Page 1 2003 Application for Methyl Bromide Critical Use Exemption Florida Tomatoes ( CUE 02 0046) Florida Strawberries ( CUE 02 0053) Florida Peppers/ Eggplants ( CUE 02 0054)

Submitted to:

U. S. Environmental Protection Agency Methyl Bromide Critical Use Exemption Office of Pesticide Programs 911 Bay, BEAD 1921 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 308 8200 August 8, 2003 Florida Fruit and Vegetable Association Page 2 2003 Application for Methyl Bromide Critical Use Exemption Florida Tomato, Strawberry and Pepper/ Eggplant 1) Introduction Industry Status   Tomato   Strawberry   Pepper/ Eggplant 2) Crop Production Time Lines   Tomato   Strawberry   Pepper   Eggplant 3) Regulatory Issues   Pebulate   Telone   Herbicide Registration Status   Emerging Alternatives 4) Pest Complex and Economic Thresholds   Tomato   Strawberry   Pepper   Eggplant 5) Best Available Alternatives   Tomato  North Florida, Ruskin Palmetto, Southern Florida  Dade County   Strawberry   Pepper   Eggplant Page 3 6) Emission Reduction   Virtually Impermeable Film 7) Florida Methyl Bromide Alternatives Research   Historical Perspective   Research Priorities   Future Research Plans 8) 2003 Application Forms   Tomato  North Florida  Ruskin Palmetto  Southern Florida   Palm Beach  Southern Florida  Southwest  Dade County   Strawberry   Pepper   Eggplant Page 4 Appendices Appendix I: Methyl Bromide Alternatives Research A) Funded Research 2002/ 2003 B) Future Research Plans C) Bibliography   Methyl Bromide Alternatives Research D) Methyl Bromide Alternatives Research Reports Appendix II: Economic, Crop Production and Other Supporting Documentation A) Bibliography of Supporting Documentation B) Supporting Documents 1. General Information 2. Economics/ Crop Budgets/ Production 3. Regulatory Issues Page 5 1) Introduction Florida Fruit and Vegetable Association was the collection point and submitter for petitions pertaining to Critical Use Exemptions for Tomato ( CUE 02 0046), Pepper and Eggplant ( CUE 02

0054), and Strawberry ( CUE 02 0053). These petitions covered preplant soil fumigation use of methyl bromide as currently utilized in plastic mulched culture of vegetables in Florida ( and adjoining counties of Georgia for tomatoes packed and shipped from the Quincy area in north Florida). As a result of the similarity in use practice and common issues associated with the introduction of alternatives, the Association has approached the updates to the above referred petitions for quantities requested in 2005/ 2006, the new submission to cover the 2006/ 2007 request period as outlined in the FR Notice, and Application Forms, as a single package. Each industry and regional subunits will be handled as was done in the 2002 petition.

Industry Status Tomato No major status number changes have occurred since the development of the petition in 2002.

The general acreage relationships have not changed significantly within the state or region as described previously. Table 1 provides the most recent acreage available for tomato production.

Table 1: Florida Tomato Production Acreage, 2002. Farm Gate Values.

Region 2001/ 2002 1 2000/ 2001 2 2002 3 Including Specialty Tomatoes Value $ Millions North Florida 3,400 3,400 4,800 36 Ruskin Palmetto 13,000 13,000 15,600 156 Southern Florida 23,500 23,500 28,100 282 Dade County 3,000 3,300 3,600 48 Total 42,900 43,200 52,100 522 1 Base number NASS   Regional Numbers   FTGE 2 Base number NASS   Regional Numbers   FTGE 3 Based on round tomatoes, and cherry/ grapes and roma   Grower and Commodity Group Interviews The relative stability of the acreage over the past five years has been a result of acreage shifting from traditional round tomatoes to the specialty items, i. e., grapes, romas and cherry tomatoes. Page 6 Table 2: Florida Statewide Tomato Production and Acreage, 2002*. Farm Gate Values, reflecting values for round tomatoes ONLY.

Crop Year Total Acres Total Cartons Produced ( x 1,000) Yield Per Acre ( 25 pound cartons) Value Per Carton Value Per Harvested Acre** Total Value ( Millions)

2001 02 43,500 58,750 1,351 $ 8.07 $ 10,903 $ 474.3 2000 01 43,800 60,152 1,373 $ 9.26 $ 12,714 $ 557.0 1999 00 43,200 62,185 1,439 $ 6.67 $ 9,598 $ 414.8 1998 99 43,400 61,922 1,427 $ 7.50 $ 10,702 $ 464.2 1997 98 39,300 56,091 1,427 $ 9.05 $ 12,914 $ 507.5 1996 97 37,300 54,750 1,468 $ 8.08 $ 11,861 $ 442.4 1995 96 45,500 56,866 1,250 $ 7.82 $ 9,775 $ 444.5 1994 95 49,000 65,183 1,330 $ 7.25 $ 9,642 $ 472.8 * Source: Florida Agricultural Statistics Service Vegetable Summary, 1994 2003.

** Value Per Acre = bushels per acre X value per bushel.

Strawberry The Florida Strawberry industry is concentrated within a 25 mile radius around Plant City in Hillsborough County. The acreage planted during the 2002 production season increased to 6,900 acres, an increase of 6 percent from the 2001 production season, which was comprised of 6,500 acres.

Table 3: Florida Strawberry Production and Acreage, 2002*. Farm Gate Values.

Crop Year Total Acres Total Flats Produced ( x 1,000) Yield Per Acre ( 12 pound flat) Value Per Flat Value Per Harvested Acre** Total Value ( Millions)

2001 02 6,900 14,667 2,126 $ 10.46 $ 22,238 $ 153.5 2000 01 6,500 14,083 2,167 $ 11.88 $ 25,744 $ 167.3 1999 00 6,300 18,375 2,917 $ 9.12 $ 26,603 $ 167.6 1998 99 6,200 15,500 2,500 $ 9.72 $ 24,300 $ 150.7 1997 98 6,200 13,433 2,167 $ 12.00 $ 26,004 $ 161.2 1996 97 6,100 14,772 2,417 $ 9.91 $ 23,952 $ 146.1 1995 96 6,000 13,000 2,167 $ 8.66 $ 18,766 $ 112.6 1994 95 6,000 14,000 2,333 $ 8.47 $ 19,007 $ 118.6 * Source: Florida Agricultural Statistics Service Vegetable Summary, 1994 2003. ** Value Per Acre = flats per acre X value per flat.

Pepper While acreage of vegetable crops statewide in Florida increased overall, acreage producing pepper crops ( bell peppers, jalapeno peppers and other miscellaneous specialty pepper varieties) Page 7 actually declined somewhat during 2001 02. Similarly, for a variety of reasons, the 2001 02 yield per acre estimates for Florida peppers dropped as well.

Over the last decade, acres planted to pepper have varied from a high of 25,200 acres planted in 1993 94 to a low of 20,250 planted in 2001 02. Since 2000, pepper acreage has declined approximately 11 percent, primarily because of issues such as production challenges and unfavorable market/ pricing values. The value of a 28 pound bushel of peppers dropped nearly 20 percent between 2000 and 2002. The reduction in acreage factor, combined with the lower value per bushel pricing issue, resulted in the fact that the overall total value of Florida peppers dropped more than 28 percent over the last two production seasons. In fact, the value of the 2002 crop statewide was actually worth less ( both in terms of value per bushel and total value of the state s crop) than peppers were worth predating the 1993 values, because of the acreage reduction and lower value paid per bushel. Production and marketing competition issues continue to plague Florida s pepper production industry, and could threaten the state s status as the nation s # 1 producer of peppers if the trend continues.

Table 4: Florida Pepper Production and Acreage, 2002*. Farm Gate Values.

Crop Year Total Acres Total Bushels Produced ( x 1,000) Yield Per Acre ( 28 pound bushel) Value Per Bushel Value Per Harvested Acre** Total Value ( Millions)

2001 02 20,250 19,532 1,142 $ 8.72 $ 9,958 $ 170.3 2000 01 21,600 21,742 1,195 $ 10.75 $ 12,846 $ 233.7 1999 00 22,300 21,901 1,190 $ 10.68 $ 12,709 $ 233.9 1998 99 22,200 21,620 1,138 $ 11.21 $ 12,757 $ 242.4 1997 98 22,000 20,165 1,073 $ 13.70 $ 14,700 $ 276.2 1996 97 22,300 22,148 1,119 $ 9.91 $ 11,089 $ 219.5 1995 96 24,000 19,021 937 $ 9.76 $ 9,145 $ 185.7 1994 95 24,700 16,018 789 $ 12.03 $ 9,492 $ 192.7 * Source: Florida Agricultural Statistics Service Vegetable Summary, 1994 2003.

** Value Per Acre = bushels per acre X value per bushel.

Eggplant The crop of eggplants harvested off of producing acreage in the state of Florida during 2001 02 was valued at more than $ 14 million. While the value of the eggplant crop is significant, overall, the eggplant acreage and value may be considered minor in comparison to certain other Florida vegetable crops. Even with decreases in acreage experienced since the mid 1990s, Florida still ranks first in all states with respect to eggplant production, with more than twice the acreage of the next largest eggplant growing state. Production confrontations have resulted in net yields dropping at a fairly consistent rate in recent years, with produced bushels per acre dropping from 842 in 1999 down to 766 in 2001 02. This reduction equates to nearly a 10 percent decline in attainable yields per acre for eggplant fruits. Page 8 Table 5: Florida Eggplant Production and Acreage, 2002*. Farm Gate Values.

Crop Year** Total Acres Total Production ( x 1,000) Yield Per Acre ( 33 pound bushel) Value Per Bushel Value Per Harvested Acre*** Total Value ( millions)

2001 02 1,600 1,242 766 $ 11.33 $ 8,679 $ 14.1 2000 01 1,600 1,242 766 $ 11.33 $ 8,679 $ 14.1 1999 00 1,800 1,515 842 $ 10.02 $ 8,437 $ 15.2 1998 99 2,000 1,622 811 $ 10.35 $ 8,394 $ 16.8 1997 98 2,200 1,700 773 $ 9.32 $ 7,204 $ 15.8 1996 97 2,400 1,696 707 $ 8.63 $ 6,101 $ 14.6 1995 96 2,400 1,533 639 $ 9.02 $ 5,564 $ 13.8 1994 95 2,300 1,500 652 $ 9.00 $ 5,868 $ 13.5 * Source: Florida Agricultural Statistics Service Vegetable Summaries, 1994 2001. ** Updated production/ value information not available yet for 2001 02 cycle. *** Value Per Acre = bushels per acre X value per bushel. Page 9 2) Crop Production Time Lines During the review of the analysis performed under the 2002 application, it became apparent to those versed in crop production that there had been a misunderstanding relative to the   double cropped  scenario as described in the application. This section is being provided in order to clarify the crop production scenario and to provide a more accurate description template of the crop production sequences.

Tomato Production Timeline This description of the production timeline for Florida tomatoes is presented from a perspective that should be considered   typical . Variations to suggested intervals do and will occur on either side of proposed timeline boundaries, which is distinctive of an activity that is highly dependent upon uncontrollable characteristics such as weather and marketing opportunities. These timelines are designed to provide specific information on normally expected crop production activities associated with Florida s fresh market tomato crop.

It needs to be made clear that the vast, inclusive fresh market tomato industry is extremely competitive towards Florida from both the domestic and worldwide standpoints. Production and marketing of Florida tomatoes is highly dependent upon influences from production and marketing of tomatoes grown in other regions of the global market, Mexico in particular.

Tomato   North Florida Production Timeline The typical grower of fresh market tomatoes in north Florida produces about 380 acres of field grown fresh market tomatoes. Half of those tomatoes are produced in the fall and the other half are produced in the spring. Double cropping is not a prevalent production practice in north Florida ( less than 10 percent of the acres).

Table 6: Tomato   North Florida Production Timeline Overview Operation Earliest Start Date Activity Variance Land Preparation Feb. 15 July 1 Feb. 15   April 1 July 1   Sept. 1 Fumigation/ Bedding March 1 July 15 March 1   April 15 July 15   Sept. 15 Transplanting March 15 Aug. 1 March 15   May 1 Aug. 1   Sept. 15 Harvesting June 15 Nov. 1 June 15   July 15 Nov. 1   Dec. 31 Mulch Removal/ Post Crop Land Maintenance July 1 Dec. 1 July 1   Aug. 15 Dec. 1   Jan. 31 Cover Crop Establishment July 15 Dec. 15 July 15   Sept 1 Dec. 1   Jan. 15 Page 10 Tomato   Palmetto Ruskin Production Timeline The Ruskin   Palmetto production region is located in west central Florida and is concentrated in Manatee and Hillsborough Counties. The 15,600 acres of production are split into fall and spring seasons, with 6,240 acres in the fall and 9,360 acres in the spring. The fall crop is transplanted in early August with harvest beginning in late October and continuing through late December. The spring crop is transplanted from mid January until early March with harvest beginning in mid April and continuing through late May. A small portion of the plastic laid for the fall tomato crop is double cropped with spring plantings of cucurbits.

The   typical  farm in the Ruskin Palmetto area produces about 400 acres of field grown fresh market tomatoes. A total of 240 acres are produced in the spring market as a single crop and 144 acres are grown in the fall as a single crop. Of the 160 acres typically planted in the fall, 16 acres or 10 percent of the plastic would be double cropped.

Table 7: Palmetto Ruskin Production Timeline Overview; Non Double Cropped Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Jan. 15 Fumigation/ Bedding Aug. 1 Aug. 1   Feb. 1 Transplanting Aug. 15 Aug. 15   Sept. 15 Jan. 15   Feb. 15 Harvesting Oct. 15 Oct. 15   Dec. 31 May 1   June 1 Mulch Removal/ Post Crop Land Maintenance Dec. 15 Dec. 15   Dec. 31 May 1   July 1 Cover Crop Establishment Jan. 1 Jan. 1   July 1 Table 8: Palmetto Ruskin Production Timeline Overview; Double Cropped*

Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Jan. 15 Fumigation/ Bedding Aug. 1 Aug. 1   Feb. 1 Transplanting Aug. 15 Aug. 15   Sept. 15 Jan. 15   Feb. 15 Harvesting Oct. 15 Oct. 15   Dec. 31 May 1   July 1 Tomato Crop Destruction Dec. 1 Dec. 1   Feb. 15 Plant Second Crop Dec. 15 Dec. 15   March 1 Harvest Second Crop Feb. 15 Feb 15   May 1 Mulch Removal/ Post Crop Land Maintenance June 1 June 1   July 1 * For purposes of timeline and economic considerations, the second crop is assumed to be a cucurbit crop. Page 11 Tomato   South Florida Production Timeline This production region includes the flatwoods soils of the east coast of Florida from St. Lucie, Palm Beach and Broward Counties, through central Florida south of Lake Okeechobee, and over to the lower west coast of Florida in Lee and Collier Counties. This large production area overlaps with the fall production and early spring production in Ruskin   Palmetto but is concentrated in the winter months of December through late March. Limited production occurs through the end of April. Production is spread across the three production periods with 40 percent occurring in the fall, 25 percent in the winter, and 35 percent occurring in the spring. The length of the growing season allows for a portion of the acreage, primarily the fall production period, to be double cropped usually with cucurbits ( squash, cucumber, or melons). Double cropping is practiced on approximately 60 percent of the fall and winter acreage, with cucumbers being the typical second crop. The soils in this production area are the classic flatwoods soils that have a spodic layer of impermeable material, 18 to 36 inches below the bed surface, that allows efficient seepage irrigation of the plastic mulched bed.

The typical grower of fresh market tomatoes in the east coast, Palm Beach County area produces about 400 acres of field grown fresh market tomatoes. In the east coast production region, a total of 60 acres are produced as a single crop and 240 acres are grown as a double crop. For the southwest production area, the typical grower of fresh market tomatoes likewise produces about 400 acres of field grown fresh market tomatoes. However, a total of 272 acres are produced as a single crop and only 128 acres are grown in the fall as a double crop.

Table 9: South Florida Production Timeline Overview; Non Double Cropped Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Jan. 15 Fumigation/ Bedding Aug. 1 Aug. 1   Feb. 1 Transplanting Aug. 15 Aug. 15   Feb. 15 Harvesting Nov. 15 Nov. 15   May 31 Mulch Removal/ Post Crop Land Maintenance Jan. 1 Jan. 1   June 15 Cover Crop Establishment Jan. 15 Jan. 15   July 1 Table 10: South Florida Production Timeline Overview; Double Cropped*

Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Jan. 15 Fumigation/ Bedding Aug. 1 Aug. 1   Feb. 1 Transplanting Aug. 15 Aug. 15   Feb. 15 Harvesting Nov. 15 Nov. 15   May 31 Tomato Crop Destruction Jan. 1 Jan. 1   Feb. 15 Plant Second Crop Jan. 15 Jan. 15   March 1 Harvest Second Crop April 1 April 1   July 1 Mulch Removal/ Post Crop Land Maintenance July 1 July 1   July 15 * For purposes of timeline and economic considerations, the second crop is assumed to be a cucurbit crop. Page 12 Tomato   Dade County Production Timeline The Dade County production area is unique due to the soils and the tropical climate. The krome gravely loam soil ( Rockdale) is only present in this production area in the continental United States. This highly porous soil lies upon a surficial aquifer, and care must be exercised to prevent leaching of fertilizer and pesticides into this source of drinking water. Therefore, this soil, due to its unique characteristics, requires a totally different set of pest management options. The climatic conditions create a situation where the only guaranteed supply of winter vegetables is produced in this area. Production of tomatoes is concentrated in the winter months with harvest typically occurring from December through mid April. Limited production occurs in the late fall. Approximately 10 percent is double cropped.

The typical grower of fresh market tomatoes in Dade County, Florida produces about 350 acres of field grown fresh market tomatoes during the winter period. Double cropping is not a prevalent production practice in Dade County ( less than 10 percent of the acres).

Table 11: Dade County Production Timeline Overview Operation Earliest Start Date Activity Variance Land Preparation Aug. 15 Aug. 15   Dec. 15 Fumigation/ Bedding Sept. 1 Sept. 1   Dec. 15 Transplanting Sept. 15 Sept. 15   Dec. 31 Harvesting Dec. 15 Dec. 15   April 15 Mulch Removal/ Post Crop Land Maintenance Feb. 1 Feb. 1   April 30 Cover Crop Establishment May 15 May 15   July 1 Strawberry Production Timeline This description of the production timeline for Florida strawberries is presented from a perspective that should be considered   typical . Variations to suggested intervals do and will occur on either side of proposed timeline boundaries, which is distinctive of an activity that is highly dependent upon uncontrollable characteristics such as weather and marketing opportunities. These timelines are designed to provide specific information on normally expected crop production activities associated with Florida s fresh market strawberry crop.

It needs to be made clear that the vast, inclusive fresh market strawberry industry is extremely competitive towards Florida from both the domestic and worldwide standpoints. Production and marketing of Florida strawberries is highly dependent upon influences from production and marketing of strawberries grown in other regions of the country in particular. Page 13 Table 12: Strawberry Production Timeline Overview; Non Double Cropped Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Aug. 15 Fumigation/ Bedding Aug. 15 Aug. 15   Sept. 15 Transplanting Sept. 25 Sept. 25   Oct. 31 Harvesting Dec. 1 Dec. 1   April 15 Mulch Removal/ Post Crop Land Maintenance May 1 May 1   May 15 Cover Crop Establishment May 15 May 15   May 30 Table 13: Strawberry Production Timeline Overview; Double Cropped*

Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Aug. 15 Fumigation/ Bedding Aug. 15 Aug. 15   Sept. 15 Transplanting Sept. 25 Sept. 25   Oct. 31 Harvesting Dec. 1 Dec. 1   April 15 Strawberry Crop Removal March 21 March 21   April 15 Plant Second Crop March 25 March 25   April 30 Harvest Second Crop June 1 June 1   July 7 Mulch Removal/ Post Crop Land Maintenance July 7 July 7   July 15 * For purposes of timeline and economic considerations, the second crop is assumed to be a cucurbit crop.

Pepper Production Timeline This description of the production timeline for Florida peppers is presented from a perspective that should be considered   typical . Variations to suggested intervals do and will occur on either side of proposed timeline boundaries, which is distinctive of an activity that is highly dependent upon uncontrollable characteristics such as weather and marketing opportunities. These timelines are designed to provide specific information on normally expected crop production activities associated with Florida s fresh market pepper crop.

Table 14: Pepper Production Timeline Overview; Non Double Cropped Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Jan. 15 Fumigation/ Bedding Aug. 15 Aug. 15   Jan. 31 Transplanting Sept. 1 Sept. 1   March 15 Harvesting Nov. 15 Nov. 15   June 1 Mulch Removal/ Post Crop Land Maintenance May 1 May 1   June 15 Cover Crop Establishment May 15 May 15   July 1 Page 14 Table 15: Pepper Production Timeline Overview; Double Cropped*

Operation Earliest Start Date Activity Variance Land Preparation July 15 July 15   Aug. 15 Fumigation/ Bedding Aug. 15 Aug. 15   Sept. 15 Transplanting Sept. 1 Sept. 1   Oct. 31 Harvesting Nov. 15 Nov. 15   April 15 Pepper Crop Destruction Feb. 1 Feb. 1   March 15 Plant Second Crop Feb. 15 Feb. 15   April 30 Harvest Second Crop May 1 May 1   July 1 Mulch Removal/ Post Crop Land Maintenance July 1 July 1   July 15 * For purposes of timeline and economic considerations, the second crop is assumed to be a cucurbit crop.

Eggplant Production Timeline This description of the production timeline for Florida eggplants is presented from a perspective that should be considered   typical . Variations to suggested intervals do and will occur on either side of proposed timeline boundaries, which is distinctive of an activity that is highly dependent upon uncontrollable characteristics such as weather and marketing opportunities. These timelines are designed to provide specific information on normally expected crop production activities associated with Florida s fresh market eggplant crop.

Table 16: Eggplant Production Timeline Overview; Non Double Cropped Operation Earliest Start Date Activity Variance Land Preparation June 1 June 1   Jan. 15 Fumigation/ Bedding June 15 June 15   Feb. 1 Transplanting July 1 July 1   Feb. 15 Harvesting Nov. 1 Nov. 1   July 31 Mulch Removal/ Post Crop Land Maintenance April 15 April 15   June 15 Cover Crop Establishment May 1 May 1   July 1 Table 17: Eggplant Production Timeline Overview; Double Cropped*

Operation Earliest Start Date Activity Variance Land Preparation June 1 June 1   Jan. 15 Fumigation/ Bedding June 15 June 15   Sept. 15 Transplanting July 1 July 1   Oct. 1 Harvesting Nov. 1 Nov. 1   Jan. 15 Eggplant Crop Destruction Jan. 15 Jan. 15   Feb. 1 Plant Second Crop Feb. 1 Feb. 1   Feb. 30 Harvest Second Crop April 15 April 15   May 15 Mulch Removal/ Post Crop Land Maintenance May 15 May 15   June 1 * For purposes of timeline and economic considerations, the second crop is assumed to be a cucurbit crop. Page 15 3) Regulatory Issues Several critical actions have taken place since the submission of the initial CUE petitions that have influenced the potential choices among alternative strategies. The unsettled regulatory status creates difficulty in the decision matrix for both research planning purposes, as well as budgetary comparisons with methyl bromide based production practices.

Some of the major regulatory decisions that have influenced the alternative strategies for methyl bromide include:

  The loss of pebulate   Changes to PPE and buffer requirements on 1,3 dichloropropene   Changes to registration status for herbicides Also of significant influence over the process of determining the best available alternative strategies is the moving time frame associated with potential registration status of new crop protection tools such as iodomethane and fosthiozate.

While each of these have been considered in the development of the strategies discussed below,

the long term impacts on the technical and economic viability of the proposed strategies have not been determined.

Pebulate The loss of pebulate ( Tillam 6E ® ) resulting from bankruptcy of the technical registrant, Cedar Chemical, and the subsequent nonpayment of the annual registration maintenance fee, has created tremendous uncertainty with the alternative strategies for methyl bromide. Pebulate, where registered, provided efficacy against the primary weed species that impact plastic mulched vegetable production system ( yellow and purple nutsedge). This weed, while providing direct competition for the crop, also increases potential losses by growing through the plastic mulch, disrupting the fertilization margin program and creating potential physical damage to the crops because of abrasion caused as the mulch is lifted by the wind.

Beginning with initial small scale research plots to determine the best alternatives for methyl bromide, the need to establish nutgrass control was clearly established. Pebulate was identified as the material of choice, especially for tomatoes, as it could be applied prior to laying the plastic to control the nutgrass before it emerged through the mulch.

Telone In June 2003, EPA OPP/ Registration Division approved label changes for products containing 1,3

dichloropropene. These label changes reduced the buffer restrictions from 300 to 100 feet from occupied structures and reduced the Personal Protective Equipment for some field workers, applicators and handlers. The impacts of these changes, while anticipated to be favorable,

cannot be determined at this time. Page 16 Much of the research effort involving 1,3 dichloropropene in Florida has focused on broadcast applications in advance of bed formation as a result of the restrictive PPE requirements imposed upon early reentry field workers involved in the plastic laying operation. There is a strong possibility that the preferred application process for this alternative may shift back to the in bed fumigation process. Existing research projects have been modified to begin to test this alternative.

An important issue not resolved in this action by the Office of Pesticide Programs is the label language regarding Karst geology. Current label language states,   Do not apply in areas overlying Karst geology . This language taken literally would appear to prohibit the use of Telone products in Florida. The historical approach has been to restrict uses where surficial topography exhibits Karst features, i. e., sink holes, and there is a proposed label change that would formalize this approach. The Florida Department of Agriculture and Consumer Services has reviewed the proposed language   Do not make application within 25 feet of Karst topogeographical features . We remain concerned that with current language many of the areas where Telone is considered an alternative may not actually be able to use this product.

Several publications from the USGS are provided in Appendix II, B, 3, which detail the ubiquitous nature of limestone solution channels as a subsurface feature of Florida s geology. Until this issue is resolved, Telone products should not be considered as available alternatives from a regulatory perspective. The Florida industry in cooperation and full knowledge of the Florida Department of Agriculture and Consumer Services is looking to this product as a primary component of methyl bromide alternatives strategies.

Herbicide Registration Status In addition to the above referred loss of pebulate, other herbicidal active ingredients have received changes in their regulatory status associated with the crops addressed in this petition. Prominently among these are halosulfuron ( Sandea ® ) , rimsulfulron ( Matrix ® ) , and S metolachlor ( Dual Magnum ® ) . Also included with the discussion of these newly available alternative products, it is important to note the issues surrounding use of other labeled herbicides and their role in the replacement strategies for methyl bromide.

Halosulfuron Halosulfuron, a sulfonylurea herbicide, received labeling during 2003 allowing use on crops such as tomatoes, cucumber, winter squash, pumpkins, cantaloupe and snap beans. In addition, row middle applications are labeled for the fruiting vegetables and cucurbit crop groupings. Halosulfuron is a selective herbicide that is intended to provide both pre and post emergence control of purple and yellow nutsedge. Halosulfuron inhibits an essential plant enzyme, acetolactate synthase, thus blocking the production of the three amino acids: isoleucine, leucine and valine. In tomatoes, this product may be used as a pre transplant spray applied directly to the bed immediately before the plastic laying operation, or as a post emergent spray targeting nutsedge weeds that have emerged through the plastic within the bed. The level of weed control is dependent upon application rates and methods of application, specific weed species,

size and infestation intensity at the time of application, and growing conditions. While this product appears to have favorable activity when applied in a post emergent fashion, its level of activity when applied pre emergent is not of an acceptable level for commercial tomato Page 17 production. Post emergent applications to pepper and eggplant crops are not recommended, as foliage/ plants of these crops are very sensitive to halosulfuron. In addition, where crops such as a cucurbit might be grown on the same land subsequent to the labeled crop, producers are prohibited from planting fruiting vegetable or cucurbit crops to that land for an additional four months following the last halosulfuron application under the crop rotational restrictions referenced on the label. For certain other crops, the plant back restriction is as long as 36 months. This issue potentially affects succeeding cropping strategies. The plant back interval needs to be extended if dry conditions prevail. Rotation to other crops, such as snap beans,

cannot take place for a full nine months after the last halosulfuron application. These plant back restrictions clearly limit the use of this product. Since application in pepper and eggplant fields is for row middle only, this product does not provide nutsedge control in the raised bed, the area where competition from nutsedge is the most critical. Also, halosulfuron should not be applied if the crop or target weeds are under stress due to drought, water saturated soils, low fertility, or other poor growing conditions. Compounding other pest management strategies within the overall production system is the fact that this herbicide cannot be applied to crops treated with soil applied organophosphate insecticides, and foliar applications of organophosphate insecticides may not be made within 21 days before or 7 days after a halosulfuron application.

Rimsulfuron The rimsulfuron registrant claims only suppression of yellow nutsedge. Research supports registrants  claim. This product does not suppress development of purple nutsedge. Tank mixing with organophosphate insecticides may cause crop injury. Plant back restrictions are 12 months or greater for many vegetable crops.

S metolachlor S metolachlor is a chloroacetanilide classed herbicide, which received a federal label allowing its use on tomato crops during 2003. Use of this selective herbicide on pepper has been allowed in Florida under a Special Local Need registration since approximately 1995. S metolachlor may be used as a pre transplant spray applied directly to the bed immediately before the plastic laying operation for control of nightshade and pigweed. Application may also be made post directed to transplants after the first setting rain, and also to treat row middles, although this product may damage transplants that have been weakened by environmental stress. This herbicide will not control emerged weeds. S metolachlor may not be applied within 90 days of tomato harvest, making harvest of early season varieties a challenge in certain years. S metolachlor is not registered for use on eggplant. S Metolachlor applied under plastic mulch offers only suppression of yellow nutsedge development. It does not impact purple nutsedge development. Both nutsedge species are present in most vegetable fields. Further work is required to address potential crop tolerance issues with this new tomato label.

Glyphosate Glyphosate is a non selective herbicide that usually only suppresses nutsedge development. Additionally, glyphosate provides no residual weed control and repetitive applications would be required to manage nutsedge. Glyphosate may be applied prior to planting or only between vegetable rows. Contact of glyphosate with the crop will cause severe injury. Row middle Page 18 application use is limited because of the potential of glyphosate drift to the crop causing severe injury.

Napropamide Napropamide is a pre emergent herbicide applied at a rate of 2   4 lbs. a. i. per acre, depending on specific crop usage. It may be applied at transplanting or during the early stage of crop development. Napropamide application to the soil must be incorporated within a few days of application with sufficient rainfall or sprinkler irrigation. It can be used to manage certain annual grass and annual broadleaf weeds if applied before the weeds have emerged. It is important that this product be applied to weed free ground. The use of napropamide can delay maturity and result in 10   20 percent yield reductions, although this is not typically seen in banded bed fumigation. Application once crop plants begin blooming is prohibited. Napropamide is only fair in its nutsedge management capabilities. This is an old compound that has not held a lot of favor in the past. It breaks down quickly in sunlight and without overhead irrigation there is no easy way to move it into the soil surface to protect it. While it is effective against certain grass and broadleaf weeds, it is weak on nutsedge, especially at the current tomato/ pepper rate.

Strawberry allows a 2X increase in use rate. Napropamide also has a plant back restriction, which is 12 months for non labeled crops. Another significant drawback of this material is that napropamide, according to its label, does not control established weeds, and weeds such as nutsedge are a postemergent weed problem in Florida vegetable fields annually. Napropamide is not even marginally efficacious in managing nightshade or morningglory. Consequently, neither of these weeds is listed under the Weeds Controlled portion of the napropramide label.

Oxyfluorfen Oxyfluorfen is a diphenyl ether herbicide used for broad spectrum pre and post emergent control of annual broadleaf weeds. The use of oxyfluorfen is not practical for use on fruiting vegetable and strawberry crops because of the long replant period required following application. Oxyfluorfen s use would be limited to long fallow periods, a rare condition for fields that are typically in production most of the year. This product could provide effective control of difficult weed species that other herbicides cannot control if used during renovation or a fallow period, but must be a long enough timeframe prior to initiation of the next cropping cycle. A minimum of 30 days must pass between oxyfluorfen treatment and transplanting. Not incorporating this product at the time of application increases the potential for crop injury later, especially under wet conditions.

Paraquat Paraquat is a non selective herbicide that provides poor control of nutsedge. Additionally, paraquat does not provide residual weed control. Paraquat may be applied prior to planting or only between vegetable rows. Contact of paraquat with the crop causes severe injury.

Paraquat, which in the past was the industry standard for nightshade management in Florida vegetable fields, no longer manages weeds such as nightshade. Resistance to paraquat ( as high as nearly 20 fold) has been documented in the state. With the occurrence and expansion of resistance among the nightshades to the bipyridilium class of chemistry, producers are not able to effectively manage this weed. Nightshade is also an alternate host capable of sustaining large populations of insect pests including whiteflies, aphids, thrips and leafminers. Additional Page 19 treatments of alternative herbicides are necessary to help eliminate bipyridilium class resistant nightshade, thus eliminating this alternate host for these insect pests. In addition to their inherent feeding damage, whiteflies, aphids, thrips and leafminers are the vectors for numerous virus diseases that attack vegetable crops and severely inhibit yield.

Trifluralin Trifluralin is used to aid in the control of annual grasses, but this product does little towards management of broadleaf weeds. Tolerance exhibited by crops such as eggplants is only marginal, so much so that the users are cautioned about the tolerance parameters on the trifluralin supplemental labeling for eggplant use. Additionally, use of this product, when combined with effects of certain cultural practices and unfavorable soils or environmental conditions, may cause excessive crop stress resulting in retarded crop growth, stand reductions and reduced yield.

Emerging Alternatives Among the other active ingredients being looked at as potential alternatives, several have been moving toward regulatory decisions that would influence the consideration of combination treatments to replace methyl bromide. Both iodomethane and fosthiozate represent potential chemical replacements. Iodomethane exhibits a broader spectrum of efficacy where fosthiozate is targeted specifically as a nematicide. There has been research on both compounds in Florida, but many issues remain in determining their appropriate place in current production schemes and the application methodology required to maximizing their efficacy.

In addition, trifloxysulfuron Na is also of interest to Florida tomato producers. The spectrum of efficacy of this research compound appears to make this a product of choice as we search for a selective herbicide with efficacy toward pre emergent control of nutgrass. Page 20 4) Pest Complex and Economic Thresholds In the 2002 CUE process, one of the more difficult aspects was capturing the complex relationship between a crop production system and pest control program that one begins with the application of extremely efficacious broad spectrum material such as methyl bromide. Also complicating the decision process of prioritizing pests to be used in the targeted search for the best alternative is the long history of access to methyl bromide across the current production areas. The emergence of new pests or resurgence of pests no longer has to be considered as a result of the efficacy of methyl bromide.

As a starting point, the list of currently identified pests across the four crops included in the 2002 submission that are at least partially controlled with methyl bromide were utilized. As a further step with the 2003 submission, the research and grower communities were asked to address the priority of control associated with each major segment of pest management, weed control, pest diseases and nematodes. This request was further refined to look at regional aspects of specific pest control needs for the separate areas of tomato production. The results of that effort are provided in Tables (), (), and () for tomatoes, strawberries and peppers/ eggplants, respectively.

The relative ranking down major pest segments does not indicate a ranking that would include all of the weeds prior to a decision for nematode or plant disease control. The inherent complexity of this management discussion rationale makes a simplistic   sample pest analysis  of critical need a basic screening effort at best. The research data collected to date illustrates this problem in that we have very few trials where all major categories of pests potentially controlled by methyl bromide were present. Where multiple pests did occur, the relative efficacy differences across alternative treatment strategies were magnified. The reverse of this is also true in that many of the alternative strategies were commercially screened in production areas that had been in continuous production utilizing the preplant fumigant methyl bromide and may have appeared to be more efficacious than actually warranted.

Pest Complexes Tomato For tomato, the relative priority of the major categories did not change across regions, with weed control followed by plant disease then nematodes as the decending order of concern from a direct crop/ yield perspective. The internal priorities for specific weed species and plant diseases did shift based on production region. The consistent nematode that represented the highest priority was the root knot nematode, Meloidogyne spp.

The Dade County production area represents a unique situation because of the soils encountered in this production area. There is significant concern over the possible resurgence of a soilborne disease, corky brown root rot, Pyrenochaeta lycopersici, that has not been a problem since the introduction of methyl bromide as a soil fumigant of choice. Page 21 Table 18: Pest Complex and Control Priorities   Tomato North Florida Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus &

C. esculentus) Nightshade ( Solanum spp.)

2 Plant Diseases Bacterial Wilt ( Ralstonia solanacerum) Damping Off ( Rhizoctonia solani,

Pythium spp., Phytophthora spp.)

3 Nematodes Root Knot ( Meloidogyne spp.)

Ruskin   Palmetto Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Nightshade ( Solanum spp.) Eclipta ( Eclipta prostrata) Morningglory ( Ipomoea spp.)

2 Plant Diseases Fusarium Wilt ( Fusarium oxysporum)

3 Nematodes Root Knot ( Meloidogyne spp.)

Palm Beach Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus &

C. esculentus) Nightshade ( Solanum spp.) Eclipta ( Eclipta prostrata)

2 Plant Diseases Fusarium ( Fusarium oxysporum f sp. radiscislycopersici Southern Blight ( Schlerosium rolfsii) Damping Off ( Rhizoctonia solani,

Pythium spp., Phytophthora spp.) White Mold ( Schlerotinia sclerotiorum)

3 Nematodes Root Knot ( Meloidogyne spp.)

Southwest Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Nightshade ( Solanum spp.) Eclipta ( Eclipta prostrata) Morningglory ( Ipomoea spp.)

2 Plant Diseases Fusarium ( Fusarium oxysporum f sp. radiscislycopersici Damping Off ( Rhizoctonia solani,

Pythium spp., Phytophthora spp.) White Mold ( Schlerotinia sclerotiorum)

3 Nematodes Root Knot ( Meloidogyne spp.) Page 22 Table 18: Pest Complex and Control Priorities   Tomato ( cont.)

Dade County Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Pigweed ( Amareanthus spp.) Crabgrass ( Digetaria spp.) Barnyardgrass ( Echinochloa crusgalli

2 Plant Diseases Verticillium Wilt ( Verticillium albaatrum Fusarium ( Fusarium oxysporum f sp. raadiscislycopersici Corky Brown Root Rot ( Pyrenochaeta lycopersici)

3 Nematodes Root Knot ( Meloidogyne spp.) Reniform ( Rotylenchulus spp.)

Strawberry The pest complex targeted for strawberry contains the same component as tomatoes, but in a different order. The nematode complex is top priority, followed by weeds and the plant diseases, with a different spectrum of pest to be considered. The primary nematode to be controlled is the sting nematode, Belonolaimus longicaudatus, and additional weed species have been added to nutsedge in the weed matrix. Plant diseases, while a consideration, do not appear to be on the same order of magnitude as the other two major categories.

Table 19: Pest Complex and Control Priorities Strawberry Priority 1 2 3 4 1 Nematodes Sting Nematode ( Belonolaimus longicaudatus) Root Knot ( Meloidogyne spp.)

2 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Carolina Geranium ( Geranium carolinianum) Cut Leaf Evening Primrose ( Onoethera laciniata)

3 Plant Diseases Phytophthora Crown Rot ( Phytophthora citricola & P. cactorum)

Pepper/ Eggplant The relative priority among major pest categories for these two solanaceous crops are the same as tomato, with weeds representing the top priority followed by plant diseases and then nematodes. The spectrum of weeds is similar regionally to those for the regional considerations for tomato where production areas overlap. There was no attempt to further refine the statewide distributions for these two crops. The nematode pests are the same with root knot being far and away the primary pest to be controlled. The plant disease spectrum was different as would be expected. We are currently seeing an increase in incidence of white mold across the Page 23 growing region even with methyl bromide. The factors influencing this increase appear to be climactic in nature.

Table 20: Pest Complex and Control Priorities Pepper Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Nightshade ( Solanum spp.) Morningglory ( Ipomoea spp.)

2 Plant Diseases Phytophthora Blight ( Phytophthora spp.) Damping Off ( Rhizoctonia solani, Pythium spp.,) White Mold ( Schlerotinia sclerotiorum)

3 Nematodes Root Knot ( Meloidogyne spp.)

Eggplant Priority 1 2 3 4 1 Weeds Nutsedge ( Cyperus rotundus & C. esculentus) Nightshade ( Solanum spp.) Morningglory ( Ipomoea spp.)

2 Plant Diseases Southern Blight ( Schlerosium rolfsii) Damping Off ( Rhizoctonia solani, Pythium spp., Fusarium spp.) Verticillium Wilt ( Verticillium albaatrum

3 Nematodes Root Knot ( Meloidogyne spp.)

Economic Thresholds Justification for the continued use and availability of broad spectrum soil fumigants like methyl bromide are fundamentally based on the common occurrence, diversity and distribution of pests problems which occur in the field, and to the avoidance of crop loss that these pests cause.

Most vegetable crops produced in Florida and dependent upon methyl bromide soil fumigation are susceptible to nematode and disease injury. The ability to predict crop losses attributable to nematodes and other pests first requires accurate assessment and description of pest density,

distribution, and areas of pest species overlap within the field. The areas of overlap are important since they form the critical areas for pest interactions. With methyl bromide soil fumigation, specific grower decisions regarding soilborne pest and disease monitoring were never truly essential because of the broad spectrum efficacy of the fumigant. Although progress is being made to develop new soil sampling/ plant bioassay/ pest monitoring protocols, cost effective, reliable sampling procedures to accurately quantify soilborne pest and disease population levels are currently not available for grower use.

Even if reliable soil sampling methodologies were available in Florida, it is also currently not possible to confidently predict crop losses due to nematodes and other soilborne diseases based solely on soil and root sample information of pest population density. Based on previous university research efforts, much is known about the impact of specific pests, agronomic inputs, Page 24 and environmental factors on plant growth when they are manipulated and studied separately. Significantly less is known about multiple pest interaction effects on plant growth and epidemiological processes. As such, damage functions and economic thresholds quantitatively relating pest population levels to pest management decisions have not been accurately determined and field validated for grower use for either individual or concomitant pest species.

Most research does show that plant symptoms and yield reductions are not only related to preplant pest infestation levels of nematodes, diseases, and weeds in soil but to interactive effects and other environmental stresses imposed upon the plant during crop growth. As a result of these interactions, most attempts to characterize crop losses based on even a single pest species model typically underestimate observed production losses in the field.

Based on additional risk assessments, university recommendations for pest management for the high value vegetable crops of Florida caution growers that even the mere presence of root knot nematode in preplant soil samples indicates a potentially serious problem, particularly on sandy ground during the fall when temperature and rainfall patterns favor high levels of pest activity and growth, and or in fields where various wilt diseases occur concomitantly. The bestdocumented example of this type of multiple pest interaction is the root knot nematode, Meloidogyne spp., and Fusarium wilt disease on old tomato production land in Florida. The rootknot nematode, by causing the development of root galls, provides a nutrient rich food source that the fungus colonizes rapidly. Root knot nematode can thus significantly enhance disease development and yield loss, elevating primary or secondary pathogens to major pest status even though population levels or pathogenic potential of the fungi were initially very low and yield losses would have been minimal in the absence of the nematode.

To be practical and meaningful to growers, prediction of crop loss and development of economic thresholds for advisory purposes must be able to partition and account for the interaction of multiple pests under varying agronomic practices and economic and environmental conditions.

Crop loss and economic threshold information from the total pest complex forms the basis for rational or optimal farm, crop, and pest management decisions. Development of   pest complex  based crop loss predictions that consider environmental and economic flux have not been developed for use in Florida and therefore must await further refinements in many different areas of nematology, plant pathology, weed science, and agricultural economics. Page 25 5) Best Available Alternatives In keeping with the process utilized in the 2002 application, the 2003 budgets and analysis of impacts are based on conversations among the research community on the best currently available treatment strategies. While there are differences of opinions about the absolute value of these alternatives at the research level, these represent the   best currently available alternatives  to methyl bromide. Some of these treatment alternatives have not received a tremendous amount of research based scrutiny, as most work prior to the 2003 spring use season was done with the assumption that pebulate would be the herbicide product of choice where available   the largest use sector being tomato. Also, with some of the more recently registered herbicides, further refinement in use patterns and application rates may affect the utility of these products. The most recent change in personal protective equipment ( PPE) and buffer zone reductions for 1,3 dichloropropene containing compounds may shift some of the crops back to an in bed fumigation as the application method of choice. With the above caveats,

we have attempted to capture the alternative treatment regimes and the impacts of those alternatives to crop production practices. The direct costs associated with the changes are reflected in the alternative crop budgets found in Appendix II. Brief descriptions of those impacts are included in the individual regional or crop based alternative presented below.

Tomato The alternatives for tomato are split on a geographical basis between Dade County and the rest of the Florida production regions. For clarity, the two alternative treatment strategies will be discussed separately.

Tomato ( Florida and adjacent counties in Georgia)

To replace the industry standard methyl bromide: Chloropicrin C 35 formulation, plus, the following products were added to the crop production scenarios.

Telone C 35, 26 gallons per acre, broadcast applied, 3   5 weeks prior to bed formation. A subsequent chloropicrin application four weeks later at 150 pounds per treated acre is shanked directly into the bed, with a combination herbicide application of napropamide at 2 pounds of active ingredient per treated acre and S metolachlor at 1.27 pounds of active ingredient per treated acre, applied as a tank mix to the bed immediately prior to laying plastic on the pressed bed. For areas with heavy nutsedge pressure, there is the need to include an additional application of halosulfuron at 0.05 pounds of active ingredient per treated acre applied as a postemergent directed spray.

This treatment regime adds an additional fumigation application, and an additional herbicide application when compared to the industry standard bed fumigation with methyl bromide. In addition to the direct materials and application costs, the longer time interval to transplanting also creates a management cost associated with field and soil moisture maintenance. Page 26 Tomato ( Dade County)

Rockdale and marl soils, coupled with use prohibitions of Telone in Dade County, make the alternative fumigants Vapam or K pam at 75 gallons or 60 gallons per acre, respectively, depending on grower choice, as the best currently available alternatives. This application is applied with 150 pounds of chloropicrin per treated acre and shanked into the bed at time of plastic laying. The same additional herbicides as for the rest of Florida tomatoes are also part of this treatment regime.

The major changes in the crop budgets under this alternative treatment strategy are the differential cost of the fumigant, and the added cost of the herbicides and application costs associated with those products.

Strawberry The best currently available treatment alternative for strawberry includes the broadcast application of 26 gallons of Telone C 35 per acre, followed four weeks later by the in bed application of 150 gallons of chloropicrin per treated acre shanked into the bed at plastic laying. The herbicide combination includes oxyfluorfen at 0.5 pounds of active ingredient per treated acre plus napropamide at 4 pounds of active ingredient per treated acre, broadcast to the bed surface at plastic laying. No post emergent nutsedge material is available at this time for strawberry.

Cost considerations under this alternative treatment scenario include the differential fumigation costs and the additional application costs associated with the herbicide applications at plastic laying. The additional field maintenance period required by the broadcast application of Telone was also factored into the crop budgets.

Pepper/ Eggplant The non tomato solanaceous crops pepper and eggplant share the same fumigation regime as the best currently available alternative to methyl bromide. This includes the Telone C 35 26 gallons per acre broadcast fumigation. Also required is the additional application of chloropicrin at 150 pounds per treated acre four weeks later shanked into the bed at plastic laying. For peppers, an additional herbicide application is required at plastic laying with the treatment of choice currently being napropamide at 2 pounds of active ingredient per treated acre combined with S metolachlor at 0.95 pounds of active ingredient per acre per treated acre, applied at plastic laying. For eggplants, the additional napropamide application is instead combined with trifluralin at 0.5 pounds of active ingredient per treated acre.

The impact on the enterprise budgets in adopting these alternatives includes the alternative fumigant costs, the additional application costs associated with the broadcast fumigation, and the additional herbicide application costs. Increased field maintenance costs, as a result of the increased time required for the crop cycle, was also included. Page 27 6) Emission Reduction   Virtually Impermeable Film Mulch Virtually Impermeable Films ( VIF) have been developed to reduce overall field application rates and soil emissions of methyl bromide. VIF has been used for agricultural mulch film in Europe for some time now, but its use in the United States has been very limited. There are many reasons for this differential adoption rate between Europe and the USA. The following narrative outlines major constraints to implementation that must be overcome prior to expansion of agricultural use of VIF in Florida.

Linear Shearing Most soil fumigant applications in Europe are broadcast, solid tarp ( i. e. the entire field is fumigated) fumigation employing slower ground speeds than typically used in Florida. Most Florida growers, and many of those throughout the southeastern U. S., inject soil fumigants like methyl bromide into the soil in an 8 inch tall, raised bed about 32 inches in width and cover just the treated bed with mulch film. Application of mulch film to raised beds requires burial of the film in the soil on both sides of the bed. Film is typically applied at ground speeds of 4.5 mph or faster. The speed of application, the equipment used, and the process of stretching the film across a raised bed and down into soil on either side, then covering it with a coarse, abrasive,

sandy soil, subjects the film to shear forces much greater than would be encountered with a broadcast application. These shear forces have resulted in linear shearing of most of the VIF products tested in Florida, which has subsequently caused growers to reject these products as viable options to standard low density polyethylene film mulch.

Photodegradation Broadcast, solid tarp fumigation generally requires a film which will hold up for at most 2 weeks, while Florida vegetable growers require a film that maintains its integrity for at least 6 months or longer, depending upon the crop and subsequent cropping practices, such as production of a second crop on the same beds with the existing mulch film. To date, all of the commercially available VIF has been produced in Europe, and designed to satisfy the needs of the European market. As a result, producers include very little uv inhibitor in the film as the film will be covering the soil for such a short time interval. The lack of sufficient uv inhibitor means the film deteriorates rapidly in the climate of the southeastern U. S. and does not remain intact for the length of the season.

Wind Lift None of the VIF products currently available are embossed. Embossing allows the film to have some natural elasticity and   memory  that allows it to tighten as the temperature drops and stretch as the temperature increases, thereby maintaining a tight fit on the raised bed. Without embossing, it is difficult to lay the film tight across the bed and maintain that tension, resulting in increased problems with wind lift. Wind is a problem during much of the production season in Florida. In the spring we experience high winds as the weather changes with the season and weather fronts come through the state. In the period of July through November, a time encompassing most of our fall production season, Florida is vulnerable to hurricanes and other Page 28 tropical storms which deliver torrential rains and high winds; conditions ideal for massive loss of mulch film from the raised beds. Tight fitting film is important because any looseness provides an opportunity for wind to lift the film and blow it off the bed.

Installation Costs Vegetable growers are always pressed for time and because of the many different operations involved in forming beds ( applying fertilizer and fumigant, laying plastic and drip irrigation tubing), minimum requirements for a successful fumigation operation make it necessary to lay a mulch film at ground speeds of at least 4.5 mph, in order to be able to prepare the necessary 20 to 25 acres per day. Anything that slows that process costs more in terms of manpower. Since most VIF products tested to date have had problems with linear shear, and shear problems increase with increased ground speed, the physical limitations of VIF film application can reduce that figure to 10 to 12 acres per day; a number which is not acceptable or cost effective.

Manufacture/ Distribution/ Logistics Since all of the currently available VIF products are produced in Europe, there is considerable cost associated with importation, including shipping fees, the fee charged by a customs broker,

import duties and trucking fees from the port to the local distributor. As a result, growers can expect to pay more than twice as much for VIF as they pay for standard polyethylene mulch film. There is little to no warehoused supply of VIF in Florida or the U. S., thus it is imported as it is ordered and that can mean delivery delays in excess of 2 months. Growers, like most of us, are not keen on ordering something sight unseen and having to wait months to receive it. Unexpected transoceanic delivery delays are common as a result of increased scrutiny of imported products into the U. S., and this lack of stability in the market can leave a grower without the film he needs when he has to have it.

Since reduction in methyl bromide rate is an integral part of the use of VIF, the resultant lack of VIF mulch can force a grower to reduce his acreage in order to increase the rate of methyl bromide on the remainder of his acreage. While this may seem like a minor issue, it must be remembered that all other production inputs have been ordered by this time and a grower s production finances are based on projected returns from planned acreage. When the planned acreage changes, a grower may find themselves in financial problems.

Grower Adoption Growers have not had enough experience with VIF mulch and the experience they have had generally has been bad due to poor handling and laying characteristics. Problems such as reduction of ground speed done in an effort to eliminate linear shear during installation, and wind damage ( lifting, complete release) of film due to it not being held tightly enough against the soil, have kept grower interest in VIF to a minimum. While research and grower education efforts have been conducted with VIF for the past 5 years, poor handling characteristics under commercial conditions, confusion about what constitutes a VIF and a lack of understanding of their potential market on the part of some VIF manufacturers have resulted in low interest and adoption of VIF technology. Page 29 Another problem growers confront with VIF is the lack of an accepted standard. The only published standard for VIF is the French standard for permeability, and there is a great deal of variability among products that comply with the French standard. Indeed, there can be variability among films produced by the same manufacturer. Growers require a consistent product with good handling characteristics. Most of the VIF tested to date in Florida and the U. S. has not provided that. There is much confusion as to what VIF mulch really is, as some suppliers have been marketing   high barrier  polyethylene mulch as being the same as VIF, which it most definitely is not. Hopefully, future exposure of growers to true VIF products will eliminate that confusion.

Continuing Research Research on the use of VIF to reduce soil application rates and emissions of methyl bromide and other soil fumigants has been broadly conducted in the state. It is clear from this research with VIF that fumigant use rates can be potentially reduced by as much as 20   25 percent without serious loss of crop yield or pest control efficacy. The conduct of the research was also instrumental in identifying all of the potential problems of actual grower use and adoption.

Research and demonstration projects continue in the west central, south and southwest production regions of Florida to evaluate the most promising VIF mulch under commercial conditions and to collect efficacy and handling characteristics data in cooperation with growers.

It is hoped that this project will aid in the adoption of VIF as a practical means of reducing methyl bromide rate and emissions. Page 30 7) FLORIDA METHYL BROMIDE ALTERNATIVES RESEARCH Historical Perspective Since 1993, alternatives to methyl bromide research efforts in Florida have been formulated and collectively defined by a core group of individuals from agricultural commodity groups, fruit and vegetable associations, as well as University of Florida and USDA scientists. The alternatives to methyl bromide research task force was initially assembled in 1994 to discuss, organize and optimize future alternatives to methyl bromide research efforts within the state, as well as to draft a long term plan to characterize potential phase out impacts, possible avenues of research funding, and to develop long term plans of work for defining and moving economically viable alternatives for methyl bromide into commercial use.

Florida research efforts were also formulated and regionally defined to account for the broad, yet distinct, geographic, environmental and cultural variation in agricultural production that occurs throughout the state. Separate, yet interconnected, research programs of the University of Florida have been developed in primary fruit and vegetable producing areas of northwest, north central, west central, southwest and south Florida. Within each production region, research protocols for the evaluation of chemical and nonchemical methyl bromide alternatives were standardized among research locations to minimize possible response variability associated with differences in site preparation, chemical use rates, application and incorporation methodology, as well as timings and measurement units of pest and crop response. Initially, selection and funding priorities were given to projects which emphasized 1) treatment comparisons that had the widest applicability across crops and soils; 2) projects that examined multiple pests and control strategies ( IPM); or 3) projects that addressed multicropping. In addition, research priorities were also assigned to chemical alternatives with defined potential to replace methyl bromide and where they could be repeatedly evaluated as independent treatments in replicated field trials, often in the same location, with the same crops for repeated production cycles to insure response consistency and or to characterize any response degradation.

In total, Florida based research projects have involved more than 21 University of Florida and United States Department of Agriculture  Agricultural Research Service scientists with primary emphasis on this issue. Small plot research trials have been annually conducted at six University of Florida Research & Education Centers located in Quincy, Gainesville, Lake Alfred, Bradenton, Immokalee, and Homestead, FL, and at the USDA Horticultural Research Laboratory in Ft. Pierce, FL. The Florida research program has been diverse, involving evaluations of various chemical,

nonchemical, and integrated pest management ( IPM) tactics. Overall, the principal objective of this research has been to evaluate and validate the effectiveness and economic viability of alternatives to methyl bromide soil fumigation for nematode, soilborne disease, and weed control in plastic mulch vegetable production systems in Florida.

In addition to USDA ARS and CSREES sponsored research, the USDA s IR 4 research program in Florida has also been actively involved in identifying and evaluating alternative chemicals either alone or in combination as potential replacements of methyl bromide. The Florida IR 4 program has involved the University of Florida, USDA and contract researchers in soil fumigation studies with methyl bromide alternatives in fresh market strawberries and tomatoes. Funding for these studies have been exclusively supported by contributions from various chemical companies Page 31 desiring field testing of potential alternative replacements, either alone or in combination, to that of methyl bromide.

Research Priorities An effort was made to coordinate the research effort and funding as much as possible. Funding for projects undertaken during this initiative has come from federal government sources, USDA and EPA, state level institutional support, University of Florida IFAS Dean for Research,

commodity organizations, and individual grower and industry support.

Since 1993, significant advances have been attempted in Florida towards the evaluation and integration of various chemical and nonchemical tactics to replace the broad spectrum efficacy of soil fumigation uses of methyl bromide. Overall, the results of this collective work also have shown that pest control efficacy for all of the chemical alternatives are generally more highly dependent upon parameters such as uniform delivery and distribution in soil compared to that of methyl bromide. This research has also clearly demonstrated that prevailing soil, soil moisture and climatic conditions can be much more important determinants of efficacy and crop response with the alternative tactics. Previous research evaluating various chemical alternatives to methyl bromide suggests that the mixture of 1,3 dichloropropene ( Telone) with chloropicrin, coupled with separate, but complementary chloropicrin and herbicide treatments for weed control, has a potential as an IPM alternative to methyl bromide to manage soilborne pests and sustain crop yields. Field research continues to focus on fumigant combinations and new herbicide partners, as well refinements in application and incorporation technologies to define and reduce causes of pest and crop response inconsistencies.

The breadth and focus of the methyl bromide alternatives research program in Florida has not been limited exclusively to evaluations of chemical combinations treatment regimes. Rather, the program has encompassed an evaluation of a diversity of nonchemical tactics as well. The nonchemical alternatives which continue to be evaluated in field experimentation include 1) Cover Crops; 2) Host Plant Resistance; 3) Organic Amendments; 4) Solarization/ Biofumigation;

5) Biological Control; 6) Paper and Plastic Mulch Technologies and Emission Reduction; 7) Natural Product Pesticides; and 8) Crop Rotation. A considerable amount of Florida research is also currently evaluating microbial approaches to the enhancement of crop growth and yield potential. Unfortunately, most of these approaches are only marginally effective and remain largely undeveloped and essentially unranked as potential replacements to methyl bromide. Continued research and development of these tactics will require significant commitments of additional research funds and human resources.

Future Research Plans Historically, the principal objective of Florida research has been to evaluate and validate the effectiveness and economic viability of alternatives to methyl bromide soil fumigation for nematode, soilborne disease, and weed control in plastic mulch vegetable production systems in Florida. During the period 1995 to the present, significant advances have been made in the evaluation and integration of various chemical and nonchemical tactics. Ongoing Florida research is still broadly defined to include a diverse mix of chemical and nonchemical alternatives. The magnitude of these research efforts has diminished however with the overall decline in federal and state research funding. Page 32 Underlying the current research projects, and serving as a foundation of future research directives, is a need to focus on long term practical solutions for a very complex cropping system. Current research priorities include the following:

  Continue to identify and further define optimum conditions and procedures required to maximize performance of Telone, chloropicrin, and other fumigant and herbicide products.

  Develop a more comprehensive understanding of the possible biologic and economic impacts of implementing the proposed alternatives to methyl bromide in commercial Florida agriculture.

  Continue to identify and resolve implementational constraints to methyl bromide alternatives ( i. e., high costs, lower efficacy, increased production or environmental risks,

regulatory constraints, and/ or reduced farm profitability) that negatively impact future widespread adoption of such alternatives.

  Identify and evaluate new herbicide partners to Tillam ( Pebulate), which has identified as an integral component of the methyl bromide potential alternative for tomatoes.

  Expand alternative to methyl bromide research efforts in Florida to include pepper, eggplant, cucurbits, cut flowers, caladiums, turf, and ornamentals.

  Continue to develop effective multi crop, IPM based systems, including characterization of impacts and residual effects within current double cropping systems.

  Maintain technology transfer projects to educate growers to learn how to effectively choose, apply, and incorporate alternative chemical so as to maximize pest control, crop response and to avoid problems of plant phytotoxicity and crop loss.

  Continue to identify and evaluate new pest monitoring systems to provide rationale and justification for Florida pest management/ crop production systems.

  Continue to evaluate mulch technologies and procedures to minimize emissions of methyl bromide and other soil fumigant compounds from soil.

  Continue to identify and evaluate emerging nonchemical alternatives.

As research data becomes available and is reviewed, the focus of individual research areas will change. The Florida Alternatives Research Task Force will continue to serve as an information review committee for this research. Additional funding is required to insure a timely and effective research effort.

A sampling of the types of research efforts and individual research programs are attached in Appendix II, A and B, Research Program Information. This is not an all inclusive survey of ongoing research efforts in Florida. Page 33 8) 2003 Application Forms Individual application forms have been completed for the crops and sub regions as identified in the CUE petitions filed last year, Tomato 02 0046, Strawberry 02 0053, and Solanaceous crops other than Tomato 02 0054. A summary of the total amounts request for each crop group is provided in Table 21.

Table 21: Summary of amounts of methyl bromide quantities requested by Florida Tomato, Strawberry, Eggplant and Pepper.

2005 2006 2007 Crop Acres Amount Acres Amount Acres Amount Tomato 52,460 7,344,400 52,460 7,029,640 52,460 7,029,640 Strawberry 7,100 1,278,000 7,100 1,278,000 7,100 1,278,000 Eggplant 1,600 214,400 1,600 214,400 1,600 214,400 Pepper 20,250 2,713,500 20,250 2,713,500 20,250 2,713,500 Attached in the order referenced are the individual completed forms. Completed Application Form OMB Control Number 2060 0482 Tomato ( North Florida) Completed Application Form OMB Control Number 2060 0482 Tomato ( Ruskin Palmetto) Completed Application Form OMB Control Number 2060 0482 Tomato ( Southern Florida   Palm Beach) Completed Application Form OMB Control Number 2060 0482 Tomato ( Southern Florida   Southwest) Completed Application Form OMB Control Number 2060 0482 Tomato ( Dade County) Completed Application Form OMB Control Number 2060 0482 Strawberry Completed Application Form OMB Control Number 2060 0482 Pepper Completed Application Form OMB Control Number 2060 0482 Eggplant


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80314-80315]
[FR Doc No: 2023-25470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0980]

Assessing the Credibility of Computational Modeling and
Simulation in Medical Device Submissions; Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Assessing the
Credibility of Computational Modeling and Simulation in Medical Device
Submissions; Guidance for Industry and Food and Drug Administration
Staff.'' Computational modeling and simulation (CM&S) can be used in a
variety of ways in medical device applications, including to perform
``in silico'' device testing or as part of software embedded in a
device. This guidance provides a risk-informed framework for
credibility assessment of CM&S used in medical device regulatory
submissions. The guidance is intended to promote consistency and
facilitate efficient review of medical device submissions, to increase
confidence in the use of CM&S in regulatory submissions, and to
facilitate improved interpretation of CM&S credibility evidence
submitted in regulatory submissions.

DATES: The announcement of the guidance is published in the Federal
Register on November 17, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0980 for ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Assessing the Credibility of Computational Modeling and Simulation in
Medical Device

Submissions'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Pras Pathmanathan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm 1133, Silver Spring, MD 20993-0002, at
301-796-3490.

SUPPLEMENTARY INFORMATION:

I. Background

    CM&S can be used in a variety of ways in medical device
applications, including to perform ``in silico'' (virtual) device
testing or to influence algorithms within software embedded in a
device. This guidance provides a general risk-informed framework that
can be used in the credibility assessment of CM&S used in medical
device regulatory submissions. For the purposes of this guidance, CM&S
refers to first principles-based (e.g., physics-based or mechanistic)
computational models, and not statistical or data-driven (e.g., machine
learning or artificial intelligence-based) models. This guidance is
intended to help improve the consistency and transparency of the review
of CM&S, to increase confidence in the use of CM&S in regulatory
submissions, and to facilitate improved interpretation of CM&S
credibility evidence submitted in regulatory submissions
    A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72969). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including revising the categorization of credibility
evidence defined in the guidance, clarifying the scope of the guidance,
and clarifying how the recommendations in the guidance relate to the
framework described in the FDA-recognized standard American Society of
Mechanical Engineers V&V 40, ``Assessing Credibility of Computational
Modeling through Verification and Validation: Application to Medical
Devices.''
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Assessing the Credibility of
Computational Modeling and Simulation in Medical Device Submissions''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI01500056 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
     21 CFR part; or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-Submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
------------------------------------------------------------------------

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25470 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35635]
[DOCID:fr21jn06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER03-509-003, ER99-3197-003, ER99-3077-003, ER92-521-001,
ER01-751-007, ER05-698-005, and ER04-1027-001]

Centennial Power, Inc.; BIV Generation Company, LLC; Colorado
Power Partners; Hartwell Energy Limited Partnership; Mountain View
Power Partners, LLC; San Joaquin Cogen LLC; and Rocky Mountain Power,
Inc.; Notice of Filing

June 13, 2006.

    Take notice that on May 18, 2006, Centennial Power, Inc, BIV
Generation Company, LLC; Colorado Power Partners; Hartwell Energy
Limited Partnership; Mountain View Power Partners, LLC; San Joaquin
Cogen LLC and Rocky Mountain Power, Inc. filed a notice of change in
status to reflect the transfer by NAPG San Joaquin, LLC of its member
interests in San Joaquin Cogen, LLC to Centennial Power, Inc.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 23, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9771 Filed 6-20-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40036-40037]
[FR Doc No: 2012-16576]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL9003-8]

Environmental Impacts Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 06/25/2012 Through 06/29/2012

Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

SUPPLEMENTARY INFORMATION: EPA is seeking agencies to participate in
its e-NEPA electronic EIS submission pilot. Participating agencies can
fulfill all requirements for EIS filing, eliminating the need to submit
paper copies to EPA Headquarters, by filing documents online and
providing feedback on the process. To participate in the pilot,
register at: https://cdx.epa.gov.

EIS No. 20120212, Draft EIS, BLM, NM, Rio Puerco Resource Management
Plan, Implementation, Cibola, McKinney, Sandoval, Torrance, and
Valencia Counties, NM, Comment Period Ends: 10/03/2012, Contact: Angel
Martinez<PHONE_NUMBER>.
EIS No. 20120213, Draft EIS, FRA, IL, Chicago to St. Louis High Speed
Rail Program Tier 1, Improvements, Several Counties in IL and St. Louis
County, MO, Comment Period Ends: 08/20/2012, Contact: Andrea Martin
202-493-6201.
EIS No. 20120214, Draft Supplement, NPS, 00, Yellowstone National Park
Draft Winter Use Plan, Addressing the Issue of Oversnow Vehicle Use in
the Interior of the Park, Implementation, WY, MT, and ID, Comment
Period Ends: 08/20/2012, Contact: David Jacob<PHONE_NUMBER>.
EIS No. 20120215, Draft Supplement, NRC, NY, Generic--License Renewal
of Nuclear Plants, Supplement 38, Regarding Indian Point Nuclear
Generating Unit Nos. 2 and 3, New Information, Westchester County, NY,
Comment Period Ends: 08/20/2012, Contact: Michael Wentzel<PHONE_NUMBER>.
EIS No. 20120216, Draft EIS, NOAA, OR, PROGRAMMATIC--Portland Harbor
Restoration Plan, Restoration of Injured Natural Resources, Multnomah
County, OR, Comment Period Ends: 10/08/2012, Contact: Jeff Shenot 301-
427-8689.
EIS No. 20120217, Final EIS, BOEM, 00, Gulf of Mexico Outer Continental
Shelf (OCS) Oil and Gas Lease Sales: 2012-2017 Western Planning Area
Lease Sales 229, 233, 238, 246, and 248: Central Planning Area Lease
Sales 227, 231, 235, 241, and 247, TX, LA, MS, AL and Northwestern FL,
Review Period Ends: 08/06/2012, Contact: Gary Goeke<PHONE_NUMBER>.
EIS No. 20120218, Final EIS, FRA, NY, ADOPTION--East Side Access
Project, Transportation Improvements, To Provide Railroad
Rehabilitation and Improvement Financing Program, New York, Queens,
Bronx, Nassau, and Suffolk Counties, NY, Review Period Ends: 08/06/
2012, Contact: Michelle Fishburne<PHONE_NUMBER>. The U.S. Department of
Transportation's Federal Railroad Administration (FRA) has adopted the
Federal Transit Administration's FEIS filed 3-9-2001. FRA was not a
Cooperating Agency for the above final EIS. Recirculation of the
document is necessary under Section 506.3(b) of the Council on
Environmental Quality Regulations.
EIS No. 20120219, Final EIS, USFS, NM, Santa Fe National Forest Travel
Management, Proposes to Provide for a System of Road, Trails, and Areas
Designated for Motorized Use, Santa Fe, NM, Review Period Ends: 08/06/
2012, Contact: Julie Bain<PHONE_NUMBER>.
EIS No. 20120220, Final EIS, BLM, NV, Hycroft Mine Expansion Project,
Proposes to Expand Mining Activities on BLM Managed Public Land and
Private Land, Approval, Humboldt and Pershing Counties, NV, Review
Period Ends: 08/06/2012, Contact: Kathleen Rehberg<PHONE_NUMBER>.
EIS No. 20120221, Draft EIS, USACE, CA, Mather Specific Plan Project,
Development of Large Scale Mixed Use Development to Promote Economic
and Wetland Conservation Opportunities, Sacramento County, CA, Comment
Period Ends: 08/20/2012, Contact: Kathleen Dadey<PHONE_NUMBER>.
EIS No. 20120222, Final EIS, BOEM, 00, PROGRAMMATIC EIS--Outer
Continental Shelf Oil and Gas Leasing Program--2012-2017 in Six
Planning Area, Western, Central and Eastern Gulf of Mexico, Cook Inlet,
the Beaufort Sea, and the Chukchi Sea, Review Period Ends: 08/06/2012,
Contact: James F. Bennett<PHONE_NUMBER>.

Amended Notices

EIS No. 20050514, Final EIS, NIH, ME, National Emerging Infectious
Diseases Laboratories, Construction of National Biocontainment
Laboratory, BioSquare Research Park, Boston University Medical Center
Campus, Boston, MA, Review Period Ends: 01/09/2006, Contact: Valerie
Nottingham<PHONE_NUMBER>.

    In Support of this Final ESI, NIH is publishing a Final
Supplementary Risk Assessment for the Boston University National
Emerging Infectious Diseases Laboratories (NEIDL). The wait period will
end on 08/06/2012; for more information, please visit http://nihblueribbonpanel-bumc-neidl.od.nih.gov/default.asp.
EIS No. 20100269, Final EIS, USAF, ND, ADOPTION--Grand Forks Air Force
Base Project, Beddown and Flight Operations of Remotely Piloted
Aircraft, Base Realignment and Closure (BRAC), ND, Contact: Doug
Allbright<PHONE_NUMBER>.

    ADOPTION --The U.S. Department of Transportation's Federal Aviation
Administration adopted partial of the U.S. Air Force's Final EIS filed
with EPA. The FAA was a cooperating Agency on the USAF's EIS therefore,
distribution was not necessary for this adoption and there is no
comment period.
EIS No. 20120207, Final EIS, USACE, LA, WITHDRAWN--Mississippi River
Gulf Outlet Ecosystem Restoration, To Develop a Comprehensive Ecosystem
Restoration Plan to Restore the Lake Borgne Ecosystems, LA and MS,
Review Period Ends: 07/30/2012, Contact: Tammy Gilmore<PHONE_NUMBER>
Revision to FR Notice Published on 06/29/2012: Officially Withdrawn by
the USACE.

    Dated: July 2, 2012.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2012-16576 Filed 7-5-12; 8:45 am]
BILLING CODE 6560-50-P