[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44138-44139]
[FR Doc No: 2022-15874]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4648-DR; Docket ID FEMA-2022-0001]

Alaska; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alaska (FEMA-4648-DR), dated March 24, 2022, and
related determinations.

DATES: This change occurred on June 15, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Yolanda J.
Jackson, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Thomas J. Dargan as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA);

97.046, Fire Management Assistance Grant; 97.048, Disaster Housing
Assistance to Individuals and Households In Presidentially Declared
Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidentially Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-15874 Filed 7-22-22; 8:45 am]
BILLING CODE 9111-23-P


1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code No. 129111 DP Barcode: D330783 Date: July 28, 2006 MEMORANDUM SUBJECT: EFED Drinking Water Assessment for the IR 4 Tolerance Petition for Use of Kresoxim Methyl on Curcurbit Vegetables [ Second revision]

TO: Tamue Gibson, Risk Manager Reviewer Mary Waller, Risk Manager Registration Division Sara Levy, Chemist Health Effects Division FROM: Cheryl A. Sutton, Ph. D., Environmental Scientist Roxolana Kashuba, Environmental Scientist Environmental Risk Branch IV Environmental Fate and Effects Division ( 7507C)

REVIEWED BY: R. David Jones, Ph. D. Senior Agronomist Environmental Risk Branch IV Environmental Fate and Effects Division ( 7507C)

APPROVED BY: Elizabeth Behl, Branch Chief Environmental Risk Branch IV Environmental Fate and Effects Division ( 7507C)

The Environmental Fate and Effects Division ( EFED) has completed its drinking water assessment [ second revision] in support of the IR 4 tolerance petition for the use of kresoxim methyl ( Sovran ® Fungicide: 50.0% active ingredient by mass; PC Code 129111) as a wettable granule fungicide on cucurbit vegetables to control gummy stem blight ( Didymella bryoniae) or powdery mildew ( Sphaerotheca fulginea, Erysiphe cichoracearum). Sovran ® is proposed for use as ground and aerial sprays as well as through irrigation systems. The proposed application rate is 0.15 lb ai/ A/ application ( 4.8 oz Sovran ® / A, by mass), with up to 4 applications a season, for a total maximum seasonal rate of 0.6 lb ai/ A ( 19.2 oz Sovran ® / A, by mass). [ The first revision of this drinking water assessment ( D326550) was conducted using unrevised label rates of 0.2 lb ai/ A/ application. RD has since submitted EFED a revised label.] Generally, cucurbits such as field cucumbers are planted twice a year, once in spring and once in the fall, and, thus, have two seasons per year. For the purposes of determining Estimated Drinking Water Concentrations ( EDWC), EFED assumes that the label rate expressed in terms of " per season" results in two sets of ( four) applications per year ( for a total of eight applications per year), as, in some locations, there may be two growing seasons per year for cucurbit vegetables. Therefore, the modeling scenario used to determine EDWCs for this assessment simulates the use of kresoxim methyl on two crops of a specific

2

cucurbit vegetable ( both a spring planting and a fall planting) at a single site for a total maximum yearly rate of 1.2 lb ai/ A ( 38.4 oz Sovran ® / A, by mass).

The " EFED Risk Assessment for the Section 3 Registration of Kresoxim Methyl on Apples, Grapes, and Pecans" ( DP Barcodes D244862, D248122, D248123, D248359, D245119, D246782, D246987, D250295) was completed in 1999. In the Section 3 chapter, EFED stated that:

" Based on the environmental fate properties for kresoxim methyl, with consideration of the product formulation and application rates, EFED believes that the rapidly degraded parent compound is unlikely to have adverse effects on the environment. However, since the major acid degradate ( BF 490 1) has the physical/ chemical characteristics in common with those pesticides that are known to leach to ground water or to move offsite to surface water, the potential for BF 490 1 to reach ground water and surface water exists, especially when it is applied to fields with one or more of the following characteristics: alkaline soils, low organic matter, high sand, shallow ground water table, and nearby bodies of water."

Thus, this current assessment includes both the parent and the major degradate BF 490 1. To model concentrations of BF 490 1, full conversion to the degradate from the rapidly degrading parent compound was assumed. Also, as stated by EFED in the Section 3 chapter, " Because of the concerns raised by HED with regard to cancer risk to mammals, a tier II drinking water assessment was conducted." No monitoring data are available.

Although the proposed rates are less than the rate modeled previously, new Tier II EDWCs were estimated because the initial risk assessment was conducted based on a ground spray application and the proposed new use includes aerial spray applications. Also, the newer values are based on input parameter guidance for Tier II modeling that was developed in 2002. Finally, based on new use related information from the Biological and Economic Analysis Division ( BEAD), two seasons of cucurbits per year are modeled in this assessment. Previously, only one season per year was modeled. The groundwater EDWCs are approximately 1.5X higher than those in the previous assessment done for apples, grapes and pecans. In the previous assessment, the groundwater concentration values reported for use in the human health risk assessment were 2.57x10 4 µ g/ L for parent kresoxim methyl and 4.2 µ g/ L for BF 490 1. The surface water EDWCs are approximately 3 10X higher for acute and 2 20X higher for chronic than those in the previous assessment done for apples, grapes and pecans. In the previous assessment, the surface water concentration values reported for use in the acute human health risk assessment were 1.2 µ g/ L for parent kresoxim methyl and 13.8 µ g/ L for BF 490 1. The surface water values for the chronic and cancer human health risk assessments were reported in the previous assessment as the " long term average values of 5.8 ng/ L for parent kresoxim methyl and 5.0 µ g/ L for BF 490 1." New Tier II values for the proposed use of kresoxim methyl on curcurbit vegetables are reported below in Table 1. The input parameter values used in Tier I modeling ( SCI GROW2) to determine the groundwater EDWC and in Tier II modeling ( PRZM/ EXAMS) to determine the surface water EDWCs are presented in Tables 2 and 3, respectively. The source environmental fate and physical/ chemical property data are presented in Appendix A. Output files for Tier I modeling are presented in Appendix B. Input and output files for Tier II modeling are presented in 129111 D330783 DWA. zip, as follows:

Parent input  KresoximMethyl. pzr ( file dated 07/ 17/ 2006) Degradate input  BF490 1deg. pzr ( file dated 07/ 17/ 2006) Parent and degradate output  129111 D330783 DWA output. doc ( file dated 07/ 17/ 2006) Parent and degradate time series  129111 D330783 DWA time series. xls ( file dated 07/ 17/ 2006)

3

In determining EDWCs for drinking water exposure assessment, EFED utilizes a standard EXAMS scenario referred to as the " index reservoir" in Tier II modeling with PRZM ( v. 3.12 beta; input generated by PE4VO1. pl, dated 8/ 8/ 03) and EXAMS ( 2.98.04). Scenarios simulate a 173 hectare watershed draining into a 5.3 hectare flow through reservoir that is 2.3 meters. The reservoir serves as a surrogate for a variety of small water bodies used for drinking water. It is assumed that runoff is equally likely to flow into the reservoir from all areas of the treated field, and the applied Percent Crop Area ( PCA) accounts for the portion of the watershed that is cropped and treated. Additional information on the models PRZM and EXAMS can be located at: http:// www. epa. gov/ oppefed1/ models/ water/.

The standard PRZM/ EXAMS scenario selected for modeling is Florida cucumbers, modified for two seasons per year. The standard Florida cucumbers scenario represents one fall season of cucumbers per year, with emergence date of 10/ 10/ 61, maturation date of 12/ 05/ 61, and harvest date of 12/ 10/ 61. A spring season of cucumbers was added to the modified scenario with emergence date of 04/ 10/ 61, maturation date of 06/ 05/ 61, and harvest date of 06/ 10/ 61 ( Record 11). The number of different crops ( NDC) in the simulation ( Record 8) was changed from 1 to 2. Additionally, to adjust runoff parameters associated with cropped land for the spring season, RUSLE numbers ( Record 9C) for dates ( format MM/ DD) 01/ 04, 16/ 04, 01/ 05, 15/ 05, 16/ 05, 25/ 05, 01/ 06, and 16/ 06 were changed from 0.881, 0.881, 0.880, 0.836, 0.849, 0.938, 0.840, and 0.572 to 0.636, 0.683, 0.715, 0.743, 0.768, and 0.793, respectively. Record 9 was repeated twice ( ie., NDC times). The modified scenario, FLcucumberCnew. txt ( file dated 07/ 05/ 2006), can be found in 129111 D330783 DWA. zip. The use scenario reflects twice the proposed maximum seasonal application rate on the label. An aerial use is selected over a ground spray use to maximize potential spray drift to surface water bodies. Application dates are chosen based on label information, as well as on crop specific information presented in EFED's PRZM/ EXAMS standard scenario metadata files and the USDA agricultural crop profiles ( www. pestdata. ncsu. edu/ cropprofiles). This scenario was chosen as it is expected to be more vulnerable than most areas in the US used to grow cucurbits A default PCA of 0.87 is used for this assessment as there is no crop specific PCA for cucumbers.

Chemical property input values are chosen according to the current EFED standard guidance document ( Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II, February 28, 2002). Per this guidance, the Koc of the parent input value and the Koc of the degradate input value for PRZM EXAMS surface water modeling are each the mean of 4 values in four different soils. As there was only a single aerobic soil metabolism measurement available each for parent and degradate, the aerobic soil metabolism input values are these single half lives multiplied by 3 to account for uncertainty. The aerobic aquatic metabolism input value for parent is the 90th percentile value on the mean of 2 values. The aerobic aquatic metabolism input value for the degradate is assumed stable ( as the two available halflives are reported only as >> 100 days). [ The aerobic aquatic metabolism degradate input value has been changed from the input value used in previous kresoxim methyl assessments ( 300 days). The assumption of degradate stability to aerobic aquatic metabolism, however, only increased surface water drinking water concentrations by 1 23%. For chemicals with half lives longer than the reservoir turnover rate ( approximately three times a year), reservoir turnover decreases DWECs via dissipation more than degradation decreases DWECs. The assumption of degradate stability to aerobic aquatic metabolism was made after the kresoxim methyl cucurbits ecological exposure assessment ( D326550) was completed. Therefore, environmental surface water concentrations used in the kresoxim methyl cucurbits ecological exposure assessment are calculated using the degradate aerobic aquatic metabolism input value of 300 days.] The anaerobic aquatic metabolism input value for parent is the 90th percentile value on the mean of 2 values. In the absence of data, it is assumed that the degradate is stable to anaerobic aquatic metabolism.

For further details on the environmental fate of kresoxim methyl and its acid degradate BF 490 1, please see the complete risk assessment. If additional refinements of this new use drinking water assessment are requested, please notify Cheryl Sutton ( 308 6168) or Betsy Behl ( 308 6128).

4

Table 1. EDWCs for the drinking water assessment based on the aerial application of kresoxim methyl to cucurbits at the maximum annual rate of 1.2 lb ai/ A ( 0.6 lb ai/ A per season for two seasons).

Surface water drinking water sources Parent Acute 1 in 10 year peak : 11.7 µ g/ L ( ppb) 1 Chronic 1 in 10 year annual mean: 0.11 µ g/ L ( ppb) 30 year mean: 0.07 µ g/ L ( ppb) BF 490 1 Acute 1 in 10 year peak: 46.3 µ g/ L ( ppb) 1 Chronic: 1 in 10 year annual mean: 14.8 µ g/ L ( ppb) 30 year mean: 7.81 µ g/ L ( ppb)

Groundwater drinking water sources 3.85 x 10 4 µ g/ L ( ppb) 6.27 µ g/ L ( ppb)

1All surface water values are corrected for the national default percent crop area ( PCA) factor of 0.87.

Table 2. SCI GROW2 input parameter values kresoxim methyl applied to cucurbits. Parameter Value Source/ Comment Maximum Application Rate ( lb a. i./ A/ application) 0.15 lb ai/ A/ application Label Maximum Number of Applications per Year 8 Label Aerobic Soil Metabolism Half life ( days) < 1 ( parent)

131 ( BF 490 1) MRIDs 43864269, 43864270, 43864271 Organic Carbon Partition Coefficient ( Koc; mL/ g) 431 ( parent)

44 ( BF 490 1) MRID 43864276; input value represents the median of four values MRID 44341034; input value is the median of three values

5

Table 3. PRZM/ EXAMS input parameter values for the drinking water assessment for kresoxim methyl applied to cucumbers in Florida by aerial spray. Parameter Value Source/ Comment Application Rate 0.15 lb ai/ A/ application ( 0.168 kg ai/ ha/ application) Label.

Number of Applications 4 per season ( 8 per year) Label and BEAD personal communication ( 6/ 29/ 2006).

Date of First Application May 1 USDA Crop Profiles Information.

Interval Between Apps. ( days) 7 w/ n season; 160 b/ w seasons Label.

Organic Carbon Normalized Soil Partition Coefficient ( Koc; mL/ g) 419 ( parent)

49 ( BF 490 1) MRID 43864276; input value is mean of 4 values ( parent), MRID 44341034; input value is mean of 3 values ( degradate).

Aerobic Soil Metabolism Halflife ( days) 3 ( parent)

393 ( BF 490 1) MRIDs 43864269, 43864270, 43864271; input values are single half lives multiplied by 3.

Spray Drift Fraction ( aerial spray) 0.16 EFED Input Parameter Guidance.

Application Efficiency ( aerial spray) 0.95 EFED Input Parameter Guidance.

Percent Cropped Area 0.87 EFED Input Parameter Guidance.

Molecular Weight 313.4 ( parent) 299.3 ( BF 490 1) Phys/ chem. property data ( Section 3).

Solubility in Water ( ppm; @ 20 C) 2 ( parent)

3661 ( BF 490 1) Phys/ chem. property data ( Section 3).

Estimated based on Koc Vapor Pressure (@ 20 C) 1.7x10 9 torr ( parent) Phys/ chem. property data ( Section 3); parent data used as default for degradate.

Henry's Law Constant 3.5x10 10 atm m3/ mol ( parent) Phys/ chem. property data ( Section 3); parent data used as default for degradate.

Aerobic Aquatic Metabolism Half life ( days) 1.4 ( parent)

stable ( BF 490 1) MRID 43864273; input value is 90th percentile value on the mean of 2 values ( parent); assumed stability ( degradate).

Anaerobic Aquatic Metabolism Half life ( days) 1.7 ( parent)

stable ( BF 490 1) MRID 43864272; input values are 90th percentile value on mean of 2 values ( parent); assumed stability ( degradate).

Hydrolysis Half life @ pH 5 = stable ( parent)

@ pH 7 = 34 days ( parent)

@ pH 9 = 7 hours ( parent)

@ pH 5, 7, 9 = stable ( BF 490 1) MRID 43864268.

Aquatic Photolysis Half life @ pH 5 ( days) 29.8 ( parent)

stable ( BF 490 1) MRID 44341031.

6

APPENDIX A PHYSICAL AND CHEMICAL PROPERTY VALUES FOR KRESOXIM METHYL AND BF 490 1 Parameter Value Source/ Comment Molecular Weight 313.4 ( parent)

299.3 ( BF 490 1) Phys/ chem. property data ( Section 3)

Solubility in Water ( ppm; @ 20 C) 2 ( parent)

3661 ( BF 490 1) Phys/ chem. property data ( Section 3)

Estimated based on Koc Vapor Pressure (@ 20 C) 1.7x10 9 torr ( parent) Phys/ chem. property data ( Section 3)

Henry's Law Constant 3.5x10 10 atm m3/ mol ( parent) Phys/ chem. property data ( Section 3)

Hydrolysis Half life @ pH 5 = stable ( parent)

@ pH 7 = 34 days ( parent)

@ pH 9 = 7 hours ( parent)

@ pH 5, 7, 9 = stable ( BF 490 1) MRID 43864268 Aquatic Photolysis Half life @ pH 5 ( days) 29.8 ( parent)

stable ( BF 490 1) MRID 44341031 Soil Photolysis Half life ( days) 70.4 ( parent)

stable ( BF 490 1) MRID 44341033 Soil Partition Coefficient ( Kd; mL/ g) 0.93, 3.45, 6.49, 10.52 ( parent)

0.44, 0.79, 0.87 ( BF 490 1) MRID 43864276 MRID 44341034 Organic Carbon Normalized Soil Partition Coefficient ( Koc; mL/ g) 249, 320, 541, 567 ( parent)

33, 44, 69 ( BF 490 1) MRID 43864276 MRID 44341034 Aerobic Soil Metabolism Half life ( days) < 1 ( parent)

131 ( BF 490 1) MRIDs 43864269, 43864270, 43864271 Anaerobic Aquatic Metabolism Half life ( days) 0.9, 1.3 ( parent) MRID 43864272 Aerobic Aquatic Metabolism Half life ( days) 1.2, 1.3 ( parent)

>> 100 ( BF 490 1) MRID 43864273 BCF in Fish 220X MRID 44341037

7

APPENDIX B SCI GROW2 MODELING OUTPUT FILES 1) Kresoxim Methyl EDWC SCIGROW VERSION 2.3 ENVIRONMENTAL FATE AND EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS U. S. ENVIRONMENTAL PROTECTION AGENCY SCREENING MODEL FOR AQUATIC PESTICIDE EXPOSURE SciGrow version 2.3 chemical: Kresoxim methyl time is 6/ 29/ 2006 10: 52: 22  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.150 8.0 1.200 4.31E+ 02 1.0  groundwater screening conc ( ppb) = 3.85E 04 ** See note below. ************************************************************************ ** Values below 0.006 ppb ( 6 ng/ L) are beyond the scope of the regression data in SCIGROW 2.3 and have not been verified. If concerns are raised by exposures of less than 0.006 ppb, a higher_ tier ground_ water exposure assessment should be considered, regardless of how low a screening concentration is returned by SCIGROW.

2) BF 490 1 EDWC SCIGROW VERSION 2.3 ENVIRONMENTAL FATE AND EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS U. S. ENVIRONMENTAL PROTECTION AGENCY SCREENING MODEL FOR AQUATIC PESTICIDE EXPOSURE SciGrow version 2.3 chemical: BF 490 1 time is 6/ 29/ 2006 10: 51: 46  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.150 8.0 1.200 4.40E+ 01 131.0  groundwater screening conc ( ppb) = 6.27E+ 00 ************************************************************************


OBJECTIVES: To study work exposure and respiratory symptoms in New Zealand plywood mill workers. METHODS: Personal inhalable dust (n = 57), bacterial endotoxin (n = 20), abietic acid (n = 20), terpene (n = 20) and formaldehyde (n = 22) measurements were taken and a respiratory health questionnaire was administered to 112 plywood mill workers. RESULTS: Twenty-six percent of the dust exposures exceeded 1 mg/m(3); however, none of the samples exceeded the legal limit of 5 mg/m(3) [geometric mean (GM) = 0.7 mg/m(3), geometric standard deviation (GSD) = 1.9]. Workers in the composer area (where broken sheets are joined together) were significantly (P < 0.01) more highly exposed. Endotoxin levels were low to moderate (GM = 23.0 EU/m(3), GSD = 2.8). Abietic acid levels ranged from 0.3 to 2.4 micro g/m(3) (GM = 0.7 micro g/m(3), GSD = 1.8) and were significantly (P < 0.05) higher for workers in the composer area of the process. Geometric mean levels of alpha-pinene, beta-pinene and Delta(3)-carene were 1.0 (GSD = 2.7), 1.5 (GSD = 2.8) and 0.1 (GSD = 1.4), respectively, and alpha-pinene and beta-pinene levels were significantly (P < 0.001) higher for workers in the 'green end' of the process, up to and including the veneer dryers. Formaldehyde levels ranged from 0.01 to 0.74 mg/m(3) [GM = 0.08 mg/m(3) (= 0.06 ppm.), GSD = 3.0]. Asthma symptoms were more common in plywood mill workers (20.5%, n = 112) than in the general population [12.8%, n = 415, adjusted OR (95% CI) = 1.5 (0.9-2.8)]. Asthma symptoms were associated with duration of employment and were reported to lessen or disappear during holidays. No clear association with any of the measured exposures was found, with the exception of formaldehyde, where workers with high exposure reported more asthma symptoms (36.4%) than low exposed workers [7.9%, adjusted OR (95% CI) = 4.3 (0.7-27.7)]. CONCLUSIONS: Plywood mill workers are exposed to inhalable dust, bacterial endotoxin, abietic acid, terpenes and formaldehyde, and they appear to have an increased risk of developing work-related respiratory symptoms. These symptoms may be due to formaldehyde exposure, although a potential causal role for other exposures cannot be excluded.

Salient Points:
* Personal measurements for inhalable dust (n = 57), bacterial endotoxin (n = 20), abietic acid (n = 20), terpene (n = 20) and formaldehyde (n = 22) were taken and a respiratory health questionnaire was administered to 112 New Zealand plywood mill workers.

* Formaldehyde levels ranged from 0.08 ppm to 0.60 ppm (0.01 to 0.74 mg/m[3]), the geometric mean of this range was determined to be 0.06 ppm (0.08 mg/m[3])

* Asthma symptoms were more common in plywood mill workers (20.5%, n = 112) than in the general population (12.8%, n = 415). No clear association with any of the measured exposures was found, with the exception of formaldehyde, where workers with high exposure reported more asthma symptoms (36.4%) than low exposed workers.

* Plywood mill workers appear to have an increased risk of developing work-related respiratory symptoms. These symptoms may be due to formaldehyde exposure, although a potential causal role for other exposures cannot be excluded.
Ballarin C et al.

Micronucleated cells in nasal mucosa of formaldehyde-exposed workers.

Mutat Res. 1992 Jul; 280(1):1-7.
0.07-0.08 ppm (0.1 mg/m[3]) in the sawmill and shearing-press departments

0.32 ppm (0.39 mg/m[3]) in the warehouse area.
15 nonsmoking workers in a plywood factory
Abstract:
The frequency of micronuclei (MN) and cytology of respiratory nasal mucosa cells were evaluated in 15 nonsmokers exposed to formaldehyde in a plywood factory. Each subject was paired with a control matched for age and sex. Mean levels of exposure to formaldehyde ranged from about 0.1 mg/m3 in the sawmill and shearing-press departments to 0.39 mg/m[3] in the warehouse area. There was a contemporary exposure to low levels of wood dust (inspirable mass ranged from 0.23 mg/m[3] in the warehouse to 0.73 mg/m[3] during sawing operations). Nasal respiratory cell samples were collected by an otorhinolaryngologist near the inner turbinate using a brush for endocervical cytology. After staining (Feulgen plus Fast Green and Papanicolaou's method for MN analysis and cytology, respectively), about 6000 cells were screened for micronuclei and scored in parallel for cytology according to a histopathological scale. A higher frequency of micronucleated cells was observed in the exposed group than in the controls (0.90+-0.47 vs. 0.25+-0.22, Mann-Whitney U test: p less than 0.01). Cytological examination indicated chronic phlogosis in the nasal respiratory mucosa of plywood factory workers, with a high frequency of squamous metaplasia cells (mean score 2.3+-0.5 vs. 1.6+-0.5 in the control group, Mann-Whitney U test: p less than 0.01).

Salient Points:
* The authors examined smears of nasal respiratory mucosa cells sampled from the inner turbinate of 15 nonsmokers who were exposed to formaldehyde released from a urea-formaldehyde glue used in a plywood factory.

* Estimates of formaldehyde air concentrations ranged from: 0.21 to 0.60 mg/m[3] (mean 0.39+-0.20 mg/m[3]) in the warehouse where seven subjects worked, 0.08 to 0.14 mg/m[3] (mean 0.1+-0.02 mg/m[3]) in the shearing press where six subjects worked, and 0.09 mg/m[3] (only one sample taken) in the sawmill area where two subjects worked.

* Mean wood dust concentrations for the three areas were 0.23+-0.1mg/m[3], 0.41+-0.21 mg/m3, and 0.73 mg/m3, respectively. Exposed subjects worked at the factory for 2 to 19 years (mean 6.8+-5.0 years).

* The authors found a statistically significantly higher percentage of micronucleated mucosal cells in the exposed group compared with the control group (0.91%+-0.47 versus 0.25%+-0.22).
Malaka T and Kodama AM.

Respiratory health of plywood workers occupationally exposed to formaldehyde.

Arch Environ Health. 1990 Sep-Oct; 45(5):288-94
0.28 ppm  to 3.48 ppm

Average personal exposure was 1.13 ppm
186 male plywood workers
Abstract:
This study was undertaken to enlarge our understanding of the adverse health effects of formaldehyde exposure in the workplace and community environment. The respiratory health status of 186 male plywood workers was evaluated by spirometric tests, respiratory questionnaires, and chest x-rays. Area concentrations of formaldehyde were measured in the work environment and found to range from 0.28 to 3.48 ppm. The average personal exposure was to 1.13 ppm of formaldehyde. Exposure to formaldehyde was associated with decrements in the baseline spirometric values (i.e., forced expiratory volume in 1 sec (FEV1.0), forced expiratory volume/forced vital capacity (FEV/FVC), and FEF25%-75%) and with several respiratory symptoms and diseases, including cough, phlegm, asthma, chronic bronchitis, and chest colds. The results of the study support the hypothesis that chronic exposure to formaldehyde induces symptoms and signs of chronic obstructive lung disease.

Salient Points:
* In this cross-sectional study of 186 plywood workers, area concentrations of formaldehyde ranged from 0.28 to 3.48 ppm. The average personal exposure was 1.13 ppm.

* Reported average respirable and total wood-dust concentrations in workplace air were 0.60 and 1.35 mg/m[3], respectively.

* Exposure was associated with increased complaints of cough, phlegm production, asthma, chronic bronchitis and colds.

* Decrement in FEV1/FVC ratio in exposed subjects compared to controls was small but significant, although the authors noted that the clinical significance of the differences was unclear.

Table H-3. Formaldehyde Exposure Levels for Particleboard and Medium-Density Fiberboard Manufacture
(Includes Wood Workers and Oriented Strand Board Manufacture)
                                Authors/Article
                                  Publication
                      Air concentrations of Formaldehyde
                      Study Population (Exposed Workers)
                          Abstract and Salient Points
The Workers' Compensation Board BC (WorkSafeBC)

Discussion Paper  -  Occupational exposure limit for formaldehyde. March 20, 2007
Not Applicable
0.03-0.032 ppm for oriented strand board
Workers in a variety of industries in British Columbia including those in the plywood, particle/fiberboard, and oriented strand board manufacturing facilities.
Abstract:
None available

Salient Points:
* Sampling data collected by WorkSafeBC over a period of 15 years (1990 to 2005) in British Columbia and other locations, including Ontario, Quebec, and the Netherlands indicate that worker exposure to formaldehyde is likely to occur primarily in the forest panel board manufacturing sector (plywood, particle/ fiberboard, oriented strand board, laminated wood products manufacturing), resin manufacture, acute care hospitals, university and other laboratories, and funeral homes.

* Industries in which the current 0.3 ppm 8-hour TWA exposure limit (for British Columbia) was exceeded include (range of exposure shown):
  oo   Paperboard & cardboard manufacturing (0.04 to 0.38 ppm);
  oo   Laminated wood products manufacturing (0.24 to 0.38 ppm);
  oo   Pressed/panel particle/fiberboard manufacturing (0.07 to 5.00 ppm);
  oo   Oriented strand board manufacturing (0.03 to 0.32 ppm);
  oo   Funeral homes (none detected to 0.74 ppm);
  oo   University laboratories (0.52 to 1.15 ppm);
  oo   Hospitals & medical clinics and laboratories (0.02 to 1.35 ppm); and
  oo   Poultry hatcheries (0.1 to 0.35 ppm).

For other details of this study, as they relate to exposure levels in plywood and particle/fiberboard manufacturing, see Table H-1.
Lavoue J et al. 2005

Investigation of Determinants of Past
and Current Exposures to Formaldehyde in the Reconstituted
Wood Panel Industry in Quebec
Annals of Occupational Hygiene. 2005 49(7):587-602
Geometric means (GMs) of personal and area levels between 0.1 and 0.4 ppm for MDF and PB.
Highest estimated ambient GM 0.43 ppm in the main production area of MDF manufacturing facilities.
Highest personal estimated GM 0.22 ppm for workers in close proximity to the press in the PB manufacture process.
Employees in the 12 plants  (number not specified)
Abstract:
OBJECTIVES: Past and present formaldehyde measurements made in facilities manufacturing reconstituted wood panels in Quebec have been collected to assess formaldehyde exposure and its determinants in this industry.
METHODS: All 12 plants manufacturing OSB, MDF, and PB in Quebec were visited by a research team which took area and personal measurements. Past measurements taken by governmental occupational health teams in these plants were also collected. Log-transformed formaldehyde concentrations were analyzed with extended linear mixed-effects models.
RESULTS: During 2001 - 2002, 275 measurements were taken by the research team, while 590 measurements dating back to 1984 were collected from governmental files. The area measurements had a global GM of 0.28 ppm [geometric standard deviation (GSD): 3.1]. The GM of the personal measurements was 0.17 ppm (GSD: 2.3). The fixed-effects of the models for personal and area measurements explained 61 and 57% of the variance, respectively. Job (working area for area concentrations), process (PB, MDF, OSB), season of sampling, origin of the data (research, governmental) and year of sampling were significant determinants of exposure. Proximity to the press, winter conditions, PB and MDF processes and governmental data resulted in the highest exposures. Significant within-sampling campaign correlation was found for both personal and area models. The final models include different residual variances by process for personal measurements and by working area for area measurements.

CONCLUSIONS: Several determinants of exposure to formaldehyde in the reconstituted wood panel industry were successfully identified. Higher levels found in governmental data as compared to research data may be explained by a `worst-case' strategy bias. The observed intra-sampling campaign correlation supports existing results suggesting that measurements taken in a small time frame tend to be correlated. Exposures in this sector are low compared to the 8-hour TWA OELs of most Canadian jurisdictions (e.g., 0.75 ppm) but close to the most demanding ones (e.g., 0.3 ppm, as for British Columbia).

Salient Points:
* Twelve plants manufacturing OSB, MDF, and PB in Quebec were visited from June 2001 to March 2002. The visits were conducted by a team of 2 - 4 industrial hygienists and technicians and lasted 1 to 2 days.
* The research team took area and personal measurements. Past measurements taken by governmental occupational health teams in these plants were also collected. The visits performed by the research team yielded 275 measurements while 590 measurements were available from governmental files.
* Exposures to formaldehyde in the OSB manufacturing industry were mostly below 0.1 ppm with some work zones/jobs associated with somewhat higher levels according to the governmental data.
* Formaldehyde exposure levels in the MDF and PB manufacturing industries were similar, with observed and estimated GMs of personal and area levels between 0.1 and 0.4 ppm depending on the source of data. The highest estimated ambient GM was 0.43 ppm in the main production area of MDF manufacturing facilities (this estimate is increased to 1.28 ppm when governmental data are used). The highest personal estimated GM is 0.22 ppm for workers in close proximity to the press in the PB manufacture process (this estimate is increased to 0.62 ppm if the governmental data are considered).

* Governmental measurements were consistently found higher than those measured by the research team, pointing to the probable existence of a `worst-case' bias in governmental data.
* Area measurements were consistently higher than personal measurements. This is consistent with the fact that the most exposed workers are those who spend the most time in the production area unprotected by ventilated booths. While none of the personal measurements in this study was greater than 2 ppm, 4% and 6% of the research and governmental ambient concentrations, respectively, were greater than this value.
* Although the results of this study point to generally low personal full-shift exposure to formaldehyde in the industrial sector studied, the potential for short-term high exposures associated with specific and occasional tasks cannot be ruled out on the basis of our study.
* Levels reported prior to 1985 are consistently higher than those in this study database. According to the authors, this maybe explained by the generalized use, around 1985, of low formaldehyde emission resins.
* The measured and estimated TWA levels of exposure to formaldehyde in this sector can be considered low compared to the 8 hour TWA OELs of most Canadian jurisdictions (e.g. 0.75 ppm) but close to the most demanding ones (e.g., 0.3 ppm, as for British Columbia).
Chung KY et al.
A study on dust emission, particle size distribution and formaldehyde concentration during machining of MDF.

Ann Occup Hyg. 2000 Sep; 44(6): 455-66.

Less than 0.14 ppm (0.17mg/m[3])
N/A
Abstract:
A study to characterize the quantity, particle size distribution, and morphology of dust created during the machining of MDF was carried out. Four different types of MDF boards were included in this study, including a 'zero-formaldehyde' board that contains isocyanate-based resin, rather than urea-formaldehyde resin. In addition, natural softwood (pine) and natural hardwood (oak) were included in the study, for comparison with MDF. The results show that in general, the dust generated by machining MDF is comparable in terms of particle size distribution and morphology with the dust generated by similarly machining hardwood or softwood. The quantity of dust generated during sanding is higher for sanding MDF compared with sanding either hardwood or softwood. However, for sawing, there is no significant difference between MDF and natural woods, in terms of the quantity of dust generated. Free formaldehyde in the air was less than 0.17mg/m[3] during machining of the Class B (higher formaldehyde potential) MDF board. There was no measurable isocyanate in the dust generated from the boards.
Herbert FA et al.
Respiratory consequences of exposure to wood dust and formaldehyde of workers manufacturing oriented strand board.

Arch Environ Health. 1994 Nov-Dec; 49(6):465-70.
Up to 0.27 ppm
99 workers employed in the manufacture of oriented strand board.
Abstract:
A cross-sectional study was performed at a plant in which 99 workers were employed in the manufacture of oriented strand board. This group was compared with 165 unexposed workers from the petroleum industry. Both groups were assessed, using a questionnaire, spirometry, and skin prick tests to common environmental antigens. Environmental studies showed a low dust level of 0.27 mg/m[3], consisting of particles of a mass median aerodynamic equivalent diameter of 2.5 microns. There were parameter concentrations of formaldehyde, up to 0.27 ppm. A significant difference between the oriented strand board workers and oil field workers was noted for the forced expiratory volume in 1s/forced vital capacity ratio, without significant differences in either the forced expiratory volume in 1 s or the forced vital capacity. Oriented strand board workers who were current smokers were three times as likely to have a forced expiratory volume in 1s/forced vital capacity ratio of less than 75% of that found in the currently smoking oil field workers. Significant reductions in forced expiratory volume in 1s (p = .044) and forced vital capacity (p = .022) in oriented strand board workers were noted across the work shift. The oriented strand board workers complained of self-reported asthma and of lower respiratory tract symptoms significantly more frequently than did oil workers for all of the symptoms examined. The prevalence of atopy was not different in the two groups. Lung function was significantly better in oriented strand board workers who had no symptoms, compared with oriented strand board workers who were symptomatic. (ABSTRACT TRUNCATED AT 250 WORDS)

Salient Points:
* In this cross-sectional study, 99 workers employed in the manufacture of oriented strand board were compared with 165 unexposed workers from the petroleum industry.

* Parameter concentrations of formaldehyde, up to 0.27 ppm, were noted.
* Environmental studies showed a low dust level of 0.27mg/m[3], consisting of particles of a mass median aerodynamic equivalent diameter of 2.5 microns.
* Significant reductions in forced expiratory volume and forced vital capacity were noted across the work shift in oriented strand board workers.
* Oriented strand board workers complained of self-reported asthma and of lower respiratory tract symptoms significantly more frequently than did oil workers for all of the symptoms examined.
Edling C et al.

Occupational exposure to formaldehyde and histopathological changes in the nasal mucosa.

Br J Ind Med. 1988 Nov; 45(11):761-5.

0.08 to 0.9 ppm. (midpoint of this range is 0.49 ppm).

Peaks of up to 4.1 ppm were measured during the 8-year period
75 workers from two particle board processing plants and a laminate plant
Abstract:
To study the cytotoxic effect of formaldehyde on the human nasal mucosa, 75 men with occupational exposure to formaldehyde or to formaldehyde and wood dust were examined, looking particularly at early signs of irritative effects and histopathological changes in the nasal mucosa. All men underwent a medical examination, and a nasal biopsy specimen was examined by a pathologist and graded from 0-8 according to the morphological changes. A high frequency of nasal symptoms, mostly a running nose and crusting, was related to exposure to formaldehyde. Only three men had a normal mucosa; the remainder had loss of cilia and goblet cell hyperplasia (11%) and squamous metaplasia (78%); in six cases (8%) there was a mild dysplasia. The histological grading showed a significantly higher score when compared with unexposed contents (2.9 v 1.8). There was no dose response relation, no malignancies, and no difference in the histological score between those exposed to formaldehyde or to formaldehyde and wood dust.

Salient Points:
* Measurements taken by in-house hygienists during an 8-year period before the study (between 1975 and 1983) were in the range 0.08 to 0.9 ppm with peaks reaching 4.07 ppm. A mean TWA concentration was not reported, but the midpoint of this range is 0.49 ppm. Air concentrations were qualitatively assessed as being "somewhat higher" during earlier periods.
* Wood dust air concentrations in the particle board plants ranged from 0.6 to 1.1 mg/m[3]; air in the laminate plant was reported to be without wood dust.
* Employment durations ranged from 1 to 39 years with a mean of 10.5 years.
* Runny nose, nasal crusting, and runny eyes when at work were reported by 60 and 75% of the exposed subjects, respectively. Gross clinical examination showed that 25% of exposed workers had either swollen nasal mucosa or dry nasal mucosa.
* The authors reported that the average histological score for the exposed group (2.8) was statistically significantly greater than the control score (1.8) and that there was no difference in average histological scores between the exposed workers from the particle board plants, where confounding exposure to wood dust occurred, and those from the laminate plant (without wood dust exposure). This observation supports the hypothesis that the observed nasal epithelial lesions were caused by formaldehyde and not by an interaction between formaldehyde and wood dust.
Horvath EP et al. 1988.

Effects of formaldehyde on the mucous membranes and lungs: A study of an industrial population.

JAMA. 1988 Feb 5; 259(5):701-7.
0.17 to 2.93 ppm (mean of 0.69 ppm)
109 workers in a particle board and molded plastics plant
Abstract:
One hundred nine workers and 254 control subjects were studied to evaluate the effects of formaldehyde on the mucous membranes and lungs. A modified, respiratory symptom questionnaire and spirometry were administered to all study participants before and after their work shift, and formaldehyde levels were determined for each test subject. Over the course of the monitored work shift, test subjects demonstrated a dose-dependent excess of irritant symptoms and a statistically significant decline in certain lung function parameters. Analysis of test and control subject data combined revealed a correlation between formaldehyde exposure and these pulmonary changes. Baseline spirometry values were not significantly different between test and control groups, and formaldehyde-exposed workers did not report an excess of respiratory symptoms. Formaldehyde is a dose-dependent irritant of the eyes and mucous membranes at low-level exposures. It can exert a small, across-shift effect on airways but after a mean exposure of 10 years does not appear to cause permanent respiratory impairment.

Salient Points:
* The duration of exposure among exposed workers ranged from <1 year to 20 years, with a mean and median of 10.3 and 10 years, respectively.
* Estimates of formaldehyde air concentrations ranged from 0.17 to 2.93 ppm with a mean of 0.69 ppm. Nuisance particles (predominantly softwood dust) were also detected in the particle board area.

* The percentages of particle board workers reporting a number of symptoms of respiratory irritation over a work shift were statistically significantly greater than work shift reporting percentages for a nonexposed group of 264 food-processing workers: cough (34.9 versus 18.9%), chest pains (9.2 versus 2%), phlegm production (26.6 versus 9.8%),burning nose (28.4 versus 2%), stuffy nose (33.9 versus 14.2%), burning or watering eyes (39.5 versus 9.1%), itchy nose (21.1 versus 7.9%), and sore/burning throat (22 versus 3.9%).
* The authors concluded that the effects noted were possibly not only due to formaldehyde alone but could also be attributed to the presence of respirable particles of wood dust.
Kauppinen TP and Niemelä RI

Occupational exposure to chemical agents in the particleboard industry.

Scand J Work Environ Health. 1985 Oct; 11(5):357-63.
Before 1975, greater than 2 ppm during many work phases.

Means below 2 ppm during most work phases during 1975 and 1984.

For area measurements, means between 0.4 ppm and 2.3 ppm (depending on individual locations in the plant).
Not available
Abstract:
Most of the measurements concerned formaldehyde and wood dust. The other substances measured included terpenes, solvents, and heptachlor. Before 1975, the formaldehyde concentration regularly exceeded 2 ppm during many work phases. Considerable improvements in ventilation and the composition of glues have occurred since then, and today the exposure level is below 2 ppm during most work phases. High peak concentrations, 20 to 30 ppm at the highest, were characteristic of exposure in earlier years. The concentrations of wood dust have also decreased (e.g., from over 5 mg/m[3] to 1 mg/m[3] or below during forming). These data have been used to evaluate past exposures in an epidemiologic study on cancer risks in the particleboard, plywood, and sawmill industries.
Alexandersson R et al.

Exposure to formaldehyde: Effects on pulmonary function.

Arch Environ Health. 1982 Sep-Oct; 37(5):279-84.
0.37 ppm (0.45 mg/m[3])
47 woodworkers
Abstract:
Forty-seven subjects exposed to formaldehyde (mean air concentration 0.45 mg/m[3]) and 20 unexposed subjects, all of whom were employed at a carpentry shop, were studied with regard to symptoms and pulmonary function. Symptoms involving eyes and throat irritation as well as chest oppression were significantly more common in the exposed subjects than in the unexposed controls. Spirometry and single breath nitrogen washout were normal Monday morning before exposure to formaldehyde. A reduction in forced expiratory volume in 1 sec by an average of 0.2 L (P = 0.002), percent forced expiratory volume by 2% (P = 0.04), maximum midexpiratory flow by 0.3 L/sec (P = 0.04), and an increase in closing volume in percentage of vital capacity by 3.4% (P - 0.002) were seen after a day of work and exposure to formaldehyde, suggesting bronchoconstriction. Smokers and nonsmokers displayed similar changes in spirometry and nitrogen washout.

Appendix I
MODEL RESULTS FOR INDOOR AIR CONCENTRATIONS AT CWP FABRICATION SITES USING PRE-BASELINE EMISSION RATES

Table I-1. Results for the Calculation Trials for the What-If Low- and High-End Pre-Baseline Indoor Air Concentrations
                               Varied Parameter
                Calculated Concentration for Pre-Baseline, ppm

                               Intermediate [4]
                                  Low End [5]
                                 High End [6]

                                     HWPW
                                      PB
                                      MDF
                                     HWPW
                                      PB
                                      MDF
                                     HWPW
                                      PB
                                      MDF
Vary Emitting Surface Area [1]
                                     0.019
                                     0.024
                                     0.044
                                     0.006
                                     0.007
                                     0.009
                                     0.142
                                     0.197
                                     0.399
Vary Effective Ventilation Rate [2]

                                     0.007
                                     0.008
                                     0.011
                                     0.414
                                     0.580
                                     1.186
Vary Emission Rate [3]

                                     0.012
                                     0.018
                                     0.018
                                     0.022
                                     0.044
                                     0.090
  [1] For area, the intermediate value is based on the aggregate average per-site throughput calculated using domestic composite wood product consumption data from the EPA market profile. The high-end and low-end values are calculated assuming 1,000% and 10% of the aggregate average throughput, respectively.
  [2] Effective ventilation is varied based on values shown in Table 3-3. The low-end, typical, and high-end values are 50, 1,500 and 10,000 cfm, respectively.
  3 Emission rate is varied based on values shown in Table 3-4.
  [4] Intermediate concentration is calculated using intermediate value for surface area, typical value for effective ventilation rate, and weighted-average pre-baseline emission rate for each CWP type.
  [5] Low-end values calculated according to Table 3-2.
  [6] High-end values calculated according to Table 3-2.

Table I-2.  Combined (for All CWP) Results: Estimated Range of Values for the What-If Low- and High-End Indoor Air Concentrations for Pre-Baseline
                                     Case
                              Intermediate (ppm)
                                 Low End (ppm)
                                High End (ppm)
Pre-Baseline
                                0.019  -  0.044
                                0.006  -  0.018
                                0.022  -  1.186


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74270-74271]
[FR Doc No: 2012-30146]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0379]

Agency Information Collection Activities; Revision of a
Currently-Approved Information Collection Request: Financial
Responsibility for Motor Carriers of Passengers and Motor Carriers of
Property

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The information
collected will be used to help ensure that motor carriers of passengers
and property maintain appropriate levels of financial responsibility to
operate on public highways.

DATES: We must receive your comments on or before February 11, 2013.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2012-0379 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m. e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement for the Federal Docket Management System
published in the Federal Register on January 17, 2008 (73 FR 3316), or
you may visit http://edocket.access.gpo.gov/2008/pdfE8-794.pdf.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Ms. Tura Gatling and Gerald Folsom,
Ph.D., Office of Registration and Safety Information, Federal Motor
Carrier Safety Administration, West Building 6th Floor, 1200 New Jersey
Avenue SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>/2412; email
<EMAIL_ADDRESS>and<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The Secretary of Transportation is responsible for
implementing regulations which establish minimal levels of financial
responsibility for: (1) For-hire motor carriers of property to cover
public liability, property damage and environment restoration, and (2)
for-hire motor carriers of passengers to cover public liability and
property damage. The Endorsement for Motor Carrier Policies of
Insurance for Public Liability (Forms MCS-90/90B) and the Motor Carrier
Public Liability Surety Bond (Forms MCS-82/82B) contain the minimum
amount of information necessary to document that a motor carrier of
property or passengers has obtained, and has in effect, the minimum
levels of financial responsibility as set forth in applicable
regulations (motor carriers of property--49 CFR 387.9; and motor
carrier of passengers--49 CFR 387.33). FMCSA and the public can verify
that a motor carrier of property or passengers has obtained, and has in
effect, the required minimum levels of financial responsibility, by use
of the information enclosed within these documents.
    Title: Financial Responsibility for Motor Carrier of Passengers and
Motor Carriers of Property.
    OMB Control Number: 2126-0008.
    Type of Request: Revision of a currently-approved information
collection.
    Respondents: Insurance and surety companies of motor carriers of
property (Forms MCS-90 and MCS-82) and motor carriers of passengers
(Forms MCS-90B and MCS-82B).
    Estimated Number of Respondents: 6,074.
    Estimated Time per Response: The FMCSA estimates it takes two
minutes to complete the Endorsement for Motor Carrier Policies of
Insurances for Public Liability or three minutes for the Motor Carrier
Public Liability Surety Bond; and one minute to place either document
on board the vehicle (foreign-domiciled motor carriers only) [49 CFR
387.7(f)]. These endorsements are maintained at the motor carrier's
principal place of business [49 CFR 387.7 (iii) (d)].
    Expiration Date: March 31, 2013.
    Frequency of Response: Upon creation, change or replacement of an
insurance policy or surety bond.
    Estimated Total Annual Burden: 4,480 hours [(3,874 annual burden
hours for Form MCS-90B, Form MCS-90, Form MCS-82B and Form MCS-82) +
(606 annual burden hours for placing legible copies of the carrier's
Insurance Endorsements or Surety Bonds in the cabs of all vehicles
operated in the United States) = 4,480].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected

information. The agency will summarize or include your comments in the
request for OMB's clearance of this information collection.

    Issued on: December 7, 2012.
Kelly Leone,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2012-30146 Filed 12-12-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14637-14638]
[FR Doc No: 2018-06779]

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

ENVIRONMENTAL PROTECTION AGENCY

[9976-15--Region 1]

Proposed CERCLA Administrative Cost Recovery Settlement; Gould
Electronics Inc., New Hampshire Dioxane Site, Atkinson/Hampstead, New
Hampshire

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement; request for public comments.

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

SUMMARY: In accordance with section 122(i) of the Comprehensive
Environmental Response Compensation, and Liability Act, as amended
(``CERCLA''), notice is hereby given of a proposed administrative
Settlement Agreement for recovery of Past Response Costs, as defined in
the Settlement Agreement, under CERCLA section 122(h) of CERCLA,
concerning the New Hampshire Dioxane Site, located in Atkinson and
Hampstead, New Hampshire with Gould Electronics Inc. The settlement
requires Gould Electronics Inc. to pay $1,900,000, plus interest on
that amount calculated from March 28, 2016 through the date of payment,
to the Hazardous Substance Superfund.

DATES: Comments must be submitted by May 7, 2018.

ADDRESSES: Comments should be addressed to John Hultgren, Enforcement
Counsel, U.S. Environmental Protection Agency, 5 Post Office Square,
Suite 100 (OES04-2), Boston, MA 02109-3912 and should refer to: In re:
New Hampshire Dioxane Site, EPA Region 1 CERCLA Docket No. 01-2018-
0013.

FOR FURTHER INFORMATION CONTACT: A copy of the proposed Settlement
Agreement may be obtained from John Hultgren, Enforcement Counsel, U.S.
Environmental Protection Agency, 5 Post Office Square, Suite 100
(OES04-2), Boston, MA 02109-3912;<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION: For 30 days following the date of
publication of this notice, the Agency will receive written comments
relating to the settlement. The United States will consider all
comments received and may modify or withdraw its consent to the
settlement if comments received disclose facts or considerations which
indicate that the settlement is inappropriate, improper, or inadequate.
The Agency's response to any comments received will be available for
public inspection at 5 Post Office Square, Boston, MA 02109-3912.
    The proposed Settlement Agreement includes a covenant from EPA not
to sue or take administrative action against Gould Electronics Inc.
pursuant to section 107(a) of CERCLA, 42 U.S.C. 9607(a), to recover
Past Response Costs, and protection for Gould Electronics, Inc. from
contribution actions or claims as provided by sections 113(f)(2) and
122(h)(4) of CERCLA, 42 U.S.C. Section 9613(f)(2) and 9622(h)(4). The
settlement has been approved by the

Environmental and Natural Resources Division of the United States
Department of Justice.

    Dated: March 2, 2018.
Nancy Barmakian,
Acting Director, Office of Site Remediation and Restoration.
[FR Doc. 2018-06779 Filed 4-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Rules and Regulations]
[Pages 13218-13220]
[FR Doc No: 2014-05061]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2014-N-0107]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Absorbable Lung Biopsy Plug

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
absorbable lung biopsy plug into class II (special controls). The
special controls that will apply to the device are identified in this
order, and will be part of the codified language for the absorbable
lung biopsy plug's classification. The Agency is classifying the device
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.

DATES: This order is effective April 9, 2014. The classification was
effective on December 19, 2012.

FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2532, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i), to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Stat. 1054), provides two procedures by which a
person may request FDA to classify a device under the criteria set
forth in section 513(a)(1). Under the first procedure, the person
submits a premarket notification under section 510(k) for a device that
has not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1),
the person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) and then a request for classification under the
first procedure, the person determines that there is no legally
marketed device upon which to base a determination of substantial
equivalence and requests a classification under section 513(f)(2). If
the person submits a request to classify the device under this second
procedure, FDA may decline to undertake the classification request if
FDA identifies a legally marketed device that could provide a
reasonable basis for review of substantial equivalence with the device
or if FDA determines that the device submitted is not of ``low-moderate
risk'' or that general controls would be inadequate to control the
risks and special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on March 19, 2009, classifying the Bio-Seal Lung Biopsy Tract
Plug System into class III, because it was not substantially equivalent
to a device that was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
a device which was subsequently reclassified into class I or class II.
On April 16, 2009, Angiotech submitted a request for classification of
the Bio-Seal Lung Biopsy Tract Plug System under section 513(f)(2) of
the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on December 19, 2012, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.4755.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an absorbable
lung biopsy plug will need to comply with the special controls named in
this final order.
    The device is assigned the generic name Absorbable Lung Biopsy
Plug, and it is identified as a preformed (polymerized) absorbable lung
biopsy plug intended to provide accuracy in marking a biopsy location
for visualization during surgical resection and closure of pleural
punctures associated with percutaneous, transthoracic needle lung
biopsies. Upon deployment into the biopsy tract, the plug expands to
fill the biopsy void and remains in place until resorbed.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures.

------------------------------------------------------------------------
       Identified potential risk          Recommended mitigation measure
------------------------------------------------------------------------
Inability to deploy plug...............  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Delayed plug expansion.................  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Leakage around plug....................  Design and Material
                                          Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Plug migration (whole plug and/or        Design and Material
 fragments).                              Characterization
                                         Bench Testing
                                         In Vivo Evaluation
                                         Labeling
Procedural complications...............  In Vivo Evaluation
                                         Labeling
Adverse tissue reaction................  Biocompatibility
                                         In Vivo Evaluation
Infection..............................  Biocompatibility
                                         Sterility
                                         Shelf-Life Testing
Use error..............................  Labeling
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
    (1) The design characteristics of the device must ensure that the
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate deployment as indicated in
the accompanying labeling, including the indicated introducer needles,
and demonstrate expansion and resorption characteristics in a
clinically relevant environment.
    (3) In vivo evaluation must demonstrate performance characteristics
of the device including the ability of the plug to not prematurely
resorb or migrate and the rate of pneumothorax.
    (4) Sterility testing must demonstrate the sterility of the device
and the effects of the sterilization process on the physical
characteristics of the plug.
    (5) Shelf-life testing must demonstrate the shelf-life of the
device including the physical characteristics of the plug.
    (6) The device must be demonstrated to be biocompatible.
    (7) Labeling must include a detailed summary of the device-related
and procedure-related complications pertinent to the use of the device
and appropriate warnings. Labeling must include identification of
compatible introducer needles.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the absorbable lung biopsy plug they
intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

    1. Request from Angiotech, dated April 16, 2009.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 878.4755 is added to subpart E to read as follows:

Sec.  878.4755  Absorbable Lung Biopsy Plug.

    (a) Identification. A preformed (polymerized) absorbable lung
biopsy plug is intended to provide accuracy in marking a biopsy
location for visualization during surgical resection and closure of
pleural punctures associated with percutaneous, transthoracic needle
lung biopsies. Upon deployment into the biopsy tract,

the plug expands to fill the biopsy void and remains in place until
resorbed.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The design characteristics of the device must ensure that the
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate deployment as indicated in
the accompanying labeling, including the indicated introducer needles,
and demonstrate expansion and resorption characteristics in a
clinically relevant environment.
    (3) In vivo evaluation must demonstrate performance characteristics
of the device, including the ability of the plug to not prematurely
resorb or migrate and the rate of pneumothorax.
    (4) Sterility testing must demonstrate the sterility of the device
and the effects of the sterilization process on the physical
characteristics of the plug.
    (5) Shelf-life testing must demonstrate the shelf-life of the
device including the physical characteristics of the plug.
    (6) The device must be demonstrated to be biocompatible.
    (7) Labeling must include a detailed summary of the device-related
and procedure-related complications pertinent to the use of the device
and appropriate warnings. Labeling must include identification of
compatible introducer needles.

    Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05061 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P