GERAGHTY & MILLER Screening and Selection of Coatings for Reducing Dislodgeable Arsenic from CCA Treated Wood Quality Assurance Project Plan Category III/ Sampling and Analysis Draft   Revision 1.2 U. S. Environmental Protection Agency Air Pollution Prevention and Control Division March 2003 Contract No. 68 C99 201 Work Assignment No. 4 38 Project No. RN992014.0038 Prepared for:

U. S. Environmental Protection Agency Air Pollution Prevention and Control Division Research Triangle Park, NC 27711 P. O. Box 13109 Research Triangle Park North Carolina 27709 QAPP DRAFT   Revision 1.2 March 27, 2003 Screening and Selection of Coatings for Reducing Dislodgeable Arsenic from CCA Treated Wood Quality Assurance Project Plan Category III/ Sampling and Analysis Draft   Revision 1.2 U. S. Environmental Protection Agency Air Pollution Prevention and Control Division March 2003 Contract No. 68 C99 201 Work Assignment No. 4 38 Project No. RN992014.0038 Prepared for:

U. S. Environmental Protection Agency Air Pollution Prevention and Control Division Research Triangle Park, NC 27711 EPA Work Assignment Manager __________________________ _______ Mark Mason Date ARCADIS Geraghty & Miller Work Assignment Leader __________________________ _______ Victor D'Amato Date EPA QA Representative __________________________ _______ Paul Groff Date ARCADIS Geraghty & Miller QA Officer __________________________ _______ Laura Beach Nessley Date i CONTENTS Section Page 1 Project Description and Organization 1 1 1.1 Project Scope 1 1 1.2 Background 1 1 1.3 Data Quality Objectives 1 2 1.4 Project Organization and Responsibilities 1 2 2 Sampling Approach 2 1 2.1 Preparation and Characterization of Wood Specimens 2 1 2.2 Selection of Coatings for Screening 2 4 2.3 Coating Application 2 7 2.4 Sample Schedule 2 10 2.5 Test Conditions 2 12 2.6 Sampling 2 12 2.6.1 Wipe Sampling 2 12 2.6.2 Wood Sampling 2 13 3 Testing and Measurement Protocols 3 1 3.1 Wipe Sampling 3 1 3.2 Sample Preparation ( Extraction/ Digestion) 3 1 3.3 Analysis by ICP MS 3 2 3.4 Preparation and Analysis of Miscellaneous Samples 3 2 3.5 Analysis of Wood Samples 3 2 3.6 Archiving of ICP MS Samples 3 2 3.7 Moisture Analysis of Wood Specimens 3 3 4 QA/ QC Checks 4 1 5 Data Reductions and Reporting 5 1 5.1 Data Reduction 5 1 5.1.1 Calculation of DA from Extraction/ Digestion Fluid Concentrations 5 1 5.1.2 Calculation of Percent Reduction of DA 5 1 5.1.3 Assessing DQI Goals 5 2 5.2 Data Validation 5 3 5.3 Data Reporting 5 3 ii List of Figures Section Page Figure 1 1. Organization Chart for Sampling/ Analytical Qualification Testing 1 3 Figure 2 1. Wood Board/ Specimen Nomenclature 2 1 Figure 2 2: Example specimen identification scheme 2 3 List of Tables Section Page Table 1 1. Data Quality Indicator Goals for Critical Measurements 1 2 Table 1 2. Contact Information for Key Project Staff 1 4 Table 2 1. Selected Products for Screening Study 2 6 Table 2 2. Summary of Coating Application Measurements 2 10 Table 2 3. Schedule of Specimens 2 10 Table 2 4. Miscellaneous Samples to be Collected during Screening Study 2 12 iii List of Acronyms ACW Applied coating weight ANOVA Analysis of variance CCA Chromated copper arsenate CPSC Consumer Product Safety Commission DA Dislodgeable arsenic DCSW Dry coated specimen weight DCW Dry coating weight DQI Data quality indicator ECW Ending coating weight FPL Forest Products Lab HEPA High efficiency particulate air IPN Interpolymer network coating MS/ MSD Matrix spikes and matrix spike duplicates NCDC National Climate Data Center NOAA National Oceanic and Atmospheric Administration PEA Performance evaluation audit PFA Perfluoroalkoxy ( resin)

QAPP Quality Assurance Project Plan RSD Relative standard deviation SCW Starting coating weight TFE Polytetrafluoroethylene USDA United States Department of Agriculture USW Uncoated specimen weight WCSW Wet coated specimen weight WCW Wet coating weight WFT Wet film thickness iv This page intentionally left blank. ( Section Page) 1 1 of 4 Draft  Revision 1.2 March 2003 1 Project Description and Organization 1.1 Project Scope The objective of this series of tests is to screen a variety of commercially available wood coatings for their efficacy in reducing dislodgeable arsenic ( DA) from new and aged chromated copper arsenate ( CCA) treated wood in a relatively simple, short duration test. The results of this screening evaluation will be used to help select coating products to be more thoroughly tested via a larger pilot study to determine the efficacy of coatings to reduce DA from the surfaces of new and aged CCA treated wood subjected to both accelerated, indoor, artificial, and outdoor, natural weathering conditions. This Quality Assurance Project Plan ( QAPP)/ Test Plan describes the procedures and criteria to be used to screen and select potential wood coating products to be further tested per the overall project. The overall project entitled " Evaluation of the Effectiveness of Coatings in Reducing Dislodgeable Arsenic from CCA Treated Wood" will be fully described in a project specific QAPP/ Test Plan.

In the screening study described herein, selected coatings will be applied to new CCA treated southern yellow pine. After allowing the coatings to dry, the coated lumber will be wipe sampled to measure DA, which, for the purposes of this study, is defined as the amount of arsenic ( µ g/ cm2) removed from the surface of the coated wood specimens by the dermal wipe procedure developed and demonstrated by the Consumer Product Safety Commission ( CPSC), who are collaborators on this project via an interagency agreement ( CPSC I 03 1235) between EPA and CPSC. The ability of the coatings to reduce initial apparent DA will be evaluated by comparing the DA of coated wood specimens with their initial pre coat baseline DA ( as determined per wipe sampling of adjacent uncoated specimens).

Coatings will be ranked based upon initial DA reduction and 10 high ranking coatings will be selected for weathering testing. The screening test specimens for the selected coatings will be retained for continued monthly DA measurement during the weathering tests, as non weathered controls. These samples will allow for the monitoring of DA changes resulting from abrasion ( from wipe sampling) without the potentially confounding effects of weathering.

1.2 Background Existing published and unpublished data regarding the efficacy of coatings in preventing leaching of arsenic and/ or reducing DA from CCA treated wood is generally inconclusive. Recent unpublished data suggest that existing commercially available coatings may not reduce DA from CCA treated wood to levels necessary to adequately protect consumers, based on a 10 5 risk criterion. It is additionally of note that certain products clearly outperform others and that even products within the same basic coating classification can vary greatly in performance depending on specific formulation, application, and surface preparation details.

Logistical and budgetary constraints on the number of coatings that can be more fully tested under the " Evaluation of the Effectiveness of Coatings in Reducing Dislodgeable Arsenic from CCA Treated Wood" ( Section Page) 1 2 of 4 Draft  Revision 1.2 March 2003 test plan require the selection of ten ( 10) coatings for further testing. Given the uncertainty with respect to the efficacy of available coatings, basic screening tests will be conducted on a wide range of available coatings. Top ranking coatings will be selected for further testing under the " Evaluation of the Effectiveness of Coatings in Reducing Dislodgeable Arsenic from CCA Treated Wood" test plan.

1.3 Data Quality Objectives Screening tested coatings will be ranked according to their efficacy based on percentage reduction of DA from new CCA treated wood, wipe sampled after coating application and drying. Post coating DA will be compared with baseline DA. Individual baseline values of DA will be determined for each specimen to be coated and tested. The baseline DA of a specimen will be determined by averaging the DA from two adjacent specimens. The adjacent specimens will be archived uncoated after sampling ( and thus not used in any further testing). This step will avoid any data analysis and coating efficacy complications that may arise from coating pre rubbed specimens. Ten coatings ( 10) will be selected for weathering testing per the following criteria:

  Overall ranking in terms of DA reduction   Subjective factors, including:

  Ensuring that the final list of selected coatings is representative of the range of potentially effective products on the market.

  Other factors which may be identified as important during screening tests.

The critical measurement for this series of tests is total arsenic concentration. Data quality indicator goals for arsenic concentration in terms of accuracy, precision, and completeness are shown in Table 1 1.

Table 1 1. Data Quality Indicator Goals for Critical Measurements Analyte Method Accuracy (% Recovery) Precision (% RSD/ RPD) Completeness (%)

Arsenic ( total) SW 846 Method 6020 ( modified) 90 110 10 90 1.4 Project Organization and Responsibilities The EPA Work Assignment Manager for this project is Mark Mason, who will coordinate involvement other EPA staff and CPSC via an interagency agreement ( CPSC I 03 1235) between EPA and CPSC, as appropriate. Key CPSC staff include Jacque Ferrante and Warren Porter. ARCADIS' Work Assignment Leader is Victor D'Amato, PE. Libby Nessley, with ARCADIS, serves EPA by providing QA/ QC management services, while Todd Thornton and Jerry Revis, both with ARCADIS, serve EPA by providing Health and Safety management services. Kevin Bruce, ARCADIS, is the overall OLS Project Manager. He will support this project by coordinating the wood preparation, coating, sampling, and analytical tasks. Matt ( Section Page) 1 3 of 4 Draft  Revision 1.2 March 2003 Clayton, ARCADIS, will prepare and coat wood samples. Peter Kariher, ARCADIS, will take samples, prepare samples via digestion protocol, and ship digested wipe and control samples to the subcontract analytical laboratory, STL Savannah ( Angie Weimerskirk, Project Manager). An organizational chart is provided as Figure 1 1. Table 1 2 provides contact information for proposed staff.

Figure 1 1. Organizational Chart for Sampling/ Analytical Qualification Testing ( Section Page) 1 4 of 4 Draft  Revision 1.2 March 2003 Table 1 2. Contact Information for Key Project Staff Staff Contact Organization Responsibility Phone Number E mail Address Mark Mason US EPA WA Manager ( 919) 541 4835 Mason. Mark.@ epa. gov Victor D'Amato ARCADIS WA Leader ( 919) 544 4535 vd'amato@ arcadis us. com Libby Nessley ARCADIS QA Manager ( 919) 544 4535 lnessley@ arcadis us. com Todd Thornton ARCADIS H& S Manager ( 919) 544 4535 tthornton@ arcadis us. com Jerry Revis ARCADIS H& S Manager ( 919) 544 4535 jrevis@ arcadis us. com Kevin Bruce ARCADIS PM, Advisor ( 919) 544 4535 kbruce@ arcadis us. com Peter Kariher ARCADIS Lab Scientist ( 919) 544 4535 pkariher@ arcadis us. com Matt Clayton ARCADIS Lab Scientist ( 919) 541 7909 mclayton@ arcadis us. com Angie Weimerskirk STL Savannah Analytical Manager ( 912) 354 7858 aweimerskirk@ stl inc. com ( Section Page) 2 1 of 14 Draft  Revision 1.2 March 2003 2 Sampling Approach The overall objective of this testing is to develop estimates of percent reduction in DA per the use of a variety of coatings. About 30 coatings will be applied to 46 cm ( 18") new CCA treated wood specimens in triplicate. Wipe sampling will be conducted at 7 days after coating application. Post coating DA will be compared with baseline DA, as determined via wipe sampling of adjacent uncoated specimens, to determine percent reductions.

The following subsections describe the selection of materials for testing, application of selected coatings to the CCA treated substrates, test conditions, and sampling procedures. A project specific health and safety plan ( HSP) is under development and will be appended to this QAPP after the HSP is finalized and approved.

2.1 Preparation and Characterization of Wood Specimens Wood specimens will be prepared using new southern yellow pine that has been CCA treated to 0.4 pounds per cubic foot, in nominal 5/ 4" x 6" cross sectional dimensions. New southern yellow pine that has not been CCA treated will used for blank control specimens. Non treated controls will most likely be of either 1" x 6" or 2" x 6" nominal dimensions since non treated 5/ 4" x 6" decking wood is not typically available, though it may be possible to easily obtain untreated 5/ 4" x 6" southern yellow pine locally from a lumber treating company. New CCA treated wood will be purchased from a retail store and will be labeled " CCA C Ground Contact", indicating that the product has been treated with the " C" formulation of CCA preservative, which is most commonly available. Care will be taken to minimize handling of the primary ( i. e., 6" width) faces of the board, with the short edges of the board preferentially held during transport and cutting. Additionally, care will be taken to minimize contact and especially rubbing of the primary faces of the board with any other surfaces. Storage of the board/ specimens shall be on its cut ends or uncut edges ( i. e., short faces). Wood board/ specimen nomenclature used in this test plan is defined in Figure 2 1. Note that a " board" is defined as the unit of wood purchased or removed from an existing structure, while " specimen" refers to the pieces of each board cut for this project ( note that " specimens" are sometimes called " coupons" in accelerated weathering testing).

Figure 2 1. Wood Board/ Specimen Nomenclature ( Section Page) 2 2 of 14 Draft  Revision 1.2 March 2003 Boards will be cut using a circular table saw ( or other similar cutting device) into approximately equal 46 cm ( 18 inch) lengths to serve as test specimens. The saw will be decontaminated between cutting the different types of wood utilized ( new CCA, untreated) and the non CCA wood will be cut only after installation of a new blade to prevent cross contamination of samples. Decontamination will follow a similar protocol to that used to clean the wipe sampling device between samples. Fifteen cm ( 6") of each end of each board will be removed and archived and 10 cm ( 4") segments between each 46 cm test specimen will be removed and archived; some of these will be used to characterize the source wood via moisture content and total arsenic analyses. Forty seven cm wood specimens will be visually inspected and those exhibiting excessive amounts of deformities, presence of heartwood, knots, resin pockets, and other defects will be disqualified for use in the screening testing ( it will be allowable to avoid defective segments of wood during cutting and/ or using wood unacceptable for the 46 cm specimens as 10 or 15 cm end and interior segments for archiving, so as to not waste or require an excessive amount of wood). Each segment will be identified with a unique alphanumeric code as follows:

  New board codes will be prefixed by the letter " N"

  Aged board codes will be prefixed by the letter " A"

  Each new and aged board will be identified with a letter ( A, B, C, etc.)

  Each 18" test specimen from new and aged boards will be identified with a number ( 1, 2, 3, etc.)

  Each end piece will be identified with the number of the specimen adjacent to it, followed by the letter " E"

  Each 4" interior segment will be identified with the numbers of the specimens adjacent to it separated by a forward slash ("/")

  Defective segments will be suffixed with the letter " D"

For example, assuming that a 16' length of new CCA treated wood is used, samples from the first board would be identified from end to end, as follows: N A 1E, N A 1, N A 1/ 2, N A 2, N A 2/ 3, N A 3, N A 3/ 4, N A 4, N A 4/ 5, N A 5, N A 5/ 6, N A 6, N A 6/ 7, N A 7, N A 7/ 8, N A 8, N A 8E. In this example, N A 1, N A 2, N A 3, N A 4, N A 5, N A 6, N A 7, and N A 8 would be the 46 cm specimens that would be used for coating, testing, and baseline DA measurement, with the remainder being end pieces or 10 cm interior segments to be archived for possible future testing. If, for example, a segment of wood between N A 3 and N A 4 was deemed to be defective, it would be labeled as N A 3/ 4 D. The specimen identification example presented above is shown in Figure 2 2. Specimen IDs will be cross referenced with coated specimens as described in subsequent subsections. ( Section Page) 2 3 of 14 Draft  Revision 1.2 March 2003 Figure 2 2. Example Specimen Identification Scheme All samples will be identified on one cut end or uncut edge with its identification code, as well as with its " top" side ( which shall be consistent for all samples taken from a given board), both using permanent marker. Alternatively, the identification code may be correlated to a bar code affixed to one cut end of a specimen. Documentation will be kept identifying all numbered specimens taken from each original length of CCA treated wood.

After cutting and identification marking, both sides of each specimen will be rinsed with tap water using a light setting of a pressure washer. Rinsate water generated by each source ( new, untreated) will be collected, preserved using nitric acid, and stored in TFE or PFA vessels in case needed for future subsampling and analysis. Additionally, a sample of the unused tap water used to rinse the boards will be collected, preserved, and archived similarly. The specimens will then be stored in an indoor, temperature, and humidity monitored and controlled space prior to coating and testing. The same space shall also be fitted with custom built racks to hold coated specimens for coating curing/ drying. Temperature will be controlled to be between 15 and 25 º C (~ 60 80 º F). Relative humidity will be controlled to be between 25 and 75%. Temperature and relative humidity will be measured and recorded at least twice per day.

Within the temperature and humidity controlled room, 46 cm specimens will be allowed to dry, housed under a larger frame supporting a cover consisting of a continuous length of plastic sheeting or cloth to prevent deposition onto the specimens. One end of the covered drying assembly will be outfitted with a forced air high efficiency particulate air ( HEPA) filter to improve circulation of clean air through the drying rack assembly ( to be used to cure coated samples) and specimens. The other end of the covered drying rack assembly will contain an opening ( door) to allow filtered air to exit the covered drying area. The assembly cover will be constructed of untreated wood framing and plastic sheeting and the assembly shall be built within adequately vented EPA high bay space. The floor under the cover shall be thoroughly cleaned after construction of the area to prevent resuspension of dust or construction debris during testing. The drying rack assembly and housing shall allow for:

  At least 18 inches of separation between the floor and specimen and specimen and cover.

  At least 18 inches of separation between ends and edges of specimens and cover.

  At least 1 inch of separation between specimens on the rack ( Section Page) 2 4 of 14 Draft  Revision 1.2 March 2003   Only one level of specimens ( i. e., no stacking)

  Adequate access by laboratory staff Specimens will be allowed to equilibrate with storage conditions for:

  at least 7 days, and   until moisture content is less than 20% ( wet weight basis), or after 21 days, whichever occurs first Moisture content will be measured on at least one 10 cm interior specimen per board, as often as necessary to ensure that the above criteria have been achieved. Additionally, moisture content will be measured on the same 10 cm specimens after the 7 day testing/ curing period to control for changes in moisture over the course of the test. These 10 cm interior specimens used for testing shall be stored within the enclosure described above similarly to the 46 cm specimens. Care must be taken to ensure that samples for measuring moisture content are taken from similar areas on the 10 cm specimens ( using, for example, a coring drill bit), so that moisture content over time can be compared. Moisture content will be measured as described in section 3.0.

Each specimen to be tested will have two, 2 inch, 6d or 8d finishing nails or small screws driven approximately ¾ inch into each cut end, placed with at least 1 inch separating each nail from the edges of the specimen, ½ inch separating each nail from the top and bottom faces of the specimen, and 2 inches separating each nail from the other. Screws or nails should not contain appreciable levels of arsenic and/ or chromium ( as chromium analyses may be conducted depending on available project resources). As such, two samples of the screws or nails proposed for use will first be extracted, and then analyzed in accordance with the methods specified for the wipe samples in Section 3.0.

Three specimens will be used for each selected coating, for a total of 90 specimens. The three specimens for each coating shall be taken at random locations from separate boards. Three untreated wood specimens will be used, left uncoated, as controls.

Individual baseline values of DA will be determined for each specimen to be coated and tested. The baseline DA of a specimen will be determined by averaging the DAs from the two adjacent 46 cm specimens on either side of the test specimen. The adjacent specimens will be archived uncoated after sampling ( and thus not used in any further testing). This step will avoid any data analysis and coating efficacy complications that may arise from coating the pre rubbed specimens.

2.2 Selection of Coatings for Screening The selection of coatings to be tested for efficacy is obviously critical and because of the number and variety of potentially applicable coatings on the market and the budgetary constraints of testing programs, this is likely to be a weakness of any such evaluation study to be conducted. The original plan for this project did not explicitly include a screening phase for coatings but the project team identified the screening test to be a ( Section Page) 2 5 of 14 Draft  Revision 1.2 March 2003 needed addition despite its limitations. To put the task into perspective, the goal of selecting coatings is to distill a universe of hundreds or even thousands of potentially applicable coatings to approximately ten to be fully tested via the weathering testing protocol. While well beyond the scope of this project, a thorough review of available coatings and their formulations and application techniques is needed to more completely understand the characteristics that impact surface concentrations of CCA treated wood analytes ( this could include more focused involvement by the wood coating industry). For this project however, the approach is to gather basic formulation and, to a lesser extent, application information, on a number of products with reasonable availability to the project team in North Carolina ( project site). This survey of available products was primarily conducted using internet searches and visits to local retail hardware and home improvement stores. These searches allowed for the development of a " master list" of specific products. This master list of potential products includes approximately 125 entries, including some that are broadly intended for outdoor wood use, as well as some products that are not necessarily intended for such uses, but that were identified by the project team as promising.

The list is in spreadsheet format and includes fields for manufacturer, product name, product type, cover, base, and main ingredient. It must be noted that there are various levels of classifications for coatings and that no single categorization standard can be applied to adequately categorize each and every product identified. Additionally, many products overlap categories. Nevertheless, in order to communicate effectively about the products tested, and maintain the confidentiality of product names, an attempt has been made to classify the products considered. As such, several main descriptors of coatings were used. These include: base ( oil vs. water), cover ( clear, semi transparent, opaque), and product type, which for this exercise, has been broken out into the following: paints, primers, sealants, stains, and other. The " other" category embodies a vast variety of products, including, but not limited to: varnishes, epoxies, lead encapsulation products, rubber coatings, fiberglass coatings, elastic vinyl coatings, preservatives, and other plastic coatings. Additional classification descriptors include: ingredients and surface ( penetrating vs. film forming).

The master list of about 125 products includes roughly 25 paints, 5 primers, 20 wood sealants, 50 stains, and 25 " other" products. Out of the paints, approximately 2/ 3 are water based with the balance oil based. Likewise, for the primers, 2 are oil based while 3 are water based. For the wood sealants and stains, most products are oil based with a handful water based. The cover for each of these product types is quite variable, and in fact, one " type" of coating may be available in a range of covers from clear to opaque ( note that existing research on coating efficacy suggests that opaque coatings may be more effective). Likewise, the surface for each of the listed product types may also be variable, depending on the product ( note that existing research on coating efficacy suggests that film forming coatings may be more effective, though they may also be more subject to deterioration via abrasion). Paints and primers will almost invariably be considered filmforming products, while sealants, stains, and certainly " other" products may be penetrating or film forming depending on their specific formulation.

From the master list, 35 distinct products have been selected based on the following criteria:

  Products that are commonly used for outdoor wood treatment, with preference given to those that either ( Section Page) 2 6 of 14 Draft  Revision 1.2 March 2003 have been tested and/ or identified as promising by other researchers and to those that have performed well in durability testing by Consumer Reports magazine.

  Products that are typically not used for outdoor wood/ deck treatment, but that have been identified as having the potential to meet efficacy objectives.

  Products that are relatively straightforward for consumers to apply ( i. e., products that require professional application have been disqualified). Additionally, multiple product systems have generally not been considered, although it is recognized that some common products ( e. g., paints) may require the application of another product as a primer. These situations will be considered on a case by case basis as also indicated in section 2.3.

Table 2 1 generically ( to preserve required product confidentiality) lists and characterizes 35 products selected for consideration for the screening study. Since it is likely that several products may be unavailable or require unusual or difficult coating methods not known at this time, it is anticipated that only 30 products will be screening tested.

Table 2 1. Selected Products for Screening Study # Product Type Base Cover Comments 1 Paint Oil Opaque Silicone, alkyd. Very durable marine finish.

2 Paint Oil Opaque Silicone, alkyd. Very durable marine finish.

3 Paint Water Opaque Acrylic latex. Designed for porches and floors.

4 Paint Water Opaque Acrylic latex. Exterior.

5 Paint Water Opaque Acrylic latex. Exterior.

6 Paint Oil Opaque Alkyd polyurethane. Designed for porches and floors.

7 Paint Oil Opaque Alkyd polyurethane. Designed for porches and floors.

8 Paint Oil Opaque Alkyd exterior paint product 9 Primer Water Opaque Common latex primer.

10 Sealant Oil Semi Common deck product.

11 Sealant Oil Clear Common deck product.

12 Sealant Oil Clear Common deck product.

13 Sealant Oil Clear Acrylic/ alkyd/ urethane, for decks.

14 Sealant Water Clear Common deck product.

15 Sealant Oil/ Water Semi Water, linseed oil, tung oil.

16 Stain Oil Opaque Gilsonite. Tar product.

17 Stain Opaque Teflon acrylic.

18 Stain Water Semi Acrylic latex.

19 Stain Water Semi Common deck product. Acrylic. ( Section Page) 2 7 of 14 Draft  Revision 1.2 March 2003 # Product Type Base Cover Comments 20 Stain Oil Semi Common oil alkyd deck product.

21 Stain Oil Clear Common oil alkyd deck product.

22 Stain Oil Semi Contains UV absorber.

23 Stain Oil Semi Common oil alkyd resin deck product with linseed oil.

24 Stain Oil Semi Oil alkyd/ acrylic for deck, fence, and siding.

25 Stain Oil Semi Oil alkyd/ acrylic for decks.

26 Stain Oil Semi Oil acrylic.

27 Stain Oil Semi Oil resin for external wood products.

28 Stain Oil Opaque Acrylic color deck stain.

29 Stain Water Opaque Common acrylic latex deck product.

30 Other Spar varnish.

31 Other Interpolymer network coating ( IPN).

32 Other Urethane. May require professional application.

33 Other Elastic vinyl. Designed for CCA encapsulation.

34 Other Polymer. Designed for CCA encapsulation.

35 Other Acrylic mastic. Designed for lead encapsulation.

2.3 Coating Application Coatings shall be applied to fully cover the top faces of CCA treated wood specimens in accordance with manufacturers' recommendations with appropriate adaptations to the laboratory environment and this test plan. In cases where a choice of application method ( e. g., spray or brush) is offered, brush application will be employed. Care shall be taken to not apply coatings to bottom faces of specimens, as the bottom faces of some specimens may be used to measure DA if questions arise as to the accuracy of baseline DA values measured as previously described. Coating application will take place either directly on the drying rack or individually under a fume hood, on a laboratory bench top, or other appropriate location. Care shall be taken to ensure that top and bottom faces of the specimen are not allowed to contact other surfaces ( i. e., all handling shall be done using end nails and application must take place while supporting specimen by the end nails on the drying rack or other smaller rack). By preserving the bottom faces of specimens, DA may be measured via wipe sampling of the bottom faces if necessary.

It is possible that the application recommendations for certain products ( paints for example) will include some surface preparation, which may include the use of another product ( e. g., a primer). In such cases, the applicability of such a product for use on commonly contacted outdoor CCA treated wood structures will be reconsidered. If it is determined that the product is not applicable, it will be removed from consideration in the study. If the product continues to be considered applicable ( again the primer paint system is a good ( Section Page) 2 8 of 14 Draft  Revision 1.2 March 2003 example), the project team will consider modified application techniques on a case by case basis while also making an effort to equalize the application conditions for similar products.

The cut ends of each specimen shall be coated with the coating being tested. However, the cut ends shall only be coated after the top surface is fully coated, for the following reasons:

  the cut ( cross grain) ends of CCA wood specimens are expected to contain higher DA concentrations than the faces and edges and brushing them may redistribute relatively large amounts of analytes to faces to be wipe sampled, and   in general, the cut ends are not going to be explicitly coated by consumers in everyday practice ( in this testing, the percentage of end cuts to faces is much greater than in the construction of typical outdoor CCA wood structures).

Consideration was given to coating ends with a common product ( e. g., a Liquid Nails coating which has been used in previous leaching studies on CCA treated wood). However, it was decided that use of a single coating for both the top face and ends was preferable. As implied, it is possible that the method of applying coatings may contribute to DA levels. For example, applying coating using a brush may cause physical displacement of dislodged analytes and subsequent mixing with the applied coating and/ or displacement of the analyte to the finished coated surface. As such, a pre qualification study to evaluate coating application techniques was considered for inclusion as part of this test plan, but later determined to be outside of the scope and resource allocation available for this project.

Coated specimens will be allowed to dry/ cure on the drying racks, onto which specimens can be supported on either end by allowing the two nails in each end to rest on parallel rails, such that the specimen is oriented horizontally, with the " top" face pointed upwards. An unaltered aliquot of each coating will be retained under refrigeration for future analyses if/ as needed, as will separate composite samples of each leftover coating used to coat the new and aged specimens ( comparison of the results of these samples can provide some insight as to the potential of brush application technique to redistribute analytes, identified as a concern above).

Individual/ dedicated brushes will be used for each coating/ wood type combination. Brushes will be prepared for initial coating application by cleaning in accordance with brush manufacturer's recommendations. Additional preparations will be conducted only in accordance with coating manufacturer's recommendations. Between specimens and after all coatings have been applied to a given group of specimens, brushes will again be cleaned in accordance with the brush/ coating manufacturers' recommendations. Used brushes will be cleaned and then archived by storing in accordance with brush manufacturer's recommendations. Fresh cleaning solution will used for each coating. Prior to procurement of all of the brushes required for this study, two samples of deionized water used to wash two separate brushes ( after following brush manufacturer's specified cleaning/ preparation methods, if any) will be sampled and analyzed for total arsenic. Bristles from a clean, unused brush and an aliquot of the cleaner used on the brushes will be archived under refrigeration for possible future total arsenic analyses. ( Section Page) 2 9 of 14 Draft  Revision 1.2 March 2003 Separate aliquots of coating liquid will be used for each specimen to be coated with a given coating, in order to prevent cross contamination of coating liquid by re dipping the brush applicator. Separate aliquots of coating liquid will be poured into disposable plastic trays, which will be discarded after application of that coating to each given specimen. Coating remaining in the trays will be composited so that one sample is retained for each coating/ wood type. These samples will be archived for possible future analyses.

Spray coating will be used only if explicitly recommended over brushing by the manufacturer. Spraying, if employed, will be conducted by pouring coating into a manual sprayer. A new sprayer will be dedicated to each coating. Coating remaining in the sprayer will be collected into one sample for each coating. These samples will be archived for possible future analyses. Coatings having recommended application methods that have not been discussed here will be similarly managed on a coating by coating basis.

Application procedures and any notable observations will be documented for each coating. Furthermore, coatings will be retained/ archived ( stored under manufacturer recommended conditions) for future analysis if necessary. Staff performing coating and monthly wipe sampling will not be aware of the specific coating being applied or sampled in order to prevent real or perceived bias.

Coating application will be assessed in two ways: gravimetrically, and via measurement of wet film thickness. Gravimetric assessment will involve measuring the applied mass of coating on each specimen. Applied mass will be measured gravimetrically in two ways: 1) calculated as the difference in specimen mass before and after coating and 2) calculated as the difference between the starting coating aliquot and brush and the postcoating aliquot and brush weights. Neither method is ideal, as some loss of coating mass due to volatilization is expected even on the relatively short times necessary to apply a coating. Additionally, all specimens will be weighed at the end of the 7 day curing at the time of final wipe sampling ( for determination of dry coating weight) in addition to pre and post application. Corrections for moisture content instability can be made using the results of moisture analyses previously described, if necessary. Wet film thickness will be measured on film forming coatings using handheld wet film thickness gauges, as manufactured by Paul N. Gardner Co., Inc. or equal. The gauges are disposable and will be discarded after each measurement, after which a new gauge will be used on the next coated specimen. A summary of the proposed parameters to be measured either directly or by calculation is provided in Table 2 2. ( Section Page) 2 10 of 14 Draft  Revision 1.2 March 2003 Table 2 2. Summary of Coating Application Measurements Description Acronym Measurement or Calculation Uncoated specimen weight USW Weigh specimen prior to coating Wet coated specimen weight WCSW Weigh specimen immediately post coating Dry coated specimen weight DCSW Weigh specimen 7 days after coating Starting coating weight SCW Weigh coating aliquot and brush prior to coating Ending coating weight ECW Weigh coating aliquot and brush after coating Wet coating weight WCW WCW = WCSW   USW Dry coating weight DCW DCW = DCSW   USW Applied coating weight ACW ACW = ECW   SCW Wet Film Thickness WFM Measured directly using disposable gauge ( only for film formers)

Costs of coatings applied and approximate level of effort expended to apply coatings will be recorded for each.

2.4 Sample Schedule In accordance with the discussion presented in preceding sections, a schedule of test specimens is provided as Table 2 3, where coatings are numbered 1 to 30 and numbers indicted in subsequent columns are equal to the number of specimens to be tested. Note that specific coatings are not identified in part to retain confidentiality.

Table 2 3. Schedule of Specimens Coating ID Non CCA New CCA wood Remarks UC ( a) 3 As needed to establish baseline Uncoated wood 1 0 3 2 0 3 3 0 3 4 0 3 5 0 3 6 0 3 7 0 3 8 0 3 9 0 3 Refer to Table 2 1 for coating info. ( Section Page) 2 11 of 14 Draft  Revision 1.2 March 2003 Coating ID Non CCA New CCA wood Remarks 10 0 3 11 0 3 12 0 3 13 0 3 14 0 3 15 0 3 16 0 3 17 0 3 18 0 3 19 0 3 20 0 3 21 0 3 22 0 3 23 0 3 24 0 3 25 0 3 26 0 3 27 0 3 28 0 3 29 0 3 30 0 3 ( a) UC = Uncoated A table to match specimen identification code with coating/ sample ID will be prepared after randomized selection of specimens is conducted.

Other miscellaneous samples to be archived and/ or analyzed are listed in Table 2 4.

Unless otherwise stated, all samples indicated in Table 2 4 to be archived shall be held at least until the report of results for the screening study has been finalized. Longer archiving times for certain samples may be warranted upon further consideration. Liquid samples shall be preserved using nitric acid prior to archiving. ( Section Page) 2 12 of 14 Draft  Revision 1.2 March 2003 Table 2 4. Miscellaneous Samples to be Collected during Screening Study Sample Description # Samples to be Analyzed # Samples to be Archived Tap water used to wash wood N/ A 1 Rinsate water from wood washing N/ A 1 for each wood type Finishing nails 2 ( extracted in nitric) Retain nail samples Brush bristles N/ A Retain one unused brush Brush wash water 2 N/ A Brush cleaning solution N/ A Retain aliquot of cleaner Unaltered coating N/ A 1 for each coating Leftover brush applied coating N/ A 1 for each coating/ wood type Wood 2 per board Leftover wood to be stored 2.5 Test Conditions All coated specimens shall be allowed to dry/ cure within/ on the specimen drying rack assembly, and under the same process conditions, as previously described. Drying/ curing/ holding shall take place for at least 7 days, after which wipe sampling will be conducted on each coated surface and on control surfaces, as has been described.

2.6 Sampling 2.6.1 Wipe Sampling Wipe sampling shall be conducted and samples prepared and analyzed in accordance with the methods established in section 3.0. Wipe samples shall be taken from the top faces of each specimen after 7 days of holding, as described above. The length of wipe shall be consistent between specimens at 43 cm ( 17"). The back end of the wipe backstroke and the front end of the wipe frontstroke shall be identified to define the area wiped. The location of the wipe stroke shall then be identified on the specimen by marking its forward and backward range on both edges of the specimen using permanent marker.

During sampling, again, it must be ensured that the faces of the specimen are not allowed to contact any other surfaces: handling and holding must be via the end nails in the cut ends of each specimen. A " wipe sampling rack" may need to be constructed to hold the wood specimens in place during wipe sampling. After sampling, specimens shall be returned to the drying rack top face up. Specimens shall be subsequently held in this manner until the results of the screening study have been received, validated, and analyzed, with selections for weathering testing made.

Coatings will be ranked based upon initial DA reduction and ten high ranking coatings will be selected for weathering testing. The screening test specimens for the selected coatings will be retained for continued ( Section Page) 2 13 of 14 Draft  Revision 1.2 March 2003 monthly DA measurement during the weathering tests, as non weathered controls. These samples will allow for the monitoring of DA changes resulting from abrasion ( from wipe sampling) without the potentially confounding effects of weathering.

2.6.2 Wood Sampling Two, 10 cm, interior wood specimens from each board shall be sampled, digested, and analyzed for total arsenic in accordance with the procedures described in section 3.0. ( Section Page) 2 14 of 14 Draft  Revision 1.2 March 2003 This page intentionally left blank. ( Section Page) 3 1 of 4 Draft  Revision 1.2 March 2003 3 Testing and Measurement Protocols Note that this section may be modified as results of on going prequalification testing of the sampling techniques and laboratory analytical methods are processed.

3.1 Wipe Sampling Wipe sampling will be conducted in general accordance with the method developed and documented by CPSC, using the wipe sampling device constructed by CPSC.

Wipe samples will be directly transferred to extraction or digestion vessels with no intermediate sample containers employed.

3.2 Sample Preparation ( Extraction/ Digestion)

Wipe samples will be prepared for analysis using techniques similar top those employed by other researchers, including CPSC and Stilwell, et al., adapted for use with laboratory equipment available for this project. As such, a microwave assisted extraction procedure comparable to that used in prior studies, and similar to SW 846 Methods 3051 and 3052 shall be employed. Steps involved in the extraction procedure are outlined following:

  All digestion vessels and volumetric glassware will be prepared by acid cleaning. Vessels will be cleaned by leaching with hot 1: 1 nitric acid for a minimum of two hours, then rinsed with deionized water and dried in a clean environment.

  The wipe sample will be introduced to the digestion vessel and 40 ± 0.1 mL 10% nitric acid added slowly to the open vessel to allow for pre extraction. Once any initial reaction has ceased, the sample will be capped and introduced into the microwave system. Using the CEM Corp. microwave system, 11 samples may be digested in a single batch, with the twelfth vessel filled with only the acid solution to be used as a temperature/ pressure control.

  Using temperature/ pressure curves developed under other research programs for APPCD as a guide, the samples will be reacted at 60 ± 5 º C for a minimum of 1 hour.

  After microwave extraction, sample vessels will be allowed to cool for a minimum of 5 min. prior to removing them from the system. After being allowed to cool to room temperature, each vessel will be checked to ensure that they have retained a seal ( samples that show signs of pressure relief will be discarded).

  Cooled samples will be carefully uncapped, the contents transferred quantitatively to a clean 125 mL volumetric flask, using a clean glass stir rod to aid in squeezing liquid from the wipe.

  Steps 2 5 will be repeated twice more, transferring the successive extraction liquid aliquots to the same volumetric flask. After the third iteration, the flask will be filled to the mark with deionized water. Approximately half the final liquid volume will be transferred to a PTFE container, sealed and prepared ( Section Page) 3 2 of 4 Draft  Revision 1.2 March 2003 for shipment to the contract laboratory. The remainder will be transferred to a PTFE container, sealed and archived.

  Per the specified analytical method, the hold time for all metals other than mercury is 6 months, and samples shall be stored at 4 degrees C until analysis. Sample containers shall be of TFE or PFA in accordance with the Method specified in Section 3.3.

3.3 Analysis by ICP MS Analysis for total arsenic shall be conducted by STL in Savannah, GA using a modification of SW 846 Method 6020 ( ICP MS). STL utilizes ICP MS for arsenic analysis, modifying the technique to utilize hydrogen plasma, rather than argon as traditionally performed. This modification eliminates concerns over the formation of Ar40Cl35, which can create a positive bias when measuring As. STL is an accredited laboratory, participating in the CLP program, as well as numerous state programs. In addition to obtaining specific information on laboratory qualifications, each sample set submitted will include blind blanks and spiked samples, allowing for continued monitoring of laboratory performance.

3.4 Preparation and Analysis of Miscellaneous Samples The miscellaneous samples to be analyzed, listed in Table 2 4, including finishing nails, and brush wash water ( which may contain some oil phase brush cleaning solution) shall all be prepared and analyzed in accordance with the procedures specified for the wipe samples in Sections 3.2 and 3.3, or appropriate standard methods and/ or applicable modifications. Samples will be digested until they are visually homogeneous, except for the finishing nail samples, which will only be digested ( actually, extracted) for the time used to digest these other samples. Remaining solids ( nails) will be removed from the samples prior to shipping to the analytical laboratory.

3.5 Analysis of Wood Samples Wood samples will be analyzed for arsenic and chromium content using ICP MS. Wood borings and/ or ground wood of known weight will be digested using the same protocol defined earlier for the wipe samples. This procedure is consistent with American Wood Preservers Association ( AWPA) Standard A7 93 ( microwave assisted nitric acid digestion). Digestates will be analyzed by ICP MS in a manner identical to that described for the wipe samples ( SW 846 Method 6020), consistent with AWPA Standard A21 00.

3.6 Archiving of ICP MS Samples Analysis of the samples by ICP MS will consume only a fraction of the submitted sample. Remaining sample volume will be archived by the contract laboratory until results are confirmed, then subsequently returned to ARCADIS for archiving until the completion of the project. Samples will be archived by storing them in their original sample containers, as shipped to the contract laboratory. Alternately, samples may be archived by splitting samples to be sent to the contract analytical laboratory before shipment. Because nitric acid is used ( Section Page) 3 3 of 4 Draft  Revision 1.2 March 2003 in the extraction/ digestion steps, the addition of an additional preservative is not required to archive these samples. Water samples ( not extracts or digestates) will require the addition of nitric acid as a preservative prior to archiving.

3.7 Moisture Analysis of Wood Specimens The moisture content of wood samples will be determined by ASTM Method D4442 ( Primary Oven Drying). A small representative sample will be weighed prior to drying overnight at 103 ° C in a forced air oven. After 24 hours, the sample will be cooled in a dessicator, weighed, then returned to the oven. The process will be repeated until weight changes between weighings is ± 5%. Moisture content may also be screened using a hand held meter, but only after the technique has been qualified and calibrated via side by side testing with the drying oven technique, ASTM D4442. ( Section Page) 3 4 of 4 Draft  Revision 1.2 March 2003 This page intentionally left blank. ( Section Page) 4 1 of 2 Draft  Revision 1.2 March 2003 4 QA/ QC Checks Two adjacent uncoated control specimens will be tested alongside coated faces for each specimen used. This will yield over 90 samples for controls to be used to establish baseline DA. The results of the wipe samples from these specimens will be used to establish baseline ( i. e., uncoated) DA for each specimen, as well as to establish statistical information about the variability in the complete set of specimens used. Additionally, three non coated, non CCA wood specimens will be handled in the same way ( with efforts to avoid crosscontamination with CCA wood specimens, of course) as the treated samples in order to generate blank control wipe samples and assess the extent of study design/ method interferences, etc. Furthermore, a variety of control samples are proposed, as previously indicated in Table 2 4.

Each set of digested wipe samples submitted to the subcontract analytical laboratory will include an additional blind blanks, one set of three concentration spiked samples, and 5% duplicates to assess laboratory performance. So, for example, assuming that a total of 200 wipe samples will be taken for this study, shipped to the subcontract laboratory in a single batch, the following additional samples will be included:

  one ( 1) blank sample consisting of digestion fluid only   one ( 1) digestion fluid sample spiked to 1.0 µ g/ l ( 0.015 µ g in 15 ml digestion fluid) with As   one ( 1) digestion fluid samples spiked to 50 µ g/ l ( 0.75 µ g in 15 ml digestion fluid) with As   one ( 1) digestion fluid samples spiked to 1000 µ g/ l ( 15 µ g in 15 ml digestion fluid) with As   ten ( 10) duplicates ( selected split samples of digested wipes from actual samples generated)

Furthermore, the subcontract analytical laboratory will conduct analyses on project specific matrix spikes and matrix spike duplicates ( MS/ MSD) for each analyte, in addition to equipment blanks run on each batch of samples analyzed for this project. The laboratory will also have chromium and copper analytical results available for all samples ( provided QC checks are acceptable) if these results are ever desired and the project budget allows their procurement. Section 4 Draft  Revision 1.2 March 2003 Page 4 2 of 2 This page intentionally left blank. ( Section Page) 5 1 of 4 Draft  Revision 1.2 March 2003 5 Data Reductions and Reporting 5.1 Data Reduction 5.1.1 Calculation of DA from Extraction/ Digestion Fluid Concentrations Raw data from the subcontract analytical laboratory will be reported in units of µ g/ l and will represent the mass of analyte per unit volume of digestion/ extraction solution sent to the laboratory. For standard wipe sample results, data will be reduced in order to characterize the mass of analyte per unit surface area wipe sampled, in units of µ g/ cm2, using the following equation:

A V C C DF DA 1000 × = ( Equation 5.1)

Where: CDA = DA of a sample ( µ g/ cm2)

CDF = Concentration of As in digestion fluid ( µ g/ l)

V = Volume of digestion fluid sample submitted for analysis ( ml)

A = Area of wiped surface ( cm2)

5.1.2 Calculation of Percent Reduction of DA Raw data from the subcontract analytical laboratory will be reported in units of µ g/ l and will be converted to DA, in units of µ g/ cm2, per the calculation described in section 5.1.1. Percent reduction will be calculated for each sample using the following equation:

100 ×   =

initial final initial DA C C C R ( Equation 5.2)

Where: RDA = Reduction in DA (%)

Cinitial = Average background DA ( µ g/ cm2)

Cfinal = Final DA ( µ g/ cm2) ( Section Page) 5 2 of 4 Draft  Revision 1.2 March 2003 5.1.3 Assessing DQI Goals In general, data quality indicator goals are based on either ( 1) published specifications, ( 2) related quantities ( e. g., drift for precision), or ( 3) engineering judgment based on previous experience with similar systems.

Precision In order to evaluate the precision of a measurement, it is necessary to make replicate measurements of a relatively unchanging parameter. Precision can then be expressed as the relative standard deviation ( RSD) of the replicated measurement. RSD is calculated using Equation 5.4 and is typically expressed in percent. Precision will be calculated using the results of duplicates specified as control samples.

RSD = ( Y  Y )

n  1 Y i= 1 n 2 i

( Equation 5.4)

Accuracy/ Bias The accuracy of a measurement is expressed in terms of percent bias, or, in some cases recommended by the EPA standard methods, in terms of absolute difference. Percent bias is defined as:

Percent Bias = R  C C x 100 ( Equation 5.5)

Where: R = instrument response or reading C = calibration standard or audit sample value Accuracy can take on the units of the measurement, it can be expressed as a percentage of the average measurement, or it can be expressed as a percentage of the measurement range. Accuracy will be calculated using the results of matrix spike sample analyses as described for QA/ QC.

Completeness The ratio of the number of valid data points taken to the total number of data points planned is defined as data completeness. All measured data are recorded electronically or on data sheets or project notebooks. ( Section Page) 5 3 of 4 Draft  Revision 1.2 March 2003 5.2 Data Validation The subcontract laboratory will be required to submit calibration and QC data along with each data package. ARCADIS QA Officer, Libby Nessley will validate at least 10 percent of reported data by reviewing raw data and data calculations. In addition, at least one spiked performance evaluation audit ( PEA) sample for arsenic will be submitted blind to the laboratory with each sample set. Reported results for this PEA sample must agree within 10 percent with the known value. Failure to agree will result in the entire data set being flagged for re evaluation up to and including repeat analysis.

5.3 Data Reporting For each series of tests, raw and reduced data shall be reported, as applicable. Coating efficacy results will be expressed in terms of DA ( µ g/ cm2) and percent reduction.

All data validation criteria will be reported along with the associated data. In addition to reporting the data, results will be discussed and recommendations for coatings to be tested in the weathering study offered via narrative text in a test report. This report will be used to support the development of and append the test plan/ QAPPs for future phases of this project including the " Weathering Study" ( i. e., the overall test plan/ QAPP). ( Section Page) 5 4 of 4 Draft  Revision 1.2 March 2003 This page intentionally left blank.


28218 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices EPA is providing an opportunity, through this notice, for interested parties to provide written comments and input to the Agency on the risk assessments or risk mitigation proposals for the pesticide specified in this notice. Such comments and proposals could address ideas on how to manage potential residential cancer risks from the use of MGK   Repellent 326 as an insect repellent, for example, the feasibility of using a lower percent active ingredient in final products containing MGK   Repellent 326. Comments could also address the availability of additional data to further refine the risk assessments, such as information on the extent and duration of use of products containing MGK   Repellent 326. Last, comments could address the Agency's risk assessment methodologies and assumptions applied to this specific chemical. Comments should be limited to issues raised within the risk assessment and associated documents. All comments should be submitted by [ insert date 60 days after date of publication in theFederal Register] using the methods in Unit I. of the SUPPLEMENTARY INFORMATION. Comments will become part of the Agency record for MGK   Repellent 326.

List of Subjects Environmental protection, Chemicals, MGK   Repellent 326, Pesticides and pest.

Dated: May 14, 2003. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

[ FR Doc. 03   13006 Filed 5   22   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0172; FRL   7307   5]

Flonicamid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0172, must be received on or before June 23, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6502]; e mail address: sibold. ann@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are a commercial grower of food or feed crops. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. EPA Docket. EPA has established an official public docket for this action under docket ID number OPP   2003   0172. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305     5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28219 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties, or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment, will be included, as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select`` search,'' and then key in docket ID number OPP   2003   0172. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2003   0172. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2003   0172. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0172. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed, except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28220 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: May 13, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by ISK Bioscience Corporation, and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

ISK Biosciences Corporation PP 3F6552 EPA has received a pesticide petition [ 3F6552] from ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio, 44077, proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing tolerances for the combined residues of the insecticide flonicamid, ( N cyanomethyl 4 trifluoromethylnicotinamide) and its metabolites, TFNA, ( 4 trifluoromethylnicotinic acid), TFNAAM ( 4 trifluoromethylnicotinamide) and TFNG, ( N( 4 trifluoromethylnicotinoyl) glycine) in or on the raw agricultural commodities: Celery, at 1.2 parts per million ( ppm); cotton, at 0.5 ppm; cotton, gin trash, at 6.0 ppm; cotton, hulls, at 1.0 ppm; cotton, meal, at 1.0 ppm; fruit, pome, group 11, at 0.2 ppm; fruit, stone, group 12, except plum and fresh prune plum, at 0.7 ppm; lettuce, head, at 1.0 ppm; lettuce, leaf, at 4.0 ppm; plum, at 0.1 ppm; potato, at 0.2 ppm; potato, flakes, at 0.4 ppm; prune, fresh, at 0.1; spinach, at 9.0 ppm; tomato, paste, at 2.0 ppm; tomato, puree, at 0.5 ppm; vegetable, cucurbit, group 9, at 0.4 ppm; vegetable, fruiting, group 8, at 0.4 ppm; by establishing tolerances for the combined residues of the insecticide flonicamid, ( N cyanomethyl 4 trifluoromethylnicotinamide) and its metabolite TFNA AM, ( 4 trifluoromethylnicotinamide) in animal tissues and poultry meat byproducts: Cattle, fat, at 0.01 ppm; cattle, meat, at 0.04 ppm; eggs, at 0.02 ppm; goat, fat, at 0.01 ppm; goat, meat, at 0.04 ppm; hog, fat, at 0.01; hog, meat, at 0.01 ppm; horse, fat, at 0.01 ppm; horse, meat, at 0.04 ppm; milk, at 0.02 ppm; poultry, fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, meat byproducts, at 0.01 ppm; sheep, fat, at 0.01 ppm; sheep, meat, at 0.04 ppm; by establishing tolerances for the combined residues of the insecticide flonicamid, ( Ncyanomethyl 4 trifluoromethylnicotinamide) and its metabolites TFNA, ( 4 trifluoromethylnicotinic acid) and TFNA AM, ( 4 trifluoromethylnicotinamide) in the animal meat byproducts: cattle, meat byproducts, at 0.06 ppm; goat, meat byproducts, at 0.06 ppm; hog, meat byproducts, at 0.01 ppm; horse, meat byproducts, at 0.06 ppm; and sheep, meat byproducts, at 0.06 ppm.

A. Residue Chemistry 1. Plant metabolism. Wheat, potato and peach metabolism studies were conducted using [ 14C] pyridylflonicamid The metabolic profile was similar for all three matrices. The major metabolites for the various crops were: TFNA in peach, TFNA and TFNG in potato, and TFNG in wheat. The metabolism of flonicamid in plants shows, the main pathway of metabolism involves hydrolysis of  CN and CONH2 functional groups in the molecule. The metabolism of flonicamid in plants is well understood. 2. Analytical method. Analytical methodology has been developed to determine the residues of flonicamid and its three major plant metabolites, TFNA, TFNG, and TFNA AM in various crops. The residue analytical method for the majority of crops includes an initial extraction with acetonitrile ( ACN)/ deionized ( DI) water, followed by a liquid liquid partition with ethyl acetate. The residue method for wheat straw is similar, except that a C18 solid phase extraction ( SPE) is added prior to the liquid liquid partition. The final sample solution is quantitated using a liquid chromatograph ( LC) equipped with a reverse phase column and a triple quadruple mass spectrometer ( MS/ MS). 3. Magnitude of residues. Residue data were collected on various crops and crop groups during field trials. Maximum total residues for cucurbits ( total of 17 field trials) ranged from 0.164 ( summer squash) to 0.333 ppm ( cucumber). Maximum total residues for stone fruits ( total of 21 field trials) ranged from 0.092 ( plum) to 0.520 ppm ( cherry). Maximum total residues for pome fruits ( total of 18 field trials) ranged from 0.054 ( pears) to 0.169 ppm ( apples). Maximum total residues for fruiting vegetables ( total of 21 field trials) ranged from 0.195 ( bell pepper) to 0.290 ppm ( non bell pepper). Maximum total residues for leafy vegetables ( total of 24 field trials) ranged from 0.049 ( head lettuce without wrappers) to 7.978 ppm ( spinach). Maximum total residues for cottonseed with linters ( 12 field trials) were 0.343 and for gin trash were 5.001 ppm. Maximum total residues for potatoes ( total of 17 field trials) were 0.119 ppm.

B. Toxicological Profile 1. Acute toxicity. A battery of acute toxicity studies was conducted which placed flonicamid technical in Toxicity Category III for oral lethal dose ( LD) 50, Category IV for dermal LD50, inhalation LC50, dermal irritation, and eye irritation. Flonicamid technical is not a dermal sensitizer. In an acute neurotoxicity study, the no observed adverse effect levels ( NOAELs) for neurotoxicity were 600 milligrams/ kilogram ( mg/ kg) in males and 1,000 mg/ kg in female ( highest doses tested). The systemic NOAELs were 600 mg/ kg in males and 300 mg/ kg in females. 2. Genotoxicty. Flonicamid technical did not cause mutations in the bacterial reverse mutation or mouse lymphoma tests with or without metabolic activation, chromosome damage in the mouse micronucleus or cytogenetics tests with and without metabolic activation, an increase in DNA damage in the comet assay or in an in vivo rat unscheduled DNA synthesis ( UDS) study. Based on the weight of evidence, it is concluded that, flonicamid technical is not genotoxic. 3. Reproductive and developmental toxicity. A developmental toxicity study in rats resulted in the maternal and developmental no observed adverse effect levels ( NOAELs) of 100 mg/ kg/ day. The maternal lowest observed adverse effect level ( LOAEL) was 500 mg/ kg/ day based on the treatmentrelated effects observed on the liver and kidney of the dams in the highest dose group. The developmental LOAEL was 500 mg/ kg/ day based on the increases in placental weights and incidences of fetal skeletal variations seen only at maternally toxic doses of 500 mg/ kg/ day. In the rabbit developmental toxicity study, the maternal and developmental NOAELs were 7.5 mg/ kg/ day and 25 mg/ kg/ day highest dose tested ( HDT), respectively. The maternal LOAEL was 25 mg/ kg/ day based on decreased body weights and food consumption. No adverse effects on the fetuses were observed at the highest dose.

VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28221 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices In the multi generation rat reproduction study, the NOAEL was 300 ppm for both parental animals ( 13.5   32.8 and 16.3   67.0 mg/ kg/ day, respectively, for males and females) and their offspring. The effects at the highest dose of 1,800 ppm included the following: increased kidney weights and gross and histopathological alterations in the kidney. Findings noted in the top dose females included delayed vaginal opening and increased liver, kidney and spleen weights in the F1 generation and reduced ovary and adrenal weights in the parental generation and decreased uterine weights in the F1 female weanlings. There was an increase in the FSH and LH levels in F1 females tested for these endpoints. These findings did not affect the reproductive performance or survival of offspring in the study. 4. Subchronic toxicity. The NOAEL for flonicamid technical in the rat 28   day dermal toxicity study was 1,000 mg/ kg/ day, which was the highest dose tested. In a 90   day rat feeding study the NOAEL was established at 200 ppm ( 12.11 mg/ kg/ day) for males and 1,000 ppm ( 72.3 mg/ kg/ day) for females. The NOAELs were based on effects on hematology, triglycerides, and pathology in the liver and kidney. In a 13   week mouse study, the NOAEL was 100 ppm ( 15.25 mg/ kg/ day in males and 20.1 mg/ kg/ day in females). The LOAEL is 1,000 ppm ( 153.9 mg/ kg/ day in males and 191.5 mg/ kg/ day in females) based on hematology effects and changes in glucose, creatinine, bilirubin, sodium, chloride and potassium levels, increased liver and spleen weights and histopathology findings in the bone marrow, spleen and kidney. In a subchronic toxicity study in dogs with capsule administration, the NOAEL was 20 mg/ kg/ day based on findings of severe toxicity at a dose exceeding the maximum tolerated dose; symptoms included collapse, prostration and convulsions leading to early sacrifice at the LOAEL of 50 mg/ kg/ day. In a subchronic neurotoxicity study in rats, the NOAEL for dietary administration was 1,000 ppm ( 67 mg/ kg/ day in males and 81 mg/ kg/ day in females) for systemic toxicity based on body weight and food consumption effects. The NOAEL for neurotoxicity was 10,000 ppm ( 625 and 722 mg/ kg/ day in males and females, respectively ( highest dose tested). 5. Chronic toxicity. In the chronic dog study with administration via using capsules, the NOAEL was 8 mg/ kg/ day. The LOAEL was 20 mg/ kg/ day based on reduced body weights in females and effects on the circulating red blood cells. In a rat 24   month combined chronic and oncogenicity study, flonicamid technical was not carcinogenic in rats. The NOAEL was 200 ppm ( 7.32 mg/ kg/ day) for males and 1,000 ppm ( 44.1 mg/ kg/ day) for females. The LOAEL was 1,000 ppm for males and 5,000 ppm for females based on histopathology in the kidney, hematology effects, hepatic effects including changes in biochemical parameters, increased organ weights, and histopathological changes. Atrophy of striated muscle fibers, cataract and retinal atrophy observed in the high dose females were considered to be due to acceleration of spontaneous age related lesions. In the 18   month mouse study, effects were observed in the lung, liver, spleen and bone marrow at 250 ppm or higher. Findings included, centrilobular hepatocellular hypertrophy, extramedullary hematopoiesis and pigment deposition in the spleen and decreased cellularity ( hypocellularity) in the bone marrow. There were statistically significant increases in the incidence of alveolar/ bronchiolar adenomas in both sexes of treated groups with hyperplasia/ hypertrophy of epithelial cells in terminal bronchioles. There was a statistically significant increase in the incidence of alveolar/ bronchiolar carcinomas in males at 750 ppm and 2,250 ppm and in females at 2,250 ppm only. These effects in the lungs of mice were not life threatening as most of effects were observed at the terminal sacrifice and there was no effect of treatment on mortality in the study. A NOAEL could not be determined from the dose levels administered. Mechanism of action studies have indicated that the lung effects are unique to the mouse and are not likely to translate to other species including the rat. Flonicamid technical was not carcinogenic in the rat. 6. Animal metabolism. Rat, goat and poultry metabolism studies were conducted using [ 14C] pyridylflonicamid The majority of the dose was rapidly excreted. Flonicamid was a major component of rat urine 48 hours after dosing. TFNA AM was the major metabolite found in rats ( urine), goats ( milk and tissues), and in laying hens ( tissues and eggs). TFNG was found between 8   24% of the total radioactive residue ( TRR) in the livers of rats sacrificed at intervals between 0.5   6 hours after dosing. The liver samples at these time intervals had 14C residues of 2.3%   4.6% of the dose. TFNA was not a major component in animal tissues. The metabolism of flonicamid in animals shows the main pathway of metabolism involves hydrolysis of  CN and  CONH2 functional groups in the molecule, identical to plant metabolism. The main metabolic reactions were hydrolysis of cyano to the amide function and ring hydroxylation. In rats, flonicamid was further metabolized by several routes, including nitrile hydrolysis, amide hydrolysis, Noxidation and hydroxylation of the pyridine ring, leading to multiple metabolites. The metabolism of flonicamid in animals is well understood. 7. Metabolite toxicology. The main metabolites of flonicamid were examined in acute oral toxicity studies in rats and bacterial reverse mutation tests. All the metabolites were less toxic than flonicamid and not mutagenic. 8. Endocrine disruption. No special studies investigating potential estrogenic or other endocrine effects of flonicamid have been conducted. Some suggestions of possible endocrine effects were reported at the highest dose tested ( 1,800 ppm) in the multi generation reproduction study which showed increased FSH and LH levels, a delay in the time to vaginal opening in the F1 generation, and reduced ovary and adrenal weights in the parental generation. However, there were no effects on reproductive performance or survival of the offspring in the study. At levels that are expected to be found in the environment, flonicamid will not cause any endocrine related effects.

C. Aggregate Exposure 1. Dietary exposure. Potential dietary exposures from food were estimated using the proposed tolerances for all crops using the Dietary Exposure Evaluation Model ( DEEM) for acute and chronic exposure based on U. S. Department of Agriculture's ( USDA) Continuing Surveys of Food Intake by Individuals ( CSFII) conducted in 1994   1998, and percent crop treated of 100%. The following raw agricultural commodities were included: Leaf lettuce, head lettuce, celery, spinach, cotton, potatoes, fruiting vegetables, cucurbits, stone fruits, pome fruits and resulting secondary residues in meat, milk, poultry and eggs. i. Food. Acute dietary exposure was compared to the acute population adjusted dose ( aPAD) of 3.0 mg/ kg/ day based on the NOAEL of 300 mg/ kg from the acute neurotoxicity study in rats and a 100   fold uncertainty factor. The U. S. population exposure is 0.26% of the aPAD and the most highly exposed subpopulation is children 1   2 with 0.56% of the aPAD ( 95th percentile). Based on the available data, an appropriate cPAD is 0.073 mg/ kg/ day VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28222 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices based on the NOEL of 7.32 mg/ kg/ day from the chronic toxicity study in rats and a 100 fold uncertainty factor. The U. S. population exposure is 3.2% of the cPAD and the most highly exposed subpopulation exposure is children 1   6 with 7.4% of the cPAD. ii. Drinking water. A drinking water level of comparison ( DWLOC) was calculated by subtracting the chronic/ acute food exposures calculated using DEEMTM from the cPAD/ aPAD to obtain the acceptable chronic/ acute exposure to flonicamid in drinking water. The estimated average and maximum concentration of flonicamid in surface water is 1.20 ppb and 1.64 ppb, respectively. These are both well below the lowest chronic ( 676 ppb) and acute ( 29,831 ppb) DWLOC values for flonicamid. Therefore, taking into account all proposed uses, it can be concluded with reasonable certainty that residues of flonicamid in food and drinking water will not result in unacceptable levels of human health risk. 2. Non dietary exposure. There are currently no residential uses of flonicamid registered or pending action that need to be added to the total risk from exposure.

D. Cumulative Effects In consideration of potential cumulative effects of flonicamid and other substances that may have a common mechanism of toxicity, to our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by flonicamid would be cumulative with those of other chemical compounds; thus only the potential risks of flonicamid have been considered in this assessment of its aggregate exposure. If ISK Biosciences Corporation learns of any other compound with the same mechanism of toxicity they will submit information for EPA to consider concerning potential cumulative effects of flonicamid consistent with the schedule established by EPA in the Federal Register of August 4, 1997 ( 62 FR 42020) ( FRL   5734   6), and other EPA publications pursuant to the Food Quality Protection Act ( FQPA).

E. Safety Determination 1. U. S. population. Using conservative exposure assessment analyses, the acute dietary exposure estimates are well below the aPAD of 3 milligrams/ kilogram body weight/ day ( mg/ kg bwt/ day) for all population subgroups. In addition, the chronic dietary exposure estimates for the various population groups are well below the cPAD of 0.073 mg/ kg bwt/ day. Based on this information, ISK Biosciences Corporation concludes that there is reasonable certainty that no harm will result from acute or chronic exposure to flonicamid. 2. Infants and children. Based on the available developmental and reproductive data on flonicamid, ISK Biosciences Corporation, concludes that, reliable data support use of the standard 100   fold uncertainty factor, and that an additional uncertainty factor is not needed to protect the safety of infants and children under the FQPA. Although, the reproduction study indicated signs of toxicity to some reproductive organs/ systems at the high dose of 1,800 ppm in the diet, other signs of toxicity such as effects on the kidney accompanied these; there were no effects observed at a dose level of 300 ppm. There were no effects on reproduction or survival at any dose level. Since acute and chronic aggregate exposure assessments are well below the aPAD and cPAD respectively, there is reasonable certainty that no harm will result to infants and children from aggregate exposure to flonicamid residues.

F. International Tolerances There are no Canadian or Mexican residue limits or codex MRLs for the insecticide flonicamid and its metabolites TFNA, TFNA AM, and TFNG. [ FR Doc. 03   13005 Filed 5   22   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7502   9]

Proposed Administrative Settlement Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 Regarding the Central Steel Drum Superfund Site, Newark, NJ AGENCY: Environmental Protection Agency. ACTION: Notice of proposed administrative settlement and opportunity for public comment.

SUMMARY: The United States Environmental Protection Agency (`` EPA'') is proposing to enter into an administrative settlement to resolve claims under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (`` CERCLA''), 42 U. S. C. 9601 et seq. In accordance with EPA guidance, notice is hereby given of a proposed administrative settlement pursuant to section 122( h)( 1) of CERCLA concerning the Central Steel Drum Superfund Site, located in Newark, New Jersey. This notice is being published to inform the public of the proposed settlement and to provide the public with an opportunity to comment on the proposed settlement. This settlement is intended to resolve the civil liability of certain responsible parties for response costs incurred by EPA at the Central Steel Drum Superfund Site. CERCLA provides EPA the authority to settle certain claims for response costs incurred by the United States with the approval of the Attorney General of the United States. The proposed settlement provides that the potentially responsible parties, Marian Abrams and Jane Mattson, will pay $ 18,000.00 in reimbursement of response costs incurred by EPA in performing a removal action to remove the contaminants and hazardous substances from the Central Steel Drum Superfund Site in return for a covenant not to sue under sections 106 and 107 of CERCLA from the United States.

DATES: Comments must be provided on or before June 23, 2003.

ADDRESSES: Comments should be addressed to the U. S. Environmental Protection Agency, Office of Regional Counsel, 290 Broadway   17th Floor, New York, New York 10007   1866 and should refer to: In the Matter of Central Steel Drum Superfund Site, Marian Abrams and Jane Mattson, Settling Parties, U. S. EPA Region II Docket No. CERCLA   02   2003   2001.

FOR FURTHER INFORMATION CONTACT: U. S. Environmental Protection Agency, Office of Regional Counsel, 290 Broadway   17th Floor, New York, New York 10007   1866, Attention: Muthu S. Sundram, Esq. ( 212) 637   3148.

SUPPLEMENTARY INFORMATION: A copy of the proposed administrative settlement agreement, as well as background information relating to the settlement, may be obtained in person or by mail from EPA's Region II Office of Regional Counsel, 290 Broadway   17th Floor, New York, New York 10007   1866.

Dated: May 14, 2003.

George Pavlou,

Director, Emergency & Remedial Response Division. [ FR Doc. 03   13002 Filed 5   22   03; 8: 45 am]

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