree to
respond to the petition by October 7, 2011, or within 30 days after
entry of the consent decree by the Court, whichever is later.

DATES: Written comments on the proposed consent decree must be received
by August 29, 2011.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2011-0637, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Sara Froikin, Office of General
Counsel (Mail Code 2344A), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone: (202) 564-
3187; fax number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    This proposed consent decree would resolve a lawsuit alleging that
the Administrator failed to perform a nondiscretionary duty to grant or
deny, within 60 days of submission, an administrative petition to
object to a CAA Title V permit issued by the Wisconsin Department of
Natural Resources to Carmeuse Lime & Stone, a lime kiln facility in
Manitowoc, Wisconsin. Under the proposed consent decree, EPA would
agree to respond to the petition by October 7, 2011, or within 30 days
after entry of the consent decree by the Court, whichever is later, and
pay specified attorneys fees to the Plaintiffs. The Court would then
dismiss the case with prejudice once EPA has fulfilled these
obligations under the consent decree.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the consent decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2011-0348) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use the http://www.regulations.gov
to submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, select ``search,'' then key in the appropriate docket
identification number.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the

close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: July 22, 2011.
Patricia A. Embrey,
Acting Associate General Counsel.
[FR Doc. 2011-19287 Filed 7-28-11; 8:45 am]
BILLING CODE 6560-50-P


Table 15. Estimated Worker Exposure and Risk from Commercial Seed Treatment Short and Intermediate term Risk Estimates Crop Exposure Scenario Application Rate ( lb ai/ 100 lb) a Amount Handled per Day ( lb ai/ day) b Dermal MOE ( Target MOE  100) Inhalation MOE ( Target MOE  100) Total MOE c ( Target MOE  100) Level of Mitigationc Loader/ Applic ator 410 180 120 SL, G+ 90% R Sewer 1500 130 120 SL + 80% R Bagger 1000 190 160 SL + 80% R Barley, Oat, Rice, Wheat Seeds Multiple Activities 0.026 187 220 37 32 SL, G+ 90% R Loader/ Applic ator 370 160 110 SL, G+ 90% R Sewer 1400 120 110 SL + 80% R Bagger 920 170 140 SL + 80% R Cotton Seeds Multiple Activities 0.13 208 200 34 29 SL, G+ 90% R Loader/ Applic ator 260 110 78 SL, G+ 90% R Sewer 960 110 140 SL + 90% R Bagger 650 160 170 SL + 90% R Safflower Seeds Multiple Activities 0.041 294 140 24 20 SL, G+ 90% R Loader/ Applic ator 2100 460 380 SL, G+ 80% R Sewer 7800 130 130 SL + NR Bagger 5300 190 180 SL + NR Sugar Beet Seeds Multiple Activities 0.041 36 1200 190 170 SL, G+ 90% R ND = No Data; NF = Not Feasible; NR= No respirator a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the maximum application rate and the lbs of seed treated or planted/ day and: for barley, rice, safflower, and wheat seed  718000 lb/ day; for cotton seed   160000 lb/ day; and sugar beet seed   88000 lb/ day. c Baseline Dermal: Long sleeve shirt, long pants, no gloves. Baseline Inhalation: no respirator. SL, G = Single layer w/ gloves is baseline attire plus chemical resistant gloves. DL, G = Double layer w/ gloves is coveralls worn over long sleeve shirt and long pants, plus 80% R = 80% Respirator is filtering facepiece dust/ mist respirator ( that provides an 80% protection factor). 90% R = 90% Respirator is half face dust/ mist respirator ( that provides a 90% protection factor). Eng Control = Engineering control is closed mixing/ loading system, elastomeric facepiece respirator with dust/ mist filters. Page 46 of 66 Postapplication Exposure and Risk. For all of the on nursery seed treatment scenarios, individual dermal and inhalation MOEs met or exceeded the required uncertainty factor of 100 at some level of risk mitigation, and thus are not of risk concern. For on farm seed treatment scenarios, all combined dermal and inhalation risks also met or exceeded the target MOE of 100 at some level of risk mitigation.

Table 16. Estimated Worker Exposure and Risk from On Nursery Seed Treatment ( Postapplication)

Short and Intermediate term Risk Estimates Crop Acres treated/ day App Rate ( lb ai/ 100 lb) a Amount Handled per dayb ( lb ai/ day) Inhalation MOE ( Target MOE  100) Dermal MOE SL w/ gloves ( Target MOE  100) Total MOE ( Target MOE  100) Level of Mitigation LOADING/ APPLYING LIQUID SEED TREATMENTS Cotton 125 0.051 0.64 NDd LOADING/ PLANTING PREVIOUSLY TREATED SEEDS Barley 35 0.026 0.64 360 7700 350 SL, G + NR Beet; Sugar 80 0.041 0.26 1300 27000 1200 SL, G + NR Cotton 200 0.13 4.68 350 1500 280 SL, G + 80% R Oats 200 0.026 6.66 250 1100 200 SL, G+ 80% R Rice 200 0.026 7.80 210 900 170 SL, G+ 80% R Safflower 80 0.41 3.28 500 2100 400 SL, G + 80% R Wheat 200 0.026 7.80 210 900 170 SL, G+ 80% R ND = No Data; NF = Not Feasible; NR = no respirator SL, G = Single layer w/ gloves is baseline attire plus chemical resistant gloves. 80% R = 80% Respirator is filtering facepiece dust/ mist respirator ( that provides an 80% protection factor). 90% R = 90% Respirator is half face dust/ mist respirator ( that provides a 90% protection factor). a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the acres treated/ day and the maximum lb of seed planted per acre. c On nursery seed treatment with liquid formulations is generally done with automated equipment, essentially miniature versions of commercial treaters.

9.2 Antimicrobial Uses TCMTB is used in commercial/ institutional premises, as a material preservative, in industrial processes and water systems, and as a wood preservative. Examples of registered uses include use in pulp and paper process water, use for sapstain control, use as a preservative for leather products and hides, textiles, paints, adhesives, wall paper, metal working fluids, and oil recovery drill muds. Products containing TCMTB are formulated as liquid ready to use, soluble concentrate, emulsifiable liquid and suspo emulsion. The percentage of TCMTB in the various end use products ranges from 1.0% to 60%.

Based on examination of product labels describing uses for the product, it has been determined that exposure to handlers can occur in a variety of occupational settings. Additionally, postapplication exposures are likely to occur in these settings from the metal working fluid use and wood preservation uses. Representative scenarios selected for Page 47 of 66 evaluation based on the use sites and maximum application rates as recommended on the product labels for TCMTB. To assess the handler risks, AD used surrogate unit exposure data from both the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED).

Occupational Handlers. The Agency has determined that there is potential for dermal and inhalation worker exposure to TCMTB in occupational settings such as commercial/ institutional premises, and industrial processes and water systems.

For the occupational handler dermal and inhalation risk assessment, the MOEs were above the target MOE of 100 for short and intermediate term durations at single layer PPE for open pouring or through the use of mitigation ( e. g., metering pumps) for all scenarios except for the following scenarios listed below. It should be noted that the baseline ( ungloved) dermal MOEs for material preservation of paints, textiles, adhesives, and metalworking fluid were calculated using unit exposure values from the cooling tower CMA data set because baseline dermal unit exposures are not available for preservative or metal fluid categories.

  Paint Application   Airless Sprayer: ST/ IT Dermal MOE = 6.1 ( ungloved) and 17 ( gloved).   Paint Application   Paintbrush: ST/ IT Dermal MOE = 30 ( ungloved) and 97 ( gloved)   Paint Preservation   Liquid Pour: ST/ IT Dermal MOE = 1 ( ungloved)   Paint Preservation   Liquid Pump: ST/ IT Dermal MOE = 26 ( ungloved)   Textile Preservation   Liquid Pour: ST/ IT Dermal MOE = < 1 ( ungloved)   Textile Preservation   Liquid Pump: ST/ IT Dermal MOE = 64 ( ungloved)   Cutting Fluid Preservation   Liquid Pour: ST/ IT Dermal MOE = 11 ( ungloved)   Pulp and Paper   Liquid Pump: ST/ IT Dermal MOE = 5 ( ungloved)

Table 17 Short and Intermediate Term Risks Associated with Occupational Handlers ST/ IT MOE c ( Target MOE   100) Exposure Scenario Method of Application Application Rate (% a. i. by weight) Quantity Handled/ Treated per day Baseline Dermala PPE Glove Dermal b Inhalation TOTAL MOE ( dermal and inhalation)

Airless Sprayer 500 lb/ day 6.1 17 180 16 Paint Application Paintbrush 50 lb/ day 30 97 5,300 95 Liquid Pour 2,000 lb/ day 1.2 430 11,000 414 Paint Preservation Liquid Pump 0.015 a. i. weight fraction 10,000 lb/ day 26 1900 19,000 1,727 Liquid Pour < 1 220 5,400 211 Textiles/ Leather Products Liquid Pump 0.006 a. i. weight fraction 10,000 lb/ day 64 4,600 46,000 4,182 Liquid Pour 11 3,000 42,000 2,800 Cutting Fluid Liquid Pump 0.00125 a. i. weight fraction 2,502 lb/ day 1,200 1,800 1.00x105 1,768 ST = 45.9 lb/ day ST = 1000 ST = 380,000 ST = 9.40x10 6 365,235 Drilling Fluids Liquid Pour 0.00075 a. i. weight fraction IT = 22.9 lb/ day IT = 2,000 IT = 7.60x105 IT = 1.90x107 730,769 Page 48 of 66 Table 17 Short and Intermediate Term Risks Associated with Occupational Handlers ST/ IT MOE c ( Target MOE   100) Exposure Scenario Method of Application Application Rate (% a. i. by weight) Quantity Handled/ Treated per day Baseline Dermala PPE Glove Dermal b Inhalation TOTAL MOE ( dermal and inhalation)

Pulp and Paper Liquid Pump 1,000,000 lb/ day 5 510 5,600 467 Liquid Pour 90 lb/ day 43,000 21,000 3.10x106 20.858 Small Process Water Systems/ Cooling Tower Liquid Pump 0.000009 a. i. weight fraction 180,000 lb/ day 2,400 13,000 1.60x105 12,023 ST = short term; IT = intermediate term a Baseline Dermal: Long sleeve shirt, long pants, no gloves. b PPE Dermal with gloves: baseline dermal plus chemical resistant gloves. c MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose [ Where ST/ IT NOAEL = 25 mg/ kg/ day for dermal and 16 mg/ kg/ day for inhalation].

As shown on Table 17, many of these MOEs are not of concern with the addition of gloves ( PPE). The total dermal and inhalation MOEs with PPE ( gloves) are not of concern for the majority of scenarios evaluated. The total MOEs are of concern ( i. e., less than 100) for the following exposure scenarios:

  Paint Application   Airless Sprayer: MOE = 16   Paint Application   Paintbrush: MOE = 95 Postapplication Exposure and Risk.

Metal Working Fluid Use. There is a potential for dermal and inhalation exposure when a worker handles treated metal working/ cutting fluids. Exposure can occur after the chemical has been incorporated into the cutting fluid and a machinist is using/ handling this treated end product. The Agency evaluated both dermal and inhalation exposures for short, intermediate and long term exposure durations. Dermal exposure estimates were derived using the 2 hand immersion model from ChemSTEER. A screening level intermediate and long term inhalation exposure estimate for treated cutting fluids has been developed using the OSHA PEL for oil mist. Table 18 presents a summary of the risk estimates for occupational exposure to TCMTB containing metal working/ cutting fluids.

Wood Preservative Use. TCMTB is used in products that are intended to preserve wood through primarily non pressure treatment methods. It can be applied as a sapstain control to freshly cut wood, incorporated into particle board, or used to treat wood chips. When used as a sapstain control, the product may be dipped, sprayed, or impregnated into the wood via pressure treatment ( up to 0.3% a. i. solution). When used in particle board, the pesticide is incorporated into the resin or binding agent ( 0.3% a. i., based on dry weight of wood).

For the occupational postapplication risk assessment, the MOEs were above target MOE of 100 for short and intermediate term dermal and inhalation exposures, and were above 300 for long term durations, and therefore not of concern for all scenarios. The Page 49 of 66 occupational risks for metal working fluid exposures and wood preservative uses are presented on Tables 18 and 19, respectively.

Table 18 Short, Intermediate, and Long Term Risks Associated with Postapplication Exposure to Metal Working Fluids treated with TCMTB ( Machinist)

Dermal Inputs Inhalation Inputs MOE ( Target MOE   100 for ST/ IT, 300 for LT) c, d Dermal MOE Inhalation MOE TOTAL MOE ( dermal and inhalation) Weight Fraction a. i. in Fluid Hand Surface Area ( cm2) Film thickness ( mg/ cm2) Frequency ( event/ day) OSHA PEL ( mg/ m3) Inhal. rate ( m3/ hr) Exposure Duration ( hrs/ day)

ST/ IT/ LT ST/ IT LT ST/ IT LT 0.00125 840 1.75 1 5 1 8 950 22000 5300 910 806 a Absorbed Dermal Daily Dose ( mg/ kg/ day) = [ fraction a. i. in treated fluid * hand surface area* film thickness ( mg/ cm2)* Frequency ( event/ day)] / Body weight ( 70 kg). b Absorbed Inhalation Daily Dose ( mg/ kg/ day) = fraction a. i. in treated fluid * OSHA PEL ( mg/ m3) * Inhalation rate ( m3/ hr) * exposure duration ( hr/ day) / body weight ( 70 kg) c Dermal MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose ( mg/ kg/ day) [ Where: ST/ IT/ LT dermal NOAEL = 25 mg/ kg/ day]. d Inhalation MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose ( mg/ kg/ day) [ Where: ST/ IT inhalation NOAEL = 16 mg/ kg/ day and LT Inhalation NOAEL = 3.8 mg/ kg/ day].

Table 19. Short, Intermediate and Long Term Exposures and Risks for Wood Preservative Use MOEsc ( Target MOE   100 for ST/ IT, 300 for LT)

Dermal Inhalation TOTAL MOE ( dermal and inhalation) Exposure Scenarioa ( number of volunteers) ST/ IT/ LT ST/ IT LT ST/ IT LT Blender/ Spray Operator ( b) 520 5,200 1,200 478 364 Chemical Operator ( n= 11) 48,000 1.10x107 2.50x106 47,790 47,095 Grader ( n= 13) 1.50x105 1.00x107 2.40x106 147,783 141,176 Trim Saw ( n= 2) 3.40x105 4.90x106 1.20x106 317,940 264,935 Millwright ( n= 3) 36,000 5.20x106 1.20x106 35,752 34,951 Clean Up ( n= 6) 8,400 4.90x105 1.20x105 8,258 7,850 Diptank Operator 1,900 8.10x104 19,000 1,856 1,727 ST = Short term duration; IT = Intermediate term duration; and LT = long term a. Unless specified, the exposure scenario represents a worker wearing short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill. b. Single layer clothing with chemical resistant c MOE = NOAEL ( mg/ kg/ day)/ Daily dose [ Where ST/ IT/ LT dermal NOAEL = 25 mg/ kg/ day, ST/ IT NOAEL for inhalation is 16 mg/ kg/ day and LT NOAEL for inhalation is 3.8 mg/ kg/ day]. Target MOE is 100 for ST/ IT dermal and inhalation exposures, 300 for LT dermal and inhalation exposure. Page 50 of 66 10.0 ENVIRONMENTAL RISK A detailed ecological hazard and environmental risk assessment for TCMTB is presented in the attached memorandum ( memo from K. Montague/ S. Gowda/ S. Mostaghimi, April 6, 2006). A brief summary is presented below.

10.1 Environmental Modeling/ Exposure TCMTB shows pH dependent hydrolytic degradation. While hydrolytically stable at pH 5, the half life at pH 9 is 1.8 2.1 days. TCMTB breaks down rapidly by photolysis, with a half life of 1.5 hours. Biotic degradation also occurs, with half lives ranging from 1.4 days in soil under aerobic conditions to 6.9 days in water/ sediment systems under anaerobic conditions. TCMTB is mobile very mobile in various soils, which indicates that runoff into aquatic habitats is a potential concern. The Kow of TCMTB is 1995. A Kow > 1000 indicates that a chemical may potentially bioconcentrate; however, the results of a bioconcentration study in fish indicate that bioconcentration of TCMTB will be minimal.

Several major metabolites are formed during the biotic degradation processes of TCMTB, including 2 benzothiazolesulfonic acid ( BTSA) and 2 mercaptobenzothiazole ( 2 MBT). BTSA is not of toxicological concern due to being completely excreted ( sulfonic acid) and having negligible toxicity. 2 MBT is generally less toxic than parent TCMTB; therefore, mitigation of any risks from TCMTB toxicity endpoints will be protective of any risks from 2 MBT. Therefore, the environmental risk assessment was conducted for TCMTB only.

10.2. Ecological Toxicity Data.

The acute toxicity data for TCMTB are summarized on Table 20. As shown in Tables 20 and 21, TCMTB is slightly toxic and 2 MBT is practically non toxic to birds on an acute oral basis, and both TCMTB and 2 MBT are slightly toxic to birds on a subacute dietary basis.

Based on the results of mammalian studies conducted to meet human toxicity data requirements, TCMTB exhibits low acute oral and dermal toxicity ( toxicity category III). However, it is highly irritating to the eyes and skin ( toxicity category I and II, respectively) and is also considered to be highly toxic via the inhalation route of exposure ( toxicity category I). TCMTB is a dermal sensitizer. The NOAEL determined in a rat 2 generation reproduction study was 400 ppm.

Both TCMTB and 2 MBT are very highly toxic to freshwater fish, and estuarine/ marine fish on an acute basis. As shown on Table 22, chronic testing indicates that TCMTB causes reproduction and growth effects in fish at very low levels (> 0.34 ppb. TCMTB is very highly toxic and 2 MBT is moderately toxic to freshwater aquatic invertebrates on an acute basis, and TCMTB also shows very high acute toxicity to marine/ estuarine invertebrate species. Page 51 of 66 A chronic freshwater invertebrate study is outstanding. One daphnid life cycle study was submitted ( MRID# 425591 01), but was invalidated due to high variablility in the test concentrations to which the daphnids were exposed. A new daphnid life cycle study ( 72 4b/ 850.1400) is required to support the currently registered uses of TCMTB.

Some reports in the published literature indicate that TCMTB may cause sublethal effects in fish, which could result in an increase in predation and a decreased ability to survive. This information was submitted to the Agency under FIFRA § 6( a) 2 ( MRID # 424053 01). These studies demonstrate that exposure to TCMTB at levels of 8 10 ppb caused gill damage and behavioral changes, which could severely reduce the ability of fish to survive in the wild. From Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop, Nov. 5 7, 1990, Vancouver, BC, Vol. 1. ( edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M. Nassichuk and W. Knapp). Canadian Technical report of Fisheries and Aquatic Sciences, No. 1774 ( vol 1). Individual paper citations: ( Kruzynski and Birtwell, 1990; Kruzynski et al., 1990; Chew et al., 1990). The LC50 used in this risk assessment ( 8.7 µ g/ L) is comparable to the levels at which these sublethal effects occurred, however, so the risk assessment should be protective of those effects.

Table 20. Acute Toxicity of TCMTB and 2 MBT Species Chemical % active ingredient ( ai) Endpoint Toxicity Category ( TGAI) Other Effects Noted Reference/ Status Birds TCMTB 80.4% LD50 = 660 mg/ kg NOEL < 292 mg/ kg Slightly toxic Signs of toxicity and reduction of body weight and feed consumption at 292 mg/ kg MRID: 41780901 ( Campbell 1991)/ Acceptable Northern bobwhite ( Colinus virginianus)

2 MBT 98.2% LD50 > 2150 mg/ kg NOEL < 1000 mg/ kg Practically non toxic Some evidence of dose related abnormalities upon gross necropsy ( friable livers, resorbed eggs, fluid filled sacs in abdomen) MRID:

42267101 ( Pedersen end Helsten 1992a)/

Acceptable Mammals Laboratory rat ( Rattus norvegicus) TCMTB 80% ai LD50= 750 mg/ kg Moderately toxic 41583801/ Acceptable Freshwater Fish Rainbow trout Oncorhynchu s mykiss) TCMTB 90% 96hr static LC50 =

55.2 ug/ L ( ppb) Very highly toxic None reported TN 2437 ( USEPA 1980)/ Supplemental Page 52 of 66 Table 20. Acute Toxicity of TCMTB and 2 MBT Species Chemical % active ingredient ( ai) Endpoint Toxicity Category ( TGAI) Other Effects Noted Reference/ Status TCMTB 80.4% 96hr flow through LC50 = 20.91 ug/ L ( ppb) Very highly toxic NOEC = 8.7 µ g/ L ( ppb) due to mortality and lethargy and loss of equilibrium in surviving fish at higher levels 41818101 ( Machado 1991b)/ Acceptable TCMTB 75% 96hr static LC50 =

29 ug/ L ( ppb) Very highly toxic Loss of equilibrium and lying on sides observed ACC+ 0916 24 ( Knott and Woodard 1968b)/ Supplemental TCMTB 90% 96hr static LC50 =

32 ug/ L ( ppb) Very highly toxic None reported TN 2432 ( USEPA 1979)/ Supplemental TCMTB 80.4% 96hr flow through LC50 = 8.7 ug/ L ( ppb) Very highly toxic NOEC = 5.1 µ g/ L ( ppb) due to signs of toxicity at higher levels 41804201 ( Machado 1991a)/ Acceptable Bluegill sunfish ( Lepomis macrochirus)

TCMTB 75% 96hr static LC50 =

47 ug/ L ( ppb) Very highly toxic Loss of equilibrium and lying on sides observed ACC# 091624 ( Knott and Woodard 1968b)/

Supplemental Rainbow trout Oncorhynchu s mykiss) 2 MBT 98.2% 96 hr static LC50 = 730 ug/ L ( ppb) Very highly toxic NOEC = 310 µ g/ L ( ppb) due to mortality at higher treatment levels 42232201 ( Collins 1992)/ Acceptable Freshwater Invertebrates TCMTB 90%. 48 hr. static EC50 = 23 ug/ L ( ppb) Very highly toxic TN 2427 ( USEPA 1979)/

Supplemental TCMTB 80.4% 48 hr. flow through EC50 = 22 ug/ L ( ppb); NOEC = 8.7 ug/ L ( ppb) Very highly toxic 41838201 ( McNamara 1991)/ Acceptable Waterflea ( Daphnia magna)

2 MBT 100% 48 hr. static EC50 = 2,900 ug/ L ( ppb) Moderately toxic 42226001 ( Collins 1992b)/ Acceptable Estuarine/ Marine Fish Sheepshead minnow ( Cyprinodon TCMTB 80% 96 hr. static LC50 = 60 ug/ L ( ppb) Very highly toxic 40363601 ( Suprenant 1986a)/ Acceptable Page 53 of 66 Table 20. Acute Toxicity of TCMTB and 2 MBT Species Chemical % active ingredient ( ai) Endpoint Toxicity Category ( TGAI) Other Effects Noted Reference/ Status variegates) Estuarine/ Marine Invertebrates Quahog clam ( Mercenaria mercenaria) TCMTB 80% 48 hr. static EC50 = 13.9 ug/ L ( ppb); NOEC < 13 ug/ L ( ppb) Very highly toxic . 40363603 ( Suprenant 1986) / Acceptable Mysid ( Americamys is bahia, formerly Mysidopsis bahia) TCMTB 80% 96 hour static LC50= 20.3 ug/ L ( ppb); NOEC < 7.8 ug/ L ( ppb) Very highly toxic 40363602 ( Suprenant 1987) / Acceptable Table 21. Avian Subacute Dietary Toxicity of TCMTB and 2 MBT Test Type ( Chemica l and % a. i.) Chemical (% a. i.) Species Endpoint Results Other Effects Noted Reference/ Status TCMTB ( 80 83% a. i.) Mallard duck ( Anas platyrhyncho s) Mortality 8 day LC50 > 10000 ppm " practically non toxic" Feed consumption and 10% mortality at 5,000 and 10,000 ppm Accession # 009869 ( Booden, 1974)/ Acceptable TCMTB ( 75 % a. i.) Bobwhite quail ( Colinus virginianus) Mortality LC50 > 10000 ppm " Practically non toxic" Huddling and depression at levels > 1000 ppm Accession # 091624 ( Knott and Woodard, 1968a)/ Supplement al TCMTB ( 80% a. i.) Mallard duck ( Anas platyrhyncho s) Mortality 8 day LC50 > 4496 ppm " Slightly toxic" NOEC < 450 ppm based on reduction in body weight gain and food consumption 415956 01 ( Long et al., 1990/ Acceptable TCMTB ( 80% a. i.) Bobwhite quail ( Colinus virginianus) Mortality 8 day LC50 > 4496 ppm " Slightly toxic" NOEC = 450 ppm, based on reduction of average body weight gain at higher levels 415956 02 ( Long et al., 1990/ Acceptable Avian acute dietary, 850.2200/ 71 2 2 MBT ( 98.22% a. i.) Bobwhite quail ( Colinus virginianus Mortality 8 day LC50 > 3387 ppm " Slightly toxic" NOEC = 3387 ppm   no signs of toxicity at any level 424285 01( Pederse n and Helsten, 1992b)/ Acceptable Page 54 of 66 Table 22: Chronic Toxicity Values for Freshwater Fish Exposed to TCMTB Study Type Species Endpoint NOEC

g a. i./ l LOEC

g a. i./ l MRID# ( reference)/ Status Freshwater fish Early life stage toxicity ( 72 4a/ 850.1300) ( 83.78% a. i.) Rainbow trout ( Oncorhynch us mykiss) Reproduction, post hatch survival, growth 0.34 ppb based on growth and egg hatchability 0.56 ppb based on growth 425959 01 ( Rhodes, 1992)/ Acceptable No terrestrial or semi aquatic plant toxicity data have been submitted for TCMTB. These data are required to support the currently registered uses of TCMTB. Guidelines 123 1/ 850.4225 and 850.4250 ( Tier II seedling emergence and vegetative vigor) for rice are required to support wood preservative uses. Guideline 122 1/ 850.4100 ( Tier I seedling emergence) for 10 species of terrestrial plants ( to support seed treatment uses) is also required. Guideline 123 1/ 850.4100 ( Tier II seedling emergence) is reserved for seed treatment uses, pending the results of the Tier I test.

As shown on Table 23, a single aquatic plant study was submitted for TCMTB, which shows that TCMTB impairs growth of aquatic vascular plants at levels greater than 0.15 ppm ( 150 ppb). Additional aquatic phytotoxicity testing with four species of algae is required to support the currently registered uses of TCMTB.

Table 23: Toxicity of TCMTB to Aquatic Plants Test Species/% a. i. Endpoint Toxicity NOEC/ othe r effects noted MRID ( reference) Status Aquatic Vascular Plant Acute Toxicity, Tier II ( dose response), 123 2/ 850.4400 Duckweed ( Lemna gibba)/ 83.5% a. i. Frond growth 14 day static renewal EC50 = 0.43 ( 0.29   0.65) mg/ L ( ppm) 0.15 mg/ L ( ppm) 442009 01 ( Thompson and Swigert, 1996) Acceptable 10.3 Bioaccumulation in Aquatic Organisms.

The log octanol water coefficient ( log Kow) of TCMTB is 3.23. Bioconcentration testing is required for chemicals having a log Kow > 3.00 if they are likely to result in exposure to aquatic organisms, so this testing was required for TCMTB.

Radiolabeled residues accumulated in bluegill sunfish that were exposed to uniformly phenyl ring labeled [ 14C] TCMTB, at a nominal concentration of 0.40

g/ L, Page 55 of 66 under flow through aquarium conditions ( MRID # 424185 01, 424932 01, and 467052 01). Maximum bioconcentration factors ( BCF), based on total radioactivity were 302X for viscera, 64X for fillet, and 184X for whole fish tissues. Seventy five to 77%, 84 87%, and 84 86% of the mean accumulated [ 14C] residues ( exposure days 14 28) were eliminated from the fillet, viscera and whole fish tissues, respectively, by days 21 35. These results indicate that the bioaccumulation potential of TCMTB is minimal.

10.4 Environmental Exposure Assessment Aquatic exposure from seed treatment uses of TCMTB was modeled by the Environmental Fate and Effects Division ( EFED), where the Agency estimated environmental concentrations ( EEC) for the use of TCMTB as a seed treatment on cotton, wheat, barley, oats, rice, sugar beets, and safflower. For this action, EFED considered risk only from parent compound of TCMTB and not any degradates associated with TCMTB. For this screening level aquatic exposure assessment, the highest rate of 0.041 lb ai/ ac is used, along with the tier 1 GENEEC and SCI GROW models to assess estimated concentrations of TCMTB in surface water and ground water, respectively.

For surface water exposures, results from GENEEC indicate that the TCMTB concentrations of 0.28 ppb ( ug/ L), 0.26 ppb, 0.20 ppb, 0.12 ppb, and 0.08 ppb, respectively, for peak, 4 day average, 21 day average, 60 day average, and 90 day average exposure. For ground water, SCI GROW indicates that TCMTB concentrations are not likely to exceed 0.00014 ug/ L.

In addition, the Agency conducted environmental exposure modeling for the antisapstain wood preservation use. Runoff concentrations of TCMTB were estimated for facilities that treat wood with antisapstain chemicals. The concentrations were estimated using an approach developed to determine runoff concentrations of pesticides from antisapstain facilities in British Columbia, Canada ( Krahn and Strub, 1990).

Krahn and Strub ( 1990), in their protocol for a leaching study, suggest that treated wood be stored outdoors, stacked into lumber packages 24" x 48" x 16', and placed over leachate collection trays ( 1.52 m x 5.2 m). A total of 16 leaching cycles should be applied at a rate of 15 mm/ day every other day, with each rain duration lasting 5 hours and a target intensity of 3 mm/ hr. These values are based on the average precipitation that occurs in British Columbia in the worst case month of the year.

Predictions of leaching behavior ( as would be observed in a study following the Krahn and Strub ( 1990) protocol) were made based on the chemical properties of TCMTB and a number of assumptions ( see Antisapstain Environmental Modeling Chapter for details).

Aschacher and Gruendlinger ( 2000) have measured uptake of antisapstain dipping solution by pine boards. Freshly sawn pine boards ( 2.3 x 10 x 50 cm, code R2 and R2 Ab) were dipped into a 1.5% Busan 30 L solution ( a. i.: 2 thiocyanomethylthio benzthiazole, TCMTB). One set of samples was treated in April 1997, and another set was treated in Page 56 of 66 April 1998. For each type of board treated each year, the uptake was measured based on the average of 7 boards. The average uptake, based on the measurement of 28 boards, was 163 g solution/ m2.

Krahn and Strub ( 1990) assume that leachate entering the storm drain is diluted with extra runoff water at a 1: 15 ratio. This is based on measurements of runoff in storm drains at facilities using antisapstain chemicals in British Columbia. Use of the ratios 1: 6 and 1: 23 were also suggested by Krahn and Strub ( 1990) to determine a " general industry wide" predicted runoff concentration. These values were used in this assessment. The estimated leachate concentration ( 0.196 ppm) was used in conjunction with these dilution factors to estimate runoff concentrations Table 24. Estimated Runoff Concentrations for TCMTB from Antisapstain Use Parameter Dilution Factor Estimated Runoff Concentration ( ppm) a High end dilution 23.0 0.00852 Typical dilution 15.0 0.0131 Low end dilution 6.00 0.0327 aEstimated Runoff Concentration = Estimated Leachate Concentration ( 0.196 ppm) / Dilution Factor 10.5 Ecological Risk Characterization Risk assessment integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. One method of integrating the results of exposure and ecotoxicity data is called the quotient method. For this method, risk quotients ( RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic:

RQ = EXPOSURE/ TOXICITY RQs are then compared to levels of concern ( LOCs). These LOCs are criteria used by OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms. LOCs currently address the following risk presumption categories: ( 1) acute high  potential for acute risk is high regulatory action may be warranted in addition to restricted use classification; ( 2) acute restricted use  the potential for acute risk is high, but this may be mitigated through restricted use classification; ( 3) acute endangered species  the potential for acute risk to endangered species is high, and regulatory action may be warranted, and ( 4) chronic risk  the potential for chronic risk is high, and regulatory action may be warranted. Currently, AD does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/ bait formulations to mammalian or avian species.

Terrestrial Organisms. Modeling was performed to address the exposure and risk to birds and mammals consuming seeds treated with TCMTB. Using the Terrestrial Residue Exposure Model ( TREX) ( http:// www. epa. gov/ oppefed1/ models/ terrestrial/) for the seed treatment on safflower, which has the highest application rate of 0.041 lb ai/ A, the following RQs for seed treatment were calculated: Page 57 of 66 Avian: : 0.02 as ( mg ai/ kg/ day)/ LD50 The avian RQ was calculated with no toxicity scaling factor. Scaling factors are used when it is likely that a pesticide will be proportionally more toxic to smaller organisms than larger ones ( e. g., the toxicity will not be directly correlated with body weight). TREX recommends a default scaling factor of 1.15, based on Mineau et al. ( 1996); however, that scaling factor was developed based on 37 conventional pesticides, most of which are cholinesterase inhibitors. There is no information available indicating that such an adjustment is necessary or appropriate for TCMTB.

Mammalian Acute: 0.05 as ( mg ai/ kg/ day)/ LD50, 0.02 as ( mg ai/ ft2)/( LD50* BW) Chronic: 0.53 as ( mg/ kg seed)/ reproduction NOAEC All of these are below any LOCs for avian or mammalian acute risk and mammalian chronic risk. Avian chronic data are not available nor required for the currently registered uses of TCMTB, therefore chronic avian risk was not assessed.

Aquatic Organisms: To develop RQs, the EECs determined by modeling were compared to the most sensitive endpoint for each taxa. For seed treatment, the peak EEC was used for acute and endangered species risks, the 21 day average was used for invertebrate chronic risk, and the 60 day average was used for the fish chronic risk. For antisapstain uses, the worst case scenario ( low dilution) and the " best case" ( high dilution) EECs were used for acute and endangered species risks, and the typical dilution was used for fish and invertebrate chronic risks. RQs exceeding one or more LOCs ( listed in the risk presumptions section, above) are in bold text.

Table 25: Aquatic Organism Risk Quotients for Seed Treatment and Antisapstain Uses of TCMTB Taxa/ Endpoint Seed treatment EEC ( peak) Seed Treatment RQ Antisapstain EEC Low dilution High dilution Antisapstain RQ Freshwater fish Acute 8.7 ppb 0.28 ppb 0.03 32.7 ppb 8.5 ppb 3.76 0.98 Freshwater Invertebrates Acute 22 ppb 0.28 ppb 0.01 32.7 ppb 8.5 ppb 1.49 0.39 Marine/ Estuarine Fish Acute 60 ppb 0.28 ppb 0.00 32.7 ppb 8.5 ppb 0.54 0.14 Marine/ Estuarine Bivalve Acute 13.9 ppb 0.28 ppb 0.02 32.7 ppb 8.5 ppb 2.35 0.61 Marine/ Estuarine Invertebrate Acute 20.3 ppb 0.28 ppb 0.01 32.7 ppb 8.5 ppb 1.61 0.42 Green Algae Acute EC50 430 ppb 0.28 ppb 0.00 32.7 ppb 8.5 ppb 0.08 0.02 Green Algae NOEC 150 ppb 0.28 ppb 0.00 32.7 ppb 8.5 ppb 0.22 0.06 Fish Chronic 0.34 ppb 0.12 ppb 0.35 13.1 ppb 8.5 ppb 38.53 25.00 Page 58 of 66 Invertebrate Chronic   DATA GAP 0.20 ppb  13.1 ppb

For seed treatment, no LOCs are exceeded, indicating that the use poses minimal risk to aquatic organisms.

For the antisapstain use, the low dilution ( worst case) EECs exceed acute high risk LOCs for all taxa, and chronic risk to fish. Even using the high dilution (" best case") EECs still results in exceedance of acute high risk LOCs for freshwater fish and marine bivalves, and restricted use LOCs for freshwater invertebrates, marine fish and marine invertebrates, and chronic risk to fish.

Chronic risk to invertebrates cannot be assessed at this time due to the lack of chronic invertebrate toxicity data.

The model used to estimate exposure from antisapstain uses is intended as a Tier I screening model, and, as such, has inherent assumptions and uncertainties that may result in overor under estimation of exposure levels. Additional information, including, but not limited to, specific leaching data for TCMTB used as an antisapstain wood preservative, would remove some of the uncertainties, and may result in more accurate exposure estimation. An environmental monitoring study is also needed to address the potential risks of concern and provide EECs for a refined risk assessment.

Methods to reduce the amount of TCMTB potentially released from antisapstain treated wood would mitigate the risks. Possible mitigation methods might include lowering the application rate or requiring specific storage conditions to prevent exposure of recently treated wood to weather ( e. g., full covering) and/ or prevent the release of any associated runoff into aquatic habitats ( e. g., drip pads). TCMTB is very mobile in soils, so any TCMTB leached outdoors will likely reach aquatic habitats.

10.6 Endangered Species Considerations Section 7 of the Endangered Species Act, 16 U. S. C. Section 1536( a)( 2), requires all federal agencies to consult with the National Marine Fisheries Service ( NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services ( FWS) for listed wildlife and freshwater organisms, if they are proposing an " action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means " to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C. F. R. ' 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection ( a)( 2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce Page 59 of 66 appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species ( U. S. EPA 2004). After the Agency's screening level risk assessment is performed, if any of the Agency's Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co occur in the area of the proposed pesticide use. If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken. The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

Using Tier I screening modeling to assess potential exposure from antisapstain wood preservation uses of TCMTB, risks to Listed Species are indicated. Since the model is only intended as a screening level model, and, as such, has inherent uncertainties and limitations which may result in inaccurate exposure estimations, further refinement of the model is recommended before any regulatory action is taken regarding the antisapstain uses of TCMTB. An environmental monitoring study of runoff from antisapstain treatment facilities is needed to address the potential risks and to provide EECs for use in a refined risk assessment. Additionally, impacts from the antisapstain use could potentially be mitigated with precautions to prevent leaching and runoff when wood is stored outdoors. Due to these circumstances, the Agency considers the antisapstain use NLAA, provided precautions are taken to prevent the leaching and runoff of TCMTB into aquatic areas ( see Label Hazard Statements and Use Recommendations section, below). When additional data are available, the environmental exposure assessment of the antisapstain use of TCMTB will be revised, and the risks to Listed Species will be reconsidered.

11.0 DEFICIENCIES/ DATA NEEDS Hazard Data Gaps. A subchronic inhalation toxicity study is triggered because many of the inhalation risks exceed the Agency's level of concern, or are below a MOE of 1000. When the inhalation endpoints are based on oral toxicity data, it is current Agency policy for antimicrobial chemicals to require an inhalation toxicity study if the estimated inhalation MOEs are below a MOE of 1000. Also, the acute toxicity data suggest that TCMTB is more toxic via the inhalation route of exposure ( Toxicity category I) relative to oral exposure ( Toxicity category III), and thus that the oral toxicity data may underestimate the actual inhalation risks for TCMTB.

Dietary Data Gaps for Antimicrobial Use.

( 1) The registrant must address the question of whether the use of TCMTB in pulp and papermaking will result in residues of 2 mercaptobenzothiazole ( 2 MBT) in paper produced using TCMTB and provide information on the level of 2 MBT that will occur in paper. 2 MBT is the main mammalian metabolite of TCMTB. This chemical and its sodium and potassium salts are also permitted for use as slimicides by the Food & Drug Administration in pulp and papermaking ( 21 CFR 176.300).

( 2) The registrant must clarify the labeling to show the label rates( ranges) for the paper coating Page 60 of 66 uses. Several labels bear paper coating uses but the use rate for application to the coating is unclear. Example: EPA Reg.# 1448 37. The label states: " Rate of application will vary per coating rate." The registrant must clarify the labeling to show the label rates( ranges) for the paper coating uses.

( 3) In recent correspondence with the registrant ( e mail response dated 12/ 14/ 2005), the registrant states, " It might be more efficient to put limitations in the label use directions in which text is added stating in effect of ` Not for use in coatings intended for food contact'. Will this suffice?" The Agency does not consider label restrictions such as, " Not for food contact use", to be practical. The Agency would consider a label restriction( s) for paper that defines the type of paper that is to be treated; e. g., use sites such as wallboard paper, insulation backing, newsprint, photographic paper, drawing paper, etc. for label restrictions that preclude food contact as practical. These types of paper are not likely to be used for food contact.

The registrant could also revise the slimicide use on the labels in the same manner that the Agency has suggested above for the paper coating use; i. e. define the type of paper that is to be treated. This would help preclude food contact with TCMTB treated paper.

Residue Chemistry Deficiencies and Regulatory Guidelines for Agricultural Uses ( 1) Confirmatory metabolism data should be submitted depicting the nature of residues in wheat, cotton, and sugar beets; ( 2) The available enforcement method ( Method B in PAM Vol. II.) is outdated and uses toxic reagents; therefore, if an additional method that is adequate for tolerance enforcement is available, it should be submitted immediately for review; ( 3) Storage stability data were not included with the original field trial data submissions; therefore, storage stability data for the previously submitted field trials are required and should be submitted immediately; ( 4) Storage stability and method data were not provided with the original soil persistence studies summarized under OPPTS 860.1850 in this document. Storage stability and method data are required and should be submitted immediately; ( 5) Application rates in lbs a. i./ 100 lbs seed for all the submitted field trial studies should be provided; ( 6) Tolerances for barley hay and cotton gin byproducts should be proposed once the requested metabolism data are submitted and reviewed; ( 7) Data should be submitted which show whether residues concentrate in the byproducts of the registered raw agricultural commodities; ( 8) Magnitude of residue data in sugar beets following all OPPTS 860 Series Guidelines should be submitted; ( 9) Additionally, numerous OPPTS 860 Series Guidelines have been placed on reserve pending the requested plant metabolism data.

Residential/ Occupational Data Gaps. Confirmatory worker exposure data are necessary, due to the significant limitations of the existing exposure data used in this assessment. The Agency is requesting worker exposure studies that evaluate both dermal ( Guideline 875.1200) and inhalation ( Guideline 875.1400) exposure for indoor uses. The Agency also requires confirmation of descriptions of human activity ( 875.2800) associated with the uses assessed in this document. Page 61 of 66 In addition, the Agency requests confirmatory data to support the assumption that only 5% of TCMTB is transferred from treated textiles/ leather to skin.

Environmental Fate Data Gaps: The following data requirements are outstanding for the currently registered wood preservation and seed treatment uses of TCMTB: Hydrolysis ( 161 1), Aerobic soil metabolism ( 162 1), Anaerobic soil metabolism ( 162 2), Aerobic aquatic metabolism ( 162 4), and Soil column leaching study ( 163 1).

The following data requirements are reserved for TCMTB, pending the results of lower tier testing and exposure modeling: Terrestrial field dissipation ( 164 1) ( seed treatment and wood preservation), and Aquatic field dissipation ( 164 2) ( wood preservation)

Two hydrolysis studies ( OPP guideline 161 1) were reviewed by the Agency and found scientifically valid. However, information on instrumental conditions, mass spectrum, pH and temperature, and limits of detection was missing. The hydrolysis data requirement for TCMTB has been partially fulfilled. Additional data are necessary.

This aerobic aquatic metabolism study ( Guideline No. OPP 162 4) was reviewed by the Agency and found scientifically valid. However, the study does not meet guidelines for the fulfillment of data requirements for TCMTB on aerobic aquatic metabolism. A degradate present at $ 10% of the applied radioactivity was not identified, and characterization of the sediment and water was inadequate. Additional data are necessary.

This aerobic soil metabolism study ( MRID No. 435322 01, Guideline No. OPP 162 1) was reviewed by the Agency and found scientifically valid. However, the study does not meet guidelines for the fulfillment of data requirements for TCMTB on aerobic soil metabolism. The study was not conducted for a sufficient length of time to establish the patterns for the formation and/ or decline of major degradates. Additional data are necessary.

This aqueous availability study ( Guideline No. European Standard EN 84, MRID No. 441198 02) was reviewed by the Agency and found useful in providing supplemental leaching information for the environmental fate assessment of TCMTB. However, this study was not performed according to the American Wood Preservers =

Association Standard: " Standard Method of Determining Leachability of Wood Preservatives" ( 1998; E11 97; 324 326). This study should be repeated following these guidelines.

Ecological Data Gaps. The following data requirements are outstanding for the currently registered wood preservation and/ or seed treatment uses of TCMTB: Aquatic invertebrate life cycle study ( 72 4b/ 850.1400), Tier II seedling emergence and vegetative vigor with rice ( 123 1/ 850.4225 and 850.4250), Tier I seedling emergence for 10 species of terrestrial plant ( 122 1/ 850.4100), and Algal Toxicity ( 123 2/ 850.5400). In addition, the Agency requests a monitoring study of runoff from antisapstain facilities to establish EEC's for risk assessment.

The following data requirement is reserved for TCMTB, pending the results of Tier I testing: Tier II seedling emergence with 10 species of terrestrial plant ( 123 1/ 850.4100). Page 62 of 66 Label Hazard Statements/ Use Recommendations The following ecological effects/ environmental risk statements are required for TCMTB labels: " This product is toxic to fish, aquatic invertebrates, oysters and shrimp."

" Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System ( NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA."

Antisapstain labels must state: " Treated lumber must not be stored outdoors without precautions to prevent to prevent leaching by rainfall to the environment. Suitable precautions include: covering wood with plastic or other impervious covering, installation of berms and placement of plastic under the wood to prevent surface water runoff away from the storage area."

12.0 REFERENCES Accession # 009869. Booden, R. M. 1974. Avian Dietary LC50, Mallard Duck, Report # 4043620. Unpublished data, conducted by Warf Institute for Buckman Laboratories, Memphis, TN.

Accession # 091624. Knott, W. B., and G. Woodard. 1968a. Busan 72   Safety Evaluation on Bobwhite Quail. Unpublished data, conducted by Woodard Research Corp., for Buckman Laboratories, Inc., Memphis, TN.

Accession # 091624. Knott, W. B., and G. Woodard. 1968b. Busan 72   Safety Evaluation on Bluegill Sunfish and Rainbow Trout. Unpublished data, conducted by Woodard Research Corp., for Buckman Laboratories, Inc., Memphis, TN MRID # 403636 01. Surprenant, D. C. 1986a. Acute Toxicity of TCMTB to the Sheepshead Minnow, Cyprinodon variegatus. Unpublished data, conducted by Springborn Bionomics, Inc., for Buckman Laboratories, Inc., Memphis, TN MRID # 403363 02. Surprenant, D. C. 1987. Acute Toxicity of TCMTB to Mysid Shrimp ( Mysidopsis bahia). Unpublished data, conducted by Springborn Bionomics, Inc., for Buckman Laboratories, Inc., Memphis, TN.

MRID # 403636 03. Surprenant, D. C. 1986b. Acute Toxicity of TCMTB to Embryo Larvae of the Quahog Clam ( Mercenaria mercenaria). Unpublished data, conducted by Springborn Bionomics, Inc., for Buckman Laboratories, Inc., Memphis, TN.

MRID # 415956 01. Long, R. D., C. P. Driscoll, K. A. Hoxter, and G. J. Smith. 1990. TCMTB: A Dietary LC50 Study with the Mallard. Unpublished data, conducted by Wildlife International, Page 63 of 66 Ltd., for Buckman Laboratories, Inc., Memphis, TN.

MRID # 415956 02. Long, R. D., C. P. Driscoll, K. A. Hoxter, and G. J. Smith. 1990. TCMTB: A Dietary LC50 Study with the Northern Bobwhite. Unpublished data, conducted by Wildlife International, Ltd., for Buckman Laboratories, Inc., Memphis, TN.

MRID # 417809 01. Campbell, S. 1991. TCMTB: An Acute Oral Toxicity Study with the Northern Bobwhite." Unpublished data, conducted by Wildlife International, Ltd., for Buckman Laboratories, Memphis, TN MRID # 418042 01. Machado, M. W. 1991a. TCMTB   Acute Toxicity to Bluegill Sunfish ( Lepomis macrochirus) under Flow through Conditions. Unpublished data, conducted by Springborn Laboratories, Inc., for Buckman Laboratories, Inc., Memphis, TN.

MRID # 418181 01. Machado, M. W. 1991b. TCMTB   Acute Toxicity to Rainbow Trout ( Oncorhynchus mykiss) under Flow through Conditions. Unpublished data, conducted by Springborn Laboratories, Inc., for Buckman Laboratories, Inc., Memphis, TN MRID # 418382 01. McNamara, P. C. 1991. TCMTB   Acute Toxicity to Daphnids ( Daphnia magna) Under Flow Through Conditions. Unpublished data, conducted by Springborn Laboratories, Inc, for Buckman Laboratories, Inc., Memphis, TN.

MRID # 422260 01. Collins, M. K. 1992b. 2 Mercaptobenzothiazole ( ROKON)   Acute Toxicity to Daphnids ( Daphnia magna) Under Static Conditions. Unpublished data, conducted by Springborn Laboratories, Inc., for R. T. Vanderbilt Ct., Inc., Norwalk, CT.

MRID # 422322 01. Collins, M. K. 1992a. 2 Mercaptobenzothiazole ( ROKON)   Acute Toxicity to Rainbow Trout ( Oncorhynchus mykiss) Under Static Conditions. Unpublished data, conducted by Springborn Laboratories, Inc., for R. T. Vanderbilt Ct., Inc., Norwalk, CT MRID # 422671 01. Pedersen, C. A., and B. R. Helsten. 1992a. 2 Mercaptobenzothiazole ( ROKON): 14 day Acute Oral LD50 Study in Bobwhite Quail. Unpublished data, conducted by Bio Life Associates, Ltd., for R. T. Vanderbilt Co., Inc., Norwalk, CT.

MRID # 424285 01. Pedersen, C. A., and B. R. Helsten. 1992b. 2 Mercaptobenziothiazol ( ROKON): 8 Day Acute Dietary LC50 Study in Bobwhite Quail. Unpublished data, conducted by Bio Life Associates, Ltd., for R. T. Vanderbilt Co., Norwalk, CT.

MRID # 425929 01. Rhodes, J. E. 1992. Early Life Stage Toxicity of 2( Thiocyanomethylthio) benzothiazole ( TCMTB) to the Rainbow Trout Under Flow Through Conditions. Unpublished data, conducted b ABC Laboratories, Inc., for Buckman Laboratories International, Inc., Memphis, TN.

MRID # 442009 01. Thompson, S. G., and J. P. Swigert. 1996. TCMTB: A 14 Day Static Renewal Toxicity Test with Duckweed ( Lemna gibba). Unpublished data, conducted by Wildlife International, Ltd., for Buckman Laboratories International, Inc., Memphis, TN. Page 64 of 66 Additional References:

Aschacher G and Gruendlinger R, 2000. Methods to evaluate the ecotoxicological risks of anti sapstain preservatives. Holzforschung, Austria Research and Development. www. holzforschung. at/ english/ img_ eng/ ascha200. pdf.

Addinsoft, 2004. XLSTAT v7.5. http:// www. xlstat. com.

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Chew, G. L., G. M. Kruzynski, and I. K. Birtwell. Behavioural assessment of exposure of juvenile Chinook salmon ( Oncorhynchus tshawtscha) to sublethal doses of a toxicant. In Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop, Nov. 5 7, 1990, Vancouver, BC, Vol. 1. ( edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M. Nassichuk and W. Knapp). Canadian Technical report of Fisheries and Aquatic Sciences, No. 1774 ( vol 1).

Karickhoff SW, DS Brown, TA Scott, 1979. Sorption of Hydrophobic Pollutants on Natural Sediments. Water Resources. 13: 241 248.

Krahn P and Strub R, 1990. Standard Leaching Test for Antisapstain Chemicals: Regional Program Report 90 10. Environment Canada, Conservation and Protection, Pacific and Yukon Region North Vancouver, BC.

Kruzynski, G. M., and I. K. Birtwell. 1990. Some Respiratory Responses of Juvenile Pacific Salmon to the Antisapstain Chemical TCMTB. In Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop, Nov. 5 7, 1990, Vancouver, BC, Vol. 1. ( edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M. Nassichuk and W. Knapp). Canadian Technical report of Fisheries and Aquatic Sciences, No. 1774 ( vol 1).

Kruzynski, G. M., I. K. Birtwell, G. L. Chew, G. E. Piercey, and S. Spohn. 1990. An approach to testing for ecological relevance using behavioral toxicology. . In Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop, Nov. 5 7, 1990, Vancouver, BC, Vol. 1. ( edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M. Nassichuk and W. Knapp). Canadian Technical report of Fisheries and Aquatic Sciences, No. 1774 ( vol 1).

Lee R, 2004. WLM recommendation regarding chemical generalization. Memorandum to Siroos Mostaghimi, USEPA. December 15, 2004.

Mineau, P., B. T. Collins, and A. Baril. 1996. On the Use of Scaling Factors to Improve Interspecies Extrapolation of Acute Toxicity in Birds. Regul Toxicol Pharmacol 24; 24 29.

USEPA. 2006. Office of Pesticide Programs internal memorandum, " Aquatic Exposure Assessment for the Use of the Fungicide of 2 Thiocyanomethylthio) benzothiazole ( TCMTB) as a Seed Treatment on Cotton, Wheat, Barley, Oats, Rice, Sugar Beets, and Safflower," February 16, 2006. Page 65 of 66 USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, 1/ 23/ 04.

US EPA. 1979. TN 2432. Biological Report of Analysis, 90+ TCMTB, sample MB618. Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.

US EPA. 1979. TN 2427. Biological Report of Analysis, 90+ TCMTB, sample MB618. Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.

US EPA. 1980. TN 2437. Biological Report of Analysis, 90+ TCMTB, sample MB618. Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.

USEPA, 2004. Wood Leaching Model: Chemical Concentration Screening Tool, v1.0. USEPA/ OPPT/ AD, developed by Versar, Inc. Page 66 of 66


political subdivisions, or any agency or instrumentality of a state or
its political subdivisions, for the benefit of its employees, if such
plan has total assets in excess of $5,000,000; any employee benefit
plan within the meaning of the Employee Retirement Income Security Act
of 1974 if the investment decision is made by a plan fiduciary, as
defined in section 3(21) of such act, which is either a bank, savings
and loan association, insurance company, or registered investment
adviser, or if the employee benefit plan has total assets in excess of
$5,000,000 or, if a self-directed plan, with investment decisions made
solely by persons that are accredited investors;
* * * * *
    (3) Any organization described in section 501(c)(3) of the Internal
Revenue Code, corporation, Massachusetts or similar business trust,
partnership, or limited liability company, not formed for the specific
purpose of acquiring the securities offered, with total assets in
excess of $5,000,000;
* * * * *
    (5) Any natural person whose individual net worth, or joint net
worth with that person's spouse or spousal equivalent, exceeds
$1,000,000;
* * * * *

    Note 1 to paragraph (a)(5):  For the purposes of calculating
joint net worth in this paragraph (a)(5): Joint net worth can be the
aggregate net worth of the investor and spouse or spousal
equivalent; assets need not be held jointly to be included in the
calculation. Reliance on the joint net worth standard of this
paragraph (a)(5) does not require that the securities be purchased
jointly.

    (6) Any natural person who had an individual income in excess of
$200,000 in each of the two most recent years or joint income with that
person's spouse or spousal equivalent in excess of $300,000 in each of
those years and has a reasonable expectation of reaching the same
income level in the current year;
* * * * *
    (8) * * *

    Note 1 to paragraph (a)(8):  It is permissible to look through
various forms of equity ownership to natural persons in determining
the accredited investor status of entities under this paragraph
(a)(8). If those natural persons are themselves accredited
investors, and if all other equity owners of the entity seeking
accredited investor status are accredited investors, then this
paragraph (a)(8) may be available.

    (9) Any entity, of a type not listed in paragraph (a)(1), (2), (3),
(7), or (8), not formed for the specific purpose of acquiring the
securities offered, owning investments in excess of $5,000,000;

    Note 1 to paragraph (a)(9):  For the purposes this paragraph
(a)(9), ``investments'' is defined in rule 2a51-1(b) under the
Investment Company Act of 1940 (17 CFR 270.2a51-1(b)).

    (10) Any natural person holding in good standing one or more
professional certifications or designations or credentials from an
accredited educational institution that the Commission has designated
as qualifying an individual for accredited investor status. In
determining whether to designate a professional certification or
designation or credential from an accredited educational institution
for purposes of this paragraph (a)(10), the Commission will consider,
among others, the following attributes:
    (i) The certification, designation, or credential arises out of an
examination or series of examinations administered by a self-regulatory
organization or other industry body or is issued by an accredited
educational institution;
    (ii) The examination or series of examinations is designed to
reliably and validly demonstrate an individual's comprehension and
sophistication in the areas of securities and investing;
    (iii) Persons obtaining such certification, designation, or
credential can reasonably be expected to have sufficient knowledge and
experience in financial and business matters to evaluate the merits and
risks of a prospective investment; and
    (iv) An indication that an individual holds the certification or
designation is either made publicly available by the relevant self-
regulatory organization or other industry body or is otherwise
independently verifiable;

    Note 1 to paragraph (a)(10):  The Commission will designate
professional certifications or designations or credentials for
purposes of this paragraph (a)(10), by order, after notice and an
opportunity for public comment. The professional certifications or
designations or credentials currently recognized by the Commission
as satisfying the above criteria will be posted on the Commission's
website.

    (11) Any natural person who is a ``knowledgeable employee,'' as
defined in rule 3c-5(a)(4) under the Investment Company Act of 1940 (17
CFR 270.3c-5(a)(4)), of the issuer of the securities being offered or
sold where the issuer would be an investment company, as defined in
section 3 of such act, but for the exclusion provided by either section
3(c)(1) or section 3(c)(7) of such act;
    (12) Any ``family office,'' as defined in rule 202(a)(11)(G)-1
under the Investment Advisers Act of 1940 (17 CFR 275.202(a)(11)(G)-1):
    (i) With assets under management in excess of $5,000,000,
    (ii) That is not formed for the specific purpose of acquiring the
securities offered, and
    (iii) Whose prospective investment is directed by a person who has
such knowledge and experience in financial and business matters that
such family office is capable of evaluating the merits and risks of the
prospective investment; and
    (13) Any ``family client,'' as defined in rule 202(a)(11)(G)-1
under the

Investment Advisers Act of 1940 (17 CFR 275.202(a)(11)(G)-1)), of a
family office meeting the requirements in paragraph (a)(12) of this
section and whose prospective investment in the issuer is directed by
such family office pursuant to paragraph (a)(12)(iii).
* * * * *
    (j) Spousal equivalent. The term spousal equivalent shall mean a
cohabitant occupying a relationship generally equivalent to that of a
spouse.
* * * * *

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

0
6. The authority citation for part 240 continues to read in part as
follows:

    Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f,
78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78o, 78o-4,
78o-10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78x, 78ll, 78mm, 80a-20,
80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, 7201 et seq.; and
8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18 U.S.C. 1350; and
Pub. L. 111-203, 939A, 124 Stat. 1887 (2010); and secs. 503 and 602,
Pub. L. 112-106, 126 Stat. 326 (2012), unless otherwise noted.
* * * * *

0
7. Amend Sec.  240.15g-1 by revising paragraph (b), adding a note to
paragraph (b), and revising paragraph (c) to read as follows:

Sec.  240.15g-1  Exemptions for certain transactions.

* * * * *
    (b) Transactions in which the customer is an institutional
accredited investor, as defined in 17 CFR 230.501(a)(1), (2), (3), (7),
(8), (9), (12), or (13).

    Note 1 to paragraph (b): Though the definition of ``family
client'' from rule 501(a)(13) includes both natural persons and
institutions, only family clients that are institutions may be
considered institutional accredited investors.

    (c) Transactions that meet the requirements of Regulation D (17 CFR
230.500 et seq.), or transactions with an issuer not involving any
public offering pursuant to section 4(a)(2) of the Securities Act of
1933.
* * * * *

    By the Commission.

    Dated: August 26, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-19189 Filed 10-8-20; 8:45 am]
BILLING CODE 8011-01-P


44946 Federal Register / Vol. 68, No. 147 / Thursday, July 31, 2003 / Notices An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 255 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners/ operators of shipbuilding and ship repair facilities. Estimated Number of Respondents: 56. Frequency of Response: Initial, semiannual. Estimated Total Annual Hour Burden: 28,594 ( rounded) hours. Estimated Total Capital and Operations & Maintenance ( O & M) Annual Costs: $ 0. Changes in the Estimates: There is an increase of 6,445 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. The adjustment increase in burden is due to more accurate estimates of existing and anticipated new sources, and an improved calculation of burden for the reporting requirements.

Dated: July 23, 2003.

Doreen Sterling,

Acting Director, Collection Strategies Division. [ FR Doc. 03   19501 Filed 7   30   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ SFUND   2003   0003; FRL   7538   3]

Agency Information Collection Activities; Submission of EPA ICR No. 1428.06 ( OMB No. 2050   0078) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Trade Secret Claims for Emergency Planning and Community Right to Know ( EPCRA Section 322). This ICR describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before September 2, 2003.

ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sicy Jacob, Chemical Emergency Preparedness and Prevention Office ( CEPPO), OSWER, Mailcode 5104A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564   8019; fax number: ( 202) 564   8233; e mail address: jacob. sicy@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On March 6, 2003 ( 68 FR 10721), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA did not receive any comments. EPA has established a public docket for this ICR under Docket ID No. SFUND   2003   0003, which is available for public viewing at the Superfund Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Superfund Docket is ( 202) 566   0276. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to superfund. docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Superfund Docket, Mailcode 5202T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov/ edocket. Title: Trade Secret Claims for Emergency Planning and Community Right to Know and Emergency Planning ( EPCRA Section 322), ( OMB Control Number 2050   0078, EPA ICR Number 1428.06). This is a request to renew an existing approved collection that is scheduled to expire on September 30, 2003. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: This information collection request pertains to trade secrecy claims submitted under section 322 of the VerDate jul< 14> 2003 16: 42 Jul 30, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31JYN1. SGM 31JYN1 44947 Federal Register / Vol. 68, No. 147 / Thursday, July 31, 2003 / Notices Emergency Planning and Community Right to Know Act of 1986 ( EPCRA), also known as Title III of SARA, the Superfund Amendments and Reauthorization Act. Title III contains provisions requiring facilities to report to State and local authorities, and EPA, the presence, use and release of extremely hazardous substances ( described in sections 302 and 304) and hazardous and toxic chemicals ( described in sections 311, 312 and 313 respectively). Section 322 of Title III allows a facility to withhold the specific chemical identity from these Title III reports if the facility asserts a claim of trade secrecy for that chemical identity. The provision establishes the requirements and procedures that facilities must follow to request trade secrecy treatment of chemical identities, as well as the procedures for submitting public petitions to the Agency for review of the `` sufficiency'' of trade secrecy claims. EPA published the trade secrecy regulations on July 29, 1988 ( 58 FR 28772), codified in 40 CFR Part 350. Trade secrecy protection is provided for specific chemical identities contained in reports submitted under each of the following Title III sections: ( 1) 303 ( d)( 2)   Facility notification of changes that have or are about to occur; ( 2) 303 ( d)( 3)   Local Emergency Planning Committee ( LEPC) requests for facility information to develop or implement emergency plans; ( 3) 311   Material Safety Data Sheets ( MSDSs) submitted by facilities, or lists of those chemicals submitted in place of the MSDSs; ( 4) 312   Tier II emergency and hazardous chemical inventory forms; and, ( 5) 313   Toxic chemical release inventory forms. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 10 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Facilities that may want to claim trade secret for specific chemical identity contained in reports submitted under EPCRA sections 303( d)( 2) and ( d)( 3), 311, 312, and 313; members of the general public submitting petitions for trade secrets claimed by facilities; and State governors or State Emergency Response Commissions and Health Professionals requesting facilities for information on the health effects of trade secret chemicals in nonemergency and preventative measure situations. Estimated Number of Respondents: 357. Frequency of Response: Annually. Estimated Total Annual Hour Burden: 3,483 hours. Estimated Total Annual Cost: $ 147,543. No capital or operation and maintenance costs are associated with any requirements in this ICR. Changes in the Estimates: There is an increase of 362 hours in the total annual estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This is due to an increase in the number of claims submitted under sections 303( d)( 2), ( d)( 3), 311 and 312 of EPCRA. Trade secret claims under section 313 have decreased from previous ICR.

Dated: July 23, 2003. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 03   19502 Filed 7   30   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OAR   2003   0018, FRL   7538   2]

Agency Information Collection Activities; Submission of EPA ICR No. 1626.08 ( OMB No. 2060   0256) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: National Refrigerant Recycling and Emissions Reduction Program. This ICR describes the nature of the information collection and its expected burden and cost. DATES: Additional comments may be submitted on or before September 2, 2003.

ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Julius Banks, Global Programs Division, Office of Air and Radiation, Office of Atmospheric Programs; Mail Code 6205J; Environmental Protection Agency; 1200 Pennsylvania Ave., NW; Washington, DC 20460; telephone number: ( 202) 564   9870; fax number: ( 202) 565   2096; e mail address: banks. julius@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On March 10, 2003 ( 68 FR 11389), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OAR   2003   0018, which is available for public viewing at the Air and Radiation Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Air and Radiation Docket and Information Center is ( 202) 566   1742. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at: http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to OMB and EPA within 30 days of this notice, and according to the following detailed instructions: ( 1) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB),

VerDate jul< 14> 2003 16: 42 Jul 30, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31JYN1. SGM 31JYN1