This rule is issued under Marketing Order No. 981, as amended, (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department is issuing this rule in accordance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the provisions of the marketing order now in effect, salable and reserve percentages may be established for almonds during any crop year. This rule continues the scheduled relaxation of the salable and reserve percentages for marketable California almonds during the 1999-2000 crop year, which began August 1, 1999, and ends July 31, 2000. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

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

The order regulates the handling of almonds grown in California and is locally administered by the Board. During the 1999-2000 season, handlers were required to withhold as a reserve, from normal competitive markets, 22.36 percent of the almonds which they received from growers. The remaining 77.64 percent of the crop could be sold by handlers to any market at any time. These percentages are referred to as reserve and salable percentages, respectively. This rule continues to relax this regulation on handlers by continuing the scheduled release of all almonds held as reserve for sale to normal market channels. This is necessary to provide a sufficient quantity of almonds to meet anticipated trade demand and carryover needs. This action was unanimously recommended by the Board at a meeting on April 10, 2000.

Section 981.47 of the almond marketing order provides authority for the Secretary, based on recommendations by the Board and the analysis of other available information, to establish salable and reserve percentages for almonds during a crop year. To aid the Secretary in fixing the salable and reserve percentages, § 981.49 of the order requires the Board to submit information to the Department on estimates of the marketable production of almonds, trade demand needs for the year, carryin inventory at the beginning of the year, and the desirable carryout inventory at the end of the year. Reserve almonds may be disposed of in authorized reserve outlets, such as certified organic markets or for use in almond oil, almond butter, and animal feed. Reserve almonds can also be released for sale into normal marketing channels based on a revision of the aforementioned factors and other information. Authority for the Board to recommend revisions in the volume regulation percentages is provided in § 981.48 of the order. Such revisions must be recommended by May 15.

The Board met in May and July of 1999 to review projected crop estimates and marketing conditions for the 1999-2000 crop year. A record crop of 830 million kernelweight pounds was projected for the season. This would produce an estimated 796.8 marketable kernelweight pounds after an adjustment for processing losses and exempt product. When combined with estimated carryin and adjusted for desired carryout, an estimated 827.2 million pounds was available for marketing during the 1999-2000 crop year. Trade demand was estimated by the Board at 649 million pounds; thus, a projected oversupply of almonds of about 178.2 million pounds existed for the 1999-2000 crop year. The Board also considered other factors such as price levels and fluctuations, increased plantings and yields, and weather-related variations in production, and ultimately recommended establishment of a reserve for the 1999-2000 season. The Department established salable and reserve percentages of 77.64 and 22.36 percent, respectively, for almonds received by handlers during the 1999-2000 crop year, pursuant to a regulation published in the Federal Register on November 2, 1999 (64 FR 59107).

The Board met on April 10, 2000, to consider disposition of the reserve. At that time, the Board evaluated marketing and other conditions in the industry, and recommended revisions to the marketing policy estimates initially used in establishing the reserve. A comparison of the initial estimates and revised estimates are contained in the following table.

In arriving at these estimates, the Board revised its 1999-2000 crop estimate of 830 million pounds to 827.4 million pounds, and marketable production of 796.8 million pounds to 794.3 million pounds. The carryin on August 1, 1999, was initially estimated to be 100.4 million pounds. That figure was revised to reflect actual carryin of 91.8 million pounds. Thus, the total available supply for the 1999-2000 crop year is slightly lower than initially estimated.

Shipment figures for the year-to-date were analyzed. Through March 2000, total industry shipments of almonds were 525.5 million pounds, significantly higher than shipments for a comparable period in any prior year. Based on historical shipping patterns and shipments to date this season, the Board anticipates strong shipment levels to continue for the remainder of the season. Therefore, the Board revised its trade demand estimate from 649 million pounds to 695 million pounds.

A final crop estimate for the 2000-2001 crop year will not be available until June 29. A preliminary crop estimate of 675 million pounds was issued by the California Agricultural Statistics Service (CASS) on May 11, 2000. The industry continues to believe that next year's crop will be significantly smaller than the current crop. Several factors have contributed to this conclusion. In addition to the usual pattern of a shorter crop following a large crop, the weather throughout the production area during the month of February was generally cool, rainy, and windy. During this period, almond trees were in bloom, and the weather conditions were not conducive to good flower pollination. Field observations since the bloom period confirm that the 2000-2001 crop will be significantly smaller, perhaps smaller than the preliminary estimate. It is believed that next year's crop will not provide a sufficient supply of almonds to meet trade needs and provide an adequate carryout at the end of the 2000-2001 crop year. Therefore, to provide more almonds to satisfy the current year's trade demand and to augment next year's supplies, the Board recommended releasing the 1999-2000 crop year reserve. The Board also considered the timing of releasing reserve product to salable market channels. The Board determined that a gradual release schedule would best serve the industry. This would prevent a large quantity of almonds from being made available for sale by handlers immediately, which could put downward pressure on prices and create disorderly marketing conditions. Thus, the Board unanimously recommended releasing one-third of the reserve as soon as possible, one-third on June 1, 2000, and the final-third on July 1, 2000. The resulting salable and reserve percentages were 85.09 percent and 14.91 percent, respectively, on May 2, 2000; 92.55 percent and 7.45 percent, respectively, on June 1, 2000; and will be 100 and 0 percent, respectively, on July 1, 2000.

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

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

There are approximately 105 handlers of California almonds who are subject to regulation under the marketing order and approximately 6,000 producers in the regulated area. Small agricultural service firms are defined by the Small Business Administration (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 $500,000.

Based on the most current data available, about 54 percent of almond handlers ship under $5,000,000 worth of almonds and 46 percent ship over $5,000,000 worth on an annual basis. In addition, based on production and grower prices reported by the National Agricultural Statistics Service (NASS), and the total number of almond growers, the average annual grower revenue is approximately $195,000. In view of the foregoing, it can be concluded that the majority of handlers and producers of California almonds may be classified as small entities, excluding receipts from other sources.

Pursuant to §§ 981.47 and 981.49, during the 1999-2000 crop year, handlers were required to withhold as a reserve, from normal competitive markets, 22.36 percent of the almonds which they received from growers (64 FR 59107, November 2, 1999). The remaining 77.64 percent of the crop could be sold by handlers to any market at any time. Volume regulation was implemented because the available supply of almonds for the 1999-2000 crop year, adjusted by carryin and desired carryout, was estimated to be about 827 million pounds, which exceeded the estimated trade demand needs of about 649 million pounds.

Pursuant to § 981.48 of the order, this rule continues the scheduled release of reserve almonds. A total of 7.45 percent of the reserve was released on May 2, 2000, another 7.45 percent was released on June 1, 2000, and the final 7.45 percent will be released on July 1, 2000. Releasing the reserve is necessary to provide a sufficient quantity of almonds to meet anticipated trade demand and carryover needs. Shipment levels through March, 2000 and anticipated strong shipments for the remainder of the season led to an increased trade demand estimate from 649 million pounds to 695 million pounds. In addition, because a smaller 2000-2001 crop is expected, the industry would like to increase the amount of 1999-2000 carryout inventory from 70 million pounds to 191.2 million pounds to augment supplies during the next crop year. The timing of the releases was structured so that all 178 million pounds of reserve product would not enter the market at one time.

This action is expected to have a positive effect on producers and handlers of almonds. It gradually removes the regulatory requirement that handlers hold product in reserve or sell it to reserve outlets. Handlers will be able to sell reserve almonds into normal markets at prevailing prices (currently in the range of $1.15 per pound to $1.60 per pound) as opposed to selling them into lower value reserve outlets (ranging from 8 to 15 cents per pound for oil or 4 to 5 cents per pound for animal feed). Although reserve almonds can be sold to organic markets or for use in the manufacture of almond butter at higher prices than other reserve outlets, the quantity that can be sold is limited because those markets are relatively small. Handlers and growers should be able to achieve higher total revenue for their product by selling to normal markets, because trade demand for almonds has increased significantly from early season estimates, and price levels have also improved in recent months.

Releasing reserve almonds into the market in three stages has helped ensure that a large supply of almonds is not available for sale by handlers at the same time, which could have created a temporary oversupply and had a negative impact on price levels. The staged release also helped to ensure that additional product will be available for carryin to the following crop year to augment anticipated short supplies. This action is intended to promote orderly marketing conditions for the remainder of the 1999-2000 crop year and also leading into the 2000-2001 crop year, for the benefit of producers and handlers, regardless of size.

One alternative considered was to release all of the reserve product to normal market channels as soon as possible. This alternative was not recommended because it was believed that too much product would be available at one time, creating a short-term oversupply situation, which could have negatively impacted prices and market conditions. Another alternative considered was to release one-third of the reserve as soon as possible, and if the May 11, 2000, crop estimate issued by CASS for the 2000-2001 crop was less than 525 million pounds, to release the entire reserve as soon as possible after that. If the May crop estimate was more than 525 million pounds, this alternative would have released one-third of the reserve as soon as possible after May 11, and the final one-third on July 1, 2000. This was not recommended. The Board decided that three equal releases were preferable.

All the scenarios considered had the common goal of releasing all the 1999-2000 crop year reserve to the salable category. The Board ultimately recommended releasing one-third of the reserve as soon as possible (May 2, 2000), one-third on June 1, 2000, and the final one-third on July 1, 2000. The Board believed this would best achieve orderly marketing objectives. Adequate supplies should be available to meet market needs for the remainder of the crop year and for carryin to the next crop year, thus satisfying market needs and maintaining market and price stability.

This rule will not impose any additional reporting and recordkeeping requirements on either small or large handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to help reduce information requirements and duplication by industry and public sector agencies. In addition, the Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, the Board's meeting was widely publicized throughout the almond industry and all interested persons were invited to attend the meeting and participate in Board deliberations. Like all Board meetings, the April 10, 2000, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

Also, the Board has a number of appointed committees to review certain issues and make recommendations to the Board. The Board's Reserve Committee met on April 10, 2000, and discussed this issue in detail. That meeting was also a public meeting and both large and small entities were able to participate and express their views.

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.

An interim final rule concerning this action was published in the Federal Register on May 1, 2000 (65 FR 25233). Copies of the rule were mailed by the Board's staff to all Board members and almond handlers. In addition, the rule was made available through the Internet by the Office of the Federal Register. That rule provided for a 15-day comment period which ended on May 16, 2000. One comment was received. The comment was submitted by the Board in support of the release, noting that the Board met on May 16, 2000, and reaffirmed its position to release the reserve in three stages.

After consideration of all relevant material presented, including the Board's recommendation and comment, and other information, it is found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

This rule is issued under Marketing Agreement and Order No. 984, both as amended (7 CFR part 984), regulating the handling of walnuts grown in California, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

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

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

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

This rule will revise the order's administrative rules and regulations regarding reports of interhandler transfers of walnuts. Currently, handlers report to the Board transfers of walnuts between handlers on monthly shipment reports. This rule will require handlers to report such interhandler transfers on a separate form. This action will facilitate program administration by providing the Board with more accurate and complete information on transfers and shipments. This action was unanimously recommended by the Board at a meeting on February 18, 2000.

Section 984.76 of the order provides authority for the Board, with the approval of the Secretary, to require handlers to furnish reports and information to the Board as needed to enable the Board to perform its duties under the order. The Board meets during the season to make decisions on various programs authorized under the order. These programs include quality control (minimum grade and size requirements for both inshell and shelled walnuts placed into channels of commerce), volume regulation, and projects regarding production research, and marketing research and development.

Section 984.59 of the order provides authority for handlers to transfer walnuts between handlers. Paragraph (a) of that section states that inshell walnuts may be sold or delivered by one handler to another for packing or shelling within California. In such cases, the receiving handler assumes marketing order obligations with respect to the transferred walnuts, including assessment and inspection requirements. Paragraph (b) of § 984.59 pertains to transfers of walnuts when volume regulation is in effect. Specifically, handlers may, for purposes of meeting their reserve obligation, acquire walnuts from other handlers. In such cases, the buying handler assumes marketing order obligations with respect to the transferred walnuts, including assessment, reserve, and inspection requirements. Paragraph (c) of § 984.59 provides that, with the exceptions stated in paragraphs (a) and (b) of § 984.59, whenever transfers of walnuts are made between handlers, the first handler thereof shall assume all marketing order obligations pertaining to the walnuts.

Currently, handlers are required to report interhandler transfers on monthly shipment reports, WMB Form No. 6. However, the monthly shipment reports do not require handlers to indicate the date the walnuts were transferred, and whether the transferred walnuts were certified by the Dried Fruit Association (DFA). DFA is the agency designated under the order to provide inspection services for handlers. Also, the reports do not indicate the date the walnuts were received by the handler accepting the walnuts, or include a confirmation by the accepting handler that such walnuts were received. This information on transfers is useful to the Board as it reconciles handler shipments and inventories.

The Board recommended that a new form be developed specific to interhandler transfers. A handler who transfers walnuts to another handler will have to complete and submit WMB Form No. 8 to the Board within 10-calendar days following the transfer. The report will contain the following information: (1) The date of the transfer; (2) the net weight, in pounds, of the walnuts transferred; (3) whether such walnuts were certified by the DFA; (4) whether such walnuts were inshell or shelled; (5) the name and address of the transferring handler; and (6) the name and address of the receiving handler. The transferring handler will be required to send two copies of the report to the receiving handler at the same time the transferring handler will submit the report to the Board. The receiving handler will then certify, on one copy of the report, that he or she received the walnuts. The receiving handler will then submit the report to the Board within 10-calendar days after the walnuts, or copies of the report, are received, whichever is later. Transfers of reserve walnuts during periods of volume regulation will continue to be reported on WMB Form No. 17.

This rule will provide the Board with more accurate and complete information regarding handler transfers and shipments of walnuts, thereby facilitating program administration. Accordingly, a new § 984.459 will be added to the order's administrative rules and regulations.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final 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 the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 5,000 producers of walnuts in the production area and approximately 50 handlers subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $500,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

During the 1998-99 season, as a percentage, 24 percent of the handlers shipped over 2.6 million kernelweight pounds of walnuts, and 76 percent of the handlers shipped under 2.6 million kernelweight pounds of walnuts. Based on an average price of $1.88 per kernelweight pound at the point of first sale, the majority of handlers of California walnuts may be classified as small entities, excluding receipts from other sources.

This final rule will add a new § 984.459 to the order's administrative rules and regulations which requires handlers to report transfers of walnuts between handlers on a separate form. Currently, interhandler transfers are reported on handlers' monthly shipment reports. This action will facilitate program administration by providing the Board with more accurate and complete information on transfers and shipments. Authority for requiring handlers to submit this information to the Board is provided in §§ 984.59 and 984.76 of the order.

Regarding the impact of this action on affected entities, this rule will impose a minimal, additional reporting burden on handlers who transfer walnuts. Handlers who transfer walnuts are already reporting transfers to the Board on monthly shipment reports. This action will require such handlers to report transfers on a separate form. Board staff estimates that there are about 25 interhandler transfers per year (20 total during the months of October, November, and December, and 0-1 during the other 9 months). This action is designed to provide the Board with more accurate and complete information on shipments and transfers which will facilitate program administration.

Regarding alternatives to the recommended action, the Board and industry members discussed at the Board's February 18, 2000, meeting different time frames for the submission of the separate, interhandler transfer report. A 5-day time frame was considered whereby transferring handlers would submit their report to the Board within 5 days of the transfer, and the receiving handler would submit their report within 5 days of receiving the walnuts. However, the Board believed that 5 days was too short a time frame for handlers, and recommended the 10-day time frame.

This action will impose some additional reporting and recordkeeping burden on handlers. As previously mentioned, it is estimated that there are about 25 interhandler transfers per year. It will take handlers about 10 minutes to complete the new form for a total industry burden of about 4 hours per year. With interhandler transfers no longer on monthly shipment reports, the burden for handlers to complete the monthly shipment report will be reduced from 15 to 10 minutes per report, or from a total of 3 to 2 hours per year. Thus, the total annual increase in burden for the industry is estimated at 3 hours. The revised shipment report and the new, interhandler transfer report have been approved by the Office of Management and Budget (OMB) under OMB Control No. 0581-0178. As with other similar marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. The Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

In addition, the Board's meeting on February 18, 2000, where this action was deliberated was a public meeting widely publicized throughout the walnut industry. All interested persons were invited to attend the meeting and participate in the Board's deliberations.

A proposed rule concerning this action was published in the Federal Register on April 5, 2000 (65 FR 17809). Copies of the rule were mailed to all handlers, Board members, and alternate members. The rule was also made available through the Internet by the Office of the Federal Register. A 60-day comment period ending June 5, 2000, was provided to allow interested persons to respond to the proposal. No comments were received.

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.

After consideration of all relevant matter presented, including the information and recommendation submitted by the Board and other available information, it is found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) applicable to Rolls-Royce Ltd. (R-R) Dart 511, 511-7E, 514-7, 528, 528-7E, 529-7E, 532-7, 532-7L, 532-7N, 532-7P, 532-7R, 535-7R, 551-7R, and 552-7R turboprop engines was published in the Federal Register on January 12, 2000 (65 FR 1840). That action proposed to require:

• Installation of a feathering probe.

• Installation of a steel retaining ring in the reduction gear housing.

• Replacement of a torquemeter oil pressure transfer bobbin.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's economic analysis. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 1500 engines of the affected design in the worldwide fleet. The FAA estimates that 100 engines installed on aircraft of U.S. registry would be affected by this AD, that it would take approximately two work hours per engine to accomplish the actions, and that the average labor rate is $60 per work hour. Required parts would cost approximately $300 per engine. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $42,000.

This rule does not have federalism implications, as defined in Executive Order 13132, because it will 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this rule.

For the reasons discussed above, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. 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.

The regulation governing the execution of a passport application, at section 51.21(a) in Title 22 of the Code of Federal Regulations, provides that a person who has not been issued a passport in his or her own name within 12 years of the date of a new application shall appear in person when applying for a new passport. The personal appearance requirement to verify the applicant's identity is consistent with the requirement in 22 U.S.C. 212 that the Secretary of State shall issue passports only to nationals of the United States, and the mandate in 22 U.S.C. 2705 that a United States passport issued for a period of full validity is proof of United States citizenship and the identity of the bearer.

The existing regulations at 22 CFR 51.21(c) and (d) further clarify sec. 51.21(a) by providing that persons who previously have been issued a passport, when 18 years of age or older, may obtain a new passport by mail, provided that the application for a new passport is submitted together with the previous passport not more than 12 years following the issue date of the previous passport. The provision to apply by mail is pursuant to the authority in 22 U.S.C. 213 that the Secretary of State may excuse personal appearance for a passport applicant in certain circumstances.

This final rule amends 22 CFR 51.21(a), (c)(2) and (d)(2) to provide that persons who have previously been issued a full validity passport may apply for a new passport by mail if the application is accompanied by their previous passport not more than 15 years following the issue date of the previous passport. The Department has determined that during the additional three years, the appearance of the person applying for a passport is unlikely to have changed so much as to preclude identification. Accordingly, the Department believes it is reasonable that during a period of up to 15 years following the issue date of the previous passport a person may apply for a new passport by mail, provided that proper identification of the applicant can be made from the documents and photographs accompanying the application.

Further, this final rule amends 22 CFR 51.21(c)(1) and (d)(1) to provide that the age of the applicant when the most recently issued passport was issued is lowered from 18 years of age to 16 years of age. This change is required to be consistent with the provisions governing the validity of passports in 22 CFR 51.4(b), which was amended on February 1, 1998, by lowering the age of eligibility for a passport valid for ten years from 18 years of age to 16 years of age.

Finally, this rule amends 22 CFR 51.80, concerning procedures for review of adverse actions, by revising the wording in subsection 51.80(a) to read more clearly.

Since the rule makes a benefit available to the class of affected persons at a reduced cost, because the fee for a passport obtained by a mail application is less than the fee for a passport obtained by an application requiring personal appearance, the Department has determined that prepublication notice and comment are unnecessary and are exempted by 5 U.S.C. 553(b)(B), the “good cause” exemption.

The Department does not consider this rule to be a major rule for purposes of E.O. 12291. These changes to the regulations are hereby certified as not expected to have a significant impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act, 5 U.S.C. 605(b). This rule does not impose information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C., Chapter 35. Nor does the rule have federalism implications warranting the application of Executive Order No. 12372 and No. 13132. This rule is exempt from E.O. 12866, but the Department has reviewed the rule to ensure consistency with the objectives of the Executive Order, as well as with E.O. 12988, and the Office of Management and Budget has determined this rule would not constitute a significant regulatory action under E.O. 12866.

On July 30, 1982, the Secretary of the Interior conditionally approved the Pennsylvania program. You can find background on the Pennsylvania program, including the Secretary's findings, the disposition of comments, and the conditions of the approval in the July 30, 1982 Federal Register (47 FR 33079). Subsequent actions concerning the regulatory program amendments are codified at 30 CFR 938.11, 938.15 and 938.16.

By letter dated November 30, 1999 (Administrative Record No. PA-849.02), the Pennsylvania Department of Environmental Protection (PADEP) submitted an amendment to its approved permanent regulatory program pursuant to the Federal regulations at 30 CFR 732.17(b). Pennsylvania did so as a result of its Regulatory Basics Initiative (RBI) intended to revise regulations considered to be unclear, unnecessary or more stringent than the corresponding Federal regulation. The proposed rulemaking was published in the December 17, 1999 Federal Register (64 FR 70644). The public comment period closed on January 18, 2000. No one requested to speak at a public hearing, so no hearing was held.

Set forth below, pursuant to SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director's findings concerning the amendments to the Pennsylvania regulatory program. Revisions not specifically discussed below concern paragraph notations to reflect organizational changes resulting from this amendment.

PADEP is amending certain provisions of 25 Pennsylvania Code, Chapters 86 through 90, as follows:

PADEP is correcting a grammatical error by changing the word “specify” to “specifies” in the opening paragraph. This is a non-substantive change that does not require OSM approval.

PADEP is modifying subdivision (a)(4) to assure activities proposed under the application have been designed to prevent material damage to the hydrologic balance outside the proposed permit area, while eliminating the reference to damage to the hydrologic balance within the permit area, by adding the word “material” before “damage” and eliminating the words “within and” before the word “outside”. The Director finds that the changes described above render § 86.37(a)(4) substantively identical to and therefore no less effective than the corresponding portion of the Federal provision at 30 CFR 773.15(c)(5).

PADEP is modifying subdivision (a)(6) regarding the effects of proposed coal mining activities on properties listed on or eligible for listing on the National Register of Historic Places by deleting the phrase “or eligible for inclusion on” from the second sentence and re-ordering the sentences. The first two sentences of subdivision (6) now state that “[t]he proposed activities will not adversely affect any publicly owned parks or places included on the National Register of Historic Places, except as provided for in Subchapter D. The effect of the proposed coal mining activities on properties listed on or eligible for listing on the National Register of Historic Places has been taken into account by the Department”. The Director finds that the changes described above render § 86.37(a)(6) substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 773.15(c)(3) and 761.11(c).

PADEP is modifying subsection (b) by adding criteria under which the Department may grant an extension of time for commencement of mining activities by adding the phrase “or if there are conditions beyond the control and without the fault or negligence of the permittee.” The Director finds that the changes described above are substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 773.19(e)(2)(ii).

PADEP is modifying this section by adding additional criteria for documenting right of entry by adding the following sentence to subsection (a): “The description shall identify the documents by type and date of execution, identify the specific lands to which the document pertains and explain the legal rights claimed by the applicant”. Existing subdivisions (b)(1) and (2) are eliminated and new subdivisions (b)(1) through (3) are added specifying the documents required. New subsection (c) states that “[t]his section shall not be construed to provide the Department with the authority to adjudicate property rights disputes”. Existing subsection (c) is re-lettered as (d), new subdivision (d)(3) is added to state that the requirements of subsection (d) are in addition to the requirements required by subsections (a) and (b), and existing subsections (d) and (e) are re-lettered as (e) and (f), respectively. Subsection (f) is amended to state that all information required in § 86.64 shall be made part of the permit application. The Director finds that the changes described above are substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 778.15(b) and (c), except for subdivision (d)(3), which has no Federal counterpart. However, subdivision (d)(3) is not inconsistent with 30 CFR 778.15, since it provides that the right of entry requirements of subsection (d), which also have no Federal counterparts, are in addition to, (and therefore do not supersede), the requirements contained in subsections (a) and (b). Also, the Director finds that new subdivisions (b)(2) and (b)(3) satisfy the required amendment at 30 CFR 938.16(ll), which is hereby removed.

PADEP is modifying this section to require that a permit application to the Department shall contain an intent to publish, and a copy of the language to appear in the public notice as well as a copy of the advertisements or the original notarized proof of publication. The Director finds that the changes described above are substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 778.13(a) and 778.21, except that § 86.70 also requires a statement of “intent to publish,” which is not required in the Federal regulations. However, since this requirement is in addition to the Federal requirements, it is not inconsistent with the Federal regulations.

PADEP is modifying the definition of “substantially disturb,” with respect to coal exploration, by adding the word “significant” before “impact,” in order to limit its application to coal exploration activities that have a significant impact on land, air or water resources. The relevant portion of the definition now reads “For purposes of coal exploration, including, but not limited to, to have a significant impact upon land, air or water resources * * *” (Emphasis added)

The Director finds that the change described above brings the State's definition, which OSM previously found to be substantively identical to its Federal counterpart at 30 CFR 701.5 (58 FR 18149, 18151, April 8, 1993), into conformity with the precise language of the Federal definition.

PADEP is modifying subsection (e) to include a metric tonnage equivalent to the 250 ton limit for coal exploration that may be allowed without a permit, to change the words “less than” to “or less,” and to change the words “or more” to “more than.” The effect of the changes is to allow the department to waive the permitting requirement, to enable coal properties testing and analysis, where 250 tons (226 metric tons) of coal or less are removed, but to require a permit for the removal of more than 250 tons (226 metric tons) of coal. The Director finds that the changes do not render § 86.133(e) less effective than the Federal Regulations at 30 CFR 772.11 and 772.12. However, the required amendment at 30 CFR 938.16(ccc) remains unsatisfied.

PADEP is modifying this section by eliminating existing subdivisions (2) and (3) that required the person conducting coal exploration to measure environmental characteristics during the operations and to limit vehicular traffic, and adding new subdivision (2) that states “Roads used for coal exploration shall comply with the following: * * *” Existing subdivisions (4) and (5) are re-numbered as (3) and (4), existing subdivision (6), which requires revegetation of areas disturbed by coal exploration to be performed by the person who conducts the exploration, or by his agent, is eliminated and new subdivision (5) is added as follows: “All areas disturbed by coal exploration activities shall be vegetated in a manner that encourages prompt revegetation and recovery of a diverse, effective and permanent vegetative cover”. Additionally, existing subdivisions (7) through (12) are re-numbered as (6) through (11) respectively. The Director finds that the changes described above are substantively identical to and therefore no less effective than their Federal regulatory counterparts at 30 CFR 815.15(b) and (e).

PADEP is modifying subdivision (b)(1) to clarify the standards for Stage 2 bond release by requiring that topsoil and revegetation be successfully completed in accordance with the reclamation plan. The phrase “and the standards for the success of revegetation are met” is eliminated. The Director finds that the change described above renders subdivision (b)(1) substantively identical to and therefore no less effective than the corresponding Federal regulatory language contained in the Federal Regulations at 30 CFR 800.40(c)(2).

PADEP is adding, at new subsection (x), a definition of “unmanaged natural habitat.” The term is defined as idle land which does not require a specific management plan after the reclamation and revegetation have been accomplished. Although the Federal Regulations do not have a direct counterpart, the Director finds the State's definition to be consistent with the definition of “undeveloped land or no current use or land management” at 30 CFR 701.5.

PADEP is modifying subsection (a) by specifying that the permit application requirements to include protective measures apply to publicly owned parks or historic places that are listed on the National Register of Historic Places, and that may be adversely affected by the proposed operations. The Director finds that the changes described render the introductory language of subsection (a) substantively identical to and therefore no less effective than the corresponding introductory language contained in 30 CFR 780.31(a).

PADEP is modifying subdivision (a)(2) by requiring that exploration holes, other drilled or boreholes, wells or other exposed underground openings be cased, sealed or otherwise managed in order to “minimize,” rather than to “prevent to the maximum extent possible,” damage to the prevailing hydrologic balance. The Director finds that this change renders subdivision (a)(2) substantively identical to and therefore no less effective than corresponding language contained in the Federal Regulations at 30 CFR 816.13.

PADEP is modifying subdivision (e)(2)(iii) pertaining to when the Department may approve lesser distances for the barrier of undisturbed earth, by deleting the existing language and adding the following: “The measures included in the permit to minimize damage, destruction or disruption of services pursuant to § 87.173(b) are implemented.” At subsection (e), the minimum required radius for the solid barrier of undisturbed earth that must surround oil and gas wells is now also being expressed in meters, in addition to feet. The Director finds that, while subdivision (e)(2)(iii) has no direct Federal counterpart, the proposed amendments thereto do not render it inconsistent with the Federal Regulations at 30 CFR 816.13.

PADEP is modifying subsection (c) by including a metric conversion figure, in centimeters, which corresponds to the 12 inch topsoil thickness threshold, which if not in existence triggers the requirement to remove, segregate, conserve and replace a twelve inch layer that includes topsoil and other unconsolidated materials as the final surface soil layer. A centimeter measurement is also added for the 12-inch thickness threshold for topsoil and unconsolidated material combined, which if not in existence triggers the requirement to remove, segregate, conserve and replace the topsoil and all unconsolidated materials as the final surface soil layer. These changes are nonsubstantive in nature and do not require OSM approval.

Subsection (f), which currently pertains to “subsoil” substitution requirements, is amended to pertain to “topsoil” substitution requirements. The Director finds that this change renders section 86.97 substantively identical to and therefore no less effective than the counterpart language contained in the Federal Regulations at 30 CFR 816.22(b).

PADEP is modifying subsection (a), which currently requires that surface activities be planned and conducted to “prevent to the maximum extent possible” disturbances to the prevailing hydrologic balance in the permit and adjacent area. As modified, subsection (a) will require that surface activities be planned and conducted to “minimize” such disturbances. This subsection is further modified by the addition of a requirement that surface mining activities shall be planned and conducted to prevent material damage to the hydrologic balance outside the permit area. Finally, the PADEP added a provision allowing it to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. The Director finds that the changes described above render subsection (a) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.41(a).

PADEP is modifying subdivision (1) to require prevention of contributions of sediment to streamflow or runoff to the “extent possible,” rather than to the “maximum extent possible,” by deleting the word “maximum.” The Director finds that this change renders subdivision (1) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.45(a)(1).

PADEP is also modifying subdivision (3) by changing the language of the requirement from “Prevent erosion to the maximum extent possible” to “Minimize erosion to the extent possible.” The Director finds that this change renders subdivision (3) substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.45(a)(3).

PADEP is modifying subsection (a) by allowing publication of the blasting schedule in a newspaper of general circulation up to 30 days before beginning a blasting program instead of the existing 20 day period. The Director finds that the change renders subsection (a) substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.64(b)(1).

PADEP is modifying subdivision (f)(5) by deleting the prohibition against casting flyrock beyond the “line of property owned or leased by the permittee,” and by making the permit boundary the limit beyond which flyrock may not be cast. The Director finds that the change renders subdivision (f)(5) substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.67(c)(3).

PADEP is modifying this section to require a person conducting surface mining activities to, to the extent possible using the best technology currently available, minimize disturbances and adverse impacts on fish, wildlife and related environmental values, locate and operate haul and access roads to avoid or minimize impacts to fish and wildlife or other protected species, and to avoid disturbance to, enhance where practicable, or restore, habitats of unusually high value for fish and wildlife. Prior to these proposed amendments, this section required that activities use the best technology currently available to prevent such disturbances and adverse impacts. The Director finds that the changes described above render section 87.138 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.97(a) and (e)(2), and to the portion of 30 CFR 816.97(f) that pertains to habitats of unusually high value. PADEP is also modifying subsection (b) by changing the name of the Fish Commission to the Fish and Boat Commission. As modified, subsection (b) remains substantively identical to and therefore no less effective than the corresponding language contained in the Federal regulations at 30 CFR 816.97(b).

PADEP is modifying subsection (c) by deleting subdivisions (1) through (4) enumerating requirements for terraces. The Director finds that the deletions of these subdivisions, which have no Federal counterparts, do not render subsection (c) less effective than the Federal regulations at 30 CFR 816.102(g)(1). PADEP is also modifying subsection (f) by eliminating specific grading, preparation of overburden, and placement of topsoil requirements pertaining to placement in a direction other than parallel when parallel placement creates hazards to equipment operators. The Director finds that the deletion of these requirements, which have no direct Federal counterparts, does not render the state regulations less effective than the Federal Regulations at 30 CFR 816.102(j).

PADEP is eliminating the existing subsection and substituting the following new subsections:

(a) Exposed surface areas shall be protected and stabilized to effectively control erosion and air pollution attendant to erosion.

(b) Rills and gullies, which form in areas that have been regraded and topsoiled and which do one of the following shall be filled, regraded and otherwise stabilized:

(1) Disrupt the approved postmining land use or the reestablishment of the vegetative cover.

(2) Cause or contribute to a violation of water quality standards for receiving streams.

(c) For the areas listed in subsection (b), the topsoil shall be replaced and the areas shall be reseeded or replanted.

The Director finds that the changes described above are substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.95(a) and (b).

PADEP is modifying subsection (b) by eliminating subdivisions (3) and (4) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining. These deleted subdivisions have no Federal counterparts.

PADEP is also adding new subdivision (c)(3) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria * * *.” Criteria currently identified in subdivisions (c)(3), (4), and (5) are re-lettered as (i), (ii) and (iii) respectively, under new subdivision (c)(3).

PADEP is also eliminating subdivision (c)(6) pertaining to certification of plans for postmining land use by a registered professional engineer. This deleted subdivision has no Federal counterparts pertaining to postmining land uses in general. Existing subdivisions (c)(7), (8) and (9) are re-numbered as (c)(4), (5) and (6), respectively. The Director finds that the changes described above do not render section 87.159 less effective than the Federal Regulations at 30 CFR 816.133(b) and (c)(1).

PADEP is modifying subsection (a) by eliminating the phrase “prevent, to the maximum extent possible”, and substituting the words “control or prevent” prior to “erosion and contributions of sediment to streams or runoff * * *”. The Director finds that the changes described above render subsection (a) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.150(b)(1).

PADEP is modifying this section by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.”

PADEP is also modifying subdivision (4) by eliminating the requirement that roadbeds be plowed. The subdivision now reads “Roadbeds shall be ripped or scarified.” The Director finds that the changes described render section 87.166 substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.150(f) and (f)(6).

PADEP is modifying subsection (a) by eliminating criteria from the opening paragraph and deleting subdivisions (1) and (2). The deleted criteria have no Federal regulatory counterparts. PADEP is also adding new subdivisions (1) and (2), which require that support facilities be located, maintained and used in a manner that:

(1) Prevents or controls erosion and siltation, water pollution, and damage to public or private property.

(2) To the extent possible using the best technology currently available:

(i) Minimizes damage to fish, wildlife and related environmental values.

(ii) Minimizes additional contributions of suspended solids to streamflow or runoff outside the permit area. These contributions may not be in excess of limitations of State or Federal law.

The Director finds that the changes described above render section 87.173 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.181(b).

PADEP is eliminating subsection (g), which prohibits construction of unlined or unprotected drainage channels on backfilled areas unless approved by the PADEP as stable and not subject to erosion. This subsection has no direct Federal counterpart. The Director finds that the deletion of subsection (g) does not render section 87.174 less effective than the Federal Regulations at 30 CFR 816.107.

PADEP is deleting subsection (d), which prohibits auger mining to the rise of the coal unless it is demonstrated to the PADEP's satisfaction that drainage from the auger hole will not pose a pollution threat to surface waters and will comply with applicable effluent standards. Subsection (d) has no direct Federal counterpart. Existing subsection (e) is re-lettered as (d), and contains non-substantive changes in wording that are intended to improve the clarity of the subsection. The Director finds that the changes described above do not render section 87.176 less effective than the Federal Regulations at 30 CFR 819.11.

PADEP is modifying subsection (a), which pertains to the first phase of release of the bond for the pollution abatement area, by raising the amount of the bond that may be released from 50% to 60%, where the operator has not caused degradation of the baseline pollution load at any time during a period of six months prior to the bond release request, and until bond release is approved as shown by all ground and surface water monitoring. PADEP is modifying subsection (b), which pertains to the second phase of release of the bond for the pollution abatement area, by deleting the phrase that allows the additional release of up to 35% of the amount of the bond and substituting the phrase that additional funds can be released, but that the Department will retain an amount sufficient to cover the cost to the Department of reestablishing vegetation if completed by a third party.

Next, PADEP is also modifying subdivision (b)(3)(ii)(A)(I) so that an operator can receive approval for the second phase of bond release where it demonstrates that it has not caused degradation of the baseline pollution load for a period of twelve months prior to the application for bond release and until bond release is approved.

Finally, PADEP is modifying subdivision (c)(4) pertaining to the release of the remaining portion of the bond by deleting the requirement to measure the applicable liability period from the date of release of the second phase of the bond. The Director finds that the changes described above do not render section 87.209 less effective than the general bond release criteria contained in the Federal regulations at 30 CFR 800.40(c).

PADEP is adding, at new subsection (x), a definition of “unmanaged natural habitat.” The term is defined as idle land which does not require a specific management plan after the reclamation and revegetation have been accomplished. Although the Federal Regulations do not have a direct counterpart, the Director finds the State's definition to be consistent with the definition of “undeveloped land or no current use or land management” at 30 CFR 701.5.

PADEP is modifying subsection (a) by specifying that the permit application requirements to include protective measures apply to publicly owned parks or historic places that are listed on the National Register of Historic Places, and that may be adversely affected by the proposed operations. The Director finds that the changes described above render the introductory language of subsection (a) substantively identical to and therefore no less effective than the corresponding introductory language contained in 30 CFR 780.31(a).

PADEP is modifying subdivision (a)(2) by requiring that exploration holes, other drilled or boreholes, wells or other exposed underground openings be sealed or otherwise managed in order to “minimize,” rather than to “prevent to the maximum extent possible,” damage to the prevailing hydrologic balance. PADEP is modifying subdivision (e)(2)(iii) pertaining to when the Department may approve lesser distances for the barrier of undisturbed earth, by deleting the existing language and adding the following: “The measures included in the permit to minimize damage, destruction or disruption of services are implemented.” In subsection (e), the minimum required radius for the solid barrier of undisturbed earth that must surround oil and gas wells is now also being expressed in meters, in addition to feet. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a), which currently requires that surface activities be planned and conducted to “prevent to the maximum extent possible” disturbances to the prevailing hydrologic balance in the permit and adjacent area. As modified, subsection (a) will require that surface activities be planned and conducted to “minimize” such disturbances. This subsection is further modified by the addition of a requirement that surface mining activities shall be planned and conducted to prevent material damage to the hydrologic balance outside the permit area. Finally, the PADEP added a provision allowing it to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subdivision (l) to require prevention of contributions of sediment to streamflow or runoff to the “extent possible,” rather than to the “maximum extent possible,” by deleting the word “maximum.” PADEP is also modifying subdivision (3) by changing the language of the requirement from “Prevent erosion to the maximum extent possible” to “Minimize erosion to the extent possible.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (c) by deleting subdivisions (1) through (4) enumerating requirements for terraces. PADEP is also modifying subsection (f) by eliminating specific grading, preparation of overburden, and placement of topsoil requirements pertaining to placement in a direction other than parallel when parallel placement creates hazards to equipment operators. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a) by deleting the reference to Subchapter E (relating to coal exploration) and adding the reference to Subchapter F (relating to bonding and insurance requirements), thereby clarifying that affected areas be restored to conditions capable of supporting the uses they were capable of supporting prior to mining, or that they be restored to higher or better uses, prior to bond release. PADEP is also modifying subsection (b) by eliminating subdivisions (3) and (4) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining. PADEP is also adding new subdivision (3) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria * * *.” Criteria currently identified in subdivisions (3) and (4) are re-lettered as (i) and (ii), respectively, under new subdivision (3). PADEP is also eliminating subdivision (5) pertaining to certification of plans for postmining land use by a registered professional engineer. Existing subdivisions (6), (7) and (8) are re-numbered as (4), (5) and (6), respectively. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a) by eliminating the phrase “prevent, to the maximum extent possible,” and substituting the words “control or prevent” prior to “erosion and contributions of sediment to streams or runoff * * *”. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying this section by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subdivision (l) to require prevention of contributions of sediment to streamflow or runoff to the “extent possible,” rather than to the “maximum extent possible,” by deleting the word “maximum.” PADEP is also modifying subdivision (3) by changing the language of the requirement from “Prevent erosion to the maximum extent possible” to “Minimize erosion to the extent possible.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (b) by eliminating subdivisions (3) and (4) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining. PADEP is also adding new subdivision (c)(3) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria.” Criteria currently identified in subdivisions (3) and (4) are re-lettered as (i) and (ii), respectively, under new subdivision (3).

PADEP is also eliminating subdivision (5) pertaining to certification of plans for postmining land use by a registered professional engineer. Existing subdivisions (6), (7) and (8) are re-numbered as (4), (5) and (6), respectively. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a) by eliminating the phrase “prevent, to the maximum extent possible,” and substituting the words “control or prevent” prior to “erosion and contributions of sediment to streams or runoff * * *”. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying this section by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subdivision (e)(2)(iii) pertaining to when the Department may approve lesser distances for the barrier of undisturbed earth, by deleting the existing language and adding the following: “The measures included in the permit to minimize damage, destruction or disruption of services are implemented.” In subsection (e), the minimum required radius for the solid barrier of undisturbed earth that must surround oil and gas wells is now also being expressed in meters, in addition to feet. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a), which currently requires that surface activities be planned and conducted to “prevent to the maximum extent possible” disturbances to the prevailing hydrologic balance in the permit and adjacent area. As modified, subsection (a) will require that surface activities be planned and conducted to “minimize” such disturbances. This subsection is further modified by the addition of a requirement that surface mining activities shall be planned and conducted to prevent material damage to the hydrologic balance outside the permit area. Finally, the PADEP added a provision allowing it to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subdivision (l) to require prevention of contributions of sediment to streamflow or runoff to the “extent possible,” rather than to the “maximum extent possible,” by deleting the word “maximum.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a) by changing the reference from “this section (bonds)” to “Chapter 86, Subchapter F, (relating to bonding and insurance requirements).”

PADEP is modifying subsection (b) by eliminating subdivisions (3) and (4) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining.

PADEP is also modifying subdivision (c)(1) by deleting the reference to “surface mining” and substituting “coal refuse disposal.”

PADEP is also adding new subdivision (c)(3) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria.” Criteria currently identified in subdivisions (3) and (4) are re-lettered as (i) and (ii) respectively, under new subdivision (3), and (i) is further changed by deleting the reference to “surface mining” and substituting “coal refuse disposal.”

PADEP is also eliminating subdivision (5) pertaining to certification of plans for postdisposal land use by a registered professional engineer. Existing subdivisions (6), (7), and (8) are re-numbered as (4), (5) and (6), respectively. In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving these amendments to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subsection (a) by eliminating the phrase “prevent, to the maximum extent possible,” and substituting the words “control or prevent” prior to “erosion and contributions of sediment to streams or runoff. * * *” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying this section by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.” In accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11, the Director is approving this amendment to the special permanent program performance standards for anthracite mines in Pennsylvania.

PADEP is modifying subdivision (f)(1) by specifying that the permit application requirements to include protective measures apply to publicly owned parks or historic places that are listed on the National Register of Historic Places, and that may be adversely affected by the proposed operations. The Director finds that the changes described above render the introductory language of subsection (a) substantively identical to and therefore no less effective than the corresponding introductory language contained in 30 CFR 780.31(a).

PADEP is modifying subsection (a), which pertains to the first phase of release of the bond for the pollution abatement area, by raising the amount of the bond that may be released from 50% to 60%, where the operator has not caused degradation of the baseline pollution load at any time during a period of six months prior to the bond release request, and until bond release is approved as shown by all ground and surface water monitoring. PADEP is modifying subsection (b), which pertains to the second phase of release of the bond for the pollution abatement area, by deleting the phrase that allows the additional release of up to 35% of the amount of the bond and substituting the phrase that additional funds can be released, but that the Department will retain an amount sufficient to cover the cost to the Department of reestablishing vegetation if completed by a third party.

Next, PADEP is also modifying subdivision (b)(3)(ii)(A)(I) so that an operator can receive approval for the second phase of bond release where it demonstrates that it has not caused degradation of the baseline pollution load for a period of twelve months prior to the application for bond release and until bond release is approved.

Finally, PADEP is modifying subdivision (c)(4) pertaining to the release of the remaining portion of the bond by deleting the requirement to measure the applicable liability period from the date of release of the second phase of the bond. The Director finds that the changes described above do not render section 88.509 less effective than the general bond release criteria contained in the Federal regulations at 30 CFR 800.40(c).

PADEP is changing the title of this section to Archaeological and historical resources, public parks and publicly owned parks.

PADEP is modifying subsection (b) by specifying that the permit application requirements to include protective measures apply to publicly owned parks or historic places that are listed on the National Register of Historic Places, and that may be adversely affected by the proposed operations. The Director finds that the changes described above render the introductory language of subsection (b) substantively identical to and therefore no less effective than the corresponding introductory language contained in 30 CFR 784.17(a).

PADEP is modifying this section to require a person conducting surface mining activities to, to the extent possible using the best technology currently available, minimize disturbances and adverse impacts on fish, wildlife and related environmental values, locate and operate haul and access roads to avoid or minimize impacts to fish and wildlife or other protected species, and to avoid disturbance to, enhance where practicable, or restore, habitats of unusually high value for fish and wildlife. Prior to these proposed amendments, this section required that activities use the best technology currently available to prevent such disturbances and adverse impacts. The Director finds that the changes described above render section 89.65 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 817.97(a) and (e)(2), and at the portion of 30 CFR 817.97(f) that pertains to habitats of unusually high value.

PADEP is modifying subsection (a) by eliminating criteria from the opening paragraph and deleting subdivisions (1) and (2). The deleted criteria have no Federal regulatory counterparts. PADEP is also adding new subdivisions (1) and (2), which require that support facilities be located, maintained and used in a manner that:

(1) Prevents or controls erosion and siltation, water pollution, and damage to public or private property.

(2) To the extent possible using the best technology currently available:

(i) Minimizes damage to fish, wildlife and related environmental values.

(ii) Minimizes additional contributions of suspended solids to streamflow or runoff outside the permit area. These contributions may not be in excess of limitations of State or Federal law.

The Director finds that the changes described above render section 89.67 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 817.181(b).

PADEP is modifying this section to require a person conducting surface mining activities to, to the extent possible using the best technology currently available, minimize disturbances and adverse impacts on fish, wildlife and related environmental values. Prior to this proposed amendment, this section required that activities use the best technology currently available to prevent such disturbances and adverse impacts. The Director finds that the changes described above render section 89.82 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 817.97(a).

PADEP is also modifying subsections (b) and (e) by changing the name of the Fish Commission to the Fish and Boat Commission. As modified, subsections (b) and (e) remain substantively identical to and therefore no less effective than the corresponding language contained in the Federal regulations at 30 CFR 817.97(b).

PADEP is eliminating the existing subsections and substituting the following new subsections:

(a) Exposed surface areas shall be protected and stabilized to effectively control erosion and air pollution attendant to erosion.

(b) Rills and gullies, which form in areas that have been regraded and topsoiled and which do one of the following shall be filled, regraded and otherwise stabilized:

(1) Disrupt the approved postmining land use or the reestablishment of the vegetative cover.

(2) Cause or contribute to a violation of water quality standards for receiving streams.

(c) For the areas listed in subsection (b), the topsoil shall be replaced and the areas shall be reseeded or replanted.

The Director finds that the changes described above are substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 817.95.

PADEP is modifying subsection (b) by eliminating subdivisions (2) and (3) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining. These deleted subdivisions have no Federal counterparts.

PADEP is also adding new subdivision (c)(2) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria.” The criteria, which are part of the existing program, are now included in subdivision (c)(2), following the above-quoted introductory sentence.

PADEP is also eliminating subdivision (c)(3) pertaining to certification of plans for postmining land use by a registered professional engineer. This deleted subdivision has no Federal counterpart. Existing subdivisions (c)(4), (5), (6) and (7) are re-numbered as (c)(3), (4), (5) and (6), respectively.

The Director finds that the changes described above do not render section 89.88 less effective than the Federal Regulations at 30 CFR 817.133(b) and (c)(1).

PADEP is modifying subsection (a) by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.”

PADEP is also modifying subdivision (a)(4) by eliminating the requirement that roadbeds be plowed. The subdivision now reads “Roadbeds shall be ripped or scarified.” The Director finds that the changes described render section 89.90 substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 817.150(f) and (f)(6).

PADEP is adding, at new subsection (x), a definition of “unmanaged natural habitat.” The term is defined as idle land which does not require a specific management plan after the reclamation and revegetation have been accomplished. Although the Federal Regulations do not have a direct counterpart, the Director finds the State's definition to be consistent with the definition of “undeveloped land or no current use or land management” at 30 CFR 701.5.

PADEP is modifying subsection (a) by specifying that the permit application requirements to include protective measures apply to publicly owned parks or historic places that are listed on the National Register of Historic Places, and that may be adversely affected by the proposed operations. The Director finds that the changes described above render the introductory language of subsection (a) substantively identical to and therefore no less effective than the corresponding introductory language contained in 30 CFR 780.31(a).

PADEP is modifying subsection (d) by deleting the reference to the requirements of the Gas Operations, Well-Drilling, Petroleum and Coal Mining Act (52 P.S. §§ 2101-2602) and adding a reference to the Oil and Gas Act (58 P.S. §§ 601.101-601.605). While this subsection has no precise Federal counterpart, the Director finds that the change in statutory cross-references does not render it inconsistent with the Federal regulations at 30 CFR 816.13.

PADEP is modifying subdivision (e)(2)(iii) pertaining to when the Department may approve lesser distances for the barrier of undisturbed earth, by deleting the existing language and adding the following: “The measures included in the permit to minimize damage, destruction or disruption of services pursuant to 90.147(b) are implemented.” At subsection (e), the minimum required radius for the solid barrier of undisturbed earth that must surround oil and gas wells is now also being expressed in meters, in addition to feet. The Director finds that, while subdivision (e)(2)(iii) has no direct Federal counterpart, the proposed amendments thereto do not render it inconsistent with the Federal Regulations at 30 CFR 816.13.

PADEP is modifying subsection (c) by including a metric conversion figure, in centimeters, which corresponds to the 12 inch topsoil thickness threshold, which if not in existence triggers the requirement to remove, segregate, conserve and replace a twelve inch layer that includes topsoil and other unconsolidated materials as the final surface soil layer. A centimeter measurement is also added for the 12-inch thickness threshold for topsoil and unconsolidated material combined, which if not in existence triggers the requirement to remove, segregate, conserve and replace the topsoil and all unconsolidated materials as the final surface soil layer. These changes are nonsubstantive in nature and do not require OSM approval.

Subsection (f) is amended, at the end of the second sentence, by deleting the word “subsoil” and replacing it with the word “topsoil.” The Director finds that this change renders section 90.97 substantively identical to and therefore no less effective than the counterpart language contained in the Federal Regulations at 30 CFR 816.22(b).

PADEP is modifying subsection (a), which currently requires that surface activities be planned and conducted to “prevent to the maximum extent possible” disturbances to the prevailing hydrologic balance in the permit and adjacent area. As modified, subsection (a) will require that surface activities be planned and conducted to “minimize” such disturbances. This subsection is further modified by the addition of a requirement that surface mining activities shall be planned and conducted to prevent material damage to the hydrologic balance outside the permit area. Finally, the PADEP added a provision allowing it to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. The Director finds that the changes described above render subsection (a) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.41(a).

PADEP is modifying subdivision (a)(l) to require prevention of contributions of sediment to streamflow or runoff to the “extent possible,” rather than to the “maximum extent possible,” by deleting the word “maximum.” The Director finds that this change renders subdivision (a)(1) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.45(a)(1).

PADEP is also modifying subdivision (3) by changing the language of the requirement from “Prevent erosion to the maximum extent possible” to “Minimize erosion to the extent possible.” The Director finds that this change renders subdivision (3) substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.45(a)(3).

PADEP is modifying subsection (a) by eliminating the phrase “prevent, to the maximum extent possible”, and substituting the words “control or prevent” prior to “contributions of sediment to streams or runoff * * *”. The Director finds that the changes described above render subsection (a) substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.150(b)(1), with one exception. In amending this subsection, the PADEP deleted any requirement with respect to erosion. Therefore, the Director is requiring that Pennsylvania amend its performance standards for coal refuse disposal to require that haul roads and access roads be designed, constructed and maintained to control or prevent erosion.

PADEP is modifying this section by deleting the requirement that roads not to be retained for the approved postmining land use be reclaimed “immediately” after the road is no longer needed for the associated surface mining activities, and substituting a requirement that such reclamation occur “as soon as practicable.”

PADEP is also modifying subdivision (4) by eliminating the requirement that roadbeds be plowed. The subdivision now reads “Roadbeds shall be ripped or scarified.” The Director finds that the changes described render section 90.140 substantively identical to and therefore no less effective than the corresponding language contained in the Federal Regulations at 30 CFR 816.150(f) and (f)(6).

PADEP is modifying subsection (a) by eliminating criteria from the opening paragraph and deleting subdivisions (1) and (2). The deleted criteria have no Federal regulatory counterparts. The criteria to locate, maintain and use buildings is now included in new subdivisions (1), (2), (2)(i) and (2)(ii) as follows:

(1) Prevents or controls erosion and siltation, water pollution, and damage to public or private property.

(2) To the extent possible using the best technology currently available:

(i) Minimizes damage to fish, wildlife and related environmental values.

(ii) Minimizes additional contributions of suspended solids to streamflow or runoff outside the permit area. These contributions may not be in excess of limitations of State or Federal law.

The Director finds that the changes described above render section 90.147 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.181(b).

PADEP is modifying this section to require a person conducting surface mining activities to, to the extent possible using the best technology currently available, minimize disturbances and adverse impacts on fish, wildlife and related environmental values, locate and operate haul and access roads to avoid or minimize impacts to fish and wildlife or other protected species, and to avoid disturbance to, enhance where practicable, or restore, habitats of unusually high value for fish and wildlife. Prior to these proposed amendments, this section required that activities use the best technology currently available to prevent such disturbances and adverse impacts. The Director finds that the changes described above render section 90.150 substantively identical to and therefore no less effective than the Federal Regulations at 30 CFR 816.97(a) and (e)(2), and to the portion of 30 CFR 816.97(f) that pertains to habitats of unusually high value. PADEP is also modifying subsections (b) and (d) by changing the name of the Fish Commission to the Fish and Boat Commission. As modified, subsections (b) and (d) remain substantively identical to and therefore no less effective than the corresponding language contained in the Federal regulations at 30 CFR 816.97(b).

PADEP is modifying subsection (a) by changing the reference from “Subchapter E (relating to coal exploration)” to “Subchapter F (relating to bonding and insurance requirements).” The Director finds that this change does not render subsection (a) less effective than the corresponding Federal regulations at 30 CFR 816.133(a).

PADEP is modifying subsection (b) by eliminating subdivisions (3) and (4) pertaining to land that has received improper management or was changed within 5 years of the beginning of mining. These deleted subdivisions have no Federal counterparts.

PADEP is also adding new subdivision (c)(3) as follows: “The proposed postmining land use is reasonably likely to be achieved which may be demonstrated by one or more of the following or other similar criteria * * *.” Criteria currently identified in subdivisions (c)(3), (4), and (5) are re-lettered as (i), (ii) and (iii) respectively, under new subdivision (c)(3).

PADEP is also eliminating subdivision (c)(6) pertaining to certification of plans for postdisposal land use by a registered professional engineer. This deleted subdivision has no Federal counterpart. Existing subdivisions (c)(7), (8) and (9) are re-numbered as (c)(4), (5) and (6), respectively. The Director finds that the changes described above do not render section 90.166 less effective than the Federal Regulations at 30 CFR 816.133(b) and (c)(1).

On December 3, 1999, we asked for comments from various Federal agencies who may have an interest in the Pennsylvania amendment. (Administrative Record Number 849.03). We solicited comments in accordance with section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations. Two offices of the Mine Safety and Health Administration (MSHA) responded in letters dated December 22, 1999 and December 28, 1999 (Administrative Record Numbers 849.06 and 849.07, respectively). The only comment made noted that the minimum static safety factor of 1.3 is included in PA Chapters 87 and 88 for outslopes of a terrace greater than 1v:2h-50%, whereas the Federal Regulations at 30 CFR 77.215(h) specify that the minimum factor should be 1.5 for refuse piles. In response, the Director notes that neither of the Pennsylvania provisions cited by MSHA pertains to refuse piles. Rather, the provisions, at sections 87.144 and 88.118, contain general requirements for backfilling and grading of bituminous and anthracite surface coal mining operations, respectively. Use of the 1.3 minimum static safety factor for such operations is also provided for in the Federal regulations at 30 CFR 816.102(a)(3). Regardless, Pennsylvania is deleting both of these provisions in this amendment, as discussed above.

Pursuant to 30 CFR 732.17(h)(11)(ii), OSM is required to obtain the written concurrence of the EPA with respect to those provisions of the proposed program amendment that relate to air or water quality standards promulgated under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). The Director has determined that this amendment contains no such provisions and that EPA concurrence is therefore unnecessary.

OSM did, however request comments from EPA, and EPA responded in its letter dated December 13, 1999 (Administrative Record Number 849.04). EPA commented that the amendment contained slight wording changes that appeared to lessen the emphasis on preventing water quality impacts. As examples, EPA noted that Section 88.335, Haul Roads and Access Roads, and Section 88.191, Hydrologic Balance:Sediment Control Measures, were revised to require that erosion be controlled or prevented (88.335) and minimized to the extent possible (88.191), rather than prevented to the maximum extent possible, as both sections previously required. EPA also noted, however, that its understanding is that the actual requirements for erosion and sedimentation control and preventing water quality impacts will not be reduced. As explained above in the Director's Findings, OSM approved both sections in accordance with section 529(a) of SMCRA and the Federal regulations at 30 CFR 820.11.

No comments were received in response to our request for public comments.

Based on the above findings, we are approving the amendments to the Pennsylvania regulatory program. The required amendment at 30 CFR 938.16(ll) is being removed. However, the Director is requiring that Pennsylvania amend its performance standards for coal refuse disposal to require that haul roads and access roads be designed, constructed and maintained to control or prevent erosion.

The Federal regulations at 30 CFR Part 938, codifying decisions concerning the Pennsylvania program, are being amended to implement this decision. This final rule is being made effective immediately to expedite the State program amendment process and to encourage States to bring their programs into conformity with the Federal standards without undue delay. Consistency of State and Federal standards is required by SMCRA.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart federal regulations.

This rule does not have federalism implications. SMCRA delineates the roles of the federal and state governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that state laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that state programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of state regulatory programs and program amendments since each such program is drafted and promulgated by a specific state, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed state regulatory programs and program amendments submitted by the states must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed state regulatory program provision does not constitute a major federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The state submittal which is the subject of this rule is based upon counterpart federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the state. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the state submittal which is the subject of this rule is based upon counterpart federal regulations for which an analysis was prepared and a determination made that the federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8), the Coast Guard finds that good cause exists for not publishing an NPRM. Good cause exists for not publishing an NPRM due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish an NPRM for the event. Further, it is a local, community supported event with minimal impact on the waterway, vessels may still transit through the western 165 yards of the 885-yard wide Hudson River during the display, and the zone is only in affect for 1 1/2 hours and vessels can be given permission to transit the zone except for about 45 minutes during this time. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterways and protect the maritime public from the hazards associated with this fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . This is due to the following reasons: it is an annual event with local community support, it is a local event with minimal impact on the waterway, the zone is only in affect for 1 1/2 hours and vessels can be given permission to transit the zone except for about 45 minutes during this time, and marine traffic will be able to transit through the western 165 yards of the 885-yard wide Hudson River during the display. Finally, this rule creates a safety zone that will only be enforced if the annual event, scheduled for Sunday, June 25, 2000, is cancelled due to inclement weather.

The Coast Guard has received an application to hold a fireworks program on the waters of the Hudson River. This regulation establishes a safety zone in all waters of the Hudson River within a 360-yard radius of the fireworks barge in approximate position 40°44′31″ N 074°01′00″ W (NAD 1983), about 400 yards west of Pier 54, Manhattan. The safety zone is in effect from 10 p.m. (e.s.t.) until 11:30 p.m. (e.s.t.) on Monday, June 26, 2000. This is an annual event regulated by 33 CFR 100.114 for the last Sunday in June. This rule is for the rain date of June 26, 2000, which is not addressed in the current regulation. This safety zone will not be enforced on Monday, June 26, if the fireworks display is held on Sunday, June 25, 2000. The safety zone prevents vessels from transiting a portion of the Hudson River and is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area. Marine traffic will be able to transit through the western 165 yards of the 885-yard wide Hudson River during the event. This safety zone precludes the waterway users from entering only the safety zone itself. Public notifications will be made prior to the event via the Local Notice to Mariners. Furthermore, marine traffic will not be precluded from mooring at, or getting underway from, any piers in the vicinity of this event.

This final rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This finding is based on the minimal time that vessels will be restricted from the zone, that vessels may still transit through the western 165 yards of the Hudson River during the fireworks display, and advance notifications which will be made. Additionally, this is an annual event with local community support.

The size of this safety zone was determined using National Fire Protection Association and New York City Fire Department standards for 12″ mortars fired from a barge combined with the Coast Guard's knowledge of tide and current conditions in the area.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this final rule will have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

For reasons discussed in the Regulatory Evaluation above, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not provide for a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this final rule under the principles and criteria contained in Executive Order 13132 and has determined that this final rule does not have implications for federalism under that Order.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) [Pub. L. 104-4, 109 Stat. 48] requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for rules that contain Federal mandates. A Federal mandate is a new or additional enforceable duty imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in the aggregate, $100 million or more in any one year, the UMRA analysis is required. This final rule does not impose Federal mandates on any State, local, or tribal governments, or the private sector.

The Coast Guard considered the environmental impact of this final rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1C, this final rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

2. Add temporary § 165.T01-145 to read as follows:

This action is directed to the public in general. This action may, however, be of interest to those persons who are concerned about OMB approval for information collection required by EPA regulations. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPPTS-00265. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall, Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

This document updates the OMB control numbers listed in 40 CFR part 9 for various actions published in the Federal Register , since July 1, 1998, and issued under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq .). EPA will continue to present OMB control numbers in a consolidated table format in 40 CFR part 9 of the Agency's regulations. The table lists Code of Federal Regulations (CFR) citations with reporting, recordkeeping, or other information collection requirements that require OMB approval under the PRA (44 U.S.C. 3501 et seq .), and the current OMB control numbers. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320.

Under PRA, the information collection requirements included in this document were previously subject to public notice and comment prior to OMB approval, either as part of the OMB approval process or as part of a rulemaking. Therefore, EPA finds that publication of a proposed rule is unnecessary and would waste public tax dollars. This technical amendment is effective upon publication under the “good cause” clause found in section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B) which allows a regulatory action to become final without prior notice and comment.

1. The OMB approval numbers being added to the table in 40 CFR 9.1 are related to approved information collection activities contained in the following final rules:

Substituted Phenol; Significant New Use Rule; Final Rule (63 FR 23678, April 30, 1998) (FRL-5782-5). OMB most recently approved this ongoing collection under control number 2070-0012 on February 19, 1997 (EPA ICR No. 574.10) (see 62 FR 10057, March 5, 1997) (FRL-5699-4).

Lead; Requirements for Hazard Education Before Renovation of Target Housing; Final Rule (63 FR 29907, June 1, 1998) (FRL-5751-7). Approved by OMB under control number 2070-0158 on September 1, 1998 (EPA ICR No. 1669.02) (see 63 FR 57677, October 28, 1998) (FRL-6180-8).

Significant New Uses of Certain Chemical Substances; Final Rule (63 FR 44562, August 20, 1998) (FRL-5788-7). OMB most recently approved this ongoing collection under control number 2070-0012 on February 19, 1997 (EPA ICR No. 574.10 (see 62 FR 10057, March 5, 1997) (FRL-5699-4).

Significant New Uses of Certain Chemical Substances; Final Rule (63 FR 65705, November 30, 1998) (FRL-6033-6). OMB most recently approved this ongoing collection under control number 2070-0012 on February 19, 1997 (EPA ICR No. 574.10 (see 62 FR 10057, March 5, 1997) (FRL-5699-4).

Significant New Uses of Certain Chemical Substances; Direct Final Rule (65 FR 345, January 5, 2000) (FRL-6055-2). OMB most recently approved this ongoing collection under control number 2070-0012 on February 19, 1997 (EPA ICR No. 574.10 (see 62 FR 10057, March 5, 1997) (FRL-5699-4).

2. Several entries on the table in 40 CFR 9.1 are being removed, either because the collection activity has been eliminated, the OMB approval has expired, or the entry is incorrect. The following actions are related to some of the listed removals:

Certain Chemical Substances; Removal of Significant New Use Rule; Final Rule (63 FR 48127, September 9, 1998) (FRL-6020-7).

Revocation of Significant New Use Rules for Certain Chemical Substances; Final Rule (63 FR 64874, November 24, 1998) (FRL-6044-6).

3. The requested deletion of the effective date notes and the parentheticals are necessary technical corrections. The Agency no longer uses a parenthetical to display the OMB approval status for regulations. These approvals are properly listed in 40 CFR 9.1. The effective note is no longer applicable, because OMB approved the information collection contained in the final rule that established § § 372.27 and 372.95 (59 FR 61502, November 30, 1994) on March 17, 1995 (EPA ICR No. 1704.02) (see 60 FR 24631, May 9, 1995) (FRL-5204-7), and OMB has approved the renewal of this ongoing collection twice since, with the current approval on February 2, 1999 (EPA ICR No. 1704.04) (See 64 FR 12316, March 12, 1999) (FRL-0239/7).

This final rule implements a technical correction to the CFR, and does not impose any new requirements.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), OMB has determined that a technical correction is not a “significant regulatory action” subject to review by OMB.

Because this action is not economically significant as defined by section 3(f) of Executive Order 12866, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

This action will not result in environmental justice related issues and does not therefore, require special consideration under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the APA or any other statute (see Unit II.B.), this action is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 10, 1998). This rule 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, entitled Federalism (64 FR 43255, August 10, 1999).

This action does not involve any technical standards that require the Agency's consideration of voluntary consensus standards pursuant to 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).

This rule does not contain any information collection requirements that require review and approval by OMB pursuant to the PRA. The collection activities associated with the OMB control number contained in this technical correction have already been approved by OMB.

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

The Congressional Review Act (CRA), 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. CRA section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement (5 U.S.C. 808(2)). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of June 26, 2000. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under “FOR FURTHER INFORMATION CONTACT.”

1. Electronically .You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-300987. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of October 21, 1993 (58 FR 54353) (FRL-4645-7), EPA issued a notice that McLaughlin Gormley King Co. (MGK), 8810 Tenth Avenue North, Minneapolis, MN 55427, had submitted food additive petition 3H5651 to EPA proposing to amend 40 CFR part 186 by establishing a regulation, pursuant to section 409 of the Federal, Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C, 348(e), for residues of prallethrin in or on food as a result of use in food handling establishments at 1.0 part per million (ppm). On September 5, 1997, MGK at the request of EPA, submitted an amendment to bring the notice into conformity with the Food Quality Protection Act of 1996 (FQPA).

In the Federal Register of September 25, 1997 (62 FR 50337) (FRL-5748-2), EPA issued a notice pursuant to section 408 of FFDCA 21 U.S.C. 346a as amended by FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP 7F4915) for tolerance by McLaughlin Gormley King Company, 8810 Tenth Avenue North, Minneapolis, MN 55427. This notice included a summary of the petition prepared by McLaughlin Gormley King, the registrant. There were no comments received in response to the notice of filing.

The petition requested that a new regulation be established under 40 CFR part 180 for tolerances of prallethrin [( RS )-2-methyl-4-oxo-3-(2-propynyl)cyclopent-2-enyl (1 RS )- cis , trans -chrysanthemate at 1.0 ppm, in or on all food items in food handling establishments where food and food products are held, processed, prepared, and/or served.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of prallethrin in or on all food items in food handling establishments where food and food products are held, processed, prepared, and/or served at 1.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by prallethrin are discussed in this unit.

1. A battery of acute toxicity studies places prallethrin in Toxicity Category II for acute oral (LD 50 > 50 milligrams/kilograms (mg/kg)) and acute inhalation (LD 50 > 0.05 mg/L); Category III for primary eye irritation, Category IV for acute dermal (LD 50 > 5,000 mg/kg) and primary dermal irritation. Prallethrin is a non-sensitizer. The NOAEL for acute delayed neurotoxicity is 100 mg/kg bodyweight.

2. Subchronic oral toxicity feeding — Rat. In a subchronic oral toxicity study, prallethrin technical (92.0% purity) was administered by dietary admix to Crj: CD (Sprague-Dawley rats (15/sex/group) at doses of 0, 100, 300, 1,000 or 3,000 ppm (0, 7.93, 24.0, 79.1 or 230 mg/kg/day for males; 0, 8.96, 26.1, 82.3 or 244 mg/kg/day for females) for 90 days. The no observable adverse effect level (NOAEL) is 79.1 mg/kg/day and the lowest observable adverse effect level (LOAEL) is 230 mg/kg/day based on transient alopecia, decreased body weights, increased neutrophil count, decreases in hemoglobin and hematocrit, changes in clinical chemistry parameters, increased kidney weights, minimal perilobular hepatocellular hypertrophy and increased number of small follicles in the thyroid.

3. Subchronic oral toxicity feeding — Mouse. In a subchronic oral toxicity range-finding study, prallethrin technical (93.6% purity) was administered by dietary admix to Crl: CD-1 (ICR)BR mice (10/sex/dose group) at dietary levels of 0, 300, 3,000, 6,000 or 12,000 ppm (corresponding to an average intake of 0, 39, 374, 808 or 1,839 milligrams/kilograms/day (mg/kg/day) in males and 0, 47, 444, 890 or 1,884 mg/kg/day in females, respectively) for 13 weeks. The NOAEL is 374 mg/kg/day and the LOAEL is 808 mg/kg/day based on increases in liver weights, enlargement of hepatocytes and increases in cholesterol and creatinine levels in the serum.

4. Subchronic oral toxicity feeding — Dog. In a subchronic oral toxicity study, prallethrin technical (94.6% purity) was administered orally by capsule to Beagle dogs (4/sex/group) at doses of 0, 3, 10 or 30 mg/kg/day for 90 days. The NOAEL is 3 mg/kg/day and the LOAEL is 10 mg/kg/day based on tremors, decreased serum A/G ratio, increased serum cholesterol and phospholipids and enlarged livers. Mortality was observed at 30 mg/kg/day with additional clinical signs of convulsions, ataxia, salivation, tachypnea, tachycardia and increased body temperature. In the animals that died, congestion and hemorrhage were observed in multiple organs with myocardial fiber degeneration. Granulocyte juvenile cells in the bone marrow were observed in one surviving dog.

5. Repeated dose dermal — Rat. In a repeat dose dermal toxicity study, prallethrin technical (93.2 % purity) was administered via the dermal route to Crl:CD (SD)BR Sprague-Dawley rats (5/sex/group) at doses of 0 (corn oil), 30, 150 or 750 mg/kg/day on 10% of the body surface, 6 hours/day for 21 consecutive days. Occlusive dressings were used and Elizabethan collars were worn during the exposure periods. The NOAEL is 30 mg/kg/day and the LOAEL is 150 mg/kg/day based on clinical signs of toxicity and decreases in body weight gain.

6. A 28-Day inhalation — Rat. In a 28-day inhalation toxicity study, prallethrin technical (92.0% purity) was administered via inhalation to Sprague-Dawley rats (10/sex/group) at concentrations of 0, 1.01, 4.39 or 19.6 mg/m 3 , 4 hours/day in deodorized kerosene solvent for 28 days. Mean concentrations of the test article and distribution of the diameters of the mist particles were measured as well as clinical signs of toxicity, body weights, food consumption, opthalmological measurements, and hematological and blood chemistry measurements. The NOAEL is 1.01 mg/m 3 (0.0010 mg/L/day) and the LOAEL is 4.39 mg/m 3 (0.0044 mg/L/day) based on increased evidence and severity of irregular respiration, decreased spontaneous activity and nasal discharge during exposure. This is a borderline LOAEL. Study deficiencies include measuring particle sizes on only 1 day (day 21) and not measuring particle sizes in the lowest concentration.

7. Chronic toxicity—combined chronic feeding/carcinogenicity — Rat. In a chronic feeding/carcinogenicity study, prallethrin technical (92.0% purity) was administered by dietary admix to F344/DuCrj rats (50/sex/group with satellite groups of 40/sex/group) at doses of 0, 80, 400 or 2,000 ppm (0, 3.3, 16.3 or 83.5 mg/kg/day for males; 0, 4.0, 19.1 or 103.4 mg/kg/day for females) for 2 years. The additional satellite groups (10/sex/group) were sacrificed at 26, 52 and 78 weeks. Females appear to be slightly more susceptible to toxicity in the study. The NOAEL is 19.1 mg/kg/day and the LOAEL is 104.3 mg/kg/day based on decreases in body weight gains and histocytic infiltration of the liver in females. There was no evidence of an carcinogenic response. Based on the results of the study, higher dose levels could have been tolerated. In the 5-week range-finding study, tremors and death were observed at 10,000 ppm (1,121 mg/kg/day for males, 1,349 mg/kg/day for females). At 2,500 ppm (210 mg/kg/day for males, 253 mg/kg/day for females), there were significant decreases in body weights and hemoglobin, however these were not below 93% of the control groups. There were effects on clinical chemistry at this dose level and an increase in relative liver weights; however, these were not considered to be toxicologically significant because there was no associated histopathology and some of the effects may not be clinically meaningful and/or may be due to dehydration or fasting (decreases in GOT and ALP, increased albumin). Increased relative liver weights are not generally considered to be toxicologically significant without increases in absolute liver weights and without any liver pathology.

8. Chronic oral toxicity (capsule)— Dog. In a chronic oral toxicity study, prallethrin technical (93.6% purity) was administered orally by gelatin capsule to Beagle dogs (4/sex/group) at doses of 0, 2.5, 5, 10 or 20 mg/kg/day for 52 weeks. The NOAEL is 2.5 mg/kg/day and the LOAEL is 5 mg/kg/day in females based on the death of 1 female with typical clinical signs of pyrethroid toxicity and subendocardial red discoloration in the left ventricle of the heart. At 10 mg/kg/day, trembling, rapid eye blinking, hunched posture, panting, increased serum cholesterol, phospholipids and alkaline phosphatase activity were observed.

9. Developmental toxicity prenatal developmental study — Rat. In an oral developmental toxicity study, prallethrin technical (93.2% purity), was administered by gavage to Crl: CD BR VAF/Plus Sprague-Dawley rats (25/group) at doses of 0 (0.5% aqueous methylcellulose vehicle), 10, 30, 100 or 300 mg/kg/day on gestation days (GDs) 6-15, inclusively. The maternal NOAEL = 10 mg/kg/day; the maternal LOAEL = 30 mg/kg/day (tremors, excessive salivation and chromorrhinorrhea). The developmental NOAEL = 300 mg/kg/day (HDT).

10. Prenatal developmental study — Rabbit. In an oral developmental oral toxicity study, prallethrin technical (93.2% purity) was administered by gavage to New Zealand White rabbits (20/group) at doses of 0 (0.5% aqueous methylcellulose vehicle), 10, 30, 100 or 200 mg/kg/day on gestation days (GDs) 7-19, inclusively. Dose levels were selected based on a range-finding study conducted with 6 artificially inseminated rabbits/group at dose levels of 0, 10, 30, 60, 100, 300, 600 or 800 mg/kg/day on gestation days 7-19, inclusively. No maternal effects were observed at 60 mg/kg/day in the range-finding study. Based on these effects, the choice of 200 mg/kg/day as the high dose for the main study is considered appropriate based on tremors. In the main study, no developmental toxicity was observed at any dose level. The maternal NOAEL = 30 mg/kg/day (the number of animals in the range-finding study were too few to use 60 mg/kg/day as the NOAEL). The maternal LOAEL = 100 mg/kg/day from the range-finding study (tremors). The developmental NOAEL = 200 mg/kg/day (HDT in main study).

11. In a subcutaneous developmental toxicity study, prallethrin technical (92.0% purity) was administered by subcutaneous injection to New Zealand White rabbits (18/group) at doses of 0 (corn oil vehicle), 1, 3 or 10 mg/kg/day on gestation days (GDs) 6-18, inclusively. No toxicological effects on either dams or fetuses were observed at any dose level. However, in the range-finding study with nonpregnant animals, tremors were observed at 10 mg/kg/day and mortality, clinical signs, and weight loss were observed at 30 mg/kg/day. In the subcutaneous range-finding developmental rat study, maternal toxicity with nonpregnant animals was similar to that with pregnant animals. Therefore, by analogy, the choice of 10 mg/kg/day for the main rabbit study is considered to be appropriate, even though toxicity was not observed. The maternal NOAEL = 10 mg/kg/day (HDT); the maternal LOAEL = 30 mg/kg/day from the range-finding study (mortality, clinical signs, weight loss). The developmental NOAEL = 10 mg/kg/day (HDT).

12. Two-generation reproduction study — Rat. In a 2-generation reproduction study, prallethrin technical (93.6 and 92.9% purity) was administered to 30 Crl:COBS CD(SD)BR rats by dietary admix at concentrations of 0, 120, 600, 3,000 or 6,000 ppm (during premating, for males approximately 0, 6, 31, 156 or 329 mg/kg/day and for females approximately 0, 7, 37, 185 or 375 mg/kg/day). Treatment was continuous throughout the study. The two parental generations, F 0 and F 1 , produced one litter of pups each (F 1 litters, F 2 litters respectively). The parental animals received the test diet for 91 days before mating and throughout mating, pregnancy, and lactation of their litters. Pups were selected from F 1 litters to parent the F 2 generation. The F 0 generation produced 23 to 26 litters/group consisting of liveborn pups, the F 1 generation produced 18 to 25 liveborn litters/group. There was one mortality at 3,000 ppm that was preceded by clinical signs  1 and weight loss. At 6,000 ppm, treatment-related mortalities in the F 1 generation and increased basophilia in the cortical tubules (males) were observed. The parental systemic NOAEL is 31 mg/kg/day (males) and 37 mg/kg/day (females); the parental systemic LOAEL is 156 mg/kg/day (males) and 185 mg/kg/day (females) based on decreased body weights and body weight gains, increased liver weights and microscopic findings in the liver, kidney, thyroid and pituitary. No pup toxicity was observed at dose levels of 120 and 600 ppm. At 3,000 ppm and above, decreased pup body weight was observed during the lactation period in both generations. The offspring systemic NOAEL is 31 mg/kg/day (males) and 37 mg/kg/day (females); the offspring systemic LOAEL is 156 mg/kg/day (males) and 185 mg/kg/day (females) based on decreased pup body weights during the lactation period. No reproductive effects were observed at any dose level. The reproductive NOAEL is 329 mg/kg/day (males) and 375 mg/kg/day (females) (HDT).

13. Subchronic neurotoxicity. In a subchronic oral mammalian neurotoxicity study, groups of Crl: CD(SD)BR rats (12 rats/sex/group) were administered prallethrin technical (93% a.i.) via dietary admix at concentrations of 0, 120, 1,200 or 6,000 ppm for 13 weeks. These concentrations correspond to group mean intakes of 0, 9.3, 74 or 363 mg/kg/day (males) and 0, 11.1, 88 and 420 mg/kg/day (females). The systemic NOAEL is 1,200 ppm (74 mg/kg/day (males), 88 mg/kg/day (females)) and the systemic LOAEL is 6,000 ppm (363 mg/kg/day (males), 420 mg/kg/day (females)) based on decreases in mean body weight and food consumption when compared to the control values. There are no indications of neuropathology; however, there were indications of a higher arousal rate in females at 6,000 ppm.

14. Developmental neurotoxicity study. This study is not required for this chemical at this time. It may be required in the future.

15. There is no mutagenicity concern . In a reverse gene mutation study in S. typhiumurium (strains TA 100, 98, 1535, 1537, 1538) and E. coli WP2 uvrA, prallethrin technical (91.3% purity) was tested. The solvent was DMSO. Dose levels were up to 5,000 m g/plate with and without metabolic activation (S9 mix). Prallethrin did not induce any increases in reverse mutations in any of the bacterial strains tested. The positive controls ( N -ethyl- N ′-nitro- N -nitroso-guanidine, 2-nitrofluorene, methyl methanesulfonate, sodium azide, ICR-191, benzo(a)pyrene and 2-aminoanthracene) responded appropriately with highly significant increases in reverse mutations.

16. In a forward mutation study in V79 Chinese Hamster Lung Cells with DMSO as the solvent, prallethrin technical (91.2% purity) was tested. Concentrations of the test material were up to cytotoxic levels (5 x 10 −5 M concentration without metabolic activation (S9), 3 x 10 −4 M concentration with metabolic activation). Prallethrin did not induce a significant increase in forward mutations at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus in Chinese hamster lung (V79) cells. The positive controls ( N -ethyl- N ′-nitro- N -nitroso-guanidine and 9, 10-dimethyl-1, 2-benzanthracene) responded appropriately with marked increases in mutant colonies.

17. Cytogenetics . In an in vivo micronucleus test in CD-1 mice, prallethrin technical (93.2% purity) was tested. Corn oil was used as the solvent. Five mice/sex/dose/sacrifice time were administered single doses of corn oil vehicle (10 ml/kg) or test article (48, 95, 190 mg/kg) and sacrificed 24, 48 or 72 hours later. Cyclophosphamide was used in the positive controls and they were sacrificed 24 hours later. Prallethrin had no effect on micronucleus formation in bone marrow cells up to a lethal dose. There was no bone marrow cytotoxicity.

18. In an in vitro chromosomal aberration study in Chinese Hamster Ovary (CHO K1) cells with DMSO as the solvent, prallethrin technical (91.2% purity), was tested. Concentrations of the test material were up to cytotoxic levels (8 x 10 −5 M without metabolic activation and 3 x 10 −4 M with metabolic activation). Prallethrin tested negatively at all doses without metabolic activation and tested positively at all doses with metabolic activation. It was not clearly dose-related but clastogenicity was seen at nontoxic and slightly toxic doses. The positive controls (mitomycin C and benzo[a]pyrene) clearly tested positively in this test.

19. In an unscheduled DNA synthesis study in rat hepatocytes with corn oil as the solvent, prallethrin technical (91.2% purity) was tested. Male Sprague-Dawley SPF rats were administered a single dose of 400 mg/kg of the test material (maximum tolerated dose) by gavage. Hepatocytes were cultured from the animals 3, 12 and 24 hours later. Prallethrin tested negatively for inducing unscheduled DNA synthesis in rat hepatocytes. The positive control, 2-acetylaminofluorene induced a statistically significant increase in unscheduled DNA synthesis in rat hepatocytes.

20. Metabolism — Rat. The metabolism of the cis - and trans -isomers of S-4068SF was studied in male and female rats administered a single oral gavage dose of 2.0 or 100 mg/kg 14 C- cis - or 14 C- trans -isomer of S-4068SF, or a 14-day repeated oral dose of 2.0 mg/kg/day unlabeled cis - or trans -isomer of S-4068SF. The cis - and trans -isomers of 14 C-S-4968SF were rapidly absorbed, distributed, metabolized, and excreted in rats under all dosing regimens. Most of the radioactivity was recovered in the urine and feces within 48 hours for both males and females for both isomers. A much greater proportion of the administered dose of the trans -isomer was eliminated in the urine (45.2-58.1% administered dose (AD) for males, 52.1-62.1% AD for females) than was the cis -isomer (13.3-15.8% AD for males, 21-23.3% AD for females). This occurred as a result of easier cleavage of the ester linkage of the trans -isomer by esterase. For the rats administered the cis -isomer, urinary excretion was a minor route compared to fecal excretion. Females excreted a greater proportion of the radioactivity in the urine than did males for both isomers. Absorption and metabolism were not saturated at the high dose since equivalent amounts of the parent compound (about 10%) were found in urine. Repeated dosing appeared to induce metabolism since only about 2% of the parent compound was found in the feces. Radioactivity accounted for less than 1% of the dose in the tissues for both isomers. The low tissue levels of radioactivity demonstrate that bioaccumulation and retention of the cis - and trans -isomers is low. No sex-related differences in the tissue distribution patterns were found, but proportionately higher residues were found in all tissues of the high-dose group. For both isomers, higher residue levels compared to other tissues were found in the kidneys (0.018-1.127 μg/g) and liver (0.013-1.14 μg/g); higher residue levels were also found in blood (0.014-1.87 μg/g) for the trans -isomer, only. The major metabolic pathway was ester cleavage, particularly for the trans -isomer, which resulted in the metabolites ( S )-4-hydroxy-3-methyl-2-(2-propynyl)cyclopent-2-en-1-one and its glucuronide conjugate or oxidation of the propynyl group to ( RS )-4-hydroxy-2-(1-hydroxy-2-propynyl)-3-methylcyclopent-2-en-1-one and ( RS )-4-hydroxy-2-(1-hydroxy-2-oxopropyl)-3-methylcyclopent-2-en-1-one.

The metabolism of cis - and trans -S-4068 was studied in groups of male and female Sprague-Dawley rats administered a single oral dose of 2.0 mg/kg 14 C- cis - or trans -S-4068 or a single subcutaneous dose of 2.0 mg/kg 14 C- cis - or 14C - trans -S-4068. Following oral and subcutaneous administration to rats of 2.0 mg/kg of the cis - and trans -isomers of S-4068 14 C-labeled at the cyclopentenyl-2 position, each isomer was readily absorbed, distributed, metabolized and excreted in the urine and feces. Total recovery was complete ranging from 96.7% to 103.9% of the administered dose (AD) for both isomers and both dose groups. There were generally no differences in absorption, distribution, metabolism, or excretion in rats dosed orally or subcutaneously. Seven days after administration of the cis -isomer by both routes, the mean percent recovery of radioactivity showed that the feces was the major route of excretion (70.3-83.4% AD) and the urine was a relatively minor route of excretion (16.8-27.9% AD). For rats administered 2.0 mg/kg of the trans -isomer by both routes, the urine was the major route of excretion (60.1-78.4% AD), and the feces was a minor route (23-41.7% AD) 7 days postdosing. The difference in the excretion pattern between the trans - and cis -isomers is due to the extent of ester cleavage; the trans -isomer is more readily cleaved so that it is excreted in the urine to a greater extent than the cis -isomer. Sex-related differences were seen in urinary excretion with females excreting greater amounts of radioactivity in the urine than males for both isomers and both administration routes. Expired air was not considered an important route of excretion since less than 0.1% of the administered dose was excreted as 14 CO 2 in orally dosed males. Radioactivity levels in tissues was low indicating that the isomers do not persist in the tissue. The 14 C levels in the major tissues reached a maximum within 3 hours and then decreased rapidly. Based on the metabolites identified, the major biotransformation reactions of the cis - and trans -isomers as indicated by the study author include: (1) Oxidation at the methyls of the isobutenyl group in the acid moiety and at the C-1 or C-2 positions of the propynyl group in the alcohol moiety; (2) cleavage of the ester linkage; (3) conjugation of hydroxy derivatives with glucuronic acid and sulfuric acid.

21. Dermal absorption — Rat. A dermal absorption study was not required.

1. Acute toxicity . The acute reference dose (RfD) is established at 0.05 mg/kg/day (NOAEL = 5; Uncertainty Factor = 100) for use in assessing acute dietary risk for the general population, including infants and children. This RfD is based on trembling observed during week 1 at the dose of 10 mg/kg/day in the chronic oral study in the dog. The FQPA safety factor for the protection of infants and children was reduced to 1X. Therefore, the acute population adjusted dose (aPAD) is equal to acute RfD divided by 1 or 0.05 mg/kg/day.

2. Short- and intermediate-term dermal toxicity . The short- and intermediate-term dermal endpoints were selected from the 21-day dermal study in the rat (NOAEL = 30 mg/kg/day). This endpoint is based on clinical signs (trembling, fixation, abnormal gait, sensitivity to external stimuli, vocalization, twitching and writhing spasms) and decreased body weight gain observed at 150 mg/kg/day.

3. Long-term dermal toxicity . The long-term dermal endpoint was selected from the 1 year oral study in dogs (NOAEL 2.5 mg/kg/day, same study as for chronic dietary exposure). The dermal absorption rate of 20% and a margin of exposure (MOE) of 100 was selected.

4. Inhalation toxicity . The inhalation endpoints (any exposure period; in this case, short- and intermediate-term exposure) were selected from the 28-day inhalation study in the rat NOAEL = 0.0010 mg/L/day (estimated to be 0.174 mg/kg/day). This endpoint is based on clinical signs observed during exposure (increased evidence and severity of irregular respiration, decreased spontaneous activity and nasal discharge) observed at 0.0044 mg/L/day.

5. Chronic dietary toxicity . EPA has established the RfD for prallethrin at 0.025 mg/kg/day. This RfD is based on a NOAEL of 2.5 mg/kg/day and an uncertainty factor of 100. The NOAEL is based on microscopic lesions of the heart and clinical signs indicative of pyrethroid toxicity observed in one female dog at the LOAEL dose of 5 mg/kg/day. The FQPA safety factor for the protection of infants and children was reduced to 1X. Since the FQPA safety factor was reduced to 1X, the chronic Population Adjusted Dose (cPAD) is equal to the chronic RfD divided by 1 or 0.025 mg/kg/day.

4. Carcinogenicity . There is no evidence of carcinogenicity in either rats or mice.

1. From food and feed uses . Currently, there are no agricultural uses nor established tolerances for prallethrin. The requested tolerance for 1.0 ppm for the residues of prallethrin, in or on all food items in food handling establishments where food and food products are held, processed, prepared, and/or served, will be the first food tolerance. Risk assessments were conducted by EPA to assess dietary exposures from prallethrin as follows:

i. Acute exposure and risk . The Agency has conducted a Tier 2 (anticipated residues and 100% crop treated) acute dietary (food only) exposure assessment for prallethrin using the Dietary Exposure Evaluation Model (DEEM). This model incorporates individual food consumption as reported by respondents in the USDA 1989-91 Continuing Survey of Food Intake by Individuals (CSFII) and accumulates exposure to the chemical for each commodity. The DEEM acute exposure analysis was performed using anticipated residues levels and 100% percent crop treated (PCT) to estimate the Anticipated Residue Concentration (ARC) for the general population and subgroups of interest. The DEEM acute dietary analysis indicates that exposure to prallethrin from dietary (food only) sources will be below the Agency's level of concern for all population subgroups (100% of the acute Population Adjusted Dose (aPAD)). The estimated exposure will occupy 89% of the aPAD for children 1-6 years (the most highly exposed population subgroup). Acute dietary risk to all other population subgroups is less than that of children 1-6 years. The Agency further notes that these acute dietary risks are significant overestimates as it was assumed that all foods would be treated, while it is believed that the maximum percentage of food handling establishments which will be treated is 12%. In addition, it was assumed that all treated foods would have the maximum residue observed in the submitted residue studies, when, in reality, a distribution of residues with many values lower than that would be encountered in actual practice.

ii. Chronic exposure and risk . The Agency has conducted a Tier 3 (anticipated residues and PCT data) chronic dietary (food only) exposure assessment for prallethrin using the DEEM. This model incorporates individual food consumption as reported by respondents in the USDA 1989-91 CSFII and accumulates exposure to the chemical for each commodity. The DEEM chronic exposure analysis was performed using anticipated residues levels and 12% PCT to estimate the ARC for the general population and subgroups of interest. The DEEM chronic dietary analysis indicates that exposure to prallethrin from dietary (food only) sources will be below the Agency's level of concern for all population subgroups (100% of the cPAD). The estimated exposure will occupy 8.6% of the cPAD for children 1-6 years (the most highly exposed population subgroup). Chronic dietary risk to all other population subgroups is less than that of children 1-6 years (Table 1).

Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows. The DEEM chronic exposure analysis was performed using anticipated residues levels and 12% PCT to estimate the ARC for the general population and subgroups of interest. This PCT value used to perform this analysis was based on estimates received from the registrant, and the fact that anticipated sales and market share for a first time food use is not expected to reach its maximum until 5 to 7 years after market entry.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA used a maximum projected PCT for chronic dietary exposure estimates. The maximum projected PCT reasonably represents an overestimate of a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the maximum projected PCT over a lifetime. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimated. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which prallethrin may be applied in a particular area.

2. From drinking water . Based on the use patterns, negligible amounts of prallethrin are expected in the drinking water. Any that may be poured down the drain from residential uses will be removed by water treatment plants. Therefore, it is not necessary to calculate Drinking Water Levels of Comparison (DWLOCs).

i. Acute exposure and risk . Not applicable based on above comments.

ii. Chronic exposure and risk . Not applicable based on above comments.

3. From non-dietary exposure . Prallethrin is currently registered for use on the following residential non-food sites: inside households, outdoor yards and patios, and pets. Four different types of products are registered for residential use: (1) Crack and crevice sprays; (2) indoor and outdoor foggers; (3) broadcast carpet and surface sprays; and (4) pet dips, sprays and shampoos. There are 23 products containing the active ingredient prallethrin that are registered for residential use. The percent active ingredient in these products ranges from 0.03% to 0.25%. The frequency and rate of application varies with each product. Registered end use products with the highest percentage of active ingredient were used to estimate high-end exposure for residential handlers and postapplication activities. These residential uses constitute short- and intermediate-term exposures including postapplication.

i. Chronic exposure and risk . Based on the use patterns, long-term (several months to lifetime) exposures are not expected for residential handlers.

ii. Short- and intermediate-term exposure and risk (residential). The residential exposure assessment relies on the methodology used previously by the Agency in November 1997, for the tolerance reassessment of 10 other pyrethroids. Current uses may result in short-term exposures for residential handlers. Intermediate- and long-term exposures are not expected for residential handlers. Since no handler data were submitted to support the residential handler assessment, surrogate data were used. MOE values were estimated for short-term handler dermal and inhalation exposures for indoor crack and crevice products, carpet/surface products and pet products. The dermal MOEs for these products range from 350 for the pet mousse to 5,600 for the pet dip. The inhalation MOEs range from 450 for the use of the undiluted prallethrin formulation as a carpet broadcast and space spray to 52,000 for the pet spray. The short-term MOEs for residential handlers are above the Agency's target MOE of 100.

Based on the use patterns intermediate-term (7 days to several months) exposures are not expected for residential handlers. Short- and intermediate-term durations may occur for postapplication exposures. For postapplication exposure, no actual dissipation data were available. Surrogate data were used. It is expected that residue levels after 7 days exposure will be low to nondetectable. MOE values were estimated for short- and intermediate-term postapplication dermal exposures for carpet broadcast sprays, total release foggers and pet products. MOE values were estimated for short- and intermediate-term postapplication inhalation exposures for total release fogger products and space sprays. In addition to dermal and inhalation exposures, MOEs for postapplication incidental hand-to-mouth transfer were estimated for carpet broadcast sprays, foggers, space sprays and pet products. The dermal MOEs for these products range from 460 for the use of the undiluted prallethrin formulation as a carpet spray to 6,700 for the pet dip for adults and from 250 for the same carpet spray to 3,300 for the pet dip for children. The lowest inhalation MOEs are 1,500 for adults and 650 for children for the use of the diluted prallethrin formulation as a space spray and 100 for adults and 47 for children for the use of the undiluted prallethrin formulation. For hand-to-mouth transfer, the MOEs range from 930 to 17,000 for the foggers in children with the exception of the inhalation MOEs for use of the undiluted prallethrin formulation as a space spray. All of the short- and intermediate-term MOEs for postapplication residential exposure are above the Agency's target MOE of 100. Since these MOEs are estimated from exposure levels measured immediately after application and it is expected that the exposure will drop to very low levels after 7 days, the intermediate-term MOE values are low bounding estimates. Due to a low postapplication inhalation MOE (47), the use of the undiluted prallethrin formulation as a space spray will not be permitted in residential and institutional sites such as homes, schools, apartments, and condominiums.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether prallethrin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, prallethrin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that prallethrin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Acute risk . Using the exposure assumptions described in this unit, EPA has concluded that acute exposure to prallethrin from food is not expected to exceed 89% of the aPAD for any of the population subgroups analyzed. Acute aggregate exposure consists of exposures from food and drinking water. According to the use patterns, negligible amounts of prallethrin are expected in the drinking water and no estimates for expected environmental concentrations of prallethrin in the drinking water are necessary. As a result, acute dietary estimates are based only on exposure in the food and as stated above, are not expected to exceed 89% of the aPAD for any of the population subgroups analyzed.

2. Chronic risk . Chronic aggregate exposure consists of exposures from food, drinking water, and residential uses which lead to chronic exposures. Using the exposure assumptions described in this unit, EPA has concluded that chronic exposure to prallethrin from food is not expected to exceed 8.6% of the cPAD for any of the population subgroups analyzed. According to the use patterns, negligible amounts of prallethrin are expected in the drinking water and no estimates for expected environmental concentrations of prallethrin in the drinking water are necessary. Chronic residential exposures are also not expected. As a result, chronic aggregate exposure estimates are based only on exposure to the food and as stated above, are not expected to exceed 8.6% of the cPAD for any of the population subgroups analyzed.

3. Short- and intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus indoor and outdoor residential exposure. For adults, the short-term aggregate risk estimate (handler and/or postapplication exposure) includes food, dermal and inhalation exposure and the intermediate-term aggregate risk estimate (postapplication exposure only) includes food and dermal exposure (no postapplication inhalation exposure is expected for the products selected for the aggregate risk estimate for adults). For children, the short- and intermediate-term aggregate risk estimates (postapplication exposure only) include food, incidental ingestion, dermal and inhalation exposure (postapplication inhalation exposure is expected for the products selected for the aggregate risk estimates for children). As stated previously, negligible amounts of prallethrin are expected in the drinking water. The estimation of aggregate risk is based on which uses may be potentially employed simultaneously and which have the highest potential exposure (adults: carpet broadcast aerosol spray used with the pet spray; children: total release fogger and the pet mousse). Since the Agency is recommending against the use of the undiluted prallethrin formulation as a space spray in homes and schools, the short- and intermediate-term aggregate risk estimates do not include the MOE values for this product. The most conservative short-term aggregate MOE for infants and children is 260 and the most conservative short-term aggregate MOE for adults is 250. None of the aggregate short-term MOE's for either adults or children are less than the target MOE of 100. Therefore, the short-term aggregate MOEs for both adults and children are greater than the Agency's level of concern.

Since children are not expected to be residential handlers, the intermediate-term aggregate risks for children are based on postapplication exposures only. In addition, for estimation of the intermediate oral MOE, the oral NOAEL is taken from the chronic dietary endpoint. The NOAEL from the chronic dietary endpoint is one-half the NOAEL from the acute dietary endpoint from which the short-term oral MOEs were estimated. The most conservative intermediate-term aggregate MOE for infants and children is 190 and the most conservative intermediate-term aggregated MOE for adults is 670. All of the aggregate intermediate-term MOE's for both adults and/or children are greater than the target MOE of 100 and are thus, greater than the Agency's level of concern.

4. Aggregate cancer risk for U.S. population . Prallethrin is classified as not likely to be a human carcinogen. Therefore a risk assessment is not required since prallethrin is not expected to pose a cancer risk.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to prallethrin residues.

1. Safety factor for infants and children —i. In general . In assessing the potential for additional sensitivity of infants and children to residues of prallethrin, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor.

ii. Developmental toxicity studies . See the toxicological profile in Unit III.A. of this document.

iii. Reproductive toxicity study . See the toxicological profile in Unit III.A. of this document.

iv. Prenatal and postnatal sensitivity . The reproductive and developmental data provided no indication of increased susceptibility for rats and rabbits to in utero and/or postnatal exposure to prallethrin. In the prenatal developmental toxicity studies in rats and rabbits, no evidence of developmental toxicity was seen at any dose level. In the 2-generation reproduction study in rats, effects in the offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity. These effects (decreased pup body weights during the lactation period) were not considered to be qualitatively more serious than the effects observed in the parents (decreased body weights and body weight gains, increased liver weights and microscopic findings in the liver, kidney, thyroid and pituitary).

v. Conclusion . There is a complete toxicity data base for prallethrin, and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on the completeness of the toxicity data base and prenatal and postnatal toxicity of prallethrin, no additional safety factor is needed to protect infants and children.

2. Acute risk . Acute aggregate exposure consists of exposures from food and drinking water. Using the exposure assumptions described in this unit, EPA has concluded that acute exposure to prallethrin from food will utilize 89% of the aPAD for children (1-6 years), the most highly exposed population subgroup. As stated previously, negligible amounts of prallethrin are expected in drinking water. Therefore, EPA does not expect the acute aggregate exposure to prallethrin to exceed 100% of the aPAD. EPA generally has no concern for exposures below 100% of the aPAD because the aPAD represents the level at or below which daily aggregate dietary exposure will not pose appreciable risks to human health.

3. Chronic risk . Chronic aggregate exposure consists of exposures from food, drinking water, and residential uses which lead to chronic exposures. Using the exposure assumptions described in this unit, EPA has concluded that chronic exposure to prallethrin from food will utilize 8.6% of the cPAD for children (1-6 years), the most highly exposed population subgroup. As stated previously, negligible amounts of prallethrin are expected in drinking water and chronic residential exposures are not expected. Therefore, EPA does not expect the chronic aggregate exposure to prallethrin to exceed 100% of the cPAD. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily lifetime aggregate exposure will not pose appreciable risks to human health.

4. Short- or intermediate-term risk . For children, the short- and intermediate-term aggregate risk estimates (postapplication exposure only) include food, incidental ingestion, dermal and inhalation exposure (postapplication inhalation exposure is expected for the products selected for the aggregate risk estimates for children). As stated previously, negligible amounts of prallethrin are expected in the drinking water. The estimation of aggregate risk is based on which uses may be potentially employed simultaneously and which have the highest potential exposure (children: total release fogger and the pet mousse). The most conservative short-term aggregate MOE for infants and children is 260. None of the aggregate short-term MOE's for either adults or children are less than the target MOE of 100.

The intermediate-term aggregate risks for children are based on postapplication exposures only. In addition, for estimation of the intermediate oral MOE, the oral NOAEL is taken from the chronic dietary endpoint. The NOAEL from the chronic dietary endpoint is one-half the NOAEL from the acute dietary endpoint from which the short-term oral MOEs were estimated. All of the aggregate intermediate-term MOE's for children are greater than the target MOE of 100 and are thus, greater than the Agency's level of concern.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to prallethrin residues.

Currently, there are no agricultural uses for prallethrin, therefore, there are no metabolism studies in plants and animals. For food handling establishments EPA assumes that the residue of concern will be for the parent only.

Adequate enforcement methodology—gas chromatography with final electron capture detection, are available for analyses of prallethrin in/on food items associated with food handling establishments. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

Adequate residue data were provided to support a tolerance of 1.0 ppm. Residue levels of prallethrin in food items resulting from the application of ULV fogger spray and contact spray to food handling establishments were below the Agency's level of concern. No residues were detected following contact sprays with the exception of 0.1 ppm prallethrin in a peanut sample at the 4x normal application rate after 10 treatments. The highest residue found in covered commodities following ULV fogger application at the label rate was 0.54 ppm in a flour sample.

There are no CODEX, Canadian, or Mexican tolerances for prallethrin. Therefore, harmonization of international tolerances is not of concern at this time.

FQPA requires that EPA develop a screening program to determine whether certain substances (including all pesticides and inert ingredients) “may have an effect in humans similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect...” EPA has been working with interested stakeholders, including other government agencies, interest groups, industry and research scientists to develop a screening and testing program as well as a priority setting scheme to implement this program. The Agency's proposed Endocrine Disrupter Screening Program was published in the Federal Register of December 28, 1998 (63 FR 71541). The Program uses a tiered approach and anticipates issuing a Priority List of chemicals and mixtures for Tier I screening in the year 2000. As the Agency proceeds with the implementation of this program, further testing of prallethrin and its end-use products for endocrine effects may be required.

Therefore, the tolerance is established for residues of prallethrin, in or on all food items in food handling establishments where food and food products are held, processed, prepared, and/or served at 1.0 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-300987 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 25, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-300987, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to 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). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 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 final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

We intend to publish the home health prospective payment system (HH PPS) final rule in the Federal Register on or about June 30, 2000. We are planning to hold a town hall meeting on Tuesday, July 18, 2000. We anticipate interested parties to include: the home health agency (HHA) industry association representatives, HHA administrators and owners, home care professionals, university-based and private research organizations, Congressional members and staff, home care software vendors, beneficiary advocates, and other interested parties.

In this meeting, we will provide an overview of the HH PPS final rule and will focus on a number of its key components and present past and current research efforts related to the HH PPS.

This meeting will be broadcast live from the HCFA Central Office Main Auditorium and will include four satellite broadcast viewing sites in Boston, Chicago, Atlanta, and San Francisco. All five sites have a capacity of approximately 500 individuals. The audiences viewing the broadcast via satellite will have the ability to participate in the question-and-answer period at the end of this presentation. For those who cannot attend in Baltimore, the address of the downlink sites, registration information, and satellite coordinates for this presentation will be posted on the HCFA website www.hcfa.gov or you may contact Alison Horan of The Lewin Group at (703) 269-5606. Once individuals are on this website, they will need to highlight the red bullet, in the lower right hand corner, titled “Events, Meetings, and Workgroups.”

The meeting will conclude with a question-and-answer session including the HCFA Central Office location as well as the three-satellite downlink sites. The toll-free phone number to call to participate will be broadcast during the meeting.

While the meeting is open to the public, attendance is limited to the space available. Individuals must register in advance as described below.

The Lewin Group will handle registration for all five meeting sites. Individuals may register through on the HCFA website, www.hcfa.gov or you may contact Alison Horan of The Lewin Group at (703) 269-5606. Once individuals are on this website, they will need to highlight the red bullet, in the lower right hand corner, titled “Events, Meetings, and Workgroups.”

Each participant will receive a confirmation letter as receipt of registration. Each participant will be provided with a meeting agenda at the time of the meeting. If individuals have any questions regarding registration, they should contact The Lewin Group, Alison Horan of The Lewin Group at (703) 269-5606.

NMFS issues a final rule, under section 305(c) of the Magnuson-Stevens Act, to close the 2000 commercial lobster fishery in the NWHI. This emergency action is being taken because NMFS is concerned about the potential for overfishing the lobster stocks in the NWHI. While calculating the year 2000 estimates of exploitable population of lobsters, utilizing the same analytical procedures that were used to estimate exploitable populations in 1998 and 1999, Southwest Fisheries Science Center scientists expressed alarm at the increasing level of uncertainty in their computations. The scientists also noted a lack of appreciable rebuilding of lobster populations, despite significant reductions in fishing effort throughout the NWHI. Given the shortcomings in understanding the dynamics of the NWHI lobster populations, the increasing uncertainty in model parameter estimates, and the lack of appreciable rebuilding of the lobster population, NMFS is closing the NWHI commercial lobster fishery as a precautionary measure.

A proposed rule to close the fishery was published on April 28, 2000 (65 FR 24906), requesting public comments through May 15, 2000. Comments were received from five individuals; the comments did not prompt any changes to the proposed rule. The final rule, therefore, is the same as the proposed rule. Additional background information may be found in the preamble to the proposed rule.

Comment 1: A commenter strongly opposes closure of the fishery based on the uncertainty of NMFS' stock assessment models, and felt that NMFS should withdraw the proposed rule and allow the fishery to open with a harvest guideline of no more than 130,000 lobsters.

Response: While calculating the year 2000 estimates of the exploitable population of lobsters, NMFS scientists encountered an increasing level of uncertainty in their computations utilizing the same analytical procedures that were used to estimate exploitable populations in 1998 and 1999. Also they noted violations of several of the population model's assumptions and the lack of appreciable rebuilding of lobster populations, despite significant reductions in fishing effort. These are the major reasons why NMFS is taking precautionary action to close the fishery. The commenter suggests using a harvest guideline of 130,000 lobsters. Although this harvest guideline contains a bias-adjustment factor based on fishing mortality, there is also uncertainty associated with the value of F (fishing mortality). Accordingly, NMFS believes that allowing the commercial fishery to operate under a harvest guideline of 130,000 lobsters is not sufficiently precautionary for the long-term health of the stock.

Comment 2: A commenter suggests that the commercial lobster fishermen enter into an agreement with NMFS to fish according to an appropriate research protocol. The Commenter states that such an approach is as precautionary as a closure of the fishery and allows for the collection of data to improve the understanding of the fishery and model parameters.

Response: NMFS endorses joint industry initiatives that facilitate cost-effective data collection. However, given the immediate concerns about the lobster resources, NMFS believes that closure of the fishery associated with an experimental fishery program (EFP) provides cost-effective control over the number of lobsters harvested, data collected, and the specimens tagged by the commercial fishermen. NMFS notes that the Western Pacific Fishery Management Council's (Council) Crustacean Plan Team, which recommended closure of the fishery beginning in 2000, suggested several alternatives for monitoring the fishery, including the implementation of an EFP.

Comment 3: A commenter states that if the fishery is closed, NMFS' current lobster tagging study would be prematurely and effectively terminated, and that important data needed to estimate fishing mortality (F) and lobster population size would be lost. The commenter also stated that the fishery should be maintained to improve the value of the tagging program.

Response: NMFS agrees that terminating all lobster fishing would affect NMFS' ongoing and proposed lobster tagging studies, as well as compromise the Council's and NMFS' ability to make informed resource management and conservation decisions in the future. However, closing the commercial fishery and implementing an EFP is the most effective approach to achieve the objectives of the lobster tagging studies and data collection efforts.

Comment 4: A commenter feels that there is no evidence of overfishing; that the FMP's constant rate policy is conservative and precautionary; and that if the NWHI commercial lobster fishery is allowed to operate under a harvest guideline of 194,000, 130,000, or 88,000 lobsters, these levels would still be above the current overfishing threshold, either Spawning Potential Ratio- or Maximum Sustainable Yield-based.

Response: Although NMFS agrees that the FMP's constant harvest rate policy (13 percent removal of the annual exploitable population which is associated with a 10 percent risk of overfishing) is conservative, and is not aware of any written documentation showing that the lobster stocks are overfished, NMFS has serious concern over the uncertainty of the lobster population estimates of the annual exploitable lobster population. To ensure that overfishing of the lobster stocks does not occur, the precautionary approach of the closure is being taken.

Comment 5: One commenter states that the “bias-correction factor” applied by NMFS, which is based on catchability coefficients (q) to derive an adjusted 88,270 harvest guideline, is less valid than a (F)-based correction factor so that a harvest guideline of 130,000 lobsters for the 2000 NWHI lobster fishery is more appropriate.

Response: Discussions among the scientists regarding the statistical merit of using q- and F-based bias-adjustment factors underscore the concern over the uncertainty present in the model parameters used to calculate the annual exploitable population. There are no reliable estimates of (F); there is more uncertainty associated with an F-based adjustment factor than a (q)-based adjustment factor. Also, NMFS scientists have noted that model-based versus experiment-based differences in (q) result in significant differences in estimates of exploitable population. Given these uncertainties, NMFS believes the appropriately conservative course of action is to close the fishery and re-estimate the biological and fishery parameters. A lobster tagging program, under an EFP, is a way to address the concern about the increasing level of uncertainty in model parameter estimates.

Comment 6: One commenter states that NMFS is justifying closure based in part on data showing a decline in the recruitment of 2-yr old lobsters at Necker Island over the last decade, in spite of rising commercial catch per unit of effort (CPUE). This commenter states that NMFS has not presented confidence intervals to determine the validity of the declining trend, and suggested that NMFS should conduct a statistical power test on the number of trap-hauls at Necker to address the 50 percent change in population abundance.

Response: NMFS believes that while confidence intervals were not provided in the lobster recruitment data for Necker Island, the declining trend shown by the data is obvious and part of the basis for closing the NWHI lobster fishery. The other strong rationale for closing the fishery include the increasing uncertainty associated with several parameters of the model used to estimate exploitable population size (i.e., catchability) and violations of several of the model's underlying assumptions. Nonetheless, NMFS intends to provide confidence intervals and conduct a power test on the Necker lobster data.

Comment 7: A commenter states that NMFS' failure to announce the 2000 lobster harvest guideline by the end of February resulted in unnecessary stress on the NWHI lobster permit holders and that closure of the fishery will impose economic hardship on the fishermen.

Response: The need to close the fishery became apparent as NMFS analyzed the lobster data while calculating the 2000 harvest guideline. NMFS is sensitive to the economic hardship some fishermen may face as result of the closure, but notes that the closure is expected to promote a sustainable fishery having greater positive impacts on revenues and fishermen in the long term.

Comment 8: A commenter strongly opposes closure of the fishery, but said that if NMFS proceeds to close the fishery, the NWHI Area 4 lobster fishing grounds should be included in the EFP. In addition, NMFS should provide the scientific background to support an EFP harvest level substantially below 88,270 lobsters, and that NMFS should provide assurance that the 2000 EFP will enable the development of an improved population model.

Response: For 2000, NMFS does not intend to allow lobster harvest in Area 4 because NMFS scientists are unable to compute an allowable level of harvest appropriate under an EFP. NMFS is preparing a NWHI lobster research plan and intends to consult with the Council prior to implementation of an EFP. This consultation will include the scientific background on the harvest levels for Necker Island, Maro Reef, and Gardner Pinnacles under an EFP. NMFS plans to develop a sampling plan for Area 4 beyond the year 2000. The scientific and fishery information obtained through the EFP will be used to replace or improve the current NWHI lobster stock assessment model.

Comment 9: A commenter feels that there should be an explanation of the scientific process by which NMFS implemented the “precautionary approach” to offset an increase in uncertainty of model parameters, including the transparency of the estimation process.

Response: The scientific rationale for NMFS' proposed closure is contained in a memorandum, dated February 3, 2000, from the NMFS Southwest Fisheries Science Center Director (See Response 1). Also, NMFS scientists discussed the proposed closure of the lobster fishery in open meetings with the Council and its Scientific and Statistical Committee. Details on the population estimation algorithms are available in Amendments 7 and 9 to the FMP.

Comment 10: The increase in uncertainty in model parameters should be quantified.

Response: The term “uncertainty” is used in this context to reflect apparent violations and shortcomings of the model's assumptions and doubt as to the resulting calculations. It does not refer to statistical uncertainty and thus cannot be computed or quantified.

Comment 11: One commenter requests the exact Magnuson-Stevens Act citation that allows for a “precautionary closure.”

Response: The Magnuson-Stevens Act does not use the term “precautionary” in this context; however, it is used in the national standard guidelines governing fishery management plans and their implementing regulations at 50 CFR 600.31(f)(5). The term “precautionary” is used in this context to describe NMFS' proposed action in light of the increased uncertainty to ensure that the lobster stocks are not overfished. A closure is “precautionary” in the sense that there is less risk to the lobster stocks in closing the fishery than in using the current model to derive a harvest guideline. Under the discretionary provisions of section 303 of the Magnuson-Stevens Act, a fishery management plan may designate zones where, and periods when, fishing shall be limited, or shall not be permitted; establish specified limitations on the catch of fish which are necessary and appropriate for the conservation and management of the fishery; prohibit the use of specified types and quantities of fishing vessels; and prescribe such other measures, requirements, or conditions and restrictions that are determined to be necessary and appropriate for the conservation and management of the fishery.

Comment 12: A commenter wonders to what extent NMFS is working “collusively” with the environmental community under threat of litigation to close the fishery to protect marine mammals.

Response: There have been no collusive or secret agreements between NMFS and the environmental community or anyone else to close the lobster fishery under threat of litigation. NMFS proposed to close the fishery based on concerns for the potential of overfishing the lobster resources.

Comment 13: A commenter asks what the agency has done in the past year, and what it plans to do this year (aside from planning an experimental fishery) to address the uncertainty in model parameters

Response: NMFS conducted a lobster research survey and tagged lobster in 1999; a similar survey will be conducted in 2000. In addition, the agency is continuing lobster research at Necker Island utilizing the tag, release, and recapture of spiny lobsters. NMFS is also reassessing the model used to estimate exploitable lobster populations with the objective of refining the model, its assumptions, and parameter estimates. Improvements to the existing model are anticipated in the future.

Comment 14: A commenter notes that the Marine Mammal Commission, which previously recommended a 3-year closure because of its belief that the lobster fishery effects prey resources important to the recovery of the endangered Hawaiian monk seal, commented that the proposed closure for the year 2000 is a step toward this recommendation.

Response: NMFS is closing the fishery because of the potential for overfishing the lobster resources in the NWHI. NMFS believes there is insufficient data at this time to support statements that the fishery affects an important source of prey for any species of marine mammal including the Hawaiian monk seal.

Comment 15: A commenter states that the downward trend of lobster CPUE demonstrates that the lobster stock needs time to rebuild, and that there should be a 3-year closure to allow rebuilding of the lobster stocks.

Response: To a large degree, the declining trend in lobster CPUE has been attributed to a large-scale shift in the Pacific Ocean ecosystem as it changed from a more productive state to a less productive one. Similar declines in population size have been detected for reef fish and bird populations throughout the Pacific Basin (see: Polovina, et al., 1994 Physical and biological consequences of a climate event in the central North Pacific. Fish. Oceanogr. 3(1):15-21)

Comment 16: A commenter is concerned that depletion of the NWHI lobster resource has been implicated in the death of certain (emaciated) monk seals.

Response: As previously stated, the basis for closing the fishery is due to NMFS' concerns about the potential for overfishing the lobster resources. NMFS believes there are insufficient data at this time to support statements that lobster represents an important source of prey for any species of marine mammal, including the Hawaiian monk seal.

Comment 17: A commenter feels that depletion of lobster resources may be having negative effects on species of other trophic levels and may have compromised the predator/prey relationship of other species (e.g., reef fish, sharks and mollusks) in areas where lobster populations are especially depressed.

Response: The fishery is not being closed due to depletion of lobster resources, rather it is being closed as a precautionary action to prevent such an event from occurring. At this time, there are no scientific data that indicate the commercial lobster fishery is having a negative impact on the trophic levels or predator/prey relationships in the reef ecosystem of the NWHI. Future research should provide answers to any assertions regarding the impacts the fishery may be having on the trophic levels and predator-prey relationships in the NWHI coral reef ecosystem.

Comment 18: A commenter recommends that there be a moratorium until an appropriate experimental fishery program is developed and approved.

Response: NMFS agrees. NMFS is developing an EFP to obtain a reliable estimate of the exploitable population of lobsters in the NWHI. The results of the EFP will help enable NMFS to manage the lobster fishery on a sustainable basis for the long term.

Comment 19: A commenter supports closure, stating that the fishery has already been severely overfished, affecting not only lobster stocks but also monk seals that rely in part on lobster as an important food source.

Response: The fishery is being closed because of concerns about the potential for overfishing the lobster resources. The data do not support the statement that the fishery is or has been overfished or that lobster represents an important source of prey for any species of marine mammal, including the Hawaiian monk seal.

Comment 20: A commenter opposes any form of an experimental fishery in 2000 that would deplete the lobster stocks, stating that such a fishery is unwise and would present unacceptable risk to the lobsters and monk seals.

Response: NMFS will make available its complete analysis of any experimental fishery proposal prior to its implementation. Lobster harvest levels under an EFP will be determined solely on the basis of scientific needs and will be set at conservative levels.

The Assistant Administrator for Fisheries, NOAA, under 5 U.S.C. 553(d)(3), finds for good cause, namely the need to have the final rule in place on or before July 1, 2000, the scheduled opening of the lobster fishing season, would make a 30-day delay in effective date contrary to the public interest. Accordingly, the rule is being made effect on July 1, 2000. This emergency rule has been determined to be not significant for purposes of Executive Order 12866.

NMFS prepared an Initial Regulatory Flexibility Analysis (IRFA) that described the impact the proposed rule would have on small entities (65 FR 24906, April 28, 2000). No comments were received on the IRFA. A FRFA has been prepared in compliance with 5 U.S.C. 604(a). The reasons for, objectives of, and legal basis for this rule are described elsewhere in this preamble.

The FRFA discusses the economic impacts under the following scenarios: (1) Alternative 1— the fishery opens on July 1, 2000, with a harvest guideline of 243,100 lobsters (spiny and slipper lobsters combined) distributed among the four established lobster grounds (as in 1999) as follows: Necker Island, 54,600 lobsters; Gardner Pinnacles, 27,690 lobsters; Maro Reef, 89,570 lobsters; all other NWHI lobster grounds combined (Area 4), 71,240 lobsters; (2) Alternative 2—the fishery opens on July 1, 2000, with a harvest guideline of 88,270 lobsters (spiny and slipper lobsters combined) distributed among the established lobster grounds as follows: Necker Island, 35,230 lobsters; Gardner Pinnacles, 17,550 lobsters; Maro Reef, 35,490 lobsters; all other NWHI lobster grounds combined, zero lobsters; (3) Alternative 3—the fishery opens on July 1, 2000, with a harvest guideline of 194,350 lobsters (spiny and slipper lobsters combined) distributed among the established lobster grounds as follows: Necker Island, 58,110 lobsters; Gardner Pinnacles, 28,860 lobsters; Maro Reef, 85,150 lobsters; and all other NWHI lobster grounds combined, 22,230 lobsters; and (4) Alternative 4 (preferred alternative)—extend the closed season from July 1 through December 31, 2000 (the NWHI commercial lobster fishery is closed during 2000). The preferred alternative is anticipated to preserve and enhance the productive capability of the fishery's target lobster stocks as well as any incidentally caught species. However, a fishery closure will have negative impacts on the fishery participants who rely on this fishery for a portion of their annual income. The five to six participants in this fishery have realized average annual ex-vessel revenues of $1.1 million during the last two seasons (approximately $200,000 per vessel). Although all participants engage in other fisheries, the NWHI lobster fishery occurs during a comparatively slow season for their alternate fisheries; therefore, the lobster fishery represents an important component of the participants' annual activities and income. This component and its associated revenue will be lost to fishery participants under the preferred alternative. The relative importance of this fishery to participants is undetermined, but it may be roughly equal to 25 percent to 33 percent (3 to 4 months) of their annual gross revenues. The opportunity to participate in the 2000 NWHI commercial lobster fishery, and its associated revenues, will be lost to fishery participants under the preferred alternative.

The permit holders who will be impacted by the closure of the fishery are the 13 individuals who currently hold NWHI crustacean fishery limited entry permits. Currently, these permit holders own a total of 10 vessels that are registered with lobster fishing permits. In the past two seasons, five vessels fished for lobsters in 1998 and six vessels fished in 1999 (only one vessel participated in the lobster fishery during both seasons). Nonetheless, all permit holders will be vulnerable to reductions in the value of their permits. Seasonal markets for NWHI lobsters may also be adversely affected under the preferred alternative. Because this is a relatively small fishery, marketing of its product has been challenging, as wholesalers and retailers prefer predictable and reliable supply sources. However, a reputation for a locally-produced, quality product has been established and buyers willing to participate on a seasonal basis have been found. The preferred alternative will have a negative impact on these connections and reestablishment of market channels may be difficult. Assuming a 10 percent profit margin, a fishery closure that results in a loss of $1.2 million in ex-vessel product would represent an estimated net loss of $120,000 to shoreside processors and wholesalers. Despite these negative impacts, the preferred alternative is expected to promote a sustainable fishery that is anticipated to result in greater positive impacts on fishery revenues and participants over the long term. The preferred alternative will not implement any additional recordkeeping or other compliance requirements, and does not duplicate, overlap or conflict with other Federal regulations.

Alternatives 1, 2, and 3 were rejected because they do not address concerns about the potential for overfishing the lobster resources in a sufficiently precautionary manner. However, NMFS scientists have expressed concern over the lack of data that would result from a complete prohibition of all lobster fishing activities, and are developing a research plan for an experimental fishery program (EFP) that would enable NMFS to continue to collect data for lobster stock assessment in a controlled manner. The results of an EFP are expected to enable the Council and NMFS to make informed management and conservation recommendations on the NWHI lobster resource and fishery in the future. NMFS is considering a 2000 experimental lobster fishery which, if approved, will be assessed prior to implementation. A copy of the FRFA is available from NMFS (see ADDRESSES ).

An informal consultation under the Endangered Species Act was concluded for this action on April 18, 2000. As a result of the informal consultation, the Regional Administrator concluded that the emergency closure of the fishery will have no effect on federally listed species and will not result in the destruction or modification of designated critical habitat.