[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Rules and Regulations]
[Page 419]
[FR Doc No: 2011-33769]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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Federal Register / Vol. 77, No. 3 / Thursday, January 5, 2012 / Rules
and Regulations

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-1066]

Drawbridge Operation Regulation; Sacramento River, Paintersville,
CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eleventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Paintersville Drawbridge across Sacramento River, mile 33.4, at
Paintersville, CA. The deviation is necessary to allow California
Department of Transportation to paint and perform routine maintenance
on the drawbridge. This deviation allows single leaf operation of the
double leaf bascule style drawbridge during the project.

DATES: This deviation is effective from 7 a.m., January 6, 2012 to 6
p.m. on April 4, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of the docket USCG-2011-1066 and are available
online by going to http://www.regulations.gov, inserting USCG-2011-1066
in the ``Keyword'' box and then clicking ``Search''. They are also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION: The California Department of Transportation
has requested a temporary change to the operation of the Paintersville
Drawbridge, mile 33.4, over Sacramento River, at Paintersville, CA. The
drawbridge navigation span provides a vertical clearance of 24 feet
above Mean High Water in the closed-to-navigation position. The draw
opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m.
and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other
times the draw shall open on signal if at least four hours notice is
given to the drawtender at the Rio Vista bridge across the Sacramento
River, mile 12.8, as required by 33 CFR 117.189(a). Navigation on the
waterway is commercial and recreational.
    Either leaf of the double bascule drawspan may be secured in the
closed-to-navigation position from 7 a.m., January 6, 2012 to 6 p.m. on
April 4, 2012, to allow Caltrans to conduct painting and maintenance on
the bridge. The opposite leaf will continue to operate normally,
providing unlimited vertical clearance and 77 feet horizontal clearance
between leafs. A work platform will be installed below the secured
leaf, reducing vertical clearance by 6 feet. This temporary deviation
has been coordinated with waterway users. No objections to the proposed
temporary deviation were raised.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: December 9, 2011.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2011-33769 Filed 1-4-12; 8:45 am]
BILLING CODE 9110-04-P


Mancozeb (014504)

Screening Level Usage Analysis (SLUA)

Date:  July 28, 2014

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active
ingredient that is used on agricultural crops in the United States.

Pesticide usage data obtained from various sources.  The data are then
merged, averaged, and rounded so that the presented information is not
proprietary, business confidential, or trade secret.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used
on.

Available pesticide usage information from U.S. states that produce 80%
or more of a crop, in most cases, or less than 80%, in rare cases,
depending on the scope of the survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural
crop.

Average annual pounds of the pesticide applied for each agricultural
crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by
merging pesticide usage data sources together; averaging across all
observations, then rounding.  Note:  If the estimated value is less than
500, then that value is labeled <500.  Estimated values between 500 &
<1,000,000 are rounded to 1 significant digit.  Estimated values of
1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data
sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5.  Note:  If the estimated value is
less than 2.5, then the value is labeled <2.5.  If the estimated value
is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5.  Note:  If the estimated value is less than 2.5,
then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National
Agricultural Statistics Service) – pesticide usage data from 2004 to
2012.

Private pesticide market research – pesticide usage data from 2004 to
2012.

California Department of Pesticide Regulation (DPR) Pesticide Use
Reporting (PUR) data for 2004 to 2011.

What are the limitations to the data?

Additional registered uses may exist but are not included because the
available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply
zero usage.

Usage data on a particular site may be noted in data sources, but not
quantified.  In these instances, the site would not be reported in the
SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control,
etc.) are not reported in the SLUA.  A separate request must be made to
receive these estimates.

Some sites show some use, even though they are not on the label.  This
usage could be due to various factors, including, but not limited to
Section 18 requests, existing stocks of the chemical, data collection
errors, and experimental use permits (EUPs).

Date: July 28, 2014

Screening Level Estimates of Agricultural Uses of Mancozeb (014504)

Sorted Alphabetically

(Reporting Timeframe: 2004-2012)

Crop	Average Annual Lbs. A.I. Applied	Percent Crop Treated

Average	Maximum

1	Almonds	2,000	<1	<2.5

2	Apples	1,200,000	40	45

3	Asparagus	20,000	15	25

4	Barley	1,000	<2.5	<2.5

5	Beans, Green +	20,000	5	15

6	Broccoli	10,000	5	10

7	Cabbage	20,000	10	15

8	Cantaloupes	20,000	5	15

9	Carrots	1,000	<2.5	5

10	Cauliflower	2,000	<2.5	<2.5

11	Cherries	2,000	<2.5	<2.5

12	Corn	60,000	<1	<2.5

13	Cotton	6,000	<1	<2.5

14	Cucumbers	100,000	30	50

15	Garlic	3,000	5	10

16	Grapes	300,000	10	20

17	Lettuce	200,000	25	60

18	Onions	400,000	60	75

19	Oranges	2,000	<1	<2.5

20	Peaches	1,000	<2.5	<2.5

21	Peanuts	40,000	<2.5	<2.5

22	Pears	200,000	45	70

23	Peas, Green	1,000	<1	<2.5

24	Peppers	50,000	10	25

25	Potatoes	2,200,000	55	65

26	Potatoes (Seed Treatment)	400,000	45	50

27	Pumpkins	20,000	10	15

28	Rice	<500	<2.5	<2.5

29	Sorghum	20,000	5	5

30	Spinach	<500	<1	<2.5

31	Squash	40,000	20	30

32	Strawberries	20,000	<2.5	<2.5

33	Sugar Beets	30,000	<2.5	10

34	Sweet Corn	100,000	5	15

35	Tobacco	10,000	<2.5	10

36	Tomatoes	500,000	20	50

37	Walnuts	400,000	35	55

38	Watermelons	300,000	45	60

39	Wheat	50,000	<1	<2.5

40	Wheat (seed treatment)	2,000	<1	<2.5

All numbers rounded.

<500: indicates less than 500 pounds of active ingredient.

	  <2.5: indicates less than 2.5 percent of crop is treated.

	  <1: indicates less than 1 percent of crop is treated.

	  + :  Crops not known to be listed on active end use product
registrations or as Section 18 emergency

exemptions when this report was run

SLUA data sources include:

USDA-NASS (United States Department of Agriculture's National
Agricultural Statistics Service)

Private Pesticide Market Research

These results reflect amalgamated data developed by the Agency and are
releasable to the public.


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Page 45441]
[FR Doc No: 2014-18488]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12962-002; Project No. 12958-002

Newburgh Hydro, LLC; Uniontown Hydro, LLC; Notice of
Teleconference

    a. Date and Time of Meeting: Thursday, August 14, 2014 at 10:00
a.m. (Eastern Daylight Time).
    b. FERC Contact: Brandi Sangunett, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    c. Purpose of Meeting: To discuss the U.S. Fish and Wildlife
Service's request for additional freshwater mussel surveys at the
proposed Uniontown Hydroelectric Project filed on June 26, 2014.
    d. Proposed Agenda:

1. Introduction
2. Freshwater Mussel Survey
3. Summary

    e. All local, state, and federal agencies, Indian tribes, and other
interested parties are invited to participate by phone. Please contact
Brandi Sangunett by August 7, 2014, to RSVP and to receive specific
instructions on how to participate.

     Dated: July 30, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-18488 Filed 8-4-14; 8:45 am]
BILLING CODE 6717-01-P


Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Data Requirement: EPA DP Barcode None EPA MRID Not Assigned EPA Guideline Open Literature Test material: Purity: 98% Common name Atrazine Chemical name: IUPAC CAS name 6 chloro N ethyl N'( 1 methylethyl) 1,3,5 triazine 2,4 diamine CAS No. 1912 24 9 Synonyms EPA PC Code: 80803 Primary Reviewer: Thomas M. Steeger, Ph. D., Senior Biologist Date: April 29, 2003 Environmental Fate and Effects Division, ERB 4, U. S. Environmental Protection Agency Secondary Reviewer( s): Joseph E. Tietge, M. S., Research Aquatic Biologist Date: Mid Continent Ecology Division, National Health and Environmental Effects Research Laboratory ( Duluth), U. S. Environmental Protection Agency Stephanie Irene, Ph. D., Senior Advisor Date: Environmental Fate and Effects Division, ERB 3, U. S. Environmental Protection Agency Mary Frankenberry, Senior Statistician Date: Environmental Fate and Effects Division, ERB 3, U. S. Environmental Protection Agency EPA PC Code 080803 Date Evaluation Completed: 04/ 29/ 2003 CITATION: Hayes, T. B., K. Haston, M. Tsui, A. Hoang, C. Haeffele and A. Vonk. 2002. Atrazine induced hermaphroditism at 0.1 ppb in American leopard frogs ( Rana pipiens): laboratory and field evidence. Environmental Health Perspectives Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 2 of 11 EXECUTIVE SUMMARY:

The objective of this study was to examine the effects of atrazine on leopard frogs ( Rana pipiens) under controlled laboratory conditions, and once the effects were identified to examine wild R. pipiens from a variety of habitats in areas with reportedly low atrazine use and high atrazine use. Water samples were also collected at each field site to determine atrazine exposure. The combination of both laboratory and field studies was intended to address the ecological significance and relevance of the initial laboratory studies.

In the laboratory, leopard frog larvae were exposed from 48 hrs post hatch through complete tail resorption ( NF Stage 66) to atrazine at 0.1 and 25

g/ L in 0.0036% ethanol in 10% Holtfreter's solution. Animals were sacrificed; gross morphology and histological analysis of gonads revealed that 36% and 12% of the males treated with atrazine at 0.1 and 25

g/ L, respectively, suffered form gonadal dysgenesis ( under developed testes with poorly structured, closed lobules and low to absent germ cells). Further, 29% of the 0.1

g/ L and 8% of the 25

g/ L animals displayed varying degrees of sex reversal; testicular lobules of sex reversed males contained oocytes, and males that metamorphosed later contained large numbers of oocytes. In a few cases, testicular oocytes were reported to be vitellogenic, i. e., contained yolk.

In a field reconnaissance survey of leopard frogs in four low atrazine use and four high atrazine use sites, testicular oocytes were identified in males from seven of the eight collection sites. All sites with atrazine levels exceeding 0.2

g/ L had males that displayed sex reversal similar to those abnormalities induced by atrazine in the lab. The highest incidence ( 92%) and most advanced cases of hermaphroditism were observed in animals collected from the North Platte River in Wyoming where atrazine residues found in water samples were among the lowest recorded. At sites with similar atrazine residues, the incidence of gonadal abnormalities varied considerably suggesting that there was not a clear pattern of response. Even at sites where no residues were reported, the incidence of testicular oogenesis appeared to be as high as 18%. Additionally, atrazine residues reported for each of the sampling sites may not be reflective of actual exposure conditions during larval development. Although young frogs were reportedly sampled, there is no information to support when the animals may have undergone metamorphosis relative to the atrazine residue analysis.

Although the researchers conducted pesticide residue analysis for chemicals that were reportedly used in the watershed, the scope of chemical analyses was on a site by site basis. As the authors noted, even atrazine was present where it was not used, and it is likely that other chemical contaminants may have been present. Chemical profiles of the sites and information on the morphoedapic characteristics of the sites would have shed light on the comparability of the study sites.

In their paper, the study authors suggested that the enhanced response at lower doses was consistent with low dose effects reported for other endocrine disrupting chemicals; however, the data did not show a clear dose response pattern. In a previous study using Xenopus ( Hayes et al. 2002), there appeared to be a threshold effect for testicular abnormalities at 0.1

g/ L but the response appeared to remain steady across increasing concentrations of atrazine with 16  20% of the males exhibiting gonadal abnormalities. In the laboratory study, only two doses of atrazine were tested, and the field study did not indicate a clear trend. From these two studies, the study authors concluded there is an " inverted U" ( parabolic) dose response curve. Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 3 of 11 I. MATERIALS AND METHODS GUIDELINE FOLLOWED: Nonguideline Study COMPLIANCE: Not conducted under full Good Laboratory Practices A. MATERIALS:

1. Test Material Atrazine Description: Chemservice, Chester, PA Lot No./ Batch No. : Not reported Purity: 98% Stability of compound under test conditions: Not reported Storage conditions of test chemicals: Not reported 2. Test organism:

Species: American leopard frog ( Rana pipiens) . Age at test initiation: 48 hrs post hatch Weight at study initiation: ( mean and range) not reported Length at study initiation: ( mean and range) not reported Source: Leopard frogs [ eggs] obtained from Sensiba Marsh, Brown County, Wisconsin.

B. STUDY DESIGN:

Objective: To examine the effects of atrazine on leopard frogs ( Rana pipiens) under controlled laboratory conditions and once the effects were identified to examine wild Rana pipiens from a variety of habitats in areas with reportedly low atrazine use and high atrazine use. Water samples were also collected at each field site to determine level of atrazine. The combination of both laboratory and field studies was intended to address the ecological significance and relevance of the initial laboratory studies.

1. Experimental Conditions a) Range finding Study: Not reported b) Definitive Study Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 4 of 11 Table 1 . Experimental Parameters Parameter Details Acclimation: period: Conditions: ( same as test or not) Feeding: Health: ( any mortality observed) Leopard frog eggs were allowed to hatch ( conditions not stated) and then apportioned to rearing tanks.

Duration of the test 48 hrs post hatch through Nieuwkoop Faber ( NF) Stage 66 Test condition static/ flow through Type of dilution system for flowthrough method.

Renewal rate for static renewal static renewal NA complete exposure solution change every 72 hours Aeration, if any exposure tanks aerated Test vessel Material: ( glass/ stainless steel) Size:

Fill volume: plastic cages ( personal communication, T. Hayes, 2002)

4 L Source of dilution water quality: Deionized, distilled water ( personal communication, T. Hayes, 2002) Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Parameter Details Page 5 of 11 Water parameters: Hardness pH Dissolved oxygen Total Organic carbon Particulate Matter Ammonia Nitrite Metals Pesticides Chlorine Temperature Salinity Intervals of water quality measurement not reported not reported not reported not reported not reported not reported not reported not reported not reported not reported 22oC not reported not reported Number of replicates/ groups: negative control: 0.004% ethanol treated ones: 3 replicates Number of organisms per replicate / groups: 30 larvae per replicate Biomass loading rate 30 larvae/ 4 L Test concentrations: nominal: 0.1 and 25

g/ L Solvent ( type, percentage, if used) 0.0036% ethanol in 10% Holtfreter's solution Holtfreter's medium:

Lighting 12 hrs light, 12 hrs dark Feeding Purina rabbit chow ad libitum ( Purina Mills, St. Louis, MO) Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Parameter Details Page 6 of 11 Recovery of chemical Level of Quantitation Level of Detection detection limit: 0.1

g/ L Positive control { if used, indicate the chemical and concentrations} not reported Other parameters, if any 2. Observations:

Table 2: Observations Criteria Details Parameters measured including the sublethal effects/ toxicity symptoms mortality, time to metamorphosis, weight and length at metamorphosis, sex based on gross morphology ( all animals) and histology ( 9 females per treatment and on all males).

Observation intervals not reported Were raw data included? No Other observations, if any Field study sites were initially selected based on atrazine sales data and were located between 39oN and 43oN latitude. Counties with less than 0.4 kg/ km2 atrazine use were chosen as potential control sites, while areas with > 9.3 kg/ km2 atrazine use were chosen as potential atrazine exposed sites. Sampling began in Utah on July 15, 2001 and moved eastward. Sampling stopped at the Iowa Illinois border because R. pipiens populations were reportedly low or threatened in Illinois and Indiana.

A total of 8 sites ( 4 control and 4 " atrazine contaminated") were sampled with 100 frogs collected at each site. Small frogs were intentionally collected in order to sample newly metamorphosed animals. Animals were immediately euthanized and fixed in Bouin's for 48 hours and preserved in 70% ethanol.

Back in the lab animals were measured, sex determined and histological analysis conducted on the gonads of 20 males from each site and a subset of females from each site.

Water samples ( 100 ml) were collected at each site in chemical free glass jars ( Fisher Scientific Co., Houston, TX) and frozen on dry ice immediately upon collection. Atrazine levels were determined by liquid chromatography/ mass spectrophotometry ( PTRL West, Inc., Hercules, CA); duplicate samples were analyzed using gas chromatography with a nitrogen phosphorous detectro ( EPA method 507; Hygenic Laboratory Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 7 of 11 University of Iowa, Iowa City, Iowa). In addition to parent atrazine, diaminochlorotriazine ( DAC), deisopropylatrazine ( DIA), deethylatrazine ( DEA), two other triazines ( simazine and hexazinone) and two other herbicides ( diuron and norfluraone) were analyzed at all sites. The following pesticides were analyzed for water collected in Utah, Wyoming and Nebraska:: metolachlor, alachlor, glyphosate, metalaxyl, nicosulfuron, propiconazole,   cyfluthrin,   cyhalothrin, and tebupirimphos.

II. RESULTS and DISCUSSION:

Laboratory Study Control and atrazine treated animals were sexually differentiated at metamorphosis, but 36% and 12% of the males treated with atrazine at 0.1 and 25

g/ L, respectively, suffered form gonadal dysgenesis ( underdeveloped testes with poorly structured, closed lobules and low to absent germ cells.) Further, 29% of the 0.1

g/ L and 8% of the 25

g/ L animals displayed varying degrees of sex reversal. Testicular lobules of sexreversed males contained oocytes, and males that metamorphosed later contained large numbers of oocytes. Males that appear to have undergone complete sex reversal had gonads completely filled with oocytes. In 2 males, oocytes were vitellogenic making the oocytes observable by gross morphology. Control males " never" contained testicular oocytes, although 2 control males contained 2  3 degenerating extragonadal oocytes ( not in lobule) and a single male showed gonadal dysgenesis.

Field Study None of the collection sites were atrazine free ( Table 3); however, atrazine residues were not reported at site 7. Except for metalochlor at site 5 ( York County NE), pesticides were not found at any of the sites. Testicular oocytes were identified in males from 7 out of 8 collection sites. All sites with atrazine levels exceeding 0.2

g/ L had males that displayed sex reversal similar to those abnormalities induced by atrazine in the lab. The highest incidence ( 92%) and most advanced cases of hermaphroditism were observed in animals collected from the North Platte River in Wyoming ( site 3). Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 8 of 11 Table 3. Sample site, date, locality, description and atrazine residues for American leopard frog ( Rana pipien) collections ( source: Hayes et al. 2002).

Site Date State County Altitude ( m) Source Habitat Atrazine

g/ L 1 7/ 15/ 01 Utah Juab 1500 Pond Grazeland 0.1 2 7/ 17/ 01 Utah Cache 1555 Pond Golf Course 0.2 3 7/ 19/ 01 Wyoming Carbon 1952 river Wildlife Area 0.2 4 7/ 23/ 01 Nebraska Cherry 1031 Pond Prarie 0.3 5 7/ 22/ 01 Nebraska York 480 Ditch Corn Field 0.81 6 7/ 26/ 01 Iowa Polk 252 Ditch Corn Field 6.7 7 7/ 28/ 01 Iowa Polk 246 Marsh Wildlife Area NA 2 8 7/ 28/ 01 Iowa Clinton 211 Stream River Valley 0.5 1 according to report figure, this value is more likely 8.0

g/ L. 2 inconsistent results, one lab reported below level of detection According to the authors, atrazine exposure disrupted gonadal development in exposed larvae as evidenced by poorly developed testicular tubules and reduced germ cells ( gonadal dysgenesis) and oocytes developing in testes ( testicular oogenesis); in a few cases, oocytes were vitellogenic.

F. REVIEWER'S COMMENTS:

This study is useful in identifying a potential hazard to amphibians and presents information on measurement endpoints, such as gonadal deformities. The study, however, does not show a clear dose response that demonstrates a causal relationship between atrazine exposure and developmental effects. The study authors suggested that the enhanced response at lower doses was consistent with low dose effects reported for other endocrine disrupting chemicals, but the data did not show a clear pattern of response. In a previous study using Xenopus ( Hayes et al. 2002), there appeared to be a threshold effect for testicular abnormalities at 0.1

g/ L. The response, though, appeared to remain steady across increasing concentrations of atrazine with 16  20% of the males exhibiting gonadal abnormalities. Additional information is needed to support the authors conclusion that of an " inverted U" ( parabolic) dose response curve.

Access to the raw data supporting this study would also help the Agency verify the study's conclusions regarding time to metamorphosis, growth, and gonadal development. Although the study authors report that in some cases animals exhibited a mix of testicular and ovarian tissue and that the oocytes were vitellogenic, Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 9 of 11 i. e., contained yolk, they provide no evidence that any differential staining was done to verify that the oocytes were indeed vitellogenic. To better support their argument, a stain capable of differentiating phospholipids or glycolipids should have been used. The authors go on to state that induction of vitellogenesis in males would be consistent with upregulation of aromatase resulting in the increased production of endogenous estrogen. Upregulation of aromatase, according to the authors would also account for the failure to induce spermatogenesis ( demasculinization) and induction of oocyte growth ( feminization). The authors note that testicular oogenesis was not observed in any of the control animals nor in any of the R. pipiens routinely studied in their laboratories.

In this study, total atrazine residues ( including atrazine degradates) are presented in graphical form and required extrapolation. According to this graph, parent atrazine residues ( 0.2

g/ L) at site 3 ( highest incidence and most advanced cases of hermaphroditism) were similar to atrazine residues ( 0.2

g/ L) at site 2 ( second lowest incidence of hermaphroditism. At site 4 ( second highest incidence of testicular oogenesis), atrazine residues ( 0.3

g/ L) were relatively similar to site 3; however the atrazine degradates DEA, DIA and DAC resulted in total residues of approximately 1.2

g/ L. The highest residues of atrazine and its degradates occurred at site 5 [ the study reports residues at 0.8

g/ L, but , the figure suggests that the reported value is actually 8

g/ L]. This site had the third highest rate of gonadal abnormalities, and the abnormalities were primarily gonadal dysgenesis rather than hermaphroditism. The second highest site ( site 6) for atrazine residues ( 6.7

g/ L) corresponded to the third lowest incidence of gonadal abnormalities. Although the study showed gonadal effects in frogs, there was no clear pattern of response. Atrazine residues were not reported at Site 7 , and at least one of the two labs measuring atrazine reported that residues were below the level of detection; however, testicular oogenesis was reported in roughly 18% of the males examined.

In its evaluation, the Agency had questions concerning the use of ethanol as a co solvent Atrazine concentrations used in the exposures are less than the 30 mg/ L solubility limit of atrazine, and a co solvent should not have been necessary . Previous studies conducted by the authors ( personal communication: Tyrone Hayes 2002) have used dihydrotestosterone and 17   estradiol as positive controls and required ethanol as a co solvent. The current study, though, did not use these steroids, and a co solvent should not have been needed.

EPA also needs more specific information concerning the methods used to determine the presence of vitillogenic oocytes. To better support their argument, a stain capable of differentiating phospholipids or glycolipids should be be used. In this study, the authors state that induction of vitellogenesis in males would be consistent with upregulation of aromatase resulting in the increased production of endogenous estrogen. Upregulation of aromatase, according to the authors would also account for the failure to induce spermatogenesis ( demasculinization) and induction of oocyte growth ( feminization). At the same time, the authors note that testicular oogenesis has not been observed in any of the control animals nor in any of the R. pipiens routinely studied in their laboratories.

Small frogs were intentionally sampled to assure that animals had recently metamorphosed implying that measured atrazine residues may have been reflective of exposure conditions during larval development. Additional information concerning the weights and age of the animals is needed to support this contention. Actual exposure conditions may have been considerably different than those reported in the study.

Although the researchers conducted pesticide residue analysis for chemicals that were reportedly used in the watershed, the scope of chemical analyses was on a site by site basis. As the authors noted, even atrazine Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 10 of 11 Atrazine Concentration ( ug/ L) 0 2 4 6 8 Prevalence of Male Gonadal Abnormalities (%)

0 20 40 60 80 100 Figure 1. The prevalence of gonadal abnormalities in seven sites plotted against measured atrazine concentrations. One site is omitted because of a lack of atrazine analysis. Prevalence data are estimated from graphical representations of the data. This analysis also assumes that atrazine concentrations at site 5 are 0.8 ug/ L, although figure 11A of the publication indicates that it was actually 8.0 ug/ L. was present where it was not used , and it is likely that other chemical contaminants may have been present. Additional information on the chemical profile and morphoedapic characteristics of the sites is needed in order to compare the study sites. The relationship of the potential atrazine exposure at the critical developmental stages is unknown because the surface water sampling was conducted during the postmetamorphic period. When the prevalence of male gonadal abnormalities is plotted as a function of atrazine concentration, there is no clear relationship ( Figure 1). Additional data would help clarify this problem.

The Agency also needs clarifying data concerning the number of males and females collected at each site. Presumably at least 20 males were analyzed histologically, but it is unclear how these organisms were selected. If they were selected based on gross observations, then there is a strong possibility that the sample set was biased. Because a subset of organisms was selected and prevalence calculations were based on this selection, the subset should have been selected randomly.

In the laboratory study, 30 organisms per replicate with 3 replicates were exposed per treatment level. The prevalence of gonadal abnormalities was evidently based on combining the data of the replicates. It would be useful to understand the variance among the replicates and whether responses in individual tanks are driving the analysis. The Agency also needs data that indicates the distribution of males and females in the study and the sample sizes to gauge the robustness of the analyses. A further note concerning the laboratory study is the use of 30 organisms with an estimated maximal weight of 2.5 g in 4 liters of test solution. These conditions would result in a loading rate of 18.8 g/ L, which is 37 times the recommended loading rate for static renewal toxicity tests.

The highest prevalence of gonadal abnormalities was observed at the site in Wyoming. Is it possible that there is a genetic component to this phenomenon? The authors state that in 7,000 organisms collected from four different states, no gonadal abnormalities [ of the type described in the study] have ever been noted. Given the ubiquitous nature of atrazine contamination suggested in the paper, it is hard to imagine that these were all from atrazine free environments, particularly in Wisconsin. If it is, in fact, true, then these data should have been published, as they would have provided great weight to the analysis. Data Evaluation Report on Atrazine Induced Hermaphroditism at 0.1 ppb in American Leopard Frogs ( Rana pipiens): Laboratory and Field Evidence EPA MRID Number: None Page 11 of 11 As the study authors noted, the ecological relevancy of these findings is unclear because the researchers did not have problems in locating frogs. Further information is needed to determine if gonadal abnormalities impair the reproductive success, growth, and survival of amphibians.

H. REFERENCES:

Hayes, T. B., A. Collins, M. Lee, M. Mendoza, N. Noriega, A. A. Stuart, A. Vonk. 2002. Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses. Proceedings of the National Academy of Science, 99 ( 8): 5476  5480.

Nieuwkoop, P. D. and J. Faber. 1994. Normal table of Xenopus laevis ( Daudin). North Holland Publishing Company, Amsterdam.


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57768-57769]
[DOCID:fr22se10-64]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-8846-3]

Access to Confidential Business Information by Eastern Research
Group and Its Identified Subcontractor

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has authorized its contractor, Eastern Research Group
(ERG) of Lexington, MA and subcontractor Avanti Corporation of
Alexandria, VA, to access information which has been submitted to EPA
under all sections of the Toxic Substances Control Act (TSCA). Some of
the information may be claimed or determined to be Confidential
Business Information (CBI).

DATES: Access to the confidential data will occur no sooner than
September 29, 2010.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>

    For technical information contact: Scott Sherlock, Environmental
Assistance Division (7408M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2003-0004. All documents
in the docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. What Action is the Agency Taking?

    Under Contract Number EP-W-10-014, contractor ERG of 110 Hartwell
Ave., Lexington, MA and subcontractor Avanti Corporation of 5520
Cherokee Ave., Suite 205, Alexandria, VA will assist the Office of
Pollution Prevention and Toxics (OPPT) in preparing exposure and
release assessments for OPPT's new and existing chemical review
programs; providing support for regulatory efforts such as the TSCA
Inventory Update Rule Amendments; and preparing various technical
analyses to support OPPT activities under all sections of TSCA.
    In accordance with 40 CFR 2.306(j), EPA has determined that under
Contract Number EP-W-10-014, ERG and its subcontractor will require
access to CBI submitted to EPA under all sections of TSCA to perform
successfully the duties specified under the contract. ERG and its
subcontractor's personnel will be given access to information submitted
to EPA under all sections of TSCA.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA may provide ERG and its
subcontractor access to these CBI materials on a need-to-know basis
only. All access to TSCA CBI under this contract will take place at EPA
Headquarters and ERG's sites located at 14555 Avion Parkway, Suite 200,
Chantilly, VA and 110 Hartwell Ave., Lexington, MA in accordance with
EPA's TSCA CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until August 9,
2015. If the contract is extended, this access will also continue for
the duration of the extended contract without further notice.
    ERG and its subcontractor's personnel will be required to sign
nondisclosure agreements and will be briefed on appropriate security
procedures before they are permitted access to TSCA CBI.

List of Subjects

    Environmental protection, Confidential business information.

    Dated: September 16, 2010.
 Diane Sheridan,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.

[FR Doc. 2010-23721 Filed 9-21-10; 8:45 am]
BILLING CODE 6560-50-S


APPENDIX B Figures B. 1 through B. 8 are graphs from Johnson et al. ( 1996b) showing 8 hour daily maximum dose exposures for outdoor children under various air quality scenarios. Two graphs are provided for each of four study areas ( Houston, New York, Philadelphia, and Washington, D. C.). The graphs use two indicators to characterize O 3 exposure:

 Number of children experiencing 8 hour daily maximum dose exposures on one or more days under moderate exertion conditions,

 Number of total occurrences in which a child experiences a daily maximum dose exposure under moderate exertion conditions.

Moderate exertion conditions are defined as an EVR level between 13 and 27 l min 1 m 2.

Figure B. 1 presents results for the first indicator ( number of outdoor children) based on applications of pNEM/ O 3 to Houston. Nine distributions are plotted on the graph: one for baseline (" As Is") conditions; two for 1 hour, 1 exceedance standards ( 1H1EX 0.12 and 1H1EX 0.10); four for 8 hour, 1 exceedance standards ( 8H1EX 0.10, 8H1EX 0.09, 8H1EX 0.08, 8H1EX 0.07); and two for 8 hour, 5 exceedance standards ( 8H5EX 0.08, 8H5EX 0.09). For example, 8H5EX 0.08 indicates an 8 hour, 5 exceedances standard with O 3 concentration set at 8 pphm or 0.08 ppm.

The ordinate ( y coordinate) of each point on the graph shows the number of children with one or more daily maximum dose exposures equal to or above the O 3 concentration indicated by the point's abscissa ( x coordinate). In Figure B. 1, the " As Is" curve is associated with the highest number of children exposed when the specified O 3 concentrations fall between 0.05 and 0.16 ppm. The nine curves tend to converge at lower and higher O 3 concentrations. In a similar manner, the 8H1EX 0.07 standard is associated with the lowest number of children exposed when the specified O 3 concentration falls between 0.03 and 0.08 ppm.

Appendix E of Johnson et al. ( 1996b) provides similar graphs for two other EVR ranges of interest: 16 30 l min 1 m 2 and

30 l min 1 m 2 for 1 hour exposures.


[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8988-8989]
[FR Doc No: 2023-02813]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0042; Notice 2]

Continental Tire the Americas, LLC, Denial of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Denial of petition.

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SUMMARY: Continental Tire the Americas, LLC (CTA), has determined that
certain Altimax RT 43 replacement passenger car tires do not fully
comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New
Pneumatic Radial Tires for Light Vehicles. CTA filed a noncompliance
report dated April 20, 2021, and subsequently petitioned National
Highway Traffic Safety Administration (NHTSA or the ``Agency'') on May
13, 2021, for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety. This notice
announces the denial of CTA's petition.

FOR FURTHER INFORMATION CONTACT: Jayton Lindley, Office of Vehicle
Safety Compliance, NHTSA,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    CTA has determined that certain Altimax RT43 replacement passenger
car tires do not fully comply with the requirements of paragraph
S5.5.1(b) of FMVSS No. 139, New Pneumatic Radial Tires for Light
Vehicles (49 CFR 571.139). CTA filed a noncompliance report dated April
20, 2021, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. CTA subsequently petitioned NHTSA on May
13, 2021, for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556,
Exemption for Inconsequential Defect or Noncompliance.
    Notice of receipt of CTA's petition was published with a 30-day
public comment period, on June 9, 2022, in the Federal Register (87 FR
35283). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) website at https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2021-0042.''

II. Tires Involved

    Approximately three (3) Altimax RT43 replacement passenger car
tires, size 175/65R14 82T, manufactured between March 8, 2020, and
March 14, 2020, are potentially involved.

III. Noncompliance

    CTA explains that the noncompliance is due to a mold error in which
the subject tires contain a tire identification number (TIN) that omits
the 3-digit plant code and the 6-symbol manufacturer's identification
mark as required by paragraph S5.5.1(b) of FMVSS No. 139 and 49 CFR
574.5(b). Specifically, CTA should have labeled the subject tires ``DOT
036 0F934V 1020'' on the outboard sidewall and ``DOT 036 0F934V'' on
the inboard sidewall, but CTA instead labeled ``DOT 1020'' \1\ on the
outboard sidewall and ``DOT'' on the inboard sidewall.
---------------------------------------------------------------------------

    \1\ Blank spaces in this quoted label are representative of how
the labeling error appears on CTA's subject tires.
---------------------------------------------------------------------------

IV. Rule Requirements

    Paragraph S5.5.1(b) of FMVSS No. 139 includes the following
requirements, which are relevant to this petition:
     For tires manufactured on or after September 1, 2009, each
tire must be labeled with the TIN required by 49 CFR part 574 on the
intended outboard sidewall of the tire.
     If a tire does not have an intended outboard sidewall, the
tire must be labeled with the TIN required by 49 CFR part 574 on one
sidewall and with either the TIN or a partial TIN, containing all
characters in the TIN except for the date code and, at the discretion
of the manufacturer, any optional code, on the other sidewall.\2\
---------------------------------------------------------------------------

    \2\ This specific requirement does not apply to retreaded tires,
but notably, the subject tires are not retreaded tires.
---------------------------------------------------------------------------

V. Summary of CTA's Petition

    The following views and arguments presented in this section, ``V.
Summary of CTA's Petition,'' are the views and arguments provided by
CTA in support of its petition. They do not reflect the views of the
Agency. CTA describes the subject noncompliance and contends that the
noncompliance is inconsequential as it relates to motor vehicle safety.
    CTA says that in most instances, it ``tests its tires to standards
which exceed the FMVSS minimums.'' CTA asserts that ``the subject tires
contain all the necessary sidewall markings to show compliance with
FMVSS testing'' and that other than the incorrect TIN marking, the
tires ``meet or exceed'' FMVSS No. 139's performance and labeling
requirements.
    According to CTA, the serial sidewall of the subject tires displays
the correct DOT production week and year, and when combined with other
markings available on the subject tires, the tires can be uniquely
identified.
    CTA cites the following previous inconsequentiality petitions to
support its argument:
    a. Michelin North America, Inc., 85 FR 37495 (June 22, 2020).

    b. Cooper Tire & Rubber Company, 82 FR 52966 (November 15, 2017).
    c. Cooper Tire & Rubber Company, 82 FR 17510 (April 11, 2017).
    CTA states that it is not aware of any tire failures related to
performance that resulted in an accident, injury, property damage,
customer complaint, or any field reports associated with the
mislabeling.
    CTA says that it has quarantined its current inventory of the
noncompliant tires--leaving three tires remaining in the market.
    CTA concludes that the subject noncompliance is inconsequential as
it relates to motor vehicle safety and that its petition to be exempted
from providing notification of the noncompliance, as required by 49
U.S.C. 30118, and a remedy for the noncompliance, as required by 49
U.S.C. 30120, should be granted.

VI. NHTSA's Analysis

    In determining inconsequentiality of a noncompliance, NHTSA focuses
on the safety risk to individuals who experience the type of event
against which a recall would otherwise protect.\3\ In general, NHTSA
does not consider the absence of complaints or injuries when
determining if a noncompliance is inconsequential to safety. The
absence of complaints does not mean vehicle occupants have not
experienced a safety issue, nor does it mean that there will not be
safety issues in the future.\4\
---------------------------------------------------------------------------

    \3\ See Gen. Motors, LLC; Grant of Petition for Decision of
Inconsequential Noncompliance, 78 FR 35355 (June 12, 2013) (finding
noncompliance had no effect on occupant safety because it had no
effect on the proper operation of the occupant classification system
and the correct deployment of an air bag); Osram Sylvania Prods.
Inc.; Grant of Petition for Decision of Inconsequential
Noncompliance, 78 FR 46000 (July 30, 2013) (finding occupant using
noncompliant light source would not be exposed to significantly
greater risk than occupant using similar compliant light source).
    \4\ See Morgan 3 Wheeler Limited; Denial of Petition for
Decision of Inconsequential Noncompliance, 81 FR 21663, 21666 (Apr.
12, 2016); see also United States v. Gen. Motors Corp., 565 F.2d
754, 759 (D.C. Cir. 1977) (finding defect poses an unreasonable risk
when it ``results in hazards as potentially dangerous as sudden
engine fire, and where there is no dispute that at least some such
hazards, in this case fires, can definitely be expected to occur in
the future'').
---------------------------------------------------------------------------

    Arguments that only a small number of vehicles or items of motor
vehicle equipment are affected also do not justify granting an
inconsequentiality petition.\5\ Similarly, mere assertions that only a
small percentage of vehicles or items of equipment are likely to
actually exhibit a noncompliance are unpersuasive. The percentage of
potential occupants that could be adversely affected by a noncompliance
is not relevant to whether the noncompliance poses an inconsequential
risk to safety. Rather, NHTSA focuses on the consequence to an occupant
who is exposed to the consequence of that noncompliance.\6\ The Safety
Act is preventive, and manufacturers cannot and should not wait for
deaths or injuries to occur in their vehicles before they carry out a
recall.\7\ Indeed, the very purpose of a recall is to protect
individuals from risk.\8\
---------------------------------------------------------------------------

    \5\ See Mercedes-Benz, U.S.A., L.L.C.; Denial of Application for
Decision of Inconsequential Noncompliance, 66 FR 38342 (July 23,
2001) (rejecting argument that noncompliance was inconsequential
because of the small number of vehicles affected); Aston Martin
Lagonda Ltd.; Denial of Petition for Decision of Inconsequential
Noncompliance, 81 FR 41370 (June 24, 2016) (noting that situations
involving individuals trapped in motor vehicles--while infrequent--
are consequential to safety); Morgan 3 Wheeler Ltd.; Denial of
Petition for Decision of Inconsequential Noncompliance, 81 FR 21663,
21664 (Apr. 12, 2016) (rejecting argument that petition should be
granted because the vehicle was produced in very low numbers and
likely to be operated on a limited basis).
    \6\ See Gen. Motors Corp.; Ruling on Petition for Determination
of Inconsequential Noncompliance, 69 FR 19897, 19900 (Apr. 14,
2004); Cosco Inc.; Denial of Application for Decision of
Inconsequential Noncompliance, 64 FR 29408, 29409 (June 1, 1999).
    \7\ See, e.g., United States v. Gen. Motors Corp., 565 F.2d 754,
759 (D.C. Cir. 1977).
    \8\ Id.
---------------------------------------------------------------------------

    NHTSA has evaluated the merits of the petition submitted by CTA and
is denying CTA's request for relief from notification and remedy.
    The purpose of the TIN is to provide a means by which tire
manufacturers may notify purchasers of defective or nonconforming
tires.
    CTA cited three prior petitions in support of their own petition.
In the Michelin North America, Inc., 85 FR 37495 (June 22, 2020)
petition the subject tires contained a TIN, however, the symbol ``DOT''
was incorrectly placed after the 1st grouping of TIN characters. For
the Cooper Tire & Rubber Company, 82 FR 52966 (November 15, 2017) and
Cooper Tire & Rubber Company, 82 FR 17510 (April 11, 2017) petitions
the manufacturer incorrectly used the wrong characters for the plant
code portion of the TIN on one sidewall. The Agency does not find the
petitions CTA cited as relevant to this petition. In each of the
petitions cited by CTA, the tires contain a full TIN on at least 1
sidewall of the tire that can be utilized for the purposes of
identification in the event of a recall. The tires that are the subject
of this petition do not have a full or partial TIN on either sidewall.
    Furthermore, NHTSA disagrees with CTA's assertion that the date
code is sufficient to register and uniquely identify a tire. Without a
TIN, there is no means by which purchasers can register the subject
tires. In the event of a recall, CTA may be unable to timely notify
purchasers of a potential safety issue, and consumers and other drivers
will be at risk. If an original purchaser of a subject tire previously
sold or will sell their vehicle to a different consumer, it is unlikely
that CTA will be able to timely notify the subsequent consumer of
potential safety issues. Additionally, it may not even be possible for
CTA to determine how to contact a subsequent consumer. For these
reasons, the Agency is denying this petition for relief from
notification and remedy.

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA has decided that CTA has
not met its burden of persuasion that the subject FMVSS No. 139
noncompliance is inconsequential to motor vehicle safety. Accordingly,
CTA's petition is hereby denied and CTA is consequently obligated to
provide notification of and free remedy for that noncompliance under 49
U.S.C. 30118 and 30120.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Anne L. Collins,
Associate Administrator for Enforcement.
[FR Doc. 2023-02813 Filed 2-9-23; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Rules and Regulations]
[Pages 17917-17920]
[FR Doc No: 2021-07129]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0531; FRL-10017-27]

Penthiopyrad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
penthiopyrad in or on persimmon. Mitsui Chemicals Agro, Inc., c/o
Landis International, Inc. requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2021. Objections and
requests for hearings must be received on or before June 7, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0531, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0531 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
June 7, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0531, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 24, 2020 (85 FR 37806) (FRL-10010-
82), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E8773) by Mitsui Chemicals Agro, Inc. \c/o\ Landis International,
Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126. The
petition requested that 40 CFR 180.658 be amended by establishing a
tolerance for residues of the fungicide, Penthiopyrad (N-[2-(1,3-
dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-
carboxamide) in or on persimmon, at 3.0 parts per million (ppm). That
document referenced a summary of the petition prepared by Mitsui
Chemicals Agro, Inc. \c/o\ Landis International, Inc., the registrant,
which is available in the docket for this action, docket ID number EPA-
HQ-OPP-2019-0531, at http://www.regulations.gov. There were no comments
received in response to the notice of filing. EPA is setting a
tolerance of 3 ppm in persimmon, instead of the petitioner-proposed
tolerance value of 3.0 ppm. This change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

A. Statutory Background

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D) and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for penthiopyrad, including exposure resulting from
the tolerance established by this action. EPA's assessment of exposures
and risks associated with penthiopyrad follows.

B. Aggregate Risk Assessment

    In an effort to streamline Federal Register publications, EPA is
directing readers to certain sections of Federal Register notifications
for previous tolerance rulemakings for the same pesticide that contain
information that has not changed in the current risk assessment. To
that end, on June 6, 2019, EPA published in the Federal Register a
final rule establishing a tolerance for residues of penthiopyrad in or
on multiple commodities based on the Agency's conclusion that aggregate
exposure to penthiopyrad is safe for the general population, including
infants and children. See 84 FR 26352 (FRL-9994-08). Please refer to
the following sections of the previous tolerance rulemaking that
contain information that has remained the same under the current risk
assessment for this rulemaking: Units III.A (Toxicological Profile);
III.B (Toxicological Points of Departure/Levels of Concern); III.C
(Exposure Assessment), except as explained in the next paragraph; and
III.D (Safety Factor for Infants and Children).
    Updates to exposure assessment. The Agency conducted an updated
risk assessment to evaluate exposure to residues of penthiopyrad on
persimmon. EPA's acute and chronic dietary (food and drinking water)
exposure assessments have been updated to include the additional
exposure from use of penthiopyrad on persimmon. As to residue levels in
food, the dietary exposure assessments are based on tolerance-level
residues and assumed 100 percent crop treated (PCT). There will be no
U.S. registrations for use of penthiopyrad on persimmon, and there is
no proposed new residential use. Therefore, EPA's assessments of
dietary exposure from drinking water and non-dietary (i.e.,
residential) exposure, as well as cancer classification and cumulative
effects from substances with a common mechanism of toxicity, have not
changed and are described in the previous tolerance rulemaking.
    Assessment of aggregate risks. Acute aggregate risk estimates are
equal to acute dietary (food and drinking water) risk estimates, which
are below the Agency's level of concern of 100% of the acute population
adjusted dose (aPAD): The exposure estimate is 20% of the aPAD at the
95th percentile of exposure for infants less than 1 year old, which is
the population subgroup with the highest exposure estimate. Chronic
aggregate risk estimates are equal to chronic dietary (food and
drinking water) risk estimates, which are below

the Agency's level of concern of 100% of the chronic population
adjusted does (cPAD): The exposure estimate is 28% of the cPAD for
infants less than 1 year old, which is the population subgroup with the
highest exposure estimate. Short-term aggregate risk estimates are
equal to the most conservative residential exposure estimates plus
chronic dietary exposure estimates (considered to be background dietary
exposure). For adults, the most conservative residential exposure
estimate is dermal exposure through high contact lawn activity, with a
margin of exposure (MOE) above the Agency's level of concern of 100
(MOE = 560). For children, the most conservative residential exposure
estimate is combined dermal and incidental oral exposure through high
contact lawn activity, with an MOE above the Agency's level of concern
of 100 (MOE = 270). Moreover, the children 1 to less than 2 years old
population subgroup was chosen for the short-term aggregate risk
estimate for children, since the exposure estimate for this subgroup is
protective for all other children subpopulations. Considering both the
chronic dietary (food and drinking water) exposures and the high
contact lawn activity residential exposures for both adults and
children, EPA has concluded the short-term aggregate MOEs are 440 and
220 for adults and children, respectively, which are above the level of
concern of 100 and therefore are not of concern.

C. Determination of Safety

    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to penthiopyrad residues. More detailed information
on the subject action to establish a tolerance in or on persimmon can
be found in the document entitled, ``Penthiopyrad. Human Health Risk
Assessment for the Proposed Tolerance Without a U.S. Registration on
Persimmon.'' dated 12/14/2020 at www.regulations.gov, under docket ID
number EPA-HQ-OPP-2019-0531.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography-tandem
mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) is
available to enforce penthiopyrad tolerances. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
    The established Codex MRL for penthiopyrad in persimmons is 0.4 mg/
kg. The 3 ppm tolerance being established is harmonized with the
existing Japanese MRL of 3 ppm instead, which is consistent with the
tolerance value requested by the petitioner. According to the
registrant, the locations of the field trials for residue data reflect
the primary importation of persimmon from Japan. The registrant cited
USDA Economic Research Service data indicating that Spain, Israel, and
Chile are the only countries with >5% imports of persimmons into the
United States. The registrant indicated that penthiopyrad is registered
in Spain and Israel but not on persimmon and that penthiopyrad is not
registered in Chile. Therefore, the registrant posits that the only
importing country on which penthiopyrad would be registered for use on
persimmon would be Japan.

C. Revisions to Petitioned-For Tolerances

    The Agency is setting a tolerance in or on persimmon of 3 ppm
rather than the petitioned-for tolerance value of 3.0 ppm. This value
is in accordance with the Organization for Economic Cooperation and
Development (OECD) MRL calculation procedure's rounding class
practices.

V. Conclusion

    Therefore, tolerances are established for residues of penthiopyrad
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide) in or on persimmon at 3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance for
residues in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has

determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 16, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.658, amend paragraph (a)(1) by designating the table
and adding in alphabetical order in newly designated Table 1 to
paragraph (a)(1) the entry ``Persimmon'' and footnote 2 to read as
follows:

Sec.  180.658  Penthiopyrad; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Persimmon \2\..............................................           3

                                * * * * *

                                * * * * *
------------------------------------------------------------------------
\2\ There are no U.S. registrations for this commodity as of April 7,
  2021.

* * * * *
[FR Doc. 2021-07129 Filed 4-6-21; 8:45 am]
BILLING CODE 6560-50-P