Background

The regulations in 7 CFR part 319 prohibit or restrict the importation of certain plants and plant products into the United States to prevent the introduction of plant pests. Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 to 319.56-47, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States. In this document, we are proposing to make several amendments to the regulations. The proposed amendments are discussed below by topic.

In § 319.56-3, “General requirements for all imported fruits and vegetables,” paragraph (a) requires that “All fruits and vegetables imported under this subpart, whether in commercial or noncommercial consignments, must be free from plant debris, as defined in § 319.56-2.” In § 319.56-2, plant debris is defined as “Detached leaves, twigs, or other portions of plants, or plant litter or rubbish as distinguished from approved parts of clean fruits and vegetables, or other commercial articles.” While that definition does make reference to “approved parts of clean fruits and vegetables,” the definition and the regulations in § 319.56-3(a) may not adequately communicate the fact that there are also parts of clean fruits and vegetables that are not approved for entry.

In order to make that distinction clear, we are proposing to remove the current definition of plant debris and replace it with separate definitions of plant litter and debris and portions of plants . Plant litter and debris would be defined as: “Discarded or decaying organic matter; detached leaves, twigs, or stems that do not add commercial value to the product.” Portions of plants would be defined as: “Stalks or stems, including the pedicel, peduncle, raceme, or panicle, that are normally attached to fruits or vegetables.” At the same time, we would amend § 319.56-3(a) so that it requires all imported fruits and vegetable to be free of plant litter or debris and free of any portions of plants that are specifically prohibited in the regulations. We believe these amendments would make our requirements clearer and more enforceable.

The regulations in § 319.56-29 govern the importation of Ya variety pears from China. Under the regulations in that section, Ya pears may be imported from the Hebei and Shandong Provinces of China if they have been grown, harvested, and packed for export under certain conditions, and if the national plant protection organization (NPPO) of China certifies that those conditions have been met. Ya pears from Shandong Province are also required to undergo cold treatment for the Oriental fruit fly ( Bactrocera dorsalis ).

The regulations had previously required that Ya pears from Hebei Province also undergo cold treatment, but we removed that requirement in a final rule published in the Federal Register on June 10, 2003 (68 FR 34517-34519, Docket No. 02-084-2). Our removal of the cold treatment requirement for Ya pears from Hebei Province was based on trapping results and on climatological and biological considerations. In that June 2003 final rule, in response to a comment, we stated that we would consider removing the cold treatment requirement for Ya pears from Shandong Province if China provided APHIS with data similar to the data submitted for Hebei Province indicating that Oriental fruit fly is not present in Shandong Province.

China has now requested that we amend the regulations to remove the cold treatment requirement for Ya pears from Shandong requirement. China has conducted fruit fly trapping in Shandong Province to monitor for the presence of fruit flies. A total of 943 traps were used to survey a variety of areas including orchards, fruit markets, seaports, airports, etc. Trapping data for 3 years, from 2000 to 2002, show that no fruit flies were trapped. In addition to the trapping data, China's NPPO provided us with published research  1 showing that, based on developmental biology of Bactrocera dorsalis and because of low winter temperatures, large areas of China, including Shandong Province, are unsuitable habitat for the Oriental fruit fly.

The evidence supporting the removal of the cold treatment requirement is discussed in more detail in a risk management document that has been prepared in response to China's request. The document may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above), and copies may be obtained by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Based on our consideration of the information provided by China and the analysis provided in our risk management document, we are proposing to amend § 319.56-29 to remove the cold treatment requirement for Ya pears from Shandong Province.

The regulations in paragraph (a) of § 319.56-13 list a number of fruits and vegetables that may be imported from various countries subject to the specific requirements listed in paragraph (b) of that section as well as the general requirements in § 319.56-3 that apply to all imported fruits and vegetables. Among the articles listed in the table is sand pear ( Pyrus pyrifolia var. culta ) from Japan and the Republic of Korea. The entries for sand pears from each country were added when we reorganized the regulations in a final rule published in the Federal Register on July 18, 2007 (72 FR 39482-39528, Docket No. APHIS-2005-0106).

Prior to that final rule, the importation of sand pears from Japan and the Republic of Korea had been authorized under permit and the conditions of their entry were listed in the fruits and vegetables manual. 2 Under the approach we used in revising the fruits and vegetables regulations, however, we listed the sand pears in the regulations because consignments of sand pears, except sand pears imported into Hawaii, were required to be precleared in Japan and the Republic of Korea prior to their exportation to the United States.

When we added the listings for sand pears from Japan and the Republic of Korea to the table in § 319.56-13(a), we neglected to include a note that the preclearance requirement does not apply to sand pears imported into Hawaii from Japan or the Republic of Korea. While the fruits and vegetables manual continues to list the non-precleared sand pears as eligible for importation into Hawaii, the lack of a reference to that exception in the regulations has caused some confusion. Therefore, we are proposing to amend § 319.56-13(b)(5)(ix) so that it clearly states that the preclearance requirement does not apply to sand pears imported into Hawaii from Japan or the Republic of Korea.

We are also proposing to amend the entry for the Republic of Korea in the table in § 319.56-13(a) so that it appears as “Korea, Republic of.” This change would make the manner in which we list that country consistent with the manner in which the other countries are listed in the table.

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In this document, we are proposing to amend the regulations pertaining to the importation of fruits and vegetables to eliminate a treatment requirement for Ya pears imported from Shandong Province, China; to clarify the conditions that apply to the importation of sand pears from the Republic of Korea and Japan; and to clarify the distinction between plant parts that would be considered to be plant litter or debris and those that would not. Of these proposed changes, only the elimination of the treatment requirement would be expected to result in any economic effects.

Removing the cold treatment requirement for Ya pears imported from Shandong Province would reduce importers' shipping expenses and may also affect domestic pear growers, especially those who produce Ya and other Asian pears, and the wholesalers and distributors of these commodities. However, for both foreign and domestic pear producers, the proposed change in requirements is expected to have a very limited effect on the supply and demand for pears overall.

China is the world's largest producer of pears and accounts for 65 percent of world pear production. According to statistics for marketing year 2005 for three varieties of Chinese pears, including the Ya variety, Hebei Province produced the largest volume of pears, accounting for about 29 percent of pear production in China. Shandong Province produced about 9 percent of China's pears during this time. Although China's Ya pear exports are not classified by the originating province, the removal of the cold treatment requirement of Ya pears produced in Shandong Province may be expected to affect about 25 percent of total U.S. imports of Ya pears from China, assuming that the quantities exported to the United States from the two provinces reflect their relative levels of production.

The shipping expenses of importers seeking to import Ya pears from Shandong Province would, under this proposed rule, be reduced by the amount of the expense of the cold treatment. This amount is estimated to be approximately $0.06 per kilogram of pears. Since the number of Ya pears imported from Shandong Province is estimated to be approximately one-fourth of total Ya pear imports from China, the net impact on the average price of Ya pears would be considerably smaller than $0.06 per kilogram. If the cost reduction associated with the removal of the cold treatment requirement affects the retail price of Ya pears in the United States, it would be minimal.

Under the criteria established by the Small Business Administration, fruit merchant wholesalers (North American Industry Classification System code 424480) must have 100 or fewer employees to be considered small entities. In 2002, there were 5,376 fresh fruit and vegetable merchant wholesalers in the United States with a total of 110,578 paid employees, or, on the average, 21 paid employees per establishment. Therefore, domestic fruit merchant wholesalers that may be affected by the proposed rule are predominantly small entities.

The 2002 Census of Agriculture estimates that there are approximately 11,000 pear growers distributed throughout the United States, and that the vast majority of pear growers operate in orchards smaller than 250 acres, and with less than $750,000 in annual receipts. The average annual sales value of pear growers is estimated to be approximately $24,416 per grower. Based on this data, it is most likely that pear growers in the United States are predominantly small entities.

In the United States, Asian pears represent a small share of the pear industry. In California, which contains the largest number of Asian pear growers in the country, Asian pears constituted about 7 percent of the total harvested acreage in 2006. Of the Asian pear varieties produced in the United States, Ya pears are estimated to make up a very small percentage of the total number. The value of domestic Ya pears is estimated at less than $1 million.

The expected economic effect of removing the cold treatment requirement for Ya pears from Shandong Province is minor. Therefore, this proposed rule is expected to have little effect on importers or producers of Ya pears in the United States.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ).

Accordingly, we propose to amend 7 CFR part 319 as follows:

This proposed rule is issued under Marketing Agreement and Order No. 930 (7 CFR part 930), regulating the handling of tart cherries produced in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (Department) is issuing this proposed rule in conformance with Executive Order 12866.

This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order provisions now in effect, final free and restricted percentages may be established for tart cherries handled by handlers during the crop year. This proposed rule establishes final free and restricted percentages for tart cherries for the 2007-2008 crop year, beginning July 1, 2007, through June 30, 2008. This proposed rule would not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this proposed rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the Secretary a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempt therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction in equity to review the Secretary's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The order prescribes procedures for computing an optimum supply and preliminary and final percentages that establish the amount of tart cherries that can be marketed throughout the season. The regulations apply to all handlers of tart cherries that are in the regulated Districts within the production area. Tart cherries in the free percentage category may be shipped immediately to any market, while restricted percentage tart cherries must be held by handlers in a primary or secondary reserve, or be diverted in accordance with § 930.59 of the order and § 930.159 of the regulations, or used for exempt purposes (to obtain diversion credit) under § 930.62 of the order and § 930.162 of the regulations. The regulated Districts for the 2007-08 season are: District one—Northern Michigan; District two—Central Michigan; District four—New York; District seven—Utah; and District eight—Washington. Districts three, five, and six (Southwest Michigan, Oregon, and Pennsylvania, respectively) will not be regulated for the 2007-2008 season.

The order prescribes under § 930.52 that those districts to be regulated shall be those districts in which the average annual production of cherries over the prior three years has exceeded six million pounds. A district not meeting the six million-pound requirement shall not be regulated in such crop year. Because this requirement was not met in the Districts of Southwest Michigan, Oregon, and Pennsylvania, handlers in those districts would not be subject to volume regulation during the 2007-2008 crop year.

Demand for tart cherries at the farm level is derived from the demand for tart cherry products at retail. Demand for tart cherries and tart cherry products tend to be relatively stable from year to year. The supply of tart cherries, by contrast, varies greatly from crop year to crop year. The magnitude of annual fluctuations in tart cherry supplies is one of the most pronounced for any agricultural commodity in the United States. In addition, since tart cherries are processed either into cans or frozen, they can be stored and carried over from crop year to crop year. This creates substantial coordination and marketing problems. The supply and demand for tart cherries is rarely balanced. The primary purpose of setting free and restricted percentages is to balance supply with demand and reduce large surpluses that may occur.

Section 930.50(a) of the order prescribes procedures for computing an optimum supply for each crop year. The Board must meet on or about July 1 of each crop year, to review sales data, inventory data, current crop forecasts and market conditions. The optimum supply volume is calculated as 100 percent of the average sales of the prior three years to which is added a desirable carryout inventory not to exceed 20 million pounds or such other amount as may be established with the approval of the Secretary. The optimum supply represents the desirable volume of tart cherries that should be available for sale in the coming crop year.

The order also provides that on or about July 1 of each crop year, the Board is required to establish preliminary free and restricted percentages. These percentages are computed by deducting the actual carryin inventory from the optimum supply figure (adjusted to raw product equivalent—the actual weight of cherries handled to process into cherry products) and subtracting that figure from the current year's USDA crop forecast or by an average of such other crop estimates the Board votes to use. If the resulting number is positive, this represents the estimated over-production, which would be the restricted tonnage. The restricted tonnage is then divided by the sum of the crop forecast(s) for the regulated districts to obtain percentages for the regulated districts. The Board is required to establish a preliminary restricted percentage equal to the quotient, rounded to the nearest whole number, with the complement being the preliminary free tonnage percentage. If the tonnage requirements for the year are more than the USDA crop forecast, the Board is required to establish a preliminary free tonnage percentage of 100 percent and a preliminary restricted percentage of zero. The Board is required to announce the preliminary percentages in accordance with paragraph (h) of Sec. 930.50.

The Board met on June 21, 2007, and computed, for the 2007-2008 crop year, an optimum supply of 175 million pounds. The Board recommended that the desirable carryout figure be zero pounds. Desirable carryout is the amount of fruit required to be carried into the succeeding crop year and is set by the Board after considering market circumstances and needs. This figure can range from zero to a maximum of 20 million pounds.

The Board calculated preliminary free and restricted percentages as follows: The USDA estimate of the crop for the entire production area was 294 million pounds; a 42 million pound carryin (based on Board estimates) was subtracted from the optimum supply of 175 million pounds which resulted in the 2007-2008 poundage requirements (adjusted optimum supply) of 133 million pounds. The carryin figure reflects the amount of cherries that handlers actually have in inventory at the beginning of the 2006-2007 crop year. Subtracting the adjusted optimum supply of 133 million pounds from the USDA crop estimate (294 million pounds) leaves a surplus of 161 million pounds of tart cherries. Subtracting an additional 12 million pounds for USDA purchases of tart cherry products from the 2006-07 crop but not delivered until 2007 results in a final surplus of 149 million pounds of tart cherries. The surplus (149 million pounds) was divided by the production in the regulated districts (289 million pounds) and resulted in a restricted percentage of 52 percent for the 2007-2008 crop year. The free percentage was 48 percent (100 percent minus 52 percent). The Board established these percentages and announced them to the industry as required by the order.

The preliminary percentages were based on the USDA production estimate and the following supply and demand information available at the June meeting for the 2007-2008 year:

Between July 1 and September 15 of each crop year, the Board may modify the preliminary free and restricted percentages by announcing interim free and restricted percentages to adjust to the actual pack occurring in the industry.

The Secretary establishes final free and restricted percentages through the informal rulemaking process. These percentages would make available the tart cherries necessary to achieve the optimum supply figure calculated by the Board. The difference between any final free percentage designated by the Secretary and 100 percent is the final restricted percentage. The Board met on September 6, 2007, to recommend final free and restricted percentages.

The actual production reported by the Board was 248 million pounds, which is a 46 million pound decrease from the USDA crop estimate of 294 million pounds.

A 39 million pound carryin (based on handler reports estimates) was subtracted from the optimum supply of 174 million pounds, yielding an adjusted optimum supply for the 2007- 2008 crop year of 135 million pounds. Subtracting the adjusted optimum supply of 135 million pounds from the USDA crop estimate (248 million pounds) and subtracting 12 million pounds for USDA purchases of tart cherry products from the 2006-07 crop but not delivered until 2007 results in a surplus of 101 million pounds of tart cherries. The surplus was divided by the production in the regulated districts (236 million pounds) and resulted in a restricted percentage of 43 percent for the 2007-2008 crop year. The free percentage was 57 percent (100 percent minus 43 percent).

The final percentages are based on the Board's reported production figures and the following supply and demand information available in September for the 2007-2008 crop year:

USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” specify that 110 percent of recent years' sales should be made available to primary markets each season before recommendations for volume regulation are approved. This goal would be met by the establishment of a preliminary percentage which releases 100 percent of the optimum supply and the additional release of tart cherries provided under § 930.50(g). This release of tonnage, equal to 10 percent of the average sales of the prior three years sales, is made available to handlers each season. The Board recommended that such release should be made available to handlers the first week of December and the first week of May. Handlers can decide how much of the 10 percent release they would like to receive on the December and May release dates. Once released, such cherries are released for free use by such handler. Approximately 17 million pounds would be made available to handlers this season in accordance with Department Guidelines. This release would be made available to every handler and released to such handler in proportion to the handler's percentage of the total regulated crop handled. If a handler does not take his/her proportionate amount, such amount remains in the inventory reserve.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 40 handlers of tart cherries who are subject to regulation under the tart cherry marketing order and approximately 900 producers of tart cherries in the regulated area. Small agricultural service firms, which includes handlers, have been defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $6,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. A majority of the producers and handlers are considered small entities under SBA's standards.

The principal demand for tart cherries is in the form of processed products. Tart cherries are dried, frozen, canned, juiced, and pureed. During the period 2002/03 through 2006/07, approximately 97.9 percent of the U.S. tart cherry crop, or 202.9 million pounds, was processed annually. Of the 202.9 million pounds of tart cherries processed, 63.5 percent was frozen, 23.8 percent was canned, and 12.7 percent was utilized for juice and other products.

Based on National Agricultural Statistics Service data, acreage in the United States devoted to tart cherry production has been trending downward. Bearing acreage has declined from a high of 50,050 acres in 1987/88 to 35,800 acres in 2006/07. This represents a 29 percent decrease in total bearing acres. Michigan leads the nation in tart cherry acreage with 70 percent of the total and produces about 75 percent of the U.S. tart cherry crop each year.

The 2007/08 crop is moderate in size at 248 million pounds. The largest crop occurred in 1995 with production in the regulated districts reaching a record 395.6 million pounds. The price per pound received by tart cherry growers ranged from a low of 5.6 cents in 1995 to a high of 46.4 cents in 1991. These problems of wide supply and price fluctuations in the tart cherry industry are national in scope and impact. Growers testified during the order promulgation process that the prices they received often did not come close to covering the costs of production.

The industry demonstrated a need for an order during the promulgation process of the marketing order because large variations in annual tart cherry supplies tend to lead to fluctuations in prices and disorderly marketing. As a result of these fluctuations in supply and price, growers realize less income. The industry chose a volume control marketing order to even out these wide variations in supply and improve returns to growers. During the promulgation process, proponents testified that small growers and processors would have the most to gain from implementation of a marketing order because many such growers and handlers had been going out of business due to low tart cherry prices. They also testified that, since an order would help increase grower returns, this should increase the buffer between business success and failure because small growers and handlers tend to be less capitalized than larger growers and handlers.

Aggregate demand for tart cherries and tart cherry products tends to be relatively stable from year-to-year. Similarly, prices at the retail level show minimal variation. Consumer prices in grocery stores, and particularly in food service markets, largely do not reflect fluctuations in cherry supplies. Retail demand is assumed to be highly inelastic which indicates that price reductions do not result in large increases in the quantity demanded. Most tart cherries are sold to food service outlets and to consumers as pie filling; frozen cherries are sold as an ingredient to manufacturers of pies and cherry desserts. Juice and dried cherries are expanding market outlets for tart cherries.

Demand for tart cherries at the farm level is derived from the demand for tart cherry products at retail. In general, the farm-level demand for a commodity consists of the demand at retail or food service outlets minus per-unit processing and distribution costs incurred in transforming the raw farm commodity into a product available to consumers. These costs comprise what is known as the “marketing margin.”

The supply of tart cherries, by contrast, varies greatly. The magnitude of annual fluctuations in tart cherry supplies is one of the most pronounced for any agricultural commodity in the United States. In addition, since tart cherries are processed either into cans or frozen, they can be stored and carried over from year-to-year. This creates substantial coordination and marketing problems. The supply and demand for tart cherries is rarely in equilibrium. As a result, grower prices fluctuate widely, reflecting the large swings in annual supplies.

In an effort to stabilize prices and supplies, the tart cherry industry uses the volume control mechanisms under the authority of the Federal marketing order. This authority allows the industry to set free and restricted percentages. These restricted percentages are only applied to states or districts with a 3-year average of production greater than six million pounds, and to states or districts in which the production is 50 percent or more of the previous 5-year processed production average.

The primary purpose of setting restricted percentages is an attempt to bring supply and demand into balance. If the primary market is over-supplied with cherries, grower prices decline substantially.

The tart cherry sector uses an industry-wide storage program as a supplemental coordinating mechanism under the Federal marketing order. The primary purpose of the storage program is to warehouse supplies in large crop years in order to supplement supplies in short crop years. The storage approach is feasible because the increase in price—when moving from a large crop to a short crop year—more than offsets the costs for storage, interest, and handling of the stored cherries.

The price that growers receive for their crop is largely determined by the total production volume and carry-in inventories. The Federal marketing order permits the industry to exercise supply control provisions, which allow for the establishment of free and restricted percentages for the primary market, and a storage program. The establishment of restricted percentages impacts the production to be marketed in the primary market, while the storage program has an impact on the volume of unsold inventories.

The volume control mechanism used by the cherry industry results in decreased shipments to primary markets. Without volume control the primary markets (domestic) would likely be over-supplied, resulting in lower grower prices.

To assess the impact that volume control has on the prices growers receive for their product, an econometric model has been developed. The econometric model provides a way to see what impacts volume control may have on grower prices. The two districts in Michigan, along with the districts in Utah, New York, Washington, and Wisconsin are the restricted areas for this crop year and their combined total production is 236 million pounds. A 43 percent restriction means 186 million pounds is available to be shipped to primary markets.

In addition, USDA requires a 10 percent release from reserves as a market growth factor. This results in an additional 17 million pounds being available for the primary market. The 135 million pounds from the two regulated districts in Michigan, Utah, Washington, New York, and Wisconsin, the 12.3 million pounds from the other producing states, the 17 million pound release, and the 39 million pound carry-in inventory gives a total of 203 million pounds being available for the primary markets.

The econometric model is used to estimate grower prices with and without regulation. Without the volume controls, grower prices are estimated to be approximately $0.12 higher than without volume controls.

The use of volume controls is estimated to have a positive impact on growers' total revenues. Without regulation, growers' total revenues from processed cherries are estimated to be $10.1 million higher than without restrictions. The without restrictions scenario assumes that all tart cherries produced would be delivered to processors for payments.

It is concluded that the 43 percent volume control would not unduly burden producers, particularly smaller growers. The 43 percent restriction would be applied to the growers in the two districts in Michigan, New York, Utah, Washington, and Wisconsin. The growers in the other two states and the one district in Michigan covered under the marketing order will benefit from this restriction.

The use of volume controls is believed to have little or no effect on consumer prices and will not result in fewer retail sales or sales to food service outlets.

Without the use of volume controls, the industry could be expected to start to build large amounts of unwanted inventories. These inventories have a depressing effect on grower prices. The econometric model shows for every 1 million-pound increase in carryin inventories, a decrease in grower prices of $0.0033 per pound occurs. The use of volume controls allows the industry to supply the primary markets while avoiding the disastrous results of over-supplying these markets. In addition, through volume control, the industry has an additional supply of cherries that can be used to develop secondary markets such as exports and the development of new products. The use of reserve cherries in the production shortened 2002-2003 crop year proved to be very useful and beneficial to growers and packers.

In discussing the possibility of marketing percentages for the 2007-2008 crop year, the Board considered the following factors contained in the marketing policy: (1) The estimated total production of tart cherries; (2) the estimated size of the crop to be handled; (3) the expected general quality of such cherry production; (4) the expected carryover as of July 1 of canned and frozen cherries and other cherry products; (5) the expected demand conditions for cherries in different market segments; (6) supplies of competing commodities; (7) an analysis of economic factors having a bearing on the marketing of cherries; (8) the estimated tonnage held by handlers in primary or secondary inventory reserves; and (9) any estimated release of primary or secondary inventory reserve cherries during the crop year.

The Board's review of the factors resulted in the computation and announcement in September 2007 of the free and restricted percentages proposed to be established by this rule (57 percent free and 43 percent restricted).

One alternative to this action would be not to have volume regulation this season. Board members stated that no volume regulation would be detrimental to the tart cherry industry due to the size of the 2007-2008 crop. Returns to growers would not cover their costs of production for this season which might cause some to go out of business.

As mentioned earlier, the Department's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” specify that 110 percent of recent years' sales should be made available to primary markets each season before recommendations for volume regulation are approved. The quantity available under this rule is 110 percent of the quantity shipped in the prior three years.

The free and restricted percentages established by this rule release the optimum supply and apply uniformly to all regulated handlers in the industry, regardless of size. There are no known additional costs incurred by small handlers that are not incurred by large handlers. The stabilizing effects of the percentages impact all handlers positively by helping them maintain and expand markets, despite seasonal supply fluctuations. Likewise, price stability positively impacts all producers by allowing them to better anticipate the revenues their tart cherries will generate.

While the benefits resulting from this rulemaking are difficult to quantify, the stabilizing effects of the volume regulations impact both small and large handlers positively by helping them maintain markets even though tart cherry supplies fluctuate widely from season to season.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this regulation.

In addition, the Board's meeting was widely publicized throughout the tart cherry industry and all interested persons were invited to attend the meeting and participate in Board deliberations on all issues. Like all Board meetings, the September 6, 2007, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320) which implement the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the information collection and recordkeeping requirements under the tart cherry marketing order have been previously approved by OMB and assigned OMB Number 0581-0177.

Reporting and recordkeeping burdens are necessary for compliance purposes and for developing statistical data for maintenance of the program. The forms require information which is readily available from handler records and which can be provided without data processing equipment or trained statistical staff. As with other, similar marketing order programs, reports and forms are periodically studied to reduce or eliminate duplicate information collection burdens by industry and public sector agencies. This rule does not change those requirements.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services and for other purposes.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

A 30-day comment period is provided to allow interested persons to respond to this proposal. Thirty days is deemed appropriate because this rule would need to be in place as soon as possible since handlers are already shipping tart cherries from the 2007-2008 crop. All written comments timely received will be considered before a final determination is made on this matter.

For the reasons set forth in the preamble, 7 CFR part 930 is proposed to be amended as follows:

This proposal is issued under Marketing Agreement No. 97 and Marketing Order No. 948, both as amended (7 CFR part 948), regulating the handling of Irish potatoes grown in Colorado, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This proposal will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposal invites comments on a modification of the minimum size requirements under the order. The minimum size requirements for Area No. 2 potatoes currently allow the handling of potatoes that are at least 2 inches in diameter or 4 ounces minimum weight, except that round potatoes may be of any weight, and Russet Burbank, Russet Norkotah, and Silverton Russet varieties may be a minimum of 1 7/8 inches in diameter or 4 ounces in weight. This rule would remove the exception that Russet Burbank, Russet Norkotah, and Silverton Russet varieties may be 1 7/8 inches in diameter. This rule was recommended by the Committee at a meeting on August 16, 2007.

Section 948.22 authorizes the issuance of grade, size, quality, maturity, pack, and container regulations for potatoes grown in the production area. Section 948.21 further authorizes the modification, suspension, or termination of requirements issued pursuant to § 948.22.

Section 948.40 provides that whenever the handling of potatoes is regulated pursuant to §§ 948.20 through 948.24, such potatoes must be inspected by the Federal-State Inspection Service, and certified as meeting the applicable requirements of such regulations.

Under the order, the State of Colorado is divided into three areas of regulation for marketing order purposes. These include: Area No. 1, commonly known as the Western Slope, includes and consists of the counties of Routt, Eagle, Pitkin, Gunnison, Hinsdale, La Plata, and all counties west thereof; Area No. 2, commonly known as the San Luis Valley, includes and consists of the counties of Sanguache, Huerfano, Las Animas, Mineral, Archuleta, and all counties south thereof; and, Area No. 3 includes and consists of all the remaining counties in the State of Colorado which are not included in Area No. 1 or Area No. 2. The order currently regulates the handling of potatoes grown in Areas No. 2 and No. 3 only; regulation for Area No. 1 is currently not active.

Grade, size, and maturity regulations specific to the handling of potatoes grown in Area No. 2 are contained in § 948.386 of the order.

On August 16, 2001, the Committee recommended increasing the minimum size requirements from 1 7/8 inches to 2 inches in diameter or 4 ounces minimum weight for all varieties of potatoes, except for round varieties and the Russet Burbank, Russet Norkotah, and Silverton Russet varieties. This recommendation was made effective July 15, 2002 (67 FR 40844). The Russet Burbank, Russet Norkotah, and Silverton Russet varieties were left at 1 7/8 inches minimum diameter.

The Committee believes that the demand for fresh potatoes has decreased for the last several years and there are abundant supplies in the marketplace. Consumers prefer larger, higher quality potatoes. After reviewing market data over the past six years, the Committee decided to recommend removing the minimum size exception for Russet Burbank, Russet Norkotah, and Silverton Russet varieties. The Committee reports that potato size is important to consumers and that providing the sizes desired is necessary to maintain consumer confidence in the marketplace. The Committee believes that quality assurance is very important to the Colorado potato industry. The Committee also believes that most Colorado potato handlers are shipping Russet varieties at a minimum size of 2 inches in diameter or 4 ounces minimum weight. Providing customers with acceptable quality produce on a consistent basis is necessary to maintain buyer confidence in the marketplace and improve producer returns.

Under this proposal, Russet potatoes subject to minimum size requirements would meet the size requirements if they are at least 2 inches in diameter or 4 ounces in weight. Some long, thin potatoes might be smaller than 2 inches in diameter, but weigh at least 4 ounces. These potatoes would meet the proposed size requirements. Some potatoes might weigh less than 4 ounces, but be at least 2 inches in diameter. These potatoes would also meet the proposed minimum size requirements.

Twelve members voted in favor of the proposed change and one member voted in opposition. The dissenting member was concerned that some industry members who produce smaller Russet potatoes might not support the change. The Committee made the recommendation to provide buyers with the sizes they prefer and to maintain buyer confidence. The Committee believes that this change would facilitate the handling and marketing of Colorado Area No. 2 potatoes and help improve producer returns.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 77 handlers of Colorado Area No. 2 potatoes subject to regulation under the order and approximately 180 producers in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts are less than $6,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000.

During the 2006-2007 marketing year, approximately 16,061,432 hundredweight of Colorado Area No. 2 potatoes were inspected under the order and sold into the fresh market. Based on an estimated average f.o.b. price of $11.00 per hundredweight, the Committee estimates that 66 Area No. 2 handlers, or about 86 percent, had annual receipts of less than $6,500,000. In view of the foregoing, the majority of Colorado Area No. 2 potato handlers may be classified as small entities.

In addition, based on information provided by the National Agricultural Statistics Service (NASS), the average producer price for Colorado potatoes for 2006 was $8.80 per hundredweight. The average annual fresh potato revenue for the Colorado Area No. 2 potato producers is therefore calculated to be approximately $785,226. Consequently, on average, the majority of the Area No. 2 Colorado potato producers may not be classified as small entities.

This rule would remove the exception that Russet Burbank, Russet Norkotah, and Silverton Russet varieties of Area No. 2 Colorado potatoes may be 1 7/8 inches in diameter. This rule would thus have the effect of increasing the minimum size requirements for Russet potatoes from 1 7/8 inches in diameter to 2 inches in diameter or 4 ounces in weight. Authority for this action is contained in §§ 948.21, 948.22, 948.40, and 948.386.

NASS estimated planted acreage for the 2006 crop in Area No. 2 at 59,900 acres, an increase of 1,700 acres when compared with 58,200 acres planted in 2005. In 2006, NASS data shows that Russet Norkotah, the most popular variety, was planted on 60.3 percent of the total potato acreage. Other Russet varieties accounted for 20.6 percent of the total acres planted, with various other varieties making up the remaining 19.1 percent.

Based on Committee records, 89.6 percent of Area No. 2 potatoes entered the fresh market during the 2006-2007 marketing year (including potatoes produced for seed). Of those potatoes, Russet potato varieties accounted for 89.2 percent.

Only a small portion of the crop is expected to be affected by the proposed size increase (i.e., that portion of Russet Burbank, Russet Norkotah, or Silverton Russet varieties smaller than 2 inches in diameter or 4 ounces in weight, but larger than 1 7/8 inches in diameter). Based on current customer demand, many handlers are already shipping 2-inch minimum diameter Russet potatoes. The Committee believes that the expected benefits of improved quality, increased purchases and sales volume, and increased returns received by producers would greatly outweigh the costs related to the regulation.

After discussing possible alternatives to this rule, the Committee determined that an increase in the minimum size for Russet varieties would increase returns to growers while supplying the market with a higher percentage of larger high quality potatoes. The Committee believes that the expected benefits are improved quality, increased purchases and sales volume, and increased returns received by producers. During its deliberations, the Committee also considered increasing the minimum size to 2 1/8 inches or 5 ounces in weight for Russet varieties. However, the Committee decided that increasing the minimum size from 1 7/8 inches diameter to 2 1/8 inches in diameter would be too restrictive at this time.

This proposed rule would increase the size requirements for Russet varieties of potatoes under the order. Accordingly, this action would not impose any additional reporting or recordkeeping requirements on either small or large Russet potato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this proposed rule.

In addition, the Committee's meeting was widely publicized throughout the Colorado Area No. 2 potato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the August 16, 2007, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html . Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

A 15-day comment period is provided to allow interested persons to respond to this proposal. Fifteen days is deemed appropriate because this rule would need to be in place as soon as possible since handlers are already shipping potatoes from the 2007-2008 crop. All written comments timely received will be considered before a final determination is made on this matter.

For the reasons set forth in the preamble, 7 CFR part 948 is proposed to be amended as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0308; Directorate Identifier 2007-NM-160-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

A report has been completed about a joint Boeing and FAA multi-model study (following in-service trailing edge flap structure and drive system events) on the hazards posed by skewing and failed flaps. The study identified safety concerns with the transmission attachment design, which does not meet the single failure condition analysis criteria. Three bolts attach the transmission to the flap track. The fracture of one of the transmission attachment bolts in flight could lead to an overload failure of the two remaining bolts and subsequent loss of the transmission. In addition, a support housing with an undetected fracture could lead to the loss of the transmission. Loss of the flap transmission could lead to a flap skew or lateral control asymmetry. Loss of a transmission could lead to possible collateral damage to adjacent hydraulic tubing and the loss of a hydraulic system. A flap skew or asymmetry combined with collateral hydraulic system damage could result in the asymmetric flight control limits being exceeded, and could adversely affect the airplane's continued safe flight and landing.

We have reviewed Boeing Alert Service Bulletins 747-27A2398 and 747-27A2421, both dated April 19, 2007. The service bulletins describe the following procedures for modifying the outboard trailing edge flaps, including the following “airplane work”:

• Replacing the flap tracks and flap transmissions with a new configuration (flap tracks and flap transmissions 1, 2, 7, and 8);

• Reversing the bolt direction on the flap track side load fitting; and

• Installing new flap track fairing hinge braces. The service bulletins describe the following component work:

• Replacing the upper forward and the upper aft flap transmission attachment bolt hole bushings;

• Replacing the support housing;

• Machining the track and installing the larger diameter bolt hole bushings, at the upper forward and upper aft flap transmission attachment locations (flap track assemblies 1 and 8) and at the upper aft flap transmission attachment location (flap track assemblies 2 and 7); and

• Replacing the existing support housing with the new support housing (flap transmission assemblies 1, 2, 7, and 8).

The compliance time is 6 years for airplanes known to have fewer than 20,000 total flight cycles, and 3 years for all other airplanes.

Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition.

We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. For this reason, we are proposing this AD, which would require the actions specified in the service information described previously.

There are about 990 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0300; Directorate Identifier 2007-NM-191-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The Civil Aviation Authority—The Netherlands (CAA-NL), which is the aviation authority for the Netherlands, has issued Dutch Airworthiness Directive NL-2005-013, dated October 17, 2005 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

The inspection is intended to find indications of incorrect fit, damage, or wear. Corrective actions include a related investigative action (inspecting for incorrect fit, damage, or wear of the aerodynamic seal of the fairings, and inspecting for damage or wear of the abrasion resistant coating on the mating surface of the fuselage skin), restoring damaged abrasion-resistant coatings, correcting fairing positions, and replacing damaged fairing seals. You may obtain further information by examining the MCAI in the AD docket.

Fokker Services B.V. has issued Service Bulletin SBF100-53-101, dated September 30, 2005. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect about 12 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $960, or $80 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

In the 2005 proposed rule, FDA proposed to amend the definitions of “milk” and “nonfat” milk in § 133.3 (21 CFR 133.3) for cheeses and related cheese products to: (1) Provide for ultrafiltration of milk and nonfat milk; (2) define UF milk and UF nonfat milk as raw or pasteurized milk or nonfat milk that is passed over one or more semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the casein-to-whey protein ratio of the milk or nonfat milk and resulting in a liquid product; and (3) require that such treated milk be declared in the ingredient statement of the finished food as “ultrafiltered milk” and “ultrafiltered nonfat milk,” respectively.

FDA proposed these amendments principally in response to two citizen petitions, one submitted by the American Dairy Products Institute (Docket No. 1999P-5198 (formerly Docket No. 99P-5198)) and another submitted jointly by the National Cheese Institute, the Grocery Manufacturers of America, Inc., and the National Food Processors Association (the NCI petition; Docket No. 2000P-0586 (formerly Docket No. 00P-0586)). In the 2005 proposed rule, FDA explained the scientific and legal basis for its tentative conclusion to permit the use of fluid UF milk as an ingredient and provided a tentative definition of fluid UF milk. In addition, FDA tentatively concluded that fluid UF milk, as defined, is significantly different in its composition from the starting material “milk” and, therefore, proposed that fluid UF milk must be declared as “ultrafiltered milk” in the ingredient statement of the finished cheese. FDA requested comments on the 2005 proposed rule by January 17, 2006.

The agency received about 24 responses (letters and e-mails), each containing 1 or more comments, in response to the 2005 proposed rule. A majority of the comments were from industry, including cheese manufacturers and milk producers and processors, while other comments were from farmers or groups representing farmers, individual consumers, foreign governments, a research institution, and a member of Congress. Most comments supported the proposed use of fluid UF milk in standardized cheeses and related cheese products and several comments encouraged the agency to adopt the definition of fluid UF milk as proposed. However, although they did not disagree that fluid UF milk is significantly different from “milk,” several comments opposed the proposed provision to require fluid UF milk or fluid UF nonfat milk to be declared as “ultrafiltered milk” or “ultrafiltered nonfat milk,” respectively. They cited several reasons for their opposition. FDA is seeking public comment only with respect to two of their reasons that: (1) Due to economic and logistical burdens, it would be impracticable for cheese manufacturers to comply with the labeling requirement; and (2) the proposed provision to declare fluid UF milk as “ultrafiltered milk” would be misleading to consumers in that consumers incorrectly believe that cheeses that declare “ultrafiltered milk” as an ingredient are different from those cheeses that declare “milk” as an ingredient or “milk and ultrafiltered milk” as ingredients. In section III of this document, the agency discusses the primary arguments that the comments presented with respect to each of these reasons.

Comments also opposed other tentative conclusions that the agency stated in the 2005 proposed rule. The agency has considered those comments and intends to respond to all issues raised by the comments in any subsequent final rule. However, at this time, the agency is not seeking further comment on any topic other than the two related to the labeling provision, as described in section III of this document.

By way of background, section 403(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343), which governs the labeling of ingredients in foods, requires, with few exceptions, the declaration of all ingredients by their individual common or usual names. Section 403(i) of the act also provides that to the extent that compliance with this requirement “is impracticable, or results in deception or unfair competition,” FDA shall establish regulations for exemptions from this requirement.

As noted in section II of this document, FDA received comments from industry opposing the proposed requirement to declare fluid UF milk as “ultrafiltered milk” or “ultrafiltered nonfat milk” in the ingredient statement of the finished cheese in which these ingredients are used. FDA is seeking comments with respect to two of the reasons that these comments cited in support of their opposition to the proposed labeling provision, i.e., that it would be impracticable for industry to comply with the proposed labeling requirement and that declaring fluid UF milk as “ultrafiltered milk” would be misleading to consumers.

Comments previously submitted to the Division of Dockets Management do not need to be and should not be resubmitted. All comments previously submitted to the docket number found in brackets in the heading of this document, and comments submitted in response to this limited reopening of the comment period, will be considered in any final rule to the 2005 proposed rule.

Some comments stated that the proposed labeling requirement would be impracticable for the cheese industry to implement in a cost-effective way. They stated that the cost of complying with the proposed labeling requirement would outweigh any economic benefits provided by the use of fluid UF milk in cheesemaking. They further maintained that cheese manufacturers have long used UF milk in cheddar and mozzarella cheeses without declaring it as “ultrafiltered milk.” Another comment emphasized that “outsourced UF milk” (a term the comments used to refer to milk that is ultrafiltered at a facility other than the plant where the cheese is produced) is widely used in today's marketplace and labeling changes at this time would reduce or eliminate the currently realized economic benefits of using UF milk. The comments contained several arguments in support of their claim of impracticability.

(Comment 1) Some comments stated that cheese manufacturers do not use “outsourced UF milk” on a consistent basis and that they use milk and “outsourced UF milk” interchangeably as needed and economically practical and, therefore, it would be economically and logistically burdensome to monitor the use of UF milk.

(Response) The agency questions the basis for this argument. The 2005 proposed rule provides for optional (not mandatory) use of fluid UF milk and, therefore, manufacturers have the option to use fluid UF milk as an ingredient only if it is economically practical. Cost considerations would factor into a firm's decision to use fluid UF milk, as with any other ingredient. Furthermore, it is FDA's understanding that fluid UF milk is likely to be used simultaneously, not interchangeably, with milk. As FDA explained in the 2005 proposed rule (70 FR 60751 at 60759), most cheeses are amenable to the use of fluid UF milk, not in lieu of milk, but as a supplement to milk to produce a protein-standardized milk and thus increase cheese yield. In addition, the petitioners acknowledged that fluid UF milk is economically beneficial to cheese manufacturers because it increases cheese yield, decreases production time, and decreases costs associated with shipping of raw materials and disposal of whey (a byproduct of cheesemaking) (pp. 8-9, the NCI petition).

(Comment 2) According to a trade association, cheese manufacturers do not have information technology systems in place to track and measure the presence of “outsourced UF milk” and tracking “outsourced UF milk” becomes even more unmanageable as the cheese is further processed into other products, such as shredded cheese blends. Further, the comment indicated that suppliers often do not provide information on whether the cheese product is made from UF milk and to do so would mean more logistical difficulties and added costs. The comment also argued that a cheese processor has no way to test a product from a supplier to determine if UF milk was used and thus ensure that the correct label was affixed to the finished food.

(Response) It is the agency's understanding that most cheesemaking production lines are fully automated and allow manufacturers to track raw materials from receiving docks through to finished products. Published literature, including articles in trade journals, indicate that computer-integrated manufacturing systems are used to control ingredient feeders and maintain detailed records of the combination of ingredients used and results of laboratory analyses of ingredients and product formulations (Refs. 1 and 2). Another publication indicated that automation in the dairy industry enables manufacturers to track every batch of cheese that is produced, including the combination of ingredients that are fed into each batch (Ref. 3). Moreover, food manufacturers would have to monitor the ingredients that are used to manufacture the food they market in order to comply with the ingredient declaration provisions of § 101.4 (21 CFR 101.4). Therefore, it is unclear to the agency why a cheese supplier would not provide information about the ingredients (including fluid UF milk, when used) that are used to produce the cheese. With respect to the cost argument, the 2005 proposed rule provides for optional (not mandatory) use of fluid UF milk and, therefore, manufacturers have the option to weigh any associated costs against benefits to determine whether it would be economically beneficial to use fluid UF milk in cheese.

(Comment 3) The trade association also estimated that, in order to comply with the labeling requirement, cheese manufacturers will, at a minimum, need to triple their label inventory. According to this comment, associated costs that will also increase include:

• Producing more labels (estimated at $985,000 to $2.7 million);

• Carrying additional packaging inventory, risk of obsolete packaging, and additional storage space (estimated at doubling or tripling of current costs);

• Increasing raw material inventory (estimated at $470,000 to $5.8 million);

• Additional personnel (estimated at $240,000 to $900,000); and

• Administrative and logistical problems (estimates of $5.4 million and $72 million).

(Comment 4) Another comment stated that the proposed labeling requirement would result in costs to modify tracking systems, update specifications, and update quality control programs as well as costs associated with increased inventory of raw materials, packaging, and finished goods. This comment estimated the cost of complying with the labeling requirement to be about $23 million.

(Response) The comments did not provide a detailed or itemized breakdown of the estimation of these costs sufficient to enable the agency to conduct any meaningful analysis of these figures. FDA requests that interested persons submitting comments on this issue provide such data. It is FDA's current understanding that cheese manufacturing facilities are already equipped with systems that can handle multiple ingredients and combinations of ingredients in the manufacture of a cheese product and, therefore, can easily adapt to the introduction of a single, new ingredient. Indeed, manufacturers routinely adjust existing product formulations or introduce new ones based on supply and availability of ingredients and market demand. Thus, FDA questions the additional cost described in the comments associated with the labeling of this new ingredient given the extensive monitoring systems already in place.

(Comment 5) The trade association also asserted that under the proposed labeling requirement, operational efficiencies would decline, cheese plants would lose up to an hour a day changing packaging, and additional time would be spent auditing labels to ensure proper labeling.

(Response) It seems possible to FDA that declines in operational efficiencies can be avoided by proper planning of the production run. Further, any decrease in efficiency due to the labeling requirement is likely to be offset by increased yield, increased through-put (decreased time between coagulation and cutting phases), and increased overall production efficiency. Moreover, the provision for fluid UF milk, as stated in the 2005 proposed rule, is optional and, if finalized as proposed, would not limit manufacturers' ability to weigh different cost considerations to determine whether it would be economical to use fluid UF milk in their cheese production.

FDA is interested in factual information or data that would enable the agency to fully evaluate claims in these comments that it would be impracticable for the cheese industry to comply with the proposed labeling requirement. In particular, FDA seeks information on the following questions:

1. What systems do cheese plants use to monitor ingredients received and ingredients used in different cheeses and related cheese products?

2. How extensively are cheese plants automated with respect to tracking the use of different ingredients?

3. What types of costs are associated with introducing a new ingredient into cheesemaking?

4. How are costs associated with the use of fluid UF milk different from those associated with the use of any other new ingredient or other reformulation of a cheese product?

5. Are the costs associated with the labeling of UF milk that are estimated by the two comments noted previously reasonable? Explain.

6. What mechanisms do manufacturers of cheese-based products (for example, cheese spreads, processed cheeses, shredded cheese blends) currently employ to ensure that the ingredients used in their products, including the sub-ingredients of the cheeses used in their products, are accurately declared? Why are these same mechanisms inadequate to accurately identify fluid UF milk when it is a sub-ingredient of a cheese ingredient?

Comments that opposed the proposed labeling requirement stated that this requirement would lead to consumer confusion and deception. They stated that consumers would be misled by special ingredient labeling of UF milk, given that the finished cheeses made with or without UF milk are indistinguishable and that there are no differing consequences of use or allergen-related concerns between the two cheeses. One comment also stated that the use of UF milk is not material information because cheeses made with or without UF milk are the same. In addition, comments from Kraft and those submitted jointly by the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) included consumer research, which they claim indicates that consumers, when shown cheese labels that declare either “milk,” “ultrafiltered milk,” or “milk and ultrafiltered milk” in the ingredient statement, believe that the cheeses are different with respect to taste, healthfulness, and quality. Based on these results, these two comments stated that it would be misleading to consumers to declare UF milk as “ultrafiltered milk” because it would lead them to believe that the cheeses are “different” when, in fact, cheeses made with or without UF milk are “identical.” These comments urged the agency to remove the proposed labeling requirement from any final rule on this issue such that ultrafiltered milk and ultrafiltered nonfat milk, when used as ingredients in standardized cheeses and related cheese products, would be declared as simply “milk” and “nonfat milk,” respectively, in the ingredient statement of the finished food.

With respect to the consumer research information that Kraft and IDFA/NMPF submitted, the agency reviewed these submissions and notes several limitations in the design of the surveys and interpretation of the results from these surveys (Refs. 4 and 5). In the case of the IDFA-commissioned consumer research (IDFA study; n=672), as an Internet study, the survey sample cannot be considered representative of the population as a whole. The study is essentially a survey with a key measure being forced comparisons between two product labels. However, a substantial limitation of the study is that the forced comparison questions (in which respondents are directed to examine specific label information) are not reliable indicators of what consumers are likely to do in realistic product selection situations (in which consumers may or may not review or consider such information in making their choices). A more useful and appropriate research method would be an experimental study, which looks to establish cause-effect relationships between changes in label information and consumers' judgments and inferences. The results of the IDFA study suggest that some study participants whose attention is directed to the “ultrafiltered milk” in a product's ingredient list may infer that the product may be different somehow from a product that does not have that specific ingredient listed. However, this conclusion is likely to be more a product of the logical deduction that something that is labeled differently must be different than it is to any understanding of what “ultrafiltered milk” is or how this ingredient may affect the product. The IDFA study demonstrates that when study participants notice or are directed to notice a single ingredient difference between two otherwise similar product labels, some will believe the products differ in some way. Of the attributes tested, healthfulness of the product was believed to differ by the largest minority (45 percent). For taste and quality fewer expected a difference (38 percent and 35 percent respectively).

The Kraft consumer research is nearly identical to the IDFA study. It is an Internet panel study, with a smaller sample size (n=301), conducted among individuals who reported that they were cheese product consumers. Like the IDFA study, the Kraft study sample cannot be considered representative of the population as a whole or of all consumers of cheese products. As did the IDFA study, the Kraft study focuses narrowly on the question of whether disclosing “milk” or “ultrafiltered milk” in the ingredient list of a cheese product affects study participants' perceptions of the product, and the Kraft study suffers from the same shortcomings as does the IDFA study. Kraft's study demonstrates that when study participants noticed or were directed to notice the ingredient difference between two otherwise identical product labels, some inferred that the products differ in some way. Of the attributes tested, healthfulness of the product was believed to differ by nearly half (48 percent) of the respondents. For taste and quality fewer respondents expected a difference (32 percent and 42 percent respectively).

Because of the limitations in the design of these studies as noted previously, FDA tentatively concludes that the findings from both the IDFA study and the Kraft study fail to provide sufficient support for their assertion that labeling fluid UF milk on cheese products as “ultrafiltered milk” would be deceptive to consumers.

With respect to the recommendation of some comments that fluid UF milk and fluid UF nonfat milk should be permitted to be declared by the collective terms “milk” and “nonfat milk,” respectively, the agency seeks comment on the need for and appropriateness of such declaration. The existing provisions for the use of the collective terms “milk” and “nonfat milk” in § 101.4(b) are relatively narrow and limited to those forms of milk and nonfat milk from which only water is removed to varying degrees. For example, concentrated milk, reconstituted milk, and dry whole milk are all permitted as basic ingredients in standardized cheeses and § 101.4(b)(4) permits these ingredients to be declared as “milk.” However, the agency is being asked to consider extending this collective declaration provision to fluid UF milk. The petitioners and a number of comments in response to the petitions and to the 2005 proposed rule have noted that several substances present in milk (such as lactose, minerals, and water-soluble vitamins) are lost during the ultrafiltration process. The agency also explained the process of ultrafiltration and its effect on milk composition based on its own review of the scientific literature in the 2005 proposed rule (70 FR 60751 at 60752). Unlike concentrated milk, reconstituted milk, and dry whole milk, all of which differ from milk only with respect to their moisture content (and which are permitted under § 101.4 to be declared by the generic term “milk”), fluid UF milk, as defined in the 2005 proposed rule, has a composition that is significantly different from that of milk.

Another factor that should be considered is that fluid UF milk is not the standardized food “milk” as defined 21 CFR 131.110. Given that there is currently no provision in § 101.4 for fluid UF milk to be declared as “milk” in the ingredient statement of a finished food, and that fluid UF milk does not comply with the standard of identity for “milk,” current regulations do not permit fluid UF milk to be declared as “milk.” In such instances, consistent with 21 CFR 101.3, the agency generally applies the principles of common or usual name regulations in 21 CFR 102.5 to determine an appropriate name that accurately identifies or describes the basic identity of the food. Consequently, in the 2005 proposed rule, the agency proposed “ultrafiltered milk” as the appropriate declaration of this ingredient. In addition, in response to the petitions, the agency previously received comments from consumers who requested that, if ultrafiltered milk is permitted as an ingredient, cheeses made with this ingredient should be clearly labeled to distinguish them from cheeses made with only milk. The agency seeks public comment on the need for, and appropriateness of, declaring fluid UF milk (or fluid UF nonfat milk) as simply “milk” (or “nonfat milk”) when used as an ingredient in standardized cheeses and related cheese products.

Under certain conditions, FDA has previously permitted the use of “or,” “and/or,” or “contains one or more of the following:” in the declaration of ingredients to accommodate relevant concerns related to ingredient supply and availability. For example, § 101.4(b)(23) provides that when manufacturers are unable to adhere to a constant pattern of fish species ingredient(s) in the manufacture of processed seafood products containing fish protein, due to seasonal or other limitations of species availability, the common or usual name of each individual fish species need not be declared in descending order of predominance, and fish species not present in the fish protein product may be listed if they are sometimes used in the product. This provision permits the declaration of such ingredients using the terms “or,” “and/or,” or “contains one or more of the following:” to indicate to consumers that all of the listed ingredients may not be present or that they may not be present in the listed descending order of predominance. For example, the provision allows for the declaration “fish protein (contains one or more of the following: Pollock, cod, and/or pacific whiting).” Given the concerns that industry has expressed with respect to impracticability of the agency's proposed labeling requirement (see section III.A of this document), we seek comment on the need for and appropriateness of a similar provision for the labeling of fluid UF milk that is used interchangeably with milk, as needed and when economically and logistically practical, in the manufacture of standardized cheeses and related cheese products.

The agency seeks public comment on whether the labeling requirement that the agency proposed would be misleading or deceptive to consumers. Specifically, the agency seeks comment on the following questions:

1. Considering that the products of ultrafiltration, as defined in proposed § 133.3(f) and (g) in the 2005 proposed rule, are significantly different in composition from milk and nonfat milk, is it or is it not appropriate to require that they must be identified by a common or usual name other than “milk” and “nonfat milk,” respectively?

2. If it is appropriate to permit fluid UF milk and fluid UF nonfat milk to be declared by the collective terms “milk” and “nonfat milk,” respectively, when used in standardized cheeses and related cheese products, what is the scientific and legal justification?

3. Is there a need to consider the declaration of fluid UF milk and fluid UF nonfat milk by a term(s) other than their specific, individual common, or usual names when they are used as ingredients in standardized cheeses and related cheese products? Should this consideration be extended to fluid UF milk and fluid UF nonfat milk when they are used as ingredients in other foods? If they are required to be declared by different terms when used in standardized cheeses as compared to other foods, what would be the scientific and legal basis for the different labeling requirements?

4. Is there a need for the agency to consider providing for “and/or” labeling (similar to such provisions in § 101.4(b)) when fluid UF milk or fluid UF nonfat milk are used as ingredients in standardized cheeses and related cheese products? What is the scientific and legal justification for such a provision?

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a Federal Register notice announcing that date.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register .)

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

When submitting comments, remember to:

1. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

2. Follow directions—The EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns, and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified.

EPA is proposing to take several related actions. EPA is proposing to make a determination that the Kewaunee County nonattainment area has attained the 8-hour ozone standard and that this area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. EPA is thus proposing to approve Wisconsin's request to change the legal designation of the Kewaunee County area from nonattainment to attainment for the 8-hour ozone NAAQS. EPA is also proposing to approve Wisconsin's maintenance plan SIP revision for Kewaunee County (such approval being one of the CAA criteria for redesignation to attainment status). The maintenance plan is designed to keep the Kewaunee County area in attainment of the ozone NAAQS through 2018. Additionally, EPA is proposing to approve the newly-established 2012 and 2018 MVEBs for the Kewaunee County area. The adequacy comment period for the MVEBs began on September 24, 2007, with EPA's posting of the availability of the submittal on EPA's Adequacy Web site (at http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm ). The adequacy comment period for these MVEBs ended on October 24, 2007. EPA did not receive any requests for this submittal, or adverse comments on this submittal during the adequacy comment period. In a letter dated November 6, 2007, EPA informed WDNR that we had found the 2012 and 2018 MVEBs to be adequate for use in transportation conformity analyses. Please see the Adequacy section of this rulemaking for further explanation on this process. Therefore, we find adequate, and are proposing to approve, the State's 2012 and 2018 MVEBs for transportation conformity purposes.

Ground-level ozone is not emitted directly by sources. Rather, emissions of nitrogen oxides (NO X ) and volatile organic compounds (VOCs) react in the presence of sunlight to form ground-level ozone. NO X and VOCs are referred to as precursors of ozone.

The CAA establishes a process for air quality management through the NAAQS. Before promulgation of the current 8-hour standard, the ozone NAAQS was based on a 1-hour standard. On November 6, 1991 (56 FR 56693 and 56852), the Kewaunee County area was designated as a moderate nonattainment area under the 1-hour ozone NAAQS. The area was subsequently redesignated to attainment of the 1-hour standard on August 26, 1996 (61 FR 43668). At the time EPA revoked the 1-hour ozone NAAQS, on June 15, 2005, the Kewaunee County area was designated as attainment under the 1-hour ozone NAAQS.

On July 18, 1997, EPA promulgated a revised 8-hour ozone standard of 0.08 parts per million (ppm). This new standard is more stringent than the previous 1-hour standard. On April 30, 2004 (69 FR 23857), EPA published a final rule designating and classifying areas under the 8-hour ozone NAAQS. These designations and classifications became effective June 15, 2004. The CAA required EPA to designate as nonattainment any area that was violating the 8-hour ozone NAAQS based on the three most recent years of air quality data, 2001-2003.

The CAA contains two sets of provisions, subpart 1 and subpart 2, that address planning and control requirements for nonattainment areas. (Both are found in Title I, part D, 42 U.S.C. 7501-7509a and 7511-7511f, respectively.) Subpart 1 contains general requirements for nonattainment areas for any pollutant, including ozone, governed by a NAAQS. Subpart 2 provides more specific requirements for ozone nonattainment areas.

Under EPA's 8-hour ozone implementation rule, (69 FR 23951 (April 30, 2004)), an area was classified under subpart 2 based on its 8-hour ozone design value (i.e. the 3-year average annual fourth-highest daily maximum 8-hour average ozone concentration), if it had a 1-hour design value at the time of designation at or above 0.121 ppm (the lowest 1-hour design value in Table 1 of subpart 2) (69 FR 23954). All other areas were covered under subpart 1, based upon their 8-hour design values (69 FR 23958). The Kewaunee County area was designated as a subpart 1, 8-hour ozone nonattainment area by EPA on April 30, 2004 (69 FR 23857, 23947) based on air quality monitoring data from 2001-2003 (69 FR 23860).

40 CFR 50.10 and 40 CFR part 50, Appendix I provide that the 8-hour ozone standard is attained when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.08 ppm, when rounded. The data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90%, and no single year has less than 75% data completeness. See 40 CFR Part 50, Appendix I, 2.3(d).

On June 12, 2007, Wisconsin requested that EPA redesignate the Kewaunee County area to attainment for the 8-hour ozone standard. The redesignation request included three years of complete, quality-assured data for the period of 2004 through 2006, indicating the 8-hour NAAQS for ozone had been attained for the Kewaunee County area. Under the CAA, nonattainment areas may be redesignated to attainment if sufficient complete, quality-assured data are available for the Administrator to determine that the area has attained the standard, and the area meets the other CAA redesignation requirements in section 107(d)(3)(E).

On December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air Quality Management Dist. v. EPA , 472 F.3d 882 (D.C. Cir. 2006). On June 8, 2007, in South Coast Air Quality Management Dist. v. EPA , Docket No. 04 1201, in response to several petitions for rehearing, the DC Circuit clarified that the Phase 1 Rule was vacated only with regard to those parts of the rule that had been successfully challenged. Therefore, the Phase 1 Rule provisions related to classifications for areas currently classified under subpart 2 of Title I, part D, of the Act as 8-hour nonattainment areas, the 8 hour attainment dates and the timing for emissions reductions needed for attainment of the 8 hour ozone NAAQS remain effective. The June 8 decision left intact the Court's rejection of EPA's reasons for implementing the 8-hour standard in certain nonattainment areas under subpart 1 in lieu of subpart 2. By limiting the vacatur, the Court let stand EPA's revocation of the 1-hour standard and those anti-backsliding provisions of the Phase 1 Rule that had not been successfully challenged. The June 8 decision reaffirmed the December 22, 2006 decision that EPA had improperly failed to retain four measures required for 1-hour nonattainment areas under the anti-backsliding provisions of the regulations: (1) Nonattainment area New Source Review (NSR) requirements based on an area's 1-hour nonattainment classification; (2) Section 185 penalty fees for 1-hour severe or extreme nonattainment areas; (3) measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the Act, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour NAAQS, or for failure to attain that NAAQS; and (4) certain transportation conformity requirements for certain types of federal actions. The June 8 decision clarified that the Court's reference to conformity requirements was limited to requiring the continued use of 1-hour motor vehicle emissions budgets until 8-hour budgets were available for 8-hour conformity determinations.

This section sets forth EPA's views on the potential effect of the Court's rulings on this proposed redesignation action. For the reasons set forth below, EPA does not believe that the Court's rulings alter any requirements relevant to this redesignation action so as to preclude redesignation or prevent EPA from proposing or ultimately finalizing this redesignation. EPA believes that the Court's December 22, 2006 and June 8, 2007 decisions impose no impediment to moving forward with redesignation of this area to attainment, because even in light of the Court's decisions, redesignation is appropriate under the relevant redesignation provisions of the CAA and longstanding policies regarding redesignation requests.

With respect to the 8-hour standard, the Court's ruling rejected EPA's reasons for classifying areas under subpart 1 for the 8-hour standard, and remanded that matter to the Agency. Consequently, it is possible that this area could, during a remand to EPA, be reclassified under subpart 2. Although any future decision by EPA to classify this area under subpart 2 might trigger additional future requirements for the area, EPA believes that this does not mean that redesignation cannot now go forward. This belief is based upon: (1) EPA's longstanding policy of evaluating requirements in accordance with the requirements due at the time the request is submitted; and, (2) consideration of the inequity of applying retroactively any requirements that might in the future be applied.

First, at the time the redesignation request was submitted, the Kewaunee County area was classified under subpart 1 and was obligated to meet only subpart 1 requirements. Under EPA's longstanding interpretation of section 107(d)(3)(E) of the CAA, to qualify for redesignation, states requesting redesignation to attainment must meet only the relevant SIP requirements that came due prior to the submittal of a complete redesignation request. September 4, 1992, Calcagni memorandum (“Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division). See also Michael Shapiro Memorandum, September 17, 1993, and 60 FR 12459, 12465-66 (March 7, 1995) (Redesignation of Detroit-Ann Arbor). See Sierra Club v. EPA , 375 F.3d 537 (7th Cir. 2004), which upheld this interpretation. See, e.g. also 68 FR 25418, 25424, 25427 (May 12, 2003) (redesignation of St. Louis).

Moreover, it would be inequitable to retroactively apply any new SIP requirements that were not applicable at the time the request was submitted. The DC Circuit has recognized the inequity in such retroactive rulemaking. In Sierra Club v. Whitman , 285 F. 3d 63 (DC Cir. 2002), the DC Circuit upheld a District Court's ruling refusing to make retroactive an EPA determination of nonattainment that was past the statutory due date. Such a determination would have resulted in the imposition of additional requirements on the area. The Court stated: “Although EPA failed to make the nonattainment determination within the statutory time frame, Sierra Club's proposed solution only makes the situation worse. Retroactive relief would likely impose large costs on the States, which would face fines and suits for not implementing air pollution prevention plans in 1997, even though they were not on notice at the time.” Id. at 68. Similarly here it would be unfair to penalize the area by applying to it for purposes of redesignation additional SIP requirements under subpart 2 that were not in effect at the time it submitted its redesignation request.

With respect to the 1-hour standard requirements, the Kewaunee County area was an attainment area subject to a CAA section 175A maintenance plan under the 1-hour standard. The DC Circuit's decisions do not impact redesignation requests for these types of areas, except to the extent that the Court in its June 8 decision clarified that for those areas with 1-hour motor vehicle emissions budgets in their maintenance plans, anti-backsliding requires that those 1-hour budgets must be used for 8-hour conformity determinations until replaced by 8-hour budgets. To meet this requirement, conformity determinations in such areas must comply with the applicable requrements of EPA's conformity regulations at 40 CFR Part 93.

With respect to the three other anti-backsliding provisions for the 1-hour standard that the Court found were not properly retained, the Kewaunee County area is an attainment area subject to a maintenance plan for the 1-hour standard, and the NSR, contingency measure (pursuant to section 172(c)(9) or 182(c)(9)) and fee provision requirements no longer apply to an area that has been redesignated to attainment of the 1-hour standard.

Thus, the decision in South Coast Air Quality Management Dist. should not alter requirements that would preclude EPA from finalizing the redesignation of this area.

The CAA provides the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) allows for redesignation provided that: (1) The Administrator determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k); (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP and applicable federal air pollutant control regulations and other permanent and enforceable reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A; and, (5) the state containing such area has met all requirements applicable to the area under section 110 and part D.

EPA provided guidance on redesignation in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990, on April 16, 1992 (57 FR 13498), and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:

On June 12, 2007, Wisconsin requested redesignation of the Kewaunee County area to attainment for the 8-hour ozone standard. EPA believes that the area has attained the standard and has met the requirements for redesignation set forth in section 107(d)(3)(E) of the CAA.

Approval of the redesignation request would change the official designation of the area for the 8-hour ozone NAAQS found at 40 CFR part 81. It would also incorporate into the Wisconsin SIP a plan for maintaining the 8-hour ozone NAAQS through 2018. The maintenance plan includes contingency measures to remedy future violations of the 8-hour NAAQS. It also establishes MVEBs of 0.43 and 0.32 tons per day (tpd) VOC and 0.80 and 0.47 tpd NO X for the years 2012 and 2018, respectively.

EPA is proposing to make a determination that the Kewaunee County area has attained the 8-hour ozone standard and that the area has met all other applicable section 107(d)(3)(E) redesignation criteria. The basis for EPA's determination is as follows:

EPA is proposing to make a determination that the Kewaunee County area has attained the 8-hour ozone NAAQS. For ozone, an area may be considered to be attaining the 8-hour ozone NAAQS if there are no violations, as determined in accordance with 40 CFR 50.10 and part 50, Appendix I, based on three complete, consecutive calendar years of quality-assured air quality monitoring data. To attain this standard, the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations measured at each monitor within an area over each year must not exceed 0.08 ppm. Based on the rounding convention described in 40 CFR part 50, Appendix I, the standard is attained if the design value is 0.084 ppm or below. The data must be collected and quality-assured in accordance with 40 CFR part 58, and recorded in the Aerometric Information Retrieval System (AIRS). The monitors generally should have remained at the same location for the duration of the monitoring period required for demonstrating attainment.

WDNR submitted ozone monitoring data for the 2004 to 2006 ozone seasons. The WDNR quality-assured the ambient monitoring in accordance with 40 CFR 58.10, and recorded it in the AIRS database, thus making the data publicly available. The data meet the completeness criteria in 40 CFR 50, Appendix I, which requires a minimum completeness of 75 percent annually and 90 percent over each three year period. Preliminary 2007 monitoring data show that the area continues to meet the 8-hour ozone NAAQS. Monitoring data is presented in Table 1 below.

In addition, as discussed below with respect to the maintenance plans, WDNR has committed to continue monitoring ozone levels in Kewaunee County and to discuss with EPA any changes in the siting that may become necessary. WDNR will continue to quality assure monitoring data in accordance with 40 CFR part 58 and enter all data into the Air Quality System on a timely basis in accordance with federal guidelines. In summary, EPA believes that the data submitted by Wisconsin provide an adequate demonstration that the Kewaunee County area has attained the 8-hour ozone NAAQS.

We have determined that Wisconsin has met all currently applicable SIP requirements for purposes of redesignation for the Kewaunee County area under Section 110 of the CAA (general SIP requirements). We have also determined that the Wisconsin SIP meets all SIP requirements currently applicable for purposes of redesignation under part D of Title I of the CAA (requirements specific to subpart 1 nonattainment areas), in accordance with section 107(d)(3)(E)(v). In addition, we have determined that the Wisconsin SIP is fully approved with respect to all applicable requirements for purposes of redesignation, in accordance with section 107(d)(3)(E)(ii). In making these determinations, we have ascertained what SIP requirements are applicable to the area for purposes of redesignation, and have determined that the portions of the SIP meeting these requirements are fully approved under section 110(k) of the CAA. As discussed more fully below, SIPs must be fully approved only with respect to currently applicable requirements of the CAA.

The September 4, 1992 Calcagni memorandum (see “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992) describes EPA's interpretation of section 107(d)(3)(E) of the CAA. Under this interpretation, a state and the area it wishes to redesignate must meet the relevant CAA requirements that are due prior to the state's submittal of a complete redesignation request for the area. See also the September 17, 1993 Michael Shapiro memorandum and 60 FR 12459, 12465-66 (March 7, 1995) (redesignation of Detroit-Ann Arbor, Michigan to attainment of the 1-hour ozone NAAQS). Applicable requirements of the CAA that come due subsequent to the state's submittal of a complete request remain applicable until a redesignation to attainment is approved, but are not required as a prerequisite to redesignation. See section 175A(c) of the CAA. Sierra Club v. EPA , 375 F.3d 537 (7th Cir. 2004). See also 68 FR 25424, 25427 (May 12, 2003) (redesignation of the St. Louis/East St. Louis area to attainment of the 1-hour ozone NAAQS).

General SIP requirements. Section 110(a) of title I of the CAA contains the general requirements for a SIP. Section 110(a)(2) provides that the implementation plan submitted by a state must have been adopted by the state after reasonable public notice and hearing, and that, among other things, it includes enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; provides for establishment and operation of appropriate devices, methods, systems and procedures necessary to monitor ambient air quality; provides for implementation of a source permit program to regulate the modification and construction of any stationary source within the areas covered by the plan; includes provisions for the implementation of part C, Prevention of Significant Deterioration (PSD) and part D, NSR permit programs; includes criteria for stationary source emission control measures, monitoring, and reporting; includes provisions for air quality modeling; and provides for public and local agency participation in planning and emission control rule development.

Section 110(a)(2)(D) of the CAA requires that SIPs contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of air pollutants (NO X SIP Call, 1 Clean Air Interstate Rule (CAIR) (70 FR 25162)). However, the section 110(a)(2)(D) requirements for a state are not linked with a particular nonattainment area's designation and classification. EPA believes that the requirements linked with a particular nonattainment area's designation and classification are the relevant measures to evaluate in reviewing a redesignation request. When the transport SIP submittal requirements are applicable to a state, they will continue to apply to the state regardless of the attainment designation of any one particular area in the state. Therefore, we believe that these requirements should not be construed to be applicable requirements for purposes of redesignation. Further, we believe that the other section 110 elements described above that are not connected with nonattainment plan submissions and not linked with an area's attainment status are also not applicable requirements for purposes of redesignation. A state remains subject to these requirements after an area is redesignated to attainment. We conclude that only the section 110 and part D requirements which are linked with a particular area's designation and classification are the relevant measures which we may consider in evaluating a redesignation request. This approach is consistent with EPA's existing policy on applicability of conformity and oxygenated fuels requirements for redesignation purposes, as well as with section 184 ozone transport requirements. See Reading, Pennsylvania, proposed and final rulemakings (61 FR 53174-53176, October 10, 1996), (62 FR 24826, May 7, 1997); Cleveland-Akron-Lorain, Ohio, final rulemaking (61 20458, May 7, 1996); and Tampa, Florida, final rulemaking (60 FR 62748, December 7, 1995). See also the discussion on this issue in the Cincinnati ozone redesignation (65 FR 37890, June 19, 2000), and in the Pittsburgh ozone redesignation (66 FR 50399, October 19, 2001).

As discussed above, we believe that section 110 elements which are not linked to the area's nonattainment status are not applicable for purposes of redesignation. Because there are no section 110 requirements linked to the part D requirements for 8-hour ozone nonattainment areas that have become due, as explained below, there are no part D requirements applicable for purposes of redesignation under the 8-hour standard.

Part D Requirements. EPA has determined that the Wisconsin SIP meets applicable SIP requirements under part D of the CAA, since no requirements applicable for purposes of redesignation became due for the 8-hour ozone standard prior to WDNR's submission of the redesignation request for the Kewaunee County area. Under part D, an area's classification determines the requirements to which it will be subject. Subpart 1 of part D, found in sections 172-176 of the CAA, sets forth the basic nonattainment requirements applicable to all nonattainment areas. Section 182 of the CAA, found in subpart 2 of part D, establishes additional specific requirements depending on the area's nonattainment classification. The Kewaunee County area was classified as a subpart 1 nonattainment area, and, therefore, subpart 2 requirements do not apply.

Part D, subpart 1 applicable SIP requirements. For purposes of evaluating these redesignation requests, the applicable part D, subpart 1 SIP requirements for the Kewaunee County area are contained in sections 172(c)(1)-(9). A thorough discussion of the requirements contained in section 172 can be found in the General Preamble for Implementation of Title I (57 FR 13498, April 16, 1992).

No requirements applicable for purposes of redesignation under part D became due prior to submission of the redesignation request, and, therefore, none are applicable to the areas for purposes of redesignation. Since the State of Wisconsin has submitted a complete ozone redesignation request for the Kewaunee County area prior to the deadline for any submissions required for purposes of redesignation, we have determined that these requirements do not apply to the Kewaunee County area for purposes of redesignation.

Furthermore, EPA has determined that, since PSD requirements will apply after redesignation, areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR. A more detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment.” Wisconsin has demonstrated that the area to be redesignated will be able to maintain the standard without part D NSR in effect; therefore, EPA concludes that the State need not have a fully approved part D NSR program prior to approval of the redesignation request. The State's PSD program will become effective in the Kewaunee County area upon redesignation to attainment. See rulemakings for Detroit, Michigan (60 FR 12467-12468, March 7, 1995); Cleveland-Akron-Lorain, Ohio (61 FR 20458, 20469-20470, May 7, 1996); Louisville, Kentucky (66 FR 53665, October 23, 2001); and Grand Rapids, Michigan (61 FR 31834-31837, June 21, 1996).

Section 176 conformity requirements. Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that federally-supported or funded activities, including highway projects, conform to the air quality planning goals in the applicable SIPs. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded or approved under title 23 of the U.S. Code and the Federal Transit Act (transportation conformity) as well as to all other federally-supported or funded projects (general conformity). State conformity revisions must be consistent with federal conformity regulations relating to consultation, enforcement and enforceability, which EPA promulgated pursuant to CAA requirements.

EPA believes that it is reasonable to interpret the conformity SIP requirements as not applying for purposes of evaluating the redesignation request under section 107(d) for two reasons. First, the requirement to submit SIP revisions to comply with the conformity provisions of the CAA continues to apply to areas after redesignation to attainment since such areas would be subject to a section 175A maintenance plan. Second, EPA's federal conformity rules require the performance of conformity analyses in the absence of federally-approved state rules. Therefore, because areas are subject to the conformity requirements regardless of whether they are redesignated to attainment and, because they must implement conformity under federal rules if state rules are not yet approved, EPA believes it is reasonable to view these requirements as not applying for purposes of evaluating a redesignation request. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), upholding this interpretation. See also 60 FR 62748, 62749-62750 (Dec. 7, 1995) (Tampa, Florida).

EPA approved Wisconsin's general and transportation conformity SIPs on July 29, 1996 (61 FR 39329) and August 27, 1996 (61 FR 43970), respectively. Wisconsin has submitted onroad motor vehicle budgets for the Kewaunee County area of 0.43 and 0.32 tpd VOC and 0.80 and 0.47 tpd NO X for the years 2012 and 2018, respectively. The area must use the MVEBs from the maintenance plan in any conformity determination that is effective on or after the effective date of the maintenance plan approval. Thus, the Kewaunee County area has satisfied all applicable requirements under section 110 and part D of the CAA.

EPA has fully approved the Wisconsin SIP for the Kewaunee County area under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request (See the September 4, 1992 John Calcagni memorandum, page 3, Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d 984, 989-990 (6th Cir. 1998), Wall v. EPA, 265 F.3d 426 (6th Cir. 2001)) plus any additional measures it may approve in conjunction with a redesignation action. See 68 FR 25413, 25426 (May 12, 2003). Since the passage of the CAA of 1970, Wisconsin has adopted and submitted, and EPA has fully approved, provisions addressing the various required SIP elements applicable to the Kewaunee County area under the 1-hour ozone standard. No Kewaunee County area SIP provisions are currently disapproved, conditionally approved, or partially approved.

EPA finds that Wisconsin has demonstrated that the observed air quality improvement in the Kewaunee County area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIP, federal measures, and other state-adopted measures.

In making this demonstration, the State has calculated the change in emissions between 2002, one of the years used to designate the area as nonattainment, and 2005, one of the years the Kewaunee County area monitored attainment. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that Kewaunee County and upwind areas have implemented in recent years. The Kewaunee County area is impacted by the transport of ozone and ozone precursors from upwind areas. Therefore, local controls as well as controls implemented in upwind areas are relevant to the improvement in air quality in the Kewaunee County area.

The following is a discussion of permanent and enforceable measures that have been implemented in the areas:

NO X rules. Wisconsin adopted NO X controls for large existing sources and established emissions standards for new sources as part of their rate of progress plan under the 1-hour ozone standard.

Federal Emission Control Measures. Reductions in VOC and NO X emissions have occurred statewide and in upwind areas as a result of federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures include: Maximum Achievable Control Technology Standards, the National Low Emission Vehicle (NLEV) program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards. In addition, in 2004, EPA issued the Clean Air Non-road Diesel Rule (69 FR 38958 (July 29, 2004)). EPA expects this rule to reduce off-road diesel emissions through 2010, with emission reductions starting in 2008.

Control Measures in Upwind Areas. On October 27, 1998 (63 FR 57356), EPA issued a NO X SIP call requiring the District of Columbia and 22 states to reduce emissions of NO X . The reduction in NO X emissions has resulted in lower concentrations of transported ozone entering the Kewaunee County area. Emission reductions resulting from regulations developed in response to the NO X SIP call are permanent and enforceable.

Wisconsin is using 2002 for the nonattainment inventory and 2005, one of the years used to demonstrate monitored attainment of the NAAQS, for the attainment inventory. WDNR prepared comprehensive inventories for both 2002 and 2005 for Kewaunee County as part of a larger inventory effort. Point source inventories were developed using source specific data. Area source emissions were estimated based on various activity data compiled by the Census Bureau, the Energy Information Administration, the Bureau of Economic Analysis, and several Wisconsin State agencies. Nonroad mobile emissions were generated using EPA's National Mobile Inventory Model (NMIM) and adding emissions estimates for aircraft, commercial marine vessels, and railroads, three nonroad categories not included in NMIM. Onroad mobile emissions were calculated using MOBILE6.2.

Using the inventories described above, Wisconsin's submittal documents changes in VOC and NO X emissions from 2002 to 2005 for the Kewaunee County area. Because Kewaunee County is impacted by transport, WDNR also documented emissions reductions for the upwind Wisconsin areas of Milwaukee-Racine, Sheboygan, and Manitowoc County. Emissions data are shown in Tables 3 through 5 below.

Table 5 shows that the Kewaunee County area reduced VOC emissions by 0.4 tpd and NO X emissions by 0.4 tpd between 2002 and 2005. In addition, upwind areas in Wisconsin reduced VOC emissions by 38.0 tpd and NO X emissions by 77.0 tpd between 2002 and 2005. Based on the information summarized above, Wisconsin has adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.

In conjunction with its request to redesignate the Kewaunee County nonattainment area to attainment status, Wisconsin submitted a SIP revision to provide for the maintenance of the 8-hour ozone NAAQS in the area through 2018.

Section 175A of the CAA sets forth the required elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the plan must demonstrate continued attainment of the applicable NAAQS for at least ten years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the state must submit a revised maintenance plan which demonstrates that attainment will continue to be maintained for ten years following the initial ten-year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures with a schedule for implementation as EPA deems necessary to assure prompt correction of any future 8-hour ozone violations.

The September 4, 1992, John Calcagni memorandum provides additional guidance on the content of a maintenance plan. The memorandum clarifies that an ozone maintenance plan should address the following items: The attainment VOC and NO X emissions inventories, a maintenance demonstration showing maintenance for the ten years of the maintenance period, a commitment to maintain the existing monitoring network, factors and procedures to be used for verification of continued attainment of the NAAQS, and a contingency plan to prevent or correct future violations of the NAAQS.

The WDNR developed an emissions inventory for 2005, one of the years Wisconsin used to demonstrate monitored attainment of the 8-hour NAAQS, as described above. The attainment level of emissions is summarized in Table 4, above.

Wisconsin submitted with the redesignation request a revision to the 8-hour ozone SIP to include a maintenance plan for the Kewaunee County area, in compliance with section 175A of the CAA. This demonstration shows maintenance of the 8-hour ozone standard through 2018 by assuring that current and future emissions of VOC and NO X for the Kewaunee County area remain at or below attainment year emission levels. A maintenance demonstration need not be based on modeling. See Wall v. EPA , 265 F.3d 426 (6th Cir. 2001), Sierra Club v. EPA , 375 F. 3d 537 (7th Cir. 2004). See also 66 FR 53094, 53099-53100 (October 19, 2001), 68 FR 25413, 25430-25432 (May 12, 2003).

Wisconsin is using projected emissions inventories for the years 2012 and 2018 to demonstrate maintenance. Point and area source emissions were projected from the 2005 base year using growth factors. Nonroad mobile emissions were generated for 2012 and 2018 using NMIM and grown emissions for aircraft, commercial marine vessels, and railroads were added in. Onroad mobile source emissions projections were created using MOBILE6.2. Emissions estimates are presented in Table 6 below.

The emission projections show that WDNR does not expect emissions in the Kewaunee County area to exceed the level of the 2005 attainment year inventory during the maintenance period. In the Kewaunee County area, WDNR projects that VOC and NO X emissions will decrease by 0.58 tpd and 1.04 tpd, respectively.

As part of its maintenance plan, the State elected to include a “safety margin” for the area. A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan which continues to demonstrate attainment of the standard. The attainment level of emissions is the level of emissions during one of the years in which the area met the NAAQS. The Kewaunee County area attained the 8-hour ozone NAAQS during the 2004-2006 time period. Wisconsin used 2005 as the attainment level of emissions for the area. In the maintenance plan, WDNR projected emission levels for 2018. For Kewaunee County, the emissions from point, area, nonroad, and mobile sources in 2005 equaled 3.7 tpd of VOC. WDNR projected VOC emissions for the year 2018 to be 3.12 tpd of VOC. The SIP submission demonstrates that the Kewaunee County area will continue to maintain the standard with emissions at this level. The safety margin for VOC is calculated to be the difference between these amounts or, in this case, 0.58 tpd of VOC for 2018. By this same method, 1.04 tpd (i.e., 3.01 tpd less 2.41 tpd) is the safety margin for NO X for 2018. The safety margin, or a portion thereof, can be allocated to any of the source categories, as long as the total attainment level of emissions is maintained.

Wisconsin currently operates one ozone monitor in Kewaunee County. Wisconsin has committed to continue to operate and maintain an approved ozone monitoring network in Kewaunee. WDNR has also committed to consult with EPA regarding any changes in siting that may become necessary in the future. WDNR will continue to quality assure monitoring data in accordance with 40 CFR part 58 and enter all data into the Air Quality System on a timely basis in accordance with federal guidelines.

Continued attainment of the ozone NAAQS in the Kewaunee County area depends, in part, on the State's efforts toward tracking indicators of continued attainment during the maintenance period. Wisconsin's plan for verifying continued attainment of the 8-hour standard in the Kewaunee County area consists of plans to continue ambient ozone monitoring in accordance with the requirements of 40 CFR part 58. The State will also evaluate future VOC and NO X emissions inventories for increases over 2005 levels.

The contingency plan provisions are designed to promptly correct or prevent a violation of the NAAQS that might occur after redesignation of an area to attainment. Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation of the contingency measures, and a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be adopted and implemented. The maintenance plan must include a requirement that the state will implement all measures with respect to control of the pollutant(s) that were contained in the SIP before redesignation of the area to attainment. See section 175A(d) of the CAA.

As required by section 175A of the CAA, Wisconsin has adopted a contingency plan for the Kewaunee area to address possible future ozone air quality problems. A contingency plan response will be triggered whenever a three-year average fourth-high monitored value of 0.085 ppm or greater is monitored within the maintenance area. When a response is triggered, WDNR will determine whether a special event, malfunction, or non-compliance with permit conditions or rule requirements resulted in high ozone concentrations in order to immediately address needed corrective measures. The WDNR will also review meteorological conditions during high ozone episodes. The State will conduct this review within 6 months following the close of the ozone season. If the high values were found not to be prompted by an exceptional event, malfunction, or non-compliance with a permit condition or rule requirement, WDNR will evaluate existing but not fully implemented, on-the way, and, if necessary, new control measures necessary to return the area to attainment within 18 months. EPA is interpreting this commitment to mean that the measure will be in place within 18 months. In addition, it is EPA's understanding that to acceptably address a violation of the standard, existing and on-the way control measures must be in excess of emissions reductions included in the projected maintenance inventories.

In its maintenance plan, WDNR included the following list of potential contingency measures:

i. Broaden the application of the NO X RACT program by including a larger geographic area, and/or including sources with potential emissions of 50 tons per year, and/or increasing the cost-effectiveness thresholds utilized as a basis for Wisconsin's NO X RACT Program; and/or

ii. Broaden the geographic area for the idling control program for mobile sources targeting diesel vehicles; and/or

iii. Reduced VOC content in Architectural, Industrial and Maintenance coatings rule; and/or

iv. Reduced VOC content in commercial and consumer products; and/or

v. Reduced VOC content from federal motor vehicle toxics rule; and/or

Control measures identified as RACM in a regional attainment demonstration for ozone control.

As required by section 175A(b) of the CAA, Wisconsin commits to submit to the EPA updated ozone maintenance plans eight years after redesignation of the Kewaunee County area to cover an additional 10-year period beyond the initial 10-year maintenance period. As required by section 175(A) of the CAA, Wisconsin has committed to maintaining the existing controls after redesignation unless the State demonstrates that the standard can be maintained without one or more controls. Wisconsin also commits that any changes to its rules or emission limits applicable to VOC and/or NO X sources, as required for maintenance of the ozone standard in the Kewaunee County area as well as contingency measures adopted under the section 175A maintenance plan, will be submitted to EPA for approval as a SIP revision. Wisconsin has also asserted that the WDNR has the necessary resources to actively enforce any violations of its rules or permit provisions.

EPA has concluded that the maintenance plan adequately addresses the five basic components of a maintenance plan: Attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan. The maintenance plan SIP revision submitted by Wisconsin for the Kewaunee County area meets the requirements of section 175A of the CAA.

Under the CAA, states are required to submit, at various times, control strategy SIP revisions and ozone maintenance plans for ozone nonattainment areas and for areas seeking redesignations to attainment of the ozone standard. These emission control strategy SIP revisions ( e.g., reasonable further progress SIP and attainment demonstration SIP revisions) and ozone maintenance plans create MVEBs based on onroad mobile source emissions for criteria pollutants and/or their precursors to address pollution from cars and trucks. The MVEBs are the portions of the total allowable emissions that are allocated to highway and transit vehicle use that, together with emissions from other sources in the area, will provide for attainment or maintenance.

Under 40 CFR Part 93, a MVEB for an area seeking a redesignation to attainment is established for the last year of the maintenance plan. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB if needed.

Under section 176(c) of the CAA, new transportation projects, such as the construction of new highways, must “conform” to ( i.e., be consistent with) the part of the SIP that addresses emissions from cars and trucks. Conformity to the SIP means that transportation activities will not cause new air quality violations, worsen existing air quality violations, or delay timely attainment of the NAAQS. If a transportation plan does not conform, most new transportation projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP.

When reviewing SIP revisions containing MVEBs, including attainment strategies, rate-of-progress plans, and maintenance plans, EPA must affirmatively find that the MVEBs are “adequate” for use in determining transportation conformity. Once EPA affirmatively finds the submitted MVEBs to be adequate for transportation conformity purposes, the MVEBs are used by state and federal agencies in determining whether proposed transportation projects conform to the SIP as required by section 176(c) of the CAA. EPA's substantive criteria for determining the adequacy of MVEBs are set out in 40 CFR 93.118(e)(4).

EPA's process for determining adequacy of a MVEB consists of three basic steps: (1) Providing public notification of a SIP submission; (2) providing the public the opportunity to comment on the MVEB during a public comment period; and, (3) EPA's finding of adequacy. The process of determining the adequacy of submitted SIP MVEBs was initially outlined in EPA's May 14, 1999 guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” This guidance was codified in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM 2.5 National Ambient Air Quality Standards and Miscellaneous Revisions for Existing Areas; Transportation Conformity Rule Amendments—Response to Court Decision and Additional Rule Change,” published on July 1, 2004 (69 FR 40004). EPA follows this guidance and rulemaking in making its adequacy determinations.

The Kewaunee County area's maintenance plan contains new VOC and NO X MVEBs for the years 2012 and 2018. The availability of the SIP submission with these 2012 and 2018 MVEBs was announced for public comment on EPA's Adequacy Web page on September 24, 2007 at: http://www.epa.gov/otaq/stateresources/transconf/currsips.htm . The EPA public comment period on adequacy of the 2012 and 2018 MVEBs for the Kewaunee County area closed on October 24, 2007. No requests for this submittal or adverse comments on the submittal were received during the adequacy comment period. In a letter dated November 6, 2007, EPA informed WDNR that we had found the 2012 and 2018 MVEBs to be adequate for use in transportation conformity analyses.

EPA, through this rulemaking, is proposing to approve the MVEBs for use to determine transportation conformity in the Kewaunee County area because EPA has determined that the area can maintain attainment of the 8-hour ozone NAAQS for the relevant maintenance period with mobile source emissions at the levels of the MVEBs. WDNR has determined the 2012 MVEBs for the Kewaunee County area to be 0.43 tpd for VOC and 0.80 tpd for NO X . WDNR has determined the 2018 MVEBs for the area to be 0.32 tpd for VOC and 0.47 tpd for NO X . These MVEBs are consistent with the onroad mobile source VOC and NO X emissions projected by MDEQ for 2012 and 2018, as summarized in Table 6 above (“onroad” source sector). Wisconsin has demonstrated that the Kewaunee County area can maintain the 8-hour ozone NAAQS with mobile source emissions of 0.43 tpd and 0.32 tpd of VOC and 0.80 tpd and 0.47 tpd of NO X in 2012 and 2018, respectively, since emissions will remain under attainment year emission levels.

EPA is proposing to make a determination that the Keweaunee County area has attained the 8-hour ozone NAAQS. EPA is also proposing to approve the maintenance plan SIP revision for the Kewaunee County area. EPA's proposed approval of the maintenance plan is based on Wisconsin's demonstration that the plan meets the requirements of section 175A of the CAA, as described more fully above. After evaluating Wisconsin's redesignation request, EPA has determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. Therefore, EPA is proposing to approve the redesignation of the Kewaunee County area from nonattainment to attainment for the 8-hour ozone NAAQS. The final approval of this redesignation request would change the official designation for the Kewaunee County area from nonattainment to attainment for the 8-hour ozone standard. Finally, EPA is proposing to approve the 2012 and 2018 MVEBs submitted by Wisconsin in conjunction with the redesignation request.

Under Executive Order 12866 ( 58 FR 51735, September 30, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget.

This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ).

This proposed action merely proposes to approve state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Redesignation of an area to attainment under section 107(d)(3)(E) of the CAA does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ).

Because this rule proposes to approve pre-existing requirements under state law, and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 ( 64 FR 43255, August 10, 1999). Redesignation is an action that merely affects the status of a geographical area, does not impose any new requirements on sources, or allows a state to avoid adopting or implementing other requirements, and does not alter the relationship or the distribution of power and responsibilities established in the CAA.

This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing program submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a program submission for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a program submission that otherwise satisfies the provisions of the Act. Redesignation is an action that affects the status of a geographical area but does not impose any new requirements on sources. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

In the “Rules and Regulations” section of this Federal Register , EPA is authorizing these changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect adverse comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written adverse comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we get comments that oppose this action, we will withdraw the immediate final rule and it will not take immediate effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you should do so at this time.

The regulations in this part were last substantively updated on September 21, 2001 (66 FR 48614). Early in fiscal year 2005, a project entitled Federal Asset Management Evaluation (FAME) was initiated to identify any and all areas of Federal personal property management needing improvement. An interagency working group, led by GSA, was formed to work on the FAME project. At the conclusion of the FAME project, the working group identified the exchange/sale authority as an area where changes should be made. A team of GSA Office of Governmentwide Policy employees has reviewed all of the provisions in this part and has recommended a number of changes intended to update, streamline, and clarify the part. The most significant changes include:

1. Adding a new section that explains the exchange/sale authority by quoting relevant language from the statute (40 U.S.C. 503).

2. Adding definitions for “excess property”, “surplus property ”and “Service Life Extension Program”.

3. Revising the definitions for “acquire”, “replacement”, and “similar”.

4. Adding a new section that addresses which provisions in this part are subject to deviation.

5. Adding a new section that explains when agencies should consider using the exchange/sale authority.

6. Revising the section that explains why the exchange/sale authority should be used.

7. Amending the restrictions and prohibitions applicable to the exchange/sale of personal property, including the addition of language which: 1) states that under no circumstances will deviations be granted for FSC Class 1005, Guns through 30mm; and 2) clarifies the requirement for the exchange/sale of weapons for Department of Defense property in FSC Group 10, Weapons.

8. Removing the requirement that the number of items acquired must equal the number of items exchanged or sold, as this is not a requirement imposed by 40 U.S.C. 503.

9. Adding a new provision which clarifies that the exchange/sale authority can only be used to acquire property, not services.

10. Revising the requirement for documentation of exchange/sale transactions.

11. Revising the accounting requirements applicable to the exchange/sale authority.

12. Revising the annual reporting requirement.

This regulation is excepted from the definition of “regulation” or “rule” under Section 3(d)(3) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993 and, therefore, was not subject to review under Section 6(b) of that Executive Order.

This proposed rule is not required to be published in the Federal Register for notice and comment as per the exemption specified in 5 U.S.C. 553 (a)(2); therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , does not apply.

The Paperwork Reduction Act does not apply because the proposed changes to the FMR do not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This proposed rule is exempt from Congressional review under 5 U.S.C. 801 since it relates solely to agency management and personnel.

For the reasons set forth in the preamble, GSA amends 41 CFR part 102-39 as set forth below:

We will accept written comments and information during this reopened comment period on the original proposed critical habitat designation for H. paradoxus published in the Federal Register on March 27, 2007 (72 FR 14328), the revisions to proposed critical habitat described herein (see “Changes to the Proposed Rule” section), the draft economic analysis and draft environmental assessment of the proposed designation, and the amended required determinations provided in this document. We will consider information and recommendations from all interested parties. We are particularly interested in comments concerning:

(1) The reasons why habitat should or should not be designated as “critical habitat” for H. paradoxus under section 4 of the Act (16 U.S.C. 1531 et seq. ), including whether the designation of critical habitat is prudent.

(2) Specific information on the amount and distribution of H. paradoxus habitat, including which areas occupied by the species at the time of listing and that contain features essential for the conservation of the species should be included in the designation and why, and which areas that were not occupied by the species at the time of listing are essential to the conservation of the species and why.

(3) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.

(4) Any foreseeable economic, national security, or other potential impacts resulting from the proposed designation and, in particular, any impacts on small entities, and the benefits of including or excluding areas that exhibit these impacts.

(5) The existence of lands included in the proposed designation that are covered under any conservation or management plans, which we should consider for exclusion from the designation pursuant to section 4(b)(2) of the Act.

(6) Information on the benefits of including or excluding lands managed by Bitter Lake National Wildlife Refuge from the final critical habitat designation.

(7) Information on any direct or indirect impacts to the human environment as a result of designating critical habitat for H. paradoxus .

(8) Information on whether the draft economic analysis identifies all local costs attributable to the proposed critical habitat designation and information on any costs that have been inadvertently overlooked.

(9) Whether the draft economic analysis correctly assesses the effect on regional costs associated with any land use controls that may derive from the designation of critical habitat.

(10) Whether the draft economic analysis or draft environmental assessment makes appropriate assumptions regarding current practices and likely regulatory changes imposed as a result of the designation of critical habitat.

(11) Whether the draft economic analysis and draft environmental assessment appropriately identify all costs and benefits that could result from the designation.

(12) Information on whether there are any quantifiable economic benefits that could result from the designation of critical habitat.

(13) Economic data on the incremental effects that would result from designating any particular area as critical habitat, since it is our intent to include the incremental costs attributed to the critical habitat designation in the final economic analysis.

(14) Whether our approach to designating critical habitat could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments.

If you submitted comments or information during the initial comment period from March 27, 2007, to May 29, 2007, on the proposed rule (72 FR 14328), please do not resubmit them. We will incorporate them into the public record as part of this comment period, and we will fully consider them in preparation of our final determination. Our final determination concerning critical habitat will take into consideration all written comments and any additional information we receive during both comment periods. On the basis of public comment, we may, during the development of our final determination, find that areas proposed are not essential, are appropriate for exclusion under section 4(b)(2) of the Act, or are not appropriate for exclusion.

You may submit your comments and materials concerning this proposed rule, our revisions to the proposed rule, the associated draft economic analysis and draft environmental assessment of the proposed designation, and the amended required determinations section by one of the methods listed in the ADDRESSES section. We will not accept comments you send by e-mail or fax. Please note that we may not consider comments we receive after the date specified in the DATES section in our final determination.

Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that we will post your entire comment—including your personal identifying information—on http://www.regulations.gov. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office, 2105 Osuna Rd NE., Albuquerque, NM 87113; telephone 505/346-2525.

You may obtain copies of the original proposed rule, the draft economic analysis, and the draft environmental assessment by mail from the New Mexico Ecological Services Field Office at the address listed above or by visiting our Web site at http://www.fws.gov/southwest/es/NewMexico/.

It is our intent to discuss only those topics directly relevant to designation of critical habitat in this proposal. For more information on H. paradoxus , refer to the final listing rule published in the Federal Register on October 20, 1999 (64 FR 56582), the Pecos Sunflower Recovery Plan posted at http://ecos.fws.gov/docs/recovery_plans/2005/050915.pdf, and the original proposed critical habitat designation published on March 27, 2007 (72 FR 14328).

Helianthus paradoxus was listed as a threatened species on October 20, 1999 (64 FR 56582). At the time this plant was federally listed, the Service determined that the designation of critical habitat was not prudent because we believed publication of critical habitat maps would increase the degree of threats to the species by vandalism and commercial collection. On September 27, 2005, the Forest Guardians filed suit against the Service for failure to designate critical habitat for this species ( Forest Guardians v. Hall 2005). On March 20, 2006, a settlement was reached that requires the Service to re-evaluate our original prudency determination. The settlement stipulated that, if prudent, a proposed rule would be submitted to the Federal Register for publication on or before March 16, 2007, and a final rule by March 16, 2008.

On March 15, 2007, we determined that critical habitat for Helianthus paradoxus was prudent and we subsequently published a proposed rule (72 FR 14328) to designate critical habitat for H. paradoxus on March 27, 2007. We proposed five units as critical habitat in the original proposal, encompassing approximately 1,579.3 acres (ac) (639.1 hectares (ha)). We now revise our original March 27, 2007, proposed rule (72 FR 14328) to add areas to one of the units and clarify the boundaries of another unit, as described in the “Changes to the Proposed Rule” section. As a result of these additions and revisions, the proposed critical habitat now encompasses 5,745.5 ac (3,733.4 ha).

Critical habitat is defined in section 3 of the Act as the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features essential to the conservation of the species and that may require special management considerations or protection, and specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. If the proposed rule is made final, section 7 of the Act will prohibit destruction or adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions affecting areas designated as critical habitat must consult with us on the effects of their proposed actions, pursuant to section 7(a)(2) of the Act.

Section 4(b)(2) of the Act requires that we designate critical habitat based upon the best scientific and commercial data available, after taking into consideration the economic impact, impact on national security, or any other relevant impact of specifying any particular area as critical habitat. We have prepared a draft economic analysis based on the March 27, 2007, proposed rule (72 FR 14328) and the revised units described in this document.

The draft economic analysis considers the potential economic effects of all actions related to the conservation of Helianthus paradoxus, including costs associated with sections 4, 7, and 10 of the Act, as well as those attributable to designating critical habitat. It further considers the economic effects of protective measures taken as a result of other Federal, State, and local laws that aid habitat conservation for H. paradoxus in proposed critical habitat units. The draft analysis considers both economic efficiency and distributional effects. In the case of habitat conservation, efficiency effects generally reflect lost economic opportunities associated with restrictions on land use (opportunity costs). This analysis also addresses how potential economic impacts are likely to be distributed, including an assessment of any local or regional impacts of habitat conservation and the potential effects of conservation activities on small entities and the energy industry. This information can be used by decision makers to assess whether the effects of the designation might unduly burden a particular group or economic sector. Finally, this draft analysis looks retrospectively at costs that have been incurred since the date this species was listed as threatened (October 20, 1999; 64 FR 56582), and considers those costs that may occur in the 20 years following designation of critical habitat (i.e., 2007 to 2026).

The draft economic analysis is intended to quantify the economic impacts of all potential conservation efforts for Helianthus paradoxus ; some of these costs will likely be incurred regardless of whether critical habitat is designated. This analysis estimated economic impacts resulting from the implementation of H. paradoxus conservation efforts in four categories: (a) Treatment of non-native species; (b) wetland filling and development; (c) livestock management; and (d) road maintenance. Over the 20-year period 2007 to 2026, the draft economic analysis finds that costs associated with conservation activities within these four categories are estimated at $3.9 to $4.4 million in undiscounted dollars over the next 20 years ($193,000 to $221,000 annualized). The present value of these impacts is $3.3 million to $3.6 million ($186,000 to $213,000 annualized), using a discount rate of three percent; or $2.5 million to $2.9 million ($205,000 to $225,000 annualized), using a discount rate of seven percent.

As stated earlier, we solicit data and comments from the public on this draft economic analysis, as well as on all aspects of the proposal. We may revise the proposal, or its supporting documents, to incorporate or address new information received during the comment period. In particular, we may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area as critical habitat, provided such exclusion will not result in the extinction of the species.

We proposed five units as critical habitat for Helianthus paradoxus. The original proposed critical habitat in our March 27, 2007, proposed rule (72 FR 14328), and the additional proposed areas of critical habitat as described below, constitute our best assessment of areas that meet the definition of critical habitat under section 3(5)(a) of the Act. In the proposed regulation section of this notice, we provide maps and textual descriptions of the boundaries for Subunits 4a and 4b. These descriptions and maps are in addition to those published in our March 27, 2007, proposed rule, and thus included in the proposed critical habitat designation. We have also provided clarification on our Unit 5 description below.

Subunits 4a and 4b are in close proximity with or connected to Unit 4 described in the original proposed rule. Below, we present brief descriptions of the two subunits, the primary constituent elements (PCEs) they contain, and reasons why they meet the definition of critical habitat for Helianthus paradoxus . Within areas occupied by H. paradoxus at the time of listing and containing sufficient PCEs to support H. paradoxus's life processes, we previously identified the Bitter Lake National Wildlife Refuge (portion of Subunit 4a) and the associated Refuge Farm (Subunit 4b) as areas that do not require special management or protections. As a result, these areas were not originally proposed to be included in the critical habitat designation. However, we have reconsidered our preliminary analysis of section 3(5)(a) of the Act and special management or protection needs of the PCEs on these refuge lands, and are now proposing to include these areas as critical habitat. However, we are considering their exclusion from the final designation pursuant to section 4(b)(2) of the Act.

In addition to the revision of proposed critical habitat, we have provided a clarified unit description for Unit 5. In the Unit 5 description found in the preamble of the proposed rule (72 FR 14328), we identified that Unit 5 contained a small group of plants downstream of The Nature Conservancy's Diamond Y Spring Preserve at a nearby highway right-of-way. This right-of-way site should not have been included in the unit description, for this small area is not known to be able to support sufficient numbers of plants to be considered stable (Blue Earth Ecological Consultants, Inc., 2007b, p 3; Poole 2006, p. 3). While the Unit 5 description in the preamble of the proposed rule was incorrect, the map and textual boundary description for Unit 5 found in the proposed regulation section did not include the right-of-way site and thus is still accurate.

Below, we present brief descriptions of these three areas (Subunits 4a and 4b, and Unit 5), and reasons why they meet the definition of critical habitat for Helianthus paradoxus (see “Criteria Used To Identify Critical Habitat” in the March 27, 2007, proposed rule (72 FR 14328)).

Subunit 4a includes 3,572.2 ac (1,445.6 ha) of Bitter Lake National Wildlife Refuge/City of Roswell land located in Chaves County, New Mexico. This subunit is located approximately 5 miles (mi) (8 kilometers (km)) northeast of the city of Roswell.

One of the largest Helianthus paradoxus populations occurs on the Bitter Lake National Wildlife Refuge in New Mexico on Federal lands managed by the Service. Several hundred thousand to a few million plants occur nearly continuously along the shores and small islands of all the artificial lakes in the southern unit of the refuge. Also, a few small patches of plants occur on the west side of Bitter Lake Playa and adjacent springs on Lost River.

This area was occupied at the time of listing and has been visited by species experts during four or more seasons. These experts found the site occupied by Helianthus paradoxus on every visit (Ulibarri 2006a, p. 1; Sivinski 2007a, p. 2; Blue Earth Ecological Consultants, Inc. 2007a, p. 3). This area is currently occupied by the species and contains all of the PCEs essential to the conservation of the species. As noted, the portion of this subunit within Bitter Lake National Wildlife Refuge is proposed as critical habitat, but is being considered for exclusion from the final designation. Please see “Application of Section 4(b)(2) of the Act” section below for additional discussion.

Subunit 4b includes 686.2 ac (277.7 ha) of land within the Bitter Lake National Wildlife Refuge Farm (Refuge Farm). This subunit is located in Chaves County, New Mexico, approximately 5 mi (8 km) east of Roswell on the west side of the Pecos River.

Subunit 4b consists of a few large patches with several thousand plants on alkaline seeps behind the dikes on the western edge of the Refuge Farm south of Highway 380. This land is owned and managed by the Service as a grain farm and feeding area for migratory birds. The eastern portion of the Refuge Farm is a marshy spring-seep area that contains a large population of Helianthus paradoxus . The wet soils in this population are not cultivated.

This Refuge Farm subunit was occupied at the time of listing and has been visited by species experts during four or more seasons. The experts found the site occupied by Helianthus paradoxus on every visit (Ulibarri 2006b, p. 1; Sivinski 2007a, p. 2; Blue Earth Ecological Consultants, Inc. 2007a, p. 3). This subunit is currently occupied by the species and contains all of the PCEs essential to the conservation of the species. As noted, the portion of this subunit within Bitter Lake National Wildlife Refuge is proposed as critical habitat, but is being considered for exclusion from the final designation. Please see “Application of Section 4(b)(2) of the Act” section below for additional discussion.

Unit 5 includes 239.7 ac (97.0 ha) located solely on Diamond Y Spring in Pecos County, Texas. The unit is located approximately 12 mi (20 km) north-northwest of Fort Stockton, Texas.

Unit 5 consists of several hundred thousand to one million plants found on The Nature Conservancy's Diamond Y Spring Preserve and a contiguous parcel of private land. This site was occupied by the species at the time of its listing. This site has been visited by species experts during four or more seasons and has been documented to be occupied by Helianthus paradoxus on every visit (Poole 2006, p. 2). This unit is currently occupied by the species (Blue Earth Ecological Consultants, Inc. 2007b, p. 3) and contains all of the PCEs essential to the conservation of the species.

The land within The Nature Conservancy's Diamond Y Spring Preserve was purchased to protect Diamond Y Spring Preserve and other rare or endangered aquatic species in the Diamond Y Spring system. This habitat is managed for the conservation of such species (Service 2005, p. 12). Diamond Y Spring Preserve has recently expanded from 1,500 to 4,000 ac (607 to 1619 ha). However, Helianthus paradoxus on the Preserve is threatened by water withdrawal occurring outside the Preserve. On the adjacent private land, H. paradoxus is also threatened by water withdrawal, plus wetland filling and development, and livestock grazing during the growing and flowering season. As a result, special management or protections may be required to minimize these threats. At this time, we are not aware of any completed management plans that address H. paradoxus in this area.

Table 1 shows the areas occupied by Helianthus paradoxus at the time of listing, those areas that are currently occupied, and the threats to the primary constituent elements that may require special management or protections.

The approximate area encompassed within each proposed critical habitat unit is shown in Table 2.

Under section 4(b)(2), in considering whether to exclude a particular area from designation, we must identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, and determine whether the benefits of exclusion outweigh the benefits of inclusion. If exclusion is contemplated, then we must determine whether excluding the area would result in the extinction of the species. In the original proposed rule, we addressed a number of general issues that are relevant to the exclusions under section 4(b)(2) of the Act that we are considering (72 FR 14328). In addition, we have conducted a draft economic analysis and draft environmental assessment analyzing the potential impacts of the proposed critical habitat designation and related factors, which are available for public review and comment. Based on public comment on these documents and the proposed designation, additional areas may be excluded from final critical habitat by the Secretary under the provisions of section 4(b)(2) of the Act. This is provided for in the Act and in our implementing regulations at 50 CFR 424.19.

We have determined that areas managed by Bitter Lake National Wildlife Refuge (Refuge) meet the definition of critical habitat for Helianthus paradoxus. The Refuge has developed and completed a Comprehensive Conservation Plan (CCP) that provides the framework for protection and management of all trust resources, including federally listed species and sensitive natural habitats. We believe that there is minimal benefit from designating critical habitat for H. paradoxus within Refuge lands because these lands are protected areas for wildlife, and are currently managed for the conservation of wildlife, including threatened and endangered species, specifically H. paradoxus. Below we provide a description of the management being provided by the Refuge for the conservation of H. paradoxus within areas proposed for designation as critical habitat.

The Refuge was established on October 8, 1937, by Executive Order 7724 “as a refuge and breeding ground for migratory birds and other wildlife.” The Refuge Recreation Act (16 U.S.C. 460k et seq. ) identifies the refuge as being suitable for incidental fish and wildlife-oriented recreational development, the protection of natural resources, and the conservation of endangered species or threatened species. The Wilderness Act of 1964 (16 U.S.C. 1131-1136) directs the Service to “maintain wilderness as a naturally functioning ecosystem” on portions of the Refuge. While the Refuge was originally established to save wetlands vital to the perpetuation of migratory birds, the isolated gypsum springs, seeps, and associated wetlands protected by the Refuge have been recognized as providing the last known habitats in the world for several unique species. Management emphasis of the Refuge is placed on the protection and enhancement of habitat for endangered species and Federal candidate species, maintenance and improvement of wintering crane and waterfowl habitat, and monitoring and maintenance of natural ecosystem values.

The Refuge sits at a juncture between the Roswell Artesian Groundwater Basin and the Pecos River. These two systems and their interactions account for the diversity of water resources on the Refuge, including sinkholes, springs, wetlands, oxbow lakes, and riverine habitats. The federally reserved water right for Bitter Lake National Wildlife Refuge has been signed by the State of New Mexico but awaits final approval by the Federal government, a procedural process. The Refuge is currently in negotiations with the New Mexico Office of the State Engineer, a State agency responsible for administering New Mexico's water resources, to quantify these reserved rights. This water right allows for an in-stream flow in Bitter Creek and allows the Refuge to manage impounded springs for the benefit of many species, including Helianthus paradoxus. This water right protects against the threat of a future water user purchasing a Pecos River Basin water right and moving the use to a location that would be detrimental to the Refuge's ability to manage for the conservation of H. paradoxus. While the water right does not specifically protect water for the purposes of H. paradoxus conservation, it combines with management under the Refuge's CCP (discussed below) to remove the threat of water withdrawal on Refuge lands.

The National Wildlife Refuge System Improvement Act of 1997 (Pub. L. 105-57) (Refuge Improvement Act) establishes a conservation mission for refuges, gives policy direction to the Secretary of the Interior and refuge managers, and contains other provisions such as the requirement to integrate scientific principles into the management of the refuges. According to section 7(e)(1)(E) of the Refuge Improvement Act, all lands of the Refuge System are to be managed in accordance with an approved CCP that will guide management decisions and set forth strategies for achieving refuge purposes. In general, the purpose of the CCP is to provide long-range guidance for the management of National Wildlife Refuges. The Refuge Improvement Act requires all refuges to have a CCP and provides the following legislative mandates to guide the development of the CCP: (1) Wildlife has first priority in the management of refuges; (2) wildlife-dependent recreation, including hunting, fishing, wildlife observation, wildlife photography, environmental education, and environmental interpretation, are the priority public uses of the refuge system, and shall be allowed when compatible with the refuge purpose; and (3) other uses have lower priority in the refuge system and are only allowed if not in conflict with any of the priority uses and determined appropriate and compatible with the refuge purpose.

The CCP must also be revised if the Secretary determines that conditions that affect the refuge or planning unit have changed significantly. In other words, a CCP must be followed once it is approved, and regularly updated in response to environmental changes or new scientific information.

The Bitter Lake National Wildlife Refuge has a final CCP that was approved in September 1998. The CCP serves as a management tool to be used by the Refuge staff and its partners in the preservation and restoration of the ecosystem's natural resources. The plan is intended to guide management decisions for 15 years, and sets forth strategies for achieving Refuge goals and objectives within that timeframe. In 2013, the plan will not expire, but will undergo review, and any needed revisions will be incorporated at that time. Key goals of the CCP related to Helianthus paradoxus include the following:

(1) To restore, enhance, and protect the natural diversity on the Refuge including threatened and endangered species by:

(a) Appropriate management of habitat and wildlife resources on Refuge lands and

(b) Strengthening existing and establishing new cooperative efforts with public and private stakeholders and partners; and

(2) To restore and maintain selected portions of a hydrological system that more closely mimics the natural processes along the reach of the Pecos River adjacent to the Refuge by:

(a) Restoration of the river channel, as well as restoration of threatened, endangered, and special concern species, and

(b) Control of exotic species and management of trust responsibilities for maintenance of plant and animal communities and to satisfy traditional recreational demands (Service 1998, pp. 5, 46-52).

Specific objectives related to these goals include: (1) The restoration of populations of aquatic species designated as endangered, threatened, or of special concern to a sustainable level ( Helianthus paradoxus is specifically mentioned in this goal); and (2) following existing recovery plan objectives to monitor and study threatened or endangered species, their habitat requirements, exotic species encroachment, and human-induced impacts to prevent further decline and loss (Service 1998, pp. 49-52).

In summary, we believe that the Refuge lands are being adequately protected and managed for the conservation of Helianthus paradoxus and that current management provides a conservation benefit to this species and its PCEs. Furthermore, we believe that there is minimal benefit from designating critical habitat for H. paradoxus on Refuge lands because, as explained in detail above, these lands are already managed for the conservation of the species. On the basis of this management, we intend to consider lands within the Bitter Lake National Wildlife Refuge and the associated Refuge Farm containing populations of H. paradoxus for exclusion from the final critical habitat designation pursuant to section 4(b)(2) of the Act. We will complete a full analysis of the benefits of excluding and the benefits of including these lands prior to making a final decision.

In our March 27, 2007, proposed rule (72 FR 14328), we indicated that we would defer our determination of compliance with several statutes and Executive Orders until the information concerning potential economic impacts of the designation and potential effects on landowners and stakeholders was available in the draft economic analysis. Those data are now available for our use in making these determinations. In this notice we are affirming the information contained in the proposed rule concerning Executive Order (E.O.) 13132, E.O. 12988, the Paperwork Reduction Act, and the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951). Based on the information made available to us in the draft economic analysis, we are amending our Required Determinations, as provided below, concerning E.O. 12866 and the Regulatory Flexibility Act, E.O. 13211, E.O. 12630, and the Unfunded Mandates Reform Act.

In accordance with E.O. 12866, this document is a significant rule because it may raise novel legal and policy issues. Based on our draft economic analysis of the proposed designation of critical habitat for Helianthus paradoxus , costs related to conservation activities for H. paradoxus pursuant to sections 4, 7, and 10 of the Act are estimated at $3.9 to $4.4 million in undiscounted dollars over the next 20 years ($193,000 to $221,000 annualized). The present value of these impacts is $3.3 million to $3.6 million ($186,000 to $213,000 annualized), using a discount rate of three percent; or $2.5 million to $2.9 million ($205,000 to $225,000 annualized), using a discount rate of seven percent. Therefore, based on our draft economic analysis, we have determined that the proposed designation of critical habitat for H. paradoxus would not result in an annual effect on the economy of $100 million or more or affect the economy in a material way. Due to the timeline for publication in the Federal Register , the Office of Management and Budget (OMB) has not formally reviewed the proposed rule or accompanying economic analysis.

Further, E.O. 12866 directs Federal agencies promulgating regulations to evaluate regulatory alternatives (Office of Management and Budget, Circular A-4, September 17, 2003). Pursuant to Circular A-4, once it has been determined that the Federal regulatory action is appropriate, the agency will need to consider alternative regulatory approaches. Since the determination of critical habitat is a statutory requirement pursuant to the Act, we must then evaluate alternative regulatory approaches, where feasible, when promulgating a designation of critical habitat.

In developing our designations of critical habitat, we consider economic impacts, impacts to national security, and other relevant impacts pursuant to section 4(b)(2) of the Act. Based on the discretion allowable under this provision, we may exclude any particular area from the designation of critical habitat providing that the benefits of such exclusion outweigh the benefits of specifying the area as critical habitat and that such exclusion would not result in the extinction of the species. We believe that the evaluation of the inclusion or exclusion of particular areas, or combination thereof, in a designation constitutes our regulatory alternative analysis.

Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) (5 U.S.C. 802(2)), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. In our proposed rule, we withheld our determination of whether this designation would result in a significant effect as defined under SBREFA until we completed our draft economic analysis of the proposed designation so that we would have the factual basis for our determination.

According to the Small Business Administration (SBA), small entities include small organizations, such as independent nonprofit organizations, and small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents, as well as small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term significant economic impact is meant to apply to a typical small business firm's business operations.

To determine if the proposed Helianthus paradoxus critical habitat designation would affect a substantial number of small entities, we considered the number of small entities affected within particular types of economic activities (e.g., residential and commercial development and agriculture). We considered each industry or category individually to determine if certification is appropriate. In estimating the numbers of small entities potentially affected, we also considered whether their activities have any Federal involvement; some kinds of activities are unlikely to have any Federal involvement and so will not be affected by the designation of critical habitat. Designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies; non-Federal activities are not affected by the designation.

In the draft economic analysis of the proposed critical habitat designation, we evaluated the potential economic effects on small business entities resulting from conservation actions related to the listing of Helianthus paradoxus and proposed designation of its critical habitat. This analysis estimated prospective economic impacts due to the implementation of H. paradoxus conservation efforts in four categories: (a) Treatment of non-native species; (b) wetland filling and development; (c) livestock management; and (d) road maintenance. We determined from our analysis that the economic impacts of the designation on small entities are expected to be borne primarily by modifications to wetland filling and development activities. We assumed that if owners of parcels containing designated critical habitat face land use restrictions that preclude development on some or all of the parcel, the value of the properties will be reduced, essentially eliminating the option that those areas be developed. This draft economic analysis assumes that, in a high-end scenario, the entirety of forecast impacts would be borne by one small developer. The one small developer estimated to be affected represents approximately 20 percent of total small developers in the region. The total potential impact resulting from land use restrictions on development activities is forecast to be, at most, $290,000 over 20 years, or approximately $20,000 annually. Assuming the annual revenues of an average small developer in Cibola County are $400,000, the total potential impact resulting from the proposed designation would amount to approximately 5.0 percent of typical annual sales of one entity. Consequently, we certify that the designation of critical habitat for H. paradoxus will not result in a significant economic impact on a substantial number of small business entities. Please see the “Economic Analysis” section above and the draft economic analysis itself for a more detailed discussion of potential economic impacts.

On May 18, 2001, the President issued E.O. 13211 on regulations that significantly affect energy supply, distribution, or use. E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This proposed designation of critical habitat for Helianthus paradoxus is considered a significant regulatory action under Executive Order 12866 because it raises novel legal and policy issues. OMB has provided guidance for implementing this Executive Order that outlines nine outcomes that may constitute “a significant adverse effect” when compared without the regulatory action under consideration. The draft economic analysis finds that none of these criteria are relevant to this analysis. Thus, based on information in the draft economic analysis, energy-related impacts associated with H. paradoxus conservation activities within proposed critical habitat are not expected. As such, the proposed designation of critical habitat is not expected to significantly affect energy supplies, distribution, or use and a Statement of Energy Effects is not required.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501), the Service makes the following findings:

(a) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments,” with two exceptions. It excludes “a condition of federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding” and the State, local, or tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance; or (ii) a duty arising from participation in a voluntary Federal program.”

The designation of critical habitat does not impose a legally binding duty on non-Federal government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. Non-Federal entities that receive Federal funding, assistance, permits, or otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat. However, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply; nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.

(b) We do not believe that this rule will significantly or uniquely affect small governments because it will not produce a Federal mandate of $100 million or greater in any year; that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The proposed designation of critical habitat imposes no obligations on State or local governments. By definition, Federal agencies are not considered small entities, although the activities they fund or permit may be proposed or carried out by small entities. As such, a Small Government Agency Plan is not required.

In accordance with E.O. 12630 (“Government Actions and Interference with Constitutionally Protected Private Property Rights”), we have analyzed the potential takings implications of proposing critical habitat for Helianthus paradoxus. Critical habitat designation does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. We conclude that this designation of critical habitat for H. paradoxus does not pose significant takings implications.

It is our position that, outside the Jurisdiction of the Tenth Federal Circuit, we do not need to prepare environmental analyses as defined by NEPA in connection with designating critical habitat under the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This assertion was upheld by the Ninth Circuit ( Douglas County v. Babbitt , 48 F.3d 1495 (9th Cir. Ore. 1995), cert. denied 516 U. S. 1042 (1996)). However, when the range of the species includes States within the Tenth Circuit, such as that of H. paradoxus , under the Tenth Circuit ruling in Catron County Board of Commissioners v. U.S. Fish and Wildlife Service , 75 F.3d 1429 (10th Cir. 1996), we conduct an environmental assessment under NEPA for the proposed critical habitat designation. The draft environmental assessment for this proposal is now available ( http://www.fws.gov/southwest/es/NewMexico/ ). We solicit data and comments from the public on this draft document (See FOR FURTHER INFORMATION CONTACT section).

To obtain a complete list of all references we cited in this rulemaking, contact the Field Supervisor, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT section).

The primary authors of this package are staff of the New Mexico Ecological Services Field Office.

Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as proposed to be amended at 72 FR 14328, March 27, 2009, set forth below:

Public Comments

We intend that any final actions resulting from these proposals will be as accurate and as effective as possible. Therefore, we solicit comments or suggestions on these proposed rules from the public, other concerned governmental agencies, Tribes, the scientific community, industry, or any other interested parties concerning the proposed rules. We particularly seek comments on the proposed revised critical habitat designation for the San Bernardino kangaroo rat, and the proposed critical habitat designations for Poa atropurpurea and Taraxacum californicum concerning:

(1) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Act (16 U.S.C. 1531 et seq. ), including whether the benefit of designation is outweighed by the threats to each species caused by their respective designations such that the designation of critical habitat is prudent;

(2) Specific information on:

• The amount and distribution of habitat for each species;

• What areas that were occupied at the time of listing and that contain the features essential for the conservation of the species should be included in their respective designations and why; and

• What areas not occupied at the time of listing are essential to the conservation of each species and why;

(3) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat for each species;

(4) Any foreseeable economic, national security, or other potential impacts resulting from the proposed revised designation for the San Bernardino kangaroo rat, and proposed critical habitat for Poa atropurpurea and Taraxacum californicum and, in particular, any impacts on small entities, and the benefits of including or excluding areas that exhibit these impacts; and

(5) Whether our approach to designating critical habitat could be improved or modified in any way as to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments.

In addition, we seek the following specific comments on the proposed revised designation of critical habitat for the San Bernardino kangaroo rat:

(1a) Specific information on dispersal areas important for habitat connectivity, their role in the conservation and recovery of the subspecies, and reasons why such areas should or should not be included in the critical habitat designation;

(2a) Our proposed exclusions totaling 2,544 acres (ac) (1,029 hectares (ha)) of San Bernardino kangaroo rat habitat and whether the benefits of excluding these areas would outweigh the benefits of their inclusion under section 4(b)(2) of the Act. If the Secretary determines that the benefits of including these lands are not outweighed by the benefits of excluding them, they will not be excluded from final critical habitat;

(3a) Any proposed critical habitat areas covered by existing or proposed conservation or management plans that we should consider for exclusion from the final designation under section 4(b)(2) of the Act. We specifically request information on any operative or draft habitat conservation plans for the San Bernardino kangaroo rat that have been prepared under section 10(a)(1)(B) of the Act, as well as any other management or conservation plan or agreement that benefits the kangaroo rat or its primary constituent elements; and

(4a) Specific information regarding the current status of plan implementation for the following management plans: the Woolly-Star Preserve Area Management Plans; the Former Norton Air Force Base Conservation Management Plan; the Cajon Creek Habitat Conservation Management Area, Habitat Enhancement and Management Plan; and Western Riverside Multiple Species Conservation Plan.

We also seek the following specific comments on the proposed critical habitat designations for Poa atropurpurea and Taraxacum californicum :

(1b) Any proposed critical habitat areas covered by conservation or management plans that we should consider for exclusion from the designation under section 4(b)(2) of the Act. We specifically request information on any operative or draft habitat conservation plans that include Poa atropurpurea or Taraxacum californicum as covered species that have been prepared under section 10(a)(1)(B) of the Act, or any other management or other conservation plan or agreement that benefits either plant or its primary constituent elements; and

(2b) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.

You may submit your comments and materials concerning the proposed rules by one of the methods listed in the ADDRESSES section. We will not accept comments you send by e-mail or fax. We will accept written comments at the public hearing. Please note that we may not consider comments we receive after the date specified in the DATES section in our final determination.

Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that we will post your entire comment—including your personal identifying information—on http://www.regulations.gov . While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rules, will be available for public inspection on http://www.regulations.gov , or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Carlsbad Fish and Wildlife Office, 6010 Hidden Valley Road, Carlsbad, CA 92011; telephone 760-431-9440; facsimile 760-431-9624.

Comments and information submitted during the initial comment periods on the proposed rules need not be resubmitted as they will be incorporated into the public records as part of those comment periods and will be fully considered in preparation of the final rules.

On June 19, 2007, we published a proposed rule in the Federal Register (72 FR 33808) to revise critical habitat for the San Bernardino kangaroo rat. Currently, 33,295 ac (13,485 ha) are designated as critical habitat for the San Bernardino kangaroo rat in San Bernardino and Riverside counties, California. Under the proposal, approximately 9,079 ac (3,674 ha) of land located in San Bernardino and Riverside counties, California, would fall within the boundaries of the revised critical habitat designation. Further, of the 9,079 ac (3,674 ha) of revised critical habitat, we are proposing to exclude 2,544 ac (1,029 ha) of land from the revised final designation under section 4(b)(2) of the Act (see the Exclusions Under Section 4(b)(2) of the Act section of the June 19, 2007, revised proposed rule [72 FR 33808] for a detailed discussion of this proposed exclusion).

On August 7, 2007, we published a proposed rule in the Federal Register (72 FR 44232) to designate critical habitat for Poa atropurpurea and Taraxacum californicum . We propose approximately 3,014 ac (1,221 ha) of land in San Bernardino and San Diego Counties, California, as critical habitat for P. atropurpurea, and approximately 1,930 ac (782 ha) of land in San Bernardino County, California, as critical habitat for T. californicum.

Economic analyses identifying estimated impacts associated with the proposed critical habitat designations for the San Bernardino kangaroo rat, Poa atropurpurea , and Taraxacum californicum are still in development. When these analyses are completed, we will provide a separate notice informing the public of their availability and providing an opportunity for public comment.

Critical habitat is defined in section 3 of the Act as:

(i) The specific areas within the geographical area occupied by the species, at the time of listing in accordance with the Act, on which are found those physical or biological features (1) essential to the conservation of the species and (2) which may require special management considerations or protection; and

(ii) Specific areas outside the geographical area occupied by the species at the time of listing if the Secretary determines that those areas are essential for the conservation of the species.

For each species, if the proposed critical habitat designation is finalized, section 7(a)(2) of the Act would require that Federal agencies ensure that actions they fund, authorize, or carry out are not likely to jeopardize the continued existence of the species or result in the destruction or adverse modification of critical habitat.

Section 4(b)(2) of the Act requires that we designate or revise critical habitat on the basis of the best scientific and commercial data available, after taking into consideration economic, national security, and any other relevant impacts of specifying any particular area as critical habitat.

Section 4(b)(5)(E) of the Act requires a public hearing be held if any person requests it within 45 days of the publication of a proposed rule. In response to requests from the public, the Service will conduct public hearings for these two critical habitat proposals on the date and at the address and times identified in the DATES and ADDRESSES sections above.

Persons wishing to make an oral statement for the record are encouraged to provide a written copy of their statement and present it to us at the hearing. In the event there is a large attendance, the time allotted for oral statements may be limited. Oral and written statements receive equal consideration. There are no limits on the length of written comments submitted to us. If you have any questions concerning the public hearing, please contact the Carlsbad Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

Persons needing reasonable accommodations in order to attend and participate in the public hearings should contact Dixie Ward, Carlsbad Fish and Wildlife Office, at 760-431-9440 as soon as possible. In order to allow sufficient time to process requests, please call no later than one week before the hearing date. Information regarding this notice is available in alternative formats upon request.

The author of this document is the staff of the Carlsbad Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).

The Magnuson-Stevens Act established U.S. jurisdiction over the fishery resources in the exclusive economic zone (EEZ). NMFS is responsible for implementation of the Magnuson-Stevens Act and the Fishery Management Plans (FMPs) prepared by eight Regional Fishery Management Councils (Councils) and for the FMP governing Atlantic Highly Migratory Species. While each Council prepares FMPs for those fishery resources within the Council's area of authority that require conservation, NMFS implements certain requirements common to all fisheries, such as facilitation of enforcement. Associated regulations are codified at 50 CFR parts 600 through 697.

These general regulations to facilitate enforcement also apply to U.S. fishing vessels fishing under the requirements of other fisheries laws and treaties. For example, they apply to fishing activities subject to the Atlantic Coastal Fisheries Cooperative Management Act regulations at 50 CFR part 697. In addition, there are several international fisheries regimes in which U.S. fishing vessels participate, such as the Atlantic fisheries under conservation and management measures adopted by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and implemented domestically by the Atlantic Tunas Convention Act and regulations at 50 CFR part 635. U.S. fishing vessels are regulated on the high seas and under other international fishing regimes, including the High Seas Fishing Compliance Act of 1995, the Tuna Conventions Act of 1950, the South Pacific Tuna Act of 1988, the North Pacific Halibut Act of 1982, the Pacific Salmon Treaty Act of 1985, the Antarctic Marine Living Resources Convention Act of 1984, and a number of international treaties, including the 1972 Treaty Between the Government of the United States of America and the Government of the Republic of Columbia Concerning the Status of Quita Sueno, Roncador and Serrana, and the 1981 Treaty Between the Government of the United States of America and the Government of Canada on Pacific Coast Albacore Tuna Vessels and Port Privileges as amended in 2002.

Current regulations at § 600.730(c)(3) require a fishing vessel to “provide a safe ladder” to be used for boarding purposes by authorized personnel including authorized officers (e.g., Coast Guard personnel, and Enforcement Agents), observers, and scientists enforcing regulations and documenting fishing effort at sea. However, a “safe boarding ladder” is not defined in regulations for domestic fishing vessels. This has led to fishing vessel operators providing a variety of ladders for boarding.

Safety is compromised when authorized personnel use ladders that are inadequate. Within the last few years, several boarding officers fell into the water when the ladders provided for boarding failed or when they were inadequate to allow the boarding officer to maintain a grip on the ladder. This is a highly dangerous situation. Colliding with the fishing vessel, the small boat delivering the boarding party, and even the ladder itself can injure or kill a falling person or one in the water. In addition, especially in Alaskan and Northwestern Atlantic waters, cold water temperature can cause shock and the quick onset of hypothermia, which quickly becomes life threatening. Although boarding parties wear flotation gear, the threat of drowning through unconsciousness or entanglement in a ladder or other gear from the vessel are concerns.

Some vessels have provided ladders wholly unsuited to boarding a vessel at sea, such as swimming pool ladders, aluminum step ladders, rigid wooden ladders, or metal rungs welded to the side of the vessel. While U.S. Coast Guard boarding parties can sometimes provide their own ladder, the process of rigging the ladder to the fishing vessel is slow and the ladder is bulky and hazardous to carry on board a small boat. In addition, observers transferring from one fishing vessel to another at sea cannot take a boarding ladder with them.

NMFS proposes to require the use of a pilot ladder on all fishing vessels with a freeboard of 4 ft (1.25 m) or greater in order to provide an easily identifiable and obtainable ladder to provide safe means for personnel to embark and disembark vessels at sea.

In addition to defining and requiring the use of a pilot ladder, this proposed rule would define the term “freeboard” with regard to this rule. This change would clarify the requirements of existing and proposed regulations. In some cases the term freeboard has been interpreted as the height of the lowest deck open to the weather (weather deck) from the water's surface. In other cases it has been considered as the height of the gunwale (railing around the weather deck bulwarks) from the water's surface. The difference between these two measurements can be from a few inches to over 6 feet (1.8 m). In order to make the regulations more useful and consistent, NMFS proposes to define freeboard as the working distance between the top rail of the gunwale of a vessel to the water's surface. Because some vessels have openings in the bulwarks specifically for embarking and debarking personnel, NMFS proposes that, where cut-outs are provided in the bulwarks for the sole purpose of personnel boarding, freeboard means the distance between the top of the lowest portion of the structure to the water's surface.

Pursuant to section 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Magnuson-Stevens Act and other applicable law, subject to further consideration after public comment.

An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A summary of the analysis follows. A copy of this analysis is available from NMFS (see ADDRESSES ).

In determining the number of vessels that might be affected by this rule, NMFS and the Coast Guard first determined that vessels 65 ft (20.0 m) or greater in length have a freeboard (defined as the working distance between the top rail of the gunwale to the water's surface) of 4 ft (1.25 m) or greater. While some vessels 65 ft (20.0 m) or greater in length may have a freeboard of less than 4 ft (1.25 m), NMFS assumed for purposes of this analysis that all of these vessels, as well as an unknown number of smaller vessels, would be required to carry a pilot ladder if this proposed rule were implemented. According to U.S. Coast Guard vessel documentation records, 6,050 documented fishing vessels are 65 ft (20 m) long or longer and could be affected by this requirement. Because some vessels already have ladders that would meet the new requirements, it is unlikely that all of the identified fishing vessels would need to purchase a ladder. Except for some large catcher-processor vessels, mostly engaged in the Alaska fisheries, these vessels are all considered small entities for the purpose of this rule.

This rule has no reporting or recordkeeping requirements.

This rule refers to 46 CFR subpart 163.003, which provides standards and approval and production tests for pilot ladders that would be required by this proposed rule. There are no conflicting rules.

This action considered 5 alternatives including the preferred alternative and the status quo. The proposed alternative (proposed action) is to require the operators of all fishing vessels with a freeboard of over 4 feet (1.25 m) to provide a U.S. Coast Guard-approved pilot ladder for boarding parties, observers and other officials required to board the vessel. The term “pilot ladder” would replace the currently required “safe boarding ladder.” That term has been undefined and, as a result, fishing vessel operators have provided ladders that have been both inadequate and unsafe. Approved boarding ladders come in several approved versions and vary in cost. Typically, vessels would need a 10- or 12-foot (3.0 or 3.7 m) ladder that costs approximately $517-$620 for a wooden rung ladder, and $1,160-$1,392 for a synthetic rung ladder. The largest vessels may have to buy a longer ladder at a proportionate increase (approximately $50-$60 per foot) in cost. NMFS estimates the total cost to fishing vessel owners of this rule to be from $3,127,850 ($517 x 6,050 vessels) to $8,421,600 ($1,392 x 6,050 vessels).

The second alternative is the status quo, or no change to the regulations. The status quo does not meet the objectives of the action. This alternative would not increase costs to fishermen; however, neither would it provide any increased safety to persons attempting to board fishing vessels at sea. The regulations would continue to be ambiguous and vessel operators may continue to provide unsafe ladders, resulting in delayed boardings and accidents, some of which could be serious or fatal.

A third alternative considered would limit this requirement to Alaskan and Northwestern Atlantic waters where cold water and rough seas are common. This alternative does not meet the objectives of the action. The limitation would reduce the cost to fishermen, but would not reduce the hazard to boarding parties in the areas that are not subject to the requirements, since boardings are conducted in rough seas off all coasts and during all periods of the year. Therefore, limiting the extent of this requirement would compromise the safety of boarding parties in any areas of the EEZ that are not subject to the requirements.

A fourth alternative would require vessels with a freeboard of 3 feet (0.9 m) or more to provide a ladder. Some reports from U.S. Coast Guard boarding parties indicate that ladders would facilitate boarding operations in those cases. NMFS rejected this alternative because of the marginal benefit in safety and the relative difficulty in determining the number of vessels that would have to obtain ladders.

A fifth alternative would allow fishing vessel owners or operators to make their own ladders according to specifications found at 46 CFR subpart 163.003, without going through the procedures for CG approval. While fishermen could potentially make such ladders cheaper than buying them, the ladders would not be approved and there would be no assurance that they would actually perform as required. Therefore, this alternative was not adopted.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

Administrative practice and procedure, Antarctica, Canada, Exports, Fish, Fisheries, Fishing, Imports, Indians, Labeling, Marine resources, Reporting and recordkeeping requirements, Russian Federation, Transportation, Treaties, Wildlife.

Administrative practice and procedure, Confidential business information, Fisheries, Fishing, Fishing vessels, Foreign relations, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Statistics.

Administrative practice and procedure, Fisheries, Fishing, Intergovernmental relations, Reporting and recordkeeping requirements.

For the reasons set out in the preamble, 50 CFR parts 300, 600, and 697 are proposed to be amended as follows.

1. The authority citation for part 300 continues to read as follows:

2. In § 300.2, add definitions for “freeboard” and “pilot ladder” in alphabetical order to read as follows:

3. In § 300.5, paragraphs (c)(3) and (4) are revised to read as follows:

4. The authority citation for part 600 continues to read as follows:

5. In § 600.10, add definitions for “freeboard” and “pilot ladder” in alphabetical order to read as follows:

6. In § 600.730, paragraphs (c)(3) and (4) are revised to read as follows:

7. The authority citation for part 697 continues to read as follows:

8. In § 697.9, paragraph (a) is revised to read as follows: