  SEQ CHAPTER \h \r 1 	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

    TOXIC SUBSTANCES

May 30, 2006

Memorandum

SUBJECT: 	Review of the, “Osmose ACC 50% Wood Preservative:  Determination of Hexavalent Chromium Residues In and On Wood Following Treatment with Acid Copper Chromate”.  MRID No. 466447-01.  DP Barcode 329688.

FROM: 	Tim Leighton, Environmental Scientist

		Antimicrobials Division

TO:		Mark Hartman, Branch Chief

Antimicrobials Division

	Attached is a review of the post-application residue wipe study conducted with ACC-treated wood.  The study was submitted by Osmose, Inc.

EXECUTIVE SUMMARY

The purpose of this study was to examine the potential dermal exposures to treated wood associated with use of Acid Copper Chromate (ACC) as a wood preservative through pressure treatment application methods.  In particular, the goals of the study were to examine the changes in dislodgeable hexavalent chromium residues and the extent of reduction of hexavalent chromium over time.  The registered product examined in this study, Osmose ACC 50% Wood Preservative, is not currently produced or available.  An equivalent test material was prepared using cupric oxide and Osmose chromic acid.  This study was conducted under normal commercial practices at a reduced scale treatment plant. In commercial settings, the lumber to be treated (typically 2 x 6 x 8 pieces) is dead stacked (i.e., no space between layers) and metal banded into units, which are 8 pieces wide and 16 pieces high.  Each unit is treated once and maintained as a unit through the drying, storage and shipment processes.  The lumber chosen for this study included southern pine and Douglas-fir.

Two different treatment schedules were used for the two types of lumber to be treated.  For each, the treatment solution was drawn into the cylinder by an initial vacuum.  Douglas fir is much more difficult to treat; therefore, that type of lumber was subjected to full cell treatment, which has a longer initial vacuum period and a longer pressure period.  The southern pine was subjected to a modified full cell treatment.

	After treatment, the wood units were stored outdoors.  Temperature on the surface of the wood units and in the interior of the wood units was monitored every 30 minutes over the 58 day monitoring period.  The 30 minute temperatures ranged from 8 to 85oF (-13 to 29.4oC) on the outside of the unit and from 23 to 77oF (-5 to 25oC) in the interior of the unit.  Average daily temperatures in the interior of the stacked wood ranged from 31.6 to 54.7oF.  Over the course of the sampling intervals, temperatures appeared to decrease at first, with a gradual warming trend up until the end of the study.  Ambient conditions were recorded at a nearby NOAA reporting station and indicated that the temperatures recorded at the test site during the monitoring period were slightly below normal.  Precipitation over the two months of the study period totaled 5.88 inches and was reported to be normal.

Three types of samples were taken post-treatment:  (1) wipe samples were taken from the surface of boards in each unit immediately after treatment and at certain intervals after treatment,  (2) liquid samples were expressed from cross sections cut from interior pieces of lumber to determine the reduction of chromium in the interior of the board, and (3) borings were taken for confirmation of penetration and retention immediately after treatment and for qualitative determination of the presence of hexavalent chromium at certain sampling intervals post-treatment.  Wipe, wood expressate and boring samples were taken on 0, 3, 9, 23, 36, and 58 days after treatment.

Samples were analyzed for the active ingredients (test material, treating solutions, treated wood) and hexavalent chromium (borings, wipe samples, expressate samples).  The study report did not mention the analysis of control, field fortification or concurrent laboratory fortification samples.  All bore samples taken immediately after treatments were reported to have passed the AWPA requirements for penetration (AWPA Standard M2-01 Section 4) and target retention.

μg/cm2) and to have no significant trend among wood type or target retention.  The study report states that these results indicate that there is no correlation between the treatment rate and the initial level of dislodgeable hexavalent chromium.  Levels of hexavalent chromium are greater than EPA’s level-of-concern (0.0088 rounded to 0.009 μg/cm2) for both wood types at the target retention of 0.5 pcf throughout the entire study (up to DAT 58).  At a retention rate of 0.25 pcf, the hexavalent chromium levels dropped below EPA’s level of concern by the last sampling interval (DAT 58) for both wood types in all samples.

The initial levels of hexavalent chromium in the interior of the wood (i.e., wood expressate results) were also reported to be very high.  The levels on DAT 0 were of similar magnitude to the initial treating solution levels (only 32% to 83% reduction of hexavalent chromium).  Calculation of the percent reduction in hexavalent chromium on each sampling day after treatment suggests a fairly rapid reduction of Cr+6 to Cr+3 over time. However, the study authors note that although the percent reduction appears to be fairly rapid, the absolute value of Cr+6 remains high throughout the study (up to 58 days after treatment).  At the end of the study, Cr+6 was still present in the Douglas fir wood at 0.85 ppm and 15.78 ppm at retention rates of 0.25 pcf and 0.50 pcf, respectively.  In the southern pine wood, Cr+6 was still present at 72.83 ppm and 134.33 ppm at retention rates of 0.25 pcf and 0.50 pcf, respectively.

Examination of the borings using chromotropic acid, which detects the presence or absence of hexavalent chromium at levels (15 ppm, further support the study authors’ suggestion of the importance of considering the absolute amount of Cr+6 found in the interior of the wood, and not just the percent reduction.  For southern pine wood, all samples were found to contain at least 15 ppm Cr+6 for the entire study.  For Douglas fir wood, the number of samples containing at least 15 ppm of Cr+6 decreased over the course of the study, but still remained high in certain samples.

Several limitations have been noted in this study.  The limitations of this study that would tend to under estimate the residues of Cr+6 include no recovery samples were reported and there were insufficient number of passes with the cloth wipes to establish equilibrium or maximum residues to mimic human exposure from contacting treated wood.   On the other hand, the cloth wipe methodology without a hand transfer reduction factor tends to overestimate the amount of residues available for human exposure.  These data provided in this report are useful as a range finder to determine dermal exposure to ACC treated wood.  A more refined study would be necessary to accurately determine the amount of Cr+6 available for human exposure.  EPA will develop a separate risk assessment to determine potential dermal risks.

1.0  INTRODUCTION

	The purpose of this study was to examine the potential dermal exposures to treated wood associated with use of Acid Copper Chromate (ACC) as a wood preservative.  In particular, the goals of the study were to examine the changes in dislodgeable hexavalent chromium residues and the extent of reduction of hexavalent chromium over time.  The experiment was conducted under typical, commercial conditions.

Citation

Author:			Robert Inwards

Title:               			“Osmose ACC 50% Wood Preservative:  Determination of

				Hexavalent Chromium Residues In and On Wood Following

				Treatment with Acid Copper Chromate”

Report Date:			September 13, 2005

Performing Laboratory:	Osmose Holdings, Inc.

				980 Ellicott Street

				Buffalo, NY 14209

Identifying Codes:		Report #:  ACC-2005-001

				MRID 466447-01

Sponsor:			Osmose, Inc.

				980 Ellicott Street

				Buffalo, NY 14209

	The study included the signed and dated Good Laboratory Practices (GLP) and Data Confidentiality statements. A Quality Assurance statement was not provided. The study sponsor waived claims of confidentiality within the scope of FIFRA Section 10(d) (1) (A), (B), or (C).  The study sponsor and author stated that the study was conducted under EPA Good Laboratory Practice Standards (40 CFR part 160), with six exceptions.  These exceptions were noted in the study report.  None of these GLP deviations are believed to compromise the scientific integrity of the study.

2.0  TEST MATERIALS

2.1  Treatment Solution

The application process used in this study for treating wood with ACC was taken from the following label:  Osmose ACC 50% Wood Preservative (EPA Reg. No. 3008-60).  This product was not used as the test material, however, since it is not currently produced or available.  An equivalent test material was prepared using the following products:  (1) cupric oxide (EPA Reg. No. 65345-1; 98.6% ai) and (2) Osmose chromic acid (EPA Reg. No. 3008-78; 99.7% ai).  The treatment solution was reported to be identical to a diluted version of the Osmose ACC 50% registered product and was formulated according to Standard P5-05 of the American Wood-Preservers’ Association (AWPA).

	Six separate batches of ACC treating solution were prepared.  The initial batch contained 600 pounds (approximately 64 gallons) of test material and the remaining five batches contained 55 pounds.  The study report provided the following information on the production process for the 600 pound batch and stated that the smaller batches were prepared in a similar way with adjustments for the smaller size.

218 pounds chromic acid were added to 295 pounds (~35 gallons) of water at room temperature in a 55 gallon high density polyethylene (HDPE) open head drum during agitation provided by a Neptune air motor which drives a Neptune marine propeller and shaft.

Agitation was continued for at least 30 minutes to ensure formulation of the solution.

Cupric acid (87 pounds) was added slowly to the solution while monitoring the temperature (desired reaction temperature of 150oF or 65.6oC) and maintaining agitation.

After the cupric acid was fully added, the agitation continued for a minimum of 2 hours after which the product was allowed to sit for 12 hours undisturbed.

The liquid portion was removed, using a drum pump, and stored in another 55-gallon HDPE drum.  Undissolved solids were left in the bottom of the drum since they occur in the normal commercial process and are typically filtered out in the manufacturing process.

The liquid product was analyzed by X-ray spectroscopy for chromium (expressed as CrO3) and copper (expressed as CuO) to confirm compliance with the AWPA Standard P5-05.

The resulting product was used to prepare and replenish treatment solutions.

The results of the analysis of the formulated test material are provided in Table 1.  The overall average concentration for the active ingredients was reported to be 46.8%, with CrO3 comprising 71.3% and CuO comprising 28.7%.

Table 1.  Summary of Results of Test Material Analysis

Batch	Pounds	Analysis (% by weight)	% of total (a)

CrO3	CuO	Total

CrO3+ CuO 	CrO3	CuO

1	600	33.2%	13.3%	46.5%	71.3%	28.7%

2	55	33.6%	13.7%	47.3%	71.0%	29.0%

3	55	33.5%	13.6%	47.1%	71.1%	28.9%

4	55	33.7%	13.7%	47.4%	71.1%	28.9%

5	55	34.0%	13.8%	47.8%	71.1%	28.9%

6	55	33.9%	13.8%	47.7%	71.1%	28.9%

Weighted averages	33.4%	13.5%	46.8%	71.3%	28.7%

%of total for CrO3 = % by weight (e.g., 33.4%) / % by weight total (e.g., 46.8%)

The study report noted that the total percent active ingredient (46.8%) was lower than that indicated on the Osmose ACC 50% Wood Preservative label (49.53%), but that the relative proportion of the two active ingredients was the same as on the product label.  The report indicated that the amount of concentrate added to water to form the test solution was adjusted to account for the slight difference.

	2.2  Lumber

In commercial settings, lumber to be treated (typically 2” x 6” x 8’ pieces) is dead stacked (i.e., no space between layers) and metal banded into units, which are 8 pieces wide and 16 pieces high.  Each unit is treated once and maintained as a unit through the drying, storage and shipment processes.

	The lumber chosen for this study included southern pine and Douglas-fir. Table 2 provides the characteristics of the lumber chosen.

Table 2.  Summary of characteristics of the lumber

Lumber type	# Units Treated	Size of pieces	Stacking	Lumber grade

Flat sawna

Southern pine	2	2” x 6” x 8	8 pieces wide and 16 rows tall	No. 2 KD19b

Flat sawna

Incisedc Douglas fir	4 ½ units

8 pieces wide by 8 rows tall	SEL. STR. S-GRNd

Flat sawn = sawn parallel to the pith (or the small, soft core occurring near the center of a tree trunk, branch, twig, or log) and approximately tangent to the growth rings.

No. 2 = Lumber recommended for most general construction uses where moderately high design values are required; allows well-spaced knots of any quality.  KD19 = Lumber that is kiln-dried to 19% moisture content.

Incised = small slits are made on the surface of the wood.

SEL. STR. = Select Structural: Dimension lumber of this quality is limited in characteristics that affect strength and stiffness values. This grade is recommended for use in applications where both high strength and stiffness values and good appearance may be required.  S-GRN = moisture content of greater than 19%.

The lumber was received in November 2004 and stored outdoors and uncovered for about 2 months prior to treatment.  The study report states that this is typical procedure in commercial practice.

3.0  STUDY DESIGN

	According to the GLP Statement, the study does not have an approved written protocol.  The design and analytical methods are described below.

3.1  Treatment Procedure

		3.1.1  Pretreatment Handling and Preparation

	The units were taken indoors and sloped end to end at a minimum of 3 degrees for at least 3 days prior to treating to allow for temperature rise and drainage of moisture.  The units were restacked on different pallets for handling and treating processes.

		3.1.2  Treatment of Lumber

	The treatment of the lumber was performed at a reduced scale treatment plant with similar configurations as a commercial facility.  The plant was located in Buffalo, New York and treatment took place on February 28 and March 1, 2005.  A reduced scale treatment plant was used because ACC is currently not commercially used. The plant consisted of a 5 foot diameter 8 foot long carbon steel treating cylinder.  This cylinder was manufactured by shortening a commercial cylinder.  Also included were a commercial SIHI vacuum pump and a Grundfos pressure pump.  All valves, sensors and relays were configured the same as a commercial plant.  In addition, carbon steel piping and commercial process control software were also used.  Since the operation was on a small scale, the chemicals were measured and added manually.

	The charge (or treatment batch) consisted of one full unit of dead stacked 2” x 6” x 8” lumber.  The ACC concentrate was added to water to achieve the required concentration for the treating solution (about 1 or 2%) to reach a desired retention of 0.25 to 0.50 pounds per cubic feet (pcf).  The treating solutions were analyzed for pH, the active ingredients (CrO3 and CuO), and hexavalent chromium (Cr+6).  The study report noted that the pH of the treating solution was found to be higher than the recommended pH in the AWPA standard (for ACC: 2.0-3.9) and, therefore, glacial acetic acid was added, as permitted by the standard, to adjust the pH downward.  Table 3 provides the results of the pH and active ingredient analysis.

Table 3.  Summary of the Analysis of the Treatment Solutions

Wood species	Target retention (pcf)	Percent active ingredient in ACC concentratea	Percent active ingredients in treating solution (total %)b Solution pH prior to wood treatmentc	Cr(VI) (μg/gm)

CrO3	CuO

	Southern pine	0.25	71.4	28.6	0.99	3.23	3231

	0.50	71.8	28.2	2.12	2.83	6882

Douglas fir	0.25	71.6	28.4	0.99	3.27d	3418

	0.50	71.8	28.2	2.14	2.80	7404

According to standard:  CuO = 28.0 – 31.8%; CrO3 = 63.3 – 68.2%.

According to study report:  1% or 2%.

According to standard:  2.0-3.9.

pH of solution after treatment

	Two different treatment schedules were used for the two types of lumber to be treated.  For each, the treatment solution was drawn into the cylinder by an initial vacuum.  The study report noted that Douglas fir is much more difficult to treat; therefore, that type of lumber was subjected to full cell treatment, which has a longer initial vacuum period and a longer pressure period.

	Douglas fir:  Full Cell Treatment

Initial vacuum of ≥ 26 inches Hg (≥ 660.4 mmHg) for 40 minutes

Fill under vacuum

Press at ≥ 130 psig (pounds per square inch gauge) to a gauge retention of 0.22 pcf (or 0.44 pcf for the higher retention)

Pressure release over 5 minutes

Empty cylinder

Final vacuum at ≥ 22 inches Hg (558.8 mmHg) for 5 minutes

Southern pine:  Modified Full Cell Treatment

Initial vacuum of ≥ 17 inches Hg (≥ 431.8 mmHg) for 5 minutes

Fill under vacuum

Press at ≥ 130 psig to a gross gauge retention of 0.30 pcf (or 0.60 pcf for the higher retention)

Pressure release over 10 minutes to 15 psig

Relieve pressure and empty cylinder

Final vacuum at ≥ 22 inches Hg (558.8 mmHg) for ≤ 40 minutes to reach a target of 0.22 pcf net gauge retention (or 0.44 pcf for the higher retention)

After treatment, the units were moved to a sealed concrete drip pad and sloped at a minimum of 3 degrees until visual drippage ceased.  The entire treatment cycle took about 3 hours.

3.1.3  Post-Treatment Temperature Monitoring

	After treatment and once dripping ended, the units were transferred to an unheated interior alleyway for storage temporarily until the weather allowed for transport to an outside storage location for long-term exposure.  The indoor storage time did not exceed 3 days and periodic temperature checks indicated that the air temperature did not exceed 43oF (6.1oC).

	During outdoor storage, the units had individual drip/runoff containment.  The temperature was monitored using a DeltaTRAK FlashLink Data Logger Model No. 20202, which was placed under protective cover on the top of a treated unit of lumber.  In addition, a thermocouple attached to the data logger was placed in the interior of the unit at least 2 feet from the end to monitor the temperature inside the unit.  Temperatures were monitored every 30 minutes and ranged from 8 to 85oF (-13 to 29.4oC) on the outside of the unit and from 23 to 77oF (-5 to 25oC) in the interior of the unit.  Over the course of the sampling intervals, temperatures appeared to decrease at first, with a gradual warming trend up until the end of the study.  Appendix A presents the daily minimum, maximum, and average temperatures for external (i.e., ambient) and internal (i.e., stacked wood) recordings.

	Ambient conditions recorded at the closest NOAA reporting station indicated that the temperatures recorded at the test site during the monitoring period were slightly below normal.  These temperatures ranged from 9 to 77oF (-12.8 to 25oC).  Precipitation over the two months of the study period totaled 5.88 inches.  The study report indicated this was close to normal.

The monitoring period (March 3 to April 28, 2005) included both cool and warm temperatures based on ambient temperature and temperatures on the surface of the units, however, the study report states that the temperature on the inside of the stack fluctuated less than the outside temperatures, due to the insulating nature of the stack.

4.0  SAMPLING

4.1  Post-treatment Sampling

	Three types of samples were taken post-treatment:

wipe samples were taken from the surface of boards in each unit immediately after treatment and at certain intervals after treatment,

liquid samples were extracted from cross sections cut from interior pieces of lumber to determine the reduction of chromium in the interior of the board, and

borings were taken for confirmation of penetration and retention immediately after treatment and for qualitative determination of the presence of hexavalent chromium at certain sampling intervals post-treatment.

According to the study report, wipe, boring and wood expressate samples were taken on DAT (days after treatment) 0, 3, 9, 23, 36, and 58.

Sampling was conducted using the following procedure:

At the sampling interval, the top layers of eight 2” x 6” pieces were removed.

The next layer of eight 2” x 6” pieces exposed was used for sampling.

Sampling occurred on the inner four pieces in this layer (four replicate samples) and included:

a 75.4 in2 section used for wipe sampling, and

a 1” x 1” block cut (1” x 1” x ~1.5”) for the expressate sampling.

The areas for sampling on each piece were independent of one another and were at least 4 inches from each end.

At certain sampling intervals, borings (to a depth of 1 inch) were removed from the end of each piece.

At the end of sampling, the top layer of 2 x 6 pieces was replaced.  At the next sampling interval, the top layers were removed to reveal a new level of 2 x 6 pieces for sampling.

4.2  Core Boring to Confirm Penetration and Retention

A core boring was removed from the edge of each of 20 pieces from the sides of each unit within 4 hours of treatment.  This core was used to evaluate the preservative penetration and retention to ensure compliance with the AWPA Use Category System Section 6 for Sawn Products.  The study report states that Chrome Azurol, a copper sensitive indicator, was used to detect the depth of penetration according to AWPA Standard A3-04, Method 2 (“Method for determining penetration of copper-containing preservatives”).  However, it appears that this standard has been replaced by Standard A3-05, which is the standard provided in the Appendix of the study report.  The wood borings were also analyzed according to AWPA Standard A9 (“Standard Method for Analysis of Treated Wood and Treating Solutions by X-ray Spectroscopy”) for the active ingredients.  At certain sampling intervals, borings (to a depth of 1 inch) were removed from the end of each piece and evaluated using Method 11 of the AWPA Standard A3-05 (“Method for Determination of the Presence of Hexavalent Chromium in Treated Wood”).

	4.3 Wipe Sampling

	The following procedure was followed to conduct the wipe sampling:

Personnel wore powder free latex gloves which were changed as necessary.

A polyester cloth wipe (4.5 in2) was weighed and moistened with deionized water to double its weight.  It was squeezed and worked to uniformly distribute the water throughout the wipe.

The wipe was attached to a 1.1 kg steel block (covered in Parafilm®) using heavy duty rubber bands and pulled across a 75.4 in2 area of the wood five times, rotated 90o, and pulled across another five times.

The wipe was removed and placed in a labeled four ounce glass jar and immediately given to Analytical Services for extraction and analysis for hexavalent chromium.

Before the next wipe sample was taken, the Parafilm® and rubber bands were replaced.

4.4  Expressate Samples to Determine Reduction of Chromium in the Interior of the Board

	A 1 x 1 x 1.5 inch sample of wood was removed from the center of the board.  This block of wood was subjected to pressure in a pelletizer and the liquid expressed was collected and analyzed.  Four replicate samples were taken at each sampling time.

5.0  METHODS

5.1  Analytical Methods

	Determination of the Active Ingredients in the Test Material, Treatment Solution, and Treated Wood:  The test material (ACC concentrate), treatment solution, and treated wood were analyzed for total chromium (CrO3) and total copper (CuO) by X-ray spectroscopy, following the AWPA Standard A9.

	Determination of Hexavalent Chromium in the Treatment Solution and Expressate samples:  The treatment solution and expressate samples were analyzed for total hexavalent chromium using the diphenylcarbazide-UV/Vis spectroscopy method (Osmose SOP QC7-K/0).

	Determination of Hexavalent Chromium in the Wipe Samples:  The wipe samples were analyzed using the diphenylcarbazide-UV/Vis spectroscopy method (Osmose SOP QC7-N/0).

	Determination of Hexavalent Chromium in Bore Samples Using Chromotropic Acid:  The presence of the hexavalent chromium in wood boring samples was made using the chromotropic acid complexation method (AWPA Standard A3-Method 11).  This industry standard method confirms if Cr+6 is present in the boring at level of 15 ppm.

5.2  Quality Control Samples

It was stated in the study report that the core boring samples were performed to provide quality control as to the penetration and retention of the pressure treatment (see results in Section 6.1).

5.2.1  Method Validation and Storage Stability

	The methods used in this study were mostly published AWPA Standard Methods.  However, the performing laboratory did not provide method validation information for these methods.  Osmose Standard Operating Procedures (SOPs) were used to determine hexavalent chromium in the treatment solution, the wipe samples and the wood expressate samples.  No information was provided on the method efficiency or the limit of quantification of these methods either.  All methods and SOPs were provided in the Appendices to the study report.

		5.2.2	Storage Stability

	Storage stability studies were not mentioned in the study report; however, the wipe, expressate, and chromotropic acid boring sample analyses were performed on the same day the samples were taken (except for four expressate samples which were stored frozen 5 days prior to analysis).  The analysis of the borings for quality control purposes (penetration and retention) were conducted within a few days of sampling.

5.2.3  Concurrent Laboratory Recoveries

	Concurrent laboratory recoveries were not mentioned in the study report.  A review of the methods and SOPs provided in the Appendices revealed mention of concurrent laboratory recovery samples in the method for analysis of the wipe samples (Osmose SOP QC7-N/0).  The results of these samples were not provided in the study report.

5.2.4  Field Recoveries

	Field fortification samples were not mentioned in the study report.

5.2.5  Blank Controls

	Blank controls were not mentioned in the study report.  A review of the methods and SOPs provided in the Appendices revealed mention of blank control samples in the method for analysis of the wipe samples (Osmose SOP QC7-N/0).  The results of these samples were not provided in the study report.

6.0  RESULTS

6.1 Results of Core Boring Sample Analysis (Quality Control)

The study report states that all bore samples taken immediately after treatment pass the AWPA requirements for penetration (AWPA Standard M2-01 Section 4).  According to the AWPA, the penetration for southern pine must be 2.5 inches or 85% of the sapwood length, with 80% of the borings meeting that requirement.  The penetration for Douglas fir must be 0.4 inches or 90% of the sapwood depth, with 90% of the borings meeting that requirement.  Appendix 10 of the study report provides the pass/fail evaluations.

	The study report states that the results indicate that the retention treatments meet the requirements of the AWPA Standard.  At target retentions of 0.25 and 0.50 pcf, the required minimums for CrO3 are 0.136 and 0.273 pcf, respectively, and are 0.065 and 0.127 pcf for CuO, respectively.  The measured retention data are not provided for each sample; only averages are reported in the study report and are provided below in Table 4.

The combined results of the penetration and retention tests are reported to confirm that the treatment procedures met the commercial requirements.  Therefore, the authors state that the units treated can be used to examine the changes in dislodgeable Cr+6 residues over time and the extent of reduction of hexavalent chromium over time.

Table 4.  Summary of Average Retention

Wood species	Target Retention (pcf)	Average Assayed Retention (pcf)

CrO3	CuO	Total

Southern Pine	0.25	0.180	0.095	0.275

	0.50	0.392	0.172	0.564

Douglas Fir	0.25	0.156	0.074	0.230

	0.50	0.318	0.132	0.450

6.2  Residues of Hexavalent Chromium on the Surface of the Boards

	Table 5 provides a summary of the wipe sample residues.  The day after treatment (DAT) 0 values were reported to all be high (averages of 10 to 30 μg/cm2) and to have no significant trend among wood type or target retention. The high values at DAT 0 were reported to be a result of the treated surface having unabsorbed treatment solution immediately after treatment. The study report states that the DAT 0 results indicate that there is no correlation between the treatment rate and the initial level of dislodgeable hexavalent chromium.  Appendix B provides individual sampling results.

	A regression analysis was performed (by EPA) using the data points for each retention and each wood species using the results from 3, 9, 23, 36, and 58 DAT.  The residues for DAT 0 were excluded because of the unabsorbed treatment solution and the fact that the wood would remain on the drip pad at the facility while wet.  Table 6 provides the daily predicted residues over time.  The coefficient of determination (R2) was higher, and therefore a better predictor, for the lower ACC retention (i.e., 0.25 pcf) then the R2 for the higher retention (i.e., 0.5 pcf).  The R2 for the 0.25 pcf retention is 0.67 for Southern Pine and 0.80 for Douglas Fir.  The R2 for the 0.5 pcf retention is 0.36 for Southern Pine and 0.02 for Douglas Fir.

	The predicted DAT for residue levels to reach the Cr+6 level-of-concern of 0.009 μg/cm2 for Southern Pine at a retention of 0.25 pcf is 45 days and 100 days at a retention of 0.5 pcf.  For Douglas Fir, Cr+6 reduces to 0.009 μg/cm2  at 36 DAT at a retention of 0.25 pcf and not until 197 DAT at a retention of 0.5 pcf.

Table 5.  Levels of Hexavalent Chromium on the Surface of the Wood

(as determined by wipe samples)

Retention (pcf)	Hexavalent Chromium found in Wipe Samples (average µg/cm2 ± standard error)

	DAT 0	DAT 3	DAT 9	DAT 23	DAT 36	DAT 58

Douglas fir

0.25	14.028 ± 0.800	0.0681 ± 0.0089	0.0809 ± 0.0353	0.0193 ± 0.0069 0.0105 ± 0.0017	0.0029 ± 0.0008

0.50	16.198 ± 3.532	0.0352 ± 0.0012	0.0108 ± 0.0018	0.1193 ± 0.0153 0.1050 ± 0.0253	0.0111 ± 0.0038

Southern pine

0.25	10.164 ± 2.684	0.1104 ± 0.0278	0.0477 ± 0.0108	0.0964 ± 0.0306 0.0123 ± 0.0042	0.0048 ± 0.0005

0.50	30.173 ± 7.527	0.1361 ± 0.0435	0.1699 ± 0.0105	0.1338 ± 0.0190 0.0809 ± 0.0332	0.0305 ± 0.0076

Table 6.  Predicted Daily Dislodgeable Residues of Cr+6 For ACC Cloth Wipes.

DAT	SP @ 0.25 pcf	SP @ 0.5 pcf	DF @ 0.25 pcf	DF @ 0.5 pcf

1	0.106	0.161	0.075	0.040

2	0.100	0.157	0.071	0.039

3	0.095	0.152	0.066	0.039

4	0.090	0.148	0.063	0.039

5	0.085	0.144	0.059	0.038

6	0.080	0.140	0.056	0.038

7	0.076	0.136	0.052	0.038

8	0.072	0.132	0.049	0.038

9	0.068	0.128	0.047	0.037

10	0.064	0.125	0.044	0.037

11	0.061	0.121	0.041	0.037

12	0.058	0.118	0.039	0.037

13	0.055	0.114	0.037	0.036

14	0.052	0.111	0.035	0.036

15	0.049	0.108	0.033	0.036

16	0.046	0.105	0.031	0.035

17	0.044	0.102	0.029	0.035

18	0.042	0.099	0.027	0.035

19	0.039	0.096	0.026	0.035

20	0.037	0.094	0.024	0.034

21	0.035	0.091	0.023	0.034

22	0.033	0.088	0.022	0.034

23	0.032	0.086	0.020	0.034

24	0.030	0.083	0.019	0.033

25	0.028	0.081	0.018	0.033

26	0.027	0.079	0.017	0.033

27	0.025	0.077	0.016	0.033

28	0.024	0.074	0.015	0.032

29	0.023	0.072	0.014	0.032

30	0.022	0.070	0.013	0.032

31	0.020	0.068	0.013	0.032

32	0.019	0.066	0.012	0.032

33	0.018	0.065	0.011	0.031

34	0.017	0.063	0.011	0.031

35	0.016	0.061	0.010	0.031

36	0.015	0.059	0.009	0.031

37	0.015	0.058	NA	0.030

38	0.014	0.056	NA	0.030

39	0.013	0.054	NA	0.030

40	0.012	0.053	NA	0.030

41	0.012	0.051	NA	0.030

42	0.011	0.050	NA	0.029

43	0.011	0.048	NA	0.029

44	0.010	0.047	NA	0.029

45	0.009	0.046	NA	0.029

46	NA	0.044	NA	0.028

47	NA	0.043	NA	0.028

48	NA	0.042	NA	0.028

49	NA	0.041	NA	0.028

50	NA	0.040	NA	0.028

51	NA	0.039	NA	0.027

52	NA	0.037	NA	0.027

53	NA	0.036	NA	0.027

54	NA	0.035	NA	0.027

55	NA	0.034	NA	0.027

56	NA	0.033	NA	0.026

57	NA	0.032	NA	0.026

58	NA	0.032	NA	0.026

100	NA	0.009	NA	0.019

197	NA	NA	NA	0.009

NA – not applicable, predicted values below the level of concern.

Predicted Residue = exp(intercept + slope * Day)

Where:

Wood @ retention (pcf)	intercept	Slope	coefficient of determination (R2)

Southern Pine @ 0.25 pcf	-2.19	-0.05	0.67

Southern Pine @ 0.5 pcf	-1.80	-0.03	0.36

Douglas-Fir @ 0.25 pcf	-2.53	-0.06	0.80

Douglas-Fir @ 0.5 pcf	-3.22	-0.01	0.02

	6.3  Residues of Hexavalent Chromium in the Interior of the Wood

	The levels of hexavalent chromium in the interior of the wood were assessed by analyzing the expressate of the wood.  The study report states that the initial levels on DAT 0 are very high and are of similar magnitude to the treating solution levels. As the number of days after treatment increases, the levels in the expressate decrease.  The percent reduction in hexavalent chromium on each sampling day after treatment was determined using the initial levels of treating solution.  Table 7 provides a summary of the levels of hexavalent chromium and the average percent reduction over time.  Figure 1 depicts the fairly rapid reduction of Cr+6 to Cr+3 over time.   However, the study authors do note that although the percent reduction appears to be fairly rapid, the absolute value of Cr+6 remains high throughout the study (up to 58 days after treatment).  At the end of the study, Cr+6 was still present in the Douglas fir wood at 0.85 ppm and 16 ppm at retention rates of 0.25 pcf and 0.50 pcf, respectively.  In the Southern pine wood, Cr+6 was still present at 73 ppm and 134 ppm at retention rates of 0.25 pcf and 0.50 pcf, respectively.  Appendix B provides individual sampling results.

Table 7.  Levels of Hexavalent Chromium in the Interior of the Wood

(as determined by expressate samples)

Retention (pcf)	Initial Treatment Solution (ug/g)	Average Hexavalent Chromium found in Expressate Liquid (µg/g, ppm)

DAT 0	DAT 3	DAT 9	DAT 23	DAT 36	DAT 58

Douglas fir

0.25	3417.98	859.6	74.62	46.43	0.41	0.17	0.85

Average Percent Reduction	74.85%	97.82%	98.64%	99.99%	100.00%	99.98%

0.50	7403.96	1292.59	699.32	44.41	39.81	21.23	15.78

Average Percent Reduction	82.54%	90.55%	99.40%	99.46%	99.71%	99.79%

Southern pine

0.25	3230.73	1792.73	1005.83	682.64	258.76	178.71	72.83

Average Percent Reduction	44.51%	68.87%	78.87%	91.99%	94.47%	97.75%

0.50	6882.42	4708.51	1854.91	1320.28	630.38	359.88	134.33

Average Percent Reduction	31.59%	73.05%	80.82%	90.84%	94.77%	98.05%

	Examination of the borings using chromotropic acid further supported the study authors’ suggestion of the importance of considering the absolute amount of Cr+6 found in the interior of the wood, and not just the percent reduction.  Figure 2 shows the percent of samples found to contain ≥15 ppm Cr+6 over the course of the study.  For southern pine wood, all samples were found to contain at least this amount for the entire study.  For Douglas fir wood, the number of samples containing this amount of Cr+6 decreased over the course of the study (0% by DAT 58 for 0.25 pcf and 50% by DAT 58 for 0.5 pcf), but still remained high in certain samples.

7.0  CONCULSION

The study report states that the data from this study do not suggest that holding time can adequately predict the level of dislodgeable Cr+6 on the surface of wood that has been treated with ACC.  The internal levels of Cr+6 are reported to be highly variable, even among individual boards treated at the same time in one unit.  This high variability does not allow for an estimation of the rate of reduction.  Additionally, the study report states that there is no dependent relationship between the concentrations in expressates and external residues; both internal and external Cr+6 reduce to Cr+3 over time independently.

	The temperature range measured outside of the wood units and in the interior of the wood units included both cool and warm weather conditions over the course of the study.  Regardless of the temperature, the predicted wood surface residues do not reach 0.009 μg/cm2 until 36 to 197 days after treatment depending on the wood species and retention (Note:  The R2 is low for the higher retention).  The study report also states that the treated wood will retain a significant amount of unreduced hexavalent chromium in the interior of the wood over time.

	EPA notes the following issues in its review of this study.

The protocol was not submitted to the EPA prior to the initiation of the study.

The study did not control the temperature of the wood while in storage.  Instead, the study was conducted in late winter/early spring in Buffalo, NY.  The reduction of Cr+6 to Cr+3 is temperature and time dependant.  Reduction is slower at colder temperatures.  Once frozen, reduction is thought to cease.  Average daily temperatures for some days were at or below 32 F (for 24 of 57 days).  The effect would be to stop reduction of Cr+6 on those days.

The study only monitored residues determined by cloth wipes.  The wipe studies conducted previously to support CCA treated wood also included hand wipes to determine the relationship between the amounts of residues dislodged by a moistened hand versus a moistened cloth wipe.  Based on the CCA data, the hand dislodges less than the cloth wipe.  A hand transfer reduction factor (TRF) of ~18% was determined for CCA.  The TRF for CCA is not believed to be the same for ACC treated wood because of the differences in the amount of Cr+6 in the wood.  The effect of only having cloth wipe samples overestimates the amount of Cr+6 available for human exposure.

The cloth wipes included a total of 10 passes on the treated wood.  The CPSC wood wipe protocol recommends a total of 20 passes.  The effect of only 10 passes is that an equilibrium or maximum residue was not achieved.  The weight used in the study (1.1 kg) is the standard used in the CPSC protocol.  The effect of an insufficient number of passes/wipes per sample would underestimate the amount of Cr+6 available for human exposure.

The coefficients of determinations (R2) for the predicted daily dislodgeable residues are 0.67 and 0.80 for the retention of 0.25 pcf.  However, the R2 at the retention of 0.5 pcf is low (i.e., 0.36 and 0.02).  A study with more sampling intervals and controlled temperature would be needed to determine if the reduction to Cr+3 is more predictable.

Control samples were not mentioned in the study report for the wipe samples; however, the SOP provided in the Appendix did mention the inclusion of blank wipes.  If these samples were included, the results were not provided in the study report or raw data provided in the Appendix.

The study report stated that the wipe samples were turned in immediately to Analytical Services.  The study report did not mention the storage time of the expressate samples or the borings.  However, in the raw data table provided in the Appendix, the expressate samples collected on day 36 from the southern pine treated wood at a retention rate of 0.50 were reported to have been sealed in a freezer bag in a freezer for 5 days prior to analysis.  It is not clear how the other samples were kept prior to analysis or for how long.  A storage stability study was not provided.

Method validation information was not provided for AWPA methods followed in the analysis of the samples.  The SOPs followed for determination of the levels of hexavalent chromium in wood expressate and wipe samples also did not provide information on method efficiency nor the limit of quantification.

Field and concurrent laboratory fortification samples and blank samples were not reported in the study report or in the raw data table in the Appendix.  The SOP for the wipe samples indicated a blank and fortified wipe sample should be analyzed along with the study samples, but no further information was provided.

No value was provided for the Douglas fir, 0.50 pcf, DAT 9 wood expressate sample in the raw data table in the Appendix.  An explanation for this omission was not provided.

In conclusion, the limitations of this study that would tend to under estimate the residues of Cr+6 include no recovery samples were reported and there were insufficient number of passes with the cloth wipes to establish equilibrium or maximum residues to mimic human exposure from contacting treated wood.   On the other hand, the cloth wipe methodology without a hand transfer reduction factor tends to overestimate the amount of residues available for human exposure.  These data provided in this report are useful as a range finder to determine dermal exposure to ACC treated wood.  A more refined study would be necessary to accurately determine the amount of Cr+6 available for human exposure.  EPA will develop a separate risk assessment to determine potential dermal risks.

Appendix A

Summary of Temperature Measurements

Temperatures throughout study period

Date	External Temperature	Internal Temperature

	Average	Maximum	Minimum	Average	Maximum	Minimum

3/3/2005	32.5	73.4	19.4	52.7	77.0	50.0

3/4/2005	25.6	34.0	18.3	46.6	50.0	43.2

3/5/2005	20.8	27.3	14.2	40.5	43.2	38.1

3/6/2005	30.4	35.4	21.9	36.7	38.1	35.4

3/7/2005	37.0	48.2	29.3	34.6	35.4	33.6

3/8/2005	17.9	29.3	12.0	32.9	33.6	32.5

3/9/2005	16.2	25.0	9.7	32.3	32.5	32.0

3/10/2005	20.4	27.3	14.5	31.8	32.0	31.8

3/11/2005	26.5	36.3	19.2	31.9	32.0	31.8

3/12/2005	26.9	35.2	17.4	31.9	32.0	31.8

3/13/2005	26.0	32.2	18.0	31.8	31.8	31.6

3/14/2005	19.0	30.2	10.8	31.7	31.8	31.6

3/15/2005	19.4	26.6	11.5	31.7	31.8	31.6

3/16/2005	23.0	31.1	16.0	31.9	32.0	31.8

3/17/2005	27.5	35.6	21.0	31.9	32.0	31.8

3/18/2005	28.3	37.8	20.8	31.8	32.0	31.8

3/19/2005	33.5	43.2	24.8	31.8	31.8	31.6

3/20/2005	35.0	40.6	32.0	31.9	32.2	31.8

3/21/2005	34.4	41.9	31.8	31.8	32.2	31.8

3/22/2005	30.6	34.5	27.0	31.7	31.8	31.6

3/23/2005	30.0	32.9	28.2	31.6	31.8	31.5

3/24/2005	33.9	44.4	29.0	31.8	32.0	31.8

3/25/2005	35.0	42.1	27.3	31.8	32.2	31.6

3/26/2005	31.9	43.5	22.6	31.7	31.8	31.6

3/27/2005	38.3	52.2	26.6	31.8	32.0	31.8

3/28/2005	43.7	50.2	40.3	32.1	32.2	32.0

3/29/2005	41.6	52.3	34.3	32.2	32.2	32.0

3/30/2005	44.4	59.2	30.7	32.0	32.2	32.0

3/31/2005	50.6	63.9	40.1	32.1	32.4	32.0

4/1/2005	42.3	50.4	37.2	32.0	32.0	32.0

4/2/2005	35.0	43.3	32.0	31.9	32.0	31.8

4/3/2005	32.4	33.3	32.0	31.8	32.0	31.8

4/4/2005	34.3	39.6	31.8	31.8	31.8	31.8

4/5/2005	41.8	57.2	30.7	32.0	32.2	31.8

4/6/2005	51.2	63.3	40.8	35.3	37.8	32.0

4/7/2005	48.1	57.4	40.1	40.6	42.6	37.9

4/8/2005	41.7	54.0	31.5	43.2	43.5	42.8

4/9/2005	43.9	62.8	30.6	43.1	43.3	42.8

4/10/2005	48.2	65.8	35.1	43.5	43.9	42.8

4/11/2005	42.9	51.6	35.4	44.5	45.0	43.7

4/12/2005	39.9	53.2	30.4	42.9	43.7	41.7

4/13/2005	41.3	55.8	26.8	41.4	42.1	40.8

4/14/2005	44.9	60.1	30.4	41.5	41.7	40.8

4/15/2005	47.4	65.5	33.6	42.5	42.8	41.7

4/16/2005	50.9	77.2	33.4	44.1	44.8	42.8

4/17/2005	51.8	73.6	36.3	46.6	47.5	44.8

4/18/2005	58.1	84.9	40.1	48.9	49.6	47.7

4/19/2005	59.5	82.9	43.2	51.9	53.2	49.8

4/20/2005	53.2	67.8	41.2	54.7	55.2	53.4

4/21/2005	47.4	65.7	33.6	53.1	54.9	50.9

4/22/2005	48.8	75.2	32.9	50.3	50.9	49.6

4/23/2005	45.8	49.3	39.9	49.5	49.8	49.1

4/24/2005	39.1	50.0	33.1	48.2	48.9	46.9

4/25/2005	38.5	41.9	35.4	45.5	46.8	44.2

4/26/2005	53.6	75.0	37.9	43.8	44.2	43.5

4/27/2005	52.9	71.1	41.5	46.8	48.7	44.1

4/28/2005	44.1	68.7	39.7	50.5	70.5	48.7

Appendix B

Hexavalent Chromium Individual Measurements

from Douglas Fir Treated Wood and Southern Pine Treated Wood

Table B1.  Hexavalent Chromium Measurements for Douglas Fir Treated Wood

Retention (pcf)	DAT	Sample number	Hexavalent Chromium on Surface of Wood from Wipe Samples (µg/cm2)	Hexavalent Chromium in Interior of Wood from Expressate Samples (µg/g; ppm)	Concentration of Hexavalent Chromium in Treating Solution

(µg/g; ppm)	Reduction (%) of Hexavalent Chromium	Chromotropic Acid Indication (Cr+6 detected at or above 15 ppm)

0.25	0	1	15.2451	1500.35	3417.98	56.1	N/A

2	12.8112	551.28

83.87	N/A

3	12.4925	528.34

84.54	N/A

4	15.5638	858.44

74.88	N/A

Average:	14.028	859.6

	Std Error:	0.800

	% of samples above level of concern	100%

	0.5	0	1	26.0438	1324.2	7403.96	82.11	N/A

2	9.5282	2297.28

68.97	N/A

3	15.8803	1066.54

85.6	N/A

4	13.3395	482.33

93.49	N/A

Average:	16.198	1292.59

	Std Error:	3.532

	% of samples above level of concern	100%

	0.25	3	1	0.057	144.09	3417.98	95.78	+

2	0.0493	0.1

100	+

3	0.0862	67.49

98.03	+

4	0.0798	86.79

97.46	+

Average:	0.0681	74.62

% detected:	100%

Std Error:	0.0089

	% of samples above level of concern	100%

	0.5	3	1	0.0359	312.83	7403.96	95.77	+

2	0.0382	72.71

99.02	+

3	0.0329	236.55

96.81	+

4	0.0336	2175.17

70.62	+

Average:	0.0352	699.32

% detected:	100%

Std Error:	0.0012

	% of samples above level of concern	100%

	0.25	9	1	0.1067	178.27	3417.98	94.78	+

2	0.0113	0.2

99.99	-

3	0.1679	6.74

99.8	+

4	0.0377	0.5

99.99	+

Average:	0.0809	46.43

% detected:	75%

Std Error:	0.0353

	% of samples above level of concern	100%

	0.5	9	1	0.0071	a	7403.96	a	+

2	0.0148	114.63

98.45	+

3	0.0127	4.4

99.94	+

4	0.0086	14.2

99.81	+

Average:	0.0108	44.41

% detected:	100%

Std Error:	0.0018

	% of samples above level of concern	75%

	0.25	23	1	0.0139	0.58	3417.98	99.98	-

2	0.0115	0.39

99.99	-

3	0.04	0.26

99.99	-

4	0.0119	0.39

99.99	-

Average:	0.0193	0.41

% detected:	0%

Std Error:	0.0069

	% of samples above level of concern	100%

	0.5	23	1	0.112	72.28	7403.96	99.02	+

2	0.0796	11.1

99.85	+

3	0.1495	43.74

99.41	+

4	0.1361	32.12

99.57	+

Average:	0.1193	39.81

% detected:	100%

Std Error:	0.0153

	% of samples above level of concern	100%

	0.25

0.5	36	1	0.0139	0.24	3417.98	99.99	+

2	0.0086	0.13

100	-

3	0.0127	0.2

99.99	-

4	0.0069	0.11

100	+

Average:	0.0105	0.17

% detected:	50%

Std Error:	0.0017

	% of samples above level of concern	75%

36	1	0.0652	0.19	7403.96	100	+

2	0.0716	67.56

99.09	-

3	0.1076	6.12

99.92	+

4	0.1755	11.04

99.85	+

Average:	0.1050	21.23

% detected:	75%

Std Error:	0.0253

	% of samples above level of concern	100%

	0.25	58	1	0.0017	1.07	3417.98	99.97	-

2	0.002	1.035

99.94	-

3	0.0028	0.51

99.99	-

4	0.0051	0.8

99.98	-

Average:	0.0029	0.85

% detected:	0%

Std Error:	0.0008

	% of samples above level of concern	0%

	0.5	58	1	0.0222	31.07	7403.96	99.58	+

2	0.0064	27.04

99.63	-

3	0.0097	2.44

99.97	-

4	0.0061	2.55

99.97	-

Average:	0.0111	15.78

% detected:	25%

Std Error:	0.0038

	% of samples above level of concern	50%

	a	No value provided in table in Appendix and no explanation provided for why

Table B2.  Hexavalent Chromium Measurements for Southern Pine Treated Wood

Retention (pcf)	DAT	Sample number	Hexavalent Chromium on Surface of Wood from Wipe Samples (µg/cm2)	Hexavalent Chromium in Interior of Wood from Expressate Samples

(µg/g; ppm) 	Concentration of Hexavalent Chromium in Treating Solution

Ñ

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36.45	N/A

3	7.6226	4719.3

34.34	N/A

4	37.9011	4767.74

30.73	N/A

Average:	30.173	4708.51

	Std Error:	7.527

	% of samples above level of concern	100%

	0.25	3	1	0.0709	1069.83	3230.73	66.89	+

2	0.1537	1236.24

61.73	+

3	0.0544	809.72

74.94	+

4	0.1626	907.52

71.91	+

Average:	0.1104	1005.83

% detected:	100%

Std Error:	0.0278

	% of samples above level of concern	100%

	0.5	3	1	0.0141	2251.79	6882.42	67.28	+

2	0.1387	1268.48

81.57	+

3	0.1768	1999.64

70.95	+

4	0.2149	1899.71

72.4	+

Average:	0.1361	1854.91

% detected:	100%

Std Error:	0.0435

	% of samples above level of concern	100%

	0.25	9	1	0.0571	746.9	3230.73	76.88	+

2	0.0453	725.5

77.54	+

3	0.0189	640.33

80.18	+

4	0.0693	617.83

80.88	+

Average:	0.0477	682.64

% detected:	100%

Std Error:	0.0108

	% of samples above level of concern	100%

	0.5	9	1	0.1842	1113.84	6882.42	83.82	+

2	0.1715	1727.92

74.89	+

3	0.1842	909.45

86.79	+

4	0.1397	1529.92

77.77	+

Average:	0.1699	1320.28

% detected:	100%

Std Error:	0.0105

	% of samples above level of concern	100%

	0.25	23	1	0.0828	367.05	3230.73	88.64	+

2	0.0204	241.52

92.52	+

3	0.1664	313.76

90.29	+

4	0.116	112.7

96.51	+

Average:	0.0964	258.76

% detected:	100%

Std Error:	0.0306

	% of samples above level of concern	100%

	0.5	23	1	0.1404	596.58	6882.42	91.33	+

2	0.1218	613.7

91.08	+

3	0.091	576.14

91.63	+

4	0.1819	735.09

89.32	+

Average:	0.1338	630.38

% detected:	100%

Std Error:	0.0190

	% of samples above level of concern	100%

	0.25	36	1	0.0027	153.44	3230.73	95.25	+

2	0.012	196.86

93.91	+

3	0.023	190.62

94.1	+

4	0.0115	173.91

94.62	+

Average:	0.0123	178.71

% detected:	100%

Std Error:	0.0042

	% of samples above level of concern	75%

	0.5	36	1	0.152	401.51	6882.42	94.17	+

2	0.0205	312.2

95.46	+

3	0.0284	338.73

95.08	+

4	0.1226	387.06

94.38	+

Average:	0.0809	359.88

% detected:	100%

Std Error:	0.0332

	% of samples above level of concern	100%

	0.25	58	1	0.0049	83.64	3230.73	97.41	+

2	0.0058	63.14

98.05	+

3	0.0048	56.17

98.26	+

4	0.0036	88.36

97.27	+

Average:	0.0048	72.83

% detected:	100%

Std Error:	0.0005

	% of samples above level of concern	0%

	0.5	58	1	0.0109	174.57	6882.42	97.46	+

2	0.0293	129.57

98.12	+

3	0.0342	81.88

98.81	+

4	0.0477	151.29

97.8	+

Average:	0.0305	134.33

% detected:	100%

Std Error:	0.0076

	% of samples above level of concern	100%

Page   PAGE  1

Figure 1.  Percent reduction from Cr

+6

 to Cr

+3

 in the Expressate

(as percent of initial treating solution level)

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

0

3

9

23

36

58

Days after Treatment (DAT)

% Cr

+6

 Reduction

Southern pine 0.25

Southern pine 0.5

Douglas fir 0.25

Douglas fir 0.5

Figure 2.  Percent of samples containing >=15ppm Cr

+6

as detected in Borings using Chromotropic ACid

0%

20%

40%

60%

80%

100%

3

9

23

36

58

Days after Treatment

Percent of samples

Douglas fir 0.25

Douglas fir 0.50

Southern pine 0.25

Southern pine 0.50


[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Rules and Regulations]
[Pages 66618-66620]
[FR Doc No: 2011-27771]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1033; Directorate Identifier 2009-SW-43-AD;
Amendment 39-16815; AD 2011-20-05]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France (Eurocopter) Model
EC225LP Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: This amendment adopts a new airworthiness directive (AD) for
the Eurocopter Model EC225LP helicopters. This AD requires inspecting
the dome fairing support for a crack at the dome fairing attachment
point. If a crack is found, this AD requires replacing the dome fairing
support and the associated coning stop support assembly before further
flight. If no crack is found, this AD requires repetitive inspections
and retorquing the screws at specified intervals. This AD is prompted
by the discovery of two fatigue cracks in the dome fairing attachment
on the dome fairing support. This condition, if not corrected, could
lead to the loss of the dome fairing in flight, causing damage to the
helicopter and injury to people on the ground.

DATES: Effective November 14, 2011.
    Comments for inclusion in the Rules Docket must be received on or
before December 27, 2011.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.eurocopter.com.

    Examining the Docket:
    You may examine the docket that contains the AD, any comments, and
other information on the Internet at http://www.regulations.gov, or in
person at the Docket Operations office between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The Docket Operations
office (telephone<PHONE_NUMBER>) is located in Room W12-140 on the
ground floor of the West Building at the street address stated in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
FAA, Regulations and Policy Group, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2009-0023, dated February 20, 2009, to correct an unsafe condition for
the Eurocopter Model EC225LP helicopters. EASA advises that two fatigue
cracks were discovered in the dome fairing attachment on the dome
fairing support due to the loss of the tightening torque of the screws
which secure the assembly. Since then, Eurocopter has developed a
modification (MOD) which includes installation of redesigned parts with
``modified geometrics'' in the main rotor hub area.

Related Service Information

    Eurocopter has issued Emergency Alert Service Bulletin No. 05A005,
Revision 1, dated February 3, 2009 (EASB 05A005), which applies to FAA
type-certificated Model EC225LP helicopters and non-FAA type
certificated Model EC725AP military helicopters. Eurocopter also issued
Service Bulletin No. 62-007, Revision 1, dated July 10, 2009, which
applies to FAA type-certificated Model EC225LP helicopters, and
specifies reinforcing the cone restrainer support, MOD 0743718. EASB
05A005 specifies checking the dome fairing support for a crack and
readjusting the tightening torque of the dome fairing-to-dome fairing
support attachment screws. If a crack is found, the EASB specifies
complying with MOD 0743718 before resuming flight. Eurocopter states
that installing this MOD exempts the operator from the monitoring
requirements. They also state that this MOD reinforces the coning stop
support and improves the dome fairing support attachment on the coning
stop support. The EASA classified this service information as mandatory
and issued EASA AD No. 2009-0023, dated February 20, 2009, to ensure
the continued airworthiness of these helicopters.

FAA's Evaluation and Unsafe Condition Determination

    This helicopter model has been approved by the aviation authority
of France and is approved for operation in the United States. Pursuant
to our bilateral agreement with France, EASA, their technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined an unsafe condition exists
and is likely to exist or develop on other helicopters of the same type
design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Registry in the future.

Differences Between This AD and the EASA AD

    This AD differs from the EASA AD in that we:
     Use ``hours time-in-service'' rather than ``flight
hours.''
     Do not impose a calendar date compliance time.
     Use the term ``inspect'' rather than ``check.''

Costs of Compliance

    There are no costs of compliance since there are no helicopters of
this type design on the U.S. Registry.

FAA's Determination of the Effective Date

    Since there are currently no affected U.S. registered helicopters,
we have determined that notice and opportunity for prior public comment
before issuing this AD are unnecessary and that good cause exists for
making this amendment effective in less than 30 days.

Requirements of This AD

    This unsafe condition is likely to exist or develop on other
helicopters of the same type design registered in the United States.
Therefore, this AD is being issued to prevent loss of the dome fairing
in flight, causing damage to the helicopter and injury to people on the
ground. This AD requires inspecting for a crack in the dome fairing
support at the dome fairing attachment points. If a crack is found,
this AD requires replacing the dome fairing support and the associated
coning stop support assembly before further flight. If no crack is
found, this AD requires repetitive inspections and retorquing the
screws securing the dome fairing support to the dome fairing at
specified intervals. This AD is prompted by the discovery of two
fatigue cracks in the dome fairing attachment on the dome fairing
support. Accomplishing Eurocopter MOD 0743718 constitutes terminating
action for the requirements of this AD.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES. Include ``Docket No. FAA-2011-1033; Directorate
Identifier 2009-SW-43-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
docket web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that notice and prior public comment are
unnecessary in promulgating this regulation; therefore, it can be
issued immediately to correct an unsafe condition in aircraft since
none of these model helicopters are registered in the United States. We
have also determined that this regulation is not a ``significant
regulatory action'' under Executive Order 12866. It has been determined
further that this action involves an emergency regulation under DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If
it is determined that this emergency regulation otherwise would be

significant under DOT Regulatory Policies and Procedures, a final
regulatory evaluation will be prepared and placed in the AD docket.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
Reference, Safety.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2011-20-05 Eurocopter France (Eurocopter): Amendment 39-16815;
Docket No. FAA-2011-1033; Directorate Identifier 2009-SW-43-AD.

    Applicability: Model EC225LP helicopters, certificated in any
category, that have not been modified in accordance with Eurocopter
Modification (MOD) 0743718.
    Compliance: Required as indicated.
    To prevent loss of the dome fairing in flight, damage to the
helicopter, and injury to people on the ground, accomplish the
following:
    (a) Within 15 hours time-in-service (TIS), unless accomplished
previously, inspect for a crack in the dome fairing support at the
dome fairing attachment points.
    (1) If a crack is found in the dome fairing support or at a dome
fairing attachment point, before further flight, replace the dome
fairing support and the associated coning stop support assembly.
    (2) If no crack is found, thereafter at intervals not exceeding
165 hours TIS, inspect for a crack in the dome fairing support, and
re-torque the screws securing the dome fairing support to the dome
fairing.

    Note 1:  Eurocopter Emergency Alert Service Bulletin No. 05A005,
Revision 1, dated February 3, 2009, and Service Bulletin No. 62-007,
Revision 1, dated July 10, 2009, which are not incorporated by
reference, contain additional information about the subject of this
AD.

    (b) Accomplishing Eurocopter MOD 0743718 constitutes terminating
action for the requirements of this AD.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Safety Management Group, FAA, Attn: Gary Roach,
Aviation Safety Engineer, FAA, Regulations and Policy Group, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>, for information about previously approved
alternative methods of compliance.
    (d) A special flight permit will not be issued.
    (e) The Joint Aircraft System/Component (JASC) Code is 6300:
Main Rotor Drive System.
    (f) This amendment becomes effective on November 14, 2011.

    Note 2:  The subject of this AD is addressed in European
Aviation Safety Agency AD No. 2009-0023, dated February 20, 2009.

    Issued in Fort Worth, Texas, on September 13, 2011.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-27771 Filed 10-26-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Pages 57695-57696]
[FR Doc No: 2022-20380]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8956-03-OAR]

Administration of Cross-State Air Pollution Rule Trading Program
Assurance Provisions for 2021 Control Periods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of data availability.

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

SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of the availability of data on the administration of the assurance
provisions of the Cross-State Air Pollution Rule (CSAPR) trading
programs for the control periods in 2021. Total emissions of nitrogen
oxides (NOX) reported by Missouri units participating in the
CSAPR NOX Ozone Season Group 2 Trading Program during the
2021 control period exceeded the state's assurance level under the
program. Data demonstrating the exceedance and EPA's final calculations
of the amounts of additional allowances that the owners and operators
of certain Missouri units must surrender have been posted in a
spreadsheet on EPA's website.

DATES: September 21, 2022.

FOR FURTHER INFORMATION CONTACT: Questions concerning this action
should be addressed to Garrett Powers at<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION: The regulations for each CSAPR trading
program contain ``assurance provisions'' designed to ensure that the
emissions reductions required from each state covered by the program
occur within the state. If the total emissions from a given state's
affected units exceed the state's assurance level under the program,
then two allowances must be surrendered for each ton of emissions
exceeding the assurance level (in addition to the ordinary obligation
to surrender one allowance for each ton of emissions). In the quarterly
emissions reports covering the 2021 control period, Missouri units
participating in the CSAPR NOX Ozone Season Group 2 Trading
Program reported emissions that exceed the state's assurance level
under the program by 1,295 tons, resulting in a requirement for the
surrender of 2,590 additional allowances.
    When a state's assurance level is exceeded, responsibility for
surrendering the required additional allowances is apportioned among
groups of units in the state represented by ``common designated
representatives'' based on the extent to which each such group's
emissions exceeded the group's share of the state's assurance level.
For the CSAPR NOX Ozone Season Group 2 Trading Program, the
procedures are set forth at 40 CFR 97.802 (definitions of ``common
designated representative,'' ``common designated representative's
assurance level,'' and ``common designated representative's share''),
97.806(c)(2), and 97.825.
    On July 15, 2022, EPA published a document in the Federal Register
providing notice of the data relied on to determine the amount of the
exceedance of the Missouri assurance level and the preliminary
calculations of the amounts of additional allowances that the owners
and operators of certain Missouri units must surrender as a result of
the exceedance and describing the process for submitting any objections
(87 FR 42459). EPA received no written submissions objecting to the
data and preliminary calculations.
    In this document, EPA is providing notice of the final calculations
of the amounts of additional allowances that must be surrendered.
Responsibility for surrendering 2,590 additional allowances for the
Missouri exceedance has been apportioned almost entirely to the group
of units operated by Associated Electric Cooperative, Inc. (2,570
allowances), with much smaller shares apportioned to the groups of
units operated by the municipal utilities of Chillicothe and
Higginsville (4 and 16 allowances, respectively). Each set of owners
and operators identified pursuant to this notice of the final
calculations must hold the required additional allowances in an
assurance account by November 1, 2022.
    The data and final calculations are set forth in an Excel
spreadsheet entitled
``2021_CSAPR_assurance_provision_calculations_final.xlsx'' available at
http://www.epa.gov/csapr/csapr-assurance-provision-nodas. The
spreadsheet contains data for the 2021 control period showing, for each
Missouri unit identified as affected under the CSAPR NOX
Ozone Season Group 2 Trading Program, the amount of NOX
emissions reported by the unit and the amount of CSAPR NOX
Ozone Season Group 2 allowances allocated to the unit, including any
allowances allocated from a new unit set-aside. The spreadsheet also
contains calculations for the 2021 control period showing the total
NOX emissions reported by all such units in the state and
the amount by which the total reported NOX emissions
exceeded the state's assurance level under the program. Finally, the
spreadsheet also includes calculations for the 2021 control period
showing, for each common designated representative for a group of such
units in the state, the common designated representative's share of the
total reported NOX emissions, the common designated
representative's share of the state's assurance level, and the amount
of additional CSAPR NOX Ozone Season Group 2 allowances that
the owners and operators of the units in the group must surrender.

(Authority: 40 CFR 97.825(b).)

Rona Birnbaum,
Director, Clean Air Markets Division, Office of Atmospheric Programs,
Office of Air and Radiation.
[FR Doc. 2022-20380 Filed 9-20-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Proposed Rules]
[Pages 65645-65646]
[FR Doc No: 2012-26439]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Chapter I

[Docket No. AD12-6-000]

Retrospective Analysis of Existing Rules: Notice of Staff
Memorandum

SUMMARY: Take notice that the Commission staff is issuing a memorandum
setting forth certain minor revisions to the Commission's Natural Gas
Pipeline regulations that may be appropriate to remove reporting
requirements that may no longer serve their intended purpose. The
memorandum was issued pursuant to the Nov. 8, 2011 Plan for
Retrospective Analysis of Existing Rules prepared in response to
Executive Order 13579, which requested independent regulatory agencies
issue plans for periodic retrospective analysis of their existing
regulations.

    The Staff Memorandum is being placed in the record in the above-
referenced administrative docket. The Staff Memorandum will also be
available on the Commission's Web site at http://www.ferc.gov.

DATES: Comments on the Staff Memorandum should be filed by November 29,
2012.

ADDRESSES: The Commission encourages electronic submission of comments
in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
Persons unable to file electronically should submit an original of the
comment to the Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426.
    All filings in this docket are accessible on-line at http://www.ferc.gov, using the ``eLibrary'' link. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket. For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christy Walsh, Office of the General
Counsel, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: October 18, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-26439 Filed 10-29-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76635-76636]
[FR Doc No: 2013-30074]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0977]

Merchant Marine Personnel Advisory Committee: Intercessional
Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee working group meeting.

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

SUMMARY: A working group of the Merchant Marine Personnel Advisory
Committee (MERPAC) will meet to work

on Task Statement 80, concerning crew training requirements onboard
vessels subject to the International Code of Safety for ships using
gases or low flash-point fuels (IGF Code). This meeting will be open to
the public.

DATES: A MERPAC working group will meet on January 8, 2014, and January
9, 2014, from 8 a.m. until 4 p.m. Please note that the meeting may
adjourn early if all business is finished. Written comments to be
distributed to working group members and placed on MERPAC's Web site
are due by January 6, 2014.

ADDRESSES: The working group will meet in Room A307 of the Maritime
Institute of Technology and Graduate Studies (MITAGS), 692 Maritime
Boulevard, Linthicum Heights, MD 21090. For further information on the
location of MITAGS or services for individuals with disabilities or to
request special assistance, please contact Mr. Brian Senft at (410)
859-5700.
    To facilitate public participation, we are inviting public comment
on the issue to be considered by the work group, which is listed in the
``Agenda'' section below. Written comments must be submitted on or
before January 6, 2014, and must be identified by Docket No. USCG-2013-
0977, and may be submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments (preferred method to
avoid delays in processing).
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, enter the
docket number in the ``Search'' field and follow instructions on the
Web site.
    Public oral comment periods will be held during the working group
meeting. Speakers are requested to limit their comments to 3 minutes.
Please note that the public oral comment periods may end before the
prescribed ending time following the last call for comments. Contact
Gerald Miante as indicated below no later than January 6, 2014 to
register as a speaker.
    This notice may be viewed in our online docket, USCG-2013-0977, at
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Gerald Miante, Alternate
Designated Federal Officer of MERPAC, telephone<PHONE_NUMBER> or at
<EMAIL_ADDRESS>If you have any questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92-
463).
    MERPAC is an advisory committee authorized under section 871 of the
Homeland Security Act of 2002, Title 6, United States Code, section
451, and chartered under the provisions of the FACA. The Committee acts
solely in an advisory capacity to the Secretary of the Department of
Homeland Security (DHS) through the Commandant of the Coast Guard and
the Director of Commercial Regulations and Standards on matters
relating to personnel in the U.S. merchant marine, including but not
limited to training, qualifications, certification, documentation, and
fitness standards. The Committee will advise, consult with, and make
recommendations reflecting its independent judgment to the Secretary.
    A copy of all meeting documentation, including the Task Statement,
is available at https://homeport.uscg.mil by using these key strokes:
Missions; Port and Waterways Safety; Advisory Committees; MERPAC; and
then use the announcements key. Alternatively, you may contact Mr.
Miante as noted in the FOR FURTHER INFORMATION CONTACT section above.

Agenda

Day 1

    The agenda for the January 8, 2014, working group meeting is as
follows:
    (1) Review and make recommendations concerning the draft
International Maritime Organization (IMO) training tables and
correspondence group tables for crewmembers serving onboard vessels
fueled by gases or low flash-point fuels;
    (2) Public comment period;
    (3) Discuss and prepare proposed recommendations for the full
committee to consider with regards to Task Statement 80, concerning
crew training requirements onboard vessels subject to the International
Code of Safety for ships using gases or low flash-point fuels (IGF
Code); and
    (4) Adjournment of meeting.

Day 2

    The agenda for the January 9, 2014, working group meeting is as
follows:
    (1) Continue discussion on proposed recommendations;
    (2) Public comment period;
    (3) Discuss and prepare final recommendations for the full
committee to consider with regards to Task Statement 80, concerning
crew training requirements onboard vessels subject to the IGF Code; and
    (4) Adjournment of meeting.

    Dated: December 12, 2013.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2013-30074 Filed 12-17-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47197-47210]
[FR Doc No: 2011-19622]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0543]

Authorization of Emergency Use of Oral Formulations of
Doxycycline; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for oral formulations of doxycycline for the post-exposure prophylaxis
of inhalational anthrax during a public health emergency involving
aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by the Centers for Disease Control and Prevention
(CDC). The Authorization contains, among other things, conditions on
the emergency use of the authorized doxycycline products. The
Authorization follows the determination by the Secretary of the
Department of Homeland Security (DHS) that there is a significant
potential for a domestic emergency involving a heightened risk of
attack with a specified biological, chemical, radiological, or nuclear
agent or agents--in this case, B. anthracis. On the basis of such
determination, the Secretary of the Department of Health and Human
Services (HHS) declared an emergency justifying the authorization of
the emergency use of doxycycline hyclate tablets, accompanied by
emergency use information, and later renewed that declaration. The
Secretary of HHS then renewed and amended that declaration so that it
applies to all doxycycline products covered by this authorization. The
Authorization, which includes an explanation of the reasons for
issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 21, 2011.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4121, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your request or include a fax number to which the
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4280, Silver Spring, MD 20993,
301-796-8510.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276), allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product during a
public health emergency that affects,

or has a significant potential to affect, national security, and that
involves biological, chemical, radiological, or nuclear agent or
agents, or a specified disease or condition that may be attributable to
such agent or agents. With this EUA authority, FDA can help assure that
medical countermeasures may be used in an emergency to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
such agents, when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary must declare an emergency justifying the
authorization based on one of the following grounds: ``(A) A
determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents; (B) a
determination by the Secretary of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military forces of attack
with a specified biological, chemical, radiological, or nuclear agent
or agents; or (C) a determination by the Secretary of a public health
emergency under section 319 of the Public Health Service Act (PHS Act)
that affects, or has a significant potential to affect, national
security, and that involves a specified biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents.''
    Once the Secretary has declared an emergency justifying an
authorization under section 564 of the FD&C Act, FDA may authorize the
emergency use of a drug, device, or biological product if the Agency
concludes that the statutory criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is required to publish, in the Federal
Register, a notice of each authorization, and each termination or
revocation of an authorization, and an explanation of the reasons for
the action. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in a declared emergency. Products appropriate
for emergency use may include products and uses that are not approved,
cleared, or licensed under sections 505, 510(k), and 515 of the FD&C
Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42
U.S.C. 262). FDA may issue an EUA only if, after consultation with the
National Institutes of Health and CDC (to the extent feasible and
appropriate given the circumstances of the emergency), FDA \1\
concludes: (1) That an agent specified in a declaration of emergency
can cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) the product may be
effective in diagnosing, treating, or preventing--(1) Such disease or
condition; or (2) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product; (3)
that there is no adequate, approved, and available alternative to the
product for diagnosing, preventing, or treating such disease or
condition; and (4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
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    \1\ The Secretary has delegated her authority to issue an EUA
under section 564 of the FD&C Act to the Commissioner of Food and
Drugs.
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    No other criteria of issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement
the EUA authority. However, in the Federal Register of July 26, 2007
(72 FR 41083), FDA announced the availability of a guidance entitled
``Emergency Use Authorization of Medical Products.'' The guidance
provides more information for stakeholders and the public about the EUA
authority and the Agency's process for the consideration of EUA
requests.

II. EUA Request for Oral Formulations of Doxycycline Products

    In 2004, the Secretary of DHS issued a material threat
determination indicating that B. anthracis, the biological agent that
causes anthrax disease, presents a material threat against the
population of the United States sufficient to affect national security.
On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act, the
Secretary of DHS determined that there is a significant potential for a
domestic emergency involving a heightened risk of attack with a
specified biological, chemical, radiological, or nuclear agent or
agents--in this case, B. anthracis. On October 1, 2008, under section
564(b) of the FD&C Act, and on the basis of such determination, the
Secretary of HHS then declared an emergency justifying the
authorization of the emergency use of doxycycline hyclate tablets
accompanied by emergency use information subject to the terms of any
authorization issued under section 564(a) of the FD&C Act, and on
October 1, 2009, and on October 1, 2010, renewed that declaration. On
July 20, 2011, the Secretary of HHS renewed and amended that
declaration so that it applies to all doxycycline products covered by
this authorization. Notice of the determination and the declaration of
the Secretary were published in the Federal Register on July 27, 2011
(76 FR 44926). On May 5, 2011, CDC requested and, on July 21, 2011, FDA
issued an EUA for oral formulations of doxycycline products for the
post-exposure prophylaxis of inhalational anthrax during a public
health emergency involving aerosolized B. anthracis, subject to the
terms and conditions of this authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of oral formulations of doxycycline
products for the post-exposure prophylaxis of inhalational anthrax
during a public health emergency involving aerosolized B. anthracis
subject to the terms and conditions of the authorization.
    The Authorization for doxycycline products follows and provides an
explanation of the reasons for its issuance, as required by section
564(h)(1) of the FD&C Act:
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    Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19622 Filed 8-3-11; 8:45 am]
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