  SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision for Metam-sodium, Metam-potassium, and MITC (PC 039003, 039002, 068103)

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the reregistration for active ingredients within the case covered by this RED.  It contains generic data requirements that apply to metam-sodium, metam-potassium, and MITC in all products, including data requirements for which a “typical formulation” is the test substance.

The data table is organized in the following formats:

Data requirement (Column 1).  The data requirements are listed in the order in which they appear in 40 CFR 158.  The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which is available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161.  (703) 487-4650.

Use Pattern (Column 2).  This column indicates the use patterns for which the data requirements apply.  The following letter designations are used for the given use patterns.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

  Indoor non-food

  Indoor medical

  Indoor residential

X .   Materials preservatives

Y.    Industrial processes and    water systems-once through

Z.    Industrial processes and water  systems-not once through

BB. Wood preservatives

FF.  High Exposure Antimicrobial

GG. Low Exposure Antimicrobial

3.  Bibliographic Citation (Column 3).  If the Agency has acceptable data in its files, this column lists the identifying number of each study.  This normally is the Master Record Identification (MRID) number, but may be a “GS” number is no MRID number has been assigned.  Refer to the Bibliography appendix for a complete citation of the study.

Data Requirement	Use Patterns	Citations

New Guideline Number	Old Guideline Number	Description

PRODUCT CHEMISTRY

830.1600	61-2A	Description of materials used to produce the product	ALL 41241601, 44453602, 00162081, 44459101, 43953901

830.1620	61-2B	Description of production process	ALL	41241601, 44453602, 00162081, 44459101, 43953901

830.1670	61-2B	Formation of Impurities	ALL	41241601, 44453602, 00162081, 43953901

830.1700	62-1	Preliminary Analysis	ALL	41241602, 44453603, 00162080

830.6302	63-2	Color	ALL	41241603, 41286003, 00162079, 45919401

830.6303	63-3	Physical State	ALL	41241603, 41286003, 43457708, 00162079, 45919401

830.6304

	63-4	Odor	ALL	41241603, 41286003, 43457708, 00162079, 45919401

830.6313	63-13	Stability to normal and elevated temperatures, metals, and metal ions	ALL	41241603, 41286003, 00162079

830.7000	63-12	pH	ALL	41241603, 41286003, 43457708, 00162079

830.7050	None	UV/Visible Absorption	ALL	45919401, 45919401, DATA GAP

830.7200

Melting Point/melting range	ALL	45919401

830.7220	63-6	Boiling Point/boiling range	ALL	41241603, 41286003, 45919401

830.7300	63-7	Density	ALL	41241603, 41286003, 43457708, 00162079, 45919401

830.7370	63-10	Dissociation Constants in Water	ALL	41241603, 41286003, 45919404,

830.7550	63-11	Partition coefficient, shake flask method	ALL	41241603, 41286003, 45919401

830.7840	63-8	Water solubility: column elution method; shake flask method	ALL	41241603, 41286003, 45919401, 45919403

830.7950

	63-9	Vapor Pressure	ALL	41241603, 41286003, 45919401

ECOLOGICAL EFFECTS

850.1010	72-2   	Acute Toxicity to Freshwater Invertebrates	ALL 41106203, 40098001, 42680601, 41819302, 45919419

850.1025	72-3B	Estuarine/Marine Toxicity – Mollusk	ALL	42632201, DATA GAP

850.1035	72-3C	Estuarine/Marine Toxicity – Shrimp	ALL	42476301, 43457708, DATA GAP

850.1075	72-1A	Fish Acute Toxicity Bluegill	ALL	42363201, 44523412 , DATA GAP

850.1075	72-1B	Fish Acute Toxicity – Rainbow Trout	ALL	42363202, 44523413, 45919420

850.1075	72-3A	Estuarine/Marine Toxicity – Fish	ALL	42436301, DATA GAP

850.1300

Aquatic Invertebrate Lifecycle (Freshwater)	ALL	45634001

850.2100	71-1A	Avian Acute Oral Toxicity – Mallard 	ALL	41476402

850.2200	71-2a,b	Avian Dietary	ALL	41476403, 42914001, 00022923,

42914002, 41476401, 00022923

850.2300

Avian Reproduction	ALL	DATA GAP

850.3020	141-1

	Honey bee acute contact LD50	ALL	00018842, DATA GAP

850.4225	122-1(a)	Seedling Emergence, Tier II	ALL	DATA GAP

850.4250	122-1(b)	Vegetative Vigor, Tier II	ALL	45919421, 45919422, 45919416, 44588903, DATA GAP

850.5400	122-2B	Aquatic Plant Growth, Tier II	ALL	DATA GAP

RESIDUE CHEMISTRY

860.1300

Nature of the Residue - Plants	C, I	41137101 41137102

41137103 436326024

92097021

860.1340

Residue Analytical Method - Plants	C, I	41142502 41631102

41631104 436326014

92098034

860.1360

Multiresidue Method	C, I	41631103

860.1500

Crop Field Trials	C, I	40951601 40951602

40951603 40951606

40951607 40951608

40951609 41097001 41097002 41097003

41142501 41142502

41142503 41218101

41218102 41218103

41218104 92098035

92098036 92098037

92098038 92098039

92098040 92098041

92098042 92098043

92098044 92098045

92098046 92098047

92098048 92098049

92098050 92098051

92098052 92098053

92098054 92098055, 45703705 43703706 43703707 45123901

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity - Rat	ALL	41277002, 00162331

870.1200	81-2	Acute Dermal Toxicity – Rat	ALL	41277003, 00162330, 42442501

870.1300	81-3	Acute Inhalation Toxicity – Rat 	ALL	41277004, 00162327, 42365605

870.2400	81-4	Primary Eye Irritation  - Rabbit	ALL	44400401, 41277005, 00162328

870.2500	81-5	Primary Skin Irritation – Rabbit 	ALL	41277006, 00162329

870.2600	81-6	Dermal Sensitization	ALL	41277007

870.3200	82-2	21-Day Dermal – Rabbit/Rat	ALL

	870.3100

Subchronic Feeding – Rat/Mouse 	ALL	41865502, 42117302, 42117301

870.3150

Subchronic Feeding – Dog 	ALL

	870.3465	82-5	90- Day Inhalation Toxicity – Rat/Mouse	ALL	00162041, 43514802, 00162041

870.3700	83-3A	Developmental Toxicity – Rat	ALL	41577101, DATA GAP

870.3800	83-4	Reproduction and Developmental Effects	ALL	DATA GAP

870.4100	83-1B	Chronic Feeding Toxicity Study - Dog	ALL	43275801

870.4200	83-2	Carcinogenicity – Mouse/Rat	ALL	47067501, 43275802, DATA GAP

870.5100	84-2	Bacterial Reverse Mutation Test (Ames Assay)	ALL	40305602, 305603

870.5375	84-2	Chromosomal Aberration in Chinese Hamster Ovary	ALL 40305605

870.5395	84-2	Unscheduled DNA Synthesis – Rat 	ALL	40305601, DATA GAP

870.5700	84-2	In vitro mammalian gene mutation test	ALL	40305604

870.6200a	81-8   	Acute neurotoxicity screen study in rats, Inhalation Acute Neurotoxicity	ALL	43465302, 42977801,

42977802, DATA GAP

870.7800	85-7	Immunotoxicity	ALL	DATA GAP

ENVIRONMENTAL FATE

835.1230	163-1	Soil Adsorption	ALL	00152844

835.1240	163-1	Leaching/Adsorption/Desorption	ALL	47010302

835.8100	163-3	Field Volatility	ALL	47066501, 45703701, 45703702, 46969601, 47572201, 47131601, 47314301, 45703708, 45703704, 42659901, 46379201, 47770001, 48011601, 48005901, 47956901, 48115101, 47813901, 47956701, DATA GAP

835.2120	161-1	Hydrolysis	ALL	41631101, 00158162

835.2240	161-2	Photodegradation - Water	ALL	41517701

835.2410	161-3	Photodegradation - Soil	ALL	42978701

835.4100	162-1	Aerobic Soil Metabolism	ALL	40198502

835.4400	162-3	Anaerobic Aquatic Metabolism	ALL	43596501

835.6100	164-1	Terrestrial Field Dissipation	ALL	41514402, 41798601

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

875.1100

Dermal Exposure – Outdoor	F	DATA GAP

875.1200	233	Dermal Exposure – Indoor	X, Y, Z, BB, FF, GG	DATA GAP

875.1300	232	Inhalation Exposure – Outdoor (Applicator)	X, Y, Z, BB, FF, GG	42968401, 45123902, 45703703,

875.1400	234	Inhalation Exposure – Indoor	X, Y, Z, BB, FF, GG	DATA GAP

875.1600	235	Application exposure monitoring data reporting	X, Y, Z, BB, FF, GG	DATA GAP

875.1700	236	Product Use Information	X, Y, Z, BB, FF, GG	DATA GAP

875.2500	133-4	Inhalation Exposure – Outdoor (Post-Application)	X, Y, Z, BB, FF, GG	42968402, 45703703, DATA GAP

875.2700	235	Product Use Information	X, Y, Z, BB, FF, GG	DATA GAP

875.2800	133-1	Description of Human Activity	X, Y, Z, BB, FF, GG	DATA GAP

875.2900	134	Data Reporting and Calculations	X, Y, Z, BB, FF, GG	DATA GAP

Special 	NA	Fumigant Buffer Zone Posting Signs	C, I	DATA GAP

Special 	NA	Training for Applicators Supervising Fumigations	C, I	DATA GAP

Special	NA	Training Material for Handlers	C, I	DATA GAP


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59765-59766]
[FR Doc No: 2015-25125]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP15-1286-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Contract--
140766 to be effective 10/21/2015.
    Filed Date: 9/21/15.
    Accession Number: 20150921-5166.
    Comments Due: 5 p.m. ET 10/5/15.

    Docket Numbers: RP15-1287-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Sec.  4(d) Rate Filing: Northern Access 2015 to be
effective 11/1/2015.
    Filed Date: 9/22/15.
    Accession Number: 20150922-5116.
    Comments Due: 5 p.m. ET 10/5/15.

    Docket Numbers: RP15-1288-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Sec.  4(d) Rate Filing: Tuscarora Lateral (Supply CF)
to be effective 11/1/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5067.
    Comments Due: 5 p.m. ET 10/6/15.

    Docket Numbers: RP15-1289-000.
    Applicants: Enable Mississippi River Transmission, L.
    Description: 2015 Annual Penalty Revenue Credit Filing of Enable
Mississippi River Transmission, LLC under New Docket.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5071.
    Comments Due: 5 p.m. ET 10/6/15.

    Docket Numbers: RP15-1290-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Sec.  4(d) Rate Filing: DPEs-NYFG and UGI to be
effective 10/25/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5134.
    Comments Due: 5 p.m. ET 10/6/15.

    Docket Numbers: RP15-1291-000.
    Applicants: Questar Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Statement of Negotiated Rates
Version 11.0.0 to be effective 9/25/2015.
    Filed Date: 9/25/15.
    Accession Number: 20150925-5002.
    Comments Due: 5 p.m. ET 10/7/15.

    Docket Numbers: RP15-1292-000.
    Applicants: North Baja Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: TC Plus Revisions_Cleanup to
be effective 10/26/2015.
    Filed Date: 9/25/15.
    Accession Number: 20150925-5027.
    Comments Due: 5 p.m. ET 10/7/15.

    Docket Numbers: RP15-1293-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Pipeline Safety and Greenhouse
Gas Cost Adjustment Mechanism--2015 to be effective 11/1/2015.

    Filed Date: 9/25/15.
    Accession Number: 20150925-5133.
    Comments Due: 5 p.m. ET 10/7/15.

    Docket Numbers: RP15-1294-000.
    Applicants: Gas Transmission Northwest LLC.
    Description: Sec.  4(d) Rate Filing: Compliance to Docket CP12-494-
000--Carty Lateral Project to be effective 12/31/9998.
    Filed Date: 9/25/15.
    Accession Number: 20150925-5155.
    Comments Due: 5 p.m. ET 10/7/15.

    Docket Numbers: RP15-1295-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg. Rate Agrmts
with Antero Resources et al. to be effective 11/1/2015.
    Filed Date: 9/25/15.
    Accession Number: 20150925-5233.
    Comments Due: 5 p.m. ET 10/7/15.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP15-1147-001.
    Applicants: Horizon Pipeline Company, L.L.C.
    Description: Compliance filing Compliance Filing--Docket No. RP15-
1147 to be effective 9/1/2015.
    Filed Date: 9/22/15.
    Accession Number: 20150922-5095.
    Comments Due: 5 p.m. ET 10/5/15.

    Docket Numbers: RP13-886-002.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Compliance filing Rate Case Settlement--2015
Implementation to be effective 11/1/2015.
    Filed Date: 9/25/15.
    Accession Number: 20150925-5212.
    Comments Due: 5 p.m. ET 10/7/15.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 28, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-25125 Filed 10-1-15; 8:45 am]
BILLING CODE 6717-01-P


notice (PMN) or consolidated PMN submitted in accordance with part 720
of this chapter.
    (ii) Significant new use notice. Persons shall remit a fee totaling
$7,880 for each significant new use notice (SNUN) submitted in
accordance with part 721 of this chapter.
    (iii) Exemption application. Persons shall remit a fee totaling
$2,650 for each of the following exemption requests submitted under
section 5 of the Act:
    (A) * * *
    (iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $2,650 for each instant photographic film
article exemption notice submitted in accordance with Sec.
[thinsp]723.175 of this chapter.
    (v) Microbial commercial activity notice and consolidated microbial
commercial activity notice. Persons shall remit a fee totaling $7,880
for each microbial commercial activity notice (MCAN) or consolidated
MCAN submitted in accordance with Sec. Sec.  725.25 through 725.36 of
this chapter.
    (vi) Test rule, test order, or enforceable consent agreement.
Persons shall remit a total of twenty percent of the applicable fee
under paragraph (c)(2)(vi), (vii) or (viii) of this section for a test
rule, test order, or enforceable consent agreement.
    (vii) EPA-initiated risk evaluation. Persons shall remit a total
fee of twenty percent of the applicable fee under paragraphs (c)(2)(ix)
of this section for an EPA-initiated risk evaluation.
    (viii) Manufacturer-requested risk evaluation. Persons shall remit
the total fee under paragraph (c)(2)(x) or (xi) of this section, as
applicable, for a manufacturer-requested risk evaluation.
    (2) * * *
    (i) PMN and consolidated PMN. Persons shall remit a fee totaling

$45,000 for each PMN or consolidated PMN submitted in accordance with
part 720 of this chapter.
    (ii) SNUN. Persons shall remit a fee totaling $45,000 for each
significant new use notice submitted in accordance with part 721 of
this chapter.
    (iii) Exemption applications. Persons shall remit a fee totaling
$13,230 for each of the following exemption requests, and modifications
to previous exemption requests, submitted under section 5 of the Act:
    (A) * * *
    (iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $13,230 for each exemption notice submitted
in accordance with Sec.  [thinsp]723.175 of this chapter.
    (v) MCAN and consolidated MCAN. Persons shall remit a fee totaling
$45,000 for each MCAN or consolidated MCAN submitted in accordance with
Sec. Sec.  [thinsp]725.25 through 725.36 of this chapter.
    (vi) Test rule. Persons shall remit a fee totaling $50,000 for each
test rule.
    (vii) Test order. Persons shall remit a fee totaling $25,000 for
each test order.
    (viii) Enforceable consent agreement. Persons shall remit a fee
totaling $50,000 for each enforceable consent agreement.
    (ix) EPA-initiated chemical risk evaluation. Persons shall remit a
fee totaling $5,081,000.
    (x) Manufacturer-requested risk evaluation of a Work Plan Chemical.
Persons shall remit an initial fee of $1,497,000, a second payment of
$1,497,000, and final payment to total 50% of the actual costs of this
activity, in accordance with the procedures in paragraph (g) of this
section. The final payment amount will be determined by EPA, and
invoice issued to the requesting manufacturer.
    (xi) Manufacturer-requested risk evaluation of a non-work plan
chemical. Persons shall remit an initial fee of $2,993,000, a second
payment of $2,993,000, and final payment to total 100% of the actual
costs of the activity, in accordance with the procedures in paragraph
(g) of this section. The final payment amount will be determined by
EPA, and invoice issued to the requesting manufacturer.
* * * * *
    (d) Fees for 2025 fiscal year and beyond.
    (1) Fees for the 2025 and later fiscal years will be adjusted on a
three-year cycle by multiplying the fees in paragraph (c) of this
section by the current PPI index value with a base year of 2023 using
the following formula:

FA = F x I

Where:

FA = the inflation-adjusted future year fee amount.
F = the fee specified in paragraph (c) of this section.
I = Producer Price Index for Chemicals and Allied Products inflation
value with 2023 as a base year.

    (2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption notices,
exemption applications, and manufacturer-requested risk evaluation
requests apply to submissions received by the Agency on or after
October 1 of every three-year fee adjustment cycle beginning in fiscal
year 2023 (October 1, 2022). Updated fee amounts also apply to test
rules, test orders, enforceable consent agreements and EPA-initiated
risk evaluations that are ``noticed'' on or after October 1 of every
three-year fee adjustment cycle, beginning in fiscal year 2025.
    (3) The Agency will initiate public consultation through notice-
and-comment rulemaking prior to making fee adjustments beyond
inflation. If it is determined that no additional adjustment is
necessary beyond for inflation, EPA will provide public notice of the
inflation-adjusted fee amounts through posting to the Agency's web page
by the beginning of each three-year fee adjustment cycle (October 1,
2025, October 1, 2028, etc.). If the Agency determines that adjustments
beyond inflation are necessary, EPA will provide public notice of that
determination and the process to be followed to make those adjustments.
* * * * *
    (f) * * *
    (2) * * *
    (i) The consortium must identify a principal sponsor and provide
notification to EPA that a consortium has formed. The notification must
be accomplished within 90 days of the publication date of a test rule
under section 4 of the Act, or within 90 days of the effective date of
a test order under section 4 of the Act, or within 90 days of the
signing of an enforceable consent agreement under section 4 of the Act.
EPA may permit additional entities to join an existing consortium after
the expiration of the notification period if the principal sponsor
provides updated notification.
* * * * *
    (3) * * *
    (i) Notification must be provided to EPA that a consortium has
formed. The notification must be accomplished within 90 days of the
publication of the final scope of a chemical risk evaluation under
section 6(b)(4)(D) of the Act or within 90 days of EPA providing
notification to a manufacturer that a manufacturer-requested risk
evaluation has been granted. EPA may permit additional entities to join
an existing consortium after the expiration of the notification period
if the principal sponsor provides updated notification.
* * * * *
    (4) If multiple persons are subject to fees triggered by section 4
or 6(b) of the Act and no consortium is formed, EPA will determine the
portion of the total applicable fee to be remitted by each person
subject to the requirement.
    (i) Each person's share of the applicable fees triggered by section
4 of the Act specified in paragraph (c) of this section shall be in
proportion to the total number of manufacturers and/or processors of
the chemical substance, with lower fees for small businesses:
[GRAPHIC] [TIFF OMITTED] TP16NO22.005

Where:

Ps = the portion of the fee under paragraph (c) of this
section that is owed by a person who qualifies as a small business
concern under Sec.  700.43 of this chapter.
    Po = the portion of the fee owed by a person other
than a small business concern.
    F = the total fee required under paragraph (c) of this section.
    Mt = the total number of persons subject to the fee
requirement.
    Ms = the number of persons subject to the fee
requirement who qualify as a small business concern.

    (ii) Each person's share of the applicable fees triggered by
section 6(b) of the Act specified in paragraph (c) of this section
shall be in proportion to the total number of manufacturers and their
reported production volume as described in Sec.  700.45(b)(v) of the
chemical substance, with lower fees for small businesses:
[GRAPHIC] [TIFF OMITTED] TP16NO22.006

    (iii) Remaining manufacturers (i.e., those that do not qualify as a
small business concern) are then ranked in ascending order (from lowest
to highest) based on reported production volume as described in Sec.
700.45(b)(v). Each remaining manufacturer is assigned a number with 1
for lowest production volume, 2 for second lowest production volume,
etc.

Table 1--Example of Placing Manufacturers That Do Not Qualify as a Small
                   Business Concern in Ascending Order
------------------------------------------------------------------------
                                                                Assigned
                        Manufacturer(s)                          No. (N)
------------------------------------------------------------------------
Manufacturer with lowest production volume....................         1
Manufacturer with 2nd lowest production volume................         2
Manufacturer with 3rd lowest production volume................         3
* * * etc.....................................................  ........
------------------------------------------------------------------------

                                                                [GRAPHIC] [TIFF OMITTED] TP16NO22.007

Where:

Ps = the portion of the fee under paragraph (c) of this
section that is owed by a person who qualifies as a small business
concern under Sec.  700.43 of this chapter.
P>=20th = the portion of the fee owed by a person other
than a small business concern in the top 20th percentile.
P<20th = the portion of the fee owed by a person other
than a small business concern not in the top 20th percentile.
F = the total fee required under paragraph (c) of this section.
Mt = the total number of persons subject to the fee
requirement.
Ms = the number of persons subject to the fee requirement
who qualify as a small business concern.
N20th = The assigned number as illustrated in Table 1 to
the manufacturer(s) with a production volume as described in Sec.
700.45(b)(v) at which the manufacturers with production volume
greater than or equal to are in the top 20th percentile.
M>=20th = the total number of persons with production
volume as described in Sec.  700.45(b)(v) greater than or equal to
the manufacturer(s) with a production volume as N20th.
M<20th = the total number of persons with production
volume as described in Sec.  700.45(b)(v) less than the
manufacturer(s) with a production volume as N20th.
    Fo = the total fee required under paragraph (c) of
this section by all person(s) other than a small business concern.

    (vi) In the event there are three or less manufacturers identified
for a chemical substance, EPA will distribute the fee evenly among
those three or less fee payers, regardless of production volume.
    (v) In the event the number assigned to the top 20th percentile is
not an integer, EPA will round to the nearest integer to determine the
manufacturer(s) with the reported production volume as described in
Sec.  700.45(b)(v) greater than or equal to the top 20th percentile.
    (vi) In the event multiple manufacturers report the same production
volume as described in Sec.  700.45(b)(v) and are greater than or equal
to the top 20th percentile, EPA will include all manufacturers with
that same production volume in the fee calculation for the top 20th
percentile group.
    (5) If multiple persons are subject to fees triggered by section 4
of the Act and some inform EPA of their intent to form a consortium
while others choose not to associate with the consortium, EPA will take
the following steps to allocate fee amounts:
    (i) Count the total number of manufacturers, including the number
of manufacturers within any consortia; divide the total fee amount by
the total number of manufacturers; and allocate equally on a per capita
basis to generate a base fee;
    (ii) Provide all small businesses who are either not associated
with a consortium, or associated with an all- small business
consortium, with an 80% discount from the base fee referenced
previously;
    (iii) Calculate the total remaining fee and total number of
remaining manufacturers by subtracting out the discounted fees and the
number of small businesses identified;
    (iv) Reallocate the remaining fee across those remaining
individuals and groups in equal amounts, counting each manufacturer in
a consortium as one person; and
    (v) Inform consortia and individuals of their requisite fee amount.
Small businesses in a successfully-formed consortium, other than a
consortium of all small businesses, will not be afforded the 80%
discount by EPA, but consortia managers are strongly encouraged to
provide a discount for small business concerns.
    (6) If multiple persons are subject to fees triggered by section
6(b) of the Act and some inform EPA of their intent to form a
consortium while others choose not to associate with the consortium,
EPA will take the following steps to allocate fee amounts:
    (i) Count the total number of manufacturers, including the number
of manufacturers within any consortia; divide the total fee amount by
the total number of manufacturers; and allocate equally on a per capita
basis to generate a base fee;
    (ii) Provide all small businesses who are either not associated
with a consortium, or associated with an all-small business consortium,
with an 80% discount from the base fee referenced previously;
    (iii) Calculate the total remaining fee and total number of
remaining manufacturers by subtracting out the discounted fees and the
number of small businesses identified;
    (iv) Place remaining manufacturers in ascending order (from lowest
to highest) based on reported production volume as described in Sec.
700.45(b)(v). Assign each remaining manufacturer a number with 1 for
lowest production volume, 2 for second lowest production volume, etc.;
    (v) Determine the manufacturer(s) in the top 20th percentile by
multiplying the total number of remaining manufacturers by 0.8. then
comparing that number to the manufacturer(s) with that assigned number
as described in paragraph (iv) of this section;
    (vi) Reallocate 80% of the total remaining fee evenly across that
manufacturer(s) with a production volume amount equal to or larger than
that manufacturer(s) (the top 20th percentile), counting each
manufacturer in a consortium as one person;
    (vii) Reallocate the remaining fee evenly across the remaining
manufacturers, counting each manufacturer in a consortium as one
person; and
    (v) Inform consortia and individuals of their requisite fee amount.
Small businesses in a successfully-formed consortium, other than a
consortium of all small businesses, will not be afforded the 80%
discount by EPA, but consortia managers are strongly encouraged to
provide a discount for small business concerns.
* * * * *
    (g) * * *
    (3) * * *
    (i) Test orders and test rules. The applicable fee specified in
paragraph (c) of this section shall be paid in full not later than 180
days after the effective date of a test rule or test order under
section 4 of the Act.
* * * * *
    (iv) Risk evaluations. (A) For EPA-initiated risk evaluations, the
applicable fee specified in paragraph (c) of this section shall be paid
in two installments, with the first payment of 50% due 180 days after
publishing the final scope of a risk evaluation and the second payment
for the remainder of the fee due 545 days after publishing the final
scope of a risk evaluation under section 6(b)(4)(D) of the Act.
    (B) For manufacturer-requested risk evaluations under section
6(b)(4)(C)(ii) of the Act, the applicable fees specified

in paragraph (c) of this section shall be paid as follows:
    (1) The applicable fee specified in paragraph (c) of this section
shall be paid in three installments. The first payment shall be due no
later than 180 days after EPA provides the submitting manufacture(s)
notice that it has granted the request.
    (2) The second payment shall be due no later than 545 days after
EPA provides the submitting manufacturer(s) notice that it has granted
the request.
    (3) The final payment shall be due no later than 30 days after EPA
publishes the final risk evaluation.
* * * * *
    (5) Small business certification. (i) Each person who remits the
fee identified in paragraph (c)(1) of this section for a PMN,
consolidated PMN, or SNUN shall insert a check mark for the statement,
``The company named in part 1, section A is a small business concern
under 40 CFR 700.43 and has remitted a fee of $7,880 in accordance with
40 CFR 700.45(c).'' under ``CERTIFICATION'' on page 2 of the
Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
    (ii) Each person who remits the fee identified in paragraph (c)(1)
of this section for a LVE, LoREX, TERA, TME, or Tier II exemption
request under TSCA section 5 shall insert a check mark for the
statement, ``The company named in part 1, section A is a small business
concern under 40 CFR 700.43 and has remitted a fee of $2,650 in
accordance with 40 CFR 700.45(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(1)
of this section for an exemption notice under Sec.  723.175 of this
chapter shall include the words, ``The company or companies identified
in this notice is/are a small business concern under 40 CFR 700.43 and
has/have remitted a fee of $2,650 in accordance with 40 CFR
700.45(c).'' in the certification required in Sec.  723.175(i)(1)(x) of
this chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(1)
of this section for a MCAN or consolidated MCAN for a microorganism
shall insert a check mark for the statement, ``The company named in
part 1, section A is a small business concern under 40 CFR 700.43 and
has remitted a fee of $7,880 in accordance with 40 CFR 700.45(c).'' in
the certification required in Sec.  [thinsp]725.25(b) of this chapter.
    (6) Payment certification statement. (i) Each person who remits a
fee identified in paragraph (c)(2) of this section for a PMN,
consolidated PMN, or SNUN shall insert a check mark for the statement,
``The company named in part 1, section A has remitted the fee of
$45,000 specified in 40 CFR 700.45(c).'' under ``CERTIFICATION'' on
page 2 of the Premanufacture Notice for New Chemical Substances (EPA
Form 7710-25).
    (ii) Each person who remits a fee identified in paragraph (c)(2) of
this section for a LVE, LoREX, TERA, TME, or Tier II exemption request
under TSCA section 5 shall insert a check mark for the statement, ``The
company named in part 1, section A has remitted the fee of $13,230
specified in 40 CFR 700.45(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(2)
of this section for an exemption notice under Sec.  723.175 of this
chapter shall include the words, ``The company or companies identified
in this notice has/have remitted a fee of $13,230 in accordance with 40
CFR 700.45(c).'' in the certification required in Sec.
723.175(i)(1)(x) of this chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(2)
of this section for a MCAN for a microorganism shall insert a check
mark for the statement, ``The company named in part 1, section A has
remitted the fee of $45,000 in accordance with 40 CFR 700.45(c).'' in
the certification required in Sec.  725.25(b) of this chapter.
* * * * *
    (i) Partial fee refunds.
    (1) If a TSCA section 5 notice is withdrawn during the first 10
business days after the beginning of the applicable review period under
Sec.  720.75(a) of this chapter, the Agency will refund all but 25% of
the fee as soon as practicable.
    (2) If a TSCA section 5 notice is withdrawn during the period
beginning 10 business days after the beginning of the applicable review
period under Sec.  [thinsp]720.75(a) of this chapter and ending 5
business days after EPA has provided the submitter notice that the risk
assessment on the chemical substance(s) has concluded, the Agency will
refund all but 80% of the fee as soon as practicable.
    (3) Once withdrawn, any future submission related to the TSCA
section 5 notice must be submitted as a new notice.
    (4) If EPA determines that the initial payment for a manufacturer-
requested risk evaluation exceeds the applicable fee in paragraph (c)
of this section, EPA will refund the difference.
* * * * *
[FR Doc. 2022-24137 Filed 11-15-22; 8:45 am]
 BILLING CODE 6560-50-P


 United States Environmental Protection Agency    Office of Chemical Safety    and Pollution Prevention    (7101) EPA 730-C-11-003 December 21, 2012

Product Performance Test Guidelines

OCSPP 810.2600:

Disinfectants and Sanitizers for Use in Water  -  Efficacy Data Recommendations

                                                                                NOTICE      This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.      	 The OCSPP test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public and the companies that are subject to data submission requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.        	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

OCSPP 810.2600:  Disinfectants and sanitizers for treating water  -  efficacy data recommendations.

	(a)	Scope. --

	(1) Applicability.  This guideline describes test methods that EPA believes will generally satisfy testing requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).  It addresses testing to demonstrate the effectiveness of antimicrobial pesticides bearing label claims for the disinfection or sanitization of water.

      (2) Background.  The source materials used in developing this OCSPP test guideline are OPP guidelines 91-8 Products for treating water systems and 91-30 Acceptable methods (Pesticide Assessment Guidelines, Subdivision G, Product Performance, EPA report 540/9-82-026, October 1982).

	   (b) Purpose.  This guideline addresses efficacy testing for antimicrobial pesticides intended to be used in water systems, namely drinking water and swimming pools, as disinfectants or sanitizers.         	  (c) General considerations.  - (1)  This guideline recommends methods for use in tests to be conducted to address the data requirements for pesticide registration.  Good Laboratory Practice Standards (GLP) as defined in 40 CFR Part 160 apply to studies of disinfectants for water. According to 40 CFR §160.17: "EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with this part." 40 CFR §160.12(b) requires with any submitted research data "[a] A statement that the study was conducted in accordance with this part; [b] A statement describing in detail all differences between the practices used in the study and those required by this part; or [c] A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part." Note:  The Association of Official Analytical Chemists (AOAC) recommended tests are designed to be conducted as written. For deviations (e.g., cultures grown with shaking instead of static, dilution of culture prior to drying on carriers) proposed to be used in the conduct of these tests, obtain written approval from the Agency and document such deviations in the study reports submitted to the Agency. The Agency may consult with the AOAC prior to accepting modifications to their standardized methods. Refer to OCSPP Test Guideline 810.2000 for general testing recommendations prior to initiating tests.

		(d)  Drinking water for humans -- (1) Public water systems. Applicants should contact EPA's Antimicrobials Division prior to conducting studies to support label claims for disinfection of public water systems. Evidence should be submitted that the chemical intended for use as a drinking water disinfectant is in compliance with the EPA's Office of Drinking Water's regulations.

		(2)  Emergency water supplies. This section addresses efficacy testing for additives such as solutions, powders, or tablets intended for emergency disinfection of small quantities of drinking water of question - able potability (e.g., water obtained from lakes, streams, etc), by the general public, in the absence of bacteriological monitoring facilities.

	(i) Test procedure.  The Agency recommends the use of The Guide Standard and Protocol for Testing Microbiological Water Purifiers (Ref. 1).  Three samples of product, representing three different batches, one of which should be at least 60 days old, should be tested in triplicate.  The test organisms should be Raoultella terrigena  -  American Type Culture Collection (ATCC) 33257 (R. terrigena) (formerly designated as Klebsiella terrigena), Polio 1 (LSa) (ATCC VR-59), or Chat (ATCC VR-1562) Rotavirus (Wa or SA-11) (ATCC VR-2018 or VR-1565), Cryptosporidium parvum (C. parvum) and Giardia intestinalis (G. intestinalis) (formerly Giardia lamblia). Giardia muris may be tested in place of Giardia intestinalis.

	(ii) Evaluation of success -- (A)  Bacteria. A 6-log10 (99.9999 percent) reduction of an influent challenge of 1 x10[7] organisms per 100 mL of the bacterial challenge organism R. terrigena should be demonstrated by the testing.        (B)  Viruses.  A 4-log10 (99.99 percent) reduction of a mixed influent challenge of 1 x 10[7] organisms per liter of each of the following viruses: Po - liovirus (LSa) and Rotavirus (Wa) should be demonstrated by the testing. Virus types should be mixed in roughly equal 1 x 10[7]/L concentrations and a joint 4-log10 reduction should be demonstrated. MS2 coliphage virus may also be used as a surrogate for Poliovirus and Rotavirus.

		(C)  Cysts (Protozoan).  A 3-log10 (99.9 percent) reduction of an influent challenge of 1 x 10[6] organisms per liter of C. parvum and G. intestinalis (or G. muris if tested) or a 3-log10 reduction of an influent challenge of 1 x 107 particles or spheres of 4 to 6 um diameter (as an option for units or components based on occlusion filtration, where disinfection or other active processes are not involved) should be demonstrated by the testing. 	 		(3) Water purifier units.  This section addresses efficacy testing for products bearing label claims for microbiological water purification (removal of pathogenic microorganisms).  This section does not apply to products only used to treat water in order to achieve specific chemical removal from water or other non-microbiological claims.  National Sanitation Foundation (NSF) Standard 42 (Aesthetic Effects) provides partial guidance for chemical removal.

		(i)  Test procedure.  The Agency recommends the use of The Guide Standard and Protocol for Testing Microbiological Water Purifiers (Ref. 1).  This is a general guide and in some cases may present only the minimum features and framework for the testing of microbiological water purifiers. Users of the Guide Standard and Protocol should include pre-testing of their units in a testing rig, including the sampling techniques to be used. In some cases, it may be appropriate to alter and/or add to the guide in order to meet specific operational problems, to use an alternative organism or laboratory procedure, or to respond to innovative treatment units. However, these alterations and/or additions should not decrease the level of testing or alter the intent of the protocol and should be submitted to the Antimicrobials Division for approval prior to initiation of testing.

		(ii)  Evaluation of microbiological water purifier success -- (A)  Bacteria.  A 6-log10 (99.9999 percent) reduction of an influent chal - lenge of 1 x 10[7] organisms per 100 mL of the bacterial challenge organism Raoultella terrigena (ATCC) 33257) should be demonstrated by the testing.

	(B)  Viruses.  A 4-log10 (99.99 percent) reduction of a mixed influent challenge of 1 x 10[7] organisms per liter of each of the following viruses: Po - liovirus (LSa) (ATCC-VR-59) or Chat (ATCC 1562 and Rotavirus (Wa) (ATCC - -VR-2018) or SA11 (ATCC 1565) should be demonstrated by the testing. Virus types should be mixed in roughly equal 1 x 10[7]/L concentrations and a joint 4-log10 reduction should be demonstrated. MS2 coliphage virus may also be used as a surrogate for Poliovirus and Rotavirus.

	(C)   Cysts (Protozoan).  A 3-log10 (99.9 percent) reduction of an influent challenge of 1 x 10[6] organisms per liter of Cryptosporidium parvum and Giardia intestinalis (formerly Giardia lamblia) or Giardia muris (if tested) or a 3-log10 reduction of an influent challenge of 1 x 10[7] particles or spheres of 4 to 6 um diameter (as an option for units or components based on occlusion filtration, where disinfection or other active processes are not involved) should be demonstrated by the testing. Note: When using spheres as surrogates for oocysts, the charge of the surrogate particle, the shape of the particle, the size range of the particle, as well as the actual method of sample collection, are critical to the accurate and conservative evaluation of the reduction efficiency of size occlusion technologies.

	(D) Voluntary Optional Protocols. The Agency will consider protocols developed by the National Sanitation Foundation (NSF) International to support microbiological water purifier label claims. Specifically, NSF 53, NSF 55, NSF 58 and NSF 62 may be used where appropriate. NSF protocols P231 and P248 may also be used to generate data to support label claims as microbiological water purifiers. A pre-registration consultation is recommended prior to the use of any of these NSF standards to ensure the data will support the label claims.

	(e)  Swimming pool, spa, and hot tub water. This section addresses efficacy testing for disinfectants bearing label claims for use in swimming pools, spas, and hot tubs. Numerous factors influence the concentrations necessary for  - disinfection of swimming pool water in practical applications: the number of swimmers/bathers in the pool; frequency of use; frequency with which water is changed; general weather conditions; and types and degree of or - ganic contamination of the water by the swimmers/bathers themselves (e.g., suntan lotion and oils) and by various debris.  Therefore, a two-phased study, consisting of a laboratory test and confirmatory field test, is recommended.

      (1)  Test procedure - Laboratory test.  The Agency recommends the use of the AOAC International Disinfectants (Water) for Swimming Pools (Ref. 2).  The test organisms should be Escherichia coli (E.coli) (ATCC 11229) and Enterococcus faecium (E. faecium) (ATCC 6569) (formerly designated as Streptococcus faecalis).              (i)  Evaluation of success.  The lowest concentration of the test substance providing results equivalent to those of the sodium hypochlorite reference standard is the lowest concentration of the product that should be considered effective.

	(2)  Test procedure - Field test. The Agency recommends efficacy data to be derived from in-use tests under an experimental use permit (EUP) in at least two swimming pools, using the following components.

	(i)  Bacteriologic monitoring.  Bacteriologic monitoring of swimming pool water following treatment with disinfectant product during the field test should be conducted in the following manner: Water samples for bac - teriologic monitoring should be taken on opposite sides of the pool in the shallow area and as remote as possible from the inlets, preferably at the midpoint between the inlets.  A minimum of 144 samples (72 samples per pool) should be collected during the test period. Samples should be taken just below the surface of the water and preferably at such times when the number of persons using the pool during the preceding hour has been at least equal to 50 percent of the maximum bather load of the pool and the number of persons in the pool water at the time the samples are collected is at least 25 percent of the maximum bather load (as defined in Suggested Ordinance and Regulations Covering Public Swimming Pools, APHA Joint Committee on Swimming Pools and Bathing Places) of the pool (Ref. 3).  Pertinent chemical characteristics (e.g., pH, nitrogenous substances, metals, and water hardness) of the pool water at the sampling site should be determined at the time of sampling. (Ref. 4)

	(ii)  Field test.  Field tests should be conducted for an entire swimming season (4 to 12 months).  Reports should include (but are not limited to) the following information.

	(A)  The daily swimmer/bather load.

	(B)  The design of the pool, the recirculation and filter system, and water capacity.

	(C)  The amount and identification of all chemicals added daily to the swimming pool water (including the time, site, and method).

	(D)  The range of chemical characteristics of the swimming pool water such as:  pH, nitrogenous substances, metals, and hardness.

	(E) The physical characteristics of the swimming pool water, includ - ing temperature and clarity, determined at least daily.

	(F)  Meteorological data, including air temperature, rainfall, and number of hours of sunlight (determined daily) for outdoor pools.

	(G)  Bacteriologic monitoring, conducted daily, in accordance with the suggested Ordinance and Regulations Covering Public Swimming Pools of the American Public Health Association. (Ref. 3)

	(H) The concentration of the antimicrobial agent in the swimming pool monitored daily at the same time intervals that the bacteriological assay samples are obtained.

	(I) The method that the product user will employ for monitoring the level (concentration in ppm) of antimicrobial agent contained in the pool water.

	(iii)  Evaluation of field testing success.  The product, when used as recommended in swimming pool water, should demonstrate that not more than 15 percent of the sam - ples collected fail to meet the following bacterial indices (Ref. 3):

      (A) The standard plate count at 35°C not to exceed 200 colonies/1.0 mL.

      (B) The most probable number of coliform bacteria to be less than 2.2 organisms/100.0 mL.  When the membrane filter test is used, no more than 1.0 coliform organism/50 mL.

		(C)  The most probable number of enterococcal organisms to be less than 2.2 organisms/100 mL.  When the membrane filter test is used, no more than 1.0 enterococcal organism/50 mL.

	(3) Voluntary Additional Test. The Agency recommends use of NSF/ANSI Standard 50. The test organisms should be Enterococcus faecium (ATCC 6569) and Pseudomonas aeruginosa (ATCC 27313).

	(i)  Evaluation of success. The product, when used as directed in swimming pool water should demonstrate a 3-log kill of the two target microorganisms, Enterococcus faecium and Pseudomonas aeruginosa.

 		(f) Data collection and reporting -- (1) General.  To assist in the proper review and evaluation of product performance, complete descriptions of the test employed and the results obtained should be submitted to the Agency.  All test reports should include, at the least, the following information:    		(i) Study title;    		(ii)  Product Identity;    		(iii)  Guideline number/Data Requirement;     		(iv)  Identification of the testing laboratory or organization;    		(v)  Location where the test was performed;    		(vi)  Name(s) of the person(s) responsible for the test;    		(vii)  Statement of Confidentiality Claims;    		(viii)  Statement of 40 CFR Part 160 Good Laboratory Practice compliance and Quality Assurance Statement;    		(ix)  Purpose of the study;    		(x)  Date and time of the start and end of the test;    		(xi)  Test employed and any modifications (e.g., organic soil, hard water, etc), when using standard tests (e.g., AOAC, ASTM, etc) all deviations to the test methods should be reported;    		(xii)  Test microorganisms employed, including identification of the specific strain (ATCC or other);    		(xiii)  Description of the test substance, including the percent of active ingredient;    		(xiv)  Concentration or dilution of the product tested and how prepared;    		(xv)  Number of samples, batches and replicates tested;    		(xvi)  Manufacture date of each product batch;     		(xvii)  Identification of all material or procedural options employed, where such choice is provided for or recommended in the test method selected (e.g., growth media, drying time for inoculated carriers, neutralization confirmation and/or subculture media, secondary subculturing);    		(xviii)  Test exposure conditions (e.g., contact time, temperature, and relative humidity);    		(xix)  Complete reports of results obtained for each replication;    		(xx)  Any control data essential to establish the validity of the test;    		(xxi)  Carrier counts;    		(xxii)  Statistical treatment of the data;    		(xxiii)  Conclusions;    		(xxiv)  References;    		(xxv)  Appendices, including study protocol and all raw data reports associated with the conduct of the study;    The applicant is encouraged to use the EPA's standard efficacy report format, which may be found at http://www.epa.gov/oppad001/efficacystudystandards.htm.    		(2)  Data for modifications of recommended methods.  When recommended methods are modified for testing conducted to support specific claims and/or use patterns for a product, the protocol, identifying and describing each modification, should be provided with the study report.  The applicant is encouraged to submit the proposed modification to the Agency for review and evaluation prior to initiation of the test.    		(3)  Data for other methods.  When recommended methods, or modifications thereto, are not employed to develop efficacy data (such as actual in-use or many kinds of simulated-use testing), complete testing protocols should be submitted with the test reports.  All materials and procedures employed in testing should be described in a manner consistent with original research reports published in technical or scientific journals.  Where references to published reports or papers are made, copies or reprints of such references should be provided with the test reports.  The applicant should submit the proposed testing protocols for in-use or simulated-use studies (with a proposed label to show the claims to be supported by the protocol) to the Agency for review and evaluation prior to initiation of the test.    		(g)  References.  The references in this paragraph may be consulted for addi - tional background information.		          			(1)	Guide Standard and Protocol for Testing Microbiological Water Purifiers.  United States Environmental Protection Agency, Registration Division, Office of Pesticide Programs and Criteria and Standards Division, Office of Drinking Water, April 1987.    			(2) Official Methods of Analysis of the Association of Official Analyt - ical Chemists, Use-Dilution Methods, Chapter 6, Disinfectants; Current Edition.  Association of Official Analytical Chemists (AOAC), 2200 Wilson Boulevard Arlington, VA 22201.    			(3)	Suggested Ordinance and Regulations Covering Public Swimming Pools.  Joint Committee on swimming Pools of the American Public Health Association, in Cooperation with the United States Public Health Service, 1964. The American Public Health Association, New York, NY.		    			(4)	Standard Methods for the Examination of Water and Wastewater, Current Edition, Standard Methods Online:  http://www.standardmethods.org.	    	     (5)  NSF/ANSI - 50 Equipment for Swimming Pools, Spas, Hot Tubs and other Recreational Water Facilities. NSF International 789 Dixboro Rd. POB 130140, Ann Arbor, MI 48113-0140.    	    	(6) NSF/ANSI  -  53 Drinking Water Treatment Units  -  Health Effects. NSF International 789 Dixboro Rd. POB 130140, Ann Arbor, MI 48113-0140.


Technical Support Document (TSD) For

Emissions Inventories for the York and Adams Counties, Pennsylvania

8 Hour Ozone Redesignation Request, Maintenance Plan, and,

State Implementation Plan (SIP) Base Year Inventory.

Original Submitted June 2007

by the Pennsylvania Department of Environmental Protection

TSD Prepared July 2007 by

Alice H. Chow

Air Quality Analysis Branch, 3AP22

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

/s/

____________________________________________

Reviewed by Walter Wilkie, Chief

Air Quality Analysis Branch (3AP22)

7/11/07

Date Signed

Introduction

The purpose of this document is to provide a technical summary of the
Air Quality Analysis Branch’s (AQAB) review of the emissions
inventories submitted with the York and Adams Counties Pennsylvania 8
Hour Ozone Redesignation Request, Maintenance Plan and State
Implementation Plan (SIP) Base Year Inventory by the Pennsylvania
Department of Environmental Protection (PADEP).  This review does not
determine the approvability of the Redesignation Request or Maintenance
Plan; but it does determine the approvability of the SIP Base Year
Inventory.  Emissions inventories in a redesignation request are used to
show permanent and enforceable emission reductions between the year the
area was designated as a  nonattainment area and the year the area came
into attainment.  In a maintenance plan, the emissions inventories are
used to reflect the emissions during the time the area came into
attainment and are then projected to show that the area will remain in
attainment.  A SIP Base Year Inventory is the starting point from which
other SIP inventories are derived as well as serving as the benchmark
for other SIP planning activities, such as the establishment of an
emissions reduction credit program.  York and Adams counties were
designated as a single 8 hour ozone nonattainment area with a Subpart 1
classification.  Subpart 1 area(s) are required to submit SIP base year
inventories to EPA by June 15, 2007.  PADEP has included the submission
of SIP base year with the redesignation request and maintenance plan
package and has requested EPA’s approval.

Any questions pertaining to this technical summary should be directed to
Walter K. Wilkie, Chief, Air Quality Analysis Branch, at<PHONE_NUMBER> or
via email at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

II 	Emissions Inventories for Redesignation Request (Base Year
Inventory)

	In a redesignation request, emissions inventories are used to support
the States claim that the area has permanent and enforceable emissions
reductions.  In order to do this, the state should estimate the percent
reduction (from the year that was used to determine the design value for
designation and classification) achieved from federal and state control
measures; this is usually termed as the “base year” inventory. The
base year inventory contains VOC and NOx emissions for all source
categories, which includes point, area, onroad mobile, and nonroad
mobile for the ozone season.

	In the York and Adams redesignation request, the base year used was
2002.  The Point Source data for 2002 is derived from the Pennsylvania
Air Information Management System (AIMS).  The AIMS database is
comprised of sources identified and inventoried by PADEP’s regional
and central offices through permitting, field inspections, and surveys.
Surveys are conducted annually as facilities must submit emission
estimates for various operations, throughputs, work hours, as well as
process data, such as combustion unit data and fuel characteristics. For
its redesignation request, PADEP provided its 2002 actual summer weekday
emissions for NOx and VOC at the facility level and by Source
Classification Codes (SCCs).  “Summer weekday emissions” is defined
by PADEP as an average day’s emissions for a typical summer day during
the ozone season.

	For the 2002 Nonpoint Source emissions, also known as “area
sources,” PADEP provided an inventory that contained estimations of
emissions by multiplying an emission factor by some known indicator or
activity level for each category at the county level.  These emissions
are typically calculated on an annual basis because the activity data
are generally only available on an annual basis.  PADEP further
converted these annual emissions to seasonal emissions, for ozone, the
summer season is defined as peak ozone season months of June, July, and
August.  Seasonal estimates were calculated using default monthly and
weekly profiles from EPA’s Emissions Modeling Clearing House (EMCH).
Nonpoint source estimates were provided by SCC.

	The Nonroad Mobile Source 2002 inventory was prepared with EPA’s
NONROAD2005 model.  NONROAD estimates fuel consumption and emissions of
total hydrocarbons, carbon monoxide, nitrogen oxides, sulfur dioxide,
and particulate matter for all nonroad mobile source categories except
for aircraft, locomotives, and commercial marine vessels.  PADEP
provided emission estimates for locomotive engines, aircraft emissions,
and commercial marine vessels separately.  For locomotive engine
emissions, PADEP projected emissions from a 1999 survey using national
fuel consumption information and EPA emission and conversion factors.
For aircraft emissions, there were no commercial aircraft operations in
York and Adams counties, but PADEP estimated emissions using small
airport operation statistics and emission factors and operational
characteristics in EPA’s Emissions and Dispersion Modeling System
(EDMS).  There were no commercial marine vessels emissions in York and
Adams counties.  All Nonroad mobile source emissions were provided by
SCC and classification.

	The Onroad Mobile Source 2002 emissions inventory was developed using
the most current version of EPA’s highway mobile source emissions
model MOBILE 6.2. PADEP also used PPSUITE, an enhanced version of the
Post Processor for Air Quality software systems used for previous
inventory and conformity submissions in Pennsylvania.  Traffic data
source and fleet data inputs were supplied by the 2002 PENNDOT Roadway
Management System.  PADEP provided Mobile6.2 input and output files for
review as a part of their redesignation request.  Mobile emissions
values were given in units of tons per summer day and were provided by
SCC.

AQAB staff reviewed the files and the emission results provided by PADEP
and found them to be reasonable for use in this redesignation request.

III.	Emissions Inventories for Maintenance Plan

2004 Attainment Year Inventory and Maintenance Plan Base Year Inventory

As stated earlier, emissions inventories are used to show emission
reductions for the area between the year of designation to nonattainment
and the year of attainment.  The inventory used for the year of
attainment is called the Attainment Year Inventory and also is referred
to as the Maintenance Plan Base Year Inventory.  This inventory is used
as the basis for the projected inventories that are used to show the
area will remain in attainment.  This section will discuss the 2004
Attainment Year Inventory that was used in the York and Adams
Redesignation Request and Maintenance Plan submitted by PADEP.

PADEP compiled an actual 2004 Point Source inventory for the York and
Adams Redesignation Request and Maintenance Plan.  The 2004 point source
inventory contained point source emissions derived from the Pennsylvania
Air Information Management System (AIMS).  As previously discussed, AIMS
houses all point source data compiled by various programs (permitting,
enforcement, etc.).  For its redesignation request, PADEP provided its
2004 actual summer weekday emissions for NOx and VOC at the facility
level and by Source Classification Codes (SCCs).  “Summer weekday
emissions” is defined by PADEP as an average day’s emissions for a
typical summer day during the ozone season.

For the 2004 Nonpoint Source emissions, PADEP provided a projected
inventory from the 2002 inventory.  The factors used for the temporal
allocation of projections were provided by the Mid-Atlantic Regional Air
Management Association (MARAMA).  The factors were from EPA’s Sparse
Matrix Operator Kernel Emissions (SMOKE) v2.2 input files.  Data from
2004 area sources is a linear projection of between the 2002 base year
and the 2009 projected inventory.  Emissions were provided by SCC and
units were in tons per summer day.

	The 2004 emissions for Nonroad Mobile Source emissions were estimated
using the EPA NONROAD2005 model.  The NONROAD model estimates emissions
of total hydrocarbons, carbon monoxide, nitrogen oxides, sulfur dioxide,
and particulate matter for diesel, gasoline, liquefied petroleum
gasoline and compressed natural gas-fueled nonroad equipment categories.
 Locomotives, aircraft, and commercial marine vessels (CMV) emissions
were developed separately by PADEP.  Just as with the 2002 nonroad
inventory, for locomotive emissions in 2004, PADEP projected emissions
from a 1999 survey using national fuel consumption information and EPA
emission and conversion factors.  For aircraft emissions, PADEP
estimated emissions using small airport operation statistics and
emission factors and operational characteristics in EPA’s Emissions
and Dispersion Modeling System (EDMS).  There were no CMV emissions in
York and Adams counties.  Nonroad mobile source emissions were provided
by SCC and classification and were given in units of tons per summer
day.

	The Onroad Mobile Source 2004 emissions inventory was developed using
the most current version of EPA’s highway mobile source emissions
model MOBILE 6.2.  In addition, PADEP uses a MOBILE pre- and post-
processing software package, PPSUITE, to process and compile
Pennsylvania’s highway data.  PPSUITE has been used in previous
inventory and conformity submittals from Pennsylvania.  Traffic data
source and fleet data inputs were supplied by the 2002 PENNDOT Roadway
Management System.  PADEP provided sample Mobile6.2 input and output
files for review.  Mobile emissions values were given in units of tons
per summer day and were provided by SCC.

AQAB staff reviewed the files and emission results and believes them to
be reasonable for use in the maintenance plan.

2009 and 2018 Projection Emission Inventories

Projection inventories are used to show that the area will remain in
attainment.  Projection inventories for the years 2009 and 2018 were
used for the York and Adams Maintenance Plan.  Inventories were
developed for all emission sources for both years.

PADEP used projection inventories for point and nonpoint sources
prepared by MACTEC Federal Programs, Inc., for the Mid-Atlantic Regional
Air Management Association (MARAMA).  MACTEC’s projected inventories
were from 2002, not 2004. PADEP’s 2004 inventory was not available at
the time of MACTEC’s work.

The Point Source emissions for 2009 and 2018 were projected, for both
EGUs and non EGUs, using growth factors from EPA’s Economic Growth and
Analysis System, Version 5.0 (EGAS 5.0) and the Department of Energy’s
Annual Energy Outlook 2005 fuel consumption forecasts.  In addition, for
non-EGUs, state-supplied population, employment and other emission
projection data were also applied to account for changes in economic
activity.  Then, control factors were applied to account for future
emission reductions from on-the-books (OTB) control regulations and
on-the-way (OTW) control regulations.

	The Nonpoint Source emissions for 2009 and 2018 were projected using
growth factors to account for population and economic activity.  Then,
as with point sources, control factors were used to account for future
emission reductions from on-the-books (OTB) control regulations and
on-the-way (OTW) control regulations.

For the 2009 and 2018 Nonroad Mobile Source inventories, PADEP used
EPA’s NONROAD2005 model to generate these future inventories.  The
NONROAD model allows for the calculation of past year, present year, and
future year inventories (up to the year 2050) to be generated.  Growth
for locomotives came from the Association of American Railroads and
compared well with EGAS; and, small aircraft growth was estimated from
the Federal Aviation Administration’s APO Terminal Area Forecast
Detailed Report.  There were no commercial marine vessel emissions in
York and Adams counties.

The 2009 and 2018 Onroad Mobile Source inventories were generated using
EPA’s MOBILE6.2.  In addition, PADEP used a PENNDOT study completed in
2005, “Statistical Evaluation of Projected Traffic Growth, Traffic
Growth Forecasting System:  Final Report, March 14, 2005” that
provided information used to forecast traffic volumes.  Growth rates for
vehicle miles traveled (VMT), and four functional road classifications
in each Pennsylvania county:  urban interstate, urban non-interstate,
rural interstate, and rural non-interstate were incorporated with
traffic data and socioeconomic forecasts which is inputted in PPSUITE to
calculate VMT and speeds; the output is then run in MOBILE6.2 to
calculate emissions.

AQAB staff reviewed the procedures, and found them to be reasonable for
development of these inventories.

IV.	2002 SIP Base Year Inventory

	The SIP base year inventory is the primary inventory from which other
inventories (3-year cycle inventories, reasonable further progress
inventories, modeling inventories) are derived.  The Clean Air Act calls
for State, local, and Tribal agencies to ensure that the base year
inventory is comprehensive, accurate, and current for all actual
emissions.  The base year inventory includes emissions estimates from
stationary point and nonpoint sources, onroad mobile sources, and
nonroad mobile sources.  For the 8-hour ozone NAAQS, the pollutants to
be inventoried are VOC, NOx and CO (carbon monoxide).  For the 8-hour
ozone NAAQS, VOC, NOx and CO emissions should be reported as actual
annual and actual summer weekday emissions (defined as an average
day’s emissions for a typical summer day during the ozone season).
PADEP’s base year inventory is for 2002.  A significant amount of
documentation is required for these SIP base year estimates which PADEP
has provided.

York and Adams counties were designated as a single 8 hour ozone
nonattainment area with a Subpart 1 classification.  Subpart 1 area(s)
are required to submit SIP base year inventories to EPA by June 15,
2007.  PADEP submitted the SIP base year with its redesignation request
and maintenance plan package and has requested EPA’s approval.

	PADEP’s methodologies concerning the generation of point, nonpoint,
onroad mobile and nonroad mobile emissions for the SIP base year are the
same as for the 2002 base year redesignation request.  However, EPA
guidance required, in addition to the NOx and VOC summer day emissions,
annual emissions for NOx and VOCs.  Further, the EPA guidance required
annual and summer day estimates for CO.

	PADEP also applied rule effectiveness and rule penetration for its 2002
8-hour ozone SIP base year inventories.  Rule effectiveness reflects the
actual ability of a regulatory program to achieve the emission
reductions required by regulation (or perhaps voluntarily adopted).  In
the 2005, EPA developed recommendations to revise EPA’s existing rule
effectiveness guidance; due to the fact that PADEP’s inventory was
developed prior to the issuance of the new rule effectiveness policy,
EPA’s previous policy was followed, which assumed an 80% rule
effectiveness for applicable sources unless otherwise specified.  Rule
penetration is an estimate of percentage of emissions in a source
category that are emitted at facilities subject to the requirements of a
rule.  PADEP applied rule penetration for its nonpoint sources at 60%.

AQAB staff reviewed the results, procedures, and methodologies for the
SIP base year, and found them to be approvable.  The following table
summarizes PADEP’s 2002 SIP Base Year for York and Adams counties.

York and Adams Counties

2002 SIP Base Year

 	VOC Emissions	NOx Emissions	CO Emissions

Source Type	Tons/yr	Tons/day	Tons/yr	Tons/day	Tons/year	Tons/day

Point Sources	3190	8.56	26392	70.23	3523	9.41

Nonpoint Sources 	11157	27.08	11157	2.95	14873	27.52

Onroad Mobile Sources	7935	25.25	12506	36.57	121936	292.37

Nonroad Mobile Sources	2885	10.36	4104	14.32	33982	124.74

TOTAL Emissions	25167	71.25	54159	124.07	174318	454.04

 “Emissions Inventory Guidance for Implementation of Ozone and
Particulate Matter National Ambient Air Quality Standards (NAAQS) and
Regional Haze Regulations” EPA-454/R-05-001, August 2005


[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Notices]
[Page 9561]
[FR Doc No: 2018-04606]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission Investor Advisory Committee will hold a meeting
on Thursday, March 8, 2018 at 9:30 a.m. (ET).

PLACE: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will begin at 9:30 a.m. (ET) and will be open to
the public. Seating will be on a first-come, first-served basis. Doors
will open at 9:00 a.m. Visitors will be subject to security checks. The
meeting will be webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED: On February 7, 2018, the Commission issued
notice of the Committee meeting (Release No. 33-10456), indicating that
the meeting is open to the public (except during that portion of the
meeting reserved for an administrative work session during lunch), and
inviting the public to submit written comments to the Committee. This
Sunshine Act notice is being issued because a quorum of the Commission
may attend the meeting.
    The agenda for the meeting includes: Remarks from Commissioners; a
discussion of regulatory approaches to combat retail investor fraud; a
discussion regarding financial support for law school clinics that
support investors (which may include a recommendation of the Committee
as a whole); a discussion regarding dual-class share structures (which
may include a recommendation of the Investor as Owner Subcommittee); a
discussion regarding efforts to combat the financial exploitation of
vulnerable adults; subcommittee reports; and a nonpublic administrative
work session during lunch.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: March 1, 2018.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2018-04606 Filed 3-2-18; 11:15 am]
 BILLING CODE 8011-01-P