[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81435-81436]
[FR Doc No: 2023-25800]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0009]

Fire Brigades Standard; Extension of the Office of Management and
Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning the proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Fire Brigades
Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
January 22, 2024.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at https://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov. Documents in the docket are
listed in the https://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions.
    Instructions: All submissions must include the agency name and OSHA
docket number (OSHA-2011-0009) for the Information Collection Request
(ICR). OSHA will place all comments, including any personal
information, in the public docket, which may be made available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as social security numbers and birthdates.
    For further information on submitting comments, see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, the collection instruments are clearly understood, and
OSHA's estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of effort in
obtaining information (29 U.S.C. 657).
    OSHA does not mandate that employers establish fire brigades;
however, if they do so, they must comply with the provisions of the
Fire Brigades Standard. The provisions of the standard, including the
paperwork requirements, apply to fire brigades, industrial fire
departments, and private or contract fire departments, but not to
airport crash rescue units or forest firefighting operations.
Paragraphs (b)(1), (b)(2), and (c)(4) contain the paperwork
requirements of the standard.
    Under paragraph (b)(1) of the standard, employers must develop and
maintain an organizational statement that establishes the: existence of
a fire brigade; the basic organizational structure of the brigade;
type, amount, and frequency of training provided to brigade members;
expected number of members in the brigade; and functions that the
brigade is to perform. This paragraph also specifies that the
organizational statement must be available for review by workers, their
designated representatives, and OSHA compliance officers. The
organizational statement describes the functions performed by the
brigade members and, thereby, determines the level of training and type
of personal protective equipment (PPE) necessary for these members to
perform their assigned functions safely. Making the statement available
to workers, their designated representatives, and OSHA compliance
officers ensures that the elements of the statement are consistent with
the functions performed by the brigade members and the occupational
hazards they experience, and that employers are providing training and
PPE appropriate to these functions and hazards.
    To permit a worker with known heart disease, epilepsy, or emphysema
to participate in fire brigade emergency activities, paragraph (b)(2)
of the standard requires employers to obtain a physician's certificate
of the worker's fitness. This provision provides employers with a
direct and efficient means of ascertaining whether or not they can
safely expose workers with these medical conditions to the hazards of
firefighting operations.
    Paragraph (c)(4) of the standard requires employers to inform fire
brigade members of special hazards, such as the storage and use of
flammable liquids and gases, toxic chemicals, radioactive sources,
water-reactive substances that may be present during fires and other
emergencies, and any changes in these special hazards. It also requires
that employers develop written procedures describing the actions that
brigade members are to take when special hazards are present, and to
make these procedures available in the education and training program
and for review by brigade members.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions to
protect workers, including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection, and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend the approval of the information
collection requirements contained in the

Fire Brigades Standard (29 CFR 1910.156). The agency is requesting an
adjustment decrease in burden hours from 2,767 to 2,695, a total
decrease of 72 hours. The adjustment is due to a decrease in the number
of manufacturing facilities with 100 or more workers from 25,546 to
24,885. Also, the number of responses decreased from 3,832 to 3,733.
    OSHA will summarize the comments submitted in response to this
notice and will include this summary in the request to OMB to extend
the approval of the information collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: The Fire Brigades Standard (29 CFR 1910.156).
    OMB Control Number: 1218-0075.
    Affected Public: Business or other for-profits.
    Number of Respondents: 24,885.
    Number of Responses: 3,733.
    Frequency of Responses: On occasion.
    Average Time per Response: Varies.
    Estimated Total Burden Hours: 2,695.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at https://www.regulations.gov, which is the
Federal eRulemaking Portal; (2) by facsimile (fax); if your comments,
including attachments, are not longer than 10 pages you may fax them to
the OSHA Docket Office at<PHONE_NUMBER>; or (3) by hard copy. All
comments, attachments, and other material must identify the agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2011-0009). You
may supplement electronic submissions by uploading document files
electronically.
    Comments and submissions are posted without change at https://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the https://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the https://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
    Contact the OSHA Docket Office at<PHONE_NUMBER>, (TTY (877) 889-
5627) for information about materials not available from the website,
and for assistance in using the internet to locate docket submissions.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 8-2020
(85 FR 58393).

    Signed at Washington, DC.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-25800 Filed 11-21-23; 8:45 am]
BILLING CODE 4510-26-P


Data Requirement:				PMRA DATA CODE {............}
                        EPA DP Barcode		420906
                        OECD Data Point	{............}
                        EPA MRID 			49307509
                        EPA Guideline		850.4400

Test material:	Dacthal	Technical					Purity:	98.3%
Common name:	DCPA
Chemical name:	IUPAC:		Not reported
            CAS name:	Not reported
            CAS No.:	1861-32-1
				Synonyms:	Not reported

Primary Reviewer: Kindra Bozicevich								Signature:
Environmental Scientist, CDM/CSS-Dynamac JV					Date: 05/16/2016
Secondary Reviewer: Adrian Graff								Signature:
Environmental Scientist, CDM/CSS-Dynamac JV					Date: 10/23/2020

Primary Reviewer:	Christina M. Wendel							Signature:
EPA/OPP/EFED/ERB2/Biologist 									Date: 10/20/2021

Secondary Reviewer(s): Michael Wagman							Signature:
EPA/OPP/EFED/ERB2/Senior Scientist							Date: 11/12/2021

Reference/Submission No.:  {.....................}

Company Code 		{............}	[For PMRA]
Active Code			{............}	[For PMRA]
Use Site Category:	{............}	[For PMRA]
EPA PC Code 		078701

Date Evaluation Completed: 12-11-2021

CITATION: Arnie, J.R., Martin, K.H., and J.R. Porch. 2013. Dacthal: A 7-Day Static-Renewal Toxicity Test with Duckweed (Lemna gibba G3). Study performed by Wildlife International, Ltd., Easton, Maryland. Project number 246P-104. Study sponsored by Amvac Chemical Corporation, Los Angeles, California. Study initiated August 21, 2013 and completed December 3, 2013.

This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel. The CDM/CSS-Dynamac Joint Venture role does not include establishing Agency policies.

EXECUTIVE SUMMARY:

In a 7-day acute toxicity study, freshwater floating aquatic vascular plants (duckweed, Lemna gibba G3) were exposed to Dacthal Technical (DCPA) to nominal concentrations of 0 (negative and solvent controls, <LOQ), 31, 63, 125, 250, and 500 ug a.i./L under static-renewal conditions. Because the test item was stable, mean-measured concentrations of <10.0 (<LOQ, controls), 27, 56, 113, 230, and 470 ug a.i./L were used for analysis and reporting.

The % growth inhibition of frond number in the treated culture as compared to the control ranged from -13 to 14%. Only frond number yield and frond number growth rate were significantly affected by exposure to the test material. After seven days, the most sensitive endpoint was frond number yield, with NOAEC, LOAEC, and IC50 values of 241, 470, and >470 ug a.i./L, respectively.

After 7 days, chlorotic fronds (>=0.3%) were observed in the solvent control and 230 ug a.i./L treatment group.  Necrotic fronds (>=0.3%) were observed in the negative control and 27 and 230 ug a.i./L treatment groups. There was a notable increase in pH during the study. The pH in both controls and all exposure levels ranged from 8.0 to 8.2 at test initiation. By test termination, the pH ranged from 8.8 to 9.1.

It should be noted that although the highest nominal concentration is at/above the solubility limit for DCPA (0.5 mg/L), both the stock solutions, and test concentrations were mixed by inversion and sonication and were clear and colorless throughout the test, indicating that the test material was in solution. The mean-measured concentrations were utilized for estimating the endpoints.

This study is scientifically sound and is classified as acceptable.

Results Synopsis

   Test Organism: Duckweed, Lemna gibba G3
   Test Type (Flow-through, Static, Static Renewal): Static-renewal

   Frond number yield
   IC05: 241 ug a.i./L			95% C.I.: N/A to 394 ug a.i./L
   IC50: >470 ug ai/L			95% C.I.: N/A
   NOAEC: 230 ug a.i./L

   Frond number growth rate
   IC05: 373 ug a.i./L			95% C.I.: 205 to 492 ug a.i./L
   IC50: >470 ug ai/L			95% C.I.: N/A
   NOAEC: 230 ug a.i./L

   Final biomass
   IC05: Not calculable			95% C.I.: N/A
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 470 ug a.i./L

   Biomass growth rate
   IC05: Not calculable			95% C.I.: N/A
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 470 ug a.i./L

   Endpoint(s) Affected: Frond number yield and frond number growth rate
   Most Sensitive Endpoint: Frond number yield and frond number growth rateI. MATERIALS AND METHODS

   GUIDELINE FOLLOWED:		This study was designed to comply with OECD 221 (2006) and OCSPP 850.4400 (2012). The reviewer assessed the study according to these same guidelines and OCSPP 850.4000 (2012), and OCSPP 850.1000 (2016), noting several deviations:

 Use of aeration or agitation was not reported. This is considered to be a minor deficiency.
 The hardness, alkalinity, specific conductivity, TOC, COD, particulate matter, and chlorine content of the dilution water were not reported as recommended by OCSPP Guidance. These water quality components are not specifically addressed by OECD. The OCSPP guideline recommends that these parameters are measured and that these water quality characteristics meet EPA specifications. The most recent analyses performed to measure concentrations of selected organic and inorganic constituents in well water that was used to prepare the algal medium are presented in Appendix 4 of the study report (pgs. 51-52). However, the lack of this information is considered to be a minor deficiency as the Kow and solubility of DCPA, (4.3 and 0.5 mg/L, respectively), in water would not result in an underestimation of toxicity.
 The physicochemical properties of the test substance were not reported as recommended by both OCSPP and OECD Guidance. This is considered to be a minor deficiency.
 Test solutions were not measured immediately before and after renewal as recommended by OCSPP Guidance (850.1000). However, the study author did provide sufficient analytical to determine that the static-renewal test design was sufficient to maintain the test concentrations at >=80% of the initial-measured concentrations of the previous interval. This is considered to be a minor deficiency.
 The light intensity (4930 to 5990 lux) was within the OCSPP recommended range of 4200 to 6700 lux but below the OECD recommended range of 6500 to 10000 lux. The Lemna were held under continuous fluorescent lighting, as recommended in the guideline. This is considered to be a minor deficiency.

   	These deviations do not affect the validity of the study.

   COMPLIANCE:			Signed and dated GLP, Quality Assurance, and No Data Confidentiality statements were provided.  The study was conducted in compliance with the GLP standards of the U.S. EPA (40 CFR parts 160 and 792), OECD Principles of GLP ENV/MC/CHEM (98)17, and Japan MAFF 11 NohSan Notification No. 6283 with the following exceptions: periodic analyses of water for potential contaminants and characterization of the test substance and stability of the test substance under storage conditions.

   A. MATERIALS:

   	1. Test material  				Dacthal Technical

      Description: 				Solid

      Lot No./Batch No. : 			090614-2

      Purity: 						98.3%

      Stability of compound
      under test conditions:		The test substance was stable under test conditions. The reviewer-calculated %CV values ranged from 5 to 10%. Measured concentrations ranged from 87 to 94% of nominal.

      Storage conditions of
      test chemicals: 				Stored at ambient temperature in the dark.
		Physicochemical properties of Dacthal Technical.
Parameter
Values
Comments
Water solubility at 20C
Not reported

Vapor pressure
Not reported

UV absorption
Not reported

pKa
Not reported

Kow
Not reported

   2. Test organism:

         Name:  Duckweed, Lemna gibba
         Strain, if provided: G3
         Source:  In-house cultures originally (maintained at Wildlife International, Easton, MD since June 			1995) obtained from the United States Department of Agriculture (USDA).
         Age of inoculum:  7 days
         Method of cultivation: Cultured and tested in 20X AAP medium under continuous warm-white fluorescent light (5450 +- 1250 lux) at 25  2C.

   B.  STUDY DESIGN:

      1. Experimental Conditions

         a. Range-finding study: A non-GLP range-finding test was conducted at nominal concentrations of 5.0, 50, and 500 ug a.i./L, and yielded 5, 2, and 15% inhibition of mean frond number relative to the mean negative control response, respectively, after 7 days of exposure. Nominal test concentrations were selected in consultation with the Sponsor and were based upon the results of the exploratory range-finding test.

         b. Definitive Study

Table 1:  Experimental Parameters
                                   Parameter
                                    Details
                                    Remarks

                                   Criteria
Acclimation period:

Culturing media and conditions:  (same as test or not)

Health:  (any mortality observed)
Continuous, 7-day old batch culture

Same as test; 20X AAP medium (Appendix 3, pg 50 in the study report).

Actively growing. Appeared healthy and uniform in size.
Obtained from cultures that had been actively growing in culture medium (20X AAP; same as test) for at least 2 weeks prior to test initiation. Plants used in this test were transferred to fresh medium 7 days prior to start of test.
Test system
Static/static renewal

Renewal rate for static renewal

Static-renewal

Renewed on days 3 and 5

EPA expects the test concentrations to be renewed every 3 to 4 days (one renewal for the 7 day test, 3-4 renewals for the 14 day test).
Incubation facility
Temperature-controlled environmental chamber at a temperature of 25 +-2°C

Duration of the test
7 days

EPA requires a duration of 14 days.  Seven day studies will be accepted for review by the Agency.
Test vessel
Material: (glass/stainless steel)
Size:
Fill volume:

Glass beakers
250 mL
100 mL
Beakers covered with sterile, polystyrene Petri dishes
Details of 20X AAP medium
pH in new solutions:
pH in old solutions:
Chelator used:
Carbon source:

8.0 (negative control)
8.6 to 9.0 (negative control)
Na2EDTA::2H2O
NaHCO3

The pH of the medium was adjusted to 7.5+-0.1 using 10% HCl and 0.1N sodium hydroxide.

The medium was sterilized by filtration (0.22 um) prior to use.
Appendix 3 (pg. 50 in the study report) contains the list of the medium constituents. Stock nutrient solutions were prepared by adding reagent-grade chemicals to NANOpure(R) water (purified Wildlife International well water).
Appendix 4 contains the results of the most recent analyses (December 26, 2012) performed to measure concentrations of contaminants in well water used to prepare the 20X AAP medium.

EPA recommends the following culture media:  Modified Hoagland's E+ or 20X-AAP. Chelating agents (e.g. EDTA) are recommended in the nutrient medium for optimum cell growth. Lower concentrations of chelating agents (down to one-third of the normal concentration recommended for AAP medium) may be used in the nutrient medium used for test solution preparation if it is
suspected that the chelator will interact with the test material. ASTM reference, E1415-91and D 3978-80 (reapproved 1987).
If non-standard nutrient medium was used, detailed composition provided (Yes/No)
A standard medium was used and a detailed composition was provided.

Dilution water used to prepare media
Source of dilution water:

Quality of dilution water
Hardness:
Alkalinity:
pH:
Specific conductivity:
Water pretreatment (if any):
TOC:
COD:
Particulate matter:
Metals:

Pesticides/PCBs:

Chlorine:

Purified Wildlife International, Ltd. well water

Not reported
Not reported
Not reported
Not reported
None
Not reported
Not reported
Not reported
Calcium  -  33.5 mg/L, Chloride  -  4.2 mg/L, Magnesium  -  12.9 mg/L, Potassium  -  6.57 mg/L, Sodium  -  18.2 mg/L

All others < Reporting Limit

< Reporting Limit

Not reported
Water analyses were performed on samples collected on December 26, 2012 (see Appendix 4 pg. 51-52 of the study report).

EPA recommends a pH of ~5.0. A solution pH of 7.5 is acceptable if type 20X-AAP nutrient media is used.
Indicate how the test material is added to the medium (added directly or used stock solution)
Primary stock solutions were prepared on days 0, 3, and 5 by adding 0.0509 g of Dacthal to 10 mL of N,N-Dimethylformamide (DMF) to achieve a nominal test concentration of 5.0 mg a.i./mL (based on reported purity of 98.3%). After inversion and sonication, the resulting solution was clear and colorless.  Aliquots of the primary stock solution were diluted with DMF and 20X AAP medium to prepare the remaining nominal test concentrations. The solvent control contained 0.1 mL DMF/L whereas the negative control consisted of 20X AAP medium only.

Aeration or agitation
Not reported

Sediment used (for rooted aquatic vascular plants)
Origin:
Textural classification (%sand, silt, and clay):
Organic carbon (%):
Geographic location:
N/A

Number of replicates
Negative control:
Solvent control:
Treatments:

4
4
4
One recovery replicate was also maintained in each experimental group.
Number of plants/replicate
4 plants/replicate

EPA requires 5 plants.
Number of fronds/plant
3 (12 fronds total per replicate)

EPA requires 3 fronds per plant.
Test concentrations
Nominal:

Mean-measured:

0 (negative and solvent controls), 31, 63, 125, 250, and 500 ug a.i./L

<10.0 (<LOQ, controls), 27, 56, 113, 230, and 470 ug a.i./L
Negative control = 20X AAP medium

EPA requires at least 5 test concentrations with a dose range of 2X or 3X progression.
Solvent (type, percentage, if used)
0.1 mL/L N,N-Dimethylformamide (DMF)

Method and interval of analytical verification
The test concentrations were measured on Day 0 (new), Day 3 (new), Day 3 (old), Day 5 (new), Day 5 (old), and Day 7 (old) using HPLC analysis with UV absorbance at 220 nm.
Samples were collected in duplicate from each experimental group (refer to copy of Excel worksheet in Appendix I).
Limit of quantitation (LOQ) was 10 ug a.i./L.
Test conditions
Temperature:
Photoperiod:
Light intensity and quality:

pH:

23.2 to 24.2ºC
Continuous
4930 to 5990 lux fluorescent light
(mean 5460 lux +- 379.6 SD)

8.0 to 9.1
Temperature measured continuously ranged from 22.6 to 24.9ºC
Reference chemical (if used)
name:
concentrations:

N/A

Other parameters, if any
N/A

      2. Observations:

Table 2: Observation parameters
                                  Parameters
                                    Details
                               Remarks/Criteria
Parameters measured (e.g., number of fronds, plant dry weight or other toxicity symptoms)
Frond number
Frond number growth rate
Frond number yield
Biomass (dry weight)
Biomass growth rate
Biomass yield

Measurement technique for frond number and other end points
Frond number was determined by direct counting.

Frond number yield and biomass yield were determined by subtracting the final values for each respective parameter from the initial values.

Growth Rates were calculated using a logarithmic growth equation.

Plants used in biomass determinations were dried at approximately 60°C for 48 hours prior to final weighing.

Observation intervals
Fronds were counted on days 0, 3, 5, and 7.

Other observations, if any
Fronds were observed for abnormalities (chlorotic and necrotic fronds).

Indicate whether there was an exponential growth in the control
Yes, the doubling time in the negative control was 1.9 days.

Were raw data included?
Yes

II. RESULTS and DISCUSSION:

	A. INHIBITORY EFFECTS:

Effects ranged from potential promotion of growth to at most low inhibitions in every test level for all endpoints tested. The maximum inhibition observed was for frond number and frond yield (14 and 15%, respectively). The detailed results are presented in Tables 3 to 5 below.

After 7 days, chlorotic fronds (>=0.3%) were observed in the solvent control and 230 ug a.i./L treatment group.  Necrotic fronds (>=0.3%) were observed in the negative control and 27 and 230 ug ai/L treatment groups. There was a notable increase in pH during the study. The pH in both controls and all exposure levels ranged from 8.0 to 8.2 at test initiation. By test termination, the pH ranged from 8.8 to 9.1.

Table 3: Effect of Dacthal Technical on frond number of duckweed, Lemna gibba.
                          Mean-Measured (and Nominal)
                                 Concentration
                                  ug a.i./L
                      Initial frond number/test solution
                                frond number at

                                    3 days
                                    5 days
                                    7 days

                                 frond number
                               % inhibition [a]
Negative control
                                      12
                                      30
                                      61
                                      160
                                      N/A
Solvent control
                                      12
                                      27
                                      56
                                      149
                                       7
27 (31)
                                      12
                                      31
                                      62
                                      167
                                      -4
56 (63)
                                      12
                                      28
                                      67
                                      180
                                      -13
113 (125)
                                      12
                                      31
                                      66
                                      173
                                      -9
230 (250)
                                      12
                                      29
                                      61
                                      161
                                      -1
470 (500)
                                      12
                                      29
                                      59
                                      137
                                      14
Reference chemical (if used)
N/A
[a] Calculated by the reviewer relative to the negative control group.
Data were obtained from Table 6 on page 27 of the study report.
LOQ was 10 ug a.i./L

Table 4: Effect of Dacthal Technical on frond number of duckweed, Lemna gibba.
                                Mean-Measured
                                 (and Nominal)
                                 Concentration
                                  ug a.i./L
            Initial frond number/test solution (or other endpoint)
                           Frond number growth rate
                                   (day[-1])
                              Frond number yield

                                   0-7 days
                               % inhibition [a]
                                   0-7 days
                               % inhibition [a]
Negative control (<LOQ)
                                      12
                                     0.369
                                      N/A
                                      148
                                      N/A
Solvent control (<LOQ)
                                      12
                                     0.359
                                       3
                                      137
                                       7
27 (31)
                                      12
                                     0.375
                                      -2
                                      155
                                      -5
56 (63)
                                      12
                                     0.386
                                      -5
                                      168
                                      -14
113 (125)
                                      12
                                     0.381
                                      -3
                                      161
                                      -9
230 (250)
                                      12
                                     0.370
                                       0
                                      149
                                      -1
470 (500)
                                      12
                                     0.347
                                       6
                                      125
                                      15
[a] Calculated by the reviewer relative to the negative control group.
Data were obtained from Table 7 on page 28 and Appendix 7 on pages 28 and 67, respectively, in the study report.
LOQ was 10 ug a.i./L

Table 5: Effect of Dacthal Technical on biomass of duckweed, Lemna gibba.
                          Mean-Measured (and Nominal)
                                 Concentration
                                  ug a.i./L
                    Initial frond weight/test solution (mg)
                              Final biomass (mg)
                              Biomass Yield (mg)
                        Biomass growth rate (days[-1])

                                     Day 7
                               % inhibition [a]
                                   0-7 days
                               % inhibition [a]
                                   0-7 days
                               % inhibition [a]
Negative control (<LOQ)
                                      1.2
                                     25.5
                                      N/A
                                     24.3
                                      N/A
                                     0.436
                                      N/A
Solvent control (<LOQ)
                                      1.2
                                     24.5
                                       4
                                     23.3
                                       4
                                     0.430
                                       1
27 (31)
                                      1.2
                                     26.3
                                      -3
                                     25.1
                                      -3
                                     0.441
                                      -1
56 (63)
                                      1.2
                                     27.0
                                      -6
                                     25.8
                                      -6
                                     0.445
                                      -2
113 (125)
                                      1.2
                                     27.7
                                      -9
                                     26.5
                                      -9
                                     0.448
                                      -3
230 (250)
                                      1.2
                                     25.3
                                       1
                                     24.1
                                       1
                                     0.435
                                       0
470 (500)
                                      1.2
                                     24.1
                                       5
                                     22.9
                                       6
                                     0.427
                                       2
[a] Calculated by the reviewer relative to the negative control group.
Data were obtained from Table 8 and Appendix 8 on pages 29 and 68, respectively, in the study report.
LOQ was 10 ug a.i./L

Table 6: Statistical endpoint values calculated by the study author based on mean-measured concentrations.
Statistical Endpoint
Frond number (final)
Frond number growth rate
Frond yield
Biomass yield
Biomass growth rate
NOAEC (ug a.i./L)
Not calculated
470
470
470
470
LOAEC (ug a.i./L)
Not calculated
>470
>470
>470
>470
IC50 or EC50
(ug a.i./L) (95% C.I.)
Not calculated
>470 (N/A)
>470 (N/A)
>470 (N/A)
>470 (N/A)
Reference chemical
NOAEC
IC50/EC50
N/A
N/A - Not applicable.

   B. REPORTED STATISTICS:

   The study author statistically analyzed mean frond number, growth rate, biomass, and biomass yield using The SAS System for Windows, Version 8.2. Negative and solvent control data were compared using a t-test and no statistically significant differences were noted. Endpoint data were evaluated for normality and homogeneity of variance using Shapiro-Wilk's and Levene's tests, respectively.  Treatment data were compared to the negative control data using Dunnett's t-test. The ICx values were determined using nonlinear regression. Toxicity values were based on mean-measured exposure concentrations.

C. VERIFICATION OF STATISTICAL RESULTS:

   Statistical Method: The reviewer assessed frond number yield, frond number growth rate, biomass, and biomass growth rate data using CETIS version <IP_ADDRESS> statistical software with database backend settings implemented by EFED on 10/20/15. The reviewer compared the negative and solvent control data using an Equal Variance t-Two Sample test (α = 0.05) and no statistically significant differences were observed. All further hypothesis testing was conducted comparing treatment data to negative control data only.

   All data were confirmed to be normally distributed using Shapiro-Wilk's test (α = 0.01) and exhibit equal variance according to Bartlett's test (α = 0.01). The data were monotonically decreasing and were therefore analyzed using Williams' test (α = 0.05). The final biomass and biomass growth rate data did not violate assumptions of monotonicity although the means of the four lowest test levels were higher than or similar to the negative control mean.

   Despite significant effects observed for frond number yield and frond number growth rate, the reviewer chose to estimate the IC50 values as greater than the highest concentration tested because the results were highly extrapolated for both endpoints and the 95% confidence limits weren't calculable for frond number growth rate. Final biomass and biomass growth rate IC50 values were estimated as greater than the highest concentration tested due to a lack of significant effects. The IC05 values were calculated using non-linear regression when possible.

   Frond number yield
   IC05: 241 ug a.i./L			95% C.I.: N/A to 394 ug a.i./L
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 230 ug a.i./L

   Frond number growth rate
   IC05: 373 ug a.i./L			95% C.I.: 205 to 492 ug a.i./L
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 230 ug a.i./L

   Final biomass
   IC05: Not calculable			95% C.I.: N/A
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 470 ug a.i./L

   Biomass growth rate
   IC05: Not calculable			95% C.I.: N/A
   IC50: >470 ug a.i./L			95% C.I.: N/A
   NOAEC: 470 ug a.i./L

   Endpoint(s) Affected: Frond number yield and frond number growth rate
   Most Sensitive Endpoint: Frond number yield and frond number growth rate

   D.  STUDY DEFICIENCIES:

   No deficiencies were noted.

   E.  REVIEWER'S COMMENTS:

   The reviewer's and study author's results were in complete agreement for biomass and biomass growth rate. Complete agreement was also noted over IC50 values for frond number yield and frond number growth rate. However, the reviewer determined more toxicologically sensitive NOAECs for these endpoints. The reason for this is likely attributed to the reviewer's use of Williams' test compared to the study author's use of Dunnett's test for analysis and reporting. The reviewer's results are presented in the Executive Summary and Conclusions sections of this report.

   The laboratory portion of the definitive test was conducted from August 23 to 30, 2013, with dry weight 	measurements completed on September 1, 2013.

   The coefficient of variation (CV) based for frond number yield, biomass yield and growth rates based on both frond number and biomass were all <20%, which meets the guideline requirement of CV<20%.

   F. CONCLUSIONS:

   This study is scientifically sound and is classified as acceptable. Only frond number yield and frond number growth rate were significantly affected by exposure to the test material. After seven days, the most sensitive endpoint was frond number yield, with NOAEC, LOAEC and IC50 values of 230, 470, and >470 ug a.i./L, respectively.

III.  REFERENCES:

American Society for Testing and Materials. 1991. ASTM Standard Guide 1415-91E. Standard Guide for Conducting Static Toxicity Tests with Lemna gibba G3.

Bruce, Robert, D. and Donald J. Versteeg. 1992. A Statistical Procedure for Modeling Continuous Toxicity Data. Environmental Toxicology and Chemistry. 11: 1485-1494.

Microsoft Corporation, Microsoft Excel 2010. Copyright 1985-2010.

Organization for Economic Cooperation and Development. 2006. OECD Guidelines for Testing of Chemicals, Guideline 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test. Adopted 23 March 2006.

The SAS System for Windows. 1999-2001. Version 8.2. SAS Institute, Inc. Cary, North Carolina.
U.S. Environmental Protection Agency. 2012. Series 850-Ecological Effects Test Guidelines, OCSPP Number 850.4400: Aquatic Plant Toxicity Test Using Lemna spp.

APPENDIX I. Copy of Excel Worksheet with Measured Concentrations


[Federal Register Volume 82, Number 158 (Thursday, August 17, 2017)]
[Rules and Regulations]
[Pages 39035-39038]
[FR Doc No: 2017-17241]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0174; FRL-9966-29-Region 4]

Air Plan Approval: Alabama; Transportation Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
portion of a revision to the Alabama State Implementation plan (SIP)
submitted by the State of Alabama on May 8, 2013, for the purpose of
amending the transportation conformity rules to be consistent with
Federal requirements.

DATES: This direct final rule is effective October 16, 2017 without
further notice, unless EPA receives adverse comment by September 18,
2017. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2017-0174 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Ms. Sheckler can
also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background and Purpose

A. Call to States for Conformity SIP Revisions

    In the Clean Air Act (CAA or Act), Congress recognized that actions
taken by federal agencies could affect a State, Tribal, or local
agency's ability to attain and maintain the national ambient air
quality standards (NAAQS). Congress added section 176(c) (42 U.S.C.
7506) to the CAA to ensure federal agencies' proposed actions conform
to the applicable SIP, Tribal Implementation Plan (TIP) or Federal
Implementation Plan (FIP) for attaining and maintaining the NAAQS. That
section requires federal entities to find that the emissions from the
federal action will conform with the purposes of the SIP, TIP or FIP or
not otherwise interfere with the State's or Tribe's ability to attain
and maintain the NAAQS.
    The CAA Amendments of 1990 clarified and strengthened the
provisions in section 176(c). Because certain provisions of section
176(c) apply only to highway and mass transit funding and approvals
actions, EPA published two sets of regulations to implement section
176(c). The Transportation Conformity Regulations, (40 CFR part 51,
subpart T, and 40 CFR part 93, subpart A) first published on November
24, 1993 (58 FR 62188),

address federal actions related to highway and mass transit funding and
approval actions. The conformity regulations have been revised numerous
times since then.
    When promulgated in 1993, the Federal Transportation Conformity
Rule at 40 CFR 51.395 mandated that the transportation conformity SIP
revisions incorporate several provisions of the rule in verbatim form,
except insofar as needed to give effect to a stated intent in the
revision to establish criteria and procedures more stringent than the
requirements stated in these sections.

B. What is transportation conformity?

    Transportation conformity is required under section 176(c) of the
CAA to ensure that federally-supported highway projects, transit
projects, and other activities are consistent with (``conform to'') the
purpose of the SIP. Transportation conformity currently applies to
areas that are designated nonattainment, as well as those areas
redesignated to attainment after 1990 (maintenance areas), with plans
developed under section 175A of the Act for the following
transportation related pollutants: Ozone, particulate matter
(PM2.5 and PM10), carbon monoxide, and nitrogen
dioxide. Conformity to the purpose of the SIP means that transportation
activities will not cause new air quality violations, worsen existing
violations, or delay timely attainment of the relevant NAAQS. The
transportation conformity regulation is found in 40 CFR part 93,
subpart A and provisions related to conformity SIPs are found in 40 CFR
51.390.

C. Transportation Conformity Provisions Affected by the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
for Users (SAFETEA-LU)

    On August 10, 2005, the SAFETEA-LU was signed into law and provided
changes to the CAA that streamlined the requirements for conformity
SIPs at section 176(c). Prior to SAFETEA-LU, states were required to
address all of the Federal conformity rule's provisions in their
conformity SIPs. After SAFETEA-LU amended CAA section 176(c)(4)(E) and
EPA revised 40 CFR 51.390 to be consistent with those amendments,
states are required to address and tailor only three sections of the
conformity rule in their transportation conformity SIPs. (The
requirement that states adopt the Federal conformity rule verbatim
results in the need for states to submit a SIP revision within one year
of EPA's adoption of any changes, including minor changes, to the
rule.) The three sections of the federal rule which must meet a state's
individual circumstances are: 40 CFR 93.105, which addresses
consultation procedures; 40 CFR 93.122(a)(4)(ii), which requires that
written commitments be obtained for control measures that are not
included in a Metropolitan Planning Organization's transportation plan
and transportation improvement program prior to a conformity
determination, and that such commitments be fulfilled; and, 40 CFR
93.125(c) which requires that written commitments be obtained for
mitigation measures prior to a project level conformity determination,
and that project sponsors must comply with such commitments. In
general, states are no longer required to submit conformity SIP
revisions that address the other sections of the conformity rule, and
they are able to streamline their SIP-approved conformity requirements
consistent with changes made through SAFETEA-LU.

D. Prior Approval of Alabama Conformity SIP Revisions

    EPA has approved several revisions to the Alabama SIP to
incorporate transportation conformity requirements consistent with the
Federal regulations. Initially, on May 11, 2000, EPA approved Alabama's
SIP revision to address consultation requirements for transportation
conformity. See 65 FR 30358. On March 26, 2009, EPA approved revisions
to the transportation conformity requirements in the Alabama SIP to
cover the specific applicable areas and address new requirements
related to both the 8-hour ozone and PM2.5 NAAQS. See FR 74
13118. EPA also approved a subsequent revision to Alabama's
transportation conformity requirements on September 26, 2012. See 77 FR
59100.

II. Analysis of State's Submittal

    On May 8, 2013, the Alabama Department of Environmental Management
submitted a SIP revision to EPA to make two changes to its
transportation conformity requirements. First, the State changed its
regulations at Alabama Administrative Code section 335-3-17-.01,
Transportation Conformity, to reflect the January 24, 2008 (73 FR 4420)
amendments to 40 CFR part 93, subpart A that address the 2005 SAFETEA-
LU. That change in Alabama's regulation streamlines the State's
transportation conformity SIP to include only Sec. Sec.  93.105,
93.122(a)(4)(ii) and 93.125(c), consistent with Federal requirements,
and not the provisions of 40 CFR 93 in entirety.
    On March 14, 2012, EPA finalized the rule entitled ``Transportation
Conformity Rule Restructuring Amendments.'' See 77 FR 14979. Through
that final action, EPA restructured several sections of the
transportation conformity rule so that they apply to any new or revised
NAAQS. Specifically, EPA amended Sec. Sec.  93.101, 93.105, 93.109,
93.116, 93.118, 93.119, and 93.121 of the Transportation Conformity
Rule. In its May 8, 2013, SIP revision, Alabama requests that EPA
incorporates by reference subsequent Federal changes EPA promulgated in
the Transportation Conformity Rule Restructuring Amendments. Although
Alabama's submission mentions that it is incorporating by reference
provisions in EPA's Transportation Conformity Rule Restructuring
Amendments, the only relevant portion for incorporation by reference is
the change that EPA made to section 93.105 because, in this same
submission, Alabama changed the State regulations and transportation
conformity requirements in its SIP to address only Sec. Sec.  93.105,
93.122(a)(4)(ii) and 93.125(c), in accordance with EPA's regulations.
The changes EPA made to Sec.  93.105 were administrative in nature and
involved updates to citations, revision of introductory paragraphs, and
redesignating paragraphs.
    EPA has reviewed Alabama's submittal to ensure consistency with the
current CAA, as amended by SAFETEA-LU, and EPA regulations governing
state procedures for transportation and general conformity (40 CFR part
93, subparts A and B). The May 8, 2013, SIP revision, upon final
approval by EPA, removes specific provisions of Alabama Administrative
Code section 335-3-17-.01, ``Transportation Conformity,'' from the SIP
that are no longer required in light of the SAFETEA-LU amendments. With
the removal of these specific provisions of 335-3-17-.01 from the SIP,
the federal rules in 40 CFR part 93, subpart A will directly govern
transportation conformity of federal actions in the State of Alabama.
This revision complies with the requirements of CAA section
176(c)(4)(e) and 40 CFR 51.390(b). 40 CFR part 93, subpart A continues
to subject certain Federal actions to transportation conformity
requirements without the need for identical state rules and SIPs.
Therefore, repealing the State rule will not impact continuity of the
transportation conformity program in Alabama.

III. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is

proposing to incorporate by reference the ADEM. Regulation chapter 335-
3-17.01 entitled ``Transportation Conformity,'' effective May 28, 2013,
which incorporates by reference the Federal Transportation Conformity
Rule that was restructured and amended on March 14, 2012 (77 FR 14979).
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and/or at the EPA Region 4 office
(please contact the person identified in the For Further Information
Contact section of this preamble for more information).

IV. Final Action

    Pursuant to section 110 of the CAA, EPA is approving the revision
to the Alabama SIP regarding the State's transportation conformity
requirements. The approval of Alabama's conformity SIP revisions will
align the Alabama SIP with the current federal conformity requirements,
as amended by SAFETEA-LU, and the most recent EPA regulations governing
state procedures for transportation conformity.
    EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
adverse comments be filed. This rule will be effective October 16, 2017
without further notice unless the Agency receives adverse comments by
September 18, 2017.
    If EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. EPA will not
institute a second comment period. Parties interested in commenting
should do so at this time. If no such comments are received, the public
is advised that this rule will be effective on October 16, 2017 and no
further action will be taken on the proposed rule.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in
any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 16, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: August 4, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart B--Alabama

0
2. Section 52.50(c) is amended by revising the entry for ``Section 335-
3-17-.01'' to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                                            EPA Approved Alabama Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
          State citation                Title/subject      effective date             EPA approval date                         Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                    Chapter No. 335-3-17 Conformity of Federal Actions to State Implementation Plans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 335-3-17-.01..............  Transportation              5/28/2013  8/17/2017 [Insert citation of
                                     Conformity.                            publication].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-17241 Filed 8-16-17; 8:45 am]
BILLING CODE 6560-50-P