Established by section 301 of the Immigration Act of 1990, IMMACT 1990, Public Law 101-649 (November 29, 1990), the Family Unity Program provides renewable periods of voluntary departure and employment authorization for the eligible spouses and children of legalized aliens. A legalized alien is a person who has been granted temporary or permanent residence status under section 210 (Special Agricultural Worker (SAW)) or section 245A (Legalization) programs of the Immigration and Nationality Act (Act), or a permanent resident under the Cuban/Haitian Adjustment Act under section 202 of the Immigrant Reform and Control Act of 1986 (IRCA), Public Law 99-603 (November 6, 1986). To establish eligibility for the benefits, the family relationship must have existed as of May 5, 1988, for the Legalization and Cuban/Haitian Adjustment Act programs or as of December 1, 1988, for SAW recipients. The family members must also have been present in the United States prior to May 5 or December 1, 1988, as applicable, and have resided in the U.S. since that date.

As part of the settlement of a Nationwide class action lawsuit, Hernandez v. Reno , C.A. No. 9:93 CV 63 (E.D. Tex., filed Dec. 30, 1997), the Service agreed to revise the existing Family Unity Program benefits application system so that an applicant no longer had to file one application (Form I-817, Application for Voluntary Departure under the Family Unity Program) to receive a grant of voluntary departure under the Family Unity Program and then file a separate application (Form I-7657, Application for Employment Authorization) to receive an employment authorization document. The implementation of this aspect of the settlement agreement has involved two phases. During the first phase, which was implemented effective January 29, 1998, the Service issued supplemental instructions which provided that from then forward, the Form I-765 would be treated as a supplement to and not a form separate from the Form I-817. The Form I-765 supplement was attached to each Form I-817 that was mailed to potential applicants. Applicants were encouraged to file the two forms jointly and were required to pay only the filing fee applicable to the Form I-817.

Since the implementation of phase one, the Service revised its fee structure including the amount charged for the Form I-817. (See 63 FR 43604). The amount currently charged as a result of the change is $120. The fee is necessary to recover the cost to the Government of both the adjudication of a request for voluntary departure and the issuance of an employment authorization document under the Family Unity Program. (63 FR 1775). A separate application and fee, however, will be required of any person granted Family Unity benefits who seeks to replace a Family Unity Program benefit based on an employment authorization document that is lost, misplaced, mutilated, or destroyed.

Phase two of the implementation of the “single application” system agreed to under the Hernandez v. Reno settlement agreement involved the development and issuance of a revised Form I-817 that would contain sufficient requests for information from the applicant so that an employment authorization document could be issued without resorting to the use of the Form I-765 as a supplement. Such a form has now been developed and has been sent to the Office of Management and Budget (OMB) for review. Approval of the revised Form I-817, now entitled “Application for Benefits under the Family Unity Program,” will result in the grant of voluntary departure for a 2-year period and the issuance of an employment authorization document valid for the same period as the grant of voluntary departure.

Under the Family Unity Program, an applicant is an “eligible immigrant” for purposes of the program if he or she is a spouse or unmarried child of a legalized alien. A legalized alien has been defined under 8 CFR § 236.11 as a temporary or permanent resident under section 210 (SAW) and section 245A (Legalization) programs of the Act or a permanent resident under the Cuban/Haitian Adjustment Act under section 202 of IRCA.

An alien has been defined, for purposes of this Act, to include, “any person not a citizen or national of the United States.” See 8 U.S.C. 1101(a)(3) (Supp. IV 1998). The Service recognizes that defining “legalized alien” to include naturalized U.S. citizens is exceptional. Nevertheless, in light of the congressional policies of family reunification and encouragement of naturalization, we think it is clear that Congress did not intend to deprive eligible legalized residents of family unity benefits under these provisions on the basis of their having obtained U.S. citizenship through naturalization. The regulatory definition thus addresses a specific situation and has not application outside this context.

This rule clarifies that an applicant does not lose eligibility under the Family Unity Program when the family member through whom the applicant claims eligibility becomes a naturalized U.S. citizen provided that the lawful permanent resident maintained status as a legalized alien up until the time of his/her naturalization. However, the naturalized family member should file a Form I-130, Petition for Alien Relative, on the applicant's behalf so that the applicant can apply for adjustment of status to become a lawful permanent resident. If the applicant is an “immediate relative,” which includes the spouse, parents and minor children of a U.S. citizen, the naturalized family member may apply for adjustment of status by submitting Form I-485, Application for Adjustment of Status to Permanent Resident at the same time as the Form I-130 petition. All other applicants may apply for adjustment of status by filing Form I-485 as soon as a Form I-130 petition is approved for them, and they are notified that a visa number is available. The visa number must be available at both the time of application and the time of approval of the Form I-485. All approved applicants will remain eligible for Family Unity Program benefits until their adjustment of status to that of a lawful permanent resident. If the sponsoring family member filed a Form I-130 petition for the family-based 2A preference category, Spouse and Children and Unmarried Sons and Daughters of Permanent Residents, for the applicant before naturalization, he may file a new Form I-130 petition after naturalization for the family-based 1A preference category, Unmarried Sons and Daughters of Citizens. The change of preference classification may significantly accelerate the applicant's priority date.

On September 30, 1996, the President signed the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), Pub. L. 104-208. Section 383 of IIRIRA provides that aliens who committed a specific act of juvenile delinquency, as defined in 18 U.S.C. 5031, are ineligible for benefits under the Family Unit Program. Disqualifying acts include acts which if committed by an adult, would be classified either (1) as a felony crime of violence that involved the use or attempted use of physical force against another individual, or (2) a felony offense which intrinsically involved a substantial risk of the use of such physical force.

The definitions to be used in implementing section 383 of IIRIRA are drawn from the United States Code. A “juvenile” is defined as a “person who has not attained his eighteenth birthday.” 18 U.S.C. 5031. “Juvenile deliquency” is defined as “the violation of a law of the United States committed by a person prior to his eighteenth birthday which would have been a crime if committed by an adult.” 18 U.S.C. 5031. As a result, the class of aliens ineligible for Family Unity Program benefits now includes individuals who, while under the age of 18, violated a law of the United States which, if committed by an adult, would have constituted either (1) a felony crime of violence involving the use or the attempted use of physical force against another individual, or (2) a felony offense involving a substantial risk of the use of violence against another individual. Section 383 also applies to any alien who is over the age of 18, and who committed such an act of juvenile delinquency before his or her 18th birthday.

The amendments made by section 383 of IIRIRA apply to benefits granted or extended after September 30, 1996.

The Service's implementation of this rule as an interim rule, with provisions for post-promulgation public comments, is based upon the “good cause” exceptions found at 5 U.S.C. 553(b)(3)(B) and (d)(3). The reason and the necessity for immediate implementation of this interim rule without prior notice and comment is because parts of this rule merely codify in the Service's regulation the statutory mandates in section 383 of Public Law 104-208. In addition, some of the changes in this rule are beneficial to the affected public in that they either serve to implement the Hernandez v. Reno settlement agreement or to clarify that certain aliens do not lose eligibility because their sponsoring family member has naturalized. Therefore, it is impracticable and unnecessary to adopt this rule with the prior notice and comment period normally required under 5 U.S.C. 553(b) or with the delayed effective date normally required under 5 U.S.C. 553(d). The removal of 8 CFR 274a.12(c)(12), Family Unity Program-based employment authorization, is an agency rule of practice and procedure and, therefore, exempt from the requirements of 5 U.S.C. 553.

The Commissioner of the Immigration and Naturalization Service, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. While this rule does affect individuals, the number affected will be minimal. There is no impact on small entities.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is considered by the Department of Justice, Immigration and Naturalization Service, to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to the OMB for review.

This rule will not have substantial direct effects on the States, on the relationships between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This interim rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

The Commissioner of the Immigration and Naturalization Service has reviewed this regulation and has determined that it may affect family well-being as that term is used in section 654 of the Treasury-General Government Appropriations Act, 1999, Public Law 105-277 Div. A. Accordingly, the Service has assessed this action in accordance with the criteria specified by section 654(c)(1). This regulation will create a positive effect on the family by allowing Family Unity Program beneficiaries to retain eligibility when their sponsoring family member naturalizes. This will have the effect of keeping families together by encouraging their adjustment of status to that of a legal permanent resident while allowing them to retain Family Unity Program benefits until that time. Additionally, when the sponsoring family member naturalizes, the subsequent change of preference classification may significantly move forward the applicant's priority date, allowing them to adjust their status even sooner. Finally, this regulation will have the effect of strengthening the stability of the family and establishing an explicit policy concerning the relationship between the behavior and personal responsibility of youth, and the norms of society.

The Service has requested expedited OMB review of the revised Form I-817 in order to comply with the settlement agreement in the Hernandez v. Reno litigation. During the course of the development of the revised Form I-817, the Service made several revisions unrelated to the implementation of the Hernandez v. Reno settlement. These additional revisions were necessary due to changes in the Family Unity provisions and inadmissibility grounds affected by the IIRIRA. Finally, changes were made on the form to reflect the changes made to the regulations by this interim rule. The Service is requesting comments on revised Form I-817.

(1) Is a temporary or permanent resident under section 210 or 245A of the Act;

(2) Is a permanent resident under section 202 of the Immigration Reform and Control Act of 1986 (Cuban/Haitian Adjustment); or

(3) Is a naturalized U.S. citizen who was a permanent resident under section 210 or 245A of the Act or section 202 of the Immigrant Reform and Control Act of 1986 (IRCA) (Cuban/Haitian Adjustment), and maintained such a status until his or her naturalization.

In an interim rule effective March 20, 2000, and published in the Federal Register on April 18, 2000 (65 FR 20713-20714, Docket No. 00-033-1), we amended the regulations in 9 CFR part 94 by removing the Republic of Korea from the list of countries in § 94.1 declared free of rinderpest and foot-and-mouth disease (FMD). We also removed the Republic of Korea from the list of countries in § 94.11 declared free of these diseases, but subject to certain restrictions because of their proximity to or trading relationships with FMD-affected regions. We took this action because the existence of foot-and-mouth disease was confirmed in the Republic of Korea. As a result of this action, the importation of ruminants or swine and any fresh (chilled or frozen) meat and other products of ruminants or swine into the United States from the Republic of Korea is prohibited or restricted.

Comments on the interim rule were required to be received on or before June 19, 2000. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Orders 12866 and 12988, and the Paperwork Reduction Act.

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

This rule affirms an interim rule that amended the regulations in 9 CFR part 94 governing the importation of certain animals, meat, and other animal products by removing the Republic of Korea from the list of regions declared free of rinderpest and FMD. We took this action because of an outbreak of FMD in that country. The interim rule prohibits or restricts the importation of any ruminant or swine and any fresh (chilled or frozen) meat or other products of ruminants or swine into the United States from the Republic of Korea. The interim rule was necessary to protect the livestock of the United States from FMD.

The following analysis addresses the economic effect of this rule on small entities, as required by the Regulatory Flexibility Act.

FMD is a highly communicable viral disease of cattle and swine. It also affects sheep, goats, and other cloven-hooved ruminants. The disease is characterized by fever and blisterlike lesions on the tongue and lips, in the mouth, on the teats, and between the hooves. It causes severe losses in the production of meat and milk. Many affected animals recover, but the disease leaves them debilitated. FMD is present in many parts of the world, but the United States has been free of the disease since 1929.

FMD viruses can be spread by animals, people, or materials that bring the virus into physical contact with susceptible animals. Imports of animal products contaminated with the virus pose the greatest risk of introducing FMD into the United States. For example, the virus can survive in chilled, frozen, salted, cured and partially cooked meats. Because it spreads widely and rapidly and has grave economic as well as physical consequences, FMD is one of the animal diseases that livestock owners dread most.

Animals in the United States are highly susceptible to FMD viruses because they have not developed immunity to the disease and are not vaccinated against it. If an outbreak did occur in the United States, this disease could spread rapidly to all sections of the country by routine livestock movements unless detected early and eradicated immediately. If allowed to spread unchecked, it could take years and cost billions of dollars to eradicate FMD from the United States.

The livestock industry plays a significant role in the U.S. economy. There were approximately 1,115,650 cattle operations in the United States in 1998, 1 with approximately 99.7 million head of cattle valued at $60.1 billion. About 99 percent of these operations had gross receipts of less than $500,000. There were approximately 114,470 hog producers in the United States in 1998, with approximately 61.1 million hogs valued at just under $5.0 billion. More than 99 percent of these producers had gross receipts of less than $500,000. There were approximately 68,810 sheep and lamb operations in the United States in 1998, with approximately 7.8 million sheep and lambs valued at $798 million. More than 99 percent of these operations had receipts of less than $500,000. Based on the 1997 Census of Agriculture, there were approximately 57,900 goat producers in the United States in 1997. They raised 1,989,799 goats with an approximate value of $74 million. More than 99 percent of these goat producers had receipts of less than $500,000.

The U.S. livestock industry also plays an important role in international trade. U.S. competitiveness in international markets relies to a great degree upon this country's reputation for producing high quality disease-free animals and animal products. Maintaining these favorable trade conditions depends, in part, on continued aggressive efforts to prevent any threat of FMD introduction into the United States. A single outbreak of FMD, anywhere in the United States, would close our major export markets of livestock and livestock products overnight. Most exports of meat, animals and byproducts would be stopped until the disease was completely eradicated. In 1998, total earnings from U.S. exports of ruminants and swine, and fresh (chilled or frozen) meat and other products of ruminants and swine were approximately $4.5 billion. Consequently, an outbreak of FMD could result in the potential loss of export sales in the billions of dollars as well as other costs to those involved in the U.S. livestock industry.

This action will produce economic benefits by protecting against the introduction of FMD into the United States. We expect that prohibiting or restricting the importation into the United States of any ruminant or swine and any fresh (chilled or frozen) meat and other products of ruminants or swine from the Republic of Korea will have little or no effect on U.S. entities (importers, members of the public, and producers), large or small. U.S. imports of these products from the Republic of Korea are very small. For example, between 1996 and 1998, the United States did not import any reportable amounts of ruminants and swine or fresh (chilled or frozen) meat or other products of ruminants and swine from the Republic of Korea, other than $4,000 in imported dairy products in 1998. Since the Republic of Korea is not a significant source of these products for the U.S. market, restrictions on imports from the Republic of Korea should not have a noticeable effect on producer, wholesale, or consumer prices in the United States. Any shortfall of supply could easily be met from domestic or other sources. Therefore, we expect that there will be very little or no effect on U.S. entities as a result of this restriction.

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

In an interim rule effective March 8, 2000, and published in the Federal Register on April 18, 2000 (65 FR 20712-20713, Docket No. 00-031-1), we amended the regulations in 9 CFR part 94 by removing Japan from the list of countries in § 94.1 declared free of rinderpest and foot-and-mouth disease (FMD). We also removed Japan from the list of countries in § 94.11 declared free of these diseases, but subject to certain restrictions because of their proximity to or trading relationships with FMD-affected regions. We took this action because the existence of foot-and-mouth disease was confirmed there. As a result of this action, the importation of any ruminant or swine and any fresh (chilled or frozen) meat and other products of ruminants or swine into the United States from Japan is prohibited or restricted.

Comments on the interim rule were required to be received on or before June 19, 2000. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Orders 12866 and 12988, and the Paperwork Reduction Act.

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

This rule affirms an interim rule that amended the regulations in 9 CFR part 94 governing the importation of certain animals, meat, and other animal products by removing Japan from the list of regions declared free of rinderpest and FMD. We took this action because of an outbreak of FMD in that country. The interim rule prohibits or restricts the importation of any ruminant or swine and any fresh (chilled or frozen) meat and other products of ruminants or swine into the United States from Japan. The interim rule was necessary to protect the livestock of the United States from FMD.

The following analysis addresses the economic effect of this rule on small entities, as required by the Regulatory Flexibility Act.

FMD is a highly communicable viral disease of cattle and swine. It also affects sheep, goats, and other cloven-hooved ruminants. The disease is characterized by fever and blisterlike lesions on the tongue and lips, in the mouth, on the teats, and between the hooves. It causes severe losses in the production of meat and milk. Many affected animals recover, but the disease leaves them debilitated. FMD is present in many parts of the world, but the United States has been free of the disease since 1929.

FMD viruses can be spread by animals, people, or materials that bring the virus into physical contact with susceptible animals. Imports of animal products contaminated with the virus pose the greatest risk of introducing FMD into the United States. For example, the virus can survive in chilled, frozen, salted, cured and partially cooked meats. Because it spreads widely and rapidly and has grave economic as well as physical consequences, FMD is one of the animal diseases that livestock owners dread most.

Animals in the United States are highly susceptible to FMD viruses because they have not developed immunity to the disease and are not vaccinated against it. If an outbreak did occur in the United States, this disease could spread rapidly to all sections of the country by routine livestock movements unless detected early and eradicated immediately. If allowed to spread unchecked, it could take years and cost billions of dollars to eradicate FMD from the United States.

The livestock industry plays a significant role in the U.S. economy. There were approximately 1,115,650 cattle operations in the United States in 1998, 1 with approximately 99.7 million head of cattle valued at $60.1 billion. About 99 percent of these operations had gross receipts of less than $500,000. There were approximately 114,470 hog producers in the United States in 1998, with approximately 61.1 million hogs valued at just under $5.0 billion. More than 99 percent of these producers had gross receipts of less than $500,000. There were approximately 68,810 sheep and lamb operations in the United States in 1998, with approximately 7.8 million sheep and lambs valued at $798 million. More than 99 percent of these operations had receipts of less than $500,000. Based on the 1997 Census of Agriculture, there were approximately 57,900 goat producers in the United States in 1997. They raised 1,989,799 goats with an approximate value of $74 million. More than 99 percent of these goat producers had receipts of less than $500,000.

The U.S. livestock industry also plays an important role in international trade. U.S. competitiveness in international markets relies to a great degree upon this country's reputation for producing high quality disease-free animals and animal products. Maintaining these favorable trade conditions depends, in part, on continued aggressive efforts to prevent any threat of FMD introduction into the United States. A single outbreak of FMD, anywhere in the United States, would close our major export markets of livestock and livestock products overnight. Most exports of meat, animals and byproducts would be stopped until the disease was completely eradicated. In 1998, total earnings from U.S. exports of ruminants and swine, and fresh (chilled or frozen) meat and other products of ruminants and swine were approximately $4.5 billion. Consequently, an outbreak of FMD could result in the potential loss of export sales in the billions of dollars as well as other costs to those involved in the U.S. livestock industry.

This action will produce economic benefits by protecting against the introduction of FMD into the United States. We expect that prohibiting or restricting the importation into the United States of any ruminant or swine and any fresh (chilled or frozen) meat and other products of ruminants or swine from Japan will have little or no effect on U.S. entities (importers, members of the public, and producers), large or small. In 1998, the United States imported from Japan ruminants and swine and fresh (chilled or frozen) meat of ruminants and swine valued at approximately $3.8 million. This represents less than 1 percent of the total U.S. imports of these products. Since Japan is not a significant source of these products for the U.S. market, restrictions on imports from Japan should not have a noticeable effect on producer, wholesale, or consumer prices in the United States. Any shortfall of supply could easily be met from domestic or other sources. Therefore, we expect that there will be very little or no effect on U.S. entities as a result of this restriction.

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

This amendment to 14 CFR 71 revises the Class E airspace at Oakley, KS. A review of the Class E airspace for Oakley Municipal Airport, KS, indicates it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the ARP to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Oakley Municipal Airport, KS, will provide additional controlled airspace for aircraft operating under IFR, revise the ARP and comply with the criteria of FAA Order 7400.2D. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a final rule and was not preceded by a notice of proposed rulemaking, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this action will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-20.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to 14 CFR 71 revises the Class E airspace at Atwood, KS. A review of the Class E airspace for Atwood-Rawlins County-City Airport, KS, indicates it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the ARP to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Atwood-Rawlins County-City County Airport, KS, will provide additional controlled airspace for aircraft operating under IFR, revise the ARP and comply with the criteria of FAA Order 7400.2D. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a final rule and was not preceded by a notice of proposed rulemaking, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this action will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-18.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Airspace, Incorporation by reference, Navigation (air).

There are Part 135 operations at the Columbia Regional Airport after the ATCT is closed. A revision to the Class E surface area changes the status from part time to full time. The Class E surface area will provide controlled airspace for Part 135 and other IFR operations when the ATCT is closed. Class E surface areas designated as a surface area for an airport are published in paragraph 6002 of FAA Order 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a final rule and was not preceded by a notice of proposed rulemaking, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarized each FAA-public contact concerned with the substance of this action will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-21.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

A final rule that implemented the measures contained in Framework 33 to the Northeast Multispecies FMP was published in the Federal Register on April 24, 2000 (65 FR 21658), and most of the measures were made effective on May 1, 2000. However, because OMB approval of the reporting requirement contained in Framework 33 had not yet been received as of the effective date of that rule, effectiveness of the Charter/party vessel requirements and related prohibitions contained in the framework was delayed. OMB approval for those measures was received on June 20, 2000. Consequently, this rule makes §§ 648.14(b)(2), 648.81(g)(2)(iii), and 648.89(e), which were codified in the April 24, 2000, final rule, effective.

NOAA codifies its OMB control numbers for information collection at 15 CFR part 902. Part 902 collects and displays the control numbers assigned to information collection requirements of NOAA by OMB pursuant to the Paperwork Reduction Act (PRA). This final rule codifies OMB control number 0648-0412 for §§ 648.81 and 648.89.

Under NOAA Administrative Order 205-11, dated December 17, 1990, the Under Secretary for Oceans and Atmosphere, NOAA, has delegated to the Assistant Administrator for Fisheries, NOAA, the authority to sign material for publication in the Federal Register .

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

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

This rule contains a collection-of-information requirement subject to the PRA that has been approved by OMB under 0648-0412. The estimated time per response for a telephone call to request a Multispecies Charter/party Gulf of Maine Closed Area Exemption Certificate is 2 minutes.

The estimated response time includes the time needed for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these reporting burden estimates or any other aspect of the collection-of-information, including suggestions for reducing the burden, to NMFS and OMB (see ADDRESSES ).

In Order No. 637-A, issued on May 19, 2000, 1 the Federal Energy Regulatory Commission (Commission) established procedures for filing pro forma tariff sheets in compliance with the order electronically through Internet E-Mail. Pipelines are to make the required filings on June 15, July 17, and August 15, 2000. 2 According to the procedures, pipelines may file the electronic pro forma tariff sheets through Internet E-Mail to 637FASTR@ferc.fed.us in the following format: on the subject line, specify the name of the filing entity; in the body of the E-Mail, specify the name, telephone number, and E-Mail address of a contact person; the pro forma tariff sheets should be attached to the E-Mail message. Pipelines not filing using Internet E-Mail are to file the pro forma tariffs on diskette along with the paper filing and must label the diskette as containing pro forma tariff sheets.

During the first set of compliance filings, questions about the procedures were raised. The following is intended to clarify the procedures for the last two sets of filings.

1. To identify the Pro Forma tariff sheets, the word “Pro Forma” should appear on each sheet before the volume name, e.g., Pro Forma Second Revised Volume No. in the upper left hand side of each sheet. The word Pro Forma need not appear before the sheet number on the upper right hand side of each sheet.

2. The E-mail file containing the Pro Forma tariff sheets should be labeled 〈 company name, or abbreviation, limited to two words 〉 followed by 637.asc. For example, Columbiagulf637.asc; MIGC637.asc; or Transco637.asc is acceptable.

3. A diskette containing an electronic copy of the notice of filing is not required for the initial Order No. 637 compliance filing. A basket notice will be issued identifying all pipelines filing on July 17 and August 15, 2000. However, if the initial Order No. 637 application is amended, the amended filing must contain a diskette with a copy of the notice. The electronic notice for an amended application should not be filed as part of the E-mail filing which should only contain the Pro Forma tariff sheets.

4. For the purpose of paginating tariff sheets, the Pro Forma tariff sheet is for informational purposes and is not an effective tariff sheet. The Pro Forma tariff sheet cannot be superseded, so the pagination of any subsequent live tariff filing should be made as if the Pro Forma Sheet had not been filed.

As a result of the Uruguay Round Agreements, approved by Congress in section 101 of the Uruguay Round Agreements Act (URAA) (Pub. L. 103-465), the President, by Presidential Proclamation No. 6763, established a tariff-rate quota for imported sugar-containing products.

Under a tariff-rate quota, the United States applies one tariff rate, known as the in-quota tariff rate, to imports of a product up to a particular amount, known as the in-quota quantity, and another, higher rate, known as the over-quota rate, to imports of a product in excess of the given amount. The preferential, in-quota tariff rate would be applicable only to the extent that the aggregate in-quota quantity of a product allocated to a country had not been exceeded.

Under Presidential Proclamation No. 7235, dated October 7, 1999, the United States Trade Representative (USTR) was given authority under section 404(a) of the URAA to implement the tariff-rate quota for sugar-containing products to ensure that they do not disrupt the orderly marketing of such products in the United States. The USTR has already assigned Canada an in-quota allocation of the sugar-containing products (64 FR 54719; October 7, 1999).

As part of the implementation of this tariff-rate quota, the USTR has established an export-certificate program under which exporting countries that have an allocation of the in-quota quantity and that wish to participate in the program may use export certificates for their sugar-containing products that are exported to the United States. The USTR issued regulations for this export-certificate program (15 CFR part 2015) (64 FR 67152; December 1, 1999).

An exporting country wishing to participate in the export-certificate program must notify the USTR and provide the necessary supporting information. As defined in the USTR regulations (15 CFR 2015.2(e)), a participating country is a country that has received an allocation of the in-quota quantity of the tariff-rate quota, and that the USTR has determined, and has so informed Customs, is eligible to use export certificates for their sugar-containing products exported to the United States. The USTR has stated that it intends to publish a notice in the Federal Register whenever a country becomes, or ceases to be, a participating country.

The particular sugar-containing products subject to a tariff-rate quota for which the USTR has established the export-certificate program are described in additional U.S. Note 8 to chapter 17 of the Harmonized Tariff Schedule of the United States (HTSUS). Specifically, unless excepted as provided in additional U.S. Note 3 to chapter 17, HTSUS, the imported sugar-containing products covered by the export-certificate program contain over 10 percent by dry weight of sugars derived from cane or sugar beets, whether or not mixed with other ingredients, and they are classified under one of the following HTSUS subheadings: 1701.91.54, 1704.90.74, 1806.20.75, 1806.20.95, 1806.90.55, 1901.90.56, 2101.12.54, 2101.20.54, 2106.90.78, or 2106.90.95.

While a country does not need to participate in the export-certificate program in order to receive the in-quota tariff rate for its share of the in-quota quantity, using export certificates assures the exporting country that only those exported sugar-containing products that it intends for the United States market are counted against its in-quota allocation. As already noted, this helps ensure that such products do not disrupt the orderly marketing of sugar-containing products in the United States.

On December 4, 1998, the Governments of the United States and Canada entered into a Record of Understanding regarding Areas of Agricultural Trade. In Annex 17 of this Record of Understanding, the United States agreed to require an export permit issued by the Government of Canada in order to enable an importer to claim the in-quota tariff rate for those sugar-containing products of Canadian origin described in additional U.S. Note 8 to chapter 17, HTSUS. Canada was thus a participating country in this export-certificate program as of January 31, 2000, the effective date of the USTR rule.

In accordance with the rulemaking of the USTR, by a document published in the Federal Register (65 FR 5430) on February 4, 2000, Customs issued an interim rule that added a new § 132.17 to the Customs Regulations (19 CFR 132.17), in order to prescribe the form and manner by which an importer establishes that a valid export certificate exists, including a unique number for the certificate that must be referenced on the entry or withdrawal from warehouse for consumption, whether filed in paper form or electronically. This was intended to ensure that no imports of the specified sugar-containing products of a participating country are counted against the country's in-quota allocation unless the products are covered by a proper export certificate. The export certificate is necessary in this regard in order to enable the importer to claim the in-quota rate of duty on the sugar-containing products.

In addition, the Interim (a)(1)(A) List set forth as an Appendix to part 163, Customs Regulations (19 CFR part 163, Appendix), that lists the records required for the entry of merchandise, was revised to add a reference to the requirement in new § 132.17 that an importer possess a valid export certificate for sugar-containing products that are subject to a tariff-rate quota and that are products of a participating country, in order for the importer to be able to claim the applicable in-quota rate of duty.

Also, § 132.15, Customs Regulations (19 CFR 132.15), was revised to make provision for electronic entry filing in the case of beef subject to a tariff-rate quota, for which the importer must similarly possess a valid export certificate in order to claim the in-quota rate of duty.

No comments were received from the public in response to the interim rule, and Customs has now determined to adopt the interim rule as a final rule without change.

As discussed in the interim rule, since the amendments are not subject to the notice and public procedure requirements of the Administrative Procedure Act (5 U.S.C. 553), they are not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Also, because this document involves a foreign affairs function of the United States and implements an international agreement, it is not subject to the provisions of E.O. 12866.

The collections of information involved in this interim rule have already been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) and assigned OMB Control Numbers 1515-0065 (Entry summary and continuation sheet) and 1515-0214 (General recordkeeping and record production requirements). This rule does not propose any substantive changes to the existing approved information collections.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by OMB.

FDA has discovered that errors have been incorporated into the agency's codified regulations for 21 CFR parts 821, 895, and 900. This document corrects those errors. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive.

This rule finalizes an interim rule (65 FR 3124, Jan. 20, 2000, as corrected at 65 FR 5024, Feb. 2, 2000) which identified six products as being exempt from certain portions of the Controlled Substances Act (21 U.S.C. 801 et seq. ) (CSA). Section 1903 of the Anabolic Steroids Control Act of 1990 (title XIX of Pub. L. 101-647) (ASCA) provides that the Attorney General may exempt products which contain anabolic steroids from all or any part of the CSA if the products have no significant potential for abuse. The procedure for implementing this section of the ASCA is described in 21 CFR 1308.33. Exempt status removes each product from application of the registration, labeling, records, reports, prescription, physical security, and import and export restrictions associated with Schedule III substances.

Manufacturers of six anabolic steroid products submitted exempt status applications to the Deputy Assistant Administrator for the DEA Office of Diversion Control in accordance with 21 CFR 1308.33. Each application delineated a set of facts which the applicant believed justified the exempt status of its product. The applicants provided information which they believed showed that because of the specific product preparation, concentration, mixture, or delivery system these products had no significant potential for abuse. Upon acceptance of the applications, the Deputy Assistant Administrator requested from the Assistant Secretary for Health, Department of Health and Human Services (HHS) a recommendation as to whether these products should be considered for exemption from certain portions of the CSA. The Deputy Assistant Administrator received the determination and recommendation of the Assistant Secretary for Health and Surgeon General that there was sufficient evidence to establish that each product does not possess a significant potential for abuse.

In the interim rule, the Deputy Assistant Administrator identified the following six products as being exempt from application of sections 302 and through 309 and 1002 through 1004 of the CSA (21 U.S.C. 822-829 and 952-954) and 21 CFR 1301.13, 1301.22, and 1301.71 through 1301.76:

The interim rule became immediately effective on publication in the Federal Register, January 20, 2000, in order to provide a health benefit to the public by more expeditiously increasing the access to these anabolic steroid products and to reduce regulatory restrictions that DEA (in consultation with HHS) has determined to be an unnecessary burden on the businesses manufacturing these products.

Comments to the interim rule were requested, none were received.

With the publication of this final rule, the complete list of products referred to in 21 CFR 1308.34 is as follows:

Additional copies of this list may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537.

The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, Telephone (202) 307-7297.

The Deputy Assistant Administrator, for the DEA Office of Diversion Control, in accordance with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has reviewed this rule and by approving it, certifies that it will not have significant economic impact on a substantial number of small business entities. The granting of exempt status relieves persons who handle the exempt products in the course of legitimate business from the registration, labeling, records, reports, prescription, physical security, and import and export restrictions imposed by the CSA.

The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866, section 1(b). The Office of Management and Budget (OMB) reviewed the interim rule as a significant action; the DEA received no comments regarding the interim rule. This final rule falls into a category of regulatory actions which OMB has determined are exempt from regulatory review. Therefore, this action has not been reviewed by the OMB.

This action has been analyzed in accordance with the principles and criteria in Executive Order 13132 and it has been determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022). (See the PBGC's two final rules published March 17, 2000, in the Federal Register (at 65 FR 14752 and 14753). Effective May 1, 2000, these rules changed how the interest assumptions are used and where they are set forth in the PBGC's regulations.)

Accordingly, this amendment (1) Adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during August 2000, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during August 2000, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during August 2000.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 7.10 percent for the first 25 years following the valuation date and 6.25 percent thereafter. These interest assumptions represent a decrease (from those in effect for July 2000) of 0.30 percent for the first 25 years following the valuation date and are otherwise unchanged.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 5.25 percent for the period during which a benefit is in pay status, 4.50 percent during the seven-year period directly preceding the benefit's placement in pay status, and 4.00 percent during any other years preceding the benefit's placement in pay status. These interest assumptions represent a decrease (from those in effect for July 2000) of 0.25 percent for the period during which a benefit is in pay status and for the seven-year period directly preceding the benefit's placement in pay status and are otherwise unchanged.

For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during August 2000, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

Pursuant to 5 U.S.C. 553(b)(B), a notice of proposed rulemaking (NPRM) will not be published for this regulation. Good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after Federal Register publication. Due to the fact that plans for this event were recently finalized, there was insufficient time to draft and publish a NPRM. Any delay encountered in this regulation's effective date would be contrary to the public interest since immediate action is needed to protect the maritime public from the hazards associated with the fireworks display, which is intended for public entertainment.

The Iron Spring Farm, Inc., is sponsoring a 10 minute fireworks display in the Atlantic Ocean, Southampton, NY. The safety zone will be in effect from 8:45 p.m., July 19, 2000 until 9:40 p.m. Eastern Daylight Savings Time, July 19, 2000. The safety zone covers all waters of the Atlantic Ocean within a 800 foot radius of the fireworks launching barge which will be located in the Atlantic Ocean, Southampton, NY, in approximate position; 40°-51′20″N, 072°-24′00″W, (NAD 1983). This zone is required to protect the maritime community from the safety dangers associated with this fireworks display. Entry into or movement within this zone will be prohibited unless authorized by the Captain of the Port or his on-scene representative.

This 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. The Office of Management and Budget has not reviewed it 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 proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. The safety zone involves only a portion of the Atlantic Ocean and entry into this zone will be restricted for only 55 minutes. Although this regulation prevents traffic from transiting this section of the Atlantic Ocean, the effect of this regulation will not be significant for several reasons: the duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises 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 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule contains no collection of information requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Governments having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

This rule will not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

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

In addition to the statutes and Executive Orders already addressed in this preamble, the Coast Guard considered the following executive orders in developing this final rule and reached the following conclusions:

E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. This final rule will not effect a taking of private property or otherwise have taking implications under this Order.

E.O. 12875, Enhancing the Intergovernmental Partnership. This final rule meets applicable standards in sections 3(a) and 3(b)(2) of this Order to minimize litigation, eliminate ambiguity, and reduce burden.

E.O. 13405, Protection of Children from Environmental Health Risks and Safety Risks. This final rule is not an economically significant rule and does not concern an environmental risk to safety disproportionately affecting children.

Pursuant to 5 U.S.C. 553(b)(B), a notice of proposed rulemaking (NPRM) will not be published for this regulation. Good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after Federal Register publication. Due to the fact that plans for this event were recently finalized, there was insufficiant time to draft and publish a NPRM. Any delay encountered in this regulation's effective date would be contrary to the public interest since immediate action is needed to protect the maritime public from the hazards associated with the fireworks display, which is intended for public entertainment.

However, we encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking CGD01-00-012 indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8.5 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them.

We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Coast Guard Group/MSO Long Island Sound Command Center at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

The Mashantucket Pequot Tribal Nation of Mashantucket, CT. is sponsoring a 30 minute fireworks display in the Thames River, New London, CT. The fireworks display will occur on July 15, 2000, from 9:25 p.m. until 9:55 p.m.. The safety zone covers all waters of the Thames River within a 1000 foot radius of the fireworks launching barges which will be located off New London, CT., in approximate positions; barge one, 41°−21′01.5″N, 072°−05′25″W, barge two, 41°−20′58″N, 072°−05′23″W, and barge three, 41°−20′53.5″N, 072°−05′21″W (NAD 1983). This zone is required to protect the maritime from the safety dangers associated with this fireworks display. Entry into or movement within this zone will be prohibited unless authorized by the Captain of the Port or his on-scene representative.

This temporary 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 been exempted from review 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 proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This safety zone involves only a portion of the Thames River and entry into this zone will be restricted for 75 minutes on July 15, 2000. Although this regulation prevents traffic from transiting this section of Thames River, the effect of this regulation will not be significant for several reasons: the duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this proposal would have a significant economic impact on a substantial number of small entities. “Small entities” include independently owned and operated small businesses that are not dominant in their field and (2) governmental jurisdictions with populations of less than 50,000.

For the reasons discussed under 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 rule will not have a significant impact on a substantial number of small entities.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. If your small business or organization would be affected by this final rule and you have questions concerning its provisions or options for compliance, please call Chief Chris Stubblefield, telephone (203) 468-4428.

The Ombudsman of Regulatory Enforcement for Small Business and Agriculture, and 10 Regional Fairness Boards, were established to receive comments from small businesses about enforcement by Federal agencies. The Ombudsman will annually evaluate such enforcement and rate each agency's responsiveness to small business. If you wish to comment on enforcement by the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule contains no collection of information requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this action in accordance with the principles and criteria contained in Executive Order 13132, and has determined that this regulations does not have federalism implications under that Order.

Under the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), the Coast Guard must consider whether this rule will result in an annual expenditure by state, local, and tribal governments, in aggregate of $100 million (adjusted annually for inflation). If so, the Act requires that a reasonable number of regulatory alternatives be considered, and that from those alternatives, the least costly, most cost-effective, or least burdensome alternative that achieves the objective of the rule be selected. No state, local, or tribal government entities will be effected by this rule, so this rule will not result in annual or aggregate costs of $100 million or more. Therefore, the Coast Guard is exempt from any further regulatory requirements under the Unfunded Mandates Act.

This proposed rule would not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this proposed rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this regulation and concluded that under Figure 2-1, paragraph 34(g), of Commandant Instruction, M 16475.C, this rule is categorically excluded from further environmental documentation. A written Categorical Exclusion Determination is available in the docket for inspection or copying where indicated under Addresses.

In addition to the statutes and Executive Orders already addressed in this preamble, the Coast Guard considered the following executive orders in developing this final rule and reached the following conclusions:

E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. This final rule will not effect a taking of private property or otherwise have taking of private property or otherwise have taking implications under this Order.

E.O. 12875, Enhancing the Intergovernmental Partnership. This final rule meets applicable standards in sections 3(a) and 3(b)(2) of this Order to minimize litigation, eliminate ambiguity, and reduce burden.

On November 30, 1999, the President signed into law the Veterans Millennium Health Care and Benefits Act, Pub. L. 106-117 (the Act). Three provisions of the Act directly affect the payment of VA benefits. These provisions concern: (1) Payment of dependency and indemnity compensation (DIC) to the surviving spouses of certain former prisoners of war (POWs); (2) provision of health care, education and home loan benefits to surviving spouses upon termination of their remarriages; and (3) addition of bronchiolo-alveolar carcinoma to the list of diseases that VA presumes are the result of exposure to radiation during active military service.

DIC benefits are generally payable to the survivors of veterans who died from their service-connected disabilities. In addition, 38 U.S.C. 1318 authorizes VA to pay DIC benefits to survivors of veterans whose deaths were not service-connected but who were continuously rated totally disabled due to service-connected disabilities for ten years or more immediately preceding the veteran's death, or for five years from the date of such veteran's discharge. Section 501 of Pub. L. 106-117 authorizes payment of DIC to the survivors of former POWs who died after September 30, 1999, and who were continuously rated totally disabled due to a service-connected disability for a period of not less than one year immediately preceding death. This provision is effective November 30, 1999, the date of enactment. This document amends 38 CFR 3.22, to reflect this change.

In 1998, Pub. L. 105-178 restored eligibility to DIC to a surviving spouse of a veteran if that person's subsequent remarriage had been terminated by death or divorce, or if a subsequent relationship had been terminated. Eligibility to DIC was restored effective October 1, 1998. This law restored eligibility only to DIC. Eligibility to ancillary benefits—including VA Civilian Health Care and Medical Program (CHAMPVA), chapter 35 education, and home loan guaranty benefits—was not restored.

Section 502 of Pub. L. 106-117 restores eligibility to health care benefits under 38 U.S.C. chapter 17 (CHAMPVA), education benefits under chapter 35, and home loan guaranty benefits under chapter 37 to a surviving spouse if his or her remarriage has been terminated by death or divorce, or if a surviving spouse has ceased living with another person and holding himself or herself out openly to the public as that person's spouse. Section 502 states that its changes shall take effect on the first day of the first month beginning after the month in which the Act is enacted, i.e., December 1, 1999. This document amends 38 CFR 3.55 to reflect these changes.

Section 503 of the Act adds bronchiolo-alveolar carcinoma to the list of diseases that VA presumes result from exposure to radiation during active military service. This provision of the law is effective November 30, 1999. This document amends 38 CFR 3.309(d) to reflect these changes.

The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. These amendments would not directly affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), these amendments are exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The CAA Amendments of 1990 were enacted on November 15, 1990. Under section 107(d)(1)(c) of the amended CAA, each CO area designated nonattainment prior to enactment of the 1990 Amendments, such as the Anchorage area, was designated nonattainment by operation of law upon enactment of the 1990 Amendments. Under section 186(a) of the Act, each CO area designated nonattainment under section 107(d) was also classified by operation of law as either “moderate” or “serious” depending on the severity of the area's air quality problem. CO areas with design values between 9.1 and 16.4 parts per million (ppm), such as the Anchorage area, were classified as moderate. These nonattainment designations and classifications were codified in 40 CFR part 81. See 56 FR 56846 (November 6, 1991).

(1) The CO nonattainment area is the “Anchorage Area, Anchorage Election District (part), Anchorage nonattainment area boundary.” 40 CFR 81.302.

States containing areas that were classified as moderate nonattainment by operation of law under section 107(d) were required to submit SIPs designed to attain the CO NAAQS as expeditiously as practicable but no later than December 31, 1995. Under section 186(a)(4), Alaska requested and EPA granted a one-year extension of the December 31, 1995 attainment deadline (61 FR 33676, June 28, 1996).

(2) The moderate area SIP requirements are set forth in section 187(a) of the Act and differ depending on whether the area's design value is above or below 12.7 ppm. The Anchorage area has a design value above 12.7 ppm. 40 CFR 81.302.

Anchorage exceeded the CO NAAQS three times during calendar year 1996. On June 12, 1998, EPA made a final finding that the Anchorage CO nonattainment area did not attain the CO NAAQS under the CAA-mandated attainment date after having received a one-year extension from the mandated attainment date of December 31, 1995 for moderate nonattainment areas to December 31, 1996. As a result of that finding, which went into effect on July 13, 1998, (63 FR 32128, June 12, 1998) the Anchorage, Alaska CO nonattainment area was reclassified as serious. The State had 18 months or until January 13, 2000 to submit a new State Implementation Plan (SIP) demonstrating attainment of the CO NAAQS as expeditiously as practicable but no later than December 31, 2000, the CAA attainment date for serious areas. Anchorage complied with the CO NAAQS in 1997, 1998, and 1999, with one or fewer exceedances recorded in each of these years, and no exceedances in the year 2000 to date.

The Alaska Department of Environmental Conservation (ADEC) and the Municipality of Anchorage (MOA) have been conducting local research aimed at quantifying the impact of motor vehicle cold start emissions and warm-up idling on ambient CO in Anchorage. The local research program included: (1) A CO saturation monitoring study to better characterize the nature of the CO problem in Anchorage's neighborhoods and near major roadways; (2) a driver idling behavior study to quantify the prevalence and duration of extended warm-up idling among Anchorage drivers in the winter months; (3) cold weather motor vehicle emission testing to quantify the proportion of emissions that occur during cold starts and warm-up idles; and (4) a “real world” CO emissions inventory that would better reflect unique winter season driving behaviors and cold weather motor vehicle emissions. MOA and ADEC anticipate that the information provided by these studies will be critical to the preparation of a credible SIP. Notwithstanding significant efforts to complete its CO SIP, the State failed to meet the January 13, 2000 deadline for the required SIP submission. EPA is therefore compelled to find that the State of Alaska has failed to make the required SIP submission for Anchorage. The CAA establishes specific consequences if EPA finds that a State has failed to meet certain requirements of the CAA. Of particular relevance here is CAA section 179(a)(1), the mandatory sanctions provisions. Section 179(a) sets forth four findings that form the basis for applications of a sanction. The first finding, that a State has failed to submit a plan required under the CAA, is the finding relevant to this rulemaking.

If Alaska has not made the required complete submittal by January 13, 2002, pursuant to CAA section 179(a) and 40 CFR 52.31, the offset sanction identified in CAA section 179(b) will be applied in the affected area. If the State has still not made a complete submission by July 13, 2002, then the highway funding sanction will apply in the affected area, in accordance with 40 CFR 52.31. In addition, CAA section 110(c) provides that EPA must promulgate a federal implementation plan (FIP).

(3) In a 1994 rulemaking, EPA established the Agency's selection of the sequence of these two sanctions: the offset sanction under section 179(b)(2) shall apply at 18 months, followed six months later by the highway sanction under section 179(b)(1) of the Act. EPA does not choose to deviate from this presumptive sequence in this instance. For more details on the timing and implementation of the sanctions, see 59 FR 39832 (August 4, 1994), promulgating 40 CFR 52.31, “Selection of sequence of mandatory sanctions for findings made pursuant to section 179 of the Clean Air Act.”

The sanctions will not take effect if, before January 13, 2002, EPA finds that the State has made a complete submittal of a plan addressing the serious area CO requirements for Anchorage. In addition, EPA will not promulgate a FIP if the State makes the required SIP submittal and EPA takes final action to approve the submittal before July 13, 2002 (section 110(c)(1) of the Act). EPA encourages the responsible parties in Alaska to continue working together on a CO SIP which can eliminate the need for potential sanctions and a FIP.

Today, EPA is making a finding of failure to submit for the Anchorage CO nonattainment area, due to failure of the State to submit a SIP revision addressing the serious area CO requirements of the CAA.

EPA has issued this action as a rulemaking because the Agency has treated this type of action as rulemaking in the past. However, EPA believes that it has the authority to issue this action in an informal adjudication, and is considering which administrative process—rulemaking or informal adjudication—is appropriate for future actions of this kind. Because EPA is issuing this notice as a rulemaking, the Administrative Procedures Act (APA) applies. Today's notice is effective as of July 13, 2000. Under the APA, 5 U.S.C. 553(d)(3), agency rulemaking may take effect before 30 days after the date of publication in the Federal Register if an agency has good cause to mandate an earlier effective date. Today's action concerns a SIP submission that is already overdue and the State is aware of the applicable provisions of the CAA relating to overdue SIPs. In addition, today's action simply starts a “clock” that will not result in sanctions for 18 months, which the State may “turn off” through the submission of a complete SIP submittal. These reasons support an effective date prior to 30 days after the date of publication.

This notice is a final agency action, but is not subject to the notice-and-comment requirements of the APA, 5 U.S.C. 533(b). EPA believes that because of the limited time provided to make findings of failure to submit regarding SIP submissions, Congress did not intend such findings to be subject to notice-and-comment rulemaking. However, to the extent such findings are subject to notice-and-comment rulemaking, EPA invokes the good cause exception pursuant to the APA, 5 U.S.C. 553(d)(3). Notice and comment are unnecessary because no EPA judgment is involved in making a nonsubstantive finding of failure to submit SIPs required by the CAA. Furthermore, providing notice and comment would be impracticable because of the limited time provided under the statute for making such determinations. Finally, notice and comment would be contrary to the public interest because it would divert Agency resources from critical substantive review of submitted SIPs. See 58 FR 51270, 51272, note 17 (October 1, 1993); 59 FR 39832, 39853 (August 4, 1994).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute (see Section II.C in this Federal Register action), it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 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. This action also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This action is not a regulation that will have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This action does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The action also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this action, 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 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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. 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 July 13, 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 the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 12, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Throughout this document whenever “we, us, or our” is used, we mean EPA. This section provides additional information by addressing the following questions:

What are the requirements of section 129 of the CAA?

What is a section 111(d) state plan?

What is Subpart Ce?

What are the requirements for the HMIWI state plan? What is contained in the Kansas state plan?

What are the approval criteria for the state plan?

Section 129 of the CAA Amendments of 1990 requires us to set air emission standards and emission guidelines (EG) under the authority of section 111 of the CAA to reduce pollution from incinerators that burn solid waste. Incinerators that burn medical waste are classified as solid waste incinerators and therefore must be regulated.

Section 111(d) of the CAA, “Standards of Performance for New Stationary Sources,” authorizes us to set air emissions standards for certain categories of sources. These standards are called new source performance standards (NSPS). When an NSPS is promulgated for new sources, we also publish an EG applicable to the control of the same pollutant from existing (designated) facilities. States with designated facilities must then develop a state plan to adopt the EG into its body of regulations and submit it to us for approval. The state plan is called a 111(d) plan.

We issued regulations to reduce air pollution from incinerators that are used to burn hospital waste and/or medical/infectious waste. The NSPS at 40 CFR Part 60, Subpart Ec, and the EG, Subpart Ce, were promulgated by us on September 15, 1997 (62 FR 48374). These rules apply to new and existing incinerators used by hospitals and health care facilities, as well as to incinerators used by commercial waste disposal companies to burn hospital waste and/or medical/infectious waste. The EG applies to existing HMIWIs that commenced construction on or before June 20, 1996.

The Subpart Ce EG is not a direct Federal regulation but is a “guideline” for states to use in regulating existing HMIWIs. The EG requires states to submit for our approval a section 111(d) state plan containing air emission regulations and compliance schedules for existing HMIWIs.

A section 111(d) state plan submittal must meet the requirements of 40 CFR Part 60, Subpart B, sections 60.23 through 60.26, and 40 CFR Part Ce. Subpart B addresses public participation, legal authority, emission standards and other emission limitations, compliance schedules, emission inventories, source surveillance, and compliance assurance and enforcement requirements. The technical requirements for existing HMIWI sources are contained in Subpart Ce. A state will generally address the HMIWI technical requirements by adopting by reference Subpart Ce. The section 111(d) state plan is required to be submitted within one year of the EG promulgation date, i.e., by September 15, 1998.

Prior to submittal to us, the state must make available to the public the state plan and provide opportunity for public comment. If a state fails to have an approvable plan in place by September 15, 1999, sources will be subject to a Federal plan when it is promulgated.

The state of Kansas submitted its section 111(d) state plan to us for approval on May 4, 2000. The state adopted the EG requirements into Kansas Department of Health and Environment (KDHE) rules at Kansas Administrative Regulations (K.A.R.) Article 19, rules 28-19-729 through 28-19-729h. The state effective date of these rules is May 5, 2000. The section 111(d) state plan contains:

1. A demonstration of the state's legal authority to implement the section 111(d) state plan. Pages one and two of the plan list 15 separate Kansas statutes which provide the basis for Kansas' authority to adopt and implement the 111(d) plan.

2. State rules K.A.R. 28-19-729 through 28-19-729h, as the enforceable mechanism. The specific rules are:

• 28-19-729—Standards for “hospital/medical/infectious waste incinerators.”

• 28-19-729a—“Hospital/medical/infections waste incinerators”; definitions.

• 28-19-729b—“Hospital/medical/infections waste incinerators”; emission standards.

• 28-19-729c—Standards for “Hospital/medical/infections waste incinerators”; compliance schedule.

• 28-19-729d—“Hospital/medical/infections waste incinerators”; operation, operator training, and qualification standards.

• 28-19-729e—“Hospital/medical/infections waste incinerators”; waste management plan.

• 28-19-729f—“Hospital/medical/infections waste incinerators”; inspections.

• 28-19-729g—“Hospital/medical/infections waste incinerators”; compliance, performance testing, and monitoring guidelines.

• 28-19-729h—“Hospital/medical/infections waste incinerators”; reporting and recordkeeping.

3. An inventory of sources in Appendix A.

4. An emissions inventory on pages six through eleven, and in Table 2 of the plan.

5. Emission limits, as protective as the EG, are contained in rule 28-19-729b and Table 1 of the rule.

6. A final compliance date of September 15, 2002, which is specified in rule 28-19-729c(b)(2).

7. Testing, monitoring, and inspection requirements, which are contained in rule 28-19-729g.

8. Reporting and recordkeeping requirements, which are contained in rule 28-19-729h.

9. Operator training and qualification requirements, which are contained in rule 28-19-729d.

10. Requirements for the development of waste management plans, which are contained in rule 28-19-729e.

11. A record of the public notice and hearing requirements is provided starting on page 14 of the plan.

12. Provisions for progress reports to EPA is discussed on page 15 of the plan.

13. Title V permit application due date requirements are specified on page 13 of the plan. Title V permit applications must be submitted no later than September 15, 2000.

14. A final compliance date of September 15, 2002, is specified in the plan on page 13 and in rule 28-19-729c.

The state plan was reviewed for approval against the following criteria: 40 CFR 60.23 through 60.26, Subpart B, “Adoption and Submittal of State Plans for Designated Facilities,” and 40 CFR 60, 60.30e through 60.39e, Subpart Ce, “Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators.” A detailed discussion of our evaluation of the state plan is included in our technical support document (TSD) located in the official file for this action and available from the EPA contact listed above. The state plan meets all of the applicable approval criteria.

Based on the rationale discussed above and in further detail in the TSD associated with this action, EPA is approving Kansas' May 4, 2000, section 111(d) state plan for the control of HMIWI emissions, except for those facilities located in Indian country. Any facilities located in Indian country will be subject to a Federal plan. In Kansas there are no known HMIWIs in Indian country. Nothing in this action should be construed as making any determinations or expressing any position with regard to Kansas' audit law (K.S.A. 60-3332, et seq. ), and this action does not express or imply any viewpoint regarding any legal deficiencies in this or any other Federally authorized, deleted, or approved program resulting from the effect of Kansas's audit law.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the state plan should adverse comments be filed. This rule will be effective September 12, 2000 without further notice unless the Agency receives adverse comments by August 14, 2000.

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 12, 2000 and no further action will be taken on the proposed rule.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves preexisting requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (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 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing state plan submissions, our role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), we have no authority to disapprove a state plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a state plan submission, to use VCS in place of a state plan submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, we have taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. section 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. We will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 12, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(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-301013. 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 January 9, 1998 (63 FR 1457) (FRL-5762-6) and February 13, 1998 (63 FR 7414) (FRL-5768-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 7F4881) for a tolerance by BASF Corporation, Agricultural Products, P.O. Box 13528, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by BASF Corporation, Agricultural Products. Also, in the Federal Register of December 22, 1999 (64 FR 71767) (FRL-6396-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP 9E6002) for a tolerance by IR-4, Center for Minor Crop Pest Management, North Brunswick, NJ 08902-3390. There were no comments received in response to either notice of filing.

The petition requested that 40 CFR 180.494 be amended by establishing a tolerance for residues of pyridaben [2-tert-butyl-5-(4-tert-butylbenzylthio-4-choropyridazin-3(2H)-one], in or on the following crops and crop groups: peach and nectarine at 2.4 ppm; plum and prune (fresh) at 0.7 ppm; prune (dried) at 2.2 ppm; cherry and apricot at 0.05 ppm; grape at 1.4 ppm; and tree nut crops at 0.05 ppm. IR-4 proposed a tolerance for cranberry at 0.50 ppm in support of regional registration. Registration for use on cranberry will be geographically limited based on the available residue data to the states of Maine, New Jersey, Rhode Island, Massachusetts, New York, Connecticut, New Hampshire, Vermont, and Delaware. Persons seeking broader registration should contact the appropriate EPA product manager concerning additional residue data required to expand the use area.

Time-limited tolerances currently exist in 40 CFR 180.494 for pyridaben on apple, pear, almond, and citrus. After further reassessment of the data base in lieu of additional data submitted by the petitioner for tolerances originally established for pyridaben on the forementioned commodities, BASF petitioned EPA to reestablish tolerances for pyridaben on apple and pear. As a result of additionally submitted crop field trial data, EPA is proposing that the tolerances be adjusted as follows: apple from 0.6 ppm to 0.5 ppm and pear from 0.75 ppm to 0.6 ppm; tolerances for citrus and almond will remain the same. Currently, a separate tolerance exists in 40 CFR 180.494(a) for pyridaben on almond. Since the crop group, tree nuts, includes almond, the existing almond tolerance is being removed. However, the existing tolerance for almond hulls at 4.0 ppm will remain the same.

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 pyridaben in or on peach at 2.5 ppm; nectarine at 2.5 ppm; plum at 0.75 ppm; cherry, sweet at 0.05 ppm; cherry, tart at 0.05 ppm; apricot at 0.05 ppm; crop group 14, tree nuts at 0.05 ppm; pistachio at 0.05 ppm; grape at 1.5 ppm; prune at 2.5 ppm; and cranberry at 0.5 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 pyridaben are discussed in this unit.

Pyridaben belongs to the pyridazinone class of pesticides. Other active ingredients that belong to this class of pesticides include pyrazon and norflurazon. EPA does not currently have data available to determine with certainty whether pyridaben has a common mechanism of toxicity with any other substances. For the purposes of this human health risk assessment, EPA has not assumed that pyridaben has a common mechanism of toxicity with other pesticides.

In general, the acute toxicology studies conducted on technical grade pyridaben demonstrate that it has moderate to mild toxic effects. It was classified as Toxicity Category III based upon the acute oral LD 50 of 1,100 milligrams/kilograms (mg/kg) in male rats and 570 mg/kg in female rats. The dermal LD 50 , in rabbits was greater than or equal to 2,000 mg/kg (Toxicity Category III) and the inhalation LC 50 was 0.66/0.64 milligram/liter (mg/L) in male/female rats, respectively (Toxicity Cateogry III). The eye irritation study (rabbits) produced slight ocular irritation (Toxicity Cateogry III). Pyridaben was not a dermal irritant (Toxicity Cateogry IV) or sensitizer.

There are guideline acute and subchronic neurotoxicity studies. The neurological symptoms in the available neurotoxicity studies and some of the other studies, were seen only at relatively high doses. The neurotoxic effects (piloerection, hypocricturty, tremors, partially closed eyes) were weak, sporadic, transient and/or non-reproducible with no neuropathological effects. In a 90-day rat study, plasma cholinesterase enzyme (ChE) was statistically-significantly inhibited in the females at the highest dose tested (HDT) of 350 ppm (25.71 mg/kg/day for males or 27.68 mg/kg/day for females). Based on these neurotoxic effects, EPA has required that a developmental neurotoxicity study be submitted. There are developmental toxicity studies in rats and rabbits (by the oral or dermal routes), and a multi-generation reproduction study in rats. The developmental and reproduction toxicity studies showed no effect on reproduction and no increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to pyridaben as demonstrated by a higher developmental lowest observed adverse effect level (LOAEL) than those observed to produce maternal toxicity.

The most common toxicity endpoint across the various studies and tested species was decreased body weight/decreased body weight gain followed by decreased feed consumption and/or feed efficiency. These effects were observed in 13-week feeding studies in mice, rats, and dogs, in a 21-day dermal toxicity study in rats, in a 28-day inhalation toxicity study in rats, in a 13-week neurotoxicity study in rats, in 1-year feeding studies in dogs, in a 78-week feeding/carcinogenicity study in mice, in developmental toxicity studies in rats and rabbits, in a 2-generation reproduction study in rats, and in a 2-year feeding/carcinogenicity study in rats. It is noteworthy that the LOAELs were always based on decreases in body weight gain/decreases in body weight or decreases in food consumption. Other effects were sporadic and involved changes in certain clinical chemistry values or increases or decreases in organ weights. There is no evidence of increased susceptibility of infants and children to any of these endpoints.

In an acceptable rat metabolism study by the oral route, pyridaben was mainly eliminated in feces where 80-97% of the administered dose was excreted regardless of dose or site of label (pyridazinone or benzyl ring). Nearly 20% of the excreted residue in the feces was unmetabolized parent compound and there was some evidence of glucuronide conjugate(s) in the bile. The plasma levels following a single low oral dose (3 mg/kg) peaked at 2-3 hours while peak levels at the high dose (30 mg/kg) were at approximately 24 hours post-dose due, at least in part, to enterohepatic circulation where nearly 22-30% of an administered radioactive dose is excreted in bile within a period of 24 hours. Residual radioactivity was at or near background levels for most tissues by 72 to 168 hours. Generally, there seemed to be increased distribution to fat over time and, compared to other tissues, fat seemed to have relatively more residual radioactivity. Several metabolites, totaling up to 20-30, were resolved in urine and feces and some were structurally identified.

1. Acute toxicity . An acute reference dose (RfD) of 0.13 mg/kg/day NOAEL = 13 mg/kg/day, uncertainty factor (UF) = 100 for use in assessing acute dietary risk for females 13 years and older. This acute RfD is based upon the developmental toxicity study with rats in which developmental effects (decreased fetal body weight and increased delayed bone ossification) were observed at the development LOAEL of 30 mg/kg/day. The acute population adjusted dose (PAD) = acute RfD/FQPA factor (1x) = 0.13 mg/kg/day for females 13 years older.

An acute RfD of 0.50 mg/kg/day (NOAEL = 50 mg/kg/day, UF = 100) was selected for use in assessing acute dietary risk for the general population. This acute RfD is based upon the acute oral neurotoxicity study with rats in which the following effects were observed at the LOAEL of 100 mg/kg/day: clinical signs of toxicity, decreased food consumption, and decreased body weight gain. The acute PAD = acute RfD/FQPA factor (1x) = 0.5 mg/kg/day for the U.S. population.

2. Short-term and intermediate-term toxicity . A NOAEL of 100 mg/kg/day was selected based on a 21-day dermal toxicity study in rats that resulted in decreased body weight gain in female rats at 300 mg/kg/day (LOAEL). A margin of exposure (MOE) of 100 or greater is adequate since the FQPA factor was reduced to 1X.

EPA concluded that for short-term and intermediate-term aggregate exposure risk assessment the MOEs cannot be combined since the toxicological endpoints were different via the oral, dermal, and inhalation routes (i.e., no common endpoint of concern).

3. Long-term dermal toxicity . A long-term dermal endpoint was not selected as the use pattern does not indicate a potential for long-term exposure.

4. Chronic toxicity . A chronic RfD of 0.005 mg/kg/day (NOAEL = < 0.50 mg/kg/day; UF = 100) was selected for use in assessing chronic dietary risk. This chronic RfD is based on the chronic toxicity study in dogs, in which the following effects were observed at the LOAEL of 0.5 mg/kg/day: increased incidence of clinical signs in both sexes and decreased body weight gain in females. An additional uncertainty factor (3x, for not establishing a NOAEL) was not applied to the chronic RfD because the toxic response observed was very minimal and was considered to be a threshold effect. The 100x UF for use in assessing chronic dietary risk was considered to be adequate. The chronic cPAD = chronic RfD/FQPA factor (1x) = 0.005 mg/kg/day.

5. Carcinogenicity . Based on the lack of evidence of carcinogenicity in acceptable studies in male and female rats and mice, pyridaben was classified as a “not likely” human carcinogen based upon the proposed EPA Weight-of-the-Evidence Categories. Also, there was no indication that pyridaben is mutagenic in acceptable in vitro and in vivo studies.

1. From food and feed uses . Tolerances have been established (40 CFR 180.494) for the residues of pyridaben, in or on a variety of raw agricultural commodities. Pyridaben is currently registered for use on almond, apple, citrus fruit, and pear. Time-limited tolerances are established in conjunction with these uses. Additionally, a time-limited tolerance for pyridaben in/on cranberries is established in conjunction with a section 18 request. BASF Corporation has proposed to make the tolerances for pyridaben in/on citrus fruit and pear permanent. Additionally, in today's action, tolerances will be established for pyridaben in/on tree nuts, pistachio, peach, nectarine, plum, prune, apricot, cherry, grape, and cranberry.

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.

i. Acute exposure and risk . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

EPA used the Dietary Exposure Evaluation Model (DEEM ) software for conducting a Tier 1 acute dietary (food only) risk analysis. DEEM is a dietary exposure analysis system developed by Novigen Sciences, Inc. that is used to estimate exposure to a pesticide chemical in foods comprising the diets of the U.S. population, including population subgroups. DEEM contains food consumption data as reported by respondents in the Department of Agriculture (USDA) Continuing Surveys of Food Intake by Individuals conducted in 1989-1992. The assumptions of the Tier 1 acute dietary exposure analysis are tolerance level residues and 100 percent crop-treated estimates. The tolerance levels were adjusted to account for organosoluble residue content.

The acute DEEM analysis indicates the resulting dietary food exposures (at the 95th percentile) occupy up to 19% of the acute PAD for population subgroups exclusive to females 13 years and older. The highest exposed subgroup for females 13 years and older is females (13+/nursing). The analysis also shows that the resulting dietary food exposures (at the 95 th percentile) occupy up to 18% of the acute PAD for population subgroups not specific to females 13 years and older. The highest exposed subgroup for population subgroups not specific to females 13 years and older is all infants (< 1-year).

ii. Chronic exposure and risk . EPA used DEEM software for conducting a Tier 2 chronic (non-cancer) dietary (food only) risk analysis. The assumptions of the Tier 2 chronic dietary exposure analysis are anticipated residue estimates and 100% crop-treated estimates. The chronic DEEM analysis indicates that the most highly exposed population subgroup is non-nursing infants which occupy up to 64% of the chronic PAD.

2. From drinking water . The Agency currently lacks sufficient water-related exposure data from monitoring to complete a quantitative drinking water exposure analysis and risk assessment for pyridaben. Therefore, the Agency is presently relying on computer-generated Estimated Environmental Concentrations (EECs). GENEEC and/or PRZM/EXAMS (both produce estimates of pesticide concentration in a farm pond) are used to generate EECs for surface water and SCI-GROW (an empirical model based upon actual monitoring data collected for a number of pesticides that serve as benchmarks) predicts EECs in ground water. These models take into account the use patterns and the environmental profile of a pesticide, but do not include consideration of the impact that processing raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for assessing whether a pesticide is likely to be present in drinking water at concentrations which would exceed human health levels of concern.

For any given pesticide, the SCI-GROW model generates a single EEC value of pesticide concentration in ground water. That EEC is used in assessments of both acute and chronic dietary risk. It is not unusual for the ground water EEC to be significantly lower than the surface water EECs. The GENEEC model generates several time-based EECs of pesticide concentration in surface water, ranging from 0-days (peak) to 56-days (average). The GENEEC peak EEC is used in assessments of acute dietary risk; the GENEEC 56-day (average) EEC is used in assessments of chronic (non-cancer and cancer) dietary risk. PRZM/EXAMS provides longer duration (up to 36 years) values of pesticide concentration in surface water and is mainly used when a refined EEC is needed.

A drinking water level of comparison (DWLOC) is the concentration of a pesticide in drinking water that would be acceptable as a theoretical upper limit in light of total aggregate exposure to that pesticide from food, water, and residential uses. EPA uses DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water. In the absence of monitoring data for a pesticide, the DWLOC is used as a point of comparison against the conservative EECs provided by computer modeling (SCI-GROW, GENEEC < PRZM/EXAMS).

EPA back-calculates DWLOCs by a two-step process: exposure food + (if applicable) residential is subtracted from the PAD to obtain the maximum acceptable exposure allowed in drinking water; DWLOCs are then calculated using that value and default body weight and drinking water consumption figures. In assessing human health risk, DWLOCs are compared to EECs. When EECs are less than DWLOCs, HED considers the aggregate risk from food + water + (if applicable) residential exposures to be acceptable.

EPA conducted its Tier II screening-level assessments using the simulation models SCI-GROW and PRZM/EXAMS to generate EECs for ground and surface water, respectively. The modeling was conducted based on the environmental profile and the maximum seasonal application rate proposed for pyridaben (0.5 lbs active ingredient (ai/acre) x 2 applications/acre/year on apples). The EECs are summarized in Table 1 below.

i. Acute exposure and risk . Drinking Water Levels of Comparison (DWLOCs). The DWLOCs value are shown in Table 2. For each population subgroup listed, the acute PAD and the acute dietary (food only) exposure for that subgroup were used to calculate the acute DWLOC for the subgroup, using the formulas in footnotes 1 and 2 of Table 2.

ii. Chronic exposure and risk .— Chronic (Non-Cancer) Dietary (Drinking Water) Exposure—Drinking water levels of comparison (DWLOCs) . The DWLOC value are shown in Table 3. For each population subgroup listed, the chronic PAD (0.005 mg/kg/day) and the chronic dietary (food only) exposure for that subgroup were used to calculate the chronic DWLOC for the subgroup, using the formulas in footnotes 1 and 2 of Table 3.

3. From non-dietary exposure . At present, there are no registered or proposed residential uses of pyridaben. Thus, a residential exposure assessment is not required. There is a potential for occupational exposure to pyridaben during mixing, loading, and application activities. However, risks from these routes of exposure are considered negligible.

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 pyridaben 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, pyridaben 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 pyridaben 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 . Acute aggregate risk is the sum of exposures resulting from acute dietary food + acute drinking water. This acute aggregate risk assessment was conducted for all population subgroups, and the acute PAD of 0.13 mg/kg/day is applied to all population subgroups exclusive to females 13 years and older and the acute PAD of 0.50 mg/kg/day is applied to all other population subgroups.

EPA used DEEM software for conducting a Tier 1 acute dietary (food only) risk analysis. The assumptions of the Tier 1 dietary exposure analysis are tolerance level residues and 100% crop-treated estimates. The tolerance levels were adjusted to account for organosoluble residue content.

The resulting dietary food exposures (at the 95 th percentile) occupy up to 19% of the acute PAD for population subgroups exclusive to females 13 years and older (females (13+/nursing)). The resulting dietary food exposures (at the 95 th percentile) occupy up to 18% of the acute PAD for population subgroups not specific to females 13 years and older (all infants (< 1-year)).

The EECs for assessing acute aggregate dietary risk are 0.006 ppb (in ground water, based on SCI-GROW) and 0.215 ppb (in surface water, based on the PRZM/EXAMS). The back-calculated DWLOCs (Table 2) for assessing acute aggregate dietary risk range from 3.2 x 10 3 ppb for the most highly exposed population subgroup (females 13 years and older/nursing) to 1.6 x 10 4 ppb for the U.S. population (all seasons) and non-Hispanic others.

The SCI-GROW and PRZM/EXAMS acute EECs are less than the Agency's level of comparison (the DWLOC value for each population subgroup) for pyridaben residues in drinking water as a contribution to acute aggregate exposure. EPA thus concludes with reasonable certainty that residues of pyridaben in drinking water will not contribute significantly to the aggregate acute human health risk and that the acute aggregate exposure from pyridaben residues in food and drinking water will not exceed the Agency's level of concern (100% of the acute PAD) for acute dietary aggregate exposure by any population subgroup. EPA generally has no concern for exposures below 100% of the acute PAD, because it is a level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to the health and safety of any population subgroup. This risk assessment is considered high confidence, conservative, and very protective of human health.

2. Chronic risk . Chronic (non-cancer) aggregate risk is the sum of exposures resulting from chronic dietary food + chronic drinking water + chronic residential uses. Pyridaben has no registered residential uses. Therefore, this risk assessment is the aggregate of chronic dietary food + chronic drinking water exposures only. This chronic aggregate risk assessment was conducted for all population subgroups, and the chronic PAD is applied to all population subgroups.

EPA used DEEM software for conducting a Tier 2 chronic (non-cancer) dietary (food) exposed analysis. Tier 2 assumptions are anticipated residue levels and 100% crop-treated estimates.

The resulting dietary food exposures occupy up to 64% of the chronic PAD for the most highly exposed population subgroup, non-nursing infants. These results should be viewed as conservative (health protective) risk estimates. Refinements such as use of percent crop-treated information and/or additional refinements of the anticipated residue estimates would yield even lower estimates of chronic dietary exposure.

The EECs for assessing chronic aggregate dietary risk are 0.006 ppb (in ground water, based on SCI-GROW) and 0.020 ppb (in surface water, based on the PRZM/EXAMS). The back-calculated DWLOCs for assessing chronic aggregate dietary risk range from 18 ppb for the most highly exposed population subgroup (non-nursing infants, < 1-year old) to 1.4 x 10 2 ppb for the U.S. population (48 contiguous States—all seasons).

The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's level of comparison (the DWLOC value for each population subgroup) for pyridaben residues in drinking water as a contribution to chronic aggregate exposure. EPA thus, concludes with reasonable certainty that residues of pyridaben in drinking water will not contribute significantly to the aggregate chronic human health risk and that the chronic aggregate exposure from pyridaben residues in food and drinking water will not exceed the Agency's level of concern (100% of the chronic PAD) for chronic dietary aggregate exposure by any population subgroup. EPA generally has no concern for exposures below 100% of the chronic PAD, because it is a level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to the health and safety of any population subgroup. This risk assessment is considered high confidence, conservative, and very protective of human health.

Cancer aggregate risk is based on the sum of exposures resulting from chronic dietary food + chronic drinking water + chronic residential uses. Pyridaben is classified as a “not likely” human carcinogen based upon the proposed EPA Weight-of-the-Evidence Categories. Thus, pyridaben does not pose a cancer risk.

3. 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 pyridaben residues.

1. Safety factor for infants and children —i. In general . 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 UF in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard UF (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/UF 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. Conclusion . There is a complete toxicity data base for pyridaben and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10x safety factor to protect infants and children should be removed. The FQPA factor is removed because:

a. The toxicity data base is complete for the assessment of the effects following in utero and /or postnatal exposure to pyridaben.

b. The toxicity data provided no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure.

c. Although a developmental neurotoxicity study is required, this requirement is not based on criteria reflecting some special concern for developing fetuses or the young which are generally used for requiring a developmental neurotoxicity study and retention of the FQPA safety factor; and, therefore, does not warrant retention of the FQPA safety factor.

d. The exposure assessments will not underestimate the potential dietary (food and water) exposures for infants and children from the use of pyridaben (currently no residential exposure is expected).

2. Acute risk . The resulting dietary food exposures (at the 95 th percentile) occupy up to 19% of the acute PAD for population subgroups exclusive to females 13 years and older (females (13+/nursing). The resulting dietary food exposures (at the 95 th percentile) occupy up to 18% of the acute PAD for population subgroups not specific to females 13 years and older (all infants < 1-year).

The EECs for assessing acute aggregate dietary risk are 0.006 ppb (in ground water, based on SCI-GROW) and 0.215 ppb (in surface water, based on the PRZM/EXAMS). The back-calculated DWLOCs for assessing acute aggregate dietary risk range from 3.2 x 10 3 ppb for the most highly exposed population subgroup (females 13 years and older/nursing) to 1.6 x 10 4 ppb for the U.S. population (all seasons) and non-Hispanic others.

3. Chronic risk . Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to pyridaben from food will utilize 64% of the RfD for infants and children. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to pyridaben in drinking water and from non-dietary, non-occupational exposure, EPA does not expect the aggregate exposure to exceed 100% of the RfD.

4. Short-term or intermediate-term risk . These aggregate risk assessments take into account chronic dietary exposure from food and water (considered to be a background exposure level) plus (short-term, intermediate-term, or long-term, as applicable) indoor and outdoor residential exposure. Since pyridaben is not registered for residential uses, short-term and intermediate-term, and long-term aggregate risk is captured by the assessment for aggregate chronic risk.

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 pyridaben residues.

1. Nature of residues in plants . EPA concludes that the tolerance expression for plant commodities will include pyridaben only and that all organosoluble residues may be presumed to be of comparable toxicity to the parent. Thus, the risk assessment for human dietary consumption of pyridaben-treated plant commodities will include all organosoluble residues. EPA has calculated a ratio of pyridaben to organosoluble residues based upon the low dose pyridaben apple and orange metabolism studies. These studies were chosen because they approximate the proposed use of pyridaben on citrus and apples. For dietary exposure analysis, tolerance levels of pyridaben in/on plant commodities will be multiplied by the ratio of organosoluble residues to pyridaben.

2. Nature of residues in animals . EPA concludes that the tolerance expression for ruminant commodities will include pyridaben and its metabolites PB-7 and PB-9 and that all organosoluble residues may be presumed to be of comparable toxicity to the parent. Thus, the risk assessment for human consumption of ruminant commodities will also include all organosoluble residues. For liver, EPA will calculate a ratio of pyridaben, PB-7 and PB-9 residues to organosoluble residues based upon the ruminant metabolism study. For milk and other tissues, best estimates of residues of concern for risk assessment may need to be based on total organosoluble residues in the goat metabolism study. Dietary exposure of poultry to pyridaben residues is not expected as a result of the proposed uses.

3. Enforcement analytical methods — Plants — Apple, pear, peach, plum, cherry, apricot, grape, pistachio and tree nuts . BASF Method D9312A: For solid samples, residues of pyridaben are extracted by blending the sample with a solution of acetone/water (8:2 v/v). For juice, residues are extracted by mixing the sample with 80% acetone/water (v/v). Following filtration to remove the sample material, the solvent is exchanged to water and an aliquot of the extract is applied to a mini-C18 silica gel column. Residues are eluted with 80% methanol/water (v/v) and the solvent is exchanged to toluene for analysis. Residues of pyridaben are quantified by analysis of the sample extracts by gas chromatography (GLC) utilizing an electron capture detector (63Ni—ECD) and a fused silica column. The method has been validated to a quantification limit of 0.05 p.m. This method has been independently validated for use with apple and pear commodities as per PR Notice 88-5.

BASF Method D9312 has been adequately validated in both apples and almonds. The submitted method is adequate for the enforcement of the proposed tolerances for residues of pyridaben in/on apples, pears, and almonds. This method has been validated by EPA and was submitted to the Food and Drug Administration (FDA) for inclusion in PAM, Volume II.

4. Citrus BASF Method D9309B BASF Method D9309B is briefly described as follows: whole fruit are homogenized and then blended with acetone:water. Sodium chloride is added to the extract and the residues are partitioned into dichloromethane, dried by evaporation, dissolved in DCM:hexane (3:7, v/v) and cleaned up on a silica gel column eluted with DCM:hexane (11:9, v/v). The samples are then dried, dissolved in toluene, and analyzed by GC/ECD. This method has been independently validated for use with citrus commodities as per PR Notice 88-5. The submitted method is adequate for enforcement of permanent tolerances for residues of pyridaben in/on citrus and will be forwarded to the Food and Drug Administration for publication in PAM Vol. II.

5. Enforcement analytical method — Animals — BASF Method D9405 for animal matrices . BASF Method D9405 is briefly described as follows: macerate animal tissue with acetone/water and milk with acetone. Filter and wash the sample with the same solvent. Methylate a portion of the extract with diazomethane. After adding water, load the methylated sample onto a octadecylsilane column and elute with methanol/water. The sample is then evaporated to dryness, dissolved in acetonitrile and analyzed by GC/ECD. This method has been independently validated for use with milk and liver commodities as per PR Notice 88-5. BASF Method D9405 has been validated in both liver and milk.

There are no established or proposed Codex, Canadian or Mexican limits for residues of pyridaben in/on plant commodities or for pyridaben and its metabolites (PB-7 and PB-9) in/on livestock commodities. Therefore, no compatibility issues exist with regard to the proposed U.S. tolerances discussed in this risk assessment.

Therefore, the tolerance is established for residues of pyridaben, in or on peach at 2.5 ppm; nectarine at 2.5 ppm; plum at 0.75 ppm; cherry, sweet at 0.05 ppm; cherry, tart at 0.05 ppm; apricot at 0.05 ppm; crop group, 14, tree nuts at 0.05 ppm; almond hulls at 4.4 ppm; pistachio at 0.05 ppm; grape at 1.5 ppm; prune at 2.5 ppm; cranberry at 0.5 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-301013 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 September 12, 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, 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 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, 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, 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-301013, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 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).

1. This is a summary of the Commission's Report and Order (R&O) FCC 00-220, adopted on June 15, 2000, and released on June 20, 2000. The full text of this R&O is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY A257, 445 12th Street, S.W., Washington, D.C. The complete text may be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, N.W. Washington, D.C. 20037.

2. By letter the Los Angeles and Long Beach Port Pilots (jointly, LA/LB Pilots) request the assignment of an intership marine VHF channel dedicated to port operations (namely, pilot-tug communications) in the Ports of Los Angeles and Long Beach, California. They note that marine VHF Channels 01A (156.050 MHz), 05A (156.250 MHz), and 63A (156.175 MHz) are currently used for U.S. Coast Guard (Coast Guard) designated Vessel Traffic Service (VTS) systems in defined areas of the United States. The LA/LB Pilots recommend that the Commission designate one of these for intership communications regarding port operations to improve vessel traffic safety in the Los Angeles and Long Beach port area.

3. Based on the record in this proceeding, we conclude that designating 156.250 MHz for intership communications related to port operations for the ports of Los Angeles and Long Beach, CA will allow the Marine Exchange of Los Angeles-Long Beach Harbor, Inc. to manage vessel traffic in those areas more efficiently. Further this action will help protect the marine environment by preventing vessel collisions and groundings. Therefore, we are amending § 80.373(f) of the Commission's Rules to indicate that frequency 156.250 MHz (marine VHF Channel 05A) is available only for intership communications related to port operations within the Los Angeles and Long Beach harbor areas. The radio protection area will be defined as “within a 25-nautical mile radius of Point Fermin, California.”

4. In light of our action designating 156.250 MHz for intership communications related to port operations for the ports of Los Angeles and Long Beach, CA, we will lift the current freeze imposed on licensing the Public Safety Pool frequencies of 156.240 and 156.2475 MHz within 100 miles of the geographic center of Los Angeles. The freeze will be lifted as of the date of the release of this R&O . In addition, we are adopting our proposal to make assignments on these Public Safety Pool frequencies within 100 miles of the geographic center of Los Angeles, CA secondary to marine port operations on 156.250 MHz. By secondary, we mean that radio communications from licensees on the Public Safety Pool frequencies 156.240 and 156.2475 MHz may not cause interference to marine port operations on 156.250 MHz and licensees on the Public Safety Pool frequencies are not protected from interference from marine port operations on 156.250 MHz.

5. Finally, we amend 47 CFR 0.331 of the Commission's Rules to authorize the Chief, WTB to amend the maritime service rules at the request of the Coast Guard to indicate that the use of marine VHF private communications frequencies in defined port areas are available for intership communications related to such port operations in order to alleviate the communications congestion related to such port operations.

6. We do not envision or anticipate that allowing the Chief, WTB at the request of the Coast Guard to amend the frequency table in 47 CFR 80.373(f) and make marine VHF frequencies available for intership port operations communications in defined port areas will impact those licenses sold in Auction No. 20, VHF Public Coast (VPC) Service. The forty-two licenses that were auctioned involved the nine channels (“working frequencies”) in the 157.1875-157.4500 MHz (ship transmit) and 161.775-162.0125 MHz (coast transmit) bands assignable to VHF public coast stations for public correspondence. These auctioned frequencies are assigned for radiotelephone working frequencies and are assignable to ship and public coast stations. The frequencies in 47 CFR 80.373(f) are for private communications and are assignable for ship-to-ship and ship-to-coast private communications and are below the frequency range of the auctioned public correspondence frequencies. Therefore the auctioned public correspondence frequencies will not be considered for intership port operations.

7. Overall, we believe the approach outlined above will allow the Commission to expedite Coast Guard requests, which will promote increased safe vessel transit and protect U.S. waters and associated natural resources from environmental harm.

8. Accordingly, we adopt rules: to amend § 80.373(f) of the Commission's Rules to indicate that frequency 156.250 MHz (marine VHF Channel 05A) is available only for intership communications related to port operations within the Los Angeles and Long Beach harbor areas (The radio protection area for these harbors will be defined as “within a 25-nautical mile radius of Point Fermin, California”); to amend § 90.20(c) of the Commission's Rules to indicate that assignments on public safety pool frequencies of 156.240 and 156.2475 MHz within 100 miles of the geographic center of Los Angeles are secondary to marine port operations on 156.250 MHz; and to amend § 0.331 of the Commission's Rules to authorize the Chief, Wireless Telecommunications Bureau to amend the maritime service rules at the request of the Coast Guard to indicate that the use of marine VHF private communications frequencies in defined port areas are available for intership communications related to port operations. We conclude that adoption of these rule changes will allow the vessel traffic in the congested areas of the Los Angeles and Long Beach harbors to be managed more efficiently and will protect the marine environment by preventing vessel collisions and groundings.

9. As required by the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking (NPRM) prepared in this proceeding. The Commission sought written public comment on the proposals in the NPRM, including comments on the IRFA. This present FRFA conforms to the RFA.

10. In this proceeding, we amend parts 0, 80 and 90 of the Commission's Rules to indicate that frequency 156.250 MHz (marine VHF Channel 05A) is available for intership communications related to port operations within the Los Angeles and Long Beach harbor areas. The adopted rules will promote safe vessel transit and protect U.S. waters and associated natural resources from environmental harm.

11. No comments were submitted specifically in response to the IRFA.

12. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The adopted rules would apply to small businesses in the marine radio services that use a marine VHF radio. According to SBA's regulations, a radiotelephone (wireless) must employ no more than 1,500 persons less in order to qualify as a small business concern. According to the Bureau of the Census, only twelve radiotelephone firms out of a total of 1,178 such firms which operated during 1992 had 1,000 or more employees.

13. There are no reporting, recordkeeping and other compliance requirements proposed.

14. By making frequency spectrum available, the adopted rules will have a beneficial economic impact on small business entities that use the frequency 156.250 for intership communications related to port operations within the Los Angeles and Long Beach harbor areas. This flexible approach allows the vessel pilots to manage vessel traffic in the Los Angeles and Long Beach harbor areas more efficiently and protect the marine environment by preventing vessel collisions and groundings. Currently under the rules frequency 156.250 MHz is similarly made available to maritime mobile and was made available for port operations purposes within the Coast Guard designated Houston and New Orleans, and Seattle Vessel Traffic Service (VTS) systems. The alternative in this context—to retain the allocation for maritime mobile in the two ports—would not assist the maritime community in the way expected, including the small entities affected. We believe that the adopted rules are sufficient to alleviate the communications congestion related to port operations in the Los Angeles and Long Beach harbor areas. This decision benefits small entities and seeks to ensure reliable marine communications, increase safe vessel transit to protect U.S. waters and associated natural resources from environmental harm, and increase port efficiency thereby promoting growth within the shipping community.

Report to Congress: The Commission will send a copy of the R&O, including this FRFA, in a report to be sent to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, see 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of the R&O, including FRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the R&O and FRFA (or summaries thereof) will also be published in the Federal Register . See 5 U.S.C. 604(b).

15. Pursuant to the authority of § 4(i), 303(r), and 332(a)(2) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), 332(a)(2), parts 0, 80 and 90 of the Commission's Rules, are amended as set forth.

16. The rule changes will become effective August 14, 2000.

17. The Commission's Reference Information Center, Consumer Information Bureau, SHALL SEND a copy of this R&O, WT Docket No. 99-332, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

18. Pursuant to Section 4(i) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), that this proceeding is terminated .

This is a summary of the Commission's Second Memorandum Opinion and Order on Reconsideration ( Second MO&O ) in PR Docket No. 93-144, adopted November 23, 1999 and released December 2, 1999. The complete text of this Second MO&O is available for inspection and copying during normal business hours in the Commission's Reference Center, room CY-A257, 445 12th Street SW, Washington, DC. This Second MO&O is also available through the Internet at http://www.fcc.gov/Bureaus/Wireless/Orders/1999/. The complete text may be purchased from the Commission's duplicating contractor, International Transcription Service, Inc. (ITS, Inc.) at 1231 20th Street NW, Washington, DC 10036, (202) 857-3800.

1. Two petitions for reconsideration (“Petitions”), were filed with the Commission seeking reconsideration of the Amendment of Part 1 of the Commission's Rules to Facilitate Future Development of SMR Systems in the 800 MHz Frequency Band, Memorandum Opinion and Order on Reconsideration (First MO&O) , 62 FR 41225 (July 31, 1997). In that document the Commission reconsidered the rules governing the upper 200 channels of the 800 MHz Specialized Mobile Radio (SMR). No pleadings were filed in response to these petitions.

2. First, petitioners request reconsideration of the Commission's decision to modify its competitive bidding rules to eliminate installment payments and adopt larger bidding credits for entities qualifying as small businesses for the auction of the upper 200 channels of the 800 MHz SMR service. Second, one petitioner claims that the Commission acted in violation of its rules regarding delegation of authority and the Administrative Procedure Act (APA), by delegating the authority to set the level of upfront payments to the Wireless Telecommunications Bureau (“Bureau”). Third, one petitioner requests review of the Commission's decisions to license the upper 200 channels of the 800 MHz SMR spectrum in contiguous blocks, eliminate the finder's preference program, and use competitive bidding to license the upper 200 channels in the 800 MHz spectrum band. Finally, one petitioner requests clarification of the Commission's decision to require incumbents seeking geographic licenses to show that their external site facilities are constructed and operational.

3. On reconsideration, the Commission affirms its decision to eliminate installment payments. At the outset, the Commission notes that Congress did not require the use of installment payments in all auctions, but rather recognized them as one means of promoting the objectives of section 309(j)(3) of the Communications Act. However, Congress has not dictated that installment payments are the only tool in assisting small business. The Commission's experience with the installment payment program has led it to conclude that installment payments may not always serve the public interest. As noted in the First MO&O, the Commission has found that obligating licensees to pay for their licenses as a condition of receipt requires greater financial accountability from applicants. The Commission determined in its Amendment of Part 1 of the Commission's Rules to Facilitate Future Development of SMR Systems in the 800 MHz Frequency Band, Third Report and Order and Second Further Notice of Proposed Rule Making (Third R&O) , 63 FR 2315 (January 15, 1998), that installment payments should not be used in the immediate future as a means of financing small business participation in our auction program. Moreover, in recent legislation, Congress dictated that certain future auctions effectively be conducted without installment payments. The Balanced Budget Act of 1997 requires the Commission to conduct the competitive bidding required by that act in a manner that ensures that the proceeds of such bidding are deposited in the U.S. Treasury by September 30, 2002. After careful consideration, the Commission concludes that it has met its statutory obligations without offering installment payment plans for 800 MHz SMR licensees. The Commission notes further that in place of installment payments, it established larger bidding credits for the 800 MHz SMR auction to provide for qualifying small businesses.

4. The Commission disagrees with petitioner's contentions that installment payments are necessary to ensure a meaningful opportunity for small businesses to participate in the 800 MHz SMR auction. The rules were changed more than ten weeks before the filing deadline, providing an adequate opportunity for the parties to alter their business plans, if necessary. The Commission also notes that the elimination of installment payments and the timing of that auction did not prevent the participation of small businesses in the 800 MHz SMR auction, in which 52 of the 62 qualified bidders were eligible for small or very small business credits.

5. Second, the Commission rejects the claim that the Bureau's authority to set the level of upfront payments constitutes an illegal delegation of authority. Section 0.131 of the Commission's rules explicitly states that the Bureau has delegated authority to develop, recommend and administer policies, programs and rules concerning auctions of spectrum for wireless telecommunications. In the Amendment of Part 1 of the Commission's Rules to Facilitate Future Development of SMR Systems in the 800 MHz Frequency Band, Order and Memorandum Opinion & Order (Part 1 Order) , 62 FR 13540 (March 21, 1997), rulemaking, the Commission clarified that pursuant to § 0.131 of its rules, the Chief of the Wireless Telecommunications Bureau has delegated authority to implement all of the Commission's rules pertaining to auctions procedures. This includes the authority to choose competitive bidding designs and methodologies; conduct auctions; administer application, payment, licenses grant and denial procedures; and determine upfront and down payment amounts as well as minimum opening bids. These actions do not fall under the prohibited activities set forth in § 0.331 of the Commission's rules, which include acting upon complaints, petitions, requests, applications for review and notices of proposed rulemaking. The Commission concludes that the Bureau's actions are valid, as they affect procedural rather than substantive issues, and are, therefore, in compliance with our rules. Furthermore, the Bureau's actions were in compliance with the APA. Pursuant to 5 U.S.C. 553(b), an agency may modify procedural rules without notice and comment. Because the rule modifications were procedural in nature and did not affect the substantive rights of interested parties, the Bureau's actions fall within that exception.

6. Third, the Commission dismisses as repetitions the request that it reconsider its decisions to allocate licenses in the upper 200 channels of the 800 MHz SMR spectrum in contiguous blocks, eliminate the finder's preference program, and use competitive bidding as the licensing mechanism for the upper 200 channels in the 800 MHz band. The Commission disagrees with petitioner's contention that these decisions were unsupported by evidence and therefore, arbitrary and capricious. These conclusions were set forth first in the Amendment of Part 1 of the Commission's Rules to Facilitate Future Development of SMR Systems in the 800 MHz Frequency Band, First Report and Order, Eighth Report and Order and Second Further Notice of Proposed Rulemaking (First R&O ), 61 FR 6212 (February 16, 1996), and reaffirmed in the First MO&O . In each case, the Commission set forth reasoned explanations for its decision. It is not in the public interest to revisit these issues.

7. Finally, the Commission finds it unnecessary to address the request for clarification of the Commission's decision to require incumbents seeking geographic licenses to show that their facilities are constructed and operational. In the First R&O , the Commission stated that such licensees are required to make a one-time filing of specific information for each of their external base station sites to assist the staff in updating the Commission database after the close of the auction for the upper 200 channels of the 800 MHz SMR spectrum. Under that decision, the Commission also requires evidence that such facilities are constructed and placed in operation and that, by operation of its rules, no other licensees would be able to use these channels within a geographic area.

8. It is ordered that the Petitions are denied.

A proposed rule was published in the Federal Register on January 5, 2000 (65 FR 429-431). Comments were received from two respondents, an industry association and the NASA Office of Inspector General (OIG). All comments were considered in the development of this final rule. This final rule includes changes for clarification of meaning, consistency of wording (and phrasing), and to eliminate informational redundancies within the clause as it references information in other related documents.

This final rule requires NASA contractors and subcontractors to comply with the security requirements outlined in NASA Policy Directive (NPD) 2810.1, Security of Information Technology, and NASA Procedures and Guidelines (NPG) 2810.1, Security of Information Technology, and additional safeguarding requirements delineated in the contract clause. Currently, NASA contractors have no definitive contractual requirement to follow NASA directed policy in safeguarding unclassified NASA data held via information technology (computer systems). This final rule establishes these requirements in a contract clause. These policies apply to all IT systems and networks under NASA's purview operated by or on behalf of the Federal Government, regardless of location.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The changes merely formalize standard procedures in using Government computer systems and databases. Small entities will not need to significantly revise internal procedures to satisfy the NFS changes.

An Office of Management and Budget (OMB) approval for data collection has been approved under OMB Control No. 2700-0098.

Government procurement.

As prescribed in 1804.470-4, insert the following clause: