This proposal is issued under Marketing Order No. 985 (7 CFR Part 985), as amended, regulating the handling of spearmint oil produced in the Far West (Washington, Idaho, Oregon, and designated parts of Nevada and Utah), hereinafter referred to as the “order.” This 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. Under the provisions of the order now in effect, salable quantities and allotment percentages may be established for classes of spearmint oil produced in the Far West. This proposed rule would establish the quantity of spearmint oil produced in the Far West, by class, that may be purchased from or handled for producers by handlers during the 2003-2004 marketing year, which begins on June 1, 2003. This proposed rule would 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.

Pursuant to authority in §§ 985.50, 985.51, and 985.52 of the order, the Committee, with seven of its eight members present, met on October 2, 2002, and recommended salable quantities and allotment percentages for both classes of oil for the 2003-2004 marketing year. With six members in favor and one opposed, the Committee recommended the establishment of a salable quantity and allotment percentage for Scotch spearmint oil of 857,444 pounds and 45 percent, respectively. For Native spearmint oil, the Committee unanimously recommended the establishment of a salable quantity and allotment percentage of 808,528 pounds and 38 percent, respectively.

This proposed rule would limit the amount of spearmint oil that handlers may purchase from, or handle for, producers during the 2003-2004 marketing year, which begins on June 1, 2003. Salable quantities and allotment percentages have been placed into effect each season since the order's inception in 1980.

The U.S. production of spearmint oil is concentrated in the Far West, primarily Washington, Idaho, and Oregon (part of the area covered by the marketing order). Spearmint oil is also produced in the Midwest. The production area covered by the marketing order currently accounts for approximately 55 percent of the annual U.S. production of Scotch spearmint oil.

When the order became effective in 1980, the United States produced nearly 100 percent of the world's supply of Scotch spearmint oil, of which approximately 72 percent was produced in the regulated production area in the Far West. The Far West continued to produce an average of about 69 percent of the world's Scotch spearmint oil supply during the period from 1980 to 1990. International production characteristics have changed since 1990, however, with foreign Scotch spearmint oil production contributing significantly to world production. The Far West's market share as a percent of total world sales has averaged about 45 percent since 1990.

Between 1996 and 2000, the Committee's marketing strategy for Scotch spearmint oil centered around an attempt to regain a substantial amount of the Far West's historical share of the global market for this class of oil. Although still interested in retaining a sizable share of the global market, the Committee has since refocused its strategy on establishing a salable quantity that is largely determined by information on price and available supply as they are affected by the estimated trade demand.

Although sales had increased somewhat, the Far West's market share as a percentage of total world sales had not increased on average, and the market price for Scotch spearmint oil had continued to decline throughout the 1996-2000 period. During the 1998-1999 and 1999-2000 marketing years, the price paid to producers for Scotch spearmint oil dropped to a low of $7.00 per pound. Although the current price for Scotch oil is about $8.00 per pound, the Committee, as well as spearmint oil producers and handlers attending the October 2, 2002, meeting, continue to believe that such returns are generally below the cost of production for most producers. The most recent information available from the Washington State University Cooperative Extension Service (WSU), indicates the production costs to be between $13.50 and $15.00 per pound.

The Committee estimates that acreage of Scotch spearmint has declined from about 10,000 acres in 1998 to about 4,000 acres currently. The reduction in acreage is directly attributable to the relatively low level of producer returns. Based on the reduced Scotch spearmint acreage, the Committee estimates that production for the current season (the 2002-2003 marketing season) will be about 472,600 pounds.

The Committee calculated the 2003-2004 Scotch spearmint oil salable quantity (857,444 pounds) and allotment percentage (45 percent) by utilizing sales estimates for 2003-2004 Scotch oil as provided by several of the industry's handlers, as well as historical and current Scotch oil sales levels. Between June 1, 2002, and September 27, 2002, 415,914 pounds of Scotch oil were sold, a level below the most recent five-year average of 490,926 pounds. Handlers are estimating that sales for the 2002-2003 marketing year may range from a low of 700,000 pounds to a high of 825,000 pounds. With 387,374 pounds carried in to the current marketing year and an estimated 472,608 pounds being produced, the total available supply this year, including the 415,914 pounds already sold, is 859,982 pounds.

The recommendation for the 2003-2004 Scotch spearmint oil volume regulation is consistent with the Committee's stated intent of keeping adequate supplies available at all times, while attempting to stabilize prices at a level adequate to sustain the farmers producing the oil. Furthermore, the recommendation takes into consideration the industry's desire to compete with less expensive oil produced outside the regulated area.

Although Native spearmint oil producers are facing market conditions similar to those affecting the Scotch spearmint oil market, unlike Scotch, over 90 percent of the U.S. production of Native spearmint is produced within the Far West production area. Also, unlike Scotch, most of the world's supply of Native spearmint is produced in the U.S.

The current, flat market contributed to the Committee's recommendation for a salable quantity of 808,528 pounds and an allotment percentage of 38 percent for Native spearmint oil for the 2003-2004 marketing year. The supply and demand characteristics of the current Native spearmint oil market are keeping the price relatively steady at about $9.00 per pound—a level the Committee considers too low for the majority of producers to maintain viability. The WSU study referenced earlier indicates that the cost of producing Native spearmint oil ranges from $10.26 to $10.92 per pound.

Although Native spearmint acreage has decreased about 11 percent over the last year, the Committee estimates that over a million pounds of Native oil is expected to be produced this year. With current sales approximating the five-year average of about 500,000 pounds, the current season's salable quantity of 800,761 pounds coupled with the June 1, 2002, carry-in of 202,872 pounds will likely produce a surplus of oil, adding to the nearly 1.2 million pounds already in reserve. Handlers are estimating that about 918,750 pounds of Native spearmint oil, on average, may be sold during the 2003-2004 marketing year. This estimate, combined with the information available regarding current supply and price, helped lead the Committee to its recommendation for a 2003-2004 salable quantity of 808,528 pounds. When considered in conjunction with the estimated carry-in of 104,562 pounds of oil on June 1, 2003, the recommended salable quantity results in a total available supply of Native spearmint oil next year of about 913,090 pounds.

Thus, with over 90 percent of the world production currently located in the Far West, the Committee's method of calculating the Native spearmint oil salable quantity and allotment percentage continues to primarily utilize information on price and available supply as they are affected by the estimated trade demand. The Committee's stated intent is to make adequate supplies available to meet market needs and improve producer prices.

Despite the downward trend in the price of both classes of spearmint oil in recent years, the Committee believes that the order has contributed extensively to the stabilization of producer prices, which prior to 1980 experienced wide fluctuations from year to year. According to the National Agricultural Statistics Service, for example, the average price paid for both classes of spearmint oil ranged from about $4.00 per pound to about $12.50 per pound during the period between 1968 and 1980. Excluding the most recent four marketing years, prices since the order's inception have generally stabilized at about $11.00 per pound for Native spearmint oil and at about $13.00 per pound for Scotch spearmint oil. However, the prices for both classes of oil have dropped over the last few years due to several factors, including the general uncertainty being experienced through the U.S. economy and the continuing overall weak farm situation, as well as an abundant global supply of spearmint oil. As noted earlier,—although lower than what producers believe to be viable—prices currently appear to be stable at about $8.00 for Scotch and $9.00 for Native.

The Committee based its recommendation for the proposed salable quantity and allotment percentage for each class of spearmint oil for the 2003-2004 marketing year on the information discussed above, as well as the data outlined below.

(A) Estimated carry-in on June 1, 2003—43,782 pounds. This figure is the difference between the estimated 2002-2003 marketing year trade demand of 816,200 pounds and the revised 2002-2003 marketing year total available supply of 859,982 pounds. The 2002-2003 marketing year total available supply was revised due to differences in the carry-in estimated on October 11, 2001, and the actual carry-in on June 1, 2002, as well as producer deficiencies on June 1, 2002. A producer is deficient when the producer is unable or unwilling to produce oil equal to his or her salable quantity and is unable to fill this deficiency from reserve pool oil or excess oil from another producer. When prices are below a producer's cost of production, they generally reduce acres and produce less oil.

(B) Estimated trade demand for the 2003-2004 marketing year—822,200 pounds. This figure represents the Committee's estimate based on the average of the estimates provided by producers at five Scotch spearmint oil production area meetings held in September 2002, as well as estimates provided by handlers and others at the October 2, 2002, meeting. Handler trade demand estimates for the 2003-2004 marketing year ranged from 750,000 to 800,000 pounds. The average of sales over the last five years was 912,209 pounds.

(C) Salable quantity required from the 2003-2004 marketing year production—778,418 pounds. This figure is the difference between the estimated 2003-2004 marketing year trade demand (822,200 pounds) and the estimated carry-in on June 1, 2003 (43,782 pounds).

(D) Total estimated allotment base for the 2003-2004 marketing year—1,905,430 pounds. This figure represents a one-percent increase over the revised 2002-2003 total allotment base. This figure is generally revised each year on June 1 due to producer base being lost due to the bona fide effort production provisions of § 985.53(e). The revision is usually minimal.

(E) Computed allotment percentage—40.9 percent. This percentage is computed by dividing the required salable quantity by the total estimated allotment base.

(F) Recommended allotment percentage—45 percent. This recommendation is based on the Committee's determination that a decrease from the current season's allotment percentage of 45 percent to the computed 40.9 percent would not adequately supply the potential 2003-2004 market. The recommended level of 45 percent is slightly higher than the 22-year average of sales.

(G) The Committee's recommended salable quantity—857,444 pounds. This figure is the product of the recommended allotment percentage and the total estimated allotment base.

(H) Estimated available supply for the 2003-2004 marketing year—901,226 pounds. This figure is the sum of the 2003-2004 recommended salable quantity (857,444 pounds) and the estimated carry-in on June 1, 2003 (43,782 pounds).

(A) Estimated carry-in on June 1, 2003—104,562 pounds. This figure is the difference between the estimated 2002-2003 marketing year trade demand of 900,000 pounds and the revised 2002-2003 marketing year total available supply of 1,004,562 pounds.

(B) Estimated trade demand for the 2003-2004 marketing year—875,000 pounds. This figure is based on input from producers at the five Native spearmint oil production area meetings held in September 2002, from handlers, and from Committee members and other meeting participants at the October 2, 2002, meeting. The average estimated trade demand provided at the five production area meetings was 907,000 pounds, whereas the average handler estimate was 918,750 pounds. According to the Committee, the more conservative estimate chosen for the 2003-2004 trade demand figure reflects a general lack of 2003 contract offers to date.

(C) Salable quantity required from the 2003-2004 marketing year production—770,438 pounds. This figure is the difference between the estimated 2003-2004 marketing year trade demand (875,000 pounds) and the estimated carry-in on June 1, 2003 (104,562 pounds).

(D) Total estimated allotment base for the 2003-2004 marketing year—2,127,706 pounds. This figure represents a one percent increase over the revised 2002-2003 total allotment base. This figure is generally revised each year on June 1 due to producer base being lost due to the bona fide effort production provisions of § 985.53(e). The revision normally involves a minimal amount of spearmint oil.

(E) Computed allotment percentage—36.2 percent. This percentage is computed by dividing the required salable quantity by the total estimated allotment base.

(F) Recommended allotment percentage—38 percent. This is the Committee's recommendation based on the computed allotment percentage, the average of the computed allotment percentage figures from the five production area meetings (38.6 percent), and input from producers and handlers at the October 2, 2002, meeting.

(G) The Committee's recommended salable quantity—808,528 pounds. This figure is the product of the recommended allotment percentage and the total estimated allotment base.

(H) Estimated available supply for the 2003-2004 marketing year—913,090 pounds. This figure is the sum of the 2003-2004 recommended salable quantity (808,528 pounds) and the estimated carry-in on June 1, 2003 (104,562 pounds).

The salable quantity is the total quantity of each class of spearmint oil, which handlers may purchase from, or handle on behalf of producers during a marketing year. Each producer is allotted a share of the salable quantity by applying the allotment percentage to the producer's allotment base for the applicable class of spearmint oil.

The Committee's recommended Scotch and Native spearmint oil salable quantities and allotment percentages of 857,444 pounds and 45 percent and 808,528 and 38 percent, respectively, are based on the Committee's goal of maintaining market stability by avoiding extreme fluctuations in supplies and prices and the anticipated supply and trade demand during the 2003-2004 marketing year. The proposed salable quantities are not expected to cause a shortage of spearmint oil supplies. Any unanticipated or additional market demand for spearmint oil, which may develop during the marketing year, can be satisfied by an increase in the salable quantities. Both Scotch and Native spearmint oil producers who produce more than their annual allotments during the 2003-2004 season may transfer such excess spearmint oil to a producer with spearmint oil production less than his or her annual allotment or put it into the reserve pool.

This proposed regulation, if adopted, would be similar to those, which have been issued, in prior seasons. Costs to producers and handlers resulting from this proposed action are expected to be offset by the benefits derived from a stable market and improved returns. In conjunction with the issuance of this proposed rule, USDA has reviewed the Committee's marketing policy statement for the 2003-2004 marketing year. The Committee's marketing policy statement, a requirement whenever the Committee recommends volume regulations, fully meets the intent of § 985.50 of the order. During its discussion of potential 2003-2004 salable quantities and allotment percentages, the Committee considered: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) prospective production of each class of oil; (4) total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity. Conformity with the USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” has also been reviewed and confirmed.

The establishment of these salable quantities and allotment percentages would allow for anticipated market needs. In determining anticipated market needs, consideration by the Committee was given to historical sales, as well as changes and trends in production and demand. This rule also provides producers with information on the amount of spearmint oil, which should be produced for next season in order to meet anticipated market demand.

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 7 spearmint oil handlers subject to regulation under the order, and approximately 98 producers of Class 1 (Scotch) spearmint oil and approximately 100 producers of Class 3 (Native) spearmint oil in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (SBA)(13 CFR 121.201) as those having annual receipts of less than $5,000,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000.

Based on the SBA's definition of small entities, the Committee estimates that 2 of the 7 handlers regulated by the order could be considered small entities. Most of the handlers are large corporations involved in the international trading of essential oils and the products of essential oils. In addition, the Committee estimates that 11 of the 98 Scotch spearmint oil producers and 13 of the 100 Native spearmint oil producers could be classified as small entities under the SBA definition. Thus, a majority of handlers and producers of Far West spearmint oil may not be classified as small entities.

The Far West spearmint oil industry is characterized by producers whose farming operations generally involve more than one commodity, and whose income from farming operations is not exclusively dependent on the production of spearmint oil. A typical spearmint oil-producing operation has enough acreage for rotation such that the total acreage required to produce the crop is about one-third spearmint and two-thirds rotational crops. Thus, the typical spearmint oil farmer has to have considerably more acreage than is planted to spearmint during any given season. Crop rotation is an essential cultural practice in the production of spearmint oil for weed, insect, and disease control. To remain economically viable with the added costs associated with spearmint oil production, most spearmint oil-producing farms fall into the SBA category of large businesses.

This proposed rule would establish the quantity of spearmint oil produced in the Far West, by class, that handlers may purchase from, or handle for, producers during the 2003-2004 marketing year. The Committee recommended this rule to help maintain stability in the spearmint oil market by avoiding extreme fluctuations in supplies and prices. Establishing quantities to be purchased or handled during the marketing year through volume regulations allows growers to plan their mint planting and harvesting to meet expected market needs. The provisions of §§ 985.50, 985.51, and 985.52 of the order authorize this action.

Small spearmint oil producers generally are not as extensively diversified as larger ones and as such are more at risk to market fluctuations. Such small farmers generally need to market their entire annual crop and do not have the luxury of having other crops to cushion seasons with poor spearmint oil returns. Conversely, large diversified producers have the potential to endure one or more seasons of poor spearmint oil markets because incomes from alternate crops could support the operation for a period of time. Being reasonably assured of a stable price and market provides small producing entities with the ability to maintain proper cash flow and to meet annual expenses. Thus, the market and price stability provided by the order potentially benefit the small producer more than such provisions benefit large producers. Even though a majority of handlers and producers of spearmint oil may not be classified as small entities, the volume control feature of this order has small entity orientation.

Demand for spearmint oil tends to be relatively stable from year-to-year. The demand for spearmint oil is expected to grow slowly for the foreseeable future because the demand for consumer products that use spearmint oil will likely expand slowly, in line with population growth.

Demand for spearmint oil at the farm level is derived from retail demand for spearmint-flavored products at retail such as chewing gum, toothpaste, and mouthwash. The manufacturers of these products are by far the largest users of mint oil. However, spearmint flavoring is generally a very minor component of the products in which it is used, so changes in the raw product price have no impact on retail prices for those goods.

Spearmint oil production tends to be cyclical. Years of large production, with demand remaining reasonably stable, have led to periods in which large producer stocks of unsold spearmint oil have depressed producer prices for a number of years. Shortages and high prices may follow in subsequent years, as producers respond to price signals by cutting back production.

The wide fluctuations in supply and prices that result from this cycle, which was even more pronounced before the creation of the marketing order, can create liquidity problems for some producers. The marketing order was designed to reduce the price impacts of the cyclical swings in production. However, producers have been less able to weather these cycles in recent years because of the decline in prices of many of the alternative crops they grow. As noted earlier, almost all spearmint oil producers diversify by growing other crops.

Instability in the spearmint oil sub sector of the mint industry is much more likely to originate on the supply side than the demand side. Fluctuations in yield and acreage planted from season-to-season tend to be larger than fluctuations in the amount purchased by buyers.

The significant variability is illustrated by the fact that between 1980 and 2001, the coefficient of variation (CV) of northwest spearmint oil production was about 0.24. The CV is a standard measure of variability above and below the average production level of 1,880,727 pounds. Production in the shortest crop year was about 48 percent of the 22-year average and the largest crop was approximately 164 percent. A key consequence is that in years of oversupply and low prices, the season average producer price of spearmint oil is below the average cost of production (as measured by the Washington State University Cooperative Extension Service).

Over the 22-year period, the CV for spearmint oil prices was about 0.13, well below the CV for production. This provides an indication of the price stabilizing impact of the marketing order.

In an effort to stabilize prices, the spearmint oil industry uses the volume control mechanisms authorized under the order. This authority allows the Committee to recommend a salable quantity and allotment percentage for each class of oil for the upcoming marketing year. The salable quantity for each class of oil is the total volume of oil that producers may sell during the marketing year. The allotment percentage for each class of spearmint oil is derived by dividing the salable quantity by the total allotment base.

Each producer is then issued an annual allotment certificate, in pounds, for the applicable class of oil, which is calculated by multiplying the producer's allotment base by the applicable allotment percentage. This is the amount of oil for the applicable class that the producer can sell.

By November 1 of each year, the Committee identifies any oil that individual producers have produced above the volume specified on their annual allotment certificates. This excess oil is placed in a reserve pool administered by the Committee.

There is a reserve pool for each class of oil that may not be sold during the current marketing year unless the Secretary approves a Committee recommendation to make a portion of the pool available. However, limited quantities of reserve oil are typically sold to fill deficiencies. A deficiency occurs when on-farm production is less than a producer's allotment. In that case, a producer's own reserve oil can be sold to fill that deficiency. Excess production (higher than the producer's allotment) can be sold to fill other producers' deficiencies.

In any given year, the total available supply of spearmint oil is composed of current production plus carry-over stocks from the previous crop. The Committee seeks to maintain market stability by balancing supply and demand, and to close the marketing year with an appropriate level of carry-out. If the industry has production in excess of the salable quantity, then the reserve pool absorbs the surplus quantity of spearmint oil, which goes unsold during that year, unless the oil is needed for unanticipated sales.

Under its provisions, the order may attempt to stabilize prices by (1) limiting supply and establishing reserves in high production years, thus minimizing the price-depressing effect that excess producer stocks have on unsold spearmint oil, and (2) ensuring that stocks are available in short supply years when prices would otherwise increase dramatically. The reserve pool stocks grown in large production years are drawn down in short crop years.

An econometric model was used to assess the impact that volume control has on the prices producers receive for their commodity. Without volume control, spearmint oil markets would likely be over-supplied, resulting in low producer prices and a large volume of oil stored and carried over to the next crop year. The model estimates how much lower producer prices would likely be in the absence of volume controls.

The Committee estimated the available supply during the 2003-2004 marketing year for both classes of oil at 1,814,356 pounds, and that the expected carry-in will be 148,344 pounds. Therefore, with volume control, sales by producers for the 2003-2004 marketing year should be limited to 1,665,972 pounds (the recommended salable quantity for both classes of spearmint oil).

The recommended salable percentages, upon which 2003-2004 producer allotments are based, are 45 percent for Scotch and 38 percent for Native. Without volume controls, producers would not be limited to these allotment levels, and could produce and sell additional spearmint. The econometric model estimated a $1.57 decline in the season average grower price per pound (from both classes of spearmint oil) resulting from the higher quantities that would be produced and marketed without volume control. Northwest grower prices for both classes of spearmint oil averaged $8.86 for 2000 and 2001, based on National Agricultural Statistics Service data, continuing a downward decline in recent years. The severe surplus situation for the spearmint oil market that would exist without volume controls in 2003-2004 also would likely dampen prospects for improved grower prices in future years because of the buildup in stocks.

The use of volume controls allows the industry to fully supply spearmint oil markets while avoiding the negative consequences of over-supplying these markets. The use of volume controls is believed to have little or no effect on consumer prices of products containing spearmint oil and will not result in fewer retail sales of such products.

The Committee discussed alternatives to the recommendations contained in this rule for both classes of spearmint oil. The Committee discussed and rejected the idea of recommending that there not be any volume regulation for Scotch spearmint oil because of the severe price-depressing effects that would occur without volume control.

The Committee also considered various alternative levels of volume control for Scotch spearmint oil, including leaving the percentage the same as the current season, increasing the percentage to a less restrictive level, or decreasing the percentage. After considerable discussion in which there was no support for increasing the percentage and minimal support for decreasing it, the Committee chose to remain at the current level (45 percent). One Committee member voted in favor of establishing an allotment percentage of 40 percent due to his belief that anything more would not help improve the current depressed prices growers are receiving for their oil.

The Committee also discussed alternative allotment percentage levels for Native spearmint oil. With the current price for Native spearmint oil lower than the 20-year average, and demand fairly flat, the Committee, after considerable discussion, determined that 808,528 pounds and 38 percent would be the most effective salable quantity and allotment percentage, respectively, for the 2003-2004 marketing year. With a market situation similar to that of Scotch, none of those in attendance at the October 2, 2002, meeting were in support of a higher level of volume regulation, and only a few voiced support for levels less than 38 percent. After considerable discussion, the Committee unanimously supported the recommendation contained herein.

As noted earlier, the Committee's recommendation to establish salable quantities and allotment percentages for both classes of spearmint oil was made after careful consideration of all available information, including: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity. Based on its review, the Committee believes that the salable quantity and allotment percentage levels recommended would achieve the objectives sought.

Without any regulations in effect, the Committee believes the industry would return to the pronounced cyclical price patterns that occurred prior to the order, and that prices in 2003-2004 would decline substantially below current levels.

As stated earlier, the Committee believes that the order has contributed extensively to the stabilization of producer prices, which prior to 1980 experienced wide fluctuations from year-to-year. National Agricultural Statistics Service records show that the average price paid for both classes of spearmint oil ranged from about $4.00 per pound to about $12.50 per pound during the period between 1968 and 1980. Prices have been consistently more stable since the marketing order's inception in 1980. For much of the 1990's, prices had stabilized at about $13.00 per pound for Scotch spearmint oil and about $11.00 per pound for Native spearmint oil.

Over the last four years, however, large production and carry-in inventories have contributed to declining prices, despite the Committee's efforts to balance available supplies with demand. Further, over the same period, prices have ranged from $8.00 to $11.00 per pound for Scotch spearmint oil and between $9.00 to $10.00 per pound for Native spearmint oil.

According to the Committee, the recommended salable quantities and allotment percentages are expected to achieve the goals of market and price stability.

As previously stated, annual salable quantities and allotment percentages have been issued for both classes of spearmint oil since the order's inception. Reporting and recordkeeping requirements have remained the same for each year of regulation. These requirements have been approved by the Office of Management and Budget under OMB Control No. 0581-0065. Accordingly, this action would not impose any additional reporting or recordkeeping requirements on either small or large spearmint oil producers and handlers. All reports and forms associated with this program are reviewed periodically in order to avoid unnecessary and duplicative information collection by industry and public sector agencies. The USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

The Committee's meeting was widely publicized throughout the spearmint oil industry and all interested persons were invited to attend and participate on all issues. In addition, interested persons are invited to submit information on 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 20-day comment period is provided to allow interested persons the opportunity to respond to the proposal, including any regulatory and informational impacts of this action on small businesses. This comment period is deemed appropriate so that a final determination can be made prior to June 1, 2003, the beginning of the 2003-2004 marketing year. All written comments received within the comment period will be considered before a final determination is made on this matter.

For the reasons set forth in the preamble, 7 CFR Part 985 is proposed to be amended as follows:

Legal authority. The Blueberry Promotion, Research, and Consumer Information Order (Order) (7 CFR part 1218) became effective on August 16, 2000 (65 FR 43961, July 17, 2000). It was issued under the Commodity Promotion, Research, and Information Act of 1996 (Act) (7 U.S.C. 7401-7425).

The Office of Management and Budget has waived the review process required by Executive Order 12866 for this action.

In addition, this rule has been reviewed under E.O. 12988, Civil Justice Reform. The rule is not intended to have retroactive effect. Section 524 of the Act provides that the Act shall not affect or preempt any other Federal or state law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the Act, a person subject to the Order may file a petition with the Secretary of Agriculture (Secretary) stating that the Order, any provision of the Order, or any obligation imposed in connection with the Order, is not established in accordance with the law, and requesting a modification of the Order or an exemption from the Order. Any petition filed challenging the Order, any provision of the Order, or any obligation imposed in connection with the Order, shall be filed within two years after the effective date of the Order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, the Secretary will issue a ruling on a petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of the Secretary's final ruling.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), AMS has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened.

There are approximately 2,000 producers, 200 first handlers, 50 importers, and 4 exporters of blueberries subject to the program. Most of the producers would be classified as small businesses under the criteria established by the Small Business Administration (SBA) (13 CFR 121.201). Most importers and first handlers would not be classified as small businesses, and, while most exporters are large, we assume that some are small. The SBA defines small agricultural handlers as those whose annual receipts are less than $5 million, and small agricultural producers are defined as those having annual receipts of not more than $500,000 annually.

This proposed rule would amend the Order to change the title of the U.S.A. Cultivated Blueberry Council to the “U.S. Highbush Blueberry Council” (Council) and to add one member and alternate to the Council to represent the state of Washington.

The proposed amendments are not considered to be substantial and will not significantly impact the blueberry industry. The name change will have a positive impact on the industry. Adding a producer member and alternate representing the state of Washington means that four additional producers will be required to submit background forms to USDA in order to be considered for appointment to the Council. Four producers will be affected because two names must be submitted to the Secretary for consideration for each position on the Council. However, serving on the Council is optional, and the burden of submitting the background form would be offset by the benefits of serving on the Council. The estimated annual cost of providing the information by four producers would be $6.00 for all four producers or $1.50 per producer.

There are no relevant Federal rules that duplicate, overlap, or conflict with the proposed rule.

We have performed this Initial Regulatory Flexibility Analysis regarding the impact of this proposed amendment to the Order on small entities, and we invite comments concerning potential effects of the proposed amendment.

In accordance with the OMB regulation (5 CFR 1320) which implements the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the background form, which represents the information collection and recordkeeping requirements that may be imposed by this rule, was previously submitted to and approved by OMB under OMB Number 0505-0001.

Title: National Research, Promotion, and Consumer Information Programs.

OMB Number: 0505-0001.

Expiration Date of Approval: October 31, 2003.

Type of Request: Increase in the information collection burden for research and promotion programs.

Abstract: The information collection requirements in this request are essential to carry out the intent of the Act. The burden associated with this action is as follows:

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.5 hours per response for each producer.

Respondents: Producers.

Estimated Number of Respondents: 4.

Estimated Number of Responses per Respondent: 1 every 3 years (0.3).

Estimated Total Annual Burden on Respondents: 0.6 hours.

The estimated annual cost of providing the information by the four producers would be $6.00 or $1.50 per producer.

This additional burden will be included in the existing information collections approved for use under OMB Number 0505-0001.

During the rulemaking process to implement the Order in 2000, members of the wild blueberry industry in Maine raised objections to the original name of the U.S.A. Blueberry Council. However, USDA did not change the name at that time, and the wild blueberry industry continued to have concerns to the generic name of the Council. Therefore, USDA issued a proposed rule to change the name of the Council to the U.S.A. Cultivated Blueberry Council on September 21, 2000 (65 FR 57104). The new name became effective on August 16, 2001, with the publication of a final rule published in the Federal Register on July 17, 2001 (66 FR 37117).

Subsequently, the Council was appointed and decided that the term “cultivated” in its name should be changed to “highbush” because cultivated blueberries are commonly called highbush blueberries, and wild blueberries are commonly called lowbush blueberries. In addition, horticultural publications use the nomenclature of highbush and lowbush for blueberries. Using the terms highbush and lowbush provides a simple means for the consumer to differentiate between these two types of blueberries and for industry members to determine whether or not they owe assessments to the Council. Accordingly, the Council recommends that the term highbush should be used to distinguish their blueberries from lowbush (wild).

Therefore, the Council voted unanimously on October 5, 2002, to change the Council's name to the U.S. Highbush Blueberry Council.

At the same meeting, the Council voted unanimously to add one member and alternate to the Council to represent the state of Washington.

The Council currently consists of nine producers, one importer, one exporter from a foreign production area, one handler, and one public member. Each member has an alternate. The nine producer members are allocated as follows: one producer member for each of the top five producing states and one producer member from each of the four regions. The states that currently have representation on the Council are Georgia, Michigan, New Jersey, North Carolina, and Oregon. In recent years, highbush blueberry production in the state of Washington has increased. In 2001, Washington represented 8 percent of U.S. production, and the estimated production for that state in 2002 is 12.5 million pounds of highbush blueberries. In addition, the five additional states producing highbush blueberries (Alabama, Arkansas, Florida, Indiana, and New York) together represent only 7 percent of U.S. production, and the seventh highest producing state-Indiana-is expected to produce a total of 3 million pounds. Therefore, the Council determined that it was appropriate for Washington producers to have a state member and alternate on the Council.

Therefore, this proposed rule would change all references in the Order from the U.S.A. Cultivated Blueberry Council to the U.S. Highbush Blueberry Council and change all references to the USACBC to the Council. In addition, this rule would revise § 1216.40(a)(2) to specify that there will be one producer member and alternate from each of the top six (rather than five) blueberry producing states. If this rule is adopted, the Council would have 14 members and alternates. Therefore, a conforming change would be made in § 1216.40(a) to remove the Council member limit of 13. USDA has also removed obsolete language from §§ 1218.40 and 1218.41.

For the reasons set forth in the preamble, 7 CFR part 1218 is proposed to be amended as follows:

1. The authority citation for part 1218 continues to read as follows:

The FAA invites interested parties to comment on this notice of policy statement. Please submit comments to the above address. The FAA will consider all comments received by the closing date before issuing a final policy statement.

Title 14, Code of Federal Regulations (14 CFR) Part 21 Certification Procedures for Products and Parts (part 21) defines the regulations for the portion of the aviation industry that supports the design and manufacture of aviation products and parts. This includes the requirements for the issue of type certificates and changes to those certificates; the issue of production certificates (PCs); the issue of airworthiness certificates; the issue of export airworthiness approvals; the rules governing the holder of any of these certificates, and procedural requirements for the approval of certain materials, parts, processes, and appliances.

14 CFR Part 43 Maintenance, Preventive Maintenance, Rebuilding and Alteration (part 43) defines regulations for the portion of the aviation industry that supports continued airworthiness standards, or more specifically those that maintain the airworthiness status of products and parts. It describes rules governing the maintenance, preventive maintenance, rebuilding and alteration of any aircraft having a U.S. airworthiness certificate; foreign-registered civil aircraft used in common carriage or carriage of mail under the provisions of 14 CFR part 121 or 135; and airframe, aircraft engines, propellers, appliances, and component parts of such aircraft. Part 43 does not apply to any aircraft for which an experimental airworthiness certificate has been issued, unless a different kind of airworthiness certificate had previously been issued for that aircraft.

For products and parts that have already met the applicability requirements of part 43, § 43.3(j) authorizes a manufacturer to rebuild or alter (emphasis added) any aircraft, aircraft engine, propeller, appliance, or part manufactured by him under a type or PC, Technical Standard Order (TSO) Authorization, an FAA Parts Manufacturer Approval (PMA), or Product and Process Specification. Any maintenance, preventive maintenance and alterations are not included in the authority of § 43.3(j).

Part 145, Subpart D, Limited Ratings for Manufacturers, permits certain manufacturers to obtain, without further showing, a repair station certificate with a limited rating under Part 145. The FAA considered that the standards met by a manufacturer to obtain a PC, approved production inspection system (APIS), or other approved quality control system, provided a level of safety equivalent to that achieved under the standards applicable to a certificated repair station with a limited rating. This has permitted the holder of a limited rating for manufacturers to maintain and approve for return to service any article for which it is rated, and perform preventive maintenance on that article if certificated mechanics and repairmen are employed directly in charge of the maintenance and preventive maintenance in accordance with current § 145.103.

As proposed in Notice No. 99-09 (66 FR 41117, August 6, 2001) the FAA is eliminating the limited rating for manufacturers because maintenance practices and aircraft technologies have evolved since the establishment of limited ratings for manufacturers, and the FAA has determined that all repair facilities' systems for inspection, recordkeeping, and quality control should be consistent. These regulatory changes should also ensure uniform FAA surveillance activities.

Effective April 6, 2003, Manufacturer Maintenance Facilities will no longer be permitted. Under the revised 14 CFR part 145, existing MMFs will be required to have a limited repair station rating under § 145.61 if they choose to continue exercising similar privileges.

A production approval holder (PAH) is a person who holds a PC, APIS, a PMA, or a TSO authorization that controls the design and quality of a product or part thereof. For many years, products and/or parts have been shipped from suppliers to PAHs, between PAHs, and from PAHs to airlines, repair stations, distributors, etc. This notice is designed to clarify at what point a supplier or PAH may no longer perform work on its product under part 21, and when that work must be performed by an appropriately certificated person under part 43, part 93, part 145, or any of the operating rules of 14 CFR Subchapter G, Air Carriers and Operations for Compensation or Hire: Certification and Operations.

Part 21 applies to new products or parts that remain under the control of a PAH. Any work performed on those products or parts while under the control of the PAH's quality system is to be accomplished in accordance with that system. However, once the products or parts leave that quality system, any work performed would be in accordance with part 43.

Part 43 applies to: (1) Aircraft having a U.S. airworthiness certificate; (2) Foreign-registered civil aircraft used in common carriage or carriage of mail under the provisions of part 121 or 135 of this chapter; and (3) Airframe, aircraft engines, propellers, appliances, and component parts of such aircraft. This indicates that any work performed on an article before it meets the applicability requirements of part 43 would not have to be accomplished in accordance with part 43.

In an effort to better define where the regulatory authority of part 21 ends and the regulatory authority of part 43 begins, the Aviation Rulemaking Advisory Committee (ARAC) for part 21 suggested incorporating new language into part 21 that would clarify a manufacturer's authority to maintain products and parts that do not meet part 43 applicability requirements, i.e., new products and parts that have not yet left the PAH's quality system. This work would be done without the need for a repairman or mechanic certificate, and would not be considered to be maintenance as it pertains to part 43. Currently, aviation authorities such as Transport Canada and the Joint Aviation Authorities allow this. Rather than initiate a lengthy rule change to accommodate ARAC's recommendation, AFS and AIR are providing the following clarification:

Products or parts that leave a PAH or supplier (either foreign or domestic) and go to a PAH for incorporation into a higher level product/part ( e.g. fuel control unit incorporated into an engine; or an engine incorporated into an aircraft) for which that PAH controls the type design must have work performed in accordance with the higher level of PAH's quality system regardless of who performs the work. Conditions are as follows:

(1) The supplier or PAH working on the product or part must have the appropriate design data to ensure that the product or part continues to conform to its type design.

(2) The PAH incorporating the product or part must have an approved system in place ( e.g., quality control system, material review board, configuration control, etc.) that defines how work is performed and documented. If the product or part is worked on by the supplier, it must then be accepted through the PAH's quality system.

(3) If the PAH incorporating the product or part chooses to work on it, the work must be accomplished by authorized personnel who are familiar with the product's or part's complexities.

(4) If a product or part has moved through several suppliers or PAHs during its assembly, the PAH that is incorporating the product or part into its type design must determine which of those organizations is the appropriate one to work on the product or part based on the above conditions.

Products or parts that leave a PAH's quality system and are delivered to an airline, repair station, distributor, etc., are intended to be installed on a higher assembly that has already met the applicability requirements of part 43. Therefore, any maintenance, preventive maintenance, or alterations on such articles will be performed by persons authorized under part 43.

Effective April 6, 2003, products or parts that leave a PAH or supplier (either foreign or domestic) and go to a PAH for incorporation into a higher level product/part for which that PAH controls the type design must have work performed in accordance with the higher level PAH's quality system under part 21.

Products or parts shipped to airlines, repair stations, distributors, etc., after leaving a PAH's approved quality system must be maintained in accordance with part 43. Any used products or parts returned to the manufacturer must be maintained in accordance with part 43 under the provisions of the new § 145.61. Any used products or parts installed on new production aircraft must have been maintained in accordance with part 43 prior to their installation. As noted in Notice Number 99-09, the FAA will give full consideration to the part 21 quality control system established by the manufacturer when it applies for the § 145.61, Limited rating under new § 145.51, Application for certificate.

Comments Invited

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-271-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2001-NM-271-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, notified the FAA that an unsafe condition may exist on certain BAE Systems (Operations) Limited Model BAe 146 series airplanes. The CAA advises that the manufacturer investigated an in-service problem and identified a specific combination of airplane modifications that can inhibit the traffic alert and collision avoidance system (TCAS). These airplane modifications interact with certain annunciator dimmer settings and cause aural messages and resolution advisories of the TCAS to remain inhibited following a ground proximity warning system alert or test message. This condition, if not corrected, could prevent the TCAS from providing attention-getting alerts, and could result in the consequent possibility of a mid-air collision or near mid-air collision.

BAE Systems (Operations) Limited has issued Modification Service Bulletin SB.34-339-50261Y, dated April 11, 2001, which describes procedures for modification of the flight annunciator box. The modification includes installing two diode modules with associated wiring, and re-routing existing wiring. Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition. The CAA classified this service bulletin as mandatory and issued British airworthiness directive 003-04-2001 in order to assure the continued airworthiness of these airplanes in the United Kingdom.

This airplane model is manufactured in the United Kingdom and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAA has kept the FAA informed of the situation described above. The FAA has examined the findings of the CAA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the service bulletin described previously, except as discussed below.

Operators should note that, although the referenced service bulletin describes procedures for completing and submitting a sheet recording compliance with the service bulletin, this proposed AD would not require those actions.

The FAA estimates that 20 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 2 work hours per airplane to accomplish the proposed modification, and that the average labor rate is $60 per work hour. Required parts would cost approximately $250 per airplane. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $7,400, or $370 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

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

Comments Invited

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-319-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2001-NM-319-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

The Luftfahrt-Bundesamt (LBA), which is the airworthiness authority for Germany, notified the FAA that an unsafe condition may exist on certain Dornier Model 328-300 series airplanes equipped with certain Pratt & Whitney PW306B engine nacelles. The LBA advises that an engine flamed out and an in-flight engine shutdown occurred during an airplane rollback event. The event was caused by a P3 air leak from a loose clamp on the anti-ice tubing joint; the leak allowed air to blow directly on the P3 transducer. This leak resulted in a corrupt P3 signal, which, in turn, caused the Full Authority Digital Engine Control (FADEC) to ramp down fuel flow, resulting in engine shutdown. Such leakage of air, if not corrected, could result in an uncommanded engine shutdown in a critical phase of flight.

Dornier has issued Service Bulletin SB-328J-71-107, Revision 1, dated July 4, 2001. The service bulletin describes procedures for performing a visual inspection of the anti-ice tubing in the engine nacelle at the joint between the anti-ice tubing adapter and duct, and also between the joint of the anti-ice shutoff valve and the same duct, to detect any air leakage at the joints. For airplanes on which leakage is found, the service bulletin describes procedures for modifying the clamps at the joints. The modification involves inspecting the flange faces for distortion and flatness; ensuring that the clamp bolt faces away from the P3 transducer; ensuring that the opening of the clamp faces away from the fan casing; and replacing certain ducts, if necessary. The service bulletin refers to Dornier Service Information SI-328J-75-033, dated July 31, 2001, as an additional source of service information for accomplishing the modification on certain airplanes.

Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition. The LBA classified this service bulletin as mandatory and issued German airworthiness directive 2001-296, dated October 18, 2001, in order to assure the continued airworthiness of these airplanes in Germany.

This airplane model is manufactured in Germany and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the LBA has kept the FAA informed of the situation described above. The FAA has examined the findings of the LBA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require performing a check of the airplane maintenance records, and accomplishment of the actions specified in the service bulletin described previously if necessary.

Operators should note that, although the Accomplishment Instructions of Dornier Service Bulletin SB-328J-71-107, Revision 1, dated July 4, 2001, calls for a visual inspection, the proposed AD would require a detailed inspection per Note 2 of the proposal.

The FAA estimates that 48 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 1 work hour per airplane to accomplish the proposed records check, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $2,880, or $60 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

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

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2003-NM-47-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2003-NM-47-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

In the early 1980's, as part of its continuing work to maintain the structural integrity of older transport category airplanes, the FAA concluded that the incidence of fatigue cracking may increase as these airplanes reach or exceed their design service objective (DSO). A significant number of these airplanes were approaching or had exceeded the DSO on which the initial type certification approval was predicated. In light of this, and as a result of increased utilization, longer operational lives, and the high levels of safety expected of the currently operated transport category airplanes, we determined that a supplemental structural inspection program (SSIP) was necessary to ensure a high level of structural integrity for all airplanes in the transport fleet.

As a follow-on from that determination, the FAA issued Advisory Circular (AC) No. 91-56, “Supplemental Structural Inspection Program for Large Transport Category Airplanes,” dated May 6, 1981. That AC provides guidance material to manufacturers and operators for use in developing a continuing structural integrity program to ensure safe operation of older airplanes throughout their operational lives. This guidance material applies to transport airplanes that were certified under the fail-safe requirements of part 4b (“Airplane Airworthiness, Transport Categories”) of the Civil Air Regulations or damage tolerance structural requirements of part 25 (“Airworthiness Standards: Transport Category Airplanes”) of the Federal Aviation Regulations (FAR) (14 CFR part 25), and that have a maximum gross weight greater than 75,000 pounds. The procedures set forth in that AC are applicable to transport category airplanes operated under subpart D (“Special Flight Operations”) of part 91 of the FAR (14 CFR part 91); part 121 (“Operating Requirements: Domestic, Flag, and Supplemental Operations”); part 125 (“Certification and Operations: Airplanes having a Seating Capacity of 20 or More Passengers or a Maximum Payload of 6,000 Pounds or More”); and part 135 (“Operating Requirements: Commuter and On-Demand Operations”) of the FAR (14 CFR parts 121, 125, and 135). The objective of the SSIP was to establish inspection programs to ensure timely detection of fatigue cracking.

In order to evaluate the effect of increased fatigue cracking with respect to maintaining fail-safe design and damage tolerance of the structure of Boeing Model 747 series airplanes, Boeing conducted a structural reassessment of those airplanes, using modern damage tolerance evaluation techniques. Boeing accomplished this reassessment using the criteria contained in AC No. 91-56, as well as Amendment (Amdt.) 25-45 of section 25.571 (“Damage-tolerance and fatigue evaluation of structure”) of the FAR (14 CFR 25.571). During the reassessment, members of the airline industry participated with Boeing in working group sessions and developed the SSIP for Model 747 series airplanes. Engineers and maintenance specialists from the FAA also attended these sessions to observe these developments. Subsequently, based on the working group's recommendations, Boeing developed the Supplemental Structural Inspection Document (SSID).

On July 18, 1994, the FAA issued AD 94-15-12, amendment 39-8983 (59 FR 37933, July 26, 1994), applicable to certain Boeing Model 747-100SR series airplanes. Additionally, on July 22, 1994, we issued AD 94-15-18, amendment 39-8989 (59 FR 41233, August 11, 1994), applicable to certain Boeing Model 747 series airplanes. Both of those ADs currently require that the FAA-approved maintenance inspection program be revised to include inspections that will give no less than the required damage tolerance rating (DTR) for each structural significant item (SSI), and repair of cracked structure. AD 94-15-12 references Boeing Document No. D6-35655, “Supplemental Structural Inspection Document (SSID) for 747-100SR,” dated April 2, 1986; and AD 94-15-18 references Boeing Document No. D6-35022, “Supplemental Structural Inspection Document (SSID) for Model 747 Airplanes,” Revision E, dated June 17, 1993; as the appropriate sources of service information. Those actions were prompted by a structural re-evaluation that identified additional structural components where fatigue cracking is likely to occur. The requirements of those ADs are intended to ensure the continued structural integrity of the entire Model 747 fleet in service at the time of issuance of those ADs.

On December 30, 1998, the FAA issued SSIP AD 98-11-03 R1, amendment 39-10983 (64 FR 989, January 7, 1999) for Boeing Model 727 series airplanes and SSIP AD 98-11-04 R1 (64 FR 987, January 7, 1999) for Boeing Model 737 series airplanes. Those ADs, in addition to their primary purpose to require inspection of baseline structure, also address repairs, alterations, and modifications (RAMs). Those ADs require operators to provide damage tolerance-based inspection programs for RAMs that affect principal structural elements or that create new principal structural elements.

This proposed AD for Boeing Model 747 series airplanes will address a damage tolerance-based inspection program only for the baseline structure and will not include RAMs. If a RAM interferes with the inspection of baseline structure, then this area must be addressed per Note 1 of the proposed AD.

In April of 2000, an FAA team was chartered to address standardization of the SSIP ADs with regard to RAMs. The team was formed due to concerns of operators regarding different approaches to addressing RAMs for the McDonnell Douglas series airplanes versus the Boeing Model 727 and 737 series airplanes. Also, since the issuances of AD 98-11-03 R1 and AD 98-11-04 R1, operators have had various problems addressing RAMs. As announced in a Notice of Public Meeting, published in the Federal Register on January 15, 2003 (68 FR 2103), a public meeting will be held to present our view and to receive comments from the public. Due to the many issues that have arisen in addressing RAMs, this proposed AD will not require damage tolerance-based inspections for RAMs on Boeing Model 747 series airplanes.

The AASR was published in the Federal Register on December 6, 2002 (67 FR 72726). That rule requires the maintenance program applicable to affected airplanes to include damage tolerance-based inspections and procedures that include all major structural repairs, alterations, and modifications. The compliance time for these procedures is four years after December 8, 2003 (the effective date of the AASR). The FAA intends to eventually require damage tolerance-based inspections for RAMs during subsequent rulemaking. (See the information under the “Interim Action” paragraph of this proposed AD.)

Since the issuance of the current SSIP ADs for Model 747 series airplanes (ADs 94-15-12 and 94-15-18), the FAA has reconsidered the following two aspects of the existing SSIP:

1. Candidate fleet vs. inspection threshold approach . Paragraph 4.4 of AC No. 91-56, Change 2, dated April 15, 1983, states, “Inspection thresholds for supplemental inspections should be established. These inspections would be supplemental to the normal inspection including the detailed internal inspections.” Moreover, paragraph 4.4.2 of AC No. 91-56 states, “ * * * this threshold should be such as to include sufficient [high-cycle] airplanes in the inspection to develop added confidence in the integrity of the structure . . . .”

A properly established inspection threshold ensures that: (1) The SSI inspections are accomplished; (2) fatigue cracks in SSIs are detected in a timely manner; (3) airplanes are automatically added to the SSIP; and (4) the SSIP includes a statistically valid number of airplanes.

Among other things, SSID D6-35655 and Revision E of SSID D6-35022 (referenced as the appropriate service information in ADs 94-15-12 and 94-15-18) define a candidate fleet approach to ensure that fatigue cracks in SSIs are detected in a timely manner in the entire fleet of Model 747 series airplanes. The initial candidate fleet of Model 747-100 and -200 series airplanes, as defined in SSID D6-35022, consisted of a number of airplanes that had exceeded 10,000 total flight cycles by June 30, 1983. The initial candidate fleet of Model 747SR series airplanes, as defined in SSID D6-35655, consisted of a number of airplanes that had exceeded 12,000 total flight cycles by January 1, 1985. In other words, Boeing considered 10,000 total flight cycles for Model 747-100 and -200 series airplanes, and 12,000 total flight cycles for Model 747SR series airplanes, to be the threshold for the airplanes in the candidate fleets. Those airplanes were the most likely airplanes in the fleets to experience initial fatigue damage, because they had the highest number of flight cycles. Boeing produced those SSIDs with the assumption that the airplanes in the candidate fleets would continue to represent the entire fleet and would have the highest number of flight cycles in the fleet.

Under the existing SSIP, Boeing intended to periodically review the airplanes in the candidate fleet for significant changes in fleet distribution, composition, or utilization, and update of the candidate fleet, if any significant change was detected. It was intended that the FAA would then mandate any change to the SSID through the rulemaking process.

The FAA finds that the candidate fleet approach is deviating from Boeing's original philosophy in that the candidate fleet has not been updated to reflect changes in the fleet. This situation could result in a statistically invalid number of airplanes in the SSIP and undetected fatigue cracks in SSIs. The candidate fleet approach also does not automatically account for non-candidate airplanes that eventually accumulate more flight cycles than those of certain candidate airplanes. High-cycle airplanes are more likely to experience initial fatigue damage in the fleet. The confidence in the structural integrity of the fleet of airplanes could be reduced if high-cycle airplanes are excluded from the SSIP.

The FAA has reconsidered the candidate fleet approach described in SSID D6-35655 and Revision E of SSID D6-35022 because it does not meet the guidelines of AC No. 91-56. We have also determined that the Model 747 SSIP must contain inspection thresholds for all Model 747 series airplanes to ensure the timely detection of fatigue cracks in the SSIs.

The FAA has reviewed the thresholds derived from Boeing's statistical analysis. The analysis is based on a certain probability that cracks will be detected in the inspected fleet before they initiate on other airplanes that have not been inspected. We find that the thresholds recommended in Revision G of SSID D6-35022 for the Model 747 airplane fleet are acceptable. Therefore, we have determined that a threshold of 20,000 total flight cycles or 100,000 total flight hours, whichever comes first, on wing structure, and 20,000 total flight cycles on all other structures are necessary in order to produce a statistically valid assessment of the service history for these airplanes. The original threshold for the Model 747SR series airplane was set higher by the manufacturer because it was believed that these airplanes were not subject to the same fatigue cycles due to use of a lower cabin differential pressure. We have since determined that an adjustment of flight cycles due to a lower cabin differential pressure is not substantiated and will not be allowed for use in determining the flight cycle threshold and inspection intervals of the SSID program. Therefore, the threshold for Model 747SR series airplanes is now the same as that of other Model 747 series airplanes.

It should be noted that, although the proposed AD specifies a threshold, the FAA may approve requests for adjustments to the compliance time (i.e., under the provisions of paragraph (g)(1) of this proposed AD) provided that no cracking is detected in the airplane structure. The request should include a new proposed inspection threshold and must include data to substantiate that such an adjustment would provide an acceptable level of safety.

Operators also should note that the alternative inspection threshold may be based solely on the analysis of the data of the existing fleet. However, the FAA has determined that the analysis that derives the new inspection threshold must include: (1) Data relevant to a sufficient number of high-cycle airplanes, and (2) data that show accomplishment of the inspections of the SSIs. An adequate statistical sampling size will provide confidence in the structural integrity of the fleet of airplanes. Therefore, additional airplanes may need to be added to the inspected fleet until a sufficient number of airplanes have been inspected with no crack findings.

2. Transferability of airplanes . Since issuance of AD 94-15-12 and AD 94-15-18, the FAA has issued several ADs that implement Corrosion Prevention and Control Programs (CPCP) for aging airplanes. While developing the ADs that mandated the CPCP, we recognized that an operator of an airplane that has been transferred from another operator could revise its maintenance or inspection program to restart the compliance times for the required corrosion tasks. This situation could lead to corrosion not being detected and corrected in a timely manner, which could reduce the structural integrity of the airplane.

As a result, the CPCP ADs require that operators establish a program for accomplishment of the subject corrosion tasks before any airplane can be added to an air carrier's operations specification. Establishment of such a program ensures that airplanes transferred from operator to operator are inspected and that corrosion is detected in a timely manner.

The FAA's intent in AD 94-15-12 and AD 94-15-18 was that operators of candidate fleet airplanes that have been previously operated under an FAA-approved maintenance or inspection program would accomplish the SSID inspections within the compliance time established by the previous operator. We assumed that, under the existing SSIDs, these airplanes would be inspected in a manner similar to CPCP requirements. However, the SSID ADs, AD 94-15-12 and AD 94-15-18, do not specifically address the transfer of airplanes in the candidate fleet from one operator to another.

AD 94-15-12 and AD 94-15-18 currently require that the revision to the maintenance inspection program be included and be implemented per the procedures specified in Sections 5.0 and 6.0 of the SSIDs. However, the FAA finds that those sections do not provide explicit instructions to repetitively inspect airplanes that have been transferred from one operator to another. Those sections also do not specify that new operators must continue the SSID inspections at the same frequency established by the previous operator.

In addition, as AD 94-15-12 and AD 94-15-18 are currently worded, the FAA finds that operators, who acquire candidate fleet airplanes that have been previously operated under a maintenance inspection program, could revise their programs to restart the compliance times. This situation is contrary to standard AD requirements. An AD typically mandates an initial compliance time and a repetitive interval that remains unchanged for all operators of the affected airplanes.

As a result of these omissions, the SSID inspections of a candidate fleet airplane could be deferred until it is required by the maintenance inspection program of the new operator. For airplanes that are transferred frequently, this situation could continue for the life of the airplane. As a result, the size of the candidate fleet is in effect reduced because fewer candidate fleet airplanes are being inspected. Even if airplanes are ultimately inspected under these circumstances, inspections would not be performed frequently enough to maintain the applicable DTR. The FAA has determined that such a reduction of the candidate fleet and the resulting reduction in the number of airplanes being inspected do not ensure the continued structural integrity of the entire fleet of Model 747 series airplanes.

Implementation of procedures in the SSID that are similar to the CPCP will ensure that: (1) Airplanes transferred from operator to operator are inspected; (2) the SSIP includes a statistically valid number of airplanes; and (3) fatigue cracks are detected in a timely manner.

Therefore, the FAA finds that, to ensure the continued structural integrity of the entire fleet of Model 747 series airplanes, AD 94-15-12 and AD 94-15-18 must be superseded to include provisions that address the transfer of airplanes. We also find that a program must be established to ensure that inspections are accomplished before any applicable airplane can be added to an air carrier's operations specifications.

The FAA has reviewed and approved Boeing Document No. D6-35022, “Supplemental Structural Inspection Document” (SSID), Revision F, dated May 1996, as an alternative method of compliance to AD 94-15-18. Revision F of SSID D6-35022 describes procedures for revising the FAA-approved maintenance inspection program for all Model 747-100, -200B, -200C, and -200F series airplanes. This revision of the SSID for Model 747 series airplanes incorporates additional and expanded inspections from those that were contained in the previous version and mandated by AD 94-15-18. We also reviewed and approved Boeing Document No. D6-35022, “Supplemental Structural Inspection Document” (SSID), Revision G, dated December 2000. Revision G affects all Model 747-SP, -SR, -100, -100B, -100SUD, -200B, -200C, -200F, -300, -400, -400D, and -400F series airplanes, and supersedes Boeing Document No. D6-35655 for 747-SR series airplanes. This revision also adds additional inspection requirements. We find that accomplishment of these inspections in Boeing Document No. D6-35022, “Supplemental Structural Inspection Document” (SSID), Revision G, dated December 2000, will ensure the continuing structural integrity of the identified fleet of Model 747 series airplanes. Accomplishment of the actions specified in Revision G is intended to adequately address the identified unsafe condition.

Since an unsafe condition has been identified that is likely to exist or develop on other products of this same type design, the proposed AD would supersede AD 94-15-12 and AD 94-15-18 to require the following actions:

Paragraph (a) of the proposed AD restates the requirements of AD 94-15-

12. Paragraph (b) of the proposed AD restates the requirements of paragraph (b) of AD 94-15-18. Although AD 94-15-18 specifies Revision E of Boeing Document No. D6-35022 as the appropriate source of service information for that AD, this proposed AD also permits incorporation of Revision F, of Boeing Document No. D6-35022, dated May 1996, until the compliance time for incorporation of Revision G is reached. (Paragraph (a) of AD 94-15-12 is no longer necessary because that paragraph required an earlier revision of the SSID than that required by paragraph (b).)

Paragraph (c) of the proposed AD would require incorporation of a revision into the FAA-approved maintenance or inspection program that provides no less than the required DTR for each SSI listed in Revision G of SSID D6-35022.

Paragraph (d) of the proposed AD would establish specific compliance times for performing the initial inspection of the structure identified in Revision G of SSID D6-35022. Once the initial inspection has been performed, operators would be required to perform repetitive inspections at the intervals specified in Revision G of SSID D6-35022 in order to remain in compliance with their maintenance or inspection programs, as specified in paragraph (c) of this proposed AD.

Paragraph (e) of the proposed AD would require that repair of any cracked structure is to be accomplished per an FAA-approved method.

Paragraph (f) of the proposed AD specifies the requirements of the inspection program for transferred airplanes. Before any airplane that is subject to this proposed AD can be added to an air carrier's operations specifications, a program for the accomplishment of the inspections required by this proposed AD must be established. Paragraph (f) of the proposed AD would require accomplishment of the following:

1. For airplanes that have been inspected per this proposed AD, the inspection of each SSI must be accomplished by the new operator per the previous operator's schedule and inspection method, or per the new operator's schedule and inspection method, at whichever time would result in the earlier accomplishment date for that SSI inspection. The compliance time for accomplishment of this inspection must be measured from the last inspection accomplished by the previous operator. After each inspection has been performed once, each subsequent inspection must be performed per the new operator's schedule and inspection method.

2. For airplanes that have not been inspected per this proposed AD, the inspection of each SSI must be accomplished either prior to adding the airplane to the air carrier's operations specification, or per a schedule and an inspection method approved by the FAA. After each inspection has been performed once, each subsequent inspection must be performed per the new operator's schedule.

Accomplishment of these actions will ensure that: (1) An operator's newly acquired airplanes comply with its SSIP before being operated; and (2) frequently transferred airplanes are not permitted to operate without accomplishment of the inspections defined in the SSID.

This is considered to be interim action. The FAA is currently considering requiring damage tolerance-based inspections and procedures that include all major structural RAMs in a superseding AD. That superseding AD would include appropriate recommendations from the previously mentioned FAA team and public meeting on how to address RAMs.

Operators should note the following differences between the procedures specified in Revision G of SSID D6-35022 and the proposed requirements of this AD:

1. Revision G of SSID D6-35022 provides for phased inspections or rotational sampling of inspections. This proposed AD would not allow phased inspections or rotational sampling.

2. Revision G of SSID D6-35022 allows individual operators to combine their affected airplanes with those of other operators to fulfill requirements of the SSIP. This proposed AD would not allow for phased inspections or a candidate fleet; therefore, this proposed AD would not allow an operator to take credit for inspections accomplished on another operator's airplane.

3. Revision G of SSID D6-35022 contains blanket provisions for touch-and-go training flights, which are not allowed by this proposed AD. Revision G of SSID D6-35022 also allows for fleet averaging, and arbitrary 10% escalations for flight cycles to achieve the required DTR. These procedures are not allowed in this proposed AD.

4. Revision G of SSID D6-35022 does not provide an implementation grace period when an operator's airplane is near or passed the threshold. This proposed AD will allow 12 months after the effective date of the AD to incorporate Revision G of SSID D6-35022 into the FAA-approved maintenance or inspection program. This proposed AD will also allow a grace period of 1,000 flight cycles measured from 12 months after the effective date of the proposed AD.

There are approximately 1,000 airplanes of the affected design in the worldwide fleet.

The FAA estimates that 87 airplanes of U.S. registry are currently affected by the requirements of AD 94-15-12 and AD 94-15-18. Those required actions take approximately 1,000 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $5,220,000, or $60,000 per airplane, per inspection cycle.

The FAA estimates that 181 airplanes of U.S. registry would be affected by this proposed AD. The new actions that are proposed in this AD action would take approximately 1,275 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the proposed requirements of this AD on U.S. operators is estimated to be $13,846,500, or $76,500 per airplane, per inspection cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the current or proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The number of proposed work hours, as indicated above, is presented as if the accomplishment of the actions proposed in this AD were to be conducted as “stand alone” actions. However, in actual practice, these actions for the most part would be accomplished coincidentally or in combination with normally scheduled airplane inspections and other maintenance program tasks. Therefore, the actual number of necessary additional work hours would be minimal in many instances. Additionally, any costs associated with special airplane scheduling would be minimal.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

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

The table contains information on the hearing dates, locations, and phone numbers for all of the hearings on “Safety Standards for the Use of a Belt Entry as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.”

EPA Regions, as well as States, Territories and Tribes authorized to implement the National Pollutant Discharge Elimination System (NPDES) program, issue permits that comply with the technology-based and water quality-based requirements of the Clean Water Act (CWA). In doing so, NPDES permitting authorities, including States, Territories, and Tribes, make several discretionary choices when they write the permit. These choices include the selection of pollutants to be measured and, in many cases, limited in permits. If EPA has “approved” ( i.e. , promulgated through rulemaking) standardized testing procedures under 40 CFR part 136 for the analysis of a given pollutant, the NPDES permit must include one of the approved testing procedures or an approved alternate test procedure. The testing procedures can include a specification for detection and quantitation levels that must be met. Therefore, entities with NPDES permits could potentially be regulated by the proposed revisions to the detection and quantitation procedures in this rulemaking. In addition, when an authorized State, Territory, or Tribe certifies Federal licenses under CWA section 401, they must use the standardized testing procedures and meet the associated detection and quantitation levels. Categories and entities that could potentially be regulated include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

1. Docket. EPA has established an official public docket for this action under Docket ID No. OW-2003-0002. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, EPA West Building, Room B102, 1301 Constitution Avenue NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in B.1.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. However, late comments may be considered if time permits.

1. Electronically . If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket , and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in Docket ID No. OW-2003-0002. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by electronic mail (e-mail) to: OW-docket@epamail.epa.gov , Attention Docket ID No. OW-2003-0002. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By Mail . Send an original and three copies of your comments to Water Docket, U.S. Environmental Protection Agency (4101T), 1200 Pennsylvania Avenue NW., Washington, DC 20460, Attention Docket ID No. OW-2003-0002.

3. By Hand Delivery or Courier . Deliver your comments to the Water Docket Center, EPA West Building, Room B102, 1301 Constitution Avenue NW., Washington, DC, Attention Docket ID No. OW-2003-0002. Such deliveries are only accepted during the Docket's normal hours of operation as identified in Unit B.1.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

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

8. Ensure proper receipt by EPA by identifying the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

This action is being proposed pursuant to the authority of sections 301(a), 304(h), and 501(a) of the Clean Water Act (“CWA” or the “Act”), 33 U.S.C. 1311(a), 1314(h), 1361(a). Section 301(a) of the Act prohibits the discharge of any pollutant into navigable waters unless the discharge complies with a National Pollutant Discharge Elimination System (NPDES) permit issued under section 402 of the Act. Section 304(h) of the Act requires the Administrator of the EPA to “promulgate guidelines establishing test procedures for the analysis of pollutants that shall include the factors which must be provided in any certification pursuant to [section 401 of this Act] or permit application pursuant to [section 402 of this Act].” Section 501(a) of the Act authorizes the Administrator to “prescribe such regulations as are necessary to carry out this function under [the Act].” EPA publishes analytical test method regulations for use in CWA programs at 40 CFR part 136. The Administrator has made these test methods applicable to monitoring and reporting of NPDES permits (40 CFR 122.21, 122.41, 122.44, and 123.25), and implementation of the pretreatment standards issued under section 307 of the Act (40 CFR 403.10 and 403.12).

EPA recently completed an assessment of procedures for determining the sensitivity of analytical test methods ( i.e. , procedures for determining detection and quantitation) and their application to Clean Water Act Programs. That assessment was conducted pursuant to a settlement agreement with the Alliance of Automobile Manufacturers, et al. (See III.B. below for details.) The assessment is contained in a document entitled, Technical Support Document for the Assessment of Detection and Quantitation Concepts or “Assessment Document” (EPA 821-R-03-005, February, 2003). A draft of the Assessment Document was peer-reviewed in August 2002 in accordance with EPA peer review guidelines. Following peer review, EPA incorporated peer review comments into the Assessment Document. EPA is providing an opportunity for public review and comment on the assessment and the Assessment Document through this notice and also in a separate notice in this Federal Register (see Notice of Document Availability and Public Comment Period on the Technical Support Document for the Assessment of Detection and Quantitation Concepts).

Based on findings from the assessment, EPA is proposing revisions to the method detection limit procedure codified at 40 CFR part 136, Appendix B and is seeking comment on the revisions proposed in this notice. EPA also is proposing to revise the definition of “Detection limit” at 40 CFR 136.2 and to add a definition of the “Minimum level of quantitation (ML)” for consistency with the proposed revisions to Appendix B.

Section 304(h) of the Clean Water Act requires that the EPA Administrator “promulgate guidelines establishing test procedures for the analysis of pollutants” to be monitored and regulated under the National Pollutant Discharge Elimination System (NPDES). EPA proposes and promulgates test methods at 40 CFR part 136 in accordance with section 304(h). The approved test methods have been drawn from a variety of sources, including methods developed by commercial vendors, EPA and other government agencies, as well as methods from voluntary consensus standards bodies (VCSBs), such as the American Public Health Association (APHA), the Water Environment Federation (WEF), and the American Water Works Association (AWWA), which jointly publish Standard Methods for the Examination of Water and Wastewater; the Association of Official Analytical Chemists (AOAC-International); and the American Society for Testing and Materials (ASTM International).

Among considerations for approval of a test method at 40 CFR part 136 are the demonstrated performance characteristics of precision, bias, and sensitivity ( i.e. , detection and quantitation). EPA generally evaluates each of these characteristics to determine if the test method will yield results at concentrations of concern that are reliable enough to meet EPA needs for permitting and compliance monitoring under the CWA. Detection and quantitation limits have been among the most controversial of these characteristics, particularly among members of the regulated community.

On June 8, 1999, EPA published a final rule adding EPA Method 1631, Revision B: Mercury in Water by Oxidation, Purge and Trap, and Cold Vapor Atomic Fluorescence Spectrometry (Method 1631B) to the “Guidelines Establishing Test Procedures for the Analysis of Pollutants” under section 304(h) of the Clean Water Act. This method was developed specifically to measure concentrations of mercury at low ( i.e. , ambient water quality criteria) levels. Following promulgation, the Alliance of Automobile Manufacturers, the Chemical Manufacturers Association, and the Utility Water Act Group (“Petitioners”) and the American Forest and Paper Association (“Intervenor”) filed a lawsuit challenging the method. (Alliance of Automobile Manufacturers, et al. v. EPA, No. 99-1420 (D.C. Cir.)). The challenge addressed specific aspects of EPA Method 1631 as well as the general procedures used to establish the method detection limit (MDL) and the minimum level of quantitation (ML) specified in the method. On October 19, 2000, EPA entered into a settlement agreement with the Petitioners and Intervenor (the “settlement agreement”). The settlement agreement included six clauses. EPA has already satisfied the requirements of clauses 1 through 5, which addressed clarification and revision of specific method procedures and requirements. This proposal partially fulfills the requirements of clause 6 of the settlement agreement, which addresses procedures for determining the sensitivity of analytical test methods.

Clause 6 provides for EPA to assess existing Agency and alternative procedures for determining detection and quantitation limits under the Clean Water Act and to sign a notice for publication in the Federal Register on or before February 28, 2003, inviting public comment on the assessment. The assessment is to include, at a minimum, evaluation of the “Definition and Procedure for Determination of the Method Detection Limit” published at 40 CFR part 136, Appendix B and used in Method 1631, and evaluation of the corresponding “minimum level” of quantitation procedures.

Clause 6 further provides for EPA to submit its assessment to formal peer review by experts in the field of analytical chemistry and in the statistical aspects of analytical data interpretation. EPA conducted peer review of its assessment in August 2002. A summary of the results of the peer review is provided in section VI of this proposal; the peer reviewers' comments and EPA's responses are included in the docket for this proposal. As stipulated in the settlement agreement, EPA provided the draft Assessment Document to the Petitioners and Intervenor for concurrent review and comment in August 2002. Their comments are also included in the docket for this proposal.

Finally, EPA agreed to invite public comment on the assessment for a period of no less than 120 days and to sign a notice taking final action on the assessment on or before September 30, 2004. Elsewhere in today's Federal Register , EPA is publishing a notice of availability of the Assessment Document, titled “Technical Support Document for the Assessment of Detection and Quantitation Concepts,” and announcing a 120-day comment period on it.

Generally speaking, a detection limit is the lowest concentration or amount of a substance that allows for differentiation between a sample that contains the substance and one that does not. A quantitation limit is the lowest concentration or amount of a substance that can be measured with some stated level of confidence. Establishing such detection and quantitation limits generally involves the application of statistics and chemistry expertise and judgement. The fact that scientific judgement is involved in the detection and quantitation decision is evidenced by the continuing debate on this subject; the number of different terms currently in use by different organizations; the number of concepts and procedures that have been advanced by different organizations to define or determine the detection and quantitation capabilities of analytical test methods; and the fact that there is no general consensus among various government agencies, method developers, or scientific organizations on a single detection and quantitation approach. EPA estimates that more than 50 different terms have been used in published analytical test methods to describe detection and quantitation capabilities of test methods and, in many instances, the same term is used by different organizations to mean different things.

Nearly all of the approaches advanced to date fall into one of two main categories: (1) Those that assume measurement error is constant or effectively constant in the low concentration range and are, therefore, based on the error observed in replicate measurements made at a single low concentration, and (2) those that assume measurement error varies as a function of concentration and are, therefore, based on the error observed in replicate measurements gathered in the region of detection and quantitation. Examples of the first category (referred to as the “single concentration approach” or “constant error model”) include those first advanced by Lloyd Currie (1968) and later adopted in various forms by the American Chemical Society (ACS), the International Organization for Standardization (also known as “ISO”), the International Union of Pure and Applied Chemistry (IUPAC), and EPA. Examples of the latter category (the “variable error model”) were adopted in various forms by the U.S. Army Toxic and Hazardous Materials Agency (USATHAMA, now the U.S. Army Environmental Center, or USAEC) and ASTM International. The two categories represent two somewhat different conceptual approaches to the problem of assessing detection and quantitation capabilities. Both approaches require estimates of measurement variability in the low concentration range, but the philosophy behind the first category is based on direct measurement of variability at a fixed concentration in the concentration region most relevant to the problem. The philosophy behind the second category is based on the concept that measurement variability throughout the low end of the measurement range is relevant to the problem of setting detection and quantitation limits. The methodology used in implementing procedures in the second category involves statistical estimation methods that allow data collected throughout the low end of the range to contribute to estimation of measurement variability in detection and quantitation region.

There are also differences in the experimental procedures used to determine detection and quantitation limits. Again, these tend to fall into two categories. The first category of single-laboratory detection limits uses data from an experiment in a single laboratory to estimate detection limits. The second category of multi-laboratory detection limits uses data from experiments from multiple laboratories to estimate detection limits. The rationale for the latter proposal is that actual measurement sensitivity varies among laboratories, regardless of the approach used to estimate the sensitivity of a given method. The Interlaboratory Detection Estimate (IDE) and the Interlaboratory Quantitation Estimate (IQE) adopted by ASTM International is an example of such an approach. Although EPA's MDL procedure does not incorporate specific procedures to account for multiple laboratory variability, EPA nonetheless has accounted for this variability during method validation as described in Section D.1 below.

The procedure for estimating the MDL was originally published in 1981 by staff at EPA's environmental research laboratory in Cincinnati, Ohio (Glaser, et al. , 1981). The MDL is based on the constant error model described by Currie (1968). EPA promulgated the procedure for determining the MDL for use in CWA programs on October 26, 1984 (49 FR 43234).

The ML was originally proposed on December 5, 1979 (44 FR 69463), in footnotes to Table 2 of EPA Method 624 and to Tables 4 and 5 of EPA Method 625. Between 1980 and 1984, EPA developed Methods 1624 and 1625 and included the ML in similar tables in those two methods. When these four methods were promulgated for use in CWA programs on October 26, 1984 (49 FR 43234), EPA replaced the MLs in Methods 624 and 625 with MDLs, and retained the MLs in Methods 1624 and 1625. Unlike the MDL, there have been changes to the definition of the ML over the years. For example, the term “recognizable signal” has been used instead of “recognizable mass spectra” for non-GC/MS methods.

Since 1984, the MDL and ML have been used in a variety of ways by analytical laboratories, permitting authorities, and regulatory communities. The three most significant uses of the MDL are described below, along with some concerns with those uses.

The primary purpose of the MDL and ML is to characterize the sensitivity of a particular test method for a particular pollutant. Information about method sensitivity is critical when deciding which method is needed to accomplish a specific measurement objective.

The MDLs published in some EPA methods have been criticized because they are based on the performance of a single laboratory that may not reflect the capabilities of the laboratory community. EPA has responded to this criticism in recent years by gathering MDL information from multiple laboratories. During development of several analytical methods, EPA's Office of Science and Technology addressed the issue by using single laboratory studies to develop an initial estimate of the MDL for each analyte and then verified these MDLs in interlaboratory studies or in additional single-laboratory studies at other facilities. For example, when EPA initially drafted Method 1631 for measurement of mercury, EPA estimated the MDL to be 0.05 ng/L, based on results produced by a contract research laboratory. Additional single-laboratory studies suggested that the MDL should be raised to 0.2 ng/L to better reflect existing capabilities of the laboratory community. During EPA's interlaboratory study for Method 1631, twelve participant laboratories were asked to conduct MDL studies. Each laboratory obtained an MDL less than 0.2 ng/L, the value published in the promulgated version of Method 1631.

The ML has been used in the 1600-series of EPA chemical methods promulgated for use under the CWA since 1984 as an additional means to characterize method sensitivity, establish the lower end of the calibration range, and serve as a quantitation limit in those methods. Although its use has thus far been limited to the 1600-series methods, the ML concept is applicable to any analytical procedure to which the MDL can be applied under the CWA.

The MDL also has been used as a means of demonstrating laboratory capability or performance. For example, a laboratory often publishes results of an MDL study to advertise its ability to detect a pollutant at a low level. Similarly, a laboratory client or a certification program may require that a laboratory demonstrate its ability to achieve a specified MDL using a particular method.

EPA also has used MDLs in approved EPA CWA methods ( i.e. , promulgated at 40 CFR part 136) to provide a standard for allowing increased flexibility and encouraging advances in technology. Under EPA's CWA Alternate Test Procedures (ATP) program and in EPA's performance-based methods, a laboratory is permitted to modify certain aspects of approved method procedures provided that it is able to achieve an MDL that is less than or equal to one-third the regulatory compliance limit or less than or equal to the MDL specified in the approved method, whichever is greater (see section 9.0 of EPA Method 1631, for example).

Both the MDL and ML have been used as reporting limits for a variety of studies and monitoring efforts under the CWA. For example, EPA often uses the MDL as a reporting threshold in surveys designed to determine levels of human exposure from consumption of water or fish under the CWA in order to characterize health risks from a variety of pollutants. In recent years, EPA has used the ML as the reporting limit in setting numeric limits for effluent guidelines limitations. EPA recommended in a 1994 draft guidance document that the ML be included in a National Pollutant Discharge Elimination System (NPDES) permit as a footnote to the water quality-based effluent limit (WQBEL) when the WQBEL is below either the MDL or ML of the most sensitive method. (See U.S. EPA Draft National Guidance for the Permitting, Monitoring, and Enforcement of Water Quality-based Effluent Limitations Set Below Analytical Detection/Quantitation Levels, 1994.) This 1994 draft guidance document was very controversial and was never finalized. Because individual States are responsible for implementation and enforcement of NPDES permits, use of the MDL and ML in the NPDES program varies among the States.

Over the years, a number of concerns have been raised about the MDL procedure. Some of these concerns are technical in nature ( e.g. , selection of appropriate spiking levels and treatment of outliers), while others focus on implementation ( e.g. , use of the MDL as a regulatory compliance limit). As part of EPA's assessment of detection and quantitation limits, the Agency identified and investigated a number of issues, including concerns that had been presented to the Agency by a variety of sources ( e.g. , commercial laboratories, permittees, State laboratory and permitting authorities, EPA and other Federal laboratories, and others). Section IV.D of this proposal highlights the most significant issues addressed during the recent assessment. A comprehensive discussion of these issues is provided in the Assessment Document that is available in the docket supporting today's proposed rule and noticed elsewhere in today's Federal Register for public comment.

EPA first began a comprehensive assessment of detection and quantitation limits in the mid-1990s as concerns about the increased use of water quality-based permitting began to push permit limits for many pollutants below the measurement capabilities of some laboratories for a number of environmental chemistry methods. One of the key areas of concern centered on the nature of measurement error in the region of detection and quantitation. Because EPA was not aware of studies that included replicate testing across or within the vicinity of this region, EPA focused its early efforts on developing such data, first with a single-laboratory study of measurement error using inductively coupled plasma-mass spectrometry (ICP-MS) techniques, and later with a similar single-laboratory study of measurement error using 10 different analytical techniques commonly used in Clean Water Act monitoring programs.

The October 2000 settlement agreement described in section III.B. of this preamble committed EPA to a fixed timetable and established specific milestones for completing its assessment. The general approach used in the Agency's assessment of detection and quantitation concepts and procedures is summarized below. Additional details concerning the assessment are presented in the Assessment Document that is available in the public docket supporting this proposed rule. EPA is also providing an opportunity for public review and comment on this assessment and the Assessment Document in a separate notice in today's Federal Register (see Notice of Document Availability and Public Comment Period on the Technical Support Document for the Assessment of Detection and Quantitation Concepts).

In December of 2001, EPA produced a draft Plan for the Assessment of Detection and Quantitation Limits Under Section 304(h) of the Clean Water Act. The December 2001 plan described roles and responsibilities for implementing the plan, provided a background discussion of detection and quantitation limit concepts, and outlined a series of events necessary to support EPA's assessment of detection and quantitation concepts and procedures as required to comply with the terms and schedules set forth in Clause 6 of the settlement agreement.

The draft plan was circulated for review by EPA staff, the Petitioners and Intervenor, and external peer reviewers. The external peer review was performed in accordance with EPA's Science Policy Council Handbook—Peer Review, 2nd Edition (EPA 100-B-00-001, December 2001; the “Peer-review Handbook”). EPA evaluated the comments and recommendations provided by reviewers and, where appropriate, integrated these comments into a revised version of the Plan for the Assessment of Detection and Quantitation Limits Under Section 304(h) of the Clean Water Act (EPA 821-R-02-010, April, 2002; the “study plan”). The study plan is included in the docket for this proposal, along with the peer review comments and the Agency's response to them..

In 1997 and 1998, EPA searched the published literature to identify documents that discussed detection and quantitation concepts and procedures. EPA conducted a follow-up search in 2001. The principal goal of these efforts was to identify concepts, procedures, and issues that should be considered by EPA during its assessment. EPA identified more than 100 documents describing detection and quantitation concepts and issues and has included a list of these documents in the docket supporting this proposed rule. Additional information concerning the literature search is presented and discussed in the Assessment Document.

EPA initially hoped to identify a large body of data containing a sufficient number of results that were generated at, below, and above the region of interest ( i.e. , at concentration levels targeting limits of detection and quantitation). EPA determined, however, that few such data sets exist. EPA identified six useful data sets for fully evaluating measurement variability in the range of analytical detection and quantitation. These included three data sets generated by EPA expressly for the purpose of characterizing measurement variability in the region of interest and three data sets suggested by the Petitioners and Intervenor. Although the Petitioners and Intervenor suggested other data sets, EPA found that these data sets either did not include a sufficient number of data results that were at, below, and above the region of detection and quantitation to yield information for the assessment or that the data included in the data sets were of questionable validity. These data, and EPA's decisions regarding the data, are discussed in the Assessment Document.

As noted above, three of these studies were conducted by EPA for the purpose of evaluating the relationship between measurement variation and concentration. In these studies, replicate measurements from each combination of analyte and measurement technique ( i.e. , analytical method) were produced by a single laboratory over a wide range and large number of concentrations. A fourth data set was developed as part of a study conducted by the American Automobile Manufacturers Association (AAMA) for the purpose of estimating a quantitation value based on a concept called the alternative minimum level that had been described in the literature (Gibbons et al. , 1997). In that study, replicate samples were measured at a limited number of concentrations by multiple laboratories. The final two data sets were jointly gathered by EPA and the Electric Power Research Institute (EPRI) to support interlaboratory validation of EPA Methods 1631 and 1638.

Additional details concerning each of these studies are provided in the Assessment Document available in the docket supporting this proposed rule. Data from these studies also are available in the docket.

As mentioned earlier in this document, EPA identified numerous terms that have been used to describe the sensitivity of a particular method or instrument. Examples of these terms are analytical detection limit, lower limit of detection, limit of sensitivity, minimum detectable quantity, system detection limit, and approximate detection limit. For its assessment, EPA considered detection and quantitation terms, concepts, or procedures advanced in the published literature and by various EPA offices, the American Chemical Society (ACS), the International Union of Pure and Applied Chemistry (IUPAC), the International Organization for Standardization (ISO), ASTM International, industry groups, and others. EPA found that most of the terms or concepts considered have no corresponding definition or procedure for calculating a value, and it may be that these terms reflect the method developer's estimate of the lowest concentration of a substance that a test method is capable of measuring. EPA did not evaluate any such terms in the assessment. EPA also did not consider terms that do not reflect the entire measurement process (such as the “Instrument Detection Limit”), concepts that are uniquely designed for a single program (such as the “Contract Required Detection Limit” used in the Superfund Contract Laboratory Program), or concepts no longer advanced by the originating organization (such as the “Compliance Monitoring Detection Limit” and the “Alternative Minimum Level”).

After eliminating terms and concepts for the reasons described above, EPA focused its assessment on four sets of concepts that are widely referenced and generally reflect the diversity of concepts advanced to date. These include (1) The EPA MDL and ML used under CWA programs, (2) the Interlaboratory Detection Estimate (IDE) and Interlaboratory Quantitation Estimate (IQE) adopted by ASTM International, (3) the Limit of Detection (LOD) and Limit of Quantitation (LOQ) adopted by the American Chemical Society (ACS), and (4) the Critical Value (CRV), Minimum Detectable Value (MDV) and Limit of Quantification (LOQ) adopted by the International Union of Pure and Applied Chemistry (IUPAC) and the International Organization for Standardization (ISO). Although the ACS, IUPAC and ISO concepts are functionally similar to EPA's MDL and ML, these organizations have not developed detailed procedures for calculating detection and quantitation values. Only the EPA and ASTM concepts are supported by detailed procedures for calculating detection and quantitation values. Without such procedural details, the ACS, IUPAC and ISO concepts are unlikely to be useful for establishing detection and quantitation limits in analytical methods for use in CWA programs. Therefore, the discussion below addresses the EPA and ASTM concepts only. Results of EPA's evaluation of the additional concepts are discussed in detail in the Assessment Document included in the docket supporting this proposed rule.

As discussed in section III.D of this document, the MDL is based on the constant error model proposed by Currie in 1968 and was initially promulgated in 1984 for use in CWA programs. The MDL and ML are supported by a procedure that involves the analysis of at least seven replicate samples containing the target analyte(s) at an estimate of the detection limit. Determination of the MDL is based on multiplication of the standard deviation among the replicate measurements by the 99th percentile of a t-distribution with n-1 degrees of freedom. The ML is also based on the constant error model proposed by Currie in 1968. The ML is derived by multiplying the standard deviation of the replicate measurements by 10. The primary differences between the MDL, ML, and detection and quantitation limit concepts first proposed by Currie are that (1) The MDL and ML are supported by detailed procedures for implementing the concepts, and (2) the EPA CWA procedures extend Currie's proposed replicate measurements of a blank with replicate measurements of reagent water (or other reference matrix) to which a small amount of the analyte is added. This latter difference results from the fact that the concepts developed by Currie assume that measurements on blank samples will produce a signal that can be used to estimate measurement variability. This is the case with radiochemistry analyses, where there is usually some background radiation that produces a response in the analysis of a blank sample. For many other types of environmental analyses, the analysis of a blank sample produces no instrumental response. Thus, the EPA CWA MDL procedure involves adding the analyte to a reference matrix ( e.g. , a blank sample) at low concentrations to ensure that a response is produced.

The IDE was approved by ASTM International's Committee D 19 for Water in 1997, as ASTM Designation 6091-97: Standard Practice for 99%/95% Interlabortory Detection Estimate (IDE) for Analytical Methods with Negligible Calibration Error. Subsequently, members of ASTM Committee D 19 developed the interlaboratory quantitation estimate (IQE) that was approved in 2000 as ASTM Designation D 6512-00: Standard Practice for Interlaboratory Quantitation Estimate. The IDE and IQE concepts are based on the variable error model and include procedures that require that data gathered in a formal study of a method be used to select from one of four possible models of the interlaboratory error and concentration. The possible models include: the “constant model,” applicable to both the IDE and IQE, in which the interlaboratory standard deviation does not change with concentration; the “straight-line model,” applicable to both the IDE and IQE, in which the interlaboratory standard deviation is a linear function of concentration; the “exponential model” applicable to the IDE, in which the interlaboratory standard deviation is an exponential function of concentration; and the “hybrid model” applicable to the IQE, in which the interlaboratory standard deviation has both additive (constant) and multiplicative (linear) components that follow the model of Rocke and Lorenzato (1995). Such studies involve samples representing at least five different concentration levels and analyzed in a minimum of six (required) to ten (recommended) laboratories. The ASTM procedures are also designed to take into account all possible sources of variability, including interlaboratory variability, when estimating detection and quantitation limits. As a result, the IDE and IQE generally produce higher limits than are produced using other procedures.

In performing the assessment, EPA identified a number of statistical and analytical chemistry issues that should be considered when evaluating detection and quantitation limit concepts and procedures in general, and in the specific context of Clean Water Act applications. The issues considered include six specific issues raised by the Petitioners and Intervenor, as well as issues identified by EPA staff, peer reviewers, and others. The six issues raised by the Petitioners are: Criteria for selection and appropriate use of statistical models; methodology for parameter estimation; statistical tolerance and prediction; criteria for design of detection and quantification studies, including selection of concentration levels (“spiking levels”); interlaboratory variability; and incorporation of elements of probability design.

Some of the significant additional issues considered by EPA in its assessment include: Matrix effects; minimization of false positives and false negatives; cost and ease of implementation; and how well detection and quantitation limits published in methods reflect individual laboratory capability. These and other issues considered by EPA are identified and discussed in Chapter 3 of the Assessment Document.

After identifying and considering the issues, EPA developed six evaluation criteria that reflect EPA's views concerning the issues. These six criteria formed the primary basis for evaluating the ability of each detection and quantitation limit approach identified in section III.C. above to meet EPA needs under the Clean Water Act. A complete discussion of these criteria and EPA's assessment of each approach against these criteria is provided in the Assessment Document that is available in the docket supporting this proposed rule. The six criteria are summarized below.

Criterion 1 : The detection and quantitation limit approaches should be scientifically valid. In evaluating this criterion, EPA considered the following factors: (1) Whether the concept can be (and has been) tested; (2) whether the concept has been subjected to peer review and publication; (3) whether the error rate associated with the concept or methodology is either known or can be estimated; (4) whether standards exist and can be maintained to control the concept's operation (i.e., it is supported by well-defined procedures for use); and (5) whether the concept has attracted (i.e., achieved) widespread acceptance within a relevant scientific community.

EPA believes that these considerations are helpful for demonstrating the scientific validity of a detection or quantitation concept.

Criterion 2 : The approach should address demonstrated expectations of laboratory and method performance, including routine variability. EPA believes that the detection and quantitation limit procedures should be capable of providing a realistic expectation of laboratory performance. In evaluating different approaches against this criterion, EPA considered the sources of variability captured by the procedure and the degree to which the statistics that underlie the procedure realistically reflect these sources.

Criterion 3 : The approach should be supported by a practical and affordable procedure that a single laboratory can use to evaluate method performance. Ideally, any required procedure for calculating analytical method sensitivity should be simple, complete, and cost-effective to implement. The laboratories that can be expected to use detection and quantitation procedures will range from large laboratories and laboratory chains with a wide range of technical capability to small laboratories operated by one or a few people with a limited set of statistical or analytical skills. If a procedure is complicated, it will be, generally, more error prone in its use. Similarly, if a procedure requires investment of extensive resources that cannot be billed to a client, laboratories will have a disincentive to use the procedure. Therefore, if EPA wishes to encourage the development and use of innovative techniques that improve measurement performance or lower measurement cost, the Agency should consider practicality and affordability as significant, if not co-equal, considerations to scientific validity.

Criterion 4 : The detection level approach should identify the signal or estimated concentration at which there is 99% confidence that the substance is actually present when the analytical method is performed by experienced staff in a well-operated laboratory. Any approach to developing detection limits should be capable of providing regulators, the regulated community, and data users with confidence that a pollutant reported as being present really is present. Historically, nearly every detection limit approach has set the criterion for detection at 99 percent confidence (i.e., the lowest level at which a pollutant will be detected with a probability of 99 percent). This criterion results in the probability of a false positive; i.e., that a pollutant will be stated as being present when it is not really present (a Type I error), of one percent.

Criterion 5 : The quantitation limit approach should identify the concentration that gives a recognizable signal that is consistent with the capabilities of the method when a method is performed by experienced staff in well-operated laboratories. Measurement capabilities among laboratories vary depending on a number of factors, including, but not limited to, instrumentation, training, and experience. Similarly, measurement capabilities among different analytical methods vary depending on a number of factors, including the techniques and instrumentation employed and the clarity of the method itself. Historical approaches to recognizing laboratory capabilities in establishing detection and quantitation limits have varied between two extremes of establishing the limit in a state-of-the-art research laboratory to reflect the lowest possible limit that can be achieved, and establishing the limit based on statistical prediction intervals calculated from a large number of laboratories with varying levels of experience, instrumentation and competence. Generally, use of the former has been employed to serve as a goal or performance standard to be met by other laboratories, whereas use of the latter treats the limit, not as a performance standard that needs to be met by each laboratory, but rather as a characterization of the future performance of the entire universe of laboratory capabilities at the time of method development. Rather than using one of these two extremes, EPA prefers to establish a quantitation limit at a concentration that is achievable with a defined level of confidence in well-operated laboratories.

Criterion 6 : Detection and quantitation approach should be applicable to the variety of decisions made under the Clean Water Act, and should support State and local obligations to implement measurement requirements that are at least as stringent as those set by the Federal Government. The Clean Water Act requires EPA to conduct, implement, and oversee a variety of data gathering programs. These programs include, but are not limited to, surveys to monitor changes in ambient water quality, screening studies to identify pollutants of concern, data gathering to support effluent guidelines, environmental assessments to establish water quality standards, and studies to evaluate human health and environmental risks under the Clean Water Act. In addition, EPA should be able to apply detection and quantitation limits to permitting, quality control in analytical laboratories, method promulgation, and other uses of the 40 CFR part 136 methods.

As noted previously, EPA considered four sets of detection and quantitation limit approaches advanced by EPA, ASTM International, ACS, and both ISO and IUPAC. Each approach was assessed against the suite of criteria described above for use under the Clean Water Act. The EPA approaches ( i.e., the MDL and ML) and the ASTM International approaches ( i.e., the IDE and IQE) are supported by clearly defined procedures for implementing the concepts. Neither the ACS nor the ISO/IUPAC approaches are supported by detailed procedures for implementation; this lack of supporting procedures was reflected in the outcome of EPA's overall assessment. Briefly, EPA found that (1) no single pair of detection and quantitation limit concepts perfectly meets EPA's criteria for use under the Clean Water Act, (2) the MDL and ML most closely meet EPA's criteria, and (3) minor revisions and clarifications to the MDL and ML would allow both concepts to fully meet the Agency's needs under the CWA. Details of these revisions and clarifications are described in section VII of this proposed rule. EPA also found that, although the IDE and IQE procedures may be acceptable for establishing detection and quantitation values derived from interlaboratory validation studies, the complexity and subjectivity of the procedures, along with their inability to address individual laboratory performance, make them unsuitable as the primary means of establishing sensitivity under the Clean Water Act. However, EPA believes that the IDE and IQE can be used to establish sensitivity under certain conditions. EPA would be willing to consider and approve under 40 CFR part 136, new test methods that include the IDE and IQE. Details of EPA's findings are provided in the Assessment Document that is available in the docket supporting this proposed rule.

In August 2002, EPA conducted a peer review of its assessment as presented in a draft Technical Support Document (draft Assessment Document). The peer review was performed in accordance with EPA's peer review policies, which are described in the Science Policy Council Handbook (EPA 100-B-00-001), and performed by two experts in the field of analytical chemistry and two experts in the statistical aspects of analytical data interpretation. Reviewers were provided with a draft copy of EPA's Assessment Document, copies of all data evaluated in the assessment, statistical programs used to analyze the data, and copies of the detection and quantitation approaches evaluated.

In the charge to the peer reviewers, EPA requested a written evaluation of whether the assessment approach described by EPA is valid and of the conceptual soundness of the assessment. Reviewers also were asked to consider and address eight specific questions pertaining to the adequacy of the concepts and procedures, the issues considered, the evaluation criteria developed by EPA, EPA's assessment and conclusions, the data used to perform the assessment, suggested improvements to the procedures discussed, and EPA's consideration of interlaboratory vs. intralaboratory issues. A copy of all materials associated with the peer review, including the peer review charge, the materials provided to the peer reviewers for review, complete copies of the peer reviewers' comments, and detailed EPA responses to each of the comments is provided in the docket supporting this proposed rule.

The comments from the peer reviewers were generally supportive of EPA's assessment and its presentation of the assessment in the draft Assessment Document. The peer reviewers stated that EPA's assessment of detection and quantitation concepts appears valid based on the evaluation criteria and is consistent with the Data Quality Act and EPA's Quality System. The peer reviewers stated further that the detection and quantitation concepts and procedures considered, the issues addressed, and the evaluation criteria developed based on those issues are sufficiently complete and adequate. Although two of the four peer reviewers believe that the use of interlaboratory measurements is important for a general understanding of the laboratory communities' capabilities, they also believe that the MDL and ML are more appropriate to address the issues that EPA must consider in support of a permittee's CWA requirements. These commenters concluded that EPA's approach between inter- and intra-laboratory studies is balanced and reasonable. Overall, the peer reviewers supported the continued use of the MDL and ML procedures, almost to the exclusion of the other approaches. The most notable exception was a suggestion that EPA consider abandoning the “traditional” concept of a quantitation limit, such as the ML, and instead consider that any measured result reported with an associated estimate of measurement precision is a quantifiable value. Reviewers stated, however, that use of the ML is practical if EPA desires to establish a quantitation limit.

Although the peer reviewers were generally supportive of the assessment and EPA's current approach to detection and quantitation under the CWA, they had some recommendations for improvement to the Agency's assessment and to the MDL procedure. The reviewers suggested that EPA consider the following: (1) Providing additional references; (2) expanding the discussion of outliers; (3) establishing a repository of reference materials that demonstrate the ability to handle interferences and low level detection; (4) making minor modifications to Evaluation Criterion 4 (i.e., edit to reflect equivalence to an implementation of Currie's critical level); (5) clarifying the MDL confidence interval calculations discussed in Chapter 5 of the Assessment Document; and (6) enhancing the focus on the impact of operational procedures (quality control) in method performance. The Assessment Document available in the docket supporting today proposed rule addresses each of these suggestions.

The peer reviewers also suggested the following improvements to the MDL procedure: (1) Provide clarification to indicate that blank samples can be used to estimate the MDL if those blanks generate a signal; (2) revise the language in Step 1 of the MDL procedure to address certain common misunderstandings ( e.g. , strengthen the discussion of the selection of the spiking level used for the MDL study); and (3) specify that the spike level used to establish the MDL should not be more than a factor of three times greater than the calculated MDL. The first two suggestions from the peer reviewers regarding improvements to the MDL procedure, have been included in the proposed revision to the MDL procedure. Although EPA agrees with the theoretical arguments related to the last suggestion regarding the spike level, EPA already tested this suggestion in one of its studies of detection and quantitation concepts and found that it could create laboratory burdens that far exceed the benefits. Specifically, EPA required a spike-to-MDL ratio of three in its multi-technique variability studies (the “Episode 6000 studies”), which are described in the Assessment Document supporting this rule. Two laboratories reported that a large number of iterations would be required (particularly in multiple-analyte methods) in order to achieved a spike-to-MDL ratio of three, and would result in increased laboratory burden and cost. Therefore, this suggestion is not incorporated into the revised MDL procedure in this proposed rule.

Based on peer review comments and comments received over the years from the laboratory community, the Petitioners, and other stakeholders, EPA is proposing revisions to the MDL procedure (see section VII below).

This proposal would revise the definition of detection limit for use under the CWA. It also would revise certain aspects of the existing procedure for determining the Method Detection Limit (MDL) in 40 CFR part 136, Appendix B (Definition and Procedure for the Determination of the Method Detection Limit) and modify the discussion to clarify implementation of the procedure. It also requests comment on whether to add a stand-alone definition of quantitation limit and procedure for determining the Minimum Level of Quantitation (ML) in Appendix B.

This proposal incorporates the results of EPA's recent assessment of detection and quantitation concepts and procedures discussed throughout this preamble and in the Assessment Document, and address various stakeholder comments received by EPA since the 1984 promulgation of the MDL (49 FR 43234, October 26, 1984).

The following discussion is divided into five sections: (1) Revisions to the definition of the detection limit are discussed in section VII.A; (2) technical revisions to the MDL procedure are discussed in section VII.B; (3) clarifications and other minor editorial changes to the MDL procedure are discussed in section VII.C; (4) the addition of a definition of quantitation limit and the addition of a procedure to calculate the ML are discussed in section VII.D; (5) section VII.E discusses EPA's continued acceptance of analytical methods from organizations that do not necessarily use EPA's MDL and ML procedures.

Section 136.2(f) currently defines the term “detection limit” to mean “the minimum concentration of an analyte (substance) that can be measured and reported with a 99% confidence that the analyte concentration is greater than zero as determined by the procedure set forth at appendix B of this part.” EPA is proposing to revise § 136.2(f) to explicitly equate the term “detection limit” with the “method detection limit” and to reflect the proposed revisions to the MDL procedure at Appendix B as follows: “ Detection limit means the method detection limit (MDL), as determined by the procedure set forth at Appendix B of this part. The MDL is an estimate of the measured concentration at which there is 99% confidence that a given analyte is present in a given sample matrix.” EPA also is proposing to revise the definition of the Method Detection Limit included in Appendix B as follows: “The MDL is an estimate of the measured concentration at which there is 99% confidence that a given analyte is present in a given sample matrix.” The MDL is the concentration at which a decision is made regarding whether an analyte is detected by a given analytical method. The MDL is calculated from replicate analyses of a matrix containing the analyte and is functionally analogous to the “critical value” described by Currie (1968, 1995) and the Limit of Detection described by the American Chemical Society (Keith et al. , 1980, McDougal et al. , 1983).

EPA also is requesting comment on an alternative approach in which the term limit of detection would be defined at § 136.2 as “the critical value, which is the concentration at which there is 99% confidence that a given analyte is present in a given sample matrix,” and the method detection limit would be defined as “the procedure set forth in Appendix B of this part, which can be used to estimate the limit of detection ( i.e. , critical value).”

This notice proposes several technical revisions to the MDL procedure at 40 CFR part 136, Appendix B. These revisions are based on EPA's recent assessment of detection and quantitation concepts described in the Assessment Document, as well as comments received from stakeholders, the Petitioners, and the peer reviewers of the assessment. Specifically, the proposed revisions would:

1. Revise the definition of the MDL to replace the term “minimum concentration” with the term “estimate of the measured concentration” and replace the phrase “greater than zero” with the phrase “present in a given sample matrix.” The revised definition would note the functional analogy of the MDL with the “critical value” described by Currie (1968 and 1995) and the “limit of detection” (LOD) described by the American Chemical Society in 1980 and 1983. The revised definition also would note that the MDL represents the concentration at which the detection decision is made. These proposed revisions are intended to make the definition of the MDL more consistent with the MDL procedure. The proposed revisions reflect peer review comments on EPA's recent assessment of detection and quantitation concepts and procedures.

2. Expand the Scope and Application discussion to recognize that there are a variety of purposes and analytical methods for which the MDL procedure may be employed. The revised text provides examples of four common uses of the MDL procedure ( i.e. , demonstrating laboratory capability with a particular method; monitoring trends in laboratory performance; characterizing method sensitivity in a particular matrix; and establishing an MDL for a new or revised method for nationwide use). The revised text also clarifies that the procedure may not be applicable to certain test methods such as those used to measure pH or temperature, for example. These revisions are based on questions from stakeholders about the scope and applicability of the MDL procedure.

3. Revise three of the four considerations for estimating the detection limit (see Step 1 of the current MDL procedure and section 4.3 of the proposed revisions), and suggest that the method-specified MDL can be used as the initial estimate when performing an MDL study to verify laboratory performance or to demonstrate that the MDL can be achieved in a specific matrix. The proposed revisions to the original considerations include: (1) Clarifying that, if analysis of blank samples yields an instrument response, the detection limit can be estimated as approximately equal to three times the standard deviation of replicate measurements of the analyte in the blank; (2) replacing “that region of the standard curve where there is a significant change in sensitivity ( i.e. , a break in the slope of the standard curve)” with “a concentration in the region of constant or effectively-constant standard deviation at low concentrations;” and (3) replacing “instrumental limitations” with “the lowest concentration that can be detected by analyzing samples containing successively lower concentrations of the analyte.”

4. Revise the specifications for establishing the test concentration range according to the intended application of the MDL as follows: (1) If verifying a published MDL, the test concentration should be no more than five times the published MDL; (2) if verifying an MDL to support a regulatory objective or the objective of a study or program, the test concentration should be no more than one third the compliance or target limit; (3) if determining an MDL for a new or revised method, the test concentration should be no more than five times the estimated detection limit; and (4) if performing an iteration, the test concentration should be no more than five times the MDL determined in the most recent iteration. (See Step 3.1 of the current procedure and section 4.3.1 of the proposed revisions.)

5. Delete the calculation of a 95% confidence interval estimate for the MDL. EPA has determined that these calculations are neither routinely performed by laboratories, nor are the results employed by regulatory agencies, including EPA.

6. Revise the discussion of the iterative procedure to require that the iterative procedure be used to verify the reasonableness of the MDL when developing an MDL for a new or revised method or when developing a matrix-specific MDL, but that it remain optional when determining an MDL to verify a method-, matrix-, program-, or study-specific MDL. This change recognizes that the iterative procedure is rarely used to verify laboratory performance, but is considered important during method development. The discussion, as revised, also would provide specific instructions on how to assess the reasonableness of an MDL used to verify laboratory performance. (See Step 7 of the current procedure and section 4.8 of the proposed revision.)

7. Add a new section (section 4.9) to the MDL procedure to address the treatment of suspected outliers. EPA is proposing to add this section in response to frequent questions from stakeholders with regard to outliers in the absence of any affirmative statements in the current MDL procedure. The discussion in this proposed section specifies that suspected outliers be examined for spurious errors that may occur as a result of human error or instrument malfunction, recommends that correctable errors be corrected before calculation of the MDL, and requires that any corrective actions be documented. The proposed section specifically would provide for invalidation of results from noncorrectable errors and preclude their use in calculating the MDL. The proposed section also describes the use of the Grubbs test for outlying values as a means to screen the results of the replicate samples for possible outliers, and provides an example application of the Grubbs test. Finally, the proposed section would reiterate the requirement that any results generated from more than seven replicates must be used to calculate the MDL unless they are determined to be outliers by the use of an appropriate outlier test. This proposed change addresses the possibility that some laboratories could prepare more than the requisite seven samples and then select only the seven results that yield the most desirable MDL value. Laboratory auditors from various agencies have identified this practice as a problem that can distort the MDL, but it is not specifically prohibited or addressed in the current procedure.

8. Delete the discussion of analysis and use of blanks included in section 4(a) of the current procedure. The current discussion applies to methods in which a blank measurement is required to calculate the measured level of an analyte; it requires separate measurements of blank samples for each MDL sample aliquot analyzed and subtraction of the average result of the blank samples from each respective MDL sample measurement. The proposed deletion of this discussion is in recognition that subtraction of a single (or average) blank sample result from the result for each MDL sample would not change the standard deviation and thus, would have no effect on the resulting MDL. Although EPA believes laboratories would be prudent to analyze blanks for assessing potential contamination, EPA also believes that requiring analysis of blanks or subtraction of blank results during MDL determinations is unnecessarily burdensome.

9. Revise the optional pre-test described in section 4(b) of the current procedure. The current procedure suggests analyzing two aliquots to evaluate the estimated detection limit before proceeding with the full seven-replicate test. Results from these analyses are evaluated to determine if the sample is in the “desirable range for determining the MDL,” but no criteria are provided for establishing this desirable range. The proposed revisions to the pre-test procedure are intended to address this issue. These revisions now appear in section 4.1 of the proposed procedure. Specifically, the pre-test has been modified to suggest analysis of three aliquots. Results from these analyses are evaluated by calculating a preliminary MDL based on the standard deviation of the analyses, and then determining if this preliminary MDL is within 0.2 to 1.0 times the concentration spiked in the sample. This revision is consistent with the current procedure's recommendation that samples used to determine an MDL contain the analyte at a concentration that is “between 1 and 5 times the estimated method detection limit.”

This notice proposes editorial changes to the MDL procedure at 40 CFR part 136, Appendix B that are designed to clarify the existing procedure and improve readability. These editorial changes include changes to the numbering scheme, the addition of clearer titles to some of the procedural steps, and minor clarifications. Specifically, the proposed changes would:

1. Add a summary section to provide an overview of the various steps included in the MDL procedure. The summary section is consistent with the current format for analytical methods and should be particularly helpful to non-laboratory readers.

2. Clarify in the Scope and Application discussion that the MDL procedure is intended for use in EPA's Clean Water Act programs, and that alternative procedures may be used to establish test method sensitivity provided the resulting detection value meets the sensitivity needs for a specific application.

3. Clarify throughout the procedure that not all of the steps are required for every application. This clarification provides consistency with the proposed revisions in the Scope and Application section of the procedure.

4. Expand the discussion of matrix selection to address use of an MDL in either a reference matrix or an alternate matrix. (See Step 2 of the current procedure and section 4.2 of the proposed revisions.) Use of matrices other than reagent water are not discussed until Step 3b of the current procedure. The expanded discussion is intended to provide additional clarity and consistency with the description of the four applications added to the MDL Scope and Application section (see section VII.B.2 above).

5. Expand the discussion of establishing the test concentration range to more clearly describe the steps required and prepare the test samples. (See Step 3 of the current procedure and section 4.3 of the proposed revisions.) These proposed changes are editorial and describe the process that may be used for determining a matrix-specific MDL as well as determining an MDL in a reference matrix such as reagent water. Additional clarifications include recognition that some analytes may require that seven aliquots be prepared individually, as opposed to preparing a bulk sample of sufficient volume to be split into seven aliquots. EPA is proposing this clarification in response to questions from laboratories regarding the appropriate means for preparing the MDL aliquots.

6. Expand the discussion of performing the analyses to include a brief introduction clarifying that the samples used for MDL analyses must be processed using the sample handling, processing, and result calculations specified in the analytical method. (See Step 4 of the current procedure and section 4.4 of the proposed revisions.) This proposed change includes moving this statement from the Reporting section of the current procedure to the more appropriate location in section 4 of the revised procedure. This proposed change also would clarify that blank-correction or recovery-correction procedures are applied to the MDL analyses only when those procedures are employed for routine sample analyses, and precludes their use if they are not specified in the test method. EPA is proposing these changes in response to questions raised by laboratories, the Petitioners, and as a result of the recent assessment.

7. Reorganize the procedural steps contained in Step 4 of the current procedure, such that the optional pre-test of the MDL is discussed before the procedure for performing the full seven-replicate test. (See section 4.4 of the proposed revisions.) EPA is proposing this change strictly to improve ease of use.

8. Expand and reorganize the description of the seven-replicate version of the MDL described in Step 4(a) of the current procedure. The revised version would appear in section 4.5 and reflects comments from stakeholders that the discussion in the current procedure is not sufficiently clear. The revised procedure also would state explicitly that all analytical results must be positive numbers, and that the results from all aliquots analyzed must be used in the calculations, except those identified as outliers using the procedures described in section 4.9 of the revised procedure (see the discussion regarding outliers in VII.B above). These proposed changes would clarify stakeholder concerns regarding those analytical methods (e.g., for metals) that may produce negative numbers at very low concentrations and would emphasize the revision made in response to concerns regarding inappropriate screening of results used for MDL determinations.

9. Simplify the calculations of standard deviation of replicate measurements in Step 5 of the current procedure. (See section 4.6 of the proposed revisions.) For example, the current procedure details the calculation of the sample variance ( s 2 ), and then details the calculation of the sample standard deviation ( s ) in a separate equation. Given that the variance term does not factor into the MDL calculation directly, the proposed revision would require only calculation of the standard deviation. The proposed revision also would include a caution warning the reader to calculate the sample standard deviation ( s ), not the population standard deviation (sigma), when using automated programs such as spreadsheets. This error was not as likely to occur in 1984, prior to the ready availability of personal computers and laboratory data systems, but is commonly seen today.

10. Move the table of Student's t -values from its current location following the text in Step 7 to section 4.7, where the t -value is employed. EPA is proposing this change to improve ease of use and increase readability.

11. Add a table of F-statistic values to the iterative procedure described in section 4.8. EPA is proposing this change to improve ease of use and address those instances in which an iterative MDL might be determined from other than seven replicates per data set.

12. Delete the “Reporting” section of the MDL procedure. The existing procedure includes a section listing the information that must be provided with the MDL for each analyte. EPA is proposing to delete this section because it is not relevant to the procedure and it is generally duplicative of reporting and recordkeeping requirements that States, other regulatory entities, or laboratory certification officials already require.

Although ML values for analytes were published in 1984 in EPA Methods 1624 and 1625 (49 FR 43234, October 26, 1984), the definition of the ML was provided in a footnote to the tables within those methods. The original definition was intended to define a minimum level of quantitation for these isotope dilution GC/MS methods. However, as described in the Assessment Document, EPA has changed the definition of the ML over the years and has expanded its applicability to other 40 CFR part 136 methods. This proposal requests comment on whether to add the following definition of the ML to Appendix B of 40 CFR part 136: “ the lowest level at which the entire analytical system gives a recognizable signal and acceptable calibration point for the analyte, as determined by the procedure set forth at Appendix B of this part. The ML represents the lowest concentration at which an analyte can be measured with a known level of confidence.” In addition to the definition, EPA requests comment on whether Appendix B should contain an explicit explanation of the calculation of the ML from an MDL value determined using the revised MDL procedure, including a table of multiplier values that may be used when the MDL value is calculated from other than seven replicate analyses.

An alternative is to not incorporate a definition in § 136.2 but to continue to specify the ML on a method-by-method basis. In this case, the ML may continue to be determined and supported with data gathered during method validation studies. This approach would allow maximum flexibility to design studies that are appropriate for the intended use of the method.

A second alternative is to incorporate into § 136.2 the definition of limit of quantitation as “The lowest concentration of an analyte that can be measured with a defined level of confidence” and to incorporate the definition of ML (minimum level) as “The procedure set forth in Appendix B of this part of the same name, which can be used to estimate the limit of quantitation.”

In this proposal, EPA is also requesting comment on whether it should encourage or require that laboratories periodically demonstrate target analyte recovery at the ML by preparing and analyzing a reference matrix sample spiked at the ML using all sample handling and processing steps described in the method. EPA recognizes that existing methods do not provide acceptance criteria for such “ML standards.” Therefore, EPA suggests that, if the method does not provide acceptance criteria for an ML standard, acceptance criteria for other spiked reference matrix samples (e.g., laboratory control samples, laboratory fortified blanks, ongoing precision and recovery samples, etc.) may be used to evaluate analyte recovery at the ML. EPA is soliciting comment on whether this recommendation should be made into a mandatory requirement, retained as a recommendation, or replaced by an alternative recommendation for demonstrating recovery at the ML.

This proposed rule would allow use of alternative detection and quantitation procedures to establish detection and quantitation limits in an analytical method, provided that the resulting detection and quantitation limits meet the sensitivity needs for the specific application. The use of detection and quantitation approaches from voluntary consensus standards bodies (VCSBs) and other organizations is encouraged under the National Technology Transfer and Advancement Act (NTTAA), because it facilitates the approval of analytical methods from these organizations at 40 CFR part 136 without requiring that these organizations specifically employ EPA's MDL and ML procedures to establish method sensitivity. This allowance would result in greater flexibility to establish or improve the sensitivity of methods for use under the Clean Water Act. It also would facilitate approval of analytical methods from VCSBs and other organizations. In selecting an appropriate test method for a specific purpose, the laboratory must always consider the sensitivity of the approved test methods. Only those test methods with the desired sensitivity should be used to meet the objective of the CWA “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.”

EPA recognizes that there are alternative detection and quantitation approaches that may be used for determining test method sensitivity. EPA has included test methods at 40 CFR part 136 that employ alternative approaches, although some of these approaches have not been rigorously defined. In its recent assessment of detection and quantitation approaches, EPA evaluated the interlaboratory detection estimate (IDE) and the interlaboratory quantitation estimate (IQE) procedures published by ASTM International. However, EPA is not aware at this time of any published test methods from any source that include specific values for the IDE and the IQE, including test methods published by ASTM International. EPA will consider test methods that include these procedures for use in CWA programs when such methods are available. If ASTM International is successful in developing single-laboratory adaptations of the IDE and IQE that may be used to verify the ability of a given laboratory to achieve the IDE and IQE, then EPA also may consider those single-laboratory approaches in evaluating both method and laboratory performance.

On December 27, 2002, the Inter-Industry Analytical Group (IIAG) submitted a proposal that recommends (1) a sensitivity test intended to “replace the MDL as a test of whether an individual laboratory is performing adequately,” and (2) an interlaboratory validation study design intended to characterize precision and accuracy of methods used for regulatory compliance. EPA did not have the opportunity to evaluate IIAG's proposal against the criteria discussed in Section IV of this preamble, but intends to do so prior to publication of a final rule. EPA is providing a summary of the recommendations contained in the “Inter-Industry Analytical Group Proposal for Sensitivity Test and Full-Range Interlaboratory Validation Study” here. The complete text of the recommendations has been placed in the docket supporting this proposed rule. EPA is soliciting comment on the industry recommendations.

IIAG is proposing a sensitivity test in place of the MDL for determining laboratory performance capability. The proposed sensitivity test includes the provision that EPA first determine the lowest calibration point of a method, prescribe a dilution of that calibration point as the spike level (e.g., at one-half or two-thirds the lowest calibration point), specify a required number of replicates, and set a quality control acceptance criterion. IIAG asserts that an advantage of such a test is that it would provide all laboratories with a single spike level and an “unambiguous pass or no-pass test.” EPA is soliciting comment on approaches that might be considered appropriate for such determinations (i.e., the lowest calibration point of a method, an appropriate dilution, a number of replicates, and an acceptance criterion for standard deviation between measurements of the replicates). EPA also is soliciting comment on how IIAG's recommended sensitivity test would be either more appropriate or less appropriate than either the current MDL and ML procedures or the MDL and ML procedures if revised according to this proposed rule.

IIAG's proposed “full range” validation study is intended to determine precision and bias across the entire working range of an analytical method ( i.e., from a blank to the upper end of the working range) and would account for variability between laboratories. IIAG recommends that, unlike the MDL and IIAG's proposed sensitivity test, the “full-range” validation study could be used to characterize bias and precision across the entire working range of the method and results of such a study could be used to establish an interlaboratory method detection level. EPA is requesting comment on the use of data generated through a “full range” validation study to determine a quantitation level, detection level, and corresponding bias and precision criteria that are applicable throughout the entire working range of the method. EPA also is soliciting comment on how IIAG's recommended “full range” validation study would be either more appropriate or less appropriate than EPA's use of interlaboratory validation studies, which are designed in accordance with ASTM Standard D 2777, or other appropriate standards. For example, EPA used the ASTM standard to validate EPA Method 1631 (see Interlaboratory Validation Study of EPA Method 1631).

EPA is hereby requesting public comment on the proposed revisions discussed in section VII of this preamble and on the industry proposal discussed in section VIII. Specifically, EPA is requesting comment on the proposed revisions to the Definition and Procedure for the Determination of the Method Detection Limit at 40 CFR part 136 (Appendix B), to the proposed revision to the definition of “Detection Limit,” on whether EPA should add definition of “Minimum Level” at 40 CFR 136.2, and on whether and how the sensitivity test described in the industry proposal could be used in CWA programs. EPA is also requesting public comment on the Assessment Document supporting the proposed revisions discussed in this notice elsewhere in today's Federal Register (see Notice of Document Availability and Public Comment Period for the Technical Support Document for the Assessment of Detection and Quantitation Concepts).

Commenters are encouraged to support their views with data or information that would assist EPA in making a final decision on detection and quantitation procedures for EPA's CWA applications. To ensure that EPA can properly respond to comments, commenters should cite, where possible, the paragraph(s) or section(s) in this proposal to which each comment refers. For further details on submission of comments, please see the DATES; ADDRESSES; and “How to Submit Comments” sections at the beginning of this preamble.

EPA is particularly requesting comment on the following:

1. EPA is requesting comment on whether to include a definition and procedure for the ML in Appendix B of 40 CFR part 136 (see section VII.D of this preamble). EPA is soliciting comment on whether the proposed addition of an ML definition and procedure in Appendix B is appropriate, or whether either of the alternatives discussed in section VII.D are more appropriate to maintain flexibility in the application of different quantitation approaches.

2. EPA is proposing a recommendation that laboratories periodically demonstrate target analyte recovery at the ML by preparing and analyzing a reference matrix sample spiked at the ML (see section VII.D of this preamble). Specifically, EPA is soliciting comment on whether this recommendation should be made into a mandatory requirement, retained as a recommendation, or replaced by an alternative recommendation for demonstrating recovery at the ML. EPA also is soliciting comments and recommendations regarding procedures for establishing acceptance criteria for ML recovery, and when application of the criteria would be appropriate ( e.g. , development of new methods, validation of data), if such a requirement were mandatory.

3. EPA is proposing to add a new Step 8 to the MDL procedure to address the identification and treatment of suspected outliers (see Section VII.B.7 of this preamble). This proposed step includes provision for invalidation of results from noncorrectable errors and precludes their use in calculating the MDL. The proposed step also states: “Given the small number of replicates typically used to determine the MDL, it is inappropriate to use a data set that contains more than one statistical outlier.” EPA requests comment on (1) the procedures for identifying outliers, (2) the specification that only one outlier may be removed from a data set that is used for MDL determination, and (3) the appropriateness of allowing use of a data set containing six results if an outlier is identified and removed from a data set containing results from the required minimum of seven replicate samples.

4. EPA is proposing to revise the specifications for establishing the test concentration (spike level) that will be used in the determining the MDL according to the intended application of the MDL (see Section VII.A.4 of this preamble). EPA is soliciting comment on these levels and on the appropriateness of applying these levels according to the intended use of the MDL.

5. EPA is soliciting comment on the sensitivity test and “full-range” validation study described by IIAG and included in the public docket supporting this proposed rule (see Section VII of this preamble). EPA is specifically soliciting comment on those aspects of IIAG's proposed study that relate to detection and quantitation issues.

6. EPA is proposing to delete the Reporting section of the existing MDL procedure. EPA is soliciting comments on whether this change is appropriate.

Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the Agency must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This action imposes no information collection, reporting or recordkeeping requirements. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the U.S. Small Business Administration definitions at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This rule proposes to modify existing procedures in 40 CFR part 136, appendix B for determination of detection and quantitation in analytical methods. This modification would clarify and improve existing procedures.

Overall, the costs of this modification are minimal. Many laboratories using analytical test methods are already implementing aspects of the modification, further minimizing any potential cost increases. Therefore, EPA believes that this rule will not have a significant economic impact on a substantial number of small entities. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, Tribal, and local governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, Tribal, and local governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation of why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for the notification of potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This proposed rule contains no Federal mandate (under the regulatory provisions of Title II of the UMRA) for State, Tribal, and local governments or the private sector in any one year. This rule imposes no enforceable duty on any State, local, or Tribal governments or the private sector. This rule proposes to modify existing procedures in 40 CFR part 136, appendix B for determination of detection and quantitation in analytical methods. This modification would clarify and improve current procedures. Overall, the costs of this modification are minimal. Thus, this rule is not subject to sections 202 and 205 of the UMRA. For the same reasons, EPA has also determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this rule also is not subject to the requirements of section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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.”

This proposed rule does not have federalism implications. It will 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. This rule proposes to modify existing procedures in 40 CFR part 136, Appendix B for determination of detection and quantitation in analytical methods. This modification would clarify and improve existing procedures. The costs of this rule for State and local governments are minimal. Thus, Executive Order 13132 does not apply to this rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comments on this proposed rule from State and local officials.

Executive Order 13175, titled “Consultation and Coordination With Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” “Policies that have Tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian Tribes, on the relationship between the Federal government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes.”

This proposed rule does not have Tribal implications. It will not have substantial direct effects on Tribal governments, 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 in Executive Order 13175. This rule proposes to modify existing procedures in 40 CFR part 136, Appendix B for determination of detection and quantitation in analytical methods. This modification would clarify and improve existing procedures. The costs of this rule for Tribal governments are minimal. Thus, Executive Order 13175 does not apply to this rule. In the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and Tribal governments, EPA specifically solicits comments on this proposed rule from Tribal officials.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This proposed rule is not subject to Executive Order 13045 because it is not “economically significant” as defined in Executive Order 12866. Furthermore, it does not concern an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children.

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

Section 12(d) of the National Technology Transfer and Advancement Act of 1995, (“NTTAA”), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., material specifications, test methods, sampling procedures, business practices) that are developed or adopted by voluntary consensus standard bodies. The NTTAA directs EPA to provide Congress, through the Office of Management and Budget (OMB), explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This proposed rulemaking involves technical standards. Therefore, the Agency identified and evaluated potential voluntary consensus standards. Specifically, EPA identified and evaluated potential detection and quantitation concepts and procedures published by the American Society for Testing and Materials (ASTM International), from the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), and the American Chemical Society (ACS). EPA determined that, although ISO, IUPAC, and ACS have published terms and definitions for detection and quantitation, these organizations have not published an applicable standard ( i.e., a step-by-step protocol to make a detection or quantitation determination). EPA did identify applicable standards from ASTM International (the IDE and IQE). This proposed rulemaking would allow the use of these procedures for methods development purposes and would allow the use of any analytical methods with an IDE and IQE, provided these test methods meet the analytical sensitivity requirements for a specific data use. There is currently no applicable voluntary consensus standard for detection and quantitation for laboratory quality control purposes. EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially applicable voluntary consensus standards and to explain why such standards should be used in this regulation.

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations, is proposed to be amended as follows:

1. Docket. EPA has established an official public docket for this action under Docket ID No. OW-2003-0003. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in I.A.1.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. However, late comments may be considered if time permits.

1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in Docket ID No. OW-2003-0003. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by electronic mail (e-mail) to OW-docket@epa.gov Attention Docket ID No. OW-2003-0003. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in I.B.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By Mail. Send an original and three copies of your comments to: Water Docket, Environmental Protection Agency, Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No. OW-2003-0003.

3. By Hand Delivery or Courier. Deliver your comments to EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC, Attention Docket ID No. OW-2003-0003. Such deliveries are only accepted during the Docket's normal hours of operation as identified in I.A.1.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

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

8. Ensure proper receipt by EPA by identifying the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

EPA completed an assessment for determining the sensitivity of analytical test methods ( i.e. , procedures for determining detection and quantitation) and their application to Clean Water Act (CWA) programs. The assessment examines the method detection limit (MDL) and minimum level of quantitation (ML) procedures currently used by the Agency for determining test sensitivity for CWA applications. It also considers alternative concepts and procedures. EPA conducted the assessment to partially fulfill certain provisions of a settlement agreement with the Alliance of Automobile Manufacturers, et al. , which is discussed further below.

On June 8, 1999, EPA published a final rule adding EPA Method 1631, Revision B: Mercury in Water by Oxidation, Purge and Trap, and Cold Vapor Atomic Fluorescence Spectrometry (Method 1631) to the “Guidelines Establishing Test Procedures for the Analysis of Pollutants” under section 304(h) of the Clean Water Act. Following promulgation, the Alliance of Automobile Manufacturers, the Chemical Manufacturers Association, and the Utility Water Act Group (“Petitioners”) and the American Forest and Paper Association (“Intervenor”) filed a lawsuit challenging the method. The challenge addressed specific aspects of EPA Method 1631 as well as the general procedures used to establish the method detection limit (MDL) and minimum level of quantitation (ML) specified in the method. On October 19, 2000, EPA entered into a settlement agreement with the Petitioners and Intervenor ( Alliance of Automobile Manufacturers, et al. v. EPA, No. 99-1420 (D.C. Cir.); the “settlement agreement”).

Clause 6 of the settlement agreement provides for EPA to assess existing Agency and alternative procedures for determining detection and quantitation limits under the Clean Water Act and to sign a notice for publication in the Federal Register on or before February 28, 2003, inviting comment on the assessment. The settlement agreement further provides for EPA to submit its assessment to formal peer review by experts in the fields of analytical chemistry and in the statistical aspects of analytical data interpretation. EPA drafted an Assessment Document describing the issues associated with the assessment process, the detection and quantitation concepts and procedures evaluated, the criteria used for the evaluation, the evaluation results, and the conclusions of the assessment. EPA then conducted a peer review of the draft Assessment Document in August 2002. As stipulated in the settlement agreement, EPA provided the draft Assessment Document to the Petitioners and Intervenor for concurrent review and comment in August 2002.

Following peer review, EPA revised the Assessment Document to incorporate peer review comments. The revised assessment is contained in a document titled, “Technical Support Document for the Assessment of Detection and Quantitation Concepts” (EPA 821- R-03-005, February, 2003), or “Assessment Document.” The Assessment Document, the peer review comments, and comments from the Petitioners and Intervenor are available in the docket for this notice. The purpose of this notice is specifically to request comment on the Assessment Document.

Elsewhere in today's Federal Register , the Agency is proposing revisions to the MDL definition and procedure codified at 40 CFR part 136, Appendix B, and is also proposing to add a definition of the ML at 40 CFR 136.2. The proposed revisions are based on the findings from the assessment and are fully discussed in the proposed rule. To comment on these proposed revisions, readers are referred to the Proposed Rules section of today's Federal Register for the Guidelines Establishing Test Procedures for the Analysis of Pollutants; Procedures for Detection and Quantitation.

The settlement agreement stipulates that EPA's assessment of concepts and procedures for detection and quantitation be submitted for public review and comment for a period of no less than 120 days. The settlement agreement also requires EPA to sign a final notice taking action on the assessment on or before September 30, 2004. By this notice, EPA invites the public to comment on the Assessment Document. The public comment period is open for 120 days and will close on July 10, 2003.

After EPA considers public comments, it will publish a notice taking final action on the assessment by September 30, 2004.

An initial application from Manomet was received on December 6, 2002, and the application was completed on January 31, 2003. The proposed study would test a modified trawl net with a separator panel, designed to separate haddock from cod. The modified net would be built with a 4-inch mesh horizontal separator panel dividing the trawl codend into an upper and lower codend. Both codends would be constructed with legal minimum mesh size and the net would be fully compliant with current regulations except for the insertion of a small mesh separator panel. The study would involve four phases. The first phase would consist of development and construction of a separator trawl net. Phase two would involve a series of sea trials conducted with an underwater video camera to ensure that the trawl and separator panel are fishing properly. Trials would take place in shallow water to ensure high quality video imaging. This process would take up to 2 days. Phase three would be the experimental sea trials. Four commercial vessels would fish 5 days each, making approximately five tows per day for a total of 100 tows for this portion of the study. Tow length would be approximately 30 minutes and experimental tows would mimic normal fishing practices. This would result in a total of 22 sea days for the entire study (including 2 days for preliminary sea trials). Participating vessels would be required to notify NMFS prior to commencing an experimental fishing trip. The final phase of the experiment would be data analysis and reporting, including a video analysis.

The proposed study area would take place off the coast of Cape Cod, MA, inside the area defined by the following coordinates: 42°15' N. lat., 70°15' W. long.; 42°15' N. lat., 69°30' W. long.; 42°00' N. lat., 69°30' W. long.; 42°00' N. lat., 68°30' W. long.; 41°30' N. lat., 68°30' W. long.; 41°30' N. lat. 70°00' W. long. following the Cape Cod shoreline north to 42°00' N. lat., 70°00' W. long.; 42°00' N. lat., 70°15' W. long.; and 42°15' N. lat., 70°15' W. long. Areas subjected to permanent closures would be avoided. The EFPs would allow for exemptions from the GOM and GB RMA minimum mesh size requirements specified at 50 CFR 648.80(a)(1) and (a)(2), and seasonal GOM Rolling Closure Areas II and III specified at 50 CFR 648.81(g).

Under this experiment, target species would be cod, haddock, yellowtail flounder, American plaice, witch flounder, pollock, and windowpane flounder. Incidental species would include skate, smooth dogfish, spiny dogfish, sculpins, sea raven and sea robin. All biological and environmental information would be recorded by trained observers (supplied by Manomet) on relevant NMFS observer logbooks. Each participating vessel would have an observer on board. All catch would be sorted and weighed on board the vessel. In addition, all commercially important species would be measured. Species that do not meet minimum size requirements would be returned to the sea immediately following scientific processing. Experimental fishing operations would take place from approximately April 1 through September 30, 2003. A final report containing the results of the study would be provided to NMFS no later than 6 months following completion of the study.

A portion of the experimental fishing area proposed in this EFP is in the GOM RMA. However, the majority of the experiment area is on GB, and all vessels participating in the proposed experimental fishery would be required to abide by existing trip limits for GB cod and haddock for the duration of this experiment. Current regulations restrict vessels fishing on GB to landing no more than 2,000 lb (907.2 kg) of cod per days-at-sea (DAS), up to a maximum of 20,000 lb (9,071.8 kg) per trip. Because each vessel is expected to utilize 5 sea days, these vessels would be limited to landing a maximum of 2,000 -10,000 lb (907.2 - 4,536 kg) of cod per trip. Vessels would also be restricted to landing no more then 30,000 lb (13,608 kg) of haddock per trip from May through September, and 50,000 lb (22,680 kg) of haddock per trip, from October through April. In addition, vessels would be subject to the haddock trip limit, by day or by trip, as required by the regulations, should a daily haddock trip limit or overall trip limit be in effect for the commercial fishery (i.e., at the start of the May 1, 2003, fishing year, and if a daily limit is imposed prior to the end of the fishing year in order to prevent the haddock TAC from being exceeded).

EFPs would be issued to four vessels, exempting them from the specific minimum mesh size requirements restrictions and seasonal GOM Rolling Closure Area II and III of the FMP.

Based on the results of the EFP, this action may lead to future rulemaking.

The fishery for reef fish is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (Reef Fish FMP) that was prepared by the Council. The fisheries for coastal migratory pelagic resources are managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (Coastal Migratory Pelagics FMP) that was prepared jointly by the Council and the South Atlantic Fishery Management Council. These FMPs were approved by NMFS and implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The Council, in cooperation with the Gulf charter vessel/headboat industry, developed Amendments 14 and 20 to address issues of increased fishing mortality and fishing effort in the for-hire sector of the recreational fishery in the Gulf of Mexico. These amendments require charter vessels and headboats operating in the fisheries for Gulf reef fish or Gulf coastal pelagic fish to obtain a moratorium permit and also establish a 3-year moratorium on issuance of additional permits for these for-hire fisheries. NMFS approved Amendments 14 and 20 and promulgated the charter vessel/headboat moratorium regulations (67 FR 43558, June 28, 2002) to implement the amendments. However, after a recent review of the administrative record, the Council and NMFS determined that the amendments contained an error relating to the permit eligibility criteria and, therefore, did not correctly reflect the action taken by the Council. Thus, the regulations implementing the amendments also contained this error, and not all persons who should have been entitled to receive charter vessel/headboat permits under the moratorium approved by the Council would be able to receive permits under the erroneous amendments and regulations. The Council, at its September and November 2002 meetings, provided further clarification of Council intent regarding the eligibility criteria that resulted in corrected Amendments 14 and 20 (corrected Amendments) and requested that NMFS implement the necessary revisions.

On December 17, 2002, NMFS issued an emergency rule (67 FR 77193), that deferred the date that the “moratorium permit” is required; automatically extended the expiration date of valid or renewable “open access” permits for these fisheries; and extended the deadlines for issuance of “moratorium permits” and for resolution of appeals. These actions allow those applicants who otherwise would have been denied, inappropriately, initial access to the fisheries to continue participating in these fisheries, pending resolution of the error. In addition, those applicants who qualified under the existing regulations will be issued “moratorium permits” as soon as possible.

This proposed rule would: (1) Revise, consistent with the Council's clarification of intent, one of the eligibility criteria for obtaining a Gulf charter vessel/headboat moratorium permit; (2) reopen the moratorium permit application process with appropriate extension of associated deadlines for application, issuance, appeals, etc.; (3) further extend, automatically, the expiration dates of valid or renewable “open access” permits for these fisheries until such time that moratorium permits would be required under a final rule implementing the corrected Amendments; (4) clarify, consistent with the Council's intent, a constraint on issuance of moratorium permits under the historical captain provision; and (5) extend the expiration date of the moratorium, consistent with the Council's intent, to account for the unanticipated delay in its implementation.

One of the three eligibility criteria for obtaining a Gulf charter vessel/headboat moratorium permit, as contained in Amendments 14 and 20 and their implementing regulations, was subsequently determined to be inconsistent with the Council's intent. The incorrect criterion was worded as follows: “ An owner of a vessel that had a valid charter vessel/headboat permit for Gulf reef fish or coastal migratory pelagic fish, or whose application for such permit had been received by NMFS, at some time during the period March 29, 2000, through March 29, 2001, and who has such a valid permit on the effective date of the final rule that contains this paragraph (r)(2)(i).” Based upon the Council's clarifications at its September and November 2002 meetings, the criterion is proposed to be reworded to read as follows: “ An owner of a vessel that had a valid charter vessel/headboat permit for Gulf reef fish or coastal migratory pelagic fish on March 29, 2001, or held such a permit during the preceding year or whose application for such permit had been received by NMFS, by March 29, 2001, and was being processed or awaiting processing.” The proposed revision removes the requirement to have had a valid permit on the effective date of the final rule that implemented Amendments 14 and 20 (i.e., on July 29, 2002) and, therefore, would be less restrictive.

Because of the error in the eligibility criterion, NMFS is proposing to reopen the application process for Gulf charter vessel/headboat moratorium permits. The procedures for application, documentation of eligibility, permit issuance, and appeals are the same as the procedures in the existing regulations, except for the revision to the eligibility criterion described above and necessary reestablishment of applicable deadlines. The complete text of these procedures is provided in § 622.4(r)(1) through (r)(8) of this proposed rule and is not repeated here. Although this reopening would apply to all applicants, those applicants who previously applied under the existing regulations and were advised by NMFS that they were eligible or have already been issued a moratorium permit, need not, and should not, reapply.

This proposed rule would extend, automatically, the expiration dates of valid or renewable “open access” charter vessel/headboat permits for these fisheries until such time that moratorium permits would be required under a final rule implementing the corrected Amendments. This will allow those applicants who would be ineligible for a moratorium permit under the existing regulations, due to the error in the eligibility criterion, to participate in these fisheries while the error is addressed through the normal rulemaking initiated by this proposed rule.

NMFS determined that it needed to clarify that a historical captain moratorium permit would not be issued to a person who has a fishery permit issued in his/her name. Section 622.4(r)(2)(iii)(A) of this proposed rule has been revised to reflect that intent.

The Council intended that the moratorium remain in effect for 3 years from the date of effectiveness of the final rule implementing the moratorium, i.e., through July 29, 2005. Because of the recently discovered error in the eligibility criterion and subsequent need to reopen the moratorium permit application process, final implementation of the moratorium would be substantially delayed. Therefore, this proposed rule would extend the expiration date of the moratorium through a date that would be 3 years from the effective date of the final rule that would implement the moratorium as revised by the corrected Amendments.

Two Council minority reports contained objections to the proposed revision of the eligibility criterion and to the procedural approach for implementing the revision -the September 2002 report was signed by two Council members; the December 2002 report was signed by one Council member. Copies of the minority reports are available from NMFS (see ADDRESSES ).

At this time, NMFS has not determined whether the corrected Amendments that this proposed rule would implement are consistent with the national standards of the Magnuson-Stevens Act and other applicable laws. NMFS, in making that determination, will take into account the data, views, and comments received during the comment period on the corrected Amendments.

This proposed rule has been determined to be not significant for purposes of E.O. 12866.

NMFS prepared an IRFA that 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. This proposed rule would not duplicate any other requirements. A summary of the analysis follows.

NMFS prepared an IRFA and concluded that this proposed rule, if adopted, would have a significant economic impact on a substantial number of small business entities. A summary of the IRFA follows.

The Magnuson-Stevens Act provides the statutory basis for the rule. Under a rule promulgated on June 28, 2002 (67 FR 43558), all for-hire operators in the reef fish and/or coastal migratory pelagic fisheries in the Gulf of Mexico exclusive economic zone (EEZ) were required to have a valid limited access moratorium permit beginning December 26, 2002. The objective of that rule is to cap the number of for-hire vessels permitted to fish for reef fish or coastal migratory pelagics in the EEZ of the Gulf of Mexico at the current level while the Council assesses the actions necessary to restore overfished reef fish and king mackerel stocks and determine whether a more comprehensive effort management system is appropriate for these fisheries. Subsequent to publication of the rule, it was determined that the amendment did not correctly reflect the actions approved by the Council, resulting in the unintentional exclusion of 935 historical participants in the fishery. As an interim measure prior to correcting this error via normal rulemaking, NMFS promulgated an emergency rule that extended several dates associated with the moratorium to allow those participants erroneously excluded from qualifying for a moratorium permit to continue participation in the fishery while the current proposed rule is prepared. The primary objective of the proposed rule is, therefore, to correct the error associated with the eligibility criterion for the for-hire moratorium permit. The proposed rule would revise, consistent with the Council's clarification of intent, one of the eligibility criteria for obtaining a Gulf charter vessel/headboat moratorium permit to remove a restrictive provision requiring that a valid permit was held on July 29, 2002. Complementary logistical adjustments, e.g., reopening the application process, extension of deadlines, etc., are also included.

The qualification requirements for the initial issuance of the moratorium permit will mandate the provision of information necessary to establish qualification for the permit, such as information on income, record of past participation in the fishery, and proof of the time a vessel was under construction. Permit renewal will require that permitted vessels participate in the standard data collection programs implemented in the region which will require that information be maintained on standard vessel operation information, such as trips, passenger loads, catch success, etc. All information elements required for these actions are standard elements essential to the successful operation of the business and should already be collected and maintained as standard operating practice by the business. These requirements do not require professional skills, and, therefore, may be deemed not to be onerous on the affected participants.

No duplicative, overlapping, or conflicting Federal rules have been identified.

Two categories of impacted entities are presumed, those that qualify for the for-hire permit and those that do not. Those who qualify for permits fall under two groups; those who qualify based on permit records and those who qualify based on the provisions for historical captains or vessel-under-construction. Based on permit records, an estimated 3,071 permitted for-hire vessels would qualify for the moratorium permit, of which 1,917 would qualify for both reef fish and coastal migratory pelagic permits, 974 would qualify for only the coastal migratory pelagic permit, and 180 would qualify for only the reef fish permit. In addition to these vessels, an indeterminate number of entities would qualify for the initial issuance of the for-hire moratorium permit under the historical captain or vessel-under-construction criteria. In total, the two groups would constitute the universe of qualified entities. A precise estimate of this universe cannot be provided as, although it can be presumed that all active permits will be maintained to allow either sale of the permit or continued use, it cannot be determined how many entities will qualify under the historical captain or vessel-under-construction criteria. Of the 3,071 qualifying vessels, 2,136 vessels qualify under the status quo moratorium program, of which 1,373 vessels qualify for both permits, 99 vessels qualify for only the reef fish permit, and 664 vessels qualify for only the coastal migratory pelagic for-hire permit. The proposed action would, therefore, allow the qualification of an additional 935 vessels, of which 544 vessels would qualify for both permits, 81 vessels would qualify for the reef fish permit, and 310 vessels would qualify for the coastal migratory pelagic permit. These 935 vessels represent approximately 30 percent of the historic fleet. It should be noted that all 3,071 vessels, including the 935 vessels that would additionally qualify as a result of the proposed rule, are all historical participants in the fishery. This condition is reflective of the Council's intent to stabilize participation at historical levels.

Business operations in the for-hire sector consist primarily, if not exclusively, of small business entities. For-hire vessel operations are considered small business entities if they generate receipts not in excess of $5.0 million per year. The average gross revenues for charter boats operating in 1997 was $83,000 for vessels operating in Alabama, Mississippi, Louisiana, and Texas (based on average numbers of trips per vessel and average fee per trip) and $68,000 for vessels in Florida, while the average gross revenues for head boats/party boats was $328,000 from Alabama through Texas and $324,000 in Florida. Current revenues may exceed those of 1997, but the revenue performance of the fishery clearly qualifies the participants to fit the definition of small business entities. Since all entities operating in the fishery as well as the 935 new qualifiers will be affected by the proposed rule, the criterion of a substantial number of the small business entities being affected by the proposed rule will be met.

The determination of significant economic impact can be ascertained by examining two criteria, disproportionality and profitability. The disproportionality question is: Will the regulations place a substantial number of small business entities at a significant competitive disadvantage to large business entities? Although some variation exists between vessel operation type (guide boat, charter boat, and head/party boat), vessel length, and degree of participation in the fishery (number of trips per year), all vessels are classified as small business entities. Thus, the issue of disproportionality is not relevant in the present case.

The profitability question is: Will the regulations significantly reduce profit for a substantial number of small entities? Two categories of operations will be affected by the final rule, qualifying vessels and non-qualifying vessels. Effects on qualifying vessels may accrue through the permit fee, the reporting requirement, and the limitation on passenger capacity expansion. While permit fees are $50 for the first permit and $20 each for any additional permit, all vessels are currently required to possess a permit. Thus, permit costs should not be substantially affected, nor should they significantly affect profits. The reporting requirement impacts time expenses rather than actual monetary outlays and, therefore, do not directly affect profitability. However, the time expenses are estimated at $13 for charterboat participants (5.5 interviews x 7 minutes per interview x $20 per hour) and $700 for headboat participants (140 logbooks per headboat x 15 minutes per logbook x $20 per hour). The effects on profits of the limitation on passenger capacity expansion cannot be estimated because neither the cost of purchasing an existing permit, the expected rate of expansion (what portion of vessels might be expected to expand their passenger capacity), or the expected average capacity expansion can be forecast.

Additionally, the 935 vessels that were previously erroneously excluded from qualification for the moratorium permit, and that would now be qualified under the proposed action, will be allowed to continue their historic participation and accompanying profit performance and in addition will experience a substantial increase in profitability over what would occur under the status quo since they would have been precluded from continued participation under the June 28, 2002 rule.

Effects on non-qualifying vessels would consist of the effects on business profits of not being allowed to continue participation in the fishery or enter the fishery without purchasing an existing permit. The effects on profits of these vessels is unknown since neither the price of the necessary permit nor the alternative business options (what they might do and what the profitability profile of this option is in lieu of participating in the for-hire fishery) for these vessels are known. It is also not possible to estimate the number of small entities this would affect.

The proposed rule would allow qualification for the moratorium permit and continued operation of 935 vessels, or approximately 30 percent of the historic participants, in addition to the 2,136 vessels qualified under the status quo moratorium program, plus an unknown number of qualifiers under the historic captain and boat-under-construction provisions. Continued participation by these 935 vessels will allow the avoidance of a significant loss in performance and profits of these small business entities and the fishery as a whole. It is, therefore, concluded that the proposed rule would result in a significant economic impact on a substantial number of small entities.

Ten alternatives to the initial eligibility requirements were considered. These were: allowing all persons who held a for-hire permit on the date of implementation of the amendment; allowing all persons who held a for-hire permit on either September 16, 1999 or November 11, 1999; using a control date of November 18, 1998 and allowing for continuous participation under permit, vessel replacement by current permitted participant and issuance of new permit, purchase of permitted vessel, or purchase of a new vessel and issuance of a new permit; establishment and eligibility requirements for a Class 1 (fully transferable) species endorsements; establishment and eligibility requirements for a Class 2 (non-transferable) species endorsements; historical captain permit/endorsement provisions (2 alternatives); boat-under-construction provisions (2 alternatives); and allowing all persons who held a for-hire permit on or before January 1, 2002. Since the intent of the Council is to accommodate actual participation existent at the time of amendment development and the perception was strong that many active participants did not possess the required permits, control dates more restrictive than the proposed control date would increase the negative impacts on the fishery through the exclusion of active participants, contrary to the intent of the Council. More liberal control dates, however, while reducing the potential universe of excluded vessels, would also be contrary to the Council's intent of stabilizing participation at the level existent at the time of amendment development. The transferability provisions could result in contraction of the fleet, contrary to the intent of stabilization and would increase the negative impacts on the fishery. The alternative historical captain provisions would have increased the burden of eligibility and increased the negative impacts. The alternative provisions for boats under construction are more restrictive than those of the proposed rule because they would have made it more difficult for fishermen to qualify for a permit. This would have increased the negative impacts on the fishery because more permit holders would have been excluded. In summary, the proposed rule accomplishes the Council's intent while minimizing impacts.

Copies of the IRFA and RIR are available upon request(see ADDRESSES).

This proposed rule contains two collection-of-information requirements subject to the Paperwork Reduction Act (PRA)—namely a requirement to submit a charter vessel/headboat permit application and submission of appeals of NMFS' initial denial of a charter vessel/headboat permit -that have been approved by OMB under control number 0648-0451. The public reporting burdens for these collections of information are estimated to average 20 minutes and 5 hours per response, respectively, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collections of information. Send comments regarding these burden estimates, or any other aspect of these data collections, including suggestions for reducing the burden, to NMFS and OMB (see ADDRESSES ).

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.